Difference between revisions of "Kaposi sarcoma"
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− | + | <span id="BackToTop"></span> | |
− | + | <div class="noprint" style="background-color:LightGray; position:fixed; bottom:2%; right:0.25%; padding-left:5px; padding-right:5px; margin: 15px; opacity:0.8; border-style: solid; border-color:DarkGray; border-width: 1px"> | |
− | + | [[#top|Back to Top]] | |
− | + | </div> | |
− | + | {{#lst:Editorial board transclusions|sarcoma}} | |
− | |||
− | |} | ||
''Are you looking for a regimen but can't find it here? For placebo or observational studies in this condition, please visit [[Kaposi sarcoma - null regimens|this page]]. If you still can't find it, please let us know so we can add it!'' | ''Are you looking for a regimen but can't find it here? For placebo or observational studies in this condition, please visit [[Kaposi sarcoma - null regimens|this page]]. If you still can't find it, please let us know so we can add it!'' | ||
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{| class="wikitable" style="float:right; margin-right: 5px;" | {| class="wikitable" style="float:right; margin-right: 5px;" | ||
|- | |- | ||
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{{TOC limit|limit=3}} | {{TOC limit|limit=3}} | ||
− | |||
=Guidelines= | =Guidelines= | ||
− | + | '''Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.''' | |
− | ==[https://www.nccn.org/ NCCN] | + | ==NCCN== |
− | + | *[https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1485 NCCN Guidelines - Kaposi Sarcoma] | |
− | *[https:// | + | **'''2019:''' Reid et al. [https://doi.org/10.6004/Jnccn.2019.0008 AIDS-Related Kaposi Sarcoma, Version 2.2019, NCCN Clinical Practice Guidelines in Oncology.] [https://pubmed.ncbi.nlm.nih.gov/30787130/ PubMed] |
=All lines of therapy= | =All lines of therapy= | ||
− | |||
==ABV (Vinblastine) {{#subobject:3b312f|Regimen=1}}== | ==ABV (Vinblastine) {{#subobject:3b312f|Regimen=1}}== | ||
− | |||
− | |||
− | |||
− | |||
ABV: '''<u>A</u>'''driamycin (Doxorubicin), '''<u>B</u>'''leomycin, '''<u>V</u>'''inblastine | ABV: '''<u>A</u>'''driamycin (Doxorubicin), '''<u>B</u>'''leomycin, '''<u>V</u>'''inblastine | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen {{#subobject:097d6d|Variant=1}}=== | ===Regimen {{#subobject:097d6d|Variant=1}}=== | ||
− | {| class="wikitable" style="width: | + | {| class="wikitable sortable" style="width: 60%; text-align:center;" |
− | ! style="width: | + | !style="width: 33%"|Study |
− | ! style="width: | + | !style="width: 33%"|Dates of enrollment |
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
|- | |- | ||
|[https://doi.org/10.1200/JCO.1984.2.10.1115 Laubenstein et al. 1984] | |[https://doi.org/10.1200/JCO.1984.2.10.1115 Laubenstein et al. 1984] | ||
+ | |1981-07 to 1983-06 | ||
| style="background-color:#91cf61" |Non-randomized | | style="background-color:#91cf61" |Non-randomized | ||
|- | |- | ||
|} | |} | ||
+ | ''Note: cycle length is not explicitly described in the reference.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | + | *[[Doxorubicin (Adriamycin)]] 40 mg/m<sup>2</sup> IV once on day 1 | |
− | *[[Doxorubicin (Adriamycin)]] | + | *[[Bleomycin (Blenoxane)]] 15 units IV once per day on days 1 & 15 |
− | *[[Bleomycin (Blenoxane)]] | + | *[[Vinblastine (Velban)]] 6 mg/m<sup>2</sup> IV once on day 1 |
− | *[[Vinblastine (Velban)]] | + | '''28-day cycles''' |
− | + | </div></div> | |
===References=== | ===References=== | ||
− | + | #Laubenstein LJ, Krigel RL, Odajnyk CM, Hymes KB, Friedman-Kien A, Wernz JC, Muggia FM. Treatment of epidemic Kaposi's sarcoma with etoposide or a combination of doxorubicin, bleomycin, and vinblastine. J Clin Oncol. 1984 Oct;2(10):1115-20. [https://doi.org/10.1200/JCO.1984.2.10.1115 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/6208343/ PubMed] | |
− | #Laubenstein LJ, Krigel RL, Odajnyk CM, Hymes KB, Friedman-Kien A, Wernz JC, Muggia FM. Treatment of epidemic Kaposi's sarcoma with etoposide or a combination of doxorubicin, bleomycin, and vinblastine. J Clin Oncol. 1984 Oct;2(10):1115-20. [https://doi.org/10.1200/JCO.1984.2.10.1115 link to original article] [https://pubmed.ncbi.nlm.nih.gov/6208343 PubMed] | ||
==ABV (Vincristine) {{#subobject:4531b5|Regimen=1}}== | ==ABV (Vincristine) {{#subobject:4531b5|Regimen=1}}== | ||
− | |||
− | |||
− | |||
− | |||
ABV: '''<u>A</u>'''driamycin (Doxorubicin), '''<u>B</u>'''leomycin, '''<u>V</u>'''incristine | ABV: '''<u>A</u>'''driamycin (Doxorubicin), '''<u>B</u>'''leomycin, '''<u>V</u>'''incristine | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen variant #1, 10/15/1 {{#subobject:b47ecf|Variant=1}}=== | ===Regimen variant #1, 10/15/1 {{#subobject:b47ecf|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
Line 64: | Line 56: | ||
|[https://doi.org/10.1200/jco.1996.14.8.2353 Gill et al. 1996] | |[https://doi.org/10.1200/jco.1996.14.8.2353 Gill et al. 1996] | ||
|1992-1994 | |1992-1994 | ||
− | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
|[[#Daunorubicin_liposomal_monotherapy|Liposomal daunorubicin]] | |[[#Daunorubicin_liposomal_monotherapy|Liposomal daunorubicin]] | ||
| style="background-color:#ffffbf" |Did not meet primary endpoint of ORR | | style="background-color:#ffffbf" |Did not meet primary endpoint of ORR | ||
|- | |- | ||
|} | |} | ||
− | + | ''Note: Gill et al. 1996 described doses but did not clearly say in the paper when these drugs were given, but this schedule is assumed based on the Northfelt et al. 1998 ABV regimen. To our knowledge, this regimen was not tested as an experimental arm in an RCT prior to becoming a standard comparator arm.'' | |
− | ''Gill et al. 1996 described doses but did not clearly say in the paper when these drugs were given, but this schedule is assumed based on the Northfelt et al. 1998 ABV regimen. To our knowledge, this regimen was not tested as an experimental arm in an RCT prior to becoming a standard comparator arm.'' | + | <div class="toccolours" style="background-color:#b3e2cd"> |
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Doxorubicin (Adriamycin)]] 10 mg/m<sup>2</sup> IV once on day 1 | *[[Doxorubicin (Adriamycin)]] 10 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Bleomycin (Blenoxane)]] 15 units IV once on day 1 | *[[Bleomycin (Blenoxane)]] 15 units IV once on day 1 | ||
*[[Vincristine (Oncovin)]] 1 mg IV once on day 1 | *[[Vincristine (Oncovin)]] 1 mg IV once on day 1 | ||
− | + | ====Supportive therapy==== | |
− | ====Supportive | ||
− | |||
*"No routine premedication was established by the protocol, but it could be provided at the discretion of the investigator" | *"No routine premedication was established by the protocol, but it could be provided at the discretion of the investigator" | ||
− | |||
'''14-day cycle for at least 2 cycles until complete remission''' | '''14-day cycle for at least 2 cycles until complete remission''' | ||
− | + | </div></div><br> | |
