Difference between revisions of "Kaposi sarcoma"
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|[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)] | ||
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Revision as of 01:27, 11 July 2022
Section editor | |
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Elizabeth J. Davis, MD Vanderbilt University Nashville, TN ejdavis25 |
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
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Guidelines
NCCN
All lines of therapy
ABV (Vinblastine)
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ABV: Adriamycin (Doxorubicin), Bleomycin, Vinblastine
Regimen
Study | Evidence |
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Laubenstein et al. 1984 | Non-randomized |
Chemotherapy
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 PubMed
ABV (Vincristine)
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ABV: Adriamycin (Doxorubicin), Bleomycin, Vincristine
Regimen variant #1, 10/15/1
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Gill et al. 1996 | 1992-1994 | Phase 3 (C) | Liposomal daunorubicin | Did not meet primary endpoint of ORR |
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 medications
- "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 | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Northfelt et al. 1998 | 1993-1994 | Phase 3 (C) | Pegylated liposomal doxorubicin | 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.
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 medications
- "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 contains verified protocol 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 contains verified protocol PubMed
Alitretinoin monotherapy
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Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Walmsley et al. 1999 | NR in abstract | Phase 3 (E-RT-esc) | Placebo | Superior ORR |
Bodsworth et al. 2001 | NR in abstract | Phase 3 (E-RT-esc) | Placebo | Superior ORR |
Topical therapy
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
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Regimen
Study | Evidence |
---|---|
Uldrick et al. 2012 (03-C-0110) | Phase 2 |
Targeted therapy
- Bevacizumab (Avastin) as follows:
- Loading: 15 mg/kg IV once as a loading dose; start regular therapy 7 days later after this loading dose
- Cycle 1 onwards: 15 mg/kg IV once on day 1
Supportive medications
- "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"
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 contains verified protocol link to PMC article PubMed NCT00055237
Daunorubicin liposomal monotherapy
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Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Presant et al. 1993 | NR | 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 medications
- "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 contains verified protocol PubMed NCT00002093
Doxorubicin pegylated liposomal monotherapy
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Regimen variant #1, q2wk
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Northfelt et al. 1998 | 1993-1994 | 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 medications
- "Colony-stimulating factors (CSFs) were prescribed at the discretion of the investigators."
14-day cycle for up to 6 cycles
Regimen variant #2, q3wk
Study | Years of enrollment | Evidence |
---|---|---|
Harrison et al. 1995 | 1991-1993 | Phase 2 (RT) |
Chemotherapy
- Pegylated liposomal doxorubicin (Doxil) 20 mg/m2 IV once on day 1
21-day cycles
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 contains protocol 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 contains protocol 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 contains verified protocol PubMed
Etoposide monotherapy
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Regimen variant #1, 8 cycles
Study | Years 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 | Evidence |
---|---|
Evans et al. 2002 | Phase 2 |
Chemotherapy
- Etoposide (Vepesid) 50 mg PO once per day on days 1 to 7
14-day cycles
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 contains verified protocol 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 PubMed NCT01352117
Interferon alfa-2a monotherapy
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Regimen
Study | Evidence |
---|---|
de Wit et al. 1988 | Phase 2 |
Immunotherapy
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 PubMed
Interferon alfa-2b monotherapy
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Regimen
Study | Years of enrollment | Evidence |
---|---|---|
Volberding et al. 1987 | 1981-1984 | Phase 2 (RT) |
Lane et al. 1988 | NR | Non-randomized (RT) |
Immunotherapy
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 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
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Regimen variant #1, 100 mg/m2
Study | Years 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 | Years of enrollment | Evidence |
---|---|---|
Saville et al. 1995 (CA139-174) | 1993-NR | Phase 2 (RT) |
Chemotherapy
- Paclitaxel (Taxol) 135 mg/m2 IV over 3 hours once on day 1
21-day cycles
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 contains protocol 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 contains verified protocol link to PMC article PubMed NCT01435018
Pomalidomide monotherapy
Regimen
Study | Years 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
- Dose adjustment to 3 mg allowed if 5 mg dose is not tolerated
Supportive medications
- Aspirin 81 mg PO once per day (unless contraindicated)
28-day cycles
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 link to original article link to PMC article PubMed NCT01495598