Tremelimumab for patients with chemotherapy-resistant advanced malignant mesothelioma: An open-label, single-arm, phase 2 trial

The Lancet Oncology

Volumn 14, Issue 11, 2013, Pages 1104-1111

  Calabrò, Luana ^a   Morra, Aldo ^b   Fonsatti, Ester ^a   Cutaia, Ornella ^a   Amato, Giovanni ^a   Giannarelli, Diana ^c   Di Giacomo, Anna Maria ^a   Danielli, Riccardo ^a   Altomonte, Maresa ^a   Mutti, Luciano ^d   Maio, Michele ^a  

^a UNIVERSITY HOSPITAL OF SIENA   (Italy)

^b Euganea Medica Diagnostic Centre   (Italy)

^c REGINA ELENA NATIONAL CANCER INSTITUTE   (Italy)

^d Department of General Medicine   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

IMMUNOGLOBULIN; PEMETREXED; PLATINUM COMPLEX; STEROID; TICILIMUMAB;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ARTHRALGIA; ARTICLE; CANCER CONTROL; CANCER RESISTANCE; CLINICAL ARTICLE; COLITIS; DIARRHEA; DRUG EFFECT; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EOSINOPHILIA; FEMALE; FEVER; GASTROINTESTINAL DISEASE; HUMAN; HUMAN CELL; HYPERAMYLASEMIA; LIVER DISEASE; LIVER TOXICITY; MALE; MALIGNANT MESOTHELIOMA; NEUROLOGIC DISEASE; NEUTROPENIA; OPEN STUDY; OVERALL SURVIVAL; PANCREAS DISEASE; PERIPHERAL NEUROPATHY; PERITONEUM MESOTHELIOMA; PHASE 2 CLINICAL TRIAL; PLEURA MESOTHELIOMA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PRURITUS; RASH; SIDE EFFECT; SKIN DISEASE;

AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; CTLA-4 ANTIGEN; DRUG RESISTANCE, NEOPLASM; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MESOTHELIOMA; MIDDLE AGED; NEOPLASM STAGING; PLEURAL NEOPLASMS; PROGNOSIS; SALVAGE THERAPY; SURVIVAL RATE;

EID: 84884703526     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(13)70381-4     Document Type: Article

References (31)

