Phase II randomized study of daily gefitinib treatment alone or with vinorelbine every 2 weeks in patients with adenocarcinoma of the lung who failed at least 2 regimens of chemotherapy

Yuh Min Chen, Jacqueline Ming Liu, Teh Ying Chou, Reury Perng, Chun Ming Tsai, Jacqueline Whang-Peng

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

BACKGROUND. The objective of this study was to assess the efficacy of adding chronic, intermittent, low-dose vinorelbine to gefitinib treatment for patients who had adenocarcinoma of the lung who failed ≥2 regimens of chemotherapy. METHODS. Patients were randomized into 2 arms: Oral gefitinib 250 mg daily (the G arm) or vinorelbine 15 mg/m2 as an intravenous infusion on Day 1 and oral gefitinib 250 mg daily on Days 2 through 14 every 2 weeks (the GV arm). From August 2004 to October 2005, 48 patients were enrolled. Epidermal growth factor receptor (EGFR) exon 18 through 21 nucleotide sequence analysis and fluorescence in situ hybridization were performed in patients who had tumor tissue specimens available for analysis. RESULTS. After randomization, each arm had 24 patients. However, 3 patients refused vinorelbine treatment and were given gefitinib treatment only. Thus, 27 patients received G treatment, and 21 patients received GV treatment. Objective response rates were 55.6% in the G arm and 52.4% in the GV arm. All toxicities in both arms were mild. The 1-year progression-free survival rate was 57.1% in the GV arm and 21.2% in the G arm (P =.008). The median survival was 13.3 months in the G arm and 23.4 months in the GV arm (P =.1231). Three of 6 patients (50%) had an exon 19 in-frame deletion, and 2 of 10 patients had EGFR gene high polysomy or amplification (20%). CONCLUSIONS. Gefitinib was highly effective in ethnic Chinese patients with adenocarcinoma of the lung who failed previous platinum and taxane treatment. The addition of low-dose vinorelbine every 2 weeks produced a significantly better 1-year progression-free survival rate.

Original languageEnglish
Pages (from-to)1821-1828
Number of pages8
JournalCancer
Volume109
Issue number9
DOIs
Publication statusPublished - May 1 2007
Externally publishedYes

Fingerprint

Drug Therapy
Therapeutics
Disease-Free Survival
Exons
gefitinib
vinorelbine
Adenocarcinoma of lung
Survival Rate
erbB-1 Genes
Random Allocation
Platinum
Fluorescence In Situ Hybridization
Epidermal Growth Factor Receptor
Intravenous Infusions
Sequence Analysis
Survival
Neoplasms

Keywords

  • Epidermal growth factor receptor
  • Gefitinib
  • Nonsmall cell lung cancer
  • Salvage therapy
  • Vinorelbine

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Phase II randomized study of daily gefitinib treatment alone or with vinorelbine every 2 weeks in patients with adenocarcinoma of the lung who failed at least 2 regimens of chemotherapy. / Chen, Yuh Min; Liu, Jacqueline Ming; Chou, Teh Ying; Perng, Reury; Tsai, Chun Ming; Whang-Peng, Jacqueline.

In: Cancer, Vol. 109, No. 9, 01.05.2007, p. 1821-1828.

Research output: Contribution to journalArticle

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abstract = "BACKGROUND. The objective of this study was to assess the efficacy of adding chronic, intermittent, low-dose vinorelbine to gefitinib treatment for patients who had adenocarcinoma of the lung who failed ≥2 regimens of chemotherapy. METHODS. Patients were randomized into 2 arms: Oral gefitinib 250 mg daily (the G arm) or vinorelbine 15 mg/m2 as an intravenous infusion on Day 1 and oral gefitinib 250 mg daily on Days 2 through 14 every 2 weeks (the GV arm). From August 2004 to October 2005, 48 patients were enrolled. Epidermal growth factor receptor (EGFR) exon 18 through 21 nucleotide sequence analysis and fluorescence in situ hybridization were performed in patients who had tumor tissue specimens available for analysis. RESULTS. After randomization, each arm had 24 patients. However, 3 patients refused vinorelbine treatment and were given gefitinib treatment only. Thus, 27 patients received G treatment, and 21 patients received GV treatment. Objective response rates were 55.6{\%} in the G arm and 52.4{\%} in the GV arm. All toxicities in both arms were mild. The 1-year progression-free survival rate was 57.1{\%} in the GV arm and 21.2{\%} in the G arm (P =.008). The median survival was 13.3 months in the G arm and 23.4 months in the GV arm (P =.1231). Three of 6 patients (50{\%}) had an exon 19 in-frame deletion, and 2 of 10 patients had EGFR gene high polysomy or amplification (20{\%}). CONCLUSIONS. Gefitinib was highly effective in ethnic Chinese patients with adenocarcinoma of the lung who failed previous platinum and taxane treatment. The addition of low-dose vinorelbine every 2 weeks produced a significantly better 1-year progression-free survival rate.",
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T1 - Phase II randomized study of daily gefitinib treatment alone or with vinorelbine every 2 weeks in patients with adenocarcinoma of the lung who failed at least 2 regimens of chemotherapy

