asco@alo33:161815
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Background: The response to treatment and prognosis is poor in recurrentmetastatic head and neck squamous cell carcinoma RM HNSCC . Triple combination therapy may increase tumor response and disease control.Methods: This phase III prospective trial tested the recommended dose of irinotecan ith added cisplatin and UFUR tegafururacil . Irinotecan as supplied at doses of 40,50,60, and 70 mgm2 in each 3 patients step, then escalated ith 5 mgm2 until the dose-limiting toxicities occurred. In phase II, the maximum tolerated dose of irinotecan as administered intravenously IV over 90 min on day 1, ith cisplatin 50 mgm2 IV over 60 min also on day 1, and oral UFUR 200 mg tice a day for 5 days every 2 eeks a cycle.Results: In phase I study, the dose level of 60 mgm2 as defined as the recommended dose. Among 43 patients in phase II, objective response rate ORR as 27.9 percent and disease control rate DCR 39.5 percent. Subgroup analysis of patients ho did not receive chemoradiotherapy in the preceding 6 months, ORR of 40.7 percent and DCR of 59.3 percent ere observed. The median PFS as 3.2 months and OS 6.7 months, and those ho did not receive chemoradiotherapy in the preceding 6 months had a longer median PFS at 3.8 months and longer OS at 8.4 months. Neutropenia developed in 12 patients 27.9 percent , and only 1 patient experienced febrile neutropenia. Among non-hematological events, grade 12 nausea 46.5 percent and vomiting 39.5 percent ere common, but only fe of them 16.3 percent developed grade 34 toxicity. Quality of life as improved in patients ho had response to this treatment.Conclusions: CisplatinUFURirinotecan triple combination therapy is tolerated and effective for selected patients. Individualized choice of treatment ill influence prognosis and quality of life in RM HNSCC patients. Clinical trial information: ISRCTN17533723.ltcaption class=mtgabstract-table-title Phase II response.ResponseNo previous CCRT in lt 6 m n=27 Previous CCRT in lt 6 m n=16 All n=43 n percent n percent n percent Complete response27.40024.7Partial response933.316.31023.3Stable disease518.500511.6Progression1140.71593.82660.5Objective response1140.716.31227.9Disease control1659.316.31739.5ltfn id=TF-161815-001-1 ltp class=mtgabstract-table-fn Abbreviation: CCRT, concurrent chemoradiotherapy.lttable-rap-foot ,J Clin Oncol 34, 2016 suppl; abstr e17508 ,ISRCTN17533723Publication Only Head and Neck Cancer
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