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen variant #2, 20/10/1 {{#subobject:d923d9|Variant=1}}=== | ===Regimen variant #2, 20/10/1 {{#subobject:d923d9|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
Line 92: | Line 81: | ||
|- | |- | ||
|[https://doi.org/10.1200/jco.1998.16.7.2445 Northfelt et al. 1998] | |[https://doi.org/10.1200/jco.1998.16.7.2445 Northfelt et al. 1998] | ||
− | |1993-1994 | + | |1993-04 to 1994-12 |
− | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
− | |[[# | + | |[[#Pegylated_liposomal_doxorubicin_monotherapy|PLD]] |
| style="background-color:#d73027" |Inferior ORR | | style="background-color:#d73027" |Inferior ORR | ||
|- | |- | ||
|} | |} | ||
− | ''Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT prior to becoming a standard comparator arm.'' | + | ''Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT in this context, prior to becoming a standard comparator arm.'' |
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Doxorubicin (Adriamycin)]] 20 mg/m<sup>2</sup> IV once on day 1 | *[[Doxorubicin (Adriamycin)]] 20 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Bleomycin (Blenoxane)]] 10 mg/m<sup>2</sup> IV once on day 1 | *[[Bleomycin (Blenoxane)]] 10 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Vincristine (Oncovin)]] 1 mg IV once on day 1 | *[[Vincristine (Oncovin)]] 1 mg IV once on day 1 | ||
− | + | ====Supportive therapy==== | |
− | ====Supportive | ||
− | |||
*"Colony-stimulating factors (CSFs) were prescribed at the discretion of the investigators." | *"Colony-stimulating factors (CSFs) were prescribed at the discretion of the investigators." | ||
− | |||
'''14-day cycle for up to 6 cycles''' | '''14-day cycle for up to 6 cycles''' | ||
− | + | </div></div> | |
+ | ===References=== | ||
+ | #Gill PS, Wernz J, Scadden DT, Cohen P, Mukwaya GM, von Roenn JH, Jacobs M, Kempin S, Silverberg I, Gonzales G, Rarick MU, Myers AM, Shepherd F, Sawka C, Pike MC, Ross ME. Randomized phase III trial of liposomal daunorubicin versus doxorubicin, bleomycin, and vincristine in AIDS-related Kaposi's sarcoma. J Clin Oncol. 1996 Aug;14(8):2353-64. [https://doi.org/10.1200/jco.1996.14.8.2353 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/8708728/ PubMed] [https://clinicaltrials.gov/study/NCT00002093 NCT00002093] | ||
+ | #Northfelt DW, Dezube BJ, Thommes JA, Miller BJ, Fischl MA, Friedman-Kien A, Kaplan LD, Du Mond C, Mamelok RD, Henry DH. Pegylated-liposomal doxorubicin versus doxorubicin, bleomycin, and vincristine in the treatment of AIDS-related Kaposi's sarcoma: results of a randomized phase III clinical trial. J Clin Oncol. 1998 Jul;16(7):2445-51. [https://doi.org/10.1200/jco.1998.16.7.2445 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/9667262/ PubMed] | ||
+ | ==Alitretinoin monotherapy {{#subobject:abb1b5|Regimen=1}}== | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen {{#subobject:bhg8gf|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
+ | !style="width: 20%"|Study | ||
+ | !style="width: 20%"|Dates of enrollment | ||
+ | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | !style="width: 20%"|Comparator | ||
+ | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
+ | |- | ||
+ | |[https://doi.org/10.1097/00126334-199911010-00004 Walmsley et al. 1999] | ||
+ | |1996-04 to 1997-07 | ||
+ | | style="background-color:#1a9851" |Phase 3 (E-RT-esc) | ||
+ | |[[Kaposi_sarcoma_-_null_regimens#Placebo|Placebo]] | ||
+ | | style="background-color:#1a9850" |Superior ORR | ||
+ | |- | ||
+ | |[https://doi.org/10.2165/00128071-200102020-00004 Bodsworth et al. 2001] | ||
+ | |Not reported | ||
+ | | style="background-color:#1a9851" |Phase 3 (E-RT-esc) | ||
+ | |[[Kaposi_sarcoma_-_null_regimens#Placebo|Placebo]] | ||
+ | | style="background-color:#1a9850" |Superior ORR | ||
+ | |- | ||
+ | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Topical therapy==== | ||
+ | *[[Alitretinoin (Panretin)]] 0.1% gel | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
− | + | #Walmsley S, Northfelt DW, Melosky B, Conant M, Friedman-Kien AE, Wagner B; Panretin Gel North American Study Group. Treatment of AIDS-related cutaneous Kaposi's sarcoma with topical alitretinoin (9-cis-retinoic acid) gel. J Acquir Immune Defic Syndr. 1999 Nov 1;22(3):235-46. [https://doi.org/10.1097/00126334-199911010-00004 link to original article] [https://pubmed.ncbi.nlm.nih.gov/10770343/ PubMed] | |
− | # | + | #Bodsworth NJ, Bloch M, Bower M, Donnell D, Yocum R; International Panretin Gel KS Study Group. Phase III vehicle-controlled, multi-centered study of topical alitretinoin gel in cutaneous AIDS-related Kaposi's sarcoma. Am J Clin Dermatol. 2001;2(2):77-87. [https://doi.org/10.2165/00128071-200102020-00004 link to original article] [https://pubmed.ncbi.nlm.nih.gov/11705307/ PubMed] |
− | # | ||
==Bevacizumab monotherapy {{#subobject:25316e|Regimen=1}}== | ==Bevacizumab monotherapy {{#subobject:25316e|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | |||
− | |||
− | |||
===Regimen {{#subobject:48507a|Variant=1}}=== | ===Regimen {{#subobject:48507a|Variant=1}}=== | ||
− | {| class="wikitable" style="width: | + | {| class="wikitable sortable" style="width: 60%; text-align:center;" |
− | ! style="width: | + | !style="width: 33%"|Study |
− | ! style="width: | + | !style="width: 33%"|Dates of enrollment |
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
|- | |- | ||
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3383119/ Uldrick et al. 2012 (03-C-0110)] | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3383119/ Uldrick et al. 2012 (03-C-0110)] | ||
− | | style="background-color:#91cf61" |Phase | + | |2003-02 to 2008-12 |
+ | | style="background-color:#91cf61" |Phase 2 | ||
|- | |- | ||
|} | |} | ||
+ | ''Note: the first "cycle" is one week in duration and is considered a loading dose.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
− | + | *[[Bevacizumab (Avastin)]] 15 mg/kg IV once on day 1 | |
− | *[[Bevacizumab (Avastin)]] | + | ====Supportive therapy==== |
− | |||
− | |||
− | |||
− | ====Supportive | ||
− | |||
*"Antihypertensive therapy was initiated for systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 95 mmHg persisting for more than 1 week or for systolic blood pressure greater than 210 mmHg or diastolic blood pressure greater than 120 mmHg at any time." | *"Antihypertensive therapy was initiated for systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 95 mmHg persisting for more than 1 week or for systolic blood pressure greater than 210 mmHg or diastolic blood pressure greater than 120 mmHg at any time." | ||
*"HIV-positive patients with CD4 count of less than 200 cells/µL received Pneumocystis jiroveci prophylaxis." | *"HIV-positive patients with CD4 count of less than 200 cells/µL received Pneumocystis jiroveci prophylaxis." | ||
Line 143: | Line 154: | ||
*Patients with HIV/AIDS continued HAART | *Patients with HIV/AIDS continued HAART | ||
*[[Filgrastim (Neupogen)]] "used as clinically indicated" | *[[Filgrastim (Neupogen)]] "used as clinically indicated" | ||
