Phase II study of carboplatin and pemetrexed in advanced EGFR-wild-type non-squamous non-small cell lung cancer

The central Japan lung study group trial 0906

Tomoki Kimura, Hiroyuki Taniguchi, Naohiro Watanabe, Hideo Saka, Yoshihito Kogure, Joe Shindo, Tomohiko Ogasawara, Eiji Kojima, Yoshinori Hasegawa, Masashi Yamamoto, Ryujiro Suzuki, Masahiko Ando, Masashi Kondo, Hiroshi Saito

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Background: Several pre-clinical and clinical studies suggest a potential predictive role of epidermal growth factor receptor (EGFR) mutation in responsiveness to cytotoxic chemotherapy. The aim of this phase II study was to evaluate the efficacy and safety of pemetrexed-carboplatin combination as first-line chemotherapy in advanced nonsquamous non-small cell lung cancer (NSCLC) limited to EGFR-wild-type cases. Patients and Methods: In this singlearm, multicenter clinical trial, patients received pemetrexed (500 mg/m2) and carboplatin (area under the curve=6) intravenously on day 1 every 3 weeks for three to six cycles. The objective response rate (ORR) was the primary end-point; secondary end-points included the disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety. Results: A total of 54 patients were enrolled and 53 patients received therapy. No complete response was observed and partial response was observed in 19 (35.8%) cases, resulting in an ORR of 35.8% [95% confidence interval (CI)=23.1-50.2%]. Stable disease was observed in 20 (37.7%) patients and therefore the DCR was 73.6% (95% CI=59.7-84.7%). The median PFS was 5.4 months (95% CI=4.1-6.8 months) and the median OS was 12.7 months (95% CI=9.3-16.1 months). Treatment-related grade 3 or 4 hematological toxicities were neutropenia, leukopenia, anemia and thrombocytopenia in 35.8%, 11.3%, 30.2%, and 32.1% of patients, respectively. No grade 3 febrile neutropenia was observed, and grade 3 or 4 non-hematological toxicities were mild. There was no treatment-related death. Conclusion: The pemetrexed-carboplatin combination was effective and welltolerated in patients with EGFR-wild-type non-squamous NSCLC (UMIN-CTR number: UMIN000003393).

Original languageEnglish
Pages (from-to)1767-1771
Number of pages5
JournalAnticancer Research
Volume36
Issue number4
Publication statusPublished - 01-04-2016

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Pemetrexed
Carboplatin
Epidermal Growth Factor Receptor
Non-Small Cell Lung Carcinoma
Japan
Lung
Confidence Intervals
Disease-Free Survival
Safety
Drug Therapy
Febrile Neutropenia
Survival
Leukopenia
Neutropenia
Thrombocytopenia
Multicenter Studies
Area Under Curve
Anemia
Therapeutics
Clinical Trials

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Kimura, T., Taniguchi, H., Watanabe, N., Saka, H., Kogure, Y., Shindo, J., ... Saito, H. (2016). Phase II study of carboplatin and pemetrexed in advanced EGFR-wild-type non-squamous non-small cell lung cancer: The central Japan lung study group trial 0906. Anticancer Research, 36(4), 1767-1771.
Kimura, Tomoki ; Taniguchi, Hiroyuki ; Watanabe, Naohiro ; Saka, Hideo ; Kogure, Yoshihito ; Shindo, Joe ; Ogasawara, Tomohiko ; Kojima, Eiji ; Hasegawa, Yoshinori ; Yamamoto, Masashi ; Suzuki, Ryujiro ; Ando, Masahiko ; Kondo, Masashi ; Saito, Hiroshi. / Phase II study of carboplatin and pemetrexed in advanced EGFR-wild-type non-squamous non-small cell lung cancer : The central Japan lung study group trial 0906. In: Anticancer Research. 2016 ; Vol. 36, No. 4. pp. 1767-1771.
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title = "Phase II study of carboplatin and pemetrexed in advanced EGFR-wild-type non-squamous non-small cell lung cancer: The central Japan lung study group trial 0906",
abstract = "Background: Several pre-clinical and clinical studies suggest a potential predictive role of epidermal growth factor receptor (EGFR) mutation in responsiveness to cytotoxic chemotherapy. The aim of this phase II study was to evaluate the efficacy and safety of pemetrexed-carboplatin combination as first-line chemotherapy in advanced nonsquamous non-small cell lung cancer (NSCLC) limited to EGFR-wild-type cases. Patients and Methods: In this singlearm, multicenter clinical trial, patients received pemetrexed (500 mg/m2) and carboplatin (area under the curve=6) intravenously on day 1 every 3 weeks for three to six cycles. The objective response rate (ORR) was the primary end-point; secondary end-points included the disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety. Results: A total of 54 patients were enrolled and 53 patients received therapy. No complete response was observed and partial response was observed in 19 (35.8{\%}) cases, resulting in an ORR of 35.8{\%} [95{\%} confidence interval (CI)=23.1-50.2{\%}]. Stable disease was observed in 20 (37.7{\%}) patients and therefore the DCR was 73.6{\%} (95{\%} CI=59.7-84.7{\%}). The median PFS was 5.4 months (95{\%} CI=4.1-6.8 months) and the median OS was 12.7 months (95{\%} CI=9.3-16.1 months). Treatment-related grade 3 or 4 hematological toxicities were neutropenia, leukopenia, anemia and thrombocytopenia in 35.8{\%}, 11.3{\%}, 30.2{\%}, and 32.1{\%} of patients, respectively. No grade 3 febrile neutropenia was observed, and grade 3 or 4 non-hematological toxicities were mild. There was no treatment-related death. Conclusion: The pemetrexed-carboplatin combination was effective and welltolerated in patients with EGFR-wild-type non-squamous NSCLC (UMIN-CTR number: UMIN000003393).",
author = "Tomoki Kimura and Hiroyuki Taniguchi and Naohiro Watanabe and Hideo Saka and Yoshihito Kogure and Joe Shindo and Tomohiko Ogasawara and Eiji Kojima and Yoshinori Hasegawa and Masashi Yamamoto and Ryujiro Suzuki and Masahiko Ando and Masashi Kondo and Hiroshi Saito",
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Kimura, T, Taniguchi, H, Watanabe, N, Saka, H, Kogure, Y, Shindo, J, Ogasawara, T, Kojima, E, Hasegawa, Y, Yamamoto, M, Suzuki, R, Ando, M, Kondo, M & Saito, H 2016, 'Phase II study of carboplatin and pemetrexed in advanced EGFR-wild-type non-squamous non-small cell lung cancer: The central Japan lung study group trial 0906', Anticancer Research, vol. 36, no. 4, pp. 1767-1771.

