1277PD - A phase II randomized trial of adjuvant chemotherapy for the patients completely resected pathological stage IB (T>5cm), II, IIIA non-small cell lu...

Date 11 September 2017
Event ESMO 2017 Congress
Session Non-metastatic NSCLC and other thoracic malignancies
Topics Anti-Cancer Agents & Biologic Therapy
Cancer in Adolescents
Non-Small-Cell Lung Cancer, Early Stage
Lung and other Thoracic Tumours
Presenter Tatsuro Okamoto
Citation Annals of Oncology (2017) 28 (suppl_5): v453-v456. 10.1093/annonc/mdx381
Authors T. Okamoto1, T. Yano2, M. Shimokawa3, S. Takeo4, K. Yamazaki4, K. Sugio5, M. Takenoyama6, A. Nagashima7, T. Tagawa1, Y. Emi8, Y. Maehara1
  • 1Department Of Surgery And Science, Kyushu University, Graduate School of Medical Sciences, 812-8582 - Fukuoka/JP
  • 2Department Of Thoracic Surgery, National Hospital Organization Beppu Medical Center, Beppu/JP
  • 3Clinical Research Institute, National Kyushu Cancer Center, 811-1395 - Fukuoka/JP
  • 4Department Of Thoracic Surgery And Clinical Research Institute, National Kyushu Medical Center Hospital, Fukuoka/JP
  • 5Department Of Thoracic And Breast Surgery, Oita University, Faculty of Medicine, Yufu/JP
  • 6Department Of Thoracic Oncology, National Kyushu Cancer Center, 811-1395 - Fukuoka/JP
  • 7Department Of Thoracic Surgery And Clinical Research Institute, Kitakyushu Municipal Medical Center, Kitakyushu/JP
  • 8Department Of Surgery, Saiseikai Fukuoka General Hospital, 810 0001 - FUKUOKA/JP

Abstract

Background

Platinum-based combination chemotherapy is a standard postoperative adjuvant treatment for pathological stage II/III non-small cell lung cancer (NSCLC). Oral S-1 therapy has been demonstrated to have a good efficacy with less toxicity for advanced NSCLC treatment. S-1 might be also useful in the adjuvant setting for surgical NSCLC.

Methods

We performed a phase II randomized open label multi-institutional study in surgical patients with pathological stage IB (T > 5 cm), II or III NSCLC (7th TNM classification), who underwent complete resection from 2009 to 2013. One hundred and thirty-nine patients were randomly assigned to two arms: S-1 80mg/m2 oral, day1 to 14, q3w, 1year (arm A, n = 70) or S-1 80mg/m2 oral day1 to 21, q5w + cisplatin 60mg/m2 day8, q5w, 4 courses, followed by S-1 80mg/m2 oral day1 to 14, q3w, total 1year (arm B, n = 69). The primary endpoint was the disease free survival (DFS) rate at 2 years and was evaluated using Bayesian method. Either treatment arm would deserve further study if the Bayesian posterior probability that the 2-year DFS rate would exceed a value of 40% were more than 0.85. The secondary endpoints were overall survival (OS), safety, and feasibility.

Results

The clinical characteristics of the patients were well balanced in terms of age, sex and pathological stage between the two arms. The DFS rate at 2 years was 51.4% (95% confidence interval [CI], 0.399–0.628) in arm A and 59.4% (95% CI, 0.476 – 0.702) in arm B. Both treatment arms met the primary endpoint: the probability of a DFS rate ≥ 40% at 2 years was over 0.97 in Arm and 1 in arm B. Neither DFS nor OS were significantly different (log-rank test; p = 0.1695 and p = 0.8684, respectively). No treatment-related deaths were observed in either treatment. The main G3/4 adverse events were appetite loss (arm A vs. arm B, 4.3% vs. 11.6%) and anemia (0% vs. 5.8%), which were not statistically different between the two arms. Treatment completion rate did not differ between the two arms (arm A vs. arm B: 45.7% [95% CI, 41.9–66.3%] vs. 43.5% [95% CI, 44.0–68.4%]).

Conclusions

Oral S-1 based adjuvant chemotherapy was feasible and promising for patients with completely resected NSCLC.

Clinical trial identification

UMIN000001765, 2009/03/12

Legal entity responsible for the study

academic group

Funding

Kyushu University Lung Surgery Study Group

Disclosure

All authors have declared no conflicts of interest.