Abstract 2305
Background
Treatment with an immune checkpoint inhibitor (ICI) on completion of concurrent chemoradiotherapy (CCRT) for pts with inoperable stage III NSCLC significantly prolongs the PFS; however the best chemotherapy regimen in CCRT has not been established. This study was conducted to evaluate whether SP or DP, both with concurrent thoracic radiotherapy, in pts with inoperable stage III NSCLC showed a favorable 2-year OS rate with less toxicity in the SP arm as presented previously (J Clin Oncol 2017; 35, suppl; abstr 8534). An update of survival, relapsed sites and post-treatment information with prolonged follow-up has been awaited.
Methods
Pts with inoperable stage III NSCLC were randomized to SP (S-1 40 mg/m2 bid on days 1-14 and 29-42 plus cisplatin 60 mg/m2 on days 1 and 29) or DP (docetaxel 50 mg/m2 and cisplatin 80 mg/m2 on days 1 and 29), with concurrent radiotherapy beginning on day 1 (60 Gy/30 fr) followed by two additional cycles of the chemotherapy. Primary endpoint was 2-year OS rate, and secondary endpoints included OS, PFS and safety.
Results
Among 110 pts enrolled, 106 (53 in each arm) were evaluable, with male/female 83/23; median age 65 (range 42-74); performance status 0/1 59/47; IIIA/IIIB 59/47. With a median follow-up of 48.1 months, 2-year survival and median OS were 79% (95% CI: 68-90%) and 55.2 months in the SP and 69% (95% CI: 57-82%) and 50.8 months in the DP arm, respectively. 5-year PFS rates in SP and DP arms were 23.2 (95% CI: 11-35) and 23.6% (95% CI: 11-36), and 5-year OS rates were 48.8 (95% CI: 34-64) and 42.3% (95%CI: 24-61), respectively. Hematological and non-hematological toxicities were less in the SP arm. Relapsed site in the RT field and in the CNS were similar between the two arms. Post-treatment chemotherapy for pts with progression was delivered in 92.5% and 71.1% pts in SP and DP arms, respectively.
Conclusions
Because of favorable 2-year OS with less toxicity, we choose SP in CCRT as a future reference regimen. High 5-year PFS and OS rates shown here should be considered in designing further studies where CCRT is followed by ICI.
Clinical trial identification
UMIN000005993.
Legal entity responsible for the study
NPO Thoracic Oncology Research Group (TORG).
Funding
Has not received any funding.
Editorial Acknowledgement
Disclosure
Y. Takiguchi, K. Yamada, K. Kubota, K. Kishi, Y. Hosomi, T. Kato, N. Nogami, T. Kasai, Y. Nakamura, T. Yamanaka, H. Okamoto: Lecture fee, Research funds: Taiho Pharmaceutical Co. H. Tanaka, T. Shimokawa, H. Saito, S. Igawa: Lecture fee: Taiho Pharmaceutical Co.
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