Phase II study of nab-paclitaxel and bevacizumab as first-line therapy for patients with unresectable stage III and IV melanoma

American Journal of Clinical Oncology: Cancer Clinical Trials

Volumn 38, Issue 1, 2015, Pages 61-67

  Spitler, Lynn E ^a   Boasberg, Peter ^b   Day, Steven O' ^b   Hamid, Omid ^b   Cruickshank, Scott ^c   Mesko, Shane ^b   Weber, Robert W ^a  

^a ST MARY S MEDICAL CENTER   (United States)

^b Angeles Clinic and Research Institute   (United States)

^c Cruickshank and Associates   (United States)

Author keywords

bevacizumab; clinical trial; melanoma; Nab paclitaxel; therapy

Indexed keywords

BEVACIZUMAB; IPILIMUMAB; PACLITAXEL; 130-NM ALBUMIN-BOUND PACLITAXEL; ALBUMINOID; ANGIOGENESIS INHIBITOR; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY;

ADULT; AGED; ALOPECIA; ARTICLE; CANCER PATIENT; CANCER STAGING; CLINICAL ARTICLE; CONSTIPATION; COUGHING; DECREASED APPETITE; DIARRHEA; DISEASE COURSE; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; DYSGEUSIA; EPISTAXIS; FATIGUE; FEMALE; FOLLOW UP; HEADACHE; HISTOPATHOLOGY; HUMAN; HYPERTENSION; LACRIMATION; MALE; METASTATIC MELANOMA; MUCOSAL DISEASE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OPEN STUDY; OVERALL SURVIVAL; PERIPHERAL NEUROPATHY; PHASE 2 CLINICAL TRIAL; PROGRESSION FREE SURVIVAL; SIDE EFFECT; STOMATITIS; VISUAL ACUITY; CLINICAL TRIAL; DISEASE FREE SURVIVAL; LUNG NEOPLASMS; LYMPH NODE; MELANOMA; MIDDLE AGED; PATHOLOGY; SECONDARY; SKIN NEOPLASMS; TREATMENT OUTCOME; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ALBUMINS; ANGIOGENESIS INHIBITORS; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; LUNG NEOPLASMS; LYMPH NODES; MALE; MELANOMA; MIDDLE AGED; NEOPLASM STAGING; PACLITAXEL; SKIN NEOPLASMS; TREATMENT OUTCOME;

EID: 84922022648     PISSN: 02773732     EISSN: 1537453X     Source Type: Journal    
DOI: 10.1097/COC.0b013e318287bbae     Document Type: Article

References (59)

