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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\u00a0mg\/m<jats:sup>2<\/jats:sup>) of tri-weekly <jats:italic>nab<\/jats:italic>-PTX.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Methods<\/jats:title>\n<jats:p>Eligible patients included those with AGC and ECOG performance status of 0\u20132 who had received one or more prior chemotherapy containing fluoropyrimidine regimens. A reduced dose of <jats:italic>nab<\/jats:italic>-PTX (220\u00a0mg\/m<jats:sup>2<\/jats:sup>) was administered tri-weekly. 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.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Results<\/jats:title>\n<jats:p>Among 33 patients enrolled, 32 were treated with protocol therapy. RR was 3.1% [95% confidence interval (CI), 0\u201316.2%], which did not reach the protocol-specified threshold (<jats:italic>p<\/jats:italic>\u2009=\u20090.966). DCR was 37.5% (95% CI, 21.1\u201356.3%). Median OS and PFS were 6.3 (95% CI, 4.4\u201314.2) and 2.2 (95% CI, 1.8\u20133.1) months, respectively. RDI was 97.8%. Twenty (62.5%) patients received subsequent chemotherapy. Toxicity was relatively mild with the most common grade\u2009\u2265\u20093 adverse events being neutropenia (38%), anemia (13%), fatigue (19%), anorexia (16%), and peripheral neuropathy (13%).<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Conclusion<\/jats:title>\n<jats:p>Tri-weekly <jats:italic>nab<\/jats:italic>-PTX with a reduced dose (220\u00a0mg\/m<jats:sup>2<\/jats:sup>) is not recommended for AGC in a second-line or later setting, despite demonstrating less toxicity than at 260\u00a0mg\/m<jats:sup>2<\/jats:sup>.<\/jats:p>\n<jats:p><jats:italic>Clinical trial registration<\/jats:italic><\/jats:p>\n<jats:p>The OGSG1302 trial was registered with UMIN-CTR as UMIN000000714.<\/jats:p>\n<\/jats:sec>","DOI":"10.1007\/s10147-020-01768-w","type":"journal-article","created":{"date-parts":[[2020,9,14]],"date-time":"2020-09-14T08:02:32Z","timestamp":1600070552000},"page":"2035-2043","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["A phase II trial of dose-reduced nab-paclitaxel for patients with previously treated, advanced or recurrent gastric cancer (OGSG 1302)"],"prefix":"10.1007","volume":"25","clinical-trial-number":[{"clinical-trial-number":"umin000000714","registry":"10.18810\/umin-japan"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1116-5586","authenticated-orcid":false,"given":"Shigeyuki","family":"Tamura","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hirokazu","family":"Taniguchi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazuhiro","family":"Nishikawa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroshi","family":"Imamura","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Junya","family":"Fujita","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Atsushi","family":"Takeno","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jin","family":"Matsuyama","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yutaka","family":"Kimura","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Junji","family":"Kawada","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Motohiro","family":"Hirao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masashi","family":"Hirota","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazumasa","family":"Fujitani","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yukinori","family":"Kurokawa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daisuke","family":"Sakai","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hisato","family":"Kawakami","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toshio","family":"Shimokawa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Taroh","family":"Satoh","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2020,9,14]]},"reference":[{"issue":"1","key":"1768_CR1","doi-asserted-by":"publisher","first-page":"54","DOI":"10.1200\/JCO.2003.04.130","volume":"21","author":"A Ohtsu","year":"2003","unstructured":"Ohtsu A, Shimada Y, Shirao K et al (2003) Randomized phase III trial of fluorouracil alone versus fluorouracil plus cisplatin versus uracil and tegafur plus mitomycin in patients with unresectable, advanced gastric cancer: The Japan Clinical Oncology Group Study (JCOG9205). 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Hiroshi Imamura has received honoraria from Taiho. Kazumasa Fujitani has received honoraria from Bristol-Myers Squibb, Eli Lilly, Ono, Taiho and Yakult. Yukinori Kurokawa has received honoraria from Taiho, Ono, Eli Lilly, Yakult, Bristol-Myers Squibb, Kaken, Chugai and Takeda, and research funding from Taiho, Ono and MSD. Daisuke Sakai has received honoraria from Chugai and Diichi-Sankyo, and research funding from Chugai, Yakult, Ono, Eli Lilly and Diichi-Sankyo. Hisato Kawakami has received honoraria from Bristol-Myers Squibb. Astra-Zeneca, Bayer Yakuhin, Eli Lilly, MSD, Ono, Chugai, Daiichi Sankyo, Takeda and Taiho, and research funding from Chugai, Taiho and Eisai. Taroh Satoh has received honoraria from Bristol-Myers Squibb, Eli Lilly, Ono, Chugai and Taiho, and research funding from MSD, Gilead, Astellas and Astra-Zeneca, and have received scholarship donations from Taiho, and endowed chairs from Ono, Chugai and Yakult. All remaining authors declare no conflict of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}