698P - Phase II study of intravenous and intraperitoneal paclitaxel combined with S-1 for gastric cancer with metastases to the distant peritoneum

Date 30 September 2012
Event ESMO Congress 2012
Session Poster presentation II
Topics Anti-Cancer Agents & Biologic Therapy
Gastric Cancer
Presenter Hironori Ishigami
Authors H. Ishigami1, J. Kitayama2, H. Yamaguchi2, S. Emoto2, T. Watanabe2
  • 1Department Of Outpatient Chemotherapy, The University of Tokyo, 113-8655 - Tokyo/JP
  • 2Department Of Surgical Oncology, The University of Tokyo, 113-8655 - Tokyo/JP

Abstract

Background

Intraperitoneal (i.p.) chemotherapy is a promising treatment option for gastric cancer with peritoneal metastasis. We previously carried out phase I and phase II studies of intravenous (i.v.) and i.p. paclitaxel (PTX) combined with S-1, and verified the safety and efficacy in gastric cancer with macroscopic peritoneal metastasis and/or cancer cells on peritoneal cytology (Oncology 2009, Ann Oncol 2010). This regimen was approved as an advanced medical treatment by the Ministry of Health, Labour and Welfare of Japan, and further clinical studies were required for approval of coverage by the Japanese Health Insurance System. Therefore, we carried out another phase II study in gastric cancer patients with macroscopic peritoneal metastasis.

Patients and methods

Gastric cancer patients with macroscopic peritoneal metastasis confirmed by staging laparoscopy were enrolled. PTX was administered i.v. at 50 mg/m2 and i.p. at 20 mg/m2 on days 1 and 8. S-1 was administered orally twice daily at 80 mg/m2/day for 14 consecutive days followed by 7 days rest. The primary endpoint was the 1-year overall survival rate. Secondary endpoints were the response rate, efficacy against malignant ascites and safety.

Results

Thirty-five patients were enrolled. All patients had several to numerous metastases to the distant peritoneum. The median number of courses was 11 (range 2-29). The 1-year overall survival rate was 77% (95% CI, 63-91%). The overall response rate was 71% in 7 patients with target lesions. Malignant ascites disappeared or decreased in 6 of 9 (67%) patients with massive ascites. Cancer cells ceased to be detected by peritoneal cytology in 28 of 29 (97%) patients. The incidences of grade 3/4 hematological and non-hematological toxicities were 34% and 9%, respectively, all of which were manageable and reversible. The frequent grade 3/4 toxicities included neutropenia (34%), leukopenia (23%) and anemia (9%). There were no treatment-related deaths.

Conclusion

Combination chemotherapy of weekly i.v. and i.p. PTX combined with S-1 is well tolerated and active in gastric cancer patients with macroscopic peritoneal metastasis.

Disclosure

All authors have declared no conflicts of interest.