A randomized, phase II study of gefitinib alone versus nimotuzumab plus gefitinib after platinum-based chemotherapy in advanced non-small cell lung cancer (KCSG LU12-01)

Hye Ryun Kim, Joung Soon Jang, Jong Mu Sun, Myung Ju Ahn, Dong Wan Kim, Inkyung Jung, Ki Hyeong Lee, Joo Hang Kim, Dae Ho Lee, Sang We Kim, Byoung Chul Cho

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

We aimed to evaluate the efficacy of dual inhibition of epidermal growth factor receptor (EGFR) with nimotuzumab (EGFR monoclonal antibody) plus gefitinib (EGFR-tyrosine kinase inhibitor) in advanced non-small cell lung cancer (NSCLC) after platinum-based chemotherapy. An open label, randomized, phase II trial was conducted at 6 centers; 160 patients were randomized (1:1) to either gefitinib alone or nimotuzumab (200 mg, i.v. weekly) plus gefitinib (250 mg p.o. daily) until disease progression or intolerable toxicity. The primary endpoint was progression-free survival (PFS) at 3 months. Of the total 160 enrolled patients, 155 (77: gefitinib, 78: nimotuzumab plus gefitinib) received at least one dose and could be evaluated for efficacy and toxicity. The majority had adenocarcinoma (65.2%) and ECOG performance status of 0 to 1 (83.5%). The median follow-up was 22.1 months, and the PFS rate at 3 months was 48.1% in gefitinib and 37.2% in nimotuzumab plus gefitinib (P = not significant, NS). The median PFS and OS were 2.8 and 13.2 months in gefitinib and 2.0 and 14.0 months in nimotuzumab plus gefitinib. Combined treatment was not associated with superior PFS to gefitinib alone in patients with EGFR mutation (13.5 vs. 10.2 months in gefitinib alone, P=NS) or those with wild-type EGFR (0.9 vs. 2.0 months in gefitinib alone, P=NS). Combined treatment did not increase EGFR inhibition-related adverse events with manageable toxicities. The dual inhibition of EGFR with nimotuzumab plus gefitinib was not associated with better outcomes than gefitinib alone as a second-line treatment of advanced NSCLC (NCT01498562).

Original languageEnglish
Pages (from-to)15943-15951
Number of pages9
JournalOncotarget
Volume8
Issue number9
DOIs
Publication statusPublished - 2017 Jan 1

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Platinum
Non-Small Cell Lung Carcinoma
Drug Therapy
Epidermal Growth Factor Receptor
Disease-Free Survival
gefitinib
nimotuzumab
Protein-Tyrosine Kinases
Disease Progression
Adenocarcinoma
Therapeutics
Survival Rate
Monoclonal Antibodies

All Science Journal Classification (ASJC) codes

  • Oncology

Cite this

Kim, Hye Ryun ; Jang, Joung Soon ; Sun, Jong Mu ; Ahn, Myung Ju ; Kim, Dong Wan ; Jung, Inkyung ; Lee, Ki Hyeong ; Kim, Joo Hang ; Lee, Dae Ho ; Kim, Sang We ; Cho, Byoung Chul. / A randomized, phase II study of gefitinib alone versus nimotuzumab plus gefitinib after platinum-based chemotherapy in advanced non-small cell lung cancer (KCSG LU12-01). In: Oncotarget. 2017 ; Vol. 8, No. 9. pp. 15943-15951.
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abstract = "We aimed to evaluate the efficacy of dual inhibition of epidermal growth factor receptor (EGFR) with nimotuzumab (EGFR monoclonal antibody) plus gefitinib (EGFR-tyrosine kinase inhibitor) in advanced non-small cell lung cancer (NSCLC) after platinum-based chemotherapy. An open label, randomized, phase II trial was conducted at 6 centers; 160 patients were randomized (1:1) to either gefitinib alone or nimotuzumab (200 mg, i.v. weekly) plus gefitinib (250 mg p.o. daily) until disease progression or intolerable toxicity. The primary endpoint was progression-free survival (PFS) at 3 months. Of the total 160 enrolled patients, 155 (77: gefitinib, 78: nimotuzumab plus gefitinib) received at least one dose and could be evaluated for efficacy and toxicity. The majority had adenocarcinoma (65.2{\%}) and ECOG performance status of 0 to 1 (83.5{\%}). The median follow-up was 22.1 months, and the PFS rate at 3 months was 48.1{\%} in gefitinib and 37.2{\%} in nimotuzumab plus gefitinib (P = not significant, NS). The median PFS and OS were 2.8 and 13.2 months in gefitinib and 2.0 and 14.0 months in nimotuzumab plus gefitinib. Combined treatment was not associated with superior PFS to gefitinib alone in patients with EGFR mutation (13.5 vs. 10.2 months in gefitinib alone, P=NS) or those with wild-type EGFR (0.9 vs. 2.0 months in gefitinib alone, P=NS). Combined treatment did not increase EGFR inhibition-related adverse events with manageable toxicities. The dual inhibition of EGFR with nimotuzumab plus gefitinib was not associated with better outcomes than gefitinib alone as a second-line treatment of advanced NSCLC (NCT01498562).",
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A randomized, phase II study of gefitinib alone versus nimotuzumab plus gefitinib after platinum-based chemotherapy in advanced non-small cell lung cancer (KCSG LU12-01). / Kim, Hye Ryun; Jang, Joung Soon; Sun, Jong Mu; Ahn, Myung Ju; Kim, Dong Wan; Jung, Inkyung; Lee, Ki Hyeong; Kim, Joo Hang; Lee, Dae Ho; Kim, Sang We; Cho, Byoung Chul.

In: Oncotarget, Vol. 8, No. 9, 01.01.2017, p. 15943-15951.

Research output: Contribution to journalArticle

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AU - Kim, Hye Ryun

AU - Jang, Joung Soon

AU - Sun, Jong Mu

AU - Ahn, Myung Ju

AU - Kim, Dong Wan

AU - Jung, Inkyung

AU - Lee, Ki Hyeong

AU - Kim, Joo Hang

AU - Lee, Dae Ho

AU - Kim, Sang We

AU - Cho, Byoung Chul

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