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Pemetrexed-Erlotinib, Pemetrexed Alone, or Erlotinib Alone as Second-Line Treatment for East Asian and Non-East Asian Never-Smokers with Locally Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer: Exploratory Subgroup Analysis of a Phase II Trial

이정신|Jie Wang|김종석|이대호|Mauro Orlando|Te-Chun Hsia
대한암학회 (Korean Cancer Association)|2015.10|Cancer Research and Treatment|제47권 제4호|pp. 616-629|DOI http://dx.doi.org/10.4143/crt.2014.051

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East AsianErlotinibPemetrexedNonsquamous non-small cell lung cancer
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초록

Purpose This subgroup analysis of a phase II trial was conducted to assess possible ethnicity-basedtrends in efficacy and safety in East Asian (EA) and non-EA populations with nonsquamousnon-small cell lung cancer (NSCLC). Materials and MethodsNever-smoker patients (n=240) with locally advanced or metastatic nonsquamous NSCLCincluded 133 EA patients randomized to pemetrexed supplemented with dexamethasone,folic acid, and vitamin B12 plus erlotinib (pemetrexed-erlotinib) (n=41), erlotinib (n=49), orpemetrexed (n=43), and 107 non-EA patients randomized to pemetrexed-erlotinib (n=37),erlotinib (n=33), or pemetrexed (n=37). The primary endpoint, progression-free survival(PFS), was analyzed using a multivariate Cox model. ResultsConsistent with the results of the overall study, a statistically significant difference in PFSamong the three arms was noted in the EA population favoring pemetrexed-erlotinib (overallp=0.003) as compared with either single-agent arm (hazard ratio [HR], 0.48; 95%confidence interval [CI], 0.29 to 0.79; p=0.004 vs. erlotinib; HR, 0.40; 95% CI, 0.23 to 0.70;p=0.001 vs. pemetrexed). The EA patients treated with pemetrexed-erlotinib achieved alonger median PFS (7.4 months) compared with erlotinib (4.5 months) and pemetrexed(4.0 months). The PFS results also numerically favored pemetrexed-erlotinib in the non-EApopulation (overall p=0.210) (HR, 0.62; 95% CI, 0.37 to 1.05; p=0.078 vs. erlotinib; HR,0.75; 95% CI, 0.42 to 1.32; p=0.320 vs. pemetrexed) (median PFS: pemetrexed-erlotinib,6.7 months; erlotinib, 3.0 months; pemetrexed, 4.4 months). ConclusionThe PFS results from this subset analysis in both EA and non-EA populations are consistentwith the results in the overall population. The PFS advantage for pemetrexed-erlotinib issignificant compared with the single agents in EA patients.

Abstract

Purpose This subgroup analysis of a phase II trial was conducted to assess possible ethnicity-basedtrends in efficacy and safety in East Asian (EA) and non-EA populations with nonsquamousnon-small cell lung cancer (NSCLC). Materials and MethodsNever-smoker patients (n=240) with locally advanced or metastatic nonsquamous NSCLCincluded 133 EA patients randomized to pemetrexed supplemented with dexamethasone,folic acid, and vitamin B12 plus erlotinib (pemetrexed-erlotinib) (n=41), erlotinib (n=49), orpemetrexed (n=43), and 107 non-EA patients randomized to pemetrexed-erlotinib (n=37),erlotinib (n=33), or pemetrexed (n=37). The primary endpoint, progression-free survival(PFS), was analyzed using a multivariate Cox model. ResultsConsistent with the results of the overall study, a statistically significant difference in PFSamong the three arms was noted in the EA population favoring pemetrexed-erlotinib (overallp=0.003) as compared with either single-agent arm (hazard ratio [HR], 0.48; 95%confidence interval [CI], 0.29 to 0.79; p=0.004 vs. erlotinib; HR, 0.40; 95% CI, 0.23 to 0.70;p=0.001 vs. pemetrexed). The EA patients treated with pemetrexed-erlotinib achieved alonger median PFS (7.4 months) compared with erlotinib (4.5 months) and pemetrexed(4.0 months). The PFS results also numerically favored pemetrexed-erlotinib in the non-EApopulation (overall p=0.210) (HR, 0.62; 95% CI, 0.37 to 1.05; p=0.078 vs. erlotinib; HR,0.75; 95% CI, 0.42 to 1.32; p=0.320 vs. pemetrexed) (median PFS: pemetrexed-erlotinib,6.7 months; erlotinib, 3.0 months; pemetrexed, 4.4 months). ConclusionThe PFS results from this subset analysis in both EA and non-EA populations are consistentwith the results in the overall population. The PFS advantage for pemetrexed-erlotinib issignificant compared with the single agents in EA patients.

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