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 R Gandara, Hak Choy, Tony Mok, Anwar Hossain, Neill Iscoe, Joseph Treat, Andrew Koustenis, Bélen San Antonio, Nadia Chouaki & 1 others Everett Vokes

Research output: Contribution to journalArticle

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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

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Pemetrexed
Consolidation Chemotherapy
Etoposide
Non-Small Cell Lung Carcinoma
Cisplatin
Radiotherapy
Thorax
Survival
Medical Futility
Chemoradiotherapy
Neutropenia
Platinum
Therapeutics
Drug Therapy
Incidence

ASJC Scopus subject areas

  • Medicine(all)
  • Oncology
  • Cancer Research

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

In: Journal of Clinical Oncology, Vol. 34, No. 9, 20.03.2016, p. 953-962.

Research output: Contribution to journalArticle

Senan, S, Brade, A, Wang, LH, Vansteenkiste, J, Dakhil, S, Biesma, B, Aguillo, MM, Aerts, J, Govindan, R, Rubio-Viqueira, B, Lewanski, C, Gandara, DR, Choy, H, Mok, T, Hossain, A, Iscoe, N, Treat, J, Koustenis, A, Antonio, BS, Chouaki, N & 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, vol. 34, no. 9, pp. 953-962. https://doi.org/10.1200/JCO.2015.64.8824
Senan, Suresh ; Brade, Anthony ; Wang, Lu Hua ; Vansteenkiste, Johan ; Dakhil, Shaker ; Biesma, Bonne ; Aguillo, Maite Martinez ; Aerts, Joachim ; Govindan, Ramaswamy ; Rubio-Viqueira, Belén ; Lewanski, Conrad ; Gandara, David R ; Choy, Hak ; Mok, Tony ; Hossain, Anwar ; Iscoe, Neill ; Treat, Joseph ; Koustenis, Andrew ; Antonio, Bélen San ; Chouaki, Nadia ; Vokes, Everett. / 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. In: Journal of Clinical Oncology. 2016 ; Vol. 34, No. 9. pp. 953-962.
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title = "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",
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.",
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T1 - PROCLAIM

T2 - 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

AU - Senan, Suresh

AU - Brade, Anthony

AU - Wang, Lu Hua

AU - Vansteenkiste, Johan

AU - Dakhil, Shaker

AU - Biesma, Bonne

AU - Aguillo, Maite Martinez

AU - Aerts, Joachim

AU - Govindan, Ramaswamy

AU - Rubio-Viqueira, Belén

AU - Lewanski, Conrad

AU - Gandara, David R

AU - Choy, Hak

AU - Mok, Tony

AU - Hossain, Anwar

AU - Iscoe, Neill

AU - Treat, Joseph

AU - Koustenis, Andrew

AU - Antonio, Bélen San

AU - Chouaki, Nadia

AU - Vokes, Everett

PY - 2016/3/20

Y1 - 2016/3/20

N2 - 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.

AB - 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.

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