{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T13:40:46Z","timestamp":1793108446849,"version":"4.5.0"},"reference-count":18,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"5","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2025,2,10]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>SWOG S1815 was a randomized, open label phase III trial, evaluating gemcitabine, nab-paclitaxel, and cisplatin (GAP) versus gemcitabine and cisplatin (GC) in patients with newly diagnosed advanced biliary tract cancers (BTCs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>\n                      Patients with newly diagnosed locally advanced unresectable or metastatic BTC, including intrahepatic cholangiocarcinoma (ICC) and extrahepatic cholangiocarcinoma (ECC) and gallbladder carcinoma (GBC), were randomly assigned 2:1 to either GAP (gemcitabine 800 mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      , cisplatin 25 mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      , and nab-paclitaxel 100 mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      intravenously once per day on days 1 and 8 of a 21-day cycle) or GC (gemcitabine 1,000 mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      and cisplatin 25 mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      intravenously once per day on days 1 and 8 of a 21-day cycle).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>\n                      Among 452 randomly assigned participants, 441 were eligible and analyzable, 67% with ICC, 16% with GBC, and 17% with ECC. There was no significant difference in overall survival (OS) between GAP versus GC. Median OS with GAP was 14.0 months (95% CI, 12.4 to 16.1) and 13.6 months with GC (95% CI, 9.7 to 16.6); hazard ratio (HR), 0.91 (95% CI, 0.72 to 1.14);\n                      <jats:italic>P<\/jats:italic>\n                      = .41. Median progression-free survival (PFS) was similar between groups with median PFS for GAP being 7.5 months (95% CI, 6.4 to 8.5) versus 6.3 months for GC (95% CI, 4.4 to 8.2); HR, 0.89 (95% CI, 0.71 to 1.12);\n                      <jats:italic>P<\/jats:italic>\n                      = .32. In exploratory subset analyses, the OS and PFS benefits of GAP versus GC treatment were greater in locally advanced disease compared with metastatic disease, although not statistically significant (interaction\n                      <jats:italic>P<\/jats:italic>\n                      = .14 for OS and\n                      <jats:italic>P<\/jats:italic>\n                      = .17 for PFS). Moreover, GAP versus GC showed greater improvement in PFS among participants with GBC than those with ICC or ECC (interaction\n                      <jats:italic>P<\/jats:italic>\n                      = .01), but not OS (interaction\n                      <jats:italic>P<\/jats:italic>\n                      = .28).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>The addition of a taxane in the GAP regimen to the standard gemcitabine-cisplatin regimen did not improve OS in newly diagnosed BTC. More toxicity was encountered with GAP versus GC.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco-24-01383","type":"journal-article","created":{"date-parts":[[2024,12,13]],"date-time":"2024-12-13T15:59:20Z","timestamp":1734105560000},"page":"536-544","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":56,"title":["SWOG S1815: A Phase III Randomized Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel Versus Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Tract Cancers"],"prefix":"10.1200","volume":"43","clinical-trial-number":[{"clinical-trial-number":"nct03768414","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0066-2672","authenticated-orcid":true,"given":"Rachna T.","family":"Shroff","sequence":"first","affiliation":[{"name":"University of Arizona Cancer Center, Tucson, AZ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7525-8802","authenticated-orcid":true,"given":"Gentry","family":"King","sequence":"additional","affiliation":[{"name":"Fred Hutchinson Cancer Center, University of Washington, Seattle, WA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Colby","sequence":"additional","affiliation":[{"name":"SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Center, Seattle, WA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0301-3072","authenticated-orcid":true,"given":"Aaron J.","family":"Scott","sequence":"additional","affiliation":[{"name":"University of Arizona Cancer Center, Tucson, AZ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2700-2658","authenticated-orcid":true,"given":"Mitesh J.","family":"Borad","sequence":"additional","affiliation":[{"name":"Mayo Clinic Cancer Center, Phoenix, AZ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Goff","sequence":"additional","affiliation":[{"name":"Vanderbilt-Ingram Cancer Center, Nashville, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Khalid","family":"Matin","sequence":"additional","affiliation":[{"name":"Virginia Commonwealth University Massey Comprehensive Cancer Center, Richmond, VA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1111-8333","authenticated-orcid":true,"given":"Amit","family":"Mahipal","sequence":"additional","affiliation":[{"name":"Case Western Reserve University, Cleveland, OH"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aparna","family":"Kalyan","sequence":"additional","affiliation":[{"name":"Northwestern University, Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9158-0941","authenticated-orcid":true,"given":"Milind M.","family":"Javle","sequence":"additional","affiliation":[{"name":"University of Texas MD Anderson Cancer Center, Houston, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Imane","family":"El Dika","sequence":"additional","affiliation":[{"name":"Memorial Sloan Kettering Cancer Center, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin","family":"Tan","sequence":"additional","affiliation":[{"name":"Washington University Siteman Cancer Center, St Louis, MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9024-9616","authenticated-orcid":true,"given":"Puneet","family":"Cheema","sequence":"additional","affiliation":[{"name":"Metro Minnesota Community Oncology Research Consortium\/Saint John's Hospital, St Louis Park, MN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7045-6957","authenticated-orcid":true,"given":"Anuj","family":"Patel","sequence":"additional","affiliation":[{"name":"Dana-Farber Harvard Cancer Center, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3643-8621","authenticated-orcid":true,"given":"Renuka","family":"Iyer","sequence":"additional","affiliation":[{"name":"Roswell Park Comprehensive Cancer Center, Buffalo, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1984-2430","authenticated-orcid":true,"given":"R. 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