, Volume 67, Issue 2, pp 249-254
Date: 30 Mar 2010

Phase II study of S-1 in patients with gemcitabine-resistant advanced pancreatic cancer

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Abstract

Purpose

The primary objective of this study was to assess the efficacy and safety of S-1 in patients with gemcitabine-resistant advanced pancreatic cancer.

Methods

Patients with histologically or cytologically proven, advanced pancreatic cancer who had received first-line chemotherapy with gemcitabine were eligible for this study. S-1 was administered orally at a dose of 40 mg/m2 twice daily for 28 days, followed by 14 days’ rest. Treatment was repeated every 6 weeks until disease progression.

Results

Twenty-one patients were enrolled in this study. Grade 3 and 4 toxicities included anorexia in 14% of the patients, abdominal pain in 4.8% and infection without neutropenia in 4.8%. S-1 was discontinued in two patients because of toxicity. Of the 21 eligible patients, 2 (9.5%) achieved a partial response and 9 (43%) had stable disease. A marked decrease (≥50%) in tumor marker (CA19-9) was observed in 5 (28%) of the 18 evaluable patients. The median progression-free survival and the median survival time from the first day of S-1 therapy were 4.1 months (95% CI, 1.3–6.9 months) and 6.3 months (95% CI, 3.6–8.9 months), respectively.

Conclusions

Second-line chemotherapy with S-1 was tolerated with acceptable toxicity and resulted in a relatively high disease control rate in patients with gemcitabine-resistant advanced pancreatic cancer. As an oral agent, S-1 may be a feasible treatment option for this patient population.

This study was performed according to the guidelines of the Declaration of Helsinki as amended in Edinburgh, Scotland, in October 2000. The protocol was approved by the Institutional Review Board of Chiba University Graduate School of Medicine. All study participants provided written informed consent. This manuscript has not been published and is not under consideration for publication elsewhere.