1. Robinson BW, Lake RA Advances in malignant mesothelioma. N Engl J Med 2005, 353:1591-1603.
2. Ceresoli G, Gridelli C, Santoro A Multidisciplinary treatment of malignant pleural mesothelioma. Oncologist 2007, 12:850-863.
3. Vogelzang NJ, Rusthoven JJ, Symanowski J, et al. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol 2003, 21:2636-2644.
4. Ceresoli GL, Zucali PA, Gianoncelli L, Lorenzi E, Santoro A Second-line treatment for malignant pleural mesothelioma. Cancer Treat Rev 2010, 36:24-32.
5. Jassem J, Ramlau R, Santoro A, et al. Phase III trial of pemetrexed plus best supportive care compared with best supportive care in previously treated patients with advanced malignant pleural mesothelioma. J Clin Oncol 2008, 26:1698-1704.
6. Grégoire M What's the place of immunotherapy in malignant mesothelioma treatments?. Cell Adh Migr 2010, 4:153-161.
7. Cornelissen R, Heuvers ME, Maat AP, et al. New roads open up for implementing immunotherapy in mesothelioma. Clin Dev Immunol 2012, 2012:927240.
8. Calabrò L, Danielli R, Sigalotti L, Maio M Clinical studies with anti-CTLA-4 antibodies in non-melanoma indications. Semin Oncol 2010, 37:460-467.
9. Hoos A, Ibrahim R, Korman A, et al. Development of ipilimumab: contribution to a new paradigm for cancer immunotherapy. Semin Oncol 2010, 37:46-53.
10. Lynch TJ, Bondarenko I, Luft A, et al. Ipilimumab in combination with paclitaxel and carboplatin as first-line treatment in stage IIIB/IV non-small-cell lung cancer: results from a randomized, double-blind, multicenter phase II study. J Clin Oncol 2012, 30:2046-2054.
11. Robert C, Thomas L, Bondarenko I, et al. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med 2011, 364:2517-2526.
12. 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.
13. Lebbe C, Weber JS, Maio M, et al. Five-year survival rates for patients (pts) with metastatic melanoma (MM) treated with ipilimumab (ipi) in phase II trials. Ann Oncol 2012, 23. abstr 1116PD.
14. Maio M, Bondarenko I, Robert C, et al. Four-year survival update for metastatic melanoma (MM) patients (pts) treated with ipilimumab (ipi) plus dacarbazine (DTIC) on phase 3 study CA184-024. Ann Oncol 2012, 23. abstr 1127P.
15. Ribas A Clinical development of the anti-CTLA-4 antibody tremelimumab. Semin Oncol 2010, 37:450-454.
16. Ribas A, Kefford R, Marshall MA, et al. Phase III randomized, clinical trial comparing tremelimumab with standard-of-care chemotherapy in patients with advanced melanoma. J Clin Oncol 2013, 31:616-622.
17. Tarhini AA, Cherian J, Moschos SJ, et al. Safety and efficacy of combination immunotherapy with interferon alfa-2b and tremelimumab in patients with stage IV melanoma. J Clin Oncol 2012, 30:322-328.
18. Callahan MK, Wolchok JD, Allison JP Anti-CTLA-4 antibody therapy: immune monitoring during clinical development of a novel immunotherapy. Semin Oncol 2010, 37:473-484.
19. Byrne MJ, Nowak AK Modified RECIST criteria for assessment of response in malignant pleural mesothelioma. Ann Oncol 2004, 15:257-260.
20. Curran D, Sahmoud T, Therasse P, van Meerbeeck J, Postmus PE, Giaccone G Prognostic factors in patients with pleural mesothelioma: the European Organisation for Research and Treatment of Cancer experience. J Clin Oncol 1998, 16:145-152.
21. Coral S, Sigalotti L, Gasparollo A, et al. Prolonged upregulation of the expression of HLA class I antigens and costimulatory molecules on melanoma cells treated with 5-aza-2'-deoxycytidine (5-AZA-CdR). J Immunother 1999, 22:16-24.
22. 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.
23. Zucali PA, Simonelli M, Michetti G, et al. Second-line chemotherapy in malignant pleural mesothelioma: results of a retrospective multicenter survey. Lung Cancer 2012, 75:360-367.
24. Di Giacomo AM, Calabrò L, Danielli R, et al. Long-term survival and immunological parameters in metastatic melanoma patients who responded to ipilimumab 10 mg/kg within an expanded access programme. Cancer Immunol Immunother 2013, 62:1021-1028.
25. Di Giacomo AM, Biagioli M, Maio M The emerging toxicity profiles of anti-CTLA4 antibodies across clinical indications. Semin Oncol 2010, 37:499-507.
26. Weber JS, Kähler KC, Hauschild A Management of immune-related adverse events and kinetics of response with ipilimumab. J Clin Oncol 2012, 30:2691-2697.
27. Voskens CJ, Goldinger SM, Loquai C, et al. The price of tumor control: an analysis of rare side effects of anti-CTLA-4 therapy in metastatic melanoma from the ipilimumab network. PLoS One 2013, 8:e53745.
28. Carthon BC, Wolchok JD, Yuan J, et al. Preoperative CTLA-4 blockade: tolerability and immune monitoring in the setting of a presurgical clinical trial. Clin Cancer Res 2010, 16:2861-2871.
29. Vonderheide RH, LoRusso PM, Khalil M, et al. Tremelimumab in combination with exemestane in patients with advanced breast cancer and treatment-associated modulation of inducible costimulator expression on patient T cells. Clin Cancer Res 2010, 16:3485.
30. Weber JS, Hamid O, Chasalow SD, et al. Ipilimumab increases activated T cells and enhances humoral immunity in patients with advanced melanoma. J Immunother 2012, 35:89-97.
31. Lesterhuis WJ, Salmons J, Nowak AK, et al. Synergistic effect of CTLA-4 blockade and cancer chemotherapy in the induction of anti-tumor immunity. PloS One 2013, 8:e61895.