Phase I trial of oral S-1 combined with gemcitabine in metastatic pancreatic cancer
2005

Combining S-1 and Gemcitabine for Pancreatic Cancer

Sample size: 21 publication Evidence: moderate

Author Information

Author(s): Nakamura K, Yamaguchi T, Ishihara T, Kobayashi A, Tadenuma H, Sudo K, Kato H, Saisho H

Primary Institution: Chiba University, Chiba, Japan

Hypothesis

The study aims to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of S-1 combined with gemcitabine in patients with metastatic pancreatic cancer.

Conclusion

The combination of S-1 and gemcitabine was well tolerated and showed promising antitumor activity, warranting further phase II studies.

Supporting Evidence

  • 21 patients with advanced pancreatic cancer were enrolled in the study.
  • 10 out of 21 patients showed a complete or partial response to the treatment.
  • The median survival time for patients was 9.3 months.

Takeaway

Doctors tested a new medicine called S-1 with an existing one called gemcitabine to see if they work better together for patients with pancreatic cancer.

Methodology

This was an open-label, single-centre, nonrandomised, dose-escalating phase I study where S-1 was given orally and gemcitabine was administered intravenously.

Limitations

The study was limited to a small sample size and was only a phase I trial focused on safety and tolerability.

Participant Demographics

{"total":21,"men":10,"women":11,"age":{"median":61,"range":"48-73"},"ecog_status":{"0":8,"1":11,"2":2},"sites_of_metastatic_disease":{"liver":18,"lung":3,"peritoneum":2}}

Statistical Information

Confidence Interval

{"median_survival_time":"9.3 months","95%_ci":"6.3-12.3"}

Digital Object Identifier (DOI)

10.1038/sj.bjc.6602644

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