+ | '''7-day cycle for 1 cycle, then 21-day cycles''' | ||
+ | </div></div> | ||
+ | ===References=== | ||
+ | #'''03-C-0110:''' Uldrick TS, Wyvill KM, Kumar P, O'Mahony D, Bernstein W, Aleman K, Polizzotto MN, Steinberg SM, Pittaluga S, Marshall V, Whitby D, Little RF, Yarchoan R. Phase II study of bevacizumab in patients with HIV-associated Kaposi's sarcoma receiving antiretroviral therapy. J Clin Oncol. 2012 May 1;30(13):1476-83. Epub 2012 Mar 19. [https://doi.org/10.1200/jco.2011.39.6853 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3383119/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/22430271/ PubMed] [https://clinicaltrials.gov/study/NCT00055237 NCT00055237] | ||
− | '''21-day cycles''' | + | ==Bleomycin & Vincristine (BO) {{#subobject:a8bvc2|Regimen=1}}== |
− | + | BV: '''<u>B</u>'''leomycin & '''<u>V</u>'''incristine | |
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen {{#subobject:6adcbc|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
+ | !style="width: 20%"|Study | ||
+ | !style="width: 20%"|Dates of enrollment | ||
+ | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | !style="width: 20%"|Comparator | ||
+ | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
+ | |- | ||
+ | |[https://doi.org/10.1200/JCO.1998.16.2.683 Stewart et al. 1998] | ||
+ | |1993-1995 | ||
+ | | style="background-color:#1a9851" |Phase 3 (C) | ||
+ | |[[#Pegylated_liposomal_doxorubicin_monotherapy|PLD]] | ||
+ | | style="background-color:#d73027" |Inferior ORR | ||
+ | |- | ||
+ | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
+ | *[[Bleomycin (Blenoxane)]] 15 IU/m<sup>2</sup> IV over 30 minutes once on day 1, '''given second''' | ||
+ | *[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV bolus once on day 1, '''given first''' | ||
+ | '''21-day cycle for 6 cycles''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
− | + | #Stewart S, Jablonowski H, Goebel FD, Arasteh K, Spittle M, Rios A, Aboulafia D, Galleshaw J, Dezube BJ; International Pegylated Liposomal Doxorubicin Study Group. Randomized comparative trial of pegylated liposomal doxorubicin versus bleomycin and vincristine in the treatment of AIDS-related Kaposi's sarcoma. J Clin Oncol. 1998 Feb;16(2):683-91. [https://doi.org/10.1200/JCO.1998.16.2.683 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/9469358/ PubMed] | |
− | # | ||
==Daunorubicin liposomal monotherapy {{#subobject:92db30|Regimen=1}}== | ==Daunorubicin liposomal monotherapy {{#subobject:92db30|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | |||
− | |||
− | |||
===Regimen {{#subobject:95ce2a|Variant=1}}=== | ===Regimen {{#subobject:95ce2a|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
− | |[https:// | + | |[https://doi.org/10.1016/0140-6736(93)91147-E Presant et al. 1993] |
− | | | + | |Not reported |
− | | style="background-color:#91cf61" |Phase | + | | style="background-color:#91cf61" |Phase 2 |
| style="background-color:#d3d3d3" | | | style="background-color:#d3d3d3" | | ||
| style="background-color:#d3d3d3" | | | style="background-color:#d3d3d3" | | ||
Line 171: | Line 204: | ||
|[https://doi.org/10.1200/jco.1996.14.8.2353 Gill et al. 1996] | |[https://doi.org/10.1200/jco.1996.14.8.2353 Gill et al. 1996] | ||
|1992-1994 | |1992-1994 | ||
− | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (E-RT-de-esc) |
|[[#ABV_.28Vincristine.29|ABV]] | |[[#ABV_.28Vincristine.29|ABV]] | ||
| style="background-color:#ffffbf" |Did not meet primary endpoint of ORR | | style="background-color:#ffffbf" |Did not meet primary endpoint of ORR | ||
|- | |- | ||
|} | |} | ||
− | ''Note: Gill et al. 1996 stopped treatment if CR was achieved.'' | + | ''Note: To our knowledge, this drug has been discontinued. Gill et al. 1996 stopped treatment if CR was achieved.'' |
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Daunorubicin liposomal (DaunoXome)]] 40 mg/m<sup>2</sup> IV over 30 to 60 minutes once on day 1 | *[[Daunorubicin liposomal (DaunoXome)]] 40 mg/m<sup>2</sup> IV over 30 to 60 minutes once on day 1 | ||
− | + | ====Supportive therapy==== | |
− | ====Supportive | ||
− | |||
*"No routine premedication was established by the protocol, but it could be provided at the discretion of the investigator" | *"No routine premedication was established by the protocol, but it could be provided at the discretion of the investigator" | ||
− | |||
'''14-day cycles''' | '''14-day cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
− | + | #Presant CA, Scolaro M, Kennedy P, Blayney DW, Flanagan B, Lisak J, Presant J. Liposomal daunorubicin treatment of HIV-associated Kaposi's sarcoma. Lancet. 1993 May 15;341(8855):1242-3. [https://doi.org/10.1016/0140-6736(93)91147-E link to original article] [https://pubmed.ncbi.nlm.nih.gov/8098393/ PubMed] | |
− | #Presant CA, Scolaro M, Kennedy P, Blayney DW, Flanagan B, Lisak J, Presant J. Liposomal daunorubicin treatment of HIV-associated Kaposi's sarcoma. Lancet. 1993 May 15;341(8855):1242-3. [https:// | + | #Gill PS, Wernz J, Scadden DT, Cohen P, Mukwaya GM, von Roenn JH, Jacobs M, Kempin S, Silverberg I, Gonzales G, Rarick MU, Myers AM, Shepherd F, Sawka C, Pike MC, Ross ME. Randomized phase III trial of liposomal daunorubicin versus doxorubicin, bleomycin, and vincristine in AIDS-related Kaposi's sarcoma. J Clin Oncol. 1996 Aug;14(8):2353-64. [https://doi.org/10.1200/jco.1996.14.8.2353 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/8708728/ PubMed] [https://clinicaltrials.gov/study/NCT00002093 NCT00002093] |
− | #Gill PS, Wernz J, Scadden DT, Cohen P, Mukwaya GM, von Roenn JH, Jacobs M, Kempin S, Silverberg I, Gonzales G, Rarick MU, Myers AM, Shepherd F, Sawka C, Pike MC, Ross ME. Randomized phase III trial of liposomal daunorubicin versus doxorubicin, bleomycin, and vincristine in AIDS-related Kaposi's sarcoma. J Clin Oncol. 1996 Aug;14(8):2353-64. [https://doi.org/10.1200/jco.1996.14.8.2353 link to original article] ''' | ||
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==Etoposide monotherapy {{#subobject:9b5ac9|Regimen=1}}== | ==Etoposide monotherapy {{#subobject:9b5ac9|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | |||
− | |||
− | |||
===Regimen variant #1, 8 cycles {{#subobject:a25060|Variant=1}}=== | ===Regimen variant #1, 8 cycles {{#subobject:a25060|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
− | |[https:// | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6030807/ Hosseinipour et al. 2018 (REACT-KS)] |
|2011-2016 | |2011-2016 | ||
− | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
|[[#Etoposide_monotherapy|Etoposide]]; as-needed | |[[#Etoposide_monotherapy|Etoposide]]; as-needed | ||
| style="background-color:#ffffbf" |Did not meet primary efficacy endpoints | | style="background-color:#ffffbf" |Did not meet primary efficacy endpoints | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Etoposide (Vepesid)]] 50 mg PO once per day on days 1 to 7 | *[[Etoposide (Vepesid)]] 50 mg PO once per day on days 1 to 7 | ||
