Phase II Study of Maintenance Pembrolizumab in Patients with Extensive-Stage Small Cell Lung Cancer (SCLC)

Journal of Thoracic Oncology

Volumn 13, Issue 9, 2018, Pages 1393-1399

  Gadgeel, Shirish M ^a   Pennell, Nathan A ^b   Fidler, Mary Jo ^c   Halmos, Balazs ^d   Bonomi, Philip ^c   Stevenson, James ^b   Schneider, Bryan ^e   Sukari, Ammar ^a   Ventimiglia, Jaclyn ^a   Chen, Wei ^a   Galasso, Cathy ^a   Wozniak, Antoinette ^a   Boerner, Julie ^a   Kalemkerian, Gregory P ^e  

^a KARMANOS CANCER INSTITUTE   (United States)

^b LERNER RESEARCH INSTITUTE   (United States)

^c RUSH UNIVERSITY MEDICAL CENTER   (United States)

^d ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

^e UNIVERSITY OF MICHIGAN   (United States)

Author keywords

Maintenance; Metastatic; Pembrolizumab; SCLC

Indexed keywords

ASPARTATE AMINOTRANSFERASE; ETOPOSIDE; PEMBROLIZUMAB; PLATINUM COMPLEX; PROGRAMMED DEATH 1 LIGAND 1; IMMUNOLOGICAL ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY;

ABDOMINAL PAIN; ADULT; AGED; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BACKACHE; BRAIN METASTASIS; CANCER CHEMOTHERAPY; CANCER STAGING; CANCER SURVIVAL; CIRCULATING TUMOR CELL; CLINICAL ARTICLE; CLINICAL EFFECTIVENESS; CONSTIPATION; COUGHING; DIABETIC KETOACIDOSIS; DIARRHEA; DIZZINESS; DRUG EFFICACY; DRUG SAFETY; DYSPNEA; FATIGUE; FEMALE; HEADACHE; HUMAN; HUMAN CELL; HUMAN TISSUE; HYPONATREMIA; HYPOTHYROIDISM; INSULIN DEPENDENT DIABETES MELLITUS; LYMPHOCYTE COUNT; MAINTENANCE THERAPY; MALE; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROPATHY; OVERALL SURVIVAL; PATIENT ASSESSMENT; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEIN EXPRESSION; PRURITUS; RASH; SEX RATIO; SMALL CELL LUNG CANCER; STROMA; SURVIVAL TIME; THORAX PAIN; TREATMENT DURATION; TUMOR CELL; WEAKNESS; CLINICAL TRIAL; LUNG TUMOR; PATHOLOGY;

AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS, IMMUNOLOGICAL; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; PROGRESSION-FREE SURVIVAL; SMALL CELL LUNG CARCINOMA;

EID: 85049919772     PISSN: 15560864     EISSN: 15561380     Source Type: Journal    
DOI: 10.1016/j.jtho.2018.05.002     Document Type: Article

References (20)

1. American Cancer Society. Key statistics for small cell lung cancer. https://www.cancer.org/cancer/small-cell-lung-cancer/about/key-statistics.html. Accessed April 2, 2018.
2. Ready, N.E., Pang, H.H., Gu, L., et al. Chemotherapy with or without maintenance sunitinib for untreated extensive-stage small-cell lung cancer: a randomized, double-blind, placebo-controlled phase II study- CALGB 30504 (Alliance). J Clin Oncol 33 (2015), 1660–1665.
3. Shin, D.S., Ribas, A., The evolution of checkpoint blockade as a cancer therapy: what's here, what's next?. Curr Opin Immunol 33 (2015), 23–35.
4. Meng, X., Liu, Y., Zhang, J., Teng, F., Xing, L., Yu, J., PD-1 blockade in advanced NSCLC: a focus on pembrolizumab. Cancer Treat Rev 62 (2018), 39–49.
5. Bracci, L., Schiavoni, G., Sistigu, A., Belardelli, F., Immune-based mechanisms of cytotoxic chemotherapy: implications for the design of novel and rationale-based combined treatments against cancer. Cell Death Differ 21 (2014), 15–25.
6. Lesterhuis, W.J., Punt, C.J., Hato, S.V., et al. Platinum-based drugs disrupt STAT6-mediated suppression of immune responses against cancer in humans and mice. J Clin Invest 121 (2011), 3100–3108.
7. Farago, A.F., Keane, F.K., Current standards for clinical management of small cell lung cancer. Transl Lung Cancer Res 7 (2018), 69–79.
8. Rossi, A., Garassino, M.C., Cinquini, M., et al. Maintenance or consolidation therapy in small-cell lung cancer: a systematic review and meta-analysis. Lung Cancer 70 (2010), 119–128.
9. Borghaei, H., Paz-Ares, L., Horn, L., et al. Nivolumab versus docetaxel in advanced non-squamous non-small-cell lung cancer. N Engl J Med 373 (2015), 1627–1639.
10. Rittmeyer, A., Barlesi, F., Waterkamp, D., et al. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicenter randomised controlled trial. Lancet 389 (2017), 255–265.
11. Ott, P.A., Elez, E., Hiret, S., et al. Pembrolizumab in patients with extensive-stage small-cell lung cancer: results from the phase Ib KEYNOTE-028 study. J Clin Oncol 35 (2017), 3823–3829.
12. Hellmann, M.D., Ott, P.A., Zugazagoitia, J., et al. Nivolumab +/- ipilimumab in advanced small-cell lung cancer (SCLC): first report of a randomized expansion cohort from CheckMate 032. [abstract] J Clin Oncol, 35, 2017, 8503.
13. Antonia, S., Callahan, M.K., Awad, M.M., et al. Impact of tumor mutation burden on the efficacy of nivolumab or nivolumab+ipilimumab in small cell lung cancer: an exploratory analysis of CheckMate 032. [abstract] J Thorac Oncol, 12, 2017, OA07.03a.
14. Patel, S.P., Kurzrock, R., PD-L1 expression as a predictive biomarker in cancer immunotherapy. Mol Cancer Ther 14 (2015), 847–856.
15. Yasuda, Y., Ozasa, H., Kim, Y.H., PD-L1 expression in small cell lung cancer. J Thorac Oncol 13 (2018), e40–e41.
16. Lin, H., Wei, S., Hurt, E.M., et al. Host expression of PD-L1 determines efficacy of PD-L1 pathway blockade-mediated tumor regression. J Clin Invest 128 (2018), 805–815.
17. Tang, H., Liang, Y., Anders, R.A., et al. PD-L1 on host cells is essential PD-L1 blockade mediated tumor regression. J Clin Invest, 2018, 580–588.
18. Schultheis, A.M., Scheel, A.H., Ozretic, L., et al. PD-L1 expression in small cell neuroendocrine carcinomas. Eur J Cancer 51 (2015), 421–426.
19. Kim, H.S., Lee, J.H., Nam, S.J., et al. Association of PD-L1 expression with tumor-infiltrating immune cells and mutation burden in high-grade neuroendocrine carcinoma of the lung. J Thorac Oncol 13 (2018), 636–648.
20. Gajewski, T.F., Schreiber, H., Fu, Y.X., Innate and adaptive immune cells in the tumor microenvironment. Nat Immunol 14 (2013), 1014–1022.