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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

1600 - A multicenter phase II trial of perioperative capecitabine plus oxaliplatin for clinical stage III gastric cancer (OGSG1601)

Date

21 Oct 2018

Session

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Topics

Cytotoxic Therapy

Tumour Site

Gastric Cancer

Presenters

Ryohei Kawabata

Citation

Annals of Oncology (2018) 29 (suppl_8): viii205-viii270. 10.1093/annonc/mdy282

Authors

R. Kawabata1, T. Terazawa2, J. Matsuyama3, S. Endo4, O. Shiraishi5, S. Fujita6, Y. Akamaru7, H. Taniguchi8, M. Tatsumi9, M. Gotoh2, S. Lee10, Y. Kurokawa11, T. Shimokawa12, D. Sakai13, T. Kato14, K. Fujitani15, T. Satoh16

Author affiliations

  • 1 Surgery, Osaka Rosai Hospital, 591-8025 - Sakai/JP
  • 2 Cancer Chemotherapy Center, Osaka Medical College, 569-8686 - Takatsuki/JP
  • 3 Surgery, Yao Municipal Hospital, 581-0069 - Yao/JP
  • 4 Surgery, Higashiosaka City General Hospital, 5788588 - Higashiosaka/JP
  • 5 Surgery, Kindai University, 5898511 - Osakasayama/JP
  • 6 Surgery, NTT West Osaka Hospital, 5438922 - Osaka/JP
  • 7 Surgery, Ikeda Municippal Hospital, 5638510 - Ikeda/JP
  • 8 Surgery, Minoh City, 5620014 - Minoh/JP
  • 9 Surgery, Hoshigaoka Medical Center, 5738511 - Hirakata/JP
  • 10 General And Gastroenterological Surgery,, Osaka Medical College, 569-8686 - Takatsuki/JP
  • 11 Gastroenterological Surgery, Osaka University Graduate School of Medicine, 565-0871 - Suita/JP
  • 12 Clinical Study Support Center, Wakayama Medical University, 6410011 - Wakayama/JP
  • 13 Department Of Frontier Science For Cancer And Chemotherapy, Osaka University Graduate School of Medicine, 565-0871 - Suita/JP
  • 14 Colorectal Surgery, National Hospital Organization Osaka National Hospital, 540-0006 - Osaka/JP
  • 15 Surgery, Osaka General Medical Center, 558-8558 - Osaka/JP
  • 16 Surgery, Osaka University Graduate School of Medicine, 565-0871 - Suita/JP
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Resources

Abstract 1600

Background

D2 gastrectomy followed by postoperative S-1 is the standard therapy for the patients (pts) with stage III gastric cancer (GC) in East Asia, but 40% of the pts develop a recurrence. We hypothesize that the perioperative capecitabine and oxaliplatin (CapeOx) might improve survival for clinical stage III GC.

Methods

In this phase II trial, the eligibility criteria included pathologically confirmed clinical SS/SE N1-3 M0 GC according to Japanese Classification of GC (JCGC) 3rd English Edition. Perioperative CapeOx consisted of three cycles of CapeOx (capecitabine; 2,000 mg/m2 for 14 days, oxaliplatin; 130 mg/m2 day 1) every 3 weeks as neoadjuvant chemotherapy (CT), followed by five cycles of adjuvant CapeOx after the D2 gastrectomy. The primary endpoint was the pathological response rate (pRR) according to JCGC (≥ Grade 1b). The planned sample size was 34 pts calculated on the hypothesis that the expected pRR was 65% and the threshold was 40%, with one-sided alpha of 0.05 and power of 90%.

Results

Thirty-seven pts were enrolled from Apr. 2016 to May. 2017, and fully evaluated for efficacy and toxicity. R0 and R1 resection were achieved in 29 and three pts, respectively. One pt underwent R2 resection, and four pts could not undergo surgical resection. Sixteen pts underwent total gastrectomy, and 17 pts underwent distal gastrectomy. The pRR was 54.1% (one-sided p = 0.058, 95% CI: 36.9-70.5). The relative dose intensity (RDI) of Capecitabine and Oxaliplatin were 90.7% and 92.0%, respectively. Twenty-seven pts received adjuvant therapy, and the RDI of capecitabine and Oxaliplatin were 80.9% and 63.4%, respectively. Grade 3/4 toxicities of neoadjuvant CT included neutropenia (8%), thrombocytopenia (8%), and anorexia (8%). Grade 3/4 toxicities of adjuvant CT included neutropenia (27%), diarrhea (8%), and anorexia (3%). Grade IIIa surgical complications included intraabdominal abscess (3%), bowel obstruction (3%), and anastomotic leakage (3%).

Conclusions

This phase II trial of perioperative CapeOx showed favorable antitumor activity with an acceptable safety profile for stage III GC, although pRR as primary endpoint did not meet the prespecified threshold.

Clinical trial identification

UMIN000021641.

Legal entity responsible for the study

Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG).

Funding

Yakult Honsha Co., Ltd.

Editorial Acknowledgement

Disclosure

D. Sakai: Belongs to a donated fund laboratory: Yakult Honsha Co., Ltd., Chugai Pharmaceutical Co., Ltd. T. Satoh: Honoraria, Consulting fee: Eli Lilly, Chugai, Merck Serono; Research funding (institution): Sanofi, Yakult Honsha, Chugai, Ono. All other authors have declared no conflicts of interest.

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