− | |||
'''14-day cycle for up to 8 cycles''' | '''14-day cycle for up to 8 cycles''' | ||
− | + | </div></div><br> | |
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen variant #2, indefinite {{#subobject:abc832|Variant=1}}=== | ===Regimen variant #2, indefinite {{#subobject:abc832|Variant=1}}=== | ||
− | {| class="wikitable" style="width: | + | {| class="wikitable sortable" style="width: 60%; text-align:center;" |
− | ! style="width: | + | !style="width: 33%"|Study |
− | ! style="width: | + | !style="width: 33%"|Dates of enrollment |
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
|- | |- | ||
|[https://doi.org/10.1200/jco.2002.12.038 Evans et al. 2002] | |[https://doi.org/10.1200/jco.2002.12.038 Evans et al. 2002] | ||
− | | style="background-color:#91cf61" |Phase | + | |1995-01 to 1998-03 |
+ | | style="background-color:#91cf61" |Phase 2 | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Etoposide (Vepesid)]] 50 mg PO once per day on days 1 to 7 | *[[Etoposide (Vepesid)]] 50 mg PO once per day on days 1 to 7 | ||
+ | '''14-day cycles''' | ||
+ | </div></div> | ||
− | |||
===References=== | ===References=== | ||
− | + | #Evans SR, Krown SE, Testa MA, Cooley TP, Von Roenn JH; AIDS Clinical Trials Group. Phase II evaluation of low-dose oral etoposide for the treatment of relapsed or progressive AIDS-related Kaposi's sarcoma: an AIDS Clinical Trials Group clinical study. J Clin Oncol. 2002 Aug 1;20(15):3236-41. [https://doi.org/10.1200/jco.2002.12.038 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/12149296/ PubMed] | |
− | #Evans SR, Krown SE, Testa MA, Cooley TP, Von Roenn JH; AIDS Clinical Trials Group. Phase II evaluation of low-dose oral etoposide for the treatment of relapsed or progressive AIDS-related Kaposi's sarcoma: an AIDS Clinical Trials Group clinical study. J Clin Oncol. 2002 Aug 1;20(15):3236-41. [https://doi.org/10.1200/jco.2002.12.038 link to original article] ''' | + | #'''REACT-KS:''' Hosseinipour MC, Kang M, Krown SE, Bukuru A, Umbleja T, Martin JN, Orem J, Godfrey C, Hoagland B, Mwelase N, Langat D, Nyirenda M, MacRae J, Borok M, Samaneka W, Moses A, Mngqbisa R, Busakhala N, Martínez-Maza O, Ambinder R, Dittmer DP, Nokta M, Campbell TB; A5264/AMC-067 REACT-KS Team. As-needed vs immediate etoposide chemotherapy in combination with antiretroviral therapy for mild-to-moderate AIDS-associated Kaposi sarcoma in resource-limited settings: A5264/AMC-067 randomized clinical trial. Clin Infect Dis. 2018 Jul 2;67(2):251-260. [https://doi.org/10.1093/cid/ciy044 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6030807/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/29365083/ PubMed] [https://clinicaltrials.gov/study/NCT01352117 NCT01352117] |
− | #'''REACT-KS:''' Hosseinipour MC, Kang M, Krown SE, Bukuru A, Umbleja T, Martin JN, Orem J, Godfrey C, Hoagland B, Mwelase N, Langat D, Nyirenda M, MacRae J, Borok M, Samaneka W, Moses A, Mngqbisa R, Busakhala N, Martínez-Maza O, Ambinder R, Dittmer DP, Nokta M, Campbell TB; A5264/AMC-067 REACT-KS Team. As-needed vs immediate etoposide chemotherapy in combination with antiretroviral therapy for mild-to-moderate AIDS-associated Kaposi sarcoma in resource-limited settings: A5264/AMC-067 randomized clinical trial. Clin Infect Dis. 2018 Jul 2;67(2):251-260. [https:// | ||
− | |||
==Interferon alfa-2a monotherapy {{#subobject:abca9e|Regimen=1}}== | ==Interferon alfa-2a monotherapy {{#subobject:abca9e|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | |||
− | |||
− | |||
===Regimen {{#subobject:bdacd4|Variant=1}}=== | ===Regimen {{#subobject:bdacd4|Variant=1}}=== | ||
− | {| class="wikitable" style="width: | + | {| class="wikitable sortable" style="width: 60%; text-align:center;" |
− | ! style="width: | + | !style="width: 33%"|Study |
− | ! style="width: | + | !style="width: 33%"|Dates of enrollment |
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
|- | |- | ||
− | |[https:// | + | |[https://doi.org/10.1016/S0140-6736(88)90810-0 de Wit et al. 1988] |
− | | style="background-color:#91cf61" |Phase | + | |1987-02 to 1988-03 |
+ | | style="background-color:#91cf61" |Phase 2 | ||
|- | |- | ||
|} | |} | ||
+ | ''Note: Please see paper for details of treatment beyond 8 weeks.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Immunotherapy==== | ====Immunotherapy==== | ||
− | + | *[[Interferon alfa-2a (Roferon-A)]] as follows: | |
− | *[[Interferon alfa-2a (Roferon-A)]] | + | **Less than 60 kg: 3,000,000 units SC once on day 1, then 9,000,000 units SC on day 2, then 18,000,000 units SC on day 3, then 27,000,000 units SC once per day on days 5 to 56 |
− | + | **60 kg or more: 3,000,000 units SC once on day 1, then 9,000,000 units SC on day 2, then 18,000,000 units SC on day 3, then 36,000,000 units SC once per day on days 5 to 56 | |
+ | '''8-week course''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
− | + | #de Wit R, Schattenkerk JK, Boucher CA, Bakker PJ, Veenhof KH, Danner SA. Clinical and virological effects of high-dose recombinant interferon-alpha in disseminated AIDS-related Kaposi's sarcoma. Lancet. 1988 Nov 26;2(8622):1214-7. [https://doi.org/10.1016/S0140-6736(88)90810-0 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/2903953/ PubMed] | |
− | #de Wit R, Schattenkerk JK, Boucher CA, Bakker PJ, Veenhof KH, Danner SA. Clinical and virological effects of high-dose recombinant interferon-alpha in disseminated AIDS-related Kaposi's sarcoma. Lancet. 1988 Nov 26;2(8622):1214-7. [https:// | ||
==Interferon alfa-2b monotherapy {{#subobject:8uga9e|Regimen=1}}== | ==Interferon alfa-2b monotherapy {{#subobject:8uga9e|Regimen=1}}== | ||
− | {| class="wikitable" style=" | + | <div class="toccolours" style="background-color:#eeeeee"> |
+ | ===Regimen variant #1 {{#subobject:ygagd4|Variant=1}}=== | ||
+ | {| class="wikitable" style="width: 60%; text-align:center;" | ||
+ | !style="width: 33%"|Study | ||
+ | !style="width: 33%"|Dates of enrollment | ||
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | |- | ||
+ | |[https://doi.org/10.1002/1097-0142(19870201)59:3%2B%3C620::AID-CNCR2820591309%3E3.0.CO;2-5 Volberding et al. 1987] | ||
+ | |1981-1984 | ||
+ | | style="background-color:#91cf61" |Phase 2 (RT) | ||
+ | |- | ||
+ | |[https://doi.org/10.1016/s0140-6736(88)90811-2 Lane et al. 1988] | ||
+ | |Not reported | ||
+ | | style="background-color:#91cf61" |Non-randomized (RT) | ||
|- | |- | ||
− | |||
|} | |} | ||
− | ===Regimen {{#subobject: | + | <div class="toccolours" style="background-color:#b3e2cd"> |
+ | ====Immunotherapy==== | ||
+ | *[[Interferon alfa-2b (Intron-A)]] 50,000,000 units/m<sup>2</sup> IV once per day on days 1 to 5 | ||
+ | '''14-day cycles''' | ||
+ | </div></div><br> | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen variant #2 {{#subobject:yga2tz|Variant=1}}=== | ||
{| class="wikitable" style="width: 60%; text-align:center;" | {| class="wikitable" style="width: 60%; text-align:center;" | ||
