Phase I Pharmacokinetic Study of Paclitaxel Combined with S-1 for Advanced Gastric Cancer

Strategic Insights -

Researchers in Tokyo, Japan, have conducted a Phase I pharmacokinetic study to determine the maximum-tolerated dose (MTD) and recommended dose (RD) of paclitaxel (PTX) combined with S-1 for advanced gastric cancer patients. The study involved nine patients with peritoneal dissemination and/or cancer cells on peritoneal cytology, who received a combination of intravenous and intraperitoneal PTX with S-1. The results showed that the MTD was 30 mg/m^2, with 2 of 3 patients developing dose-limiting toxicities. The recommended dose was determined to be 20 mg/m^2.

Key Takeaways:

  • The study aimed to determine the MTD and RD of PTX combined with S-1 for advanced gastric cancer patients.
  • Nine gastric cancer patients with peritoneal dissemination and/or cancer cells on peritoneal cytology were enrolled in the study.
  • The study showed that the MTD was 30 mg/m^2, with 2 of 3 patients developing dose-limiting toxicities, grade 3 febrile neutropenia, and diarrhea.
  • The recommended dose was determined to be 20 mg/m^2.
  • The intraperitoneal and serum PTX concentration remained effective for over 72 and 48 h, respectively.
  • The researchers concluded that combined chemotherapy of S-1 plus weekly intravenous and intraperitoneal PTX was a safe regimen that should be further explored in clinical trials.
  • H. Ishigami and colleagues from the University of Tokyo, Department of Surgical Oncology, conducted the study.

Statistics:

  • 9 patients with peritoneal dissemination and/or cancer cells on peritoneal cytology were enrolled in the study.
  • MTD was determined to be 30 mg/m^2, with 2 of 3 patients developing dose-limiting toxicities.
  • RD was determined to be 20 mg/m^2.
  • Intraperitoneal PTX concentration remained effective for over 72 h.
  • Serum PTX concentration remained effective for over 48 h.

Sources:

  • Ishigami, H., et al. "Phase I pharmacokinetic study of weekly intravenous and intraperitoneal paclitaxel combined with S-1 for advanced gastric cancer." Oncology 76.5 (2009): 311-4.
  • Publisher contact information for the journal Oncology: S. Karger AG, Allschwilerstrasse 10, CH-4009 Basel, Switzerland.