Kaposi sarcoma

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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!

Last updated on 2024-07-23:
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

28-day cycles

References

  1. 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

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

Supportive therapy

  • "Colony-stimulating factors (CSFs) were prescribed at the discretion of the investigators."

14-day cycle for up to 6 cycles

References

  1. 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
  2. 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

12-week course

References

  1. 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
  2. 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 dosing details in abstract have been reviewed by our editors 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

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

  1. 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

21-day cycle for 6 cycles

References

  1. 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

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

  1. 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
  2. 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

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

Chemotherapy

14-day cycles

References

  1. 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
  2. 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

  1. 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

14-day cycles


Regimen variant #2

Study Dates of enrollment Evidence
Volberding et al. 1987 1981-1984 Phase 2 (RT)

Immunotherapy

7-day cycles

References

  1. 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
  2. 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

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)

Chemotherapy

21-day cycles

References

  1. 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
  2. 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

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)

Chemotherapy

21-day cycles

References

  1. 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
  2. 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
  3. 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

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

  1. 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


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