PROCLAIM: Randomized Phase III trial of pemetrexed-cisplatin or etoposide-cisplatin plus thoracic radiation therapy followed by consolidation chemotherapy in locally advanced nonsquamous non-small-cell lung cancer

Suresh Senan, Anthony Brade, Lu Hua Wang, Johan Vansteenkiste, Shaker Dakhil, Bonne Biesma, Maite Martinez Aguillo, Joachim Aerts, Ramaswamy Govindan, Belén Rubio-Viqueira, Conrad Lewanski, David Gandara, Hak Choy, Tony Mok, Anwar Hossain, Neill Iscoe, Joseph Treat, Andrew Koustenis, Bélen San Antonio, Nadia ChouakiEverett Vokes

Research output: Contribution to journalArticle

166 Scopus citations

Abstract

Purpose; The phase III PROCLAIM study evaluated overall survival (OS) of concurrent pemetrexed-cisplatin and thoracic radiation therapy (TRT) followed by consolidation pemetrexed, versus etoposide-cisplatin and TRT followed by nonpemetrexed doublet consolidation therapy. Patients and Methods: Patients with stage IIIA/B unresectable nonsquamous non-small-cell lung cancer randomly received (1: 1) pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 intravenously every 3 weeks for three cycles plus concurrent TRT (60 to 66 Gy) followed by pemetrexed consolidation every 3 weeks for four cycles (arm A), or standard therapy with etoposide 50 mg/m2 and cisplatin 50 mg/m2 intravenously, every 4 weeks for two cycles plus concurrent TRT (60 to 66 Gy) followed by two cycles of consolidation platinum-based doublet chemotherapy (arm B). The primary objective was OS. The study was designed as a superiority trial with 80% power to detect an OS hazard ratio of 0.74 with a type 1 error of .05. Results: Enrollment was stopped early because of futility. Five hundred ninety-eight patients were randomly assigned (301 to arm A, 297 to arm B) and 555 patients (283 in arm A, 272 in arm B) were treated. Arm A was not superior to arm B in terms of OS (hazard ratio, 0.98; 95% CI, 0.79 to 1.20; median, 26.8 v 25.0 months; P = .831). Arm A had a significantly lower incidence of any drug-related grade 3 to 4 adverse events (64.0% v 76.8%; P = .001), including neutropenia (24.4% v 44.5%; P <.001), during the overall treatment period. Conclusion: Pemetrexed-cisplatin combined with TRT followed by consolidation pemetrexed was not superior to standard chemoradiotherapy for stage III unresectable nonsquamous non-small-cell lung cancer.

Original languageEnglish (US)
Pages (from-to)953-962
Number of pages10
JournalJournal of Clinical Oncology
Volume34
Issue number9
DOIs
StatePublished - Mar 20 2016

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Fingerprint Dive into the research topics of 'PROCLAIM: Randomized Phase III trial of pemetrexed-cisplatin or etoposide-cisplatin plus thoracic radiation therapy followed by consolidation chemotherapy in locally advanced nonsquamous non-small-cell lung cancer'. Together they form a unique fingerprint.

  • Cite this

    Senan, S., Brade, A., Wang, L. H., Vansteenkiste, J., Dakhil, S., Biesma, B., Aguillo, M. M., Aerts, J., Govindan, R., Rubio-Viqueira, B., Lewanski, C., Gandara, D., Choy, H., Mok, T., Hossain, A., Iscoe, N., Treat, J., Koustenis, A., Antonio, B. S., ... Vokes, E. (2016). PROCLAIM: Randomized Phase III trial of pemetrexed-cisplatin or etoposide-cisplatin plus thoracic radiation therapy followed by consolidation chemotherapy in locally advanced nonsquamous non-small-cell lung cancer. Journal of Clinical Oncology, 34(9), 953-962. https://doi.org/10.1200/JCO.2015.64.8824