PMID- 20485287 OWN - NLM STAT- MEDLINE DCOM- 20100701 LR - 20220310 IS - 1532-1827 (Electronic) IS - 0007-0920 (Print) IS - 0007-0920 (Linking) VI - 102 IP - 12 DP - 2010 Jun 8 TI - Phase II study of capecitabine as palliative treatment for patients with recurrent and metastatic squamous head and neck cancer after previous platinum-based treatment. PG - 1687-91 LID - 10.1038/sj.bjc.6605697 [doi] AB - BACKGROUND: Platinum-based therapy (PBT) is the standard therapy for recurrent and/or metastatic head and neck cancer (HNC), but the incidence of recurrence remains high. This study evaluates the efficacy and tolerability of capecitabine as palliative monotherapy for recurrent HNC previously treated with PBT. METHODS: Patients aged 18-75 years, with Eastern Cooperative Oncology Group performance status 0-2, squamous HNC with locoregional and/or metastatic recurrence previously treated with PBT and adequate organ functions, were included. Capecitabine (1.250 mg m(-2) BID) was administered on days 1-14 every 21 days for at least two cycles. RESULTS: A total of 40 male patients with a median age of 58 years were analysed. All patients received a median number of four cycles of capecitabine (range: 1-9) and the median relative dose intensity was 91%. Seven patients were not evaluable for response. Overall response rate was 24.2%. Median time to progression and overall survival were 4.8 and 7.3 months, respectively. Haematological adverse events (AEs) grade 3/4 were reported in six patients. Most common grade 3/4 non-haematological AEs were asthenia (12.5%), palmar-plantar eritrodisestesia (10%), mucositis (10%), dysphagia (10%) and diarrhoea (7.5%). CONCLUSIONS: Capecitabine seems to be an active, feasible and well-tolerated mode of palliative treatment for advanced HNC patients who have previously received PBT schedules. FAU - Martinez-Trufero, J AU - Martinez-Trufero J AD - Medical Oncology Department of University Hospital Miguel Servet Hospital, Paseo de Isabel La Catolica 1-3, 50009 Zaragoza, Spain. jmtrufero@seom.org FAU - Isla, D AU - Isla D FAU - Adansa, J C AU - Adansa JC FAU - Irigoyen, A AU - Irigoyen A FAU - Hitt, R AU - Hitt R FAU - Gil-Arnaiz, I AU - Gil-Arnaiz I FAU - Lambea, J AU - Lambea J FAU - Lecumberri, M J AU - Lecumberri MJ FAU - Cruz, J J AU - Cruz JJ LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20100518 PL - England TA - Br J Cancer JT - British journal of cancer JID - 0370635 RN - 0 (Platinum Compounds) RN - 0W860991D6 (Deoxycytidine) RN - 6804DJ8Z9U (Capecitabine) RN - U3P01618RT (Fluorouracil) SB - IM MH - Adult MH - Aged MH - Capecitabine MH - Carcinoma, Squamous Cell/*drug therapy/pathology/secondary MH - Deoxycytidine/adverse effects/*analogs & derivatives/therapeutic use MH - Disease Progression MH - Fluorouracil/adverse effects/*analogs & derivatives/therapeutic use MH - Head and Neck Neoplasms/*drug therapy/pathology MH - Humans MH - Male MH - Middle Aged MH - Neoplasm Metastasis MH - Neoplasm Recurrence, Local/drug therapy MH - *Palliative Care MH - Platinum Compounds/administration & dosage PMC - PMC2883700 EDAT- 2010/05/21 06:00 MHDA- 2010/07/02 06:00 PMCR- 2010/06/08 CRDT- 2010/05/21 06:00 PHST- 2010/05/21 06:00 [entrez] PHST- 2010/05/21 06:00 [pubmed] PHST- 2010/07/02 06:00 [medline] PHST- 2010/06/08 00:00 [pmc-release] AID - 6605697 [pii] AID - 10.1038/sj.bjc.6605697 [doi] PST - ppublish SO - Br J Cancer. 2010 Jun 8;102(12):1687-91. doi: 10.1038/sj.bjc.6605697. Epub 2010 May 18.