16505

Background: Dx and Cap are useful drugs in head and neck cancer. Our purpose was to establish the efficacy and safety of this combination in non selected patients (pts) with advanced or metastatic (M1) head and neck cancer. Methods: : Between Apr 2005 and Nov 2006, 33 pts with squamous cell locally advanced or M1 head and neck cancer received the following chemotherapy (Ct) schedule: Dx 75 mg/m2 day 1 and Cap 950 mg/m2/12h days 2–14, every 3 weeks.30 pts (90.9%) had received previous local radiotherapy, 11 of them with concomitant Ct. Results: Mean age was 60 years old (range 46–75). M/F: 32/1. PS 0/1/2: 1/29/3. Location of disease: only local 49%; local and M1 36%; only M1 15% (Main M1 site: lung 76.5%, nodes 11.8%, bone 5.9%, soft tissue 5.9%). Mean number of Ct cycles: 4 (range 1–7). Worst hematologic toxicities per patient G3/G4 (%): neutropenia 6/39; febrile neutropenia 36/0; anemia 3/0; trombopenia 3/3. Non-hematologic toxicities G2/G3 (%): vomiting 3/3; neuropathy 6/0; asthenia 33/6; diarrhea 21/3; mucositis 33/18; nail changes 12/0; hand foot syndrome 3/12. Other events to remark: 4 pts had neumonia (2 toxic deaths), 1 pts had angor and required a different Ct schedule, 2 pts had massive hemorrage (1 exitus). There were 7 pts not evaluable for response (4 not yet evaluated, 1 early death due to massive hemorrage, 1 toxic death due to neumonia, 1 early disphagia). Among the evaluated pts, responses were: 2 CR (7.7%), 10 PR (38.5%), 9 SD (34.6%) and 5 PD (19.2%). Median TTP was 21 weeks (95%CI 17.5 - 24.2). Median OS was 39.8 weeks (95%CI 32.4 - 47.4) by Kaplan-Meier method. Conclusions: This combination appears to be active in pts with advanced or M1 head and neck cancer. Main toxicities were neutropenia, febrile neutropenia, mucositis and asthenia. Global toxicity was important with two toxic deaths documented

No significant financial relationships to disclose.