Clinical experience with ipilimumab 10 mg/kg in patients with melanoma treated at Italian centres as part of a European expanded access programme

Journal of Experimental and Clinical Cancer Research

Volumn 32, Issue 1, 2013, Pages

  Altomonte, Maresa ^a   Di Giacomo, Anna Maria ^a   Queirolo, Paola ^b   Ascierto, Paolo Antonio ^c   Spagnolo, Francesco ^b   Bajetta, Emilio ^d   Calabrò, Luana ^a   Danielli, Riccardo ^a   De Rosa, Francesco ^e   Maur, Michela ^f   Chiarion Sileni, Vanna ^g   Ferrucci, Pier Francesco ^h   Giannarelli, Diana ⁱ   Testori, Alessandro ^h   Ridolfi, Ruggero ^e   Maio, Michele ^a  

^a UNIVERSITY HOSPITAL OF SIENA   (Italy)

^b UNIVERSITY OF GENOA   (Italy)

^c NATIONAL CANCER INSTITUTE   (Italy)

^d Istituto di Oncologia   (Italy)

^e DEPARTMENT OF MEDICAL ONCOLOGY   (Italy)

^f UNIVERSITY OF MODENA AND REGGIO EMILIA   (Italy)

^g VENETO INSTITUTE OF ONCOLOGY IOV IRCCS   (Italy)

^h EUROPEAN INSTITUTE OF ONCOLOGY   (Italy)

ⁱ REGINA ELENA NATIONAL CANCER INSTITUTE   (Italy)

Author keywords

Compassionate use; Expanded access programme; Ipilimumab; Metastatic melanoma

Indexed keywords

IPILIMUMAB;

ANEMIA; ANOREXIA; ARTICLE; ASTHENIA; BRAIN METASTASIS; CANCER CONTROL; CLINICAL PRACTICE; CLINICAL PROTOCOL; COMPASSIONATE USE; CONFUSION; CONSTIPATION; COUGHING; DERMATITIS; DIARRHEA; DISEASE COURSE; DRUG EFFICACY; DRUG ERUPTION; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DYSGEUSIA; DYSPNEA; EDEMA; EPIGASTRIC PAIN; FATIGUE; FEMALE; FLU LIKE SYNDROME; FOLLOW UP; HERPES ZOSTER; HERPES ZOSTER OPHTHALMICUS; HUMAN; HYPERTHYROIDISM; HYPOCALCEMIA; HYPOTHYROIDISM; INFECTION; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; MELANOMA; METASTASIS; NAUSEA; OVERALL SURVIVAL; PAIN; PANCYTOPENIA; PATIENT MONITORING; PENILE BLEEDING; PHYSICIAN; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PRURITUS; RETROSPECTIVE STUDY; SCROTAL PAIN; TREATMENT RESPONSE; WORLD HEALTH ORGANIZATION;

ADULT; AGED; ANTIBODIES, MONOCLONAL; CLINICAL TRIALS, PHASE III AS TOPIC; COMPASSIONATE USE TRIALS; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; ITALY; MALE; MELANOMA; MIDDLE AGED; PROGNOSIS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RETROSPECTIVE STUDIES; SURVIVAL ANALYSIS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84886119112     PISSN: None     EISSN: 17569966     Source Type: Journal    
DOI: 10.1186/1756-9966-32-82     Document Type: Article

References (28)

