TY - JOUR
T1 - Phase 2 study of pemetrexed plus carboplatin, or pemetrexed plus cisplatin with concurrent radiation therapy followed by pemetrexed consolidation in patients with favorable-prognosis inoperable stage IIIA/B non-small-cell lung cancer
AU - Choy, Hak
AU - Schwartzberg, Lee S.
AU - Dakhil, Shaker R.
AU - Garon, Edward B.
AU - Gerber, David E.
AU - Choksi, Janak K.
AU - Govindan, Ramaswamy
AU - Peng, Guangbin
AU - Koustenis, Andrew
AU - Treat, Joseph
AU - Obasaju, Coleman
N1 - Funding Information:
Disclosure: Dr. Choy's institution received research funding from Eli Lilly and Company. Dr. Schwartzberg previously served as paid consultant for Eli Lilly and Company and its subsidiary, ImClone, and received payments from Eli Lilly and Company and Bristol Myers-Squibb for lectures. Dr. Garon's institution received research funding and support to travel to meetings from Eli Lilly and Company, received funds for a consultancy from Boehringer-Ingelheim, and received research funding from Pfizer, Genentech, and AstraZeneca. Dr. Govindan previously served as a paid consultant for Genentech, Astra Zeneca, GlaxoSmithKline, and Pfizer and serves as a paid consultant for Bristol-Myers Squibb, Merck, Boehringer-Ingelheim, and Covidien. Drs. Treat and Obasaju and Messrs. Peng and Koustenis are employees of Eli Lilly and Company. Dr. Obasaju and Messrs. Peng and Koustenis own stock in Eli Lilly and Company. Drs. Choksi, Dakhil, and Gerber have no relevant disclosures to report. This trial was funded by Eli Lilly and Company. This work was also funded in part by an National Institutes of Health Cancer Center Support Grant (5P30 CA 142543-03) made to Dr. Choy's institution.
PY - 2013
Y1 - 2013
N2 - Introduction: There is no consensus chemotherapy regimen with concurrent radiotherapy (RT) for inoperable stage IIIA/B non-small-cell lung cancer. This trial evaluated pemetrexed with carboplatin (PCb) or cisplatin (PC) with concurrent RT followed by consolidation pemetrexed. Methods: In this open-label, noncomparative phase II trial, patients with inoperable stage IIIA/B non-small-cell lung cancer (initially all histologies, later restricted to nonsquamous) were randomized (1:1) to PCb or PC with concurrent RT (64-68 Gy over days 1-45). Consolidation pemetrexed monotherapy was administered every 21 days for three cycles. Primary endpoint was 2-year overall survival (OS) rate. Results: From June 2007 to November 2009, 98 patients were enrolled (PCb: 46; PC: 52). The 2-year OS rate was PCb: 45.4% (95% confidence interval [CI], 29.5-60.0%); PC: 58.4% (95% CI, 42.6-71.3%), and in nonsquamous patients was PCb: 48.0% (95% CI, 29.0-64.8%); PC: 55.8% (95% CI, 38.0-70.3%). Median time to disease progression was PCb: 8.8 months (95% CI, 6.0-12.6 months); PC: 13.1 months (95% CI, 8.3-not evaluable [NE]). Median OS (months) was PCb: 18.7 (95% CI, 12.9-NE); PC: 27.0 (95% CI, 23.2-NE). The objective response rates (ORRs) were PCb: 52.2%; PC: 46.2%. Grade 4 treatment-related toxicities (% PCb/% PC) were: anemia, 0/1.9; neutropenia, 6.5/3.8; thrombocytopenia, 4.3/1.9; and esophagitis, 0/1.9. Most patients completed scheduled chemotherapy and RT during induction and consolidation phases. No drug-related deaths were reported during chemoradiotherapy. Conclusions: Because of study design, efficacy comparisons cannot be made. However, both combinations with concurrent RT were active and well tolerated.
AB - Introduction: There is no consensus chemotherapy regimen with concurrent radiotherapy (RT) for inoperable stage IIIA/B non-small-cell lung cancer. This trial evaluated pemetrexed with carboplatin (PCb) or cisplatin (PC) with concurrent RT followed by consolidation pemetrexed. Methods: In this open-label, noncomparative phase II trial, patients with inoperable stage IIIA/B non-small-cell lung cancer (initially all histologies, later restricted to nonsquamous) were randomized (1:1) to PCb or PC with concurrent RT (64-68 Gy over days 1-45). Consolidation pemetrexed monotherapy was administered every 21 days for three cycles. Primary endpoint was 2-year overall survival (OS) rate. Results: From June 2007 to November 2009, 98 patients were enrolled (PCb: 46; PC: 52). The 2-year OS rate was PCb: 45.4% (95% confidence interval [CI], 29.5-60.0%); PC: 58.4% (95% CI, 42.6-71.3%), and in nonsquamous patients was PCb: 48.0% (95% CI, 29.0-64.8%); PC: 55.8% (95% CI, 38.0-70.3%). Median time to disease progression was PCb: 8.8 months (95% CI, 6.0-12.6 months); PC: 13.1 months (95% CI, 8.3-not evaluable [NE]). Median OS (months) was PCb: 18.7 (95% CI, 12.9-NE); PC: 27.0 (95% CI, 23.2-NE). The objective response rates (ORRs) were PCb: 52.2%; PC: 46.2%. Grade 4 treatment-related toxicities (% PCb/% PC) were: anemia, 0/1.9; neutropenia, 6.5/3.8; thrombocytopenia, 4.3/1.9; and esophagitis, 0/1.9. Most patients completed scheduled chemotherapy and RT during induction and consolidation phases. No drug-related deaths were reported during chemoradiotherapy. Conclusions: Because of study design, efficacy comparisons cannot be made. However, both combinations with concurrent RT were active and well tolerated.
KW - Chemoradiotherapy
KW - Cisplatin
KW - Non-small-cell lung cancer
KW - Pemetrexed
KW - Stage III
UR - http://www.scopus.com/inward/record.url?scp=84892443501&partnerID=8YFLogxK
U2 - 10.1097/JTO.0b013e3182a02546
DO - 10.1097/JTO.0b013e3182a02546
M3 - Article
C2 - 23981966
AN - SCOPUS:84892443501
SN - 1556-0864
VL - 8
SP - 1308
EP - 1316
JO - Journal of Thoracic Oncology
JF - Journal of Thoracic Oncology
IS - 10
ER -