Vascular sarcoma
Carboplatin & Paclitaxel (CP)
CP: Carboplatin & Paclitaxel
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Forde et al. 2022 (CheckMate 816) | 2017-2019 | Phase 3 (C) | 1a. CP & Nivolumab 1b. CVb & Nivolumab 1c. DC & Nivolumab |
Inferior EFS |
Note: there were additional comparator options depending on histology; see the respective histology-specific pages for more details. This study was conducted in the United States. The reason for the study was that an unanswered question at the time was whether adding an immune checkpoint inhibitor would improve outcomes.
Biomarker eligibility criteria
- CheckMate 816: No sensitizing EGFR or ALK mutations
Chemotherapy
- Carboplatin (Paraplatin) AUC 5 or 6 IV once on day 1
- Paclitaxel (Taxol) 175 or 200 mg/m2 IV once on day 1
21-day cycle for 3 cycles
Subsequent treatment
References
- CheckMate 816: Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. Epub 2022 Apr 11. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT02998528
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Guidelines
ESMO
- Soft tissue and visceral sarcomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. (2014) PubMed
NCCN
Angiosarcoma, all lines of therapy
Bevacizumab monotherapy
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Regimen
Study | Evidence |
---|---|
Agulnik et al. 2013 | Phase II |
Chemotherapy
- Bevacizumab (Avastin) 15 mg/kg IV once on day 1
21-day cycles, given until progression of disease, intolerance, unacceptable toxicity, patient refusal, or physician discretion
References
- Agulnik M, Yarber JL, Okuno SH, von Mehren M, Jovanovic BD, Brockstein BE, Evens AM, Benjamin RS. An open-label, multicenter, phase II study of bevacizumab for the treatment of angiosarcoma and epithelioid hemangioendotheliomas. Ann Oncol. 2013 Jan;24(1):257-63. link to original article contains verified protocol PubMed
Paclitaxel monotherapy
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Regimen
Study | Evidence |
---|---|
Penel et al. 2008 (ANGIOTAX) | Phase II |
Chemotherapy
- Paclitaxel (Taxol) 80 mg/m2 IV over 60 minutes once per day on days 1, 8, 15
Supportive medications
- Dexamethasone (Decadron) 8 mg IV once prior to paclitaxel
- Cimetidine (Tagamet) 200 mg IV once prior to paclitaxel
- Dexchlorpheniramine (Polaramine) (note: was spelled as dexchloropheramine in the Penel et al. 2008) 5 mg IV once prior to paclitaxel
- "Standard antiemetics (mainly Metoclopramide (Reglan)) were prescribed as clinically indicated by the treating physician"
28-day cycle for 6 cycles
References
- Penel N, Bui BN, Bay JO, Cupissol D, Ray-Coquard I, Piperno-Neumann S, Kerbrat P, Fournier C, Taieb S, Jimenez M, Isambert N, Peyrade F, Chevreau C, Bompas E, Brain EG, Blay JY. Phase II trial of weekly paclitaxel for unresectable angiosarcoma: the ANGIOTAX Study. J Clin Oncol. 2008 Nov 10;26(32):5269-74. Epub 2008 Sep 22. link to original article contains verified protocol PubMed
Hemangioendothelioma, all lines of therapy
Hemangiopericytoma (solitary fibrous tumor), all lines of therapy
Kaposi sarcoma, all lines of therapy
ABV
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ABV: Adriamycin (Doxorubicin), Bleomycin, Vincristine
Regimen #1
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Northfelt et al. 1998 | Phase III | Pegylated liposomal doxorubicin | Inferior ORR |
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
Regimen #2
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Gill et al. 1996 | Phase III | Liposomal daunorubicin | Seems not superior |
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.
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 minimum of 2 cycles; given until complete remission, unacceptable toxicity, disease progression, patient refusal, or death
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
- 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
Bevacizumab monotherapy
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Regimen
Study | Evidence |
---|---|
Uldrick et al. 2012 | Phase II |
Loading dose
- Bevacizumab (Avastin) 15 mg/kg IV once as a loading dose; start regular therapy 7 days later after this loading dose
Regular therapy
- Bevacizumab (Avastin) 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, given until progression of disease requiring cytotoxic therapy, lack of adherence to protocol (including HAART), or patient-requested discontinuation
References
- 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
Daunorubicin liposomal monotherapy
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Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Gill et al. 1996 | Phase III | ABV | Seems not superior |
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 cycle for minimum of 2 cycles; given until complete remission, unacceptable toxicity, disease progression, patient refusal, or death
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
Doxorubicin liposomal monotherapy
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Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Northfelt et al. 1998 | Phase III | ABV | 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
References
- 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
Study | Evidence |
---|---|
Evans et al. 2002 | Phase II |
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. 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