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, Myung Ju Ahn, Dong Wan Kim, Eun Kyung Cho, Joo Hang Kim, Sang Won Shin, Xin Wang, Jong Seok Kim, Mauro Orlando, Keunchil Park

Research output: Contribution to journalArticle

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Abstract

Purpose We recently reported on a randomized, open-label, phase 3 trial comparing pemetrexedcisplatin 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 EGFRmutation 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.

Original languageEnglish
Pages (from-to)458-464
Number of pages7
JournalCancer Research and Treatment
Volume48
Issue number2
DOIs
Publication statusPublished - 2016 Apr 1

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Pemetrexed
Non-Small Cell Lung Carcinoma
Cisplatin
Epidermal Growth Factor Receptor
Therapeutics
gefitinib

Keywords

  • Carcinoma
  • Epidermal growth factor receptor
  • Gefitinib
  • Korea
  • Non-small-cell lung carcinoma
  • Pemetrexed

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

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. / Kang, Jin Hyoung; Ahn, Myung Ju; Kim, Dong Wan; Cho, Eun Kyung; Kim, Joo Hang; Shin, Sang Won; Wang, Xin; Kim, Jong Seok; Orlando, Mauro; Park, Keunchil.

In: Cancer Research and Treatment, Vol. 48, No. 2, 01.04.2016, p. 458-464.

Research output: Contribution to journalArticle

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abstract = "Purpose We recently reported on a randomized, open-label, phase 3 trial comparing pemetrexedcisplatin 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, chemona{\"i}ve, 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 EGFRmutation 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.",
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T2 - A post hoc descriptive subgroup analysis of a randomized, phase 3 trial

AU - Kang, Jin Hyoung

AU - Ahn, Myung Ju

AU - Kim, Dong Wan

AU - Cho, Eun Kyung

AU - Kim, Joo Hang

AU - Shin, Sang Won

AU - Wang, Xin

AU - Kim, Jong Seok

AU - Orlando, Mauro

AU - Park, Keunchil

PY - 2016/4/1

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AB - Purpose We recently reported on a randomized, open-label, phase 3 trial comparing pemetrexedcisplatin 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 EGFRmutation 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.

KW - Carcinoma

KW - Epidermal growth factor receptor

KW - Gefitinib

KW - Korea

KW - Non-small-cell lung carcinoma

KW - Pemetrexed

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