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Clinical Trial
. 2016 Apr;48(2):458-64.
doi: 10.4143/crt.2015.135. Epub 2015 Oct 14.

Tolerability and Outcomes of First-Line Pemetrexed-Cisplatin Followed by Gefitinib Maintenance Therapy Versus Gefitinib Monotherapy in Korean Patients with Advanced Nonsquamous Non-small Cell Lung Cancer: A Post Hoc Descriptive Subgroup Analysis of a Randomized, Phase 3 Trial

Jin Hyoung Kang  1 , Myung-Ju Ahn  2 , Dong-Wan Kim  3 , Eun Kyung Cho  4 , Joo-Hang Kim  5 , Sang Won Shin  6 , Xin Wang  7 , Jong Seok Kim  8 , Mauro Orlando  9 , Keunchil Park  2
Affiliations
Clinical Trial

Tolerability and Outcomes of First-Line Pemetrexed-Cisplatin Followed by Gefitinib Maintenance Therapy Versus Gefitinib Monotherapy in Korean Patients with Advanced Nonsquamous Non-small Cell Lung Cancer: A Post Hoc Descriptive Subgroup Analysis of a Randomized, Phase 3 Trial

Jin Hyoung Kang et al. Cancer Res Treat. 2016 Apr.

Abstract

Purpose: We recently reported on a randomized, open-label, phase 3 trial comparing pemetrexed-cisplatin chemotherapy followed by gefitinib maintenance therapy (PC/G) with gefitinib monotherapy in patients with non-small cell lung cancer (NSCLC). Here, we report on a post hoc subgroup analysis of that study assessing the demographics and disposition of the Korean patient subgroup, and comparing the tolerability of PC/G and gefitinib monotherapy and the tumor response with respect to epidermal growth factor receptor (EGFR) status.

Materials and methods: Patients, who were ≥ 18 years, chemonaïve, Korean, light ex-smokers/never-smokers with advanced NSCLC, were randomly assigned (1:1) to PC/G or gefitinib monotherapy. Treatment-emergent adverse events (TEAEs) were graded, and tumor response was measured as change in lesion sum from baseline at best response. The study was registered with ClinicalTrials. gov, NCT01017874.

Results: Overall, 111 Korean patients were treated (PC/G, 51; gefitinib, 60). Between-arm characteristics were balanced and similar to those of the overall population. Treatment discontinuations due to adverse events were low (PC/G: 1, 2.0%; gefitinib: 7, 11.7%). Overall, 92 patients (82.9%) reported ≥ 1 TEAE (PC/G, 44; gefitinib, 48); few patients (PC/G, 16; gefitinib, 7) reported severe TEAEs; the most frequent was neutropenia (PC/G arm) and elevated alanine aminotransferase (gefitinib arm). The lesion sum was decreased by PC/G treatment in most patients, regardless of EGFR mutation status, while gefitinib monotherapy reduced the lesion sum in EGFR-positive patients but had no effect in EGFR-negative patients.

Conclusion: Our results confirm that both PC/G and gefitinib were well tolerated in Korean patients, regardless of EGFR status; however, patients with EGFR wild-type NSCLC may not benefit from gefitinib monotherapy.

Keywords: Carcinoma; Epidermal growth factor receptor; Gefitinib; Korea; Non-small-cell lung carcinoma; Pemetrexed.

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Conflict of interest statement

XW, JSK, and MO are employees of Eli Lilly and Company. MO owns shares in Eli Lilly Pty Ltd. JH Kang is an Advisory Board member for Eli Lilly and Company. MJA has consulted/advised for Eli Lilly and Company. DWK has consulted/advised for Eli Lilly and Company. KP has consulted/advised for Astellas, Astra-Zeneca, AVEO, and Boehringer. EKC, JH Kim, and SWS have no conflicts of interest to disclose.

This study was sponsored by Eli Lilly and Company, manufacturer/licensee of pemetrexed (Alimta®). Medical writing assistance was provided by Rose Boutros, PhD, and Julie Ely, PhD, CMPP, of ProScribe - Envision Pharma Group, and was funded by Eli Lilly. ProScribe’s services complied with international guidelines for Good Publication Practice (GPP2).

Figures

Fig. 1.
Fig. 1.
Disposition of Korean patients with non-small cell lung cancer treated with PC/G or gefitinib monotherapy. PC/G, pemetrexed-cisplatin/gefitinib.
Fig. 2.
Fig. 2.
Waterfall plots of percent change in lesion sum from baseline at best response by epidermal growth factor receptor(EGFR) status in Korean patients treated with pemetrexed-cisplatin/gefitinib (A) and gefitinib monotherapy (B).
Fig. 3.
Fig. 3.
Spider plots of percent change in lesion sum from baseline at best response by epidermal growth factor receptor (EGFR) status in Korean patients treated with pemetrexed-cisplatin/gefitinib (A) and gefitinib monotherapy (B).
See this image and copyright information in PMC

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