Outcome and biomarker analysis from a multicenter phase 2 study of ipilimumab in combination with carboplatin and etoposide as first-line therapy for extensive-stage SCLC

Journal of Thoracic Oncology

Volumn 11, Issue 9, 2016, Pages 1511-1521

  Arriola, Edurne ^a   Wheater, Matthew ^b   Galea, Ian ^c   Cross, Nadia ^a   Maishman, Tom ^a   Hamid, Debbie ^a   Stanton, Louise ^a   Cave, Judith ^b   Geldart, Tom ^d   Mulatero, Clive ^e   Potter, Vannessa ^f   Danson, Sarah ^g   Woll, Pennella J ^g   Griffiths, Richard ^h   Nolan, Luke ^b   Ottensmeier, Christian ^a  

^a UNIVERSITY OF SOUTHAMPTON   (United Kingdom)

^b UNIVERSITY HOSPITAL SOUTHAMPTON NHS FOUNDATION TRUST   (United Kingdom)

^c UNIVERSITY OF SOUTHAMPTON   (United Kingdom)

^d POOLE HOSPITAL NHS FOUNDATION TRUST   (United Kingdom)

^e ST JAMES S UNIVERSITY HOSPITAL   (United Kingdom)

^f NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST   (United Kingdom)

^g WESTON PARK HOSPITAL   (United Kingdom)

^h CLATTERBRIDGE CENTRE FOR ONCOLOGY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ALKALINE PHOSPHATASE; ANTINUCLEAR ANTIBODY; AUTOANTIBODY; CARBOPLATIN; ETOPOSIDE; IPILIMUMAB; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY; TUMOR MARKER;

ADULT; AGED; AGITATION; ANEMIA; ANTIBODY BLOOD LEVEL; ARTICLE; AUTOIMMUNE DISEASE; BRAIN DISEASE; CANCER COMBINATION CHEMOTHERAPY; CANCER RADIOTHERAPY; CLINICAL ARTICLE; CLINICAL OUTCOME; COLITIS; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DYSPNEA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FOLLOW UP; HEADACHE; HUMAN; HYPERGLYCEMIA; HYPONATREMIA; INFECTION; LYMPHOCYTE COUNT; MALE; MULTIPLE CYCLE TREATMENT; MUSCLE WEAKNESS; NEUROLOGIC DISEASE; NEUROPATHY; NEUTROPHIL COUNT; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RASH; RESPONSE EVALUATION CRITERIA IN SOLID TUMORS; RETROSPECTIVE STUDY; SEPSIS; SIDE EFFECT; SMALL CELL LUNG CANCER; THROMBOCYTOPENIA; THROMBOEMBOLISM; TREATMENT RESPONSE; BLOOD; CANCER STAGING; CLINICAL TRIAL; LUNG NEOPLASMS; MIDDLE AGED; MORTALITY; MULTICENTER STUDY; PATHOLOGY; SMALL CELL LUNG CARCINOMA; TREATMENT OUTCOME; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; AUTOANTIBODIES; BIOMARKERS, TUMOR; CARBOPLATIN; ETOPOSIDE; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM STAGING; SMALL CELL LUNG CARCINOMA; TREATMENT OUTCOME;

EID: 84987849612     PISSN: 15560864     EISSN: 15561380     Source Type: Journal    
DOI: 10.1016/j.jtho.2016.05.028     Document Type: Article

References (43)