!style="width: 33%"|Study | !style="width: 33%"|Study | ||
− | !style="width: 33%"| | + | !style="width: 33%"|Dates of enrollment |
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
|- | |- | ||
− | |[https:// | + | |[https://doi.org/10.1002/1097-0142(19870201)59:3%2B%3C620::AID-CNCR2820591309%3E3.0.CO;2-5 Volberding et al. 1987] |
|1981-1984 | |1981-1984 | ||
− | | style="background-color:#91cf61" |Phase | + | | style="background-color:#91cf61" |Phase 2 (RT) |
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Immunotherapy==== | ====Immunotherapy==== | ||
− | + | *[[Interferon alfa-2b (Intron-A)]] 30,000,000 units/m<sup>2</sup> SC once per day on days 1, 3, 5 | |
− | *[[Interferon alfa-2b (Intron-A)]] | + | '''7-day cycles''' |
− | + | </div></div> | |
===References=== | ===References=== | ||
− | + | #Volberding PA, Mitsuyasu RT, Golando JP, Spiegel RJ. Treatment of Kaposi's sarcoma with interferon alfa-2b (Intron A). Cancer. 1987 Feb 1;59(3 Suppl):620-5. [https://doi.org/10.1002/1097-0142(19870201)59:3%2B%3C620::AID-CNCR2820591309%3E3.0.CO;2-5 link to original article] '''dosing details in abstract have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/3492260/ PubMed] | |
− | #Volberding PA, Mitsuyasu RT, Golando JP, Spiegel RJ. Treatment of Kaposi's sarcoma with interferon alfa-2b (Intron A). Cancer. 1987 Feb 1;59(3 Suppl):620-5. [https:// | + | #Lane HC, Kovacs JA, Feinberg J, Herpin B, Davey V, Walker R, Deyton L, Metcalf JA, Baseler M, Salzman N, Quinnan G, Fauci AS. Anti-retroviral effects of interferon-alpha in AIDS-associated Kaposi's sarcoma. Lancet. 1988 Nov 26;2(8622):1218-22. [https://doi.org/10.1016/s0140-6736(88)90811-2 link to original article] [https://pubmed.ncbi.nlm.nih.gov/2903954/ PubMed] |
− | #Lane HC, Kovacs JA, Feinberg J, Herpin B, Davey V, Walker R, Deyton L, Metcalf JA, Baseler M, Salzman N, Quinnan G, Fauci AS. Anti-retroviral effects of interferon-alpha in AIDS-associated Kaposi's sarcoma. Lancet. 1988 Nov 26;2(8622):1218-22. [https:// | ||
==Paclitaxel monotherapy {{#subobject:df8a9e|Regimen=1}}== | ==Paclitaxel monotherapy {{#subobject:df8a9e|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | |||
− | |||
− | |||
===Regimen variant #1, 100 mg/m<sup>2</sup> {{#subobject:918huh|Variant=1}}=== | ===Regimen variant #1, 100 mg/m<sup>2</sup> {{#subobject:918huh|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
Line 363: | Line 342: | ||
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7236082/ Krown et al. 2020 (AMC 066)] | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7236082/ Krown et al. 2020 (AMC 066)] | ||
|2013-2018 | |2013-2018 | ||
− | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
− | |1. Bleomycin & Vincristine (BO)<br> 2. [[#Etoposide_monotherapy|Etoposide]] | + | |1. [[#Bleomycin_.26_Vincristine_.28BO.29_999|Bleomycin & Vincristine (BO)]]<br>2. [[#Etoposide_monotherapy|Etoposide]] |
| style="background-color:#ffffbf" |Inconclusive whether non-inferior PFS | | style="background-color:#ffffbf" |Inconclusive whether non-inferior PFS | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Paclitaxel (Taxol)]] 100 mg/m<sup>2</sup> IV over 60 minutes once on day 1 | *[[Paclitaxel (Taxol)]] 100 mg/m<sup>2</sup> IV over 60 minutes once on day 1 | ||
− | |||
'''21-day cycle for 6 cycles''' | '''21-day cycle for 6 cycles''' | ||
− | + | </div></div><br> | |
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen variant #2, 135 mg/m<sup>2</sup> {{#subobject:bd95c4|Variant=1}}=== | ===Regimen variant #2, 135 mg/m<sup>2</sup> {{#subobject:bd95c4|Variant=1}}=== | ||
{| class="wikitable" style="width: 60%; text-align:center;" | {| class="wikitable" style="width: 60%; text-align:center;" | ||
!style="width: 33%"|Study | !style="width: 33%"|Study | ||
− | !style="width: 33%"| | + | !style="width: 33%"|Dates of enrollment |
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
|- | |- | ||
− | |[https:// | + | |[https://doi.org/10.1016/S0140-6736(95)92654-2 Saville et al. 1995 (CA139-174)] |
− | |1993 | + | |1993 to not reported |
− | | style="background-color:#91cf61" |Phase | + | | style="background-color:#91cf61" |Phase 2 (RT) |
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Paclitaxel (Taxol)]] 135 mg/m<sup>2</sup> IV over 3 hours once on day 1 | *[[Paclitaxel (Taxol)]] 135 mg/m<sup>2</sup> IV over 3 hours once on day 1 | ||
− | |||
'''21-day cycles''' | '''21-day cycles''' | ||
− | + | </div></div> | |
+ | ===References=== | ||
+ | #'''CA139-174:''' Saville MW, Lietzau J, Pluda JM, Feuerstein I, Odom J, Wilson WH, Humphrey RW, Feigal E, Steinberg SM, Broder S, Yarchoan R. Treatment of HIV-associated Kaposi's sarcoma with paclitaxel. Lancet. 1995 Jul 1;346(8966):26-8. [https://doi.org/10.1016/S0140-6736(95)92654-2 link to original article] '''dosing details in abstract have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/7603142/ PubMed] | ||
+ | #'''AMC 066:''' Krown SE, Moser CB, MacPhail P, Matining RM, Godfrey C, Caruso SR, Hosseinipour MC, Samaneka W, Nyirenda M, Busakhala NW, Okuku FM, Kosgei J, Hoagland B, Mwelase N, Oliver VO, Burger H, Mngqibisa R, Nokta M, Campbell TB, Borok MZ; A5263/AMC066 protocol team. Treatment of advanced AIDS-associated Kaposi sarcoma in resource-limited settings: a three-arm, open-label, randomised, non-inferiority trial. Lancet. 2020 Apr 11;395(10231):1195-1207. Epub 2020 Mar 5. [https://doi.org/10.1016/s0140-6736(19)33222-2 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7236082/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/32145827/ PubMed] [https://clinicaltrials.gov/study/NCT01435018 NCT01435018] | ||
+ | ==Pegylated liposomal doxorubicin monotherapy {{#subobject:a880c2|Regimen=1}}== | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen variant #1, q2wk {{#subobject:6a33ec|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
+ | !style="width: 20%"|Study | ||
+ | !style="width: 20%"|Dates of enrollment | ||
+ | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | !style="width: 20%"|Comparator | ||
+ | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
+ | |- | ||
+ | |[https://doi.org/10.1200/jco.1998.16.7.2445 Northfelt et al. 1998] | ||
+ | |1993-04 to 1994-12 | ||
+ | | style="background-color:#1a9851" |Phase 3 (E-de-esc) | ||
+ | |[[#ABV_.28Vincristine.29|ABV]] | ||
+ | | style="background-color:#1a9850" |Superior ORR | ||
+ | |- | ||
+ | |[https://doi.org/10.1200/JCO.1998.16.2.683 Stewart et al. 1998] | ||
+ | |1993-1995 | ||
+ | | style="background-color:#1a9851" |Phase 3 (E-switch-ic) | ||
+ | |[[#Bleomycin_.26_Vincristine_.28BO.29|Bleomycin & Vincristine (BO)]] | ||
+ | | style="background-color:#1a9850" |Superior ORR | ||
+ | |- | ||
+ | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
+ | *[[Pegylated liposomal doxorubicin (Doxil)]] 20 mg/m<sup>2</sup> IV over 30 minutes once on day 1 | ||
+ | ====Supportive therapy==== | ||
+ | *"Colony-stimulating factors (CSFs) were prescribed at the discretion of the investigators." | ||
