{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,8]],"date-time":"2026-05-08T09:31:16Z","timestamp":1778232676375,"version":"3.51.4"},"reference-count":16,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"29","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2019,10,10]]},"abstract":"<jats:sec><jats:title>PURPOSE<\/jats:title><jats:p> Patients with metastatic urothelial carcinoma are often ineligible for cisplatin-based treatments. A National Cancer Institute Cancer Therapy Evaluation Program\u2013sponsored trial assessed the tolerability and efficacy of a gemcitabine-eribulin combination in this population. <\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS<\/jats:title><jats:p> Patients with treatment-na\u00efve advanced or recurrent metastatic urothelial carcinoma of the bladder, ureter, or urethra not amenable to curative surgery and not candidates for cisplatin-based therapy were eligible. Cisplatin ineligibility was defined as creatinine clearance less than 60 mL\/min (but \u2265 30 mL\/min), grade 2 neuropathy, or grade 2 hearing loss. Treatment was gemcitabine 1,000 mg\/m<jats:sup>2<\/jats:sup> intravenously followed by eribulin 1.4 mg\/m<jats:sup>2<\/jats:sup>, both on days 1 and 8, repeated in 21-day cycles until progression or unacceptable toxicity. A Simon two-stage phase II trial design was used to distinguish between Response Evaluation Criteria in Solid Tumors, version 1.1 objective response rates of 20% versus 50%. <\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p> Between June 2015 and March 2017, 24 eligible patients with a median age of 73 years (range, 62 to 88 years) underwent therapy. Performance status of 0, 1, or 2 was seen in 11, 11, and two patients, respectively. Sites of disease included: lymph nodes, 16; lungs, nine; liver, seven; bladder, five; bones, two. Median number of cycles received was four (range, one to 16). Of 24 patients, 12 were confirmed responders; the observed objective response rate was 50% (95% CI, 29% to 71%). Median overall survival was 11.9 months (95% CI, 5.6 to 20.4 months), and median progression-free survival was 5.3 months (95% CI, 4.5 to 6.7 months). The most common treatment-related any-grade toxicities were fatigue (83% of patients), neutropenia (79%), anemia (63%), alopecia (50%), elevated AST (50%), and constipation, nausea, and thrombocytopenia (42% each). <\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSION<\/jats:title><jats:p> Gemcitabine-eribulin treatment response and survival for cisplatin-ineligible patients compare favorably to other regimens. Additional research is needed. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.19.00861","type":"journal-article","created":{"date-parts":[[2019,8,7]],"date-time":"2019-08-07T19:55:18Z","timestamp":1565207718000},"page":"2682-2688","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":17,"title":["Phase II California Cancer Consortium Trial of Gemcitabine-Eribulin Combination in Cisplatin-Ineligible Patients With Metastatic Urothelial Carcinoma: Final Report (NCI-9653)"],"prefix":"10.1200","volume":"37","author":[{"given":"Sarmad","family":"Sadeghi","sequence":"first","affiliation":[{"name":"University of Southern California, Norris Comprehensive Cancer Center, Los Angeles, CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susan G.","family":"Groshen","sequence":"additional","affiliation":[{"name":"University of Southern California, Norris Comprehensive Cancer Center, Los Angeles, CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Denice D.","family":"Tsao-Wei","sequence":"additional","affiliation":[{"name":"University of Southern California, Norris Comprehensive Cancer Center, Los Angeles, CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rahul","family":"Parikh","sequence":"additional","affiliation":[{"name":"University of Kansas, Lawrence, KS"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amir","family":"Mortazavi","sequence":"additional","affiliation":[{"name":"The Ohio State University, Columbus, OH"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tanya B.","family":"Dorff","sequence":"additional","affiliation":[{"name":"City of Hope, Duarte, CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cheryl","family":"Kefauver","sequence":"additional","affiliation":[{"name":"University of Southern California, Norris Comprehensive Cancer Center, Los Angeles, CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christopher","family":"Hoimes","sequence":"additional","affiliation":[{"name":"Case Western Reserve University, Cleveland, OH"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laurence","family":"Doyle","sequence":"additional","affiliation":[{"name":"National Cancer Institute, Cancer Therapy Evaluation Program, Bethesda, MD"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David I.","family":"Quinn","sequence":"additional","affiliation":[{"name":"University of Southern California, Norris Comprehensive Cancer Center, Los Angeles, CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Edward","family":"Newman","sequence":"additional","affiliation":[{"name":"City of Hope, Duarte, CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Primo N.","family":"Lara Jr","sequence":"additional","affiliation":[{"name":"University of California, Davis, Davis, CA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"233","reference":[{"key":"B1","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21442"},{"key":"B3","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2001.19.3.666"},{"key":"B4","doi-asserted-by":"crossref","unstructured":"Bohnsack O, Hoos A, Ludajic K: Adaptation and modification of the immune related response criteria (IRRC): IrRECIST. 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