{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,23]],"date-time":"2026-03-23T15:20:17Z","timestamp":1774279217903,"version":"3.50.1"},"reference-count":30,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2025,9,8]],"date-time":"2025-09-08T00:00:00Z","timestamp":1757289600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2025,9,8]],"date-time":"2025-09-08T00:00:00Z","timestamp":1757289600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Asia-Pac J Clncl Oncology"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Trastuzumab emtansine (T\u2010DM1), an antibody\u2013drug conjugate, targets tumor cells overexpressing human epidermal growth factor receptor 2 (HER2). This single\u2010arm, phase IV study assessed the safety and efficacy of T\u2010DM1 in Indian patients with HER2\u2010positive, locally advanced, or metastatic breast cancer previously treated with trastuzumab and a taxane.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Patients received T\u2010DM1 (3.6\u00a0mg\/kg intravenously every 3\u00a0weeks) until death, disease progression, unacceptable toxicity, consent withdrawal, or up to a maximum of 12\u00a0months after the last patient's first visit, whichever occurred first. Safety was mainly assessed by the incidence and severity of adverse events (AEs). Efficacy was evaluated by progression\u2010free survival (PFS), overall survival (OS), and overall response rate (ORR). Patients were followed up posttreatment until 12\u00a0months or until lost to follow\u2010up, withdrawn consent, or death.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 70 eligible patients (median age [range]: 50.0 [27.0\u201375.0] years) received at least one dose of T\u2010DM1 (median duration [range]: 32.0 [1.0\u2013125.0] weeks). Adverse events in 21 (30.0%) patients were treatment\u2010related. The most common treatment\u2010related AEs and SAEs were thrombocytopenia (seven [10.0%] and three [4.0%] patients, respectively) and epistaxis (four [6.0%] and two [3.0%] patients, respectively). During the study, 10 (18.0%) patients died (disease progression:\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a06; AE:\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a03; and unknown reason:\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a01), while 2 patients died during the follow\u2010up period. Median PFS was 14\u00a0months (95% confidence interval [CI]: 8.0, 17.0). Among 65 evaluable patients, 16 (23.0%) achieved partial responses; ORR was 23.0%.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Trastuzumab emtansine was found to be safe and efficacious in the Indian patients.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/ajco.70007","type":"journal-article","created":{"date-parts":[[2025,9,8]],"date-time":"2025-09-08T14:05:34Z","timestamp":1757340334000},"page":"240-250","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Safety and Efficacy Assessment of Trastuzumab Emtansine in Indian Patients With Human Epidermal Growth Factor Receptor 2\u2010Positive Unresectable Locally Advanced or Metastatic Breast Cancer Previously Treated With Trastuzumab and a Taxane: An Open\u2010Label, Single\u2010Arm, Phase IV Study"],"prefix":"10.1111","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6742-6378","authenticated-orcid":false,"given":"Sudeep","family":"Gupta","sequence":"first","affiliation":[{"name":"Department of Medical Oncology Tata Memorial Hospital  Mumbai Maharashtra India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manish","family":"Singhal","sequence":"additional","affiliation":[{"name":"Indraprastha Apollo Hospitals  New Delhi India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shona","family":"Nag","sequence":"additional","affiliation":[{"name":"Jehangir Hospital  Pune Maharashtra India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Waseem","family":"Abbas","sequence":"additional","affiliation":[{"name":"Medical Oncology Max Super Speciality Hospital  New Delhi India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dinesh Chandra","family":"Doval","sequence":"additional","affiliation":[{"name":"Medical Oncology, Rajiv Gandhi Cancer Institute and Research Center  New Delhi India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hari","family":"Goyal","sequence":"additional","affiliation":[{"name":"Artemis Health Institute  Gurugram Haryana India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chirag","family":"Shah","sequence":"additional","affiliation":[{"name":"Apollo Hospitals International Limited  Gandhinagar Gujarat India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ashish","family":"Singh","sequence":"additional","affiliation":[{"name":"Medicine Christian Medical College and Hospital  Vellore Tamil Nadu India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Radheshyam","family":"Naik","sequence":"additional","affiliation":[{"name":"Healthcare Global Enterprises Limited  Bengaluru Karnataka India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nitesh","family":"Rohatgi","sequence":"additional","affiliation":[{"name":"Max Super Speciality Hospital  New Delhi India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Poonam","family":"Patil","sequence":"additional","affiliation":[{"name":"Department of Oncology Manipal Hospital  Bengaluru Karnataka India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shyam","family":"Aggarwal","sequence":"additional","affiliation":[{"name":"Medical Oncology Sir Gangaram Hospital  New Delhi India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vinod","family":"Raina","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology &amp; Haematology Fortis Memorial Research Institute  Gurugram Haryana India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vaibhav","family":"Watts","sequence":"additional","affiliation":[{"name":"Roche Products India Pvt. 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