+ | '''14- to 21-day cycle for up to 6 cycles''' | ||
+ | </div></div><br> | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen variant #2, q3wk {{#subobject:6a33ha|Variant=1}}=== | ||
+ | {| class="wikitable" style="width: 60%; text-align:center;" | ||
+ | !style="width: 33%"|Study | ||
+ | !style="width: 33%"|Dates of enrollment | ||
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | |- | ||
+ | |[https://doi.org/10.1200/JCO.1995.13.4.914 Harrison et al. 1995] | ||
+ | |1991-1993 | ||
+ | | style="background-color:#91cf61" |Phase 2 (RT) | ||
+ | |- | ||
+ | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
+ | *[[Pegylated liposomal doxorubicin (Doxil)]] 20 mg/m<sup>2</sup> IV once on day 1 | ||
+ | '''21-day cycles''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
− | + | #Harrison M, Tomlinson D, Stewart S. Liposomal-entrapped doxorubicin: an active agent in AIDS-related Kaposi's sarcoma. J Clin Oncol. 1995 Apr;13(4):914-20. [https://doi.org/10.1200/JCO.1995.13.4.914 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/7707119/ PubMed] | |
− | # | + | #Stewart S, Jablonowski H, Goebel FD, Arasteh K, Spittle M, Rios A, Aboulafia D, Galleshaw J, Dezube BJ; International Pegylated Liposomal Doxorubicin Study Group. Randomized comparative trial of pegylated liposomal doxorubicin versus bleomycin and vincristine in the treatment of AIDS-related Kaposi's sarcoma. J Clin Oncol. 1998 Feb;16(2):683-91. [https://doi.org/10.1200/JCO.1998.16.2.683 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/9469358/ PubMed] |
− | # | + | #Northfelt DW, Dezube BJ, Thommes JA, Miller BJ, Fischl MA, Friedman-Kien A, Kaplan LD, Du Mond C, Mamelok RD, Henry DH. Pegylated-liposomal doxorubicin versus doxorubicin, bleomycin, and vincristine in the treatment of AIDS-related Kaposi's sarcoma: results of a randomized phase III clinical trial. J Clin Oncol. 1998 Jul;16(7):2445-51. [https://doi.org/10.1200/jco.1998.16.7.2445 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/9667262/ PubMed] |
== Pomalidomide monotherapy {{#subobject:38huaf|Regimen=1}}== | == Pomalidomide monotherapy {{#subobject:38huaf|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | === Regimen {{#subobject:bi74c4|Variant=1}}=== | + | ===Regimen {{#subobject:bi74c4|Variant=1}}=== |
{| class="wikitable" style="width: 60%; text-align:center;" | {| class="wikitable" style="width: 60%; text-align:center;" | ||
!style="width: 33%"|Study | !style="width: 33%"|Study | ||
− | !style="width: 33%"| | + | !style="width: 33%"|Dates of enrollment |
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
|- | |- | ||
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5477825/ Polizzotto et al. 2016 (NCI 12-C-0047)] | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5477825/ Polizzotto et al. 2016 (NCI 12-C-0047)] | ||
|2012-2014 | |2012-2014 | ||
− | | style="background-color:#91cf61" | | + | | style="background-color:#91cf61" |Phase 1/2 (RT) |
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
− | |||
* [[Pomalidomide (Pomalyst)]] 5 mg PO once per day on days 1 to 21 | * [[Pomalidomide (Pomalyst)]] 5 mg PO once per day on days 1 to 21 | ||
− | + | ====Supportive medications==== | |
− | |||
− | ==== Supportive medications ==== | ||
− | |||
* [[Aspirin]] 81 mg PO once per day (unless contraindicated) | * [[Aspirin]] 81 mg PO once per day (unless contraindicated) | ||
− | + | '''28-day cycle for up to 13 cycles (1 year)''' | |
− | '''28-day cycles''' | + | </div> |
− | + | <div class="toccolours" style="background-color:#fff2ae"> | |
+ | ====Dose and schedule modifications==== | ||
+ | *Pomalidomide dose adjustment to 3 mg allowed if 5 mg dose is not tolerated | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
− | + | #'''NCI 12-C-0047:''' Polizzotto MN, Uldrick TS, Wyvill KM, Aleman K, Peer CJ, Bevans M, Sereti I, Maldarelli F, Whitby D, Marshall V, Goncalves PH, Khetani V, Figg WD, Steinberg SM, Zeldis JB, Yarchoan R. Pomalidomide for symptomatic Kaposi's sarcoma in people with and without HIV infection: a phase I/II study. J Clin Oncol. 2016 Dec;34(34):4125-4131. Epub 2016 Oct 31. [https://doi.org/10.1200/JCO.2016.69.3812 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5477825/ link to PMC article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/27863194/ PubMed] [https://clinicaltrials.gov/study/NCT01495598 NCT01495598] | |
− | #'''NCI 12-C-0047:''' Polizzotto MN, Uldrick TS, Wyvill KM, Aleman K, Peer CJ, Bevans M, Sereti I, Maldarelli F, Whitby D, Marshall V, Goncalves PH, Khetani V, Figg WD, Steinberg SM, Zeldis JB, Yarchoan R. Pomalidomide for symptomatic Kaposi's sarcoma in people with and without HIV infection: a phase I/II study. J Clin Oncol. 2016 Dec;34(34):4125-4131 [https://doi.org/10.1200/JCO.2016.69.3812 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5477825/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/27863194 PubMed] NCT01495598 | ||
− | |||
[[Category:Kaposi sarcoma regimens]] | [[Category:Kaposi sarcoma regimens]] | ||
[[Category:Disease-specific pages]] | [[Category:Disease-specific pages]] | ||
[[Category:Vascular sarcomas]] | [[Category:Vascular sarcomas]] |
Latest revision as of 23:36, 15 July 2024
Section editor | |
---|---|
Elizabeth J. Davis, MD Vanderbilt University Nashville, TN, USA |
Are you looking for a regimen but can't find it here? For placebo or observational studies in this condition, please visit this page. If you still can't find it, please let us know so we can add it!
12 regimens on this page
17 variants on this page
|
Guidelines
Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.
NCCN
All lines of therapy
ABV (Vinblastine)
ABV: Adriamycin (Doxorubicin), Bleomycin, Vinblastine
Regimen
Study | Dates of enrollment | Evidence |
---|---|---|
Laubenstein et al. 1984 | 1981-07 to 1983-06 | Non-randomized |
Note: cycle length is not explicitly described in the reference.
Chemotherapy
- Doxorubicin (Adriamycin) 40 mg/m2 IV once on day 1
- Bleomycin (Blenoxane) 15 units IV once per day on days 1 & 15
- Vinblastine (Velban) 6 mg/m2 IV once on day 1
28-day cycles
References
- Laubenstein LJ, Krigel RL, Odajnyk CM, Hymes KB, Friedman-Kien A, Wernz JC, Muggia FM. Treatment of epidemic Kaposi's sarcoma with etoposide or a combination of doxorubicin, bleomycin, and vinblastine. J Clin Oncol. 1984 Oct;2(10):1115-20. link to original article dosing details in manuscript have been reviewed by our editors PubMed
ABV (Vincristine)
ABV: Adriamycin (Doxorubicin), Bleomycin, Vincristine
Regimen variant #1, 10/15/1
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Gill et al. 1996 | 1992-1994 | Phase 3 (C) | Liposomal daunorubicin | Did not meet primary endpoint of ORR |
Note: Gill et al. 1996 described doses but did not clearly say in the paper when these drugs were given, but this schedule is assumed based on the Northfelt et al. 1998 ABV regimen. To our knowledge, this regimen was not tested as an experimental arm in an RCT prior to becoming a standard comparator arm.
