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Long-term results of S-1 plus cisplatin with concurrent thoracic radiotherapy for locally advanced non-small-cell lung cancer

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Abstract

Purpose

The purpose of this phase I/II study was to evaluate the feasibility and efficacy of S-1 plus cisplatin at the recommended schedule with concurrent thoracic radiotherapy for locally advanced non-small cell lung cancer (LA-NSCLC).

Methods

Eligible patients with LA-NSCLC were treated with cisplatin intravenously at a dose of 60 mg/m2 on day 8 plus oral S-1 at a dosage of 40 mg/m2 twice per day for two different treatment schedules for up to 4 cycles. Patients also concurrently received 60 Gy of thoracic radiation in 30 fractions. The primary endpoint of the phase II study was the proportion of patients who survived for more than 2 years.

Results

Between August 2005 and October 2010, a total of 45 patients were enrolled in this phase I/II study; their long-term survival was then followed for a median period of 5.8 years. Nineteen of the 39 patients in the phase II study survived for more than 2 years and met the primary endpoint of the study. The median overall survival period was 24.9 months [95% confidence interval (CI) 17.4–74.5 months], and the 2- and 5-year overall survival rates were 51.0 and 43.0%, respectively. The response rate was 85%, and the median progression-free survival period was 13.8 months (95% CI 9.5–27.1 months). Hematological toxicity was mild. Grade 3 febrile neutropenia and pneumonitis was observed in 5 and 5%, respectively.

Conclusion

Our study indicated that S-1 plus cisplatin with concurrent thoracic radiotherapy yielded encouraging survival outcomes and an acceptable safety profile for LA-NSCLC.

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Acknowledgements

We thank all the patients who participated in this study and their families. We also thank the assistance of the staff of the Department of Thoracic Oncology, National Cancer Center Hospital East.

Funding

This work was supported in part by a Grant-in-Aid for Cancer Research from the Ministry of Health, Labor, and Welfare of Japan.

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Corresponding author

Correspondence to Kiyotaka Yoh.

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Conflict of interest

TT has received personal fees from Taiho Pharmaceutical and Boehringer Ingelheim. KY has received personal fees from Taiho Pharmaceutical, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai phamaceutical, Eli Lilly, and ONO Pharmaceutical. KK has received personal fees from Taiho Pharmaceutical. SN has received grants from Taiho Pharmaceutical, and grants and personal fees from AstraZeneca, Eli Lilly, and grants from Pfizer, and personal fees from Bristol-Myers Squibb, MSD, and ONO Pharmaceutical. YO has received grant and personal fees from Taiho Pharmaceutical, AstraZeneca, ONO Pharmaceutical, Bristol-Myers Squibb, Chugai phamaceutical, Eli Lilly, Pfizer, MSD, and Novartis Pharma, and grant from Kyorin Pharmaceutical, Sumitomo Dainippon Pharma, and personal fees from Daiichi-Sankyo, Nippon Kayaku, Boehringer Ingelheim, and Bayer. KG has received grants and personal fees from Taiho Pharmaceutical, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai phamaceutical, Daiichi-Sankyo, Eli Lilly, MSD, Novartis Pharma, ONO Pharmaceutical, Pfizer, Kyowa Hakko Kirin, Merck Serono, RIKEN GENESIS, and GlaxoSmithKline, and grants from Eisai, Sumitomo Dainippon Pharma, Takeda Pharmaceutical, Oxonc, Astellas Pharma, Amgen Astellas BioPharma, AbbVie Stemcentrx, and Ignyta, and personal fees from ABBOTT JAPAN, Quintiles, Life Technologies Japan, and SRL. All remaining authors declare no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Taira, T., Yoh, K., Nagase, S. et al. Long-term results of S-1 plus cisplatin with concurrent thoracic radiotherapy for locally advanced non-small-cell lung cancer. Cancer Chemother Pharmacol 81, 565–572 (2018). https://doi.org/10.1007/s00280-018-3530-y

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