A phase I study of S-1 in combination with nab-paclitaxel in patients with unresectable or recurrent gastric cancer

Abstract

Based on the present results, the RD was determined as level 3a (S-1 80 mg/m twice daily plus nab-paclitaxel 260 mg/m on day 1). This combination therapy was well tolerated and showed antitumor efficacy in patients with advanced gastric cancer.

Combination therapy with gemcitabine and nab-paclitaxel for locally advanced unresectable pancreatic cancer

“…The nab-PTX formulation comprises human albumin-bound PTX nanoparticles and has been reported to be useful for treating breast, gastric and non-small-cell lung cancer (9)(10)(11). When combined with GEM for the treatment of PC, nab-PTX acts by decreasing the interstitial components of PC and increases the microvasculature within the tumor.…”

Phase II clinical trial of S‐1 plus nanoparticle albumin‐bound paclitaxel in untreated patients with metastatic gastric cancer

“…Combination of S‐1 and Nab‐PTX in the present study compared favorably with those phase III trials, although no direct comparison data are available. ORR and PFS of the current phase II trial also compared favorably with the ORR of 54.5% and PFS of 5.8 months for the recent phase I study of S‐1 plus Nab‐PTX with 16 AGC patients enrolled . In particular, S‐1 plus Nab‐PTX yielded a complete response rate of 5.5%, which is higher than data from those phase III trials.…”

“…In particular, in the present study, creatinine elevation was mild, with no ototoxicity and infrequent grade 3 to 4 peripheral neuropathy. The most frequent overall and grade 3 to 4 hematological toxicities were leukopenia and neutropenia, which occurred at a lower rate than those reported for Nab‐PTX in breast, pancreatic, non‐small‐cell and gastric cancer . The most frequent grade 3 to 4 non‐hematological toxicities were diarrhea, vomiting, peripheral neuropathy, hand‐foot syndrome, and stomatitis.…”

“…Dose schedules of Nab‐PTX varied across phase I to III trials, and three‐weekly 260 mg/m 2 doses were used in breast and gastric cancers . The ABSOLUTE trial that explored 3/4 weekly Nab‐PTX (100 mg/m 2 on d1, d8, and d15, q4w) was non‐inferior to weekly solvent‐based paclitaxel as second‐line treatment of gastric cancer, which added evidence for divided doses of Nab‐PTX .…”

“…The synergistic effect of capecitabine and Nab‐PTX was observed in a phase II study of metastatic breast cancer . Recently, a phase I study for the first time showed that the combination of S‐1 plus Nab‐PTX was well tolerated and had antitumor efficacy with an overall response rate (ORR) of 54.5% and median progression‐free survival (PFS) of 5.8 months as first‐line treatment for AGC patients …”