AU - Chen, Yuh Min

AU - Liu, Jacqueline Ming

AU - Chou, Teh Ying

AU - Perng, Reury

AU - Tsai, Chun Ming

AU - Whang-Peng, Jacqueline

PY - 2007/5/1

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N2 - BACKGROUND. The objective of this study was to assess the efficacy of adding chronic, intermittent, low-dose vinorelbine to gefitinib treatment for patients who had adenocarcinoma of the lung who failed ≥2 regimens of chemotherapy. METHODS. Patients were randomized into 2 arms: Oral gefitinib 250 mg daily (the G arm) or vinorelbine 15 mg/m2 as an intravenous infusion on Day 1 and oral gefitinib 250 mg daily on Days 2 through 14 every 2 weeks (the GV arm). From August 2004 to October 2005, 48 patients were enrolled. Epidermal growth factor receptor (EGFR) exon 18 through 21 nucleotide sequence analysis and fluorescence in situ hybridization were performed in patients who had tumor tissue specimens available for analysis. RESULTS. After randomization, each arm had 24 patients. However, 3 patients refused vinorelbine treatment and were given gefitinib treatment only. Thus, 27 patients received G treatment, and 21 patients received GV treatment. Objective response rates were 55.6% in the G arm and 52.4% in the GV arm. All toxicities in both arms were mild. The 1-year progression-free survival rate was 57.1% in the GV arm and 21.2% in the G arm (P =.008). The median survival was 13.3 months in the G arm and 23.4 months in the GV arm (P =.1231). Three of 6 patients (50%) had an exon 19 in-frame deletion, and 2 of 10 patients had EGFR gene high polysomy or amplification (20%). CONCLUSIONS. Gefitinib was highly effective in ethnic Chinese patients with adenocarcinoma of the lung who failed previous platinum and taxane treatment. The addition of low-dose vinorelbine every 2 weeks produced a significantly better 1-year progression-free survival rate.

AB - BACKGROUND. The objective of this study was to assess the efficacy of adding chronic, intermittent, low-dose vinorelbine to gefitinib treatment for patients who had adenocarcinoma of the lung who failed ≥2 regimens of chemotherapy. METHODS. Patients were randomized into 2 arms: Oral gefitinib 250 mg daily (the G arm) or vinorelbine 15 mg/m2 as an intravenous infusion on Day 1 and oral gefitinib 250 mg daily on Days 2 through 14 every 2 weeks (the GV arm). From August 2004 to October 2005, 48 patients were enrolled. Epidermal growth factor receptor (EGFR) exon 18 through 21 nucleotide sequence analysis and fluorescence in situ hybridization were performed in patients who had tumor tissue specimens available for analysis. RESULTS. After randomization, each arm had 24 patients. However, 3 patients refused vinorelbine treatment and were given gefitinib treatment only. Thus, 27 patients received G treatment, and 21 patients received GV treatment. Objective response rates were 55.6% in the G arm and 52.4% in the GV arm. All toxicities in both arms were mild. The 1-year progression-free survival rate was 57.1% in the GV arm and 21.2% in the G arm (P =.008). The median survival was 13.3 months in the G arm and 23.4 months in the GV arm (P =.1231). Three of 6 patients (50%) had an exon 19 in-frame deletion, and 2 of 10 patients had EGFR gene high polysomy or amplification (20%). CONCLUSIONS. Gefitinib was highly effective in ethnic Chinese patients with adenocarcinoma of the lung who failed previous platinum and taxane treatment. The addition of low-dose vinorelbine every 2 weeks produced a significantly better 1-year progression-free survival rate.

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