Kaposi sarcoma

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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==
*NCCN Guidelines - Kaposi Sarcoma
**2019: Reid et al. AIDS-Related Kaposi Sarcoma, Version 2.2019, NCCN Clinical Practice Guidelines in Oncology. EuroPMC
=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 EuroPMC
==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 	Lower 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 EuroPMC 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 EuroPMC
==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 	Higher ORR
Bodsworth et al. 2001	Not reported 	Phase 3 (E-RT-esc)	Placebo 	Higher ORR
====Topical therapy====
*Alitretinoin (Panretin) 0.1% gel topical twice per day
12-week course
===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 EuroPMC
#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 EuroPMC
==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 EuroPMC 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 	Lower 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 EuroPMC
==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 EuroPMC
#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 EuroPMC 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
====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 dosing details in manuscript have been reviewed by our editors EuroPMC
#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 EuroPMC 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) by the following weight-based criteria:
**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 EuroPMC
==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 EuroPMC
#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 EuroPMC
==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)	Inconclusive whether non-inferior PFS (primary outcome)PFS48: 64% vs 44%(PFS48 difference: -20%, 95% CI -33 to -7)
Krown et al. 2020 (AMC 066)	2013-2018 	Phase 3 (C)	2. Etoposide 	Inconclusive whether non-inferior PFS (primary outcome)PFS48: 50% vs 20%(PFS48 difference: -30%, 95% CI -52 to -8)
====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)
====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 dosing details in abstract have been reviewed by our editors EuroPMC
#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 EuroPMC 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 	Higher ORR
Stewart et al. 1998 	1993-1995 	Phase 3 (E-switch-ic)	Bleomycin & Vincristine (BO)	Higher 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)
====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 dosing details in manuscript have been reviewed by our editors EuroPMC
#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 EuroPMC
#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 EuroPMC
== 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 EuroPMC NCT01495598
Category:Kaposi sarcoma regimens
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Category:Vascular sarcomas