1. Avril MF, Aamdal S, Grob JJ, et al. Fotemustine compared with dacarbazine in patients with disseminated malignant melanoma: a phase III study. J Clin Oncol. 2004;22:1118-1125.
2. Bedikian AY, Millward M, Pehamberger H, et al. Bcl-2 antisense (oblimersen sodium) plus dacarbazine in patients with advanced melanoma: the Oblimersen Melanoma Study Group. J Clin Oncol. 2006;24:4738-4745.
3. Chapman PB, Einhorn LH, Meyers ML, et al. Phase III multicenter randomized trial of the Dartmouth regimen versus dacarbazine in patients with metastatic melanoma. J Clin Oncol. 1999;17:2745-2751.
4. Chapman PB, Hauschild A, Robert C, et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med. 2011;364:2507-2516.
5. Middleton MR, Grob JJ, Aaronson N, et al. Randomized phase III study of temozolomide versus dacarbazine in the treatment of patients with advanced metastatic malignant melanoma. J Clin Oncol. 2000;18:158-166.
6. Robert C, Thomas L, Bondarenko I, et al. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med. 2011;364:2517-2526.
7. Hodi FS, O'Day SJ, McDermott DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010;363:711-723.
8. Chapman PB, Hauschild A, Robert C, et al. Updated overall survival (OS) results for BRIM-3, a phase III randomized, openlabel, multicenter trial comparing BRAF inhibitor vemurafenib (vem) with dacarbazine (DTIC) in previously untreated patients with BRAFV600E-mutated melanoma. Presented at ASCO 2012. J Clin Oncol. 2012;30, (suppl; abstr 8502
9. Denijn M, Ruiter DJ. The possible role of angiogenesis in the metastatic potential of human melanoma. Clinicopathological aspects. Melanoma Res. 1993;3:5-14.
10. Erhard H, Rietveld FJ, van Altena MC, et al. Transition of horizontal to vertical growth phase melanoma is accompanied by induction of vascular endothelial growth factor expression and angiogenesis. Melanoma Res. 1997;7(suppl 2):S19-S26.
11. Straume O, Salvesen HB, Akslen LA. Angiogenesis is prognostically important in vertical growth phase melanomas. Int J Oncol. 1999;15:595-599.
12. Birck A, Kirkin AF, Zeuthen J, et al. Expression of basic fibroblast growth factor and vascular endothelial growth factor in primary and metastatic melanoma from the same patients. Melanoma Res. 1999;9:375-381.
13. Salven P, Heikkila P, Joensuu H. Enhanced expression of vascular endothelial growth factor in metastatic melanoma. Br J Cancer. 1997;76:930-934.
14. Claffey KP, Brown LF, del Aguila LF, et al. Expression of vascular permeability factor/vascular endothelial growth factor by melanoma cells increases tumor growth, angiogenesis, and experimental metastasis. Cancer Res. 1996;56:172-181.
15. Rofstad EK, Halsor EF. Vascular endothelial growth factor, interleukin 8, platelet-derived endothelial cell growth factor, and basic fibroblast growth factor promote angiogenesis and metastasis in human melanoma xenografts. Cancer Res. 2000;60:4932-4938.
16. Schuster C, Eikesdal HP, Puntervoll H, et al. Clinical efficacy and safety of bevacizumab monotherapy in patients with metastatic melanoma: predictive importance of induced early hypertension. PLoS One. 2012;7:e38364.
17. Kruijff S, Bastiaannet E, Brouwers AH, et al. Use of S-100B to evaluate therapy effects during bevacizumab induction treatment in AJCC stage III melanoma. Ann Surg Oncol. 2012;19: 620-626.
18. Gogas H, Bafaloukos D, Bedikian AY. The role of taxanes in the treatment of metastatic melanoma. Melanoma Res. 2004;14: 415-420.
19. Nathan FE, Berd D, Sato T, et al. Paclitaxel and tamoxifen: an active regimen for patients with metastatic melanoma. Cancer. 2000;88:79-87.
20. Rao RD, Holtan SG, Ingle JN, et al. Combination of paclitaxel and carboplatin as second-line therapy for patients with metastatic melanoma. Cancer. 2006;106:375-382.
21. NCCN Guidelines Version 1. 2013. Melanoma V1, 2013. Available at: http://www.nccnorg.
22. Desai N, Trieu V, Yao R, et al. Increased endothelial transcytosis of nanoparticle albumin-bound paclitaxel (ABI-007) by gp60-receptors: a pathway inhibited by taxol. SABCS. 2004:1071a.
23. Gradishar WJ, Tjulandin S, Davidson N, et al. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol. 2005;23:7794-7803.
24. Socinski MA, Bondarenko I, Karaseva NA, et al. Weekly nabpaclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial. J Clin Oncol. 2012;30:2055-2062.
25. Hersh EM, O'Day SJ, Ribas A, et al. A phase 2 clinical trial of nab-paclitaxel in previously treated and chemotherapy-naive patients with metastatic melanoma. Cancer. 2010;116:155-163.
26. Kottschade LA, Suman VJ, Amatruda T 3rd, et al. A phase II trial of nab-paclitaxel (ABI-007) and carboplatin in patients with unresectable stage IV melanoma: a North Central Cancer Treatment Group Study, N057E(1). Cancer. 2011;117:1704-1710.
27. Hersh E, Del Vecchio M, Brown M, et al. Phase 3, randomized, open-label, multicenter trial of nab-paclitaxel (nab-P) vs dacarbazine (DTIC) in previously untreated patients with metastatic malignant melanoma (MMM). Presented at annual meeting of the Society for Melanoma Research, 2012. Pigment Cell Melanoma Res. 2012;25:863.
28. Mabuchi S, Terai Y, Morishige K, et al. Maintenance treatment with bevacizumab prolongs survival in an in vivo ovarian cancer model. Clin Cancer Res. 2008;14:7781-7789.
29. Grothey A, Sugrue MM, Purdie DM, et al. Bevacizumab beyond first progression is associated with prolonged overall survival in metastatic colorectal cancer: results from a large observational cohort study (BRiTE). J Clin Oncol. 2008;26:5326-5334.
