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

Abstract

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.

Randomized Phase II Study of Consecutive-Day versus Alternate-Day Treatment with S-1 as Second-Line Chemotherapy in Advanced Pancreatic Cancer

“…In our study, the median OS of the two groups was 4.5 and 4.4 months with no statistical significance. These numbers were close to the results in two phase II studies [14,15] of S-1 monotherapy as second-line chemotherapy for advanced pancreatic cancer after gemcitabine failure (median survival time 4.5-6.3 months). The RR was disappointing as only 1 patient in the daily group showed PR with no CR/PR in the alternate-day group.…”

Phase I/II study of gemcitabine as a fixed dose rate infusion and S-1 combination therapy (FGS) in gemcitabine-refractory pancreatic cancer patients

“…Differentiating between the relative roles of gemcitabine and S-1 in overcoming tumor resistance is difficult. The efficacy and survival data obtained in the present study seem to be better than those of previous studies for oral fluoropyrimidine monotherapy as a salvage chemotherapy for advanced pancreatic carcinoma (Table 6) [1,2,17,28,29]. However, since all the data were obtained in single-arm studies, a randomized study is needed to make these suggestions reliable.…”

“…In gemcitabine-refractory metastatic pancreatic cancer, our recent phase II study of S-1 yielded results that demonstrated marginal activity including a response rate of 15%, a median progression-free survival time of 2.0 months and a median overall survival time of 4.5 months, with a favorable toxicity profile [17]. In addition, other reports also demonstrated marginal antitumor activity [1,28]. Gemcitabine administration via infusion at a fixed dose rate of 10 mg/m 2 /min (FDR-Gem) has been found to increase the intracellular drug concentrations, compared with gemcitabine at a standard dose rate infusion over a period of 30 min.…”

Results of a phase II trial of S-1 as first-line treatment of metastatic pancreatic cancer (CESAR-study group)

“…In contrast, several recent studies assessed S-1 monotherapy as second-line treatment for advanced pancreatic cancer after gemcitabine failure. Median progression-free survival was 2.0 to 4.1 months, and overall survival data 4.5 to 6.3 months, respectively [19][20][21]; thereby reaching survival data as reported in the initial first line gemcitabine trial by Burris and co-workers [2]. The authors concluded that S-1 as monotherapy had only marginal anti-tumour activity in patients with gemcitabine-refractory metastatic pancreatic cancer.…”