Phase II study of carboplatin and pemetrexed in advanced EGFR-wild-type non-squamous non-small cell lung cancer : The central Japan lung study group trial 0906. / Kimura, Tomoki; Taniguchi, Hiroyuki; Watanabe, Naohiro; Saka, Hideo; Kogure, Yoshihito; Shindo, Joe; Ogasawara, Tomohiko; Kojima, Eiji; Hasegawa, Yoshinori; Yamamoto, Masashi; Suzuki, Ryujiro; Ando, Masahiko; Kondo, Masashi; Saito, Hiroshi.

In: Anticancer Research, Vol. 36, No. 4, 01.04.2016, p. 1767-1771.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Phase II study of carboplatin and pemetrexed in advanced EGFR-wild-type non-squamous non-small cell lung cancer

T2 - The central Japan lung study group trial 0906

AU - Kimura, Tomoki

AU - Taniguchi, Hiroyuki

AU - Watanabe, Naohiro

AU - Saka, Hideo

AU - Kogure, Yoshihito

AU - Shindo, Joe

AU - Ogasawara, Tomohiko

AU - Kojima, Eiji

AU - Hasegawa, Yoshinori

AU - Yamamoto, Masashi

AU - Suzuki, Ryujiro

AU - Ando, Masahiko

AU - Kondo, Masashi

AU - Saito, Hiroshi

PY - 2016/4/1

Y1 - 2016/4/1

N2 - Background: Several pre-clinical and clinical studies suggest a potential predictive role of epidermal growth factor receptor (EGFR) mutation in responsiveness to cytotoxic chemotherapy. The aim of this phase II study was to evaluate the efficacy and safety of pemetrexed-carboplatin combination as first-line chemotherapy in advanced nonsquamous non-small cell lung cancer (NSCLC) limited to EGFR-wild-type cases. Patients and Methods: In this singlearm, multicenter clinical trial, patients received pemetrexed (500 mg/m2) and carboplatin (area under the curve=6) intravenously on day 1 every 3 weeks for three to six cycles. The objective response rate (ORR) was the primary end-point; secondary end-points included the disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety. Results: A total of 54 patients were enrolled and 53 patients received therapy. No complete response was observed and partial response was observed in 19 (35.8%) cases, resulting in an ORR of 35.8% [95% confidence interval (CI)=23.1-50.2%]. Stable disease was observed in 20 (37.7%) patients and therefore the DCR was 73.6% (95% CI=59.7-84.7%). The median PFS was 5.4 months (95% CI=4.1-6.8 months) and the median OS was 12.7 months (95% CI=9.3-16.1 months). Treatment-related grade 3 or 4 hematological toxicities were neutropenia, leukopenia, anemia and thrombocytopenia in 35.8%, 11.3%, 30.2%, and 32.1% of patients, respectively. No grade 3 febrile neutropenia was observed, and grade 3 or 4 non-hematological toxicities were mild. There was no treatment-related death. Conclusion: The pemetrexed-carboplatin combination was effective and welltolerated in patients with EGFR-wild-type non-squamous NSCLC (UMIN-CTR number: UMIN000003393).

AB - Background: Several pre-clinical and clinical studies suggest a potential predictive role of epidermal growth factor receptor (EGFR) mutation in responsiveness to cytotoxic chemotherapy. The aim of this phase II study was to evaluate the efficacy and safety of pemetrexed-carboplatin combination as first-line chemotherapy in advanced nonsquamous non-small cell lung cancer (NSCLC) limited to EGFR-wild-type cases. Patients and Methods: In this singlearm, multicenter clinical trial, patients received pemetrexed (500 mg/m2) and carboplatin (area under the curve=6) intravenously on day 1 every 3 weeks for three to six cycles. The objective response rate (ORR) was the primary end-point; secondary end-points included the disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety. Results: A total of 54 patients were enrolled and 53 patients received therapy. No complete response was observed and partial response was observed in 19 (35.8%) cases, resulting in an ORR of 35.8% [95% confidence interval (CI)=23.1-50.2%]. Stable disease was observed in 20 (37.7%) patients and therefore the DCR was 73.6% (95% CI=59.7-84.7%). The median PFS was 5.4 months (95% CI=4.1-6.8 months) and the median OS was 12.7 months (95% CI=9.3-16.1 months). Treatment-related grade 3 or 4 hematological toxicities were neutropenia, leukopenia, anemia and thrombocytopenia in 35.8%, 11.3%, 30.2%, and 32.1% of patients, respectively. No grade 3 febrile neutropenia was observed, and grade 3 or 4 non-hematological toxicities were mild. There was no treatment-related death. Conclusion: The pemetrexed-carboplatin combination was effective and welltolerated in patients with EGFR-wild-type non-squamous NSCLC (UMIN-CTR number: UMIN000003393).

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