Phase II study of capecitabine as palliative treatment for patients (p) with squamous head and neck cancer (HNC) with locoregional and/or metastatic relapse after previous platinum-based treatment (PBT): Final results of Spanish Head and Neck Cancer Group (TTCC)

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6047 Background: PBT is widely used as first line treatment in relapsed and/or metastatic HNC. Therefore, new non-platinum drugs need to be asses as second line treatment options. We proposed this study to evaluate activity and tolerability of capecitabine (X) when used as palliative monotherapy for relapsed HNC p previously treated with PBT. Methods: Forty patients (p) aged 18–75 years, ECOG PS 0–2, with advanced squamous HNC with locoregional and/or metastatic relapse previously treated with PBT and adequate bone marrow, renal and hepatic functions were included. X (1,250 mg/m2 BID) during 14 days was administered every 21 days, for at least 2 cycles. RECIST objective response rate (ORR) was assessed and toxicity following NCI-CTC v2 criteria. Results: Forty patients with median age 58 years old, all of them male, ECOG 0–2 (0:25%/1:70%/2:5%) and with squamous HNC, were analyzed. 34 p had local disease, 9 p regional disease and 19 p distant metastases(12 p lung). Median time since HNC diagnosis was 17.7 months and since disease extension diagnosis, 1.1 months. All p received a total of 169 cycles of X (median 4, range 1–9) and the median relative dose intensity was 91%. 7 p were not evaluable for response, since they do not receive at least 3 cycles ( 3 died, 2p due to toxicity, 2p due to decrease in ECOG PS ). ORR was 22.5 %.The median follow-up time was 5.2 months (alive p: 8.8 months), median TTP was 4.6 months and median OS was 6.2 months. Hematological toxicity G3/4 was reported in 6 p. 2p reported as grade 4 non-hematological toxicity: dysphagia and palmar-plantar erythrodysesthesia; grade III toxicities were: asthenia (4 p), anorexia (1 p), dehydratation (1 p), diarrhea (3 p), dysphagia (3 p) mucositis (4 p), weight loss (1 p), and palmar-plantar erythrodysesthesia (3 p). The most common grade II toxicity was asthenia (8 p). Conclusions: Capecitabine seems to be an active, feasible and well tolerated palliative treatment for advanced HNC patients that have previously received platinum-based schedules. No significant financial relationships to disclose.