A phase II trial of dose-reduced nab -paclitaxel for patients with previously treated, advanced or recurrent gastric can
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ORIGINAL ARTICLE
A phase II trial of dose‑reduced nab‑paclitaxel for patients with previously treated, advanced or recurrent gastric cancer (OGSG 1302) Shigeyuki Tamura1 · Hirokazu Taniguchi2 · Kazuhiro Nishikawa3 · Hiroshi Imamura4 · Junya Fujita5 · Atsushi Takeno6 · Jin Matsuyama7 · Yutaka Kimura8 · Junji Kawada1 · Motohiro Hirao3 · Masashi Hirota4 · Kazumasa Fujitani9 · Yukinori Kurokawa10 · Daisuke Sakai11 · Hisato Kawakami12 · Toshio Shimokawa13 · Taroh Satoh11 Received: 31 May 2020 / Accepted: 6 August 2020 © The Author(s) 2020
Abstract Background For unresectable or recurrent advanced gastric adenocarcinoma (AGC), tri-weekly administration of nanoparticle albumin-bound paclitaxel (nab-PTX) at 260 mg/m2 achieved a response rate of 27.8% in a phase II trial in Japan. However, frequent neutropenia and peripheral neuropathy limit its use in clinical settings. We, thus, conducted a single-arm phase II trial to investigate the efficacy and safety of a reduced dose (220 mg/m2) of tri-weekly nab-PTX. Methods Eligible patients included those with AGC and ECOG performance status of 0–2 who had received one or more prior chemotherapy containing fluoropyrimidine regimens. A reduced dose of nab-PTX (220 mg/m2) was administered triweekly. The primary endpoint was response rate (RR). Secondary endpoints were overall survival (OS), progression-free survival (PFS), disease-control rate (DCR), incidence of adverse events, relative dose intensity (RDI) and proportion of patients receiving subsequent chemotherapy. Results Among 33 patients enrolled, 32 were treated with protocol therapy. RR was 3.1% [95% confidence interval (CI), 0–16.2%], which did not reach the protocol-specified threshold (p = 0.966). DCR was 37.5% (95% CI, 21.1–56.3%). Median OS and PFS were 6.3 (95% CI, 4.4–14.2) and 2.2 (95% CI, 1.8–3.1) months, respectively. RDI was 97.8%. Twenty (62.5%) patients received subsequent chemotherapy. Toxicity was relatively mild with the most common grade ≥ 3 adverse events being neutropenia (38%), anemia (13%), fatigue (19%), anorexia (16%), and peripheral neuropathy (13%). Conclusion Tri-weekly nab-PTX with a reduced dose (220 mg/m2) is not recommended for AGC in a second-line or later setting, despite demonstrating less toxicity than at 260 mg/m2. Clinical trial registration The OGSG1302 trial was registered with UMIN-CTR as UMIN000000714. Keywords Advanced gastric cancer · Recurrent gastric cancer · Nab-paclitaxel · Paclitaxel
Introduction Combination of chemotherapy with platinum agents and fluoropyrimidine has been regarded as the standard of care in a first-line setting for unresectable or recurrent advanced gastric adenocarcinoma (AGC) [1], to which trastuzumab, an anti-HER2 monoclonal antibody, is added in HER2-positive * Shigeyuki Tamura shigeyuki.tamura@hosp‑yao.osaka.jp Extended author information available on the last page of the article
cases [2, 3]. Recently, oral fluoropyrimidine including S-1 and capecitabine, has generally been utilized instead of infusional 5-FU because of their convenience and t
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