Chemotherapy
- Doxorubicin (Adriamycin) 10 mg/m2 IV once on day 1
- Bleomycin (Blenoxane) 15 units IV once on day 1
- Vincristine (Oncovin) 1 mg IV once on day 1
Supportive therapy
- "No routine premedication was established by the protocol, but it could be provided at the discretion of the investigator"
14-day cycle for at least 2 cycles until complete remission
Regimen variant #2, 20/10/1
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Northfelt et al. 1998 | 1993-04 to 1994-12 | Phase 3 (C) | PLD | Inferior ORR |
Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT in this context, prior to becoming a standard comparator arm.
Chemotherapy
- Doxorubicin (Adriamycin) 20 mg/m2 IV once on day 1
- Bleomycin (Blenoxane) 10 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1 mg IV once on day 1
Supportive therapy
- "Colony-stimulating factors (CSFs) were prescribed at the discretion of the investigators."
14-day cycle for up to 6 cycles
References
- Gill PS, Wernz J, Scadden DT, Cohen P, Mukwaya GM, von Roenn JH, Jacobs M, Kempin S, Silverberg I, Gonzales G, Rarick MU, Myers AM, Shepherd F, Sawka C, Pike MC, Ross ME. Randomized phase III trial of liposomal daunorubicin versus doxorubicin, bleomycin, and vincristine in AIDS-related Kaposi's sarcoma. J Clin Oncol. 1996 Aug;14(8):2353-64. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT00002093
- Northfelt DW, Dezube BJ, Thommes JA, Miller BJ, Fischl MA, Friedman-Kien A, Kaplan LD, Du Mond C, Mamelok RD, Henry DH. Pegylated-liposomal doxorubicin versus doxorubicin, bleomycin, and vincristine in the treatment of AIDS-related Kaposi's sarcoma: results of a randomized phase III clinical trial. J Clin Oncol. 1998 Jul;16(7):2445-51. link to original article dosing details in manuscript have been reviewed by our editors PubMed
Alitretinoin monotherapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Walmsley et al. 1999 | 1996-04 to 1997-07 | Phase 3 (E-RT-esc) | Placebo | Superior ORR |
Bodsworth et al. 2001 | Not reported | Phase 3 (E-RT-esc) | Placebo | Superior ORR |
Topical therapy
- Alitretinoin (Panretin) 0.1% gel
References
- Walmsley S, Northfelt DW, Melosky B, Conant M, Friedman-Kien AE, Wagner B; Panretin Gel North American Study Group. Treatment of AIDS-related cutaneous Kaposi's sarcoma with topical alitretinoin (9-cis-retinoic acid) gel. J Acquir Immune Defic Syndr. 1999 Nov 1;22(3):235-46. link to original article PubMed
- Bodsworth NJ, Bloch M, Bower M, Donnell D, Yocum R; International Panretin Gel KS Study Group. Phase III vehicle-controlled, multi-centered study of topical alitretinoin gel in cutaneous AIDS-related Kaposi's sarcoma. Am J Clin Dermatol. 2001;2(2):77-87. link to original article PubMed
Bevacizumab monotherapy
Regimen
Study | Dates of enrollment | Evidence |
---|---|---|
Uldrick et al. 2012 (03-C-0110) | 2003-02 to 2008-12 | Phase 2 |
Note: the first "cycle" is one week in duration and is considered a loading dose.
Targeted therapy
- Bevacizumab (Avastin) 15 mg/kg IV once on day 1
Supportive therapy
- "Antihypertensive therapy was initiated for systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 95 mmHg persisting for more than 1 week or for systolic blood pressure greater than 210 mmHg or diastolic blood pressure greater than 120 mmHg at any time."
- "HIV-positive patients with CD4 count of less than 200 cells/µL received Pneumocystis jiroveci prophylaxis."
- "Mycobacterium avium prophylaxis was considered if CD4 count was less than 75 cells/µL."
- Patients with HIV/AIDS continued HAART
- Filgrastim (Neupogen) "used as clinically indicated"
7-day cycle for 1 cycle, then 21-day cycles
References
- 03-C-0110: Uldrick TS, Wyvill KM, Kumar P, O'Mahony D, Bernstein W, Aleman K, Polizzotto MN, Steinberg SM, Pittaluga S, Marshall V, Whitby D, Little RF, Yarchoan R. Phase II study of bevacizumab in patients with HIV-associated Kaposi's sarcoma receiving antiretroviral therapy. J Clin Oncol. 2012 May 1;30(13):1476-83. Epub 2012 Mar 19. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article PubMed NCT00055237
Bleomycin & Vincristine (BO)
BV: Bleomycin & Vincristine
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Stewart et al. 1998 | 1993-1995 | Phase 3 (C) | PLD | Inferior ORR |
Chemotherapy
- Bleomycin (Blenoxane) 15 IU/m2 IV over 30 minutes once on day 1, given second
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV bolus once on day 1, given first
21-day cycle for 6 cycles
References
- Stewart S, Jablonowski H, Goebel FD, Arasteh K, Spittle M, Rios A, Aboulafia D, Galleshaw J, Dezube BJ; International Pegylated Liposomal Doxorubicin Study Group. Randomized comparative trial of pegylated liposomal doxorubicin versus bleomycin and vincristine in the treatment of AIDS-related Kaposi's sarcoma. J Clin Oncol. 1998 Feb;16(2):683-91. link to original article dosing details in manuscript have been reviewed by our editors PubMed
Daunorubicin liposomal monotherapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Presant et al. 1993 | Not reported | Phase 2 | ||
Gill et al. 1996 | 1992-1994 | Phase 3 (E-RT-de-esc) | ABV | Did not meet primary endpoint of ORR |
Note: To our knowledge, this drug has been discontinued. Gill et al. 1996 stopped treatment if CR was achieved.
Chemotherapy
- Daunorubicin liposomal (DaunoXome) 40 mg/m2 IV over 30 to 60 minutes once on day 1
Supportive therapy
- "No routine premedication was established by the protocol, but it could be provided at the discretion of the investigator"
14-day cycles
References
- Presant CA, Scolaro M, Kennedy P, Blayney DW, Flanagan B, Lisak J, Presant J. Liposomal daunorubicin treatment of HIV-associated Kaposi's sarcoma. Lancet. 1993 May 15;341(8855):1242-3. link to original article PubMed
- Gill PS, Wernz J, Scadden DT, Cohen P, Mukwaya GM, von Roenn JH, Jacobs M, Kempin S, Silverberg I, Gonzales G, Rarick MU, Myers AM, Shepherd F, Sawka C, Pike MC, Ross ME. Randomized phase III trial of liposomal daunorubicin versus doxorubicin, bleomycin, and vincristine in AIDS-related Kaposi's sarcoma. J Clin Oncol. 1996 Aug;14(8):2353-64. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT00002093
Etoposide monotherapy
Regimen variant #1, 8 cycles
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Hosseinipour et al. 2018 (REACT-KS) | 2011-2016 | Phase 3 (C) | Etoposide; as-needed | Did not meet primary efficacy endpoints |
Chemotherapy
- Etoposide (Vepesid) 50 mg PO once per day on days 1 to 7
14-day cycle for up to 8 cycles
Regimen variant #2, indefinite
Study | Dates of enrollment | Evidence |
---|---|---|
Evans et al. 2002 | 1995-01 to 1998-03 | Phase 2 |
References
- Evans SR, Krown SE, Testa MA, Cooley TP, Von Roenn JH; AIDS Clinical Trials Group. Phase II evaluation of low-dose oral etoposide for the treatment of relapsed or progressive AIDS-related Kaposi's sarcoma: an AIDS Clinical Trials Group clinical study. J Clin Oncol. 2002 Aug 1;20(15):3236-41. link to original article dosing details in manuscript have been reviewed by our editors PubMed
- REACT-KS: Hosseinipour MC, Kang M, Krown SE, Bukuru A, Umbleja T, Martin JN, Orem J, Godfrey C, Hoagland B, Mwelase N, Langat D, Nyirenda M, MacRae J, Borok M, Samaneka W, Moses A, Mngqbisa R, Busakhala N, Martínez-Maza O, Ambinder R, Dittmer DP, Nokta M, Campbell TB; A5264/AMC-067 REACT-KS Team. As-needed vs immediate etoposide chemotherapy in combination with antiretroviral therapy for mild-to-moderate AIDS-associated Kaposi sarcoma in resource-limited settings: A5264/AMC-067 randomized clinical trial. Clin Infect Dis. 2018 Jul 2;67(2):251-260. link to original article link to PMC article PubMed NCT01352117
Interferon alfa-2a monotherapy
Regimen
Study | Dates of enrollment | Evidence |
---|---|---|
de Wit et al. 1988 | 1987-02 to 1988-03 | Phase 2 |
Note: Please see paper for details of treatment beyond 8 weeks.
