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Phase III Randomized Trial of Ipilimumab Plus Etoposide and Platinum Versus Placebo Plus Etoposide and Platinum in Extensive-Stage Small-Cell Lung Cancer
Abstract
Purpose: Patients with extensive-stage disease small-cell lung cancer (SCLC) have poor survival outcomes despite first-line chemotherapy with etoposide and platinum. This randomized, double-blind phase III study evaluated the efficacy and safety of ipilimumab or placebo plus etoposide and platinum in patients with newly diagnosed extensive-stage disease SCLC. Patients and Methods: Patients were randomly assigned at a ratio of one to one to receive chemotherapy with etoposide and platinum (cisplatin or carboplatin) plus ipilimumab 10 mg/kg or placebo every 3 weeks for a total of four doses each in a phased induction schedule (chemotherapy in cycles one to four; ipilimumab or placebo beginning in cycle three up to cycle six), followed by ipilimumab or placebo maintenance every 12 weeks. Primary end point was overall survival (OS) among patients receiving at least one dose of blinded study therapy. Results: Of 1,132 patients randomly assigned, 954 received at least one dose of study therapy (chemotherapy plus ipilimumab, n = 478; chemotherapy plus placebo, n = 476). Median OS was 11.0 months for chemotherapy plus ipilimumab versus 10.9 months for chemotherapy plus placebo (hazard ratio, 0.94; 95% CI, 0.81 to 1.09; P = .3775). Median progression-free survival was 4.6 months for chemotherapy plus ipilimumab versus 4.4 months for chemotherapy plus placebo (hazard ratio, 0.85; 95% CI, 0.75 to 0.97). Rates and severity of treatment-related adverse events were similar between arms, except for diarrhea, rash, and colitis, which were more frequent with chemotherapy plus ipilimumab. Rate of treatment-related discontinuation was higher with chemotherapy plus ipilimumab (18% v 2% with chemotherapy plus placebo). Five treatment-related deaths occurred with chemotherapy plus ipilimumab and two with chemotherapy plus placebo. Conclusion: Addition of ipilimumab to chemotherapy did not prolong OS versus chemotherapy alone in patients with newly diagnosed extensive-stage disease SCLC. No new or unexpected adverse events were observed with chemotherapy plus ipilimumab. Several ongoing studies are evaluating ipilimumab in combination with programmed death-1 inhibitors in SCLC.
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Cites
Improved Survival with Ipilimumab in Patients with Metastatic Melanoma
Hodi, F. S., O'Day, S. J., McDermott, D. F., Weber, R. W., Sosman, J. A., Haanen, J. B., Gonzalez, R., Robert, C., Schadendorf, D., Hassel, J. C., et al. (2010) · New England Journal of Medicine · doi:10.1056/nejmoa1003466 · Cited by 15,155
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Self-citationNivolumab versus Docetaxel in Advanced Squamous-Cell Non–Small-Cell Lung Cancer
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Self-citationCombined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma
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Reporting results of cancer treatment
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Garon, E. B., Rizvi, N. A., Hui, R., Leighl, N., Balmanoukian, A. S., Eder, J. P., Patnaik, A., Aggarwal, C., Gubens, M., Horn, L., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1501824 · Cited by 6,198
Self-citationPembrolizumab versus Ipilimumab in Advanced Melanoma
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Ipilimumab plus Dacarbazine for Previously Untreated Metastatic Melanoma
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Self-citationCancer immunotherapy efficacy and patients' sex: a systematic review and meta-analysis
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Self-citationImmune checkpoint therapy for solid tumours: clinical dilemmas and future trends
Sun, Q., Hong, Z., Zhang, C., Wang, L., Han, Z., & Ma, D. (2023) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-023-01522-4 · Cited by 598
Unravelling the biology of SCLC: implications for therapy
Sabari, J. K., Lok, B. H., Laird, J. H., Poirier, J. T., & Rudin, C. M. (2017) · Nature Reviews Clinical Oncology · doi:10.1038/nrclinonc.2017.71 · Cited by 490
Metadata
- Authors
- Reck, M., Luft, A., Szczesna, A., Havel, L., Kim, S.-W., Akerley, W., Pietanza, M. C., Wu, Y.-L., Zielinski, C., Thomas, M., Felip, E., Gold, K., Horn, L., Aerts, J., Nakagawa, K., Lorigan, P., Pieters, A., Kong Sanchez, T., Fairchild, J., & Spigel, D.
- Venue
- Journal of Clinical Oncology
- Published
- 2016-11-01
- Volume
- 34
- Issue
- 31
- Pages
- 3740-3748
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2480201404
- Cited by
- 538
- References
- 44
- FWCI
- 25.81
- Type
- journal article
- Language
- en
- Open access
- closed
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- Reck, M., Luft, A., Szczesna, A., Havel, L., Kim, S.-W., Akerley, W., Pietanza, M. C., Wu, Y.-L., Zielinski, C., Thomas, M., Felip, E., Gold, K., Horn, L., Aerts, J., Nakagawa, K., Lorigan, P., Pieters, A., Kong Sanchez, T., Fairchild, J., & Spigel, D. (2016). Phase III Randomized Trial of Ipilimumab Plus Etoposide and Platinum Versus Placebo Plus Etoposide and Platinum in Extensive-Stage Small-Cell Lung Cancer. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2016.67.6601
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