Ipilimumab and fotemustine in patients with advanced melanoma (NIBIT-M1): An open-label, single-arm phase 2 trial

The Lancet Oncology

Volumn 13, Issue 9, 2012, Pages 879-886

  Di Giacomo, Anna Maria ^a   Ascierto, Paolo A ^b   Pilla, Lorenzo ^c   Santinami, Mario ^d   Ferrucci, Pier Francesco ^e   Giannarelli, Diana ^f   Marasco, Antonella ^g   Rivoltini, Licia ^d   Simeone, Ester ^b   Nicoletti, Stefania V L ^h   Fonsatti, Ester ^a   Annesi, Diego ^a   Queirolo, Paola ^g   Testori, Alessandro ^e   Ridolfi, Ruggero ^h   Parmiani, Giorgio ^c   Maio, Michele ^a  

^a UNIVERSITY HOSPITAL OF SIENA   (Italy)

^b National Cancer Institute   (Italy)

^c SAN RAFFAELE HOSPITAL   (Italy)

^d NATIONAL CANCER INSTITUTE   (Italy)

^e EUROPEAN INSTITUTE OF ONCOLOGY   (Italy)

^f REGINA ELENA NATIONAL CANCER INSTITUTE   (Italy)

^g UNIVERSITY OF GENOA   (Italy)

^h DEPARTMENT OF MEDICAL ONCOLOGY   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

DACARBAZINE; FOTEMUSTINE; GLYCOPROTEIN GP 100; IPILIMUMAB;

ADULT; ADVANCED CANCER; AGED; ARTICLE; BONE MARROW TOXICITY; BRAIN METASTASIS; CANCER STAGING; CANCER SURVIVAL; CLINICAL PROTOCOL; COMPUTER ASSISTED TOMOGRAPHY; DIARRHEA; DISEASE CONTROL; DRUG EFFICACY; DRUG SAFETY; FEMALE; HUMAN; IMMUNE RESPONSE; LIFE EXPECTANCY; LIVER DISEASE; MAJOR CLINICAL STUDY; MALE; MELANOMA; NAUSEA; NEUROLOGIC DISEASE; NEUTROPENIA; NUCLEAR MAGNETIC RESONANCE IMAGING; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; SKIN DISEASE; THROMBOCYTOPENIA; THYROIDITIS; TREATMENT RESPONSE; VOMITING;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BRAIN NEOPLASMS; DISEASE-FREE SURVIVAL; FEMALE; HEMATOLOGIC DISEASES; HUMANS; MALE; MELANOMA; MIDDLE AGED; NEOPLASM GRADING; NEOPLASM STAGING; NITROSOUREA COMPOUNDS; ORGANOPHOSPHORUS COMPOUNDS; SKIN NEOPLASMS;

EID: 84865567547     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(12)70324-8     Document Type: Article

References (31)

