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

Abstract

This combination regimen of FGS is active and well tolerated in patients with Gem-refractory PC.

The addition of S-1 to gemcitabine-based chemotherapy improves survival with increased toxicity for patients with advanced pancreatic cancer: Combined meta-analysis of efficacy and safety profile

“…There was no standard second-line therapy after first-line chemotherapy failure. A recent phase I/II study showed that combination therapy of fixed dose rate infusion of GEM with S-1 (FGS) provided a promising antitumor activity and tolerable toxicity in GEM-refractory metastatic PC patients [24]. The median OS and PFS were 7.0 and 2.8 months respectively, seemed to be better than those treated with S-1 monotherapy [25,26].…”

Therapeutic efficacy and safety of S-1-based combination therapy compare with S-1 monotherapy following gemcitabine failure in pancreatic cancer: a meta-analysis

“…Additionally, another phase II RCT showed no significant difference in OS between a group receiving selumetinib (5.4 months) and one receiving capecitabine (5.0 months)25. Other regimens, such as S-1 plus radiotherapy, S-1 with a fixed dose of gemcitabine, and paclitaxel plus S-1 have been used for pancreatic cancer following gemcitabine failure262728, but RCTs have not been conducted for further verification.…”

Gemcitabine Compared With Gemcitabine and S-1 Combination Therapy in Advanced Pancreatic Cancer

“…In recent years, studies have identified that S-1 achieve favorable therapeutic effect in GEM-resistant PC. 27 , 28 Thus, treatment comparison between GEM and GS had been launched in several large-scale clinical trials.…”