1. Oze I, Hotta K, Kiura K, et al. Twenty-seven years of phase III trials for patients with extensive disease smallcell lung cancer: disappointing results. PloS One. 2009;4:e7835.
2. Slotman BJ, van Tinteren H, Praag JO, et al. Use of thoracic radiotherapy for extensive stage small-cell lung cancer: A phase 3 randomised controlled trial. Lancet. 2015;385:36-42.
3. Ettinger DS, Finkelstein DM, Abeloff MD, et al. A randomized comparison of standard chemotherapy versus alternating chemotherapy and maintenance versus no maintenance therapy for extensive-stage small-cell lung cancer: A phase III study of the Eastern Cooperative Oncology Group. J Clin Oncol. 1990;8: 230-240.
4. Arnold AM, Seymour L, Smylie M, et al. Phase II study of vandetanib or placebo in small-cell lung cancer patients after complete or partial response to induction chemotherapy with or without radiation therapy: National Cancer Institute of Canada Clinical Trials Group Study BR.20. J Clin Oncol. 2007;25:4278-4284.
5. Pujol JL, Breton JL, Gervais R, et al. Phase III doubleblind, placebo-controlled study of thalidomide in extensive-disease small-cell lung cancer after response to chemotherapy: An intergroup study FNCLCC cleo04 IFCT 00-01. J Clin Oncol. 2007;25:3945-3951.
6. Ready NE, Pang HH, Gu L, et al. Chemotherapy with or without maintenance sunitinib for untreated extensivestage small-cell lung cancer: A randomized, doubleblind, placebo-controlled phase II study-CALGB 30504 (Alliance). J Clin Oncol. 2015;33:1660-1665.
7. Lee SM, Woll PJ, Rudd R, et al. Anti-Angiogenic therapy using thalidomide combined with chemotherapy in small cell lung cancer: A randomized, double-blind, placebocontrolled trial. J Natl Cancer Inst. 2009;101:1049-1057.
8. Schadendorf D, Hodi FS, Robert C, et al. Pooled analysis of long-Term survival data from phase II and phase III trials of Ipilimumab in unresectable or metastatic melanoma. J Clin Oncol. 2015;33:1889-1894.
9. Postow MA, Chesney J, Pavlick AC, et al. Nivolumab and ipilimumab versus ipilimumab in untreated melanoma. N Engl J Med. 2015;372:2006-2017.
10. Garon EB, Rizvi NA, Hui R, et al. Pembrolizumab for the treatment of non-small-cell lung cancer. N Engl J Med. 2015;372:2018-2028.
11. Borghaei H, Paz-Ares L, Horn L, et al. Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer. N Engl J Med. 2015;373:1627-1639.
12. Darnell RB, Posner JB. Paraneoplastic syndromes involving the nervous system. N Engl J Med. 2003;349:1543-1554.
13. Roberts WK, Deluca IJ, Thomas A, et al. Patients with lung cancer and paraneoplastic Hu syndrome harbor HuD-specific type 2 CD8 T cells. J Clin Invest. 2009;119:2042-2051.
14. Maddison P, Newsom-Davis J, Mills KR, et al. Favourable prognosis in Lambert-Eaton myasthenic syndrome and small-cell lung carcinoma. Lancet. 1999;353:117-118.
15. Wirtz PW, Lang B, Graus F, et al. P/Q-Type calcium channel antibodies, Lambert-Eaton myasthenic syndrome and survival in small cell lung cancer. J Neuroimmunol. 2005;164:161-165.
16. Pignolet BS, Gebauer CM, Liblau RS. Immunopathogenesis of paraneoplastic neurological syndromes associated with anti-Hu antibodies: A beneficial antitumor immune response going awry. Oncoimmunology. 2013;2:e27384. http://dx.doi.org/10.4161/onci.27384.
17. Thompson CB, Allison JP. The emerging role of CTLA-4 as an immune attenuator. Immunity. 1997;7:445-450.
18. Romano E, Kusio-Kobialka M, Foukas PG, et al. Ipilimumabdependent cell-mediated cytotoxicity of regulatory Tcells ex vivo by nonclassical monocytes in melanoma patients. Proc Natl Acad Sci U S A. 2015;112:6140-6145.
19. 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.
20. Maio M, Grob JJ, Aamdal S, et al. Five-year survival rates for treatment-naive patients with advanced melanoma who received ipilimumab plus dacarbazine in a phase III trial. J Clin Oncol. 2015;33:1191-1196.