1. Balch CM, Buzaid AC, Soong SJ, et al. Final version of the American Joint Committee on Cancer staging system for cutaneous melanoma. J Clin Oncol 2001, 19:3635-3648.
2. 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.
3. Hong A, Fogarty G, Izard MA The role of radiation therapy in the management of metastatic melanoma in the brain. Int J Surg Oncol 2012, 2012:294735.
4. Agarwala SS Current systemic therapy for metastatic melanoma. Expert Rev Anticancer Ther 2009, 9:587-595.
5. Dummer R, Hauschild A, Guggenheim M, Jost L, Pentheroudakis G Melanoma: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol 2010, 21(suppl 5):v194-v197.
6. Garbe C, Peris K, Hauschild A, et al. Diagnosis and treatment of melanoma: European consensus-based interdisciplinary guideline. Eur J Cancer 2010, 46:270-283.
7. Garbe C, Eigentler TK, Keilholz U, Hauschild A, Kirkwood JM Systematic review of medical treatment in melanoma: current status and future prospects. Oncologist 2011, 16:5-24.
8. Lebbé C, Maio M, Ascierto P, et al. Treatment patterns and outcomes among patients diagnosed with unresectable stage III or IV melanoma in Europe: a retrospective, longitudinal survey (MELODY study). Eur J Oncology 2012, published online June 26. 10.1016/j.ejca.2012.05.010.
9. 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.
10. Margolin K, Ernstoff MS, Hamid O, et al. Ipilimumab in patients with melanoma and brain metastases: an open-label, phase 2 trial. Lancet Oncol 2012, 13:459-465.
11. Weber JS, Amin A, Minor D, Siegel J, Berman D, O'Day SJ Safety and clinical activity of ipilimumab in melanoma patients with brain metastases: retrospective analysis of data from a phase 2 trial. Melanoma Res 2011, 21:530-534.
12. Robert C, Thomas L, Bondarenko I, et al. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med 2011, 364:2517-2526.
13. Lipson EJ, Drake CG Ipilimumab: an anti-CTLA-4 antibody for metastatic melanoma. Clin Cancer Res 2011, 17:6958-6962.
14. 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.
15. Quereux G, Dreno B Fotemustine for the treatment of melanoma. Expert Opin Pharmacother 2011, 12:2891-2904.
16. Wolchok JD, Hoos A, O'Day S, et al. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res 2009, 15:7412-7420.
17. O'Day SJ, Maio M, Chiarion-Sileni V, et al. Efficacy and safety of ipilimumab monotherapy in patients with pretreated advanced melanoma: a multicenter single-arm phase II study. Ann Oncol 2010, 21:1712-1717.
18. Weber J, Thompson JA, Hamid O, et al. A randomized, double-blind, placebo-controlled, phase II study comparing the tolerability and efficacy of ipilimumab administered with or without prophylactic budesonide in patients with unresectable stage III or IV melanoma. Clin Cancer Res 2009, 15:5591-5598.
19. 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.
20. A'Hern RP Sample size tables for exact single-stage phase II designs. Stat Med 2001, 20:859-866.
21. Clopper CJ, Pearson ES The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika 1934, 26:404-413.
22. Brookmeyer R, Crowley J A confidence interval for the median survival time. Biometrics 1982, 38:29-41.
23. Pennock GK, Waterfield W, Wolchok JD Patient responses to ipilimumab, a novel immunopotentiator for metastatic melanoma: how different are these from conventional treatment responses?. Am J Clin Oncol 2011, published online Feb 17. 10.1097/COC.0b013e318209cda9.
24. Agarwala SS, Keilholz U, Gilles E, et al. LDH correlation with survival in advanced melanoma from two large, randomised trials (Oblimersen GM301 and EORTC 18951). Eur J Cancer 2009, 45:1807-1814.
25. Peters S, Voelter V, Zografos L, et al. Intra-arterial hepatic fotemustine for the treatment of liver metastases from uveal melanoma: experience in 101 patients. Ann Oncol 2006, 17:578-583.
26. Jacquillat C, Khayat D, Banzet P, et al. Final report of the French multicenter phase II study of the nitrosourea fotemustine in 153 evaluable patients with disseminated malignant melanoma including patients with cerebral metastases. Cancer 1990, 66:1873-1878.
27. Di Giacomo AM, Danielli R, Calabro L, et al. Ipilimumab experience in heavily pretreated patients with melanoma in an expanded access program at the University Hospital of Siena (Italy). Cancer Immunol Immunother 2011, 60:467-477.
28. Ku GY, Yuan J, Page DB, et al. Single-institution experience with ipilimumab in advanced melanoma patients in the compassionate use setting: lymphocyte count after 2 doses correlates with survival. Cancer 2010, 116:1767-1775.
29. Sarnaik AA, Yu B, Yu D, et al. Extended dose ipilimumab with a peptide vaccine: immune correlates associated with clinical benefit in patients with resected high-risk stage IIIc/IV melanoma. Clin Cancer Res 2011, 17:896-906.
30. Turrisi G, Sozzi P, Marinozzi C, Clerico MA Persistent thrombocytopenia during melanoma treatment with fotemustine. Melanoma Res 2006, 16:543-544.
31. Raizer JJ, Hwu WJ, Panageas KS, et al. Brain and leptomeningeal metastases from cutaneous melanoma: survival outcomes based on clinical features. Neuro Oncol 2008, 10:199-207.