Updated survival outcomes of NEJ005/TCOG0902, a randomized phase II study of concurrent (C) versus sequential alternating (S) gefitinib and chemotherapy in previously untreated non-small cell lung cancer (NSCLC) with sensitive epidermal growth factor receptor (EGFR) mutations.

Authors

null

Satoshi Oizumi

Department of Respiratory Medicine, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan

Satoshi Oizumi , Shunichi Sugawara , Koichi Minato , Toshiyuki Harada , Akira Inoue , Yuka Fujita , Makoto Maemondo , Satoshi Watanabe , Kazuhiko Ito , Akihiko Gemma , Yoshiki Demura , Masao Harada , Hiroshi Isobe , Ichiro Kinoshita , Satoshi Morita , Kunihiko Kobayashi , Koichi Hagiwara , Minoru Kurihara , Toshihiro Nukiwa

Organizations

Department of Respiratory Medicine, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan, Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan, Division of Respiratory Medicine, Gunma Prefectural Cancer Center, Ota, Japan, Department of Respiratory Medicine, JCHO Hokkaido Hospital, Sapporo, Japan, Department of Palliative Medicine, Tohoku University School of Medicine, Sendai, Japan, Department of Respiratory Medicine, National Hospital Organization Asahikawa Medical Center, Asahikawa, Japan, Department of Respiratory Medicine, Miyagi Cancer Center, Natori, Japan, Department of Respiratory Medicine and Infectious Diseases, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan, Department of Respiratory Medicine, Niigata City General Hospital, Niigata, Japan, Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan, Division of Respiratory Medicine, Ishikawa Prefectural Central Hospital, Kanazawa, Japan, Department of Medical Oncology, KKR Sapporo Medical Center, Sapporo, Japan, Department of Medical Oncology, Hokkaido University Graduate School of Medicine, Sapporo, Japan, Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan, Department of Respiratory Medicine, Saitama Medical University International Medical Center, Saitama, Japan, Division of Pulmonary Medicine, Jichi Medical University, Shimotsuke, Japan, The Tokyo Cooperative Oncology Group, Tokyo, Japan, Japan Anti-Tuberculosis Association, Tokyo, Japan

Research Funding

Other

Background: North East Japan Study Group (NEJ) 005/ Tokyo Cooperative Oncology Group (TCOG) 0902 study has demonstrated that first-line concurrent (C) and sequential alternating (S) combination therapies of EGFRtyrosine kinase inhibitor (gefitinib) plus platinum-based doublet chemotherapy (carboplatin/pemetrexed) offer promising efficacy with predictable toxicities for patients with EGFR-mutant NSCLC (ASCO2014, Ann Oncol 2015). However, overall survival (OS) data were insufficient because of the lack of death events in the primary report. Methods: Progression-free survival (PFS) and OS were re-evaluated at the final data cutoff point (November 2016) for the entire population (N = 80). Results: At the median follow-up time of 35.6 months, 88.8% of patients had progressive disease and 72.5% of patients had died. Median PFS was 17.5 months for the C regimen and 15.3 months for the S regimen (p = 0.13). Median OS time was 43.3 with the C regimen and 30.7 months with the S regimen (p = 0.018). Updated response rates were similar in both groups (90.2% and 82.1%, respectively; p = 0.34). Patients who had common mutations showed no significant differences in PFS according to type of mutation. Patients with Del19 displayed relatively better OS (median: 45.3 and 33.3 months for C and S regimens) than those with L858R (31.4 and 28.9 months). No severe adverse events including interstitial lung disease have occurred during the follow-up period since the primary report. Conclusions: This updated analysis has confirmed that PFS is improved with first-line combination therapies compared to that with gefitinib monotherapy, and the C regimen in particular offers an overall survival benefit of 43 months in the EGFR-mutated setting. Our on-going NEJ009 study will clarify whether this combinational strategy can be incorporated into routine clinical practice. Clinical trial information: UMIN000002789.

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Abstract Details

Meeting

2017 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Lung Cancer—Non-Small Cell Metastatic

Track

Lung Cancer

Sub Track

Metastatic Non–Small Cell Lung Cancer

Clinical Trial Registration Number

UMIN000002789

Citation

J Clin Oncol 35, 2017 (suppl; abstr 9038)

DOI

10.1200/JCO.2017.35.15_suppl.9038

Abstract #

9038

Poster Bd #

364

Abstract Disclosures