Immunotherapy
- Interferon alfa-2a (Roferon-A) as follows:
- Less than 60 kg: 3,000,000 units SC once on day 1, then 9,000,000 units SC on day 2, then 18,000,000 units SC on day 3, then 27,000,000 units SC once per day on days 5 to 56
- 60 kg or more: 3,000,000 units SC once on day 1, then 9,000,000 units SC on day 2, then 18,000,000 units SC on day 3, then 36,000,000 units SC once per day on days 5 to 56
8-week course
References
- de Wit R, Schattenkerk JK, Boucher CA, Bakker PJ, Veenhof KH, Danner SA. Clinical and virological effects of high-dose recombinant interferon-alpha in disseminated AIDS-related Kaposi's sarcoma. Lancet. 1988 Nov 26;2(8622):1214-7. link to original article dosing details in manuscript have been reviewed by our editors PubMed
Interferon alfa-2b monotherapy
Regimen variant #1
Study | Dates of enrollment | Evidence |
---|---|---|
Volberding et al. 1987 | 1981-1984 | Phase 2 (RT) |
Lane et al. 1988 | Not reported | Non-randomized (RT) |
Immunotherapy
- Interferon alfa-2b (Intron-A) 50,000,000 units/m2 IV once per day on days 1 to 5
14-day cycles
Regimen variant #2
Study | Dates of enrollment | Evidence |
---|---|---|
Volberding et al. 1987 | 1981-1984 | Phase 2 (RT) |
Immunotherapy
- Interferon alfa-2b (Intron-A) 30,000,000 units/m2 SC once per day on days 1, 3, 5
7-day cycles
References
- Volberding PA, Mitsuyasu RT, Golando JP, Spiegel RJ. Treatment of Kaposi's sarcoma with interferon alfa-2b (Intron A). Cancer. 1987 Feb 1;59(3 Suppl):620-5. link to original article dosing details in abstract have been reviewed by our editors PubMed
- Lane HC, Kovacs JA, Feinberg J, Herpin B, Davey V, Walker R, Deyton L, Metcalf JA, Baseler M, Salzman N, Quinnan G, Fauci AS. Anti-retroviral effects of interferon-alpha in AIDS-associated Kaposi's sarcoma. Lancet. 1988 Nov 26;2(8622):1218-22. link to original article PubMed
Paclitaxel monotherapy
Regimen variant #1, 100 mg/m2
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Krown et al. 2020 (AMC 066) | 2013-2018 | Phase 3 (C) | 1. Bleomycin & Vincristine (BO) 2. Etoposide |
Inconclusive whether non-inferior PFS |
Chemotherapy
- Paclitaxel (Taxol) 100 mg/m2 IV over 60 minutes once on day 1
21-day cycle for 6 cycles
Regimen variant #2, 135 mg/m2
Study | Dates of enrollment | Evidence |
---|---|---|
Saville et al. 1995 (CA139-174) | 1993 to not reported | Phase 2 (RT) |
References
- CA139-174: Saville MW, Lietzau J, Pluda JM, Feuerstein I, Odom J, Wilson WH, Humphrey RW, Feigal E, Steinberg SM, Broder S, Yarchoan R. Treatment of HIV-associated Kaposi's sarcoma with paclitaxel. Lancet. 1995 Jul 1;346(8966):26-8. link to original article dosing details in abstract have been reviewed by our editors PubMed
- AMC 066: Krown SE, Moser CB, MacPhail P, Matining RM, Godfrey C, Caruso SR, Hosseinipour MC, Samaneka W, Nyirenda M, Busakhala NW, Okuku FM, Kosgei J, Hoagland B, Mwelase N, Oliver VO, Burger H, Mngqibisa R, Nokta M, Campbell TB, Borok MZ; A5263/AMC066 protocol team. Treatment of advanced AIDS-associated Kaposi sarcoma in resource-limited settings: a three-arm, open-label, randomised, non-inferiority trial. Lancet. 2020 Apr 11;395(10231):1195-1207. Epub 2020 Mar 5. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article PubMed NCT01435018
Pegylated liposomal doxorubicin monotherapy
Regimen variant #1, q2wk
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Northfelt et al. 1998 | 1993-04 to 1994-12 | Phase 3 (E-de-esc) | ABV | Superior ORR |
Stewart et al. 1998 | 1993-1995 | Phase 3 (E-switch-ic) | Bleomycin & Vincristine (BO) | Superior ORR |
Chemotherapy
- Pegylated liposomal doxorubicin (Doxil) 20 mg/m2 IV over 30 minutes once on day 1
Supportive therapy
- "Colony-stimulating factors (CSFs) were prescribed at the discretion of the investigators."
14- to 21-day cycle for up to 6 cycles
Regimen variant #2, q3wk
Study | Dates of enrollment | Evidence |
---|---|---|
Harrison et al. 1995 | 1991-1993 | Phase 2 (RT) |
References
- Harrison M, Tomlinson D, Stewart S. Liposomal-entrapped doxorubicin: an active agent in AIDS-related Kaposi's sarcoma. J Clin Oncol. 1995 Apr;13(4):914-20. link to original article dosing details in manuscript have been reviewed by our editors PubMed
- Stewart S, Jablonowski H, Goebel FD, Arasteh K, Spittle M, Rios A, Aboulafia D, Galleshaw J, Dezube BJ; International Pegylated Liposomal Doxorubicin Study Group. Randomized comparative trial of pegylated liposomal doxorubicin versus bleomycin and vincristine in the treatment of AIDS-related Kaposi's sarcoma. J Clin Oncol. 1998 Feb;16(2):683-91. link to original article dosing details in manuscript have been reviewed by our editors PubMed
- Northfelt DW, Dezube BJ, Thommes JA, Miller BJ, Fischl MA, Friedman-Kien A, Kaplan LD, Du Mond C, Mamelok RD, Henry DH. Pegylated-liposomal doxorubicin versus doxorubicin, bleomycin, and vincristine in the treatment of AIDS-related Kaposi's sarcoma: results of a randomized phase III clinical trial. J Clin Oncol. 1998 Jul;16(7):2445-51. link to original article dosing details in manuscript have been reviewed by our editors PubMed
Pomalidomide monotherapy
Regimen
Study | Dates of enrollment | Evidence |
---|---|---|
Polizzotto et al. 2016 (NCI 12-C-0047) | 2012-2014 | Phase 1/2 (RT) |
Targeted therapy
- Pomalidomide (Pomalyst) 5 mg PO once per day on days 1 to 21
Supportive medications
- Aspirin 81 mg PO once per day (unless contraindicated)
28-day cycle for up to 13 cycles (1 year)
Dose and schedule modifications
- Pomalidomide dose adjustment to 3 mg allowed if 5 mg dose is not tolerated
References
- NCI 12-C-0047: Polizzotto MN, Uldrick TS, Wyvill KM, Aleman K, Peer CJ, Bevans M, Sereti I, Maldarelli F, Whitby D, Marshall V, Goncalves PH, Khetani V, Figg WD, Steinberg SM, Zeldis JB, Yarchoan R. Pomalidomide for symptomatic Kaposi's sarcoma in people with and without HIV infection: a phase I/II study. J Clin Oncol. 2016 Dec;34(34):4125-4131. Epub 2016 Oct 31. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors PubMed NCT01495598