21. Ma Y, Kepp O, Ghiringhelli F, et al. Chemotherapy and radiotherapy: cryptic anticancer vaccines. Semin Immunol. 2010;22:113-124.
22. Reck M, Bondarenko I, Luft A, et al. Ipilimumab in combination with paclitaxel and carboplatin as first-line therapy in extensive-disease-small-cell lung cancer: Results from a randomized, double-blind, multicenter phase 2 trial. Ann Oncol. 2013;24:75-83.
23. 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.
24. Mason WP, Graus F, Lang B, et al. Small-cell lung cancer, paraneoplastic cerebellar degeneration and the Lambert-Eaton myasthenic syndrome. Brain. 1997;120:1279-1300.
25. Shillito P, Molenaar PC, Vincent A, et al. Acquired neuromyotonia: Evidence for autoantibodies directed against K channels of peripheral nerves. Ann Neurol. 1995;38:714-722.
26. Chapman CJ, Thorpe AJ, Murray A, et al. Immunobiomarkers in small cell lung cancer: potential early cancer signals. Clin Cancer Res. 2011;17:1474-1480.
27. Brown LD, Cai TT, DasGupta A. Interval estimation for a binomial proportion. Statistical Science. 2001;16: 101-117.
28. 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.
29. Antonia SJ, Bendel JC, Taylor MH, et al. Phase I/II study of nivolumab with or without ipilimumab for treatment of recurrent small cell lung cancer (SCLC) [abstract]. J Clin Oncol. 2015;33(suppl):7503.
30. Gozzard P, Woodhall M, Chapman C, et al. Paraneoplastic neurologic disorders in small cell lung carcinoma: A prospective study. Neurology. 2015;85:235-239.
31. Titulaer MJ, Klooster R, Potman M, et al. SOX antibodies in small-cell lung cancer and Lambert-Eaton myasthenic syndrome: frequency and relation with survival. J Clin Oncol. 2009;27:4260-4267.
32. Graus F, Keime-Guibert F, Rene R, et al. Anti-Huassociated paraneoplastic encephalomyelitis: Analysis of 200 patients. Brain. 2001;124:1138-1148.
33. Maddison P, Thorpe A, Silcocks P, et al. Autoimmunity to SOX2, clinical phenotype and survival in patients with small-cell lung cancer. Lung Cancer. 2010;70:335-339.
34. Tani T, Tanaka K, Idezuka J, et al. Regulatory T cells in paraneoplastic neurological syndromes. J Neuroimmunol. 2008;196:166-169.
35. Read S, Greenwald R, Izcue A, et al. Blockade of CTLA-4 on CD4CD25 regulatory T cells abrogates their function in vivo. J Immunol. 2006;177:4376-4383.
36. Selby MJ, Engelhardt JJ, Quigley M, et al. Anti-CTLA-4 antibodies of IgG2a isotype enhance antitumor activity through reduction of intratumoral regulatory T cells. Cancer Immunol Res. 2013;1:32-42.
37. Chiou VL, Burotto M. Pseudoprogression and immunerelated response in solid tumors. J Clin Oncol. 2015;33: 3541-3543.
38. Monstad SE, Drivsholm L, Storstein A, et al. Hu and voltage-gated calcium channel (VGCC) antibodies related to the prognosis of small-cell lung cancer. J Clin Oncol. 2004;22:795-800.
39. Gozzard P, Chapman C, Vincent A, et al. Novel humoral prognostic markers in small-cell lung carcinoma: A prospective study. PloS One. 2015;10:e0143558.
40. Vural B, Chen LC, Saip P, et al. Frequency of SOX Group B (SOX1, 2, 3) and ZIC2 antibodies in Turkish patients with small cell lung carcinoma and their correlation with clinical parameters. Cancer. 2005;103: 2575-2583.
41. Darnell RB, DeAngelis LM. Regression of small-cell lung carcinoma in patients with paraneoplastic neuronal antibodies. Lancet. 1993;341:21-22.
42. Darnell RB, Posner JB. Observing the invisible: successful tumor immunity in humans. Nat Immunol. 2003;4:201.
43. Graus F, Dalmou J, Rene R, et al. Anti-Hu antibodies in patients with small-cell lung cancer: Association with complete response to therapy and improved survival. J Clinical Oncol. 1997;15:2866-2872.