{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T12:45:17Z","timestamp":1791895517991,"version":"4.3.4"},"reference-count":28,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T00:00:00Z","timestamp":1791590400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/501100001411","name":"Indian Council of Medical Research","doi-asserted-by":"publisher","award":["No.3\/2\/June-2022\/PG-IH&HRD(14)"],"award-info":[{"award-number":["No.3\/2\/June-2022\/PG-IH&HRD(14)"]}],"id":[{"id":"10.13039\/501100001411","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Oncol Pharm Pract"],"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Guideline-based prophylaxis prevents most vomiting during highly emetogenic chemotherapy (HEC), but nausea remains incompletely controlled, especially where NK1 receptor antagonists and olanzapine are inaccessible or ineffective. Amisulpride, a dopamine D2\/D3 antagonist, may add benefit with less sedation than olanzapine.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Adults receiving cisplatin-based or anthracycline-cyclophosphamide HEC were studied during a single cycle in this randomized, double-blind, placebo-controlled group sequential trial. All received intravenous ondansetron and dexamethasone on day 1 plus oral dexamethasone 8\u2005mg twice daily on days 2\u20134, with oral amisulpride (25\u2005mg before chemotherapy, then 12.5\u2005mg nightly for 3 days) or placebo. The primary endpoint was the 4-day (0\u201396\u2005h) no-nausea responder rate; the planned sample size of 94 targeted an 18 percentage-point improvement. Two interim and one final analysis used O\u2019Brien-Fleming efficacy and futility boundaries.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The trial stopped for futility at the second interim analysis (70 participants; 35 per arm). No-nausea response was 65.7% with amisulpride versus 57.1% with placebo (risk difference 8.6 percentage points; 95% CI \u221214.2 to 31.3; p\u2009=\u20090.461). Complete response (no emesis or rescue medication) was 80.0% versus 68.6% (p\u2009=\u20090.274). VAS, FLIE, rescue medication use, and adverse-event frequency were similar, apart from more frequent constipation with amisulpride.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The 8.6 percentage-point difference favored amisulpride but fell short of the 18-point practice-changing MCID, in a well-controlled placebo arm. Without an olanzapine- or NK1-containing comparator, the trial cannot position amisulpride against those regimens, nor exclude a smaller benefit worth having where they are inaccessible.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10781552261495003","type":"journal-article","created":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T12:04:53Z","timestamp":1791633893000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Add-on oral amisulpride for prevention of chemotherapy-induced nausea and vomiting during highly emetogenic chemotherapy: A randomized double-blind placebo-controlled group sequential trial"],"prefix":"10.1177","author":[{"given":"Gayathri","family":"GR","sequence":"first","affiliation":[{"name":"All India Institute of Medical Sciences"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mathan Kumar","family":"Ramasubbu","sequence":"additional","affiliation":[{"name":"All India Institute of Medical Sciences"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8837-299X","authenticated-orcid":false,"given":"Archana","family":"Mishra","sequence":"additional","affiliation":[{"name":"All India Institute of Medical Sciences"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Debasish","family":"Hota","sequence":"additional","affiliation":[{"name":"All India Institute of Medical Sciences"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7151-6539","authenticated-orcid":false,"given":"Saroj Kumar Das","family":"Majumdar","sequence":"additional","affiliation":[{"name":"All India Institute of Medical Sciences"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dillip Kumar","family":"Parida","sequence":"additional","affiliation":[{"name":"All India Institute of Medical Sciences"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0663-0922","authenticated-orcid":false,"given":"Anand","family":"Srinivasan","sequence":"additional","affiliation":[{"name":"All India Institute of Medical Sciences"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,10,10]]},"reference":[{"key":"e_1_3_2_2_2","article-title":"Evaluation of new antiemetic agents and definition of antineoplastic agent emetogenicity\u2014state of the art","volume":"19","author":"Grunberg SM","year":"2011","unstructured":"Grunberg SM, Warr D, Gralla RJ, et al. 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MASCC Antiemetic consensus recommendations: resource-limited settings. Support Care Cancer 2025; 33: 181.","journal-title":"Support Care Cancer"},{"key":"e_1_3_2_16_2","first-page":"203","article-title":"A group sequential response-adaptive randomized double-blinded clinical trial to evaluate the safety and efficacy of add-on olanzapine plus pregabalin for the prevention of chemotherapy-induced nausea and vomiting","volume":"33","author":"Ramasubbu MK","year":"2025","unstructured":"Ramasubbu MK, Hota D, Das Majumdar SK, et al. A group sequential response-adaptive randomized double-blinded clinical trial to evaluate the safety and efficacy of add-on olanzapine plus pregabalin for the prevention of chemotherapy-induced nausea and vomiting. 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