1. Current systemic therapy for metastatic melanoma. Agarwala SS, Expert Rev Anticancer Ther 2009 9 587 595 10.1586/era.09.25 19445576.
2. Final version of 2009 AJCC melanoma staging and classification. Balch CM, Gershenwald JE, Soong SJ, Thompson JF, Atkins MB, Byrd DR, Buzaid AC, Cochran AJ, Coit DG, Ding S, Eggermont AM, Flaherty KT, Gimotty PA, Kirkwood JM, McMasters KM, Mihm MC Jr, Morton DL, Ross MI, Sober AJ, Sondak VK, J Clin Oncol 2009 27 6199 6206 10.1200/JCO.2009.23.4799 19917835.
3. Cutaneous melanoma: available therapy for metastatic disease. Tarhini AA, Agostara B, Dermatol Ther 2006 19 19 25 10.1111/j.1529-8019.2005.00052.x 16405566.
4. The cost of unresectable stage III or stage IV melanoma in Italy. Maio M, Ascierto P, Testori A, Ridolfi R, Bajetta E, Queirolo P, Guida M, Romanini A, Chiarion-Sileni V, Pigozzo J, Di Giacomo AM, Calandriello M, Didoni G, van Baardewijk M, Konto C, Lucioni C, J Exp Clin Cancer Res 2012 31 91 103 10.1186/1756-9966-31-91 23116062.
5. Updated swiss guidelines for the treatment and follow-up of cutaneous melanoma. Dummer R, Guggenheim M, Arnold AW, Braun R, von Moos R, Project Group Melanoma of the Swiss Group for Clinical Cancer Research, Swiss Med Wkly 2011 141 13320 22180245.
6. Therapy for metastatic melanoma: the past, present, and future. Finn L, Markovic SN, Joseph RW, BMC Med 2012 10 23 10.1186/1741-7015-10-23 22385436.
7. Anti-cytotoxic T-lymphocyte antigen-4 antibody: the first in an emerging class of immunomodulatory antibodies for cancer treatment. Fong L, Small EJ, J Clin Oncol 2008 26 5275 5283 10.1200/JCO.2008.17.8954 18838703.
8. A prospective phase II trial exploring the association between tumor microenvironment biomarkers and clinical activity of ipilimumab in advanced melanoma. Hamid O, Schmidt H, Nissan A, Ridolfi L, Aamdal S, Hansson J, Guida M, Hyams DM, Gómez H, Bastholt L, Chasalow SD, Berman D, J Transl Med 2011 9 204 10.1186/1479-5876-9-204 22123319.
9. Efficacy and safety of ipilimumab monotherapy in patients with pretreated advanced melanoma: a multicenter single-arm phase II study. O'Day SJ, Maio M, Chiarion-Sileni V, Gajewski TF, Pehamberger H, Bondarenko IN, Queirolo P, Lundgren L, Mikhailov S, Roman L, Verschraegen C, Humphrey R, Ibrahim R, de Pril V, Hoos A, Wolchok JD, Ann Oncol 2010 21 1712 1717 10.1093/annonc/mdq013 20147741.
10. CTLA-4 blockade with ipilimumab: long-term follow-up of 177 patients with metastatic melanoma. Prieto PA, Yang JC, Sherry RM, Hughes MS, Kammula US, White DE, Levy CL, Rosenberg SA, Phan GQ, Clin Cancer Res 2012 18 2039 2047 10.1158/1078-0432.CCR-11-1823 22271879.
11. 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. Weber J, Thompson JA, Hamid O, Minor D, Amin A, Ron I, Ridolfi R, Assi H, Maraveyas A, Berman D, Siegel J, O'Day SJ, Clin Cancer Res 2009 15 5591 5598 10.1158/1078-0432.CCR-09-1024 19671877.
12. Ipilimumab monotherapy in patients with pretreated advanced melanoma: a randomised, double-blind, multicentre, phase 2, dose-ranging study. Wolchok JD, Neyns B, Linette G, Negrier S, Lutzky J, Thomas L, Waterfield W, Schadendorf D, Smylie M, Guthrie T Jr, Grob JJ, Chesney J, Chin K, Chen K, Hoos A, O'Day SJ, Lebbé C, Lancet Oncol 2010 11 155 164 10.1016/S1470-2045(09)70334-1 20004617.
13. Improved survival with ipilimumab in patients with metastatic melanoma. Hodi FS, O'Day SJ, McDermott DF, Weber RW, Sosman JA, Haanen JB, Gonzalez R, Robert C, Schadendorf D, Hassel JC, Akerley W, van den Eertwegh AJ, Lutzky J, Lorigan P, Vaubel JM, Linette GP, Hogg D, Ottensmeier CH, Lebbé C, Peschel C, Quirt I, Clark JI, Wolchok JD, Weber JS, Tian J, Yellin MJ, Nichol GM, Hoos A, Urba WJ, N Engl J Med 2010 363 711 723 10.1056/NEJMoa1003466 20525992.
14. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. Robert C, Thomas L, Bondarenko I, O'Day S, Weber J, Garbe C, Lebbe C, Baurain JF, Testori A, Grob JJ, Davidson N, Richards J, Maio M, Hauschild A, Miller WH Jr, Gascon P, Lotem M, Harmankaya K, Ibrahim R, Francis S, Chen TT, Humphrey R, Hoos A, Wolchok JD, N Engl J Med 2011 364 2517 2526 10.1056/NEJMoa1104621 21639810.
15. Long-term survival in patients with metastatic melanoma who received ipilimumab in four phase II trials [abstract]. Lebbe C, Weber JS, Maio M, Neyns B, Harmankaya K, Hamid O, O'Day S, Chin KM, Opatt McDowell D, Cykowski L, McHenry B, Wolchok JD, Lebbe C, Weber JS, Maio M, Neyns B, Harmankaya K, Hamid O, O'Day S, Chin KM, Opatt McDowell D, Cykowski L, McHenry B, Wolchok JD, J Clin Oncol 2013 31 561s.
16. Four-year survival update for metastatic melanoma patients treated with ipilimumab plus dacarbazine in phase 3 study CA184-024 [abstract]. Maio M, Bondarenko I, Robert C, Thomas L, Garbe C, Testori A, Francis S, Chin K, Wolchok J, Ann Oncol 2012 23 x367 10.1093/annonc/mdr122.
17. Characteristics and management of immunerelated adverse effects associated with ipilimumab, a new immunotherapy for metastatic melanoma. Andrews S, Holden R, Cancer Manag Res 2012 4 299 307 23049279.
18. The emerging toxicity profiles of anti-CTLA-4 antibodies across clinical indications. Di Giacomo AM, Biagioli M, Maio M, Semin Oncol 2010 37 499 507 10.1053/j.seminoncol.2010.09.007 21074065.
19. Management of immune-related adverse events and kinetics of response with ipilimumab. Weber JS, Kahler KC, Hauschild A, J Clin Oncol 2012 30 2691 2697 10.1200/JCO.2012.41.6750 22614989.
20. Ipilimumab experience in heavily pretreated patients with melanoma in an expanded access program at the university hospital of Siena (Italy). Di Giacomo AM, Danielli R, Calabro L, Bertocci E, Nannicini C, Giannarelli D, Balestrazzi A, Vigni F, Riversi V, Miracco C, Biagioli M, Altomonte M, Maio M, Cancer Immunol Immunother 2011 60 467 477 10.1007/s00262-010-0958-2 21170646.
21. Long-term survival and immunological parameters in metastatic melanoma patients who responded to ipilimumab 10 mg/kg within an expanded access programme. Di Giacomo AM, Calabrò L, Danielli R, Fonsatti E, Bertocci E, Pesce I, Fazio C, Cutaia O, Giannarelli D, Miracco C, Biagioli M, Altomonte M, Maio M, Cancer Immunol Immunother 2013 62 1021 1028 10.1007/s00262-013-1418-6 23591982.
22. Pooled analysis of long-term survival data from phase II and phase III trials of ipilimumab in metastatic or locally advanced, unresectable melanoma. Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Chen TT, Berman DM, Wolchok JD, Eur J Cancer 2013 49 2 24LBA.
23. 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. Korn EL, Liu PY, Lee SJ, Chapman JA, Niedzwiecki D, Suman VJ, Moon J, Sondak VK, Atkins MB, Eisenhauer EA, Parulekar W, Markovic SN, Saxman S, Kirkwood JM, J Clin Oncol 2008 26 527 534 10.1200/JCO.2007.12.7837 18235113. (Pubitemid 351264344)
24. Improved endpoints for cancer immunotherapy trials. Hoos A, Eggermont AM, Janetzki S, Hodi FS, Ibrahim R, Anderson A, Humphrey R, Blumenstein B, Old L, Wolchok J, J Natl Cancer Inst 2010 102 1388 1397 10.1093/jnci/djq310 20826737.
25. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Wolchok JD, Hoos A, O'Day S, Weber JS, Hamid O, Lebbé C, Maio M, Binder M, Bohnsack O, Nichol G, Humphrey R, Hodi FS, Clin Cancer Res 2009 15 7412 7420 10.1158/1078-0432.CCR-09-1624 19934295.
26. Patient responses to ipilimumab, a novel immunopotentiator for metastatic melanoma: how different are these from conventional treatment responses? Pennock GK, Waterfield W, Wolchok JD, Am J Clin Oncol 2012 35 606 611 10.1097/COC.0b013e318209cda9 21336089.
27. Immunotherapy and the concept of a clinical cure. Eggermont AM, Kroemer G, Zitvogel L, Eur J Cancer 2013 49 2965 2967 10.1016/j.ejca.2013.06.019 23890942.
28. Treatment and side effect management of CTLA-4 antibody therapy in metastatic melanoma. Kahler KC, Hauschild A, J Dtsch Dermatol Ges 2011 9 277 286 21083648.