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At least 35 phase II studies using combined nab-PTX and anthracycline in neoadjuvant settings are registered in Japan. We analyzed the efficacy and safety of nab-PTX based on patient characteristics in these studies.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>We conducted a meta-analysis using individual patient data (IPD) to investigate the average efficacy of nab-PTX-containing regimens as neoadjuvant chemotherapy for operable breast cancer. IPD were provided by principal investigators who agreed to participate. The primary endpoint was pathological complete response (pCR) rate of each breast cancer subtype.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>We analyzed the data of 16 studies involving 753 patients. The overall crude frequencies of pCR (ypT0 ypN0, ypT0\/is ypN0, and ypT0\/is ypNX) were 18.1, 26.0, and 28.6%, respectively. Specifically, the frequencies were 6.7, 10.2, and 13.4% for luminal (<jats:italic>n<\/jats:italic>\u2009=\u2009343); 40.5, 63.5, and 68.9% for human epidermal growth factor receptor 2 (HER2)-rich, (<jats:italic>n<\/jats:italic>\u2009=\u200974); 21.9, 40.6, and 42.7% for luminal\/HER2 (<jats:italic>n<\/jats:italic>\u2009=\u200996); and 26.3, 31.5, and 32.3% for triple-negative breast cancers (TNBC) (<jats:italic>n<\/jats:italic>\u2009=\u2009232). The multivariate analyses indicated that HER2 positivity, TNBC, high Ki-67, high nuclear grade, and weekly nab-PTX administration were significantly associated with the pCR. The proportion of hematological toxicities (neutropenia (39.7%) and leukopenia (22.5%)), peripheral sensory neuropathy (9.7%), myalgia (5.7%), and arthralgia (4.7%) was higher than grade 3 adverse events, but most patients recovered.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Nab-PTX is a safe and acceptable chemotherapeutic agent in neoadjuvant settings, particularly for aggressive cancers. UMIN-CTR#: UMIN000028774<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s12282-021-01238-9","type":"journal-article","created":{"date-parts":[[2021,4,3]],"date-time":"2021-04-03T12:02:21Z","timestamp":1617451341000},"page":"1023-1037","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Meta-analysis of nanoparticle albumin-bound paclitaxel used as neoadjuvant chemotherapy for operable breast cancer based on individual patient data (JBCRG-S01 study)"],"prefix":"10.1007","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5622-8352","authenticated-orcid":false,"given":"Manabu","family":"Futamura","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8374-8038","authenticated-orcid":false,"given":"Mari","family":"Oba","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7302-0278","authenticated-orcid":false,"given":"Norikazu","family":"Masuda","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroko","family":"Bando","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Morihito","family":"Okada","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yutaka","family":"Yamamoto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takanori","family":"Kin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toshiaki","family":"Saeki","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takeshi","family":"Nagashima","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takashi","family":"Kuwayama","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Uhi","family":"Toh","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Akira","family":"Hirano","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masafumi","family":"Inokuchi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazuhiko","family":"Yamagami","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yutaka","family":"Mizuno","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9991-0228","authenticated-orcid":false,"given":"Yasuyuki","family":"Kojima","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takahiro","family":"Nakayama","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroyuki","family":"Yasojima","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shinji","family":"Ohno","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,4,3]]},"reference":[{"key":"1238_CR1","first-page":"1038","volume":"8","author":"NK Ibrahim","year":"2002","unstructured":"Ibrahim NK, Desai N, Legha S, Soon-Shiong P, Theriault RL, Rivera E, et al. 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NM-Remuneration: Chugai, AstraZeneca, Pfizer, Eli-Lilly, Eisai, Takeda, Kyowa-Kirin, MSD, Novartis, Nippon-Kayaku, and Daiichi-Sankyo. Funding: Chugai. HB-Remuneration: AstraZeneca, Eisai, Kyowa-Kirin, Taiho, Chugai, Nippon-Kayaku, Pfizer, and Novartis. YY-Remuneration and Funds: Novartis, Nippon-Kayaku, Kyowa-Kirin, Taiho, and Chugai. TS-Remuneration: Ono, Kyowa-Kirin. Funding: Taiho, AstraZeneca, Chugai, and Eisai. UT-Remuneration: Chugai, Eisai, and Kyowa-Kirin. Grant: Chugai, Eisai, Taiho, Daichi-Sankyo, Nippon-Kayaku, and Kyowa-Kirin. YK-Remuneration: Chugai, Novartis, Daiichi-Sankyo, Pfizer, Eli-Lilly, AstraZeneca, Kyowa-Kirin, and Eisai. TN-Remuneration: Chugai, Eli Lilly, Novartis, AstraZeneca, and Daiichi-Sankyo. SO-Remuneration: Chugai, Eisai, Eli-Lilly, Pfizer, Taiho, and AstraZeneca. Funding: Taiho and Eisai.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This study was conducted in accordance with the Declaration of Helsinki and approved by the review board or ethical committee of each participating institute.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"This meta-analysis used only existing information as described in the \u2018\u2018Ethical Guidelines for Epidemiology Research\u2019\u2019 co-published by the Ministry of Education, Culture, Sports, Science and Technology and the Ministry of Health, Labour, and Welfare of Japan. The study purpose, methods, collection, and usage of data were published on a poster in each institution relevant to each subject population to give the opportunity to opt-out. Thus, written informed consent was not necessary.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}