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A randomized phase 3 trial comparing pemetrexed/carboplatin and docetaxel/carboplatin as first-line treatment for advanced, nonsquamous non-small cell lung cancer

 Rodrigues-Pereira, José  ;  Kim, Joo-Hang  ;  Magallanes, Manuel  ;  Lee, Dae Ho  ;  Wang, Jie  ;  Ganju, Vinod  ;  Martínez-Barrera, Luis  ;  Barraclough, Helen  ;  van Kooten, Maximiliano  ;  Orlando, Mauro 
 JOURNAL OF THORACIC ONCOLOGY, Vol.6(11) : 1907-1914, 2011 
Journal Title
Issue Date
Adenocarcinoma/drug therapy* ; Adenocarcinoma/mortality ; Adenocarcinoma/pathology ; Adult ; Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Carboplatin/administration & dosage ; Carcinoma, Large Cell/drug therapy* ; Carcinoma, Large Cell/mortality ; Carcinoma, Large Cell/pathology ; Carcinoma, Non-Small-Cell Lung/drug therapy* ; Carcinoma, Non-Small-Cell Lung/mortality ; Carcinoma, Non-Small-Cell Lung/pathology ; Female ; Follow-Up Studies ; Glutamates/administration & dosage ; Guanine/administration & dosage ; Guanine/analogs & derivatives ; Humans ; Lung Neoplasms/drug therapy* ; Lung Neoplasms/mortality ; Lung Neoplasms/pathology ; Male ; Middle Aged ; Neoplasm Staging ; Pemetrexed ; Prognosis ; Survival Rate ; Taxoids/administration & dosage
Carboplatin ; Docetaxel ; First-line therapy ; Non-small cell lung carcinoma ; Nonsquamous ; Pemetrexed
INTRODUCTION: This study compared survival without toxicity in patients with advanced, nonsquamous non-small cell lung cancer who were treated with first-line pemetrexed/carboplatin or docetaxel/carboplatin.

METHODS: This multicenter, open-label, parallel-group, phase 3 trial comprised patients randomized (1:1) to pemetrexed/carboplatin (n = 128) or docetaxel/carboplatin (n = 132). Patients received treatment on day 1 of each 21-day cycle (maximum of six cycles). Treatment included carboplatin (area under the curve = 5 mg/ml × min) and pemetrexed (500 mg/m(2)) or docetaxel (75 mg/m(2)). The primary outcome measure, survival without treatment-emergent grade 3/4 toxicity, was defined as the time from randomization to the first treatment-emergent grade 3/4 adverse event or death and was analyzed using a log-rank test. The analysis population included 106 patients in the pemetrexed/carboplatin (Pem/Carb) group and 105 patients in the docetaxel/carboplatin (Doc/Carb) group.

RESULTS: Survival without treatment-emergent grade 3/4 toxicity was significantly longer in the Pem/Carb versus the Doc/Carb group (log-rank p < 0.001; median survival without treatment-emergent grade 3/4 toxicity: 3.2 versus 0.7 months; adjusted hazard ratio = 0.45 [95% confidence interval: 0.34-0.61]). Overall survival was similar in the Pem/Carb versus the Doc/Carb group (log-rank p = 0.934; median survival: 14.9 versus 14.7 months; adjusted hazard ratio = 0.93 [95% confidence interval: 0.66-1.32]). Compared with the Doc/Carb group, fewer patients in the Pem/Carb group experienced grade 3/4 drug-related, treatment-emergent neutropenia, leukopenia, or febrile neutropenia, and more patients experienced anemia and thrombocytopenia. There were three study drug-related deaths during treatment in each group.

CONCLUSIONS: The favorable benefit-to-risk profile of pemetrexed/carboplatin suggests that pemetrexed/carboplatin is an appropriate first-line treatment option for chemonaïve patients with advanced, nonsquamous non-small cell lung cancer.
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Yonsei Authors
Kim, Joo Hang(김주항)
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