{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,28]],"date-time":"2025-10-28T10:47:05Z","timestamp":1761648425133},"reference-count":0,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[1987,2]]},"abstract":"<jats:p> Twenty-nine patients with recurrent or advanced, incurable head and neck cancer were entered into a phase I-II trial of carboplatin in combination with 5-fluorouracil (5-FU), 1,000 mg\/m2\/d continuous intravenous (IV) infusion for five days every 28 days. The initial dose of carboplatin was 300 mg\/m2 for patients with Karnofsky performance scores greater than or equal to 70%, and 240 mg\/m2 for patients with scores of 50% to 60%. Subsequent doses were modified to achieve grade 2 myelo-suppression: WBC, 2,000 to 2,999 cells\/microL; granulocytes, 1,000 to 1,499 cells\/microL; and platelets, 50,000 to 75,000 cells\/microL. Dose levels were 180, 240, 300, 360, and 420 mg\/m2. Twenty-eight patients had squamous-cell cancers and one had an adenoid cystic carcinoma of the parotid. There were 26 patients with recurrent disease; 22 had received prior RT; only two had received other chemotherapy immediately before study entry. Three patients had newly diagnosed incurable stage IV disease. The median performance status was 80% (range, 60% to 90%). All patients had objectively measurable disease, and 28 were evaluable for response. There were three complete responses (CRs) and ten partial responses (PRs) (48% CR and PR); the median duration of response was 4.7 months (range, 1.5 to 15+ months). Dose-limiting toxicities were granulocytopenia, thrombocytopenia, and stomatitis. Prolonged myelosuppression delayed retreatment in eight patients and delayed 19 of 107 (18%) courses. Stomatitis occurred in 61% and diarrhea in 29%. 5-FU dosage was decreased in ten patients (36%) for grade 2 or greater stomatitis or diarrhea. Mild to moderate nausea and vomiting occurred in 66% of patient trials in which no pretreatment antiemetics were administered. Other toxicities included phlebitis from 5-FU in 71%, skin toxicity in 11%, mild alopecia in 25%, and fatigue in 54% of patients. Nephrotoxicity (creatinine greater than 2.0 mg\/dL) occurred in one patient. The dose of carboplatin resulting in grade 2 toxicity was 180 mg\/m2 in one patient, 240 mg\/m2 in one, 300 mg\/m2 in seven, 360 mg\/m2 in ten, and 420 mg\/m2 in one. Based on these results, we recommend a starting dose of carboplatin, 300 mg\/m2, in combination with five days of continuous infusion 5-FU. In this dose and schedule, this combination was well tolerated and demonstrated antitumor activity in head and neck cancer. To confirm these promising results, a Southwest Oncology Group prospective randomized trial is in progress comparing carboplatin and 5-FU, cisplatin and 5-FU, and standard-dose weekly methotrexate in recurrent-disease patients. <\/jats:p>","DOI":"10.1200\/jco.1987.5.2.190","type":"journal-article","created":{"date-parts":[[2017,2,23]],"date-time":"2017-02-23T13:29:46Z","timestamp":1487856586000},"page":"190-196","source":"Crossref","is-referenced-by-count":35,"title":["A phase I-II trial of carboplatin and 5-fluorouracil combination chemotherapy in advanced carcinoma of the head and neck."],"prefix":"10.1200","volume":"5","author":[{"given":"A A","family":"Forastiere","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"R B","family":"Natale","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"B J","family":"Takasugi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M P","family":"Goren","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"W C","family":"Vogel","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"V","family":"Kudla-Hatch","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"233","container-title":["Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascopubs.org\/doi\/pdfdirect\/10.1200\/JCO.1987.5.2.190","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,5,25]],"date-time":"2022-05-25T22:39:13Z","timestamp":1653518353000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascopubs.org\/doi\/10.1200\/JCO.1987.5.2.190"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[1987,2]]},"references-count":0,"journal-issue":{"issue":"2","published-print":{"date-parts":[[1987,2]]}},"alternative-id":["10.1200\/JCO.1987.5.2.190"],"URL":"https:\/\/doi.org\/10.1200\/jco.1987.5.2.190","relation":{},"ISSN":["0732-183X","1527-7755"],"issn-type":[{"value":"0732-183X","type":"print"},{"value":"1527-7755","type":"electronic"}],"subject":[],"published":{"date-parts":[[1987,2]]}}}