30. Saltz LB, Clarke S, Diaz-Rubio E, et al. Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study. J Clin Oncol. 2008;26:2013-2019.
31. Stein WD, Yang J, Bates SE, et al. Bevacizumab reduces the growth rate constants of renal carcinomas: a novel algorithm suggests early discontinuation of bevacizumab resulted in a lack of survival advantage. Oncologist. 2008;13:1055-1062.
32. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45:228-247.
33. Korn EL, Liu PY, Lee SJ, et al. Meta-Analysis of phase II cooperative group trials in metastatic stage IV melanoma to determine progression-free and overall survival benchmarks for future phase II trials. J Clin Oncol. 2008;26:527-534.
34. FDA Guidance for Industry:'Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics'. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory Information/Guidances/ucm071590.pdf.
35. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc. 1958;53:457-481.
36. Schemper M, Smith TL. A note on quantifying follow-up in studies of failure time. Control Clin Trials. 1996;17:343-346.
37. Balch CM, Soong SJ, Gershenwald JE, et al. Prognostic factors analysis of 17,600 melanoma patients: validation of the American Joint Committee on Cancer melanoma staging system. J Clin Oncol. 2001;19:3622-3634.
38. Edge SB, Byrd DR, Compton CC, et al. (eds). AJCC Cancer Staging Manual. Seventh Ed. New York: Springer; 2010.
39. Balch CM, Soong SJ, Murad TM, et al. A multifactorial analysis of melanoma. IV. Prognostic factors in 200 melanoma patients with distant metastases (stage III). J Clin Oncol. 1983;1: 126-134.
40. Brand CU, Ellwanger U, Stroebel W, et al. Prolonged survival of 2 years or longer for patients with disseminated melanoma. An analysis of related prognostic factors. Cancer. 1997;79: 2345-2353.
41. Manola J, Atkins M, Ibrahim J, et al. Prognostic factors in metastatic melanoma: a pooled analysis of Eastern Cooperative Oncology Group trials. J Clin Oncol. 2000;18:3782-3793.
42. Topalian SL, Hodi FS, Brahmer JR, et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med. 2012;366:2443-2454.
43. lannone R, Gergich K, Cong C, et al. Efficacy And Safety Of MK-3475 In Patients With Advanced Melanoma. Presented at the annual meeting of the Society for Melanoma Research, 2012. Pigment Cell Melanoma Res. 2012;25:864.
44. Brahmer JR, Tykodi SS, Chow LQ, et al. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med. 2012;366:2455-2465.
45. Hauschild A, Grob JJ, Demidov LV, et al. Dabrafenib in BRAFmutated metastatic melanoma: a multicentre, open-label, phase 3 randomised controlled trial. Lancet. 2012;380:358-365.
46. Flaherty KT, Infante JR, Daud A, et al. Combined BRAF and MEK inhibition in melanoma with BRAF V600 mutations. N Engl J Med. 2012;367:1694-1703.
47. Wolchok JD, Neyns B, Linette G, et al. Ipilimumab monotherapy in patients with pretreated advanced melanoma: a randomised, double-blind, multicentre, phase 2, dose-ranging study. Lancet Oncol. 2010;11:155-164.
48. Sosman JA, Kim KB, Schuchter L, et al. Survival in BRAF V600-mutant advanced melanoma treated with vemurafenib. N Engl J Med. 2012;366:707-714.
49. Kottschade LA, Suman VJ, Perez DG, et al. A randomized phase 2 study of temozolomide and bevacizumab or nab-paclitaxel, carboplatin, and bevacizumab in patients with unresectable stage IV melanoma: a North Central Cancer Treatment Group study, N0775. Cancer. 2013;119:586-592.
50. von Moos R, Seifert B, Simcock M, et al. First-line temozolomide combined with bevacizumab in metastatic melanoma: a multicentre phase II trial (SAKK 50/07). Ann Oncol. 2012;23:531-536.
51. Gonzalez-Cao M, Viteri S, Diaz-Lagares A, et al. Preliminary results of the combination of bevacizumab and weekly Paclitaxel in advanced melanoma. Oncology. 2008;74:12-16.
52. Kim KB, Sosman JA, Fruehauf JP, et al. BEAM: a randomized phase II study evaluating the activity of bevacizumab in combination with carboplatin plus paclitaxel in patients with previously untreated advanced melanoma. J Clin Oncol. 2012;30:34-41.
53. Perez DG, Suman VJ, Fitch TR, et al. Phase 2 trial of carboplatin, weekly paclitaxel, and biweekly bevacizumab in patients with unresectable stage IV melanoma: a North Central Cancer Treatment Group study, N047A. Cancer. 2009;115:119-127.
54. Volk LD, Flister MJ, Bivens CM, et al. Nab-paclitaxel efficacy in the orthotopic model of human breast cancer is significantly enhanced by concurrent anti-vascular endothelial growth factor A therapy. Neoplasia. 2008;10:613-623.
55. Volk LD, Flister MJ, Chihade D, et al. Synergy of nab-paclitaxel and bevacizumab in eradicating large orthotopic breast tumors and preexisting metastases. Neoplasia. 2011;13:327-338.
56. Chauhan VP, Stylianopoulos T, Martin JD, et al. Normalization of tumour blood vessels improves the delivery of nanomedicines in a size-dependent manner. Nat Nanotechnol. 2012;7:383-388.
57. Desai N, Trieu V, Damascelli B, et al. SPARC expression correlates with tumor response to albumin-bound paclitaxel in head and neck cancer patients. Transl Oncol. 2009;2:59-64.
58. Von Hoff DD, Ramanathan RK, Borad MJ, et al. Gemcitabine plus nab-paclitaxel is an active regimen in patients with advanced pancreatic cancer: a phase I/II trial. J Clin Oncol. 2011;29: 4548-4554.
59. Ledda F, Bravo AI, Adris S, et al. The expression of the secreted protein acidic and rich in cysteine (SPARC) is associated with the neoplastic progression of human melanoma. J Invest Dermatol. 1997;108:210-214.