PURPOSE: To determine efficacy and toxicity of two pemetrexed-based regimens in chemonaive patients with locally advanced or metastatic non-small cell lung cancer. EXPERIMENTAL DESIGN: Patients were randomly assigned to receive pemetrexed 500 mg/m(2) plus oxaliplatin 120 mg/m(2) (PemOx) or pemetrexed plus carboplatin AUC6 (PemCb). All drugs were given on day 1 of a 21-day cycle for up to six cycles. Folic acid and vitamin B(12) were given to all patients to minimize pemetrexed-related toxicities. RESULTS: Forty-one patients received PemOx and 39 received PemCb. Objective tumor response rates were 26.8% for PemOx patients (95% confidence interval, 14.2-42.9) and 31.6% for PemCb patients (95% confidence interval, 17.5-48.7). Median time to progression was 5.5 and 5.7 months, respectively, for PemOx and PemCb. Median overall survival times were 10.5 months for both treatment groups (range, <1 to >20 months). The 1-year survival rate was 49.9% for PemOx patients and 43.9% for PemCb patients. Common toxicity criteria grade 3 or 4 hematologic toxicities among PemOx patients were grade 3 or 4 neutropenia (7.3%), grade 3 thrombocytopenia (2.4%), and grade 3 anemia (2.4%). PemCb patients experienced grade 3 or 4 neutropenia (25.6%), grade 3 or 4 thrombocytopenia (17.9%), and grade 3 anemia (7.7%). Grade 3 vomiting occurred in three PemOx patients and grade 3 fatigue occurred in three PemCb patients. One grade 3 neurosensory toxicity occurred in the PemOx group. Three patients (PemOx 1 and PemCb 2) experienced febrile neutropenia. CONCLUSIONS: Efficacy measures for both regimens seem similar to the most effective chemotherapies for advanced non-small cell lung cancer (platinum combinations) with less hematologic and nonhematologic toxicity. Comparing either of these two regimens to platinum-based therapies in a large randomized trial is warranted.
RCT Entities:
PURPOSE: To determine efficacy and toxicity of two pemetrexed-based regimens in chemonaive patients with locally advanced or metastatic non-small cell lung cancer. EXPERIMENTAL DESIGN:Patients were randomly assigned to receive pemetrexed 500 mg/m(2) plus oxaliplatin 120 mg/m(2) (PemOx) or pemetrexed plus carboplatin AUC6 (PemCb). All drugs were given on day 1 of a 21-day cycle for up to six cycles. Folic acid and vitamin B(12) were given to all patients to minimize pemetrexed-related toxicities. RESULTS: Forty-one patients received PemOx and 39 received PemCb. Objective tumor response rates were 26.8% for PemOxpatients (95% confidence interval, 14.2-42.9) and 31.6% for PemCbpatients (95% confidence interval, 17.5-48.7). Median time to progression was 5.5 and 5.7 months, respectively, for PemOx and PemCb. Median overall survival times were 10.5 months for both treatment groups (range, <1 to >20 months). The 1-year survival rate was 49.9% for PemOxpatients and 43.9% for PemCbpatients. Common toxicity criteria grade 3 or 4 hematologic toxicities among PemOxpatients were grade 3 or 4 neutropenia (7.3%), grade 3 thrombocytopenia (2.4%), and grade 3 anemia (2.4%). PemCbpatients experienced grade 3 or 4 neutropenia (25.6%), grade 3 or 4 thrombocytopenia (17.9%), and grade 3 anemia (7.7%). Grade 3 vomiting occurred in three PemOxpatients and grade 3 fatigue occurred in three PemCbpatients. One grade 3 neurosensory toxicity occurred in the PemOx group. Three patients (PemOx 1 and PemCb 2) experienced febrile neutropenia. CONCLUSIONS: Efficacy measures for both regimens seem similar to the most effective chemotherapies for advanced non-small cell lung cancer (platinum combinations) with less hematologic and nonhematologic toxicity. Comparing either of these two regimens to platinum-based therapies in a large randomized trial is warranted.
Authors: Peter M Bruno; Yunpeng Liu; Ga Young Park; Junko Murai; Catherine E Koch; Timothy J Eisen; Justin R Pritchard; Yves Pommier; Stephen J Lippard; Michael T Hemann Journal: Nat Med Date: 2017-02-27 Impact factor: 53.440
Authors: Grace K Dy; Julian R Molina; Yingwei Qi; Rafat Ansari; Sachdev Thomas; Helen J Ross; Gamini Soori; Daniel Anderson; Marie Christine Aubry; Jeffrey Meyers; Araba A Adjei; Sumithra Mandrekar; Alex A Adjei Journal: J Thorac Oncol Date: 2014-08 Impact factor: 15.609
Authors: Shirish M Gadgeel; James P Stevenson; Corey J Langer; Leena Gandhi; Hossein Borghaei; Amita Patnaik; Liza C Villaruz; Matthew Gubens; Ralph Hauke; James Chih-Hsin Yang; Lecia V Sequist; Robert Bachman; Sanatan Saraf; Harry Raftopoulos; Vassiliki Papadimitrakopoulou Journal: Lung Cancer Date: 2018-08-25 Impact factor: 5.705
Authors: Janine M Davies; Nirav S Dhruva; Christine M Walko; Mark A Socinski; Stephen Bernard; D Neil Hayes; William Y Kim; Anastasia Ivanova; Kimberly Keller; Layla R Hilbun; Michael Chiu; E Claire Dees; Thomas E Stinchcombe Journal: Lung Cancer Date: 2010-07-01 Impact factor: 5.705