Phase II study: Docetaxel-cisplatin and pro drug tegafur (TPF) as neoadjuvant treatment in advanced patients with head and neck cancer (HNC): Results and correlation between tandem magnesium/creatinine and toxicity.

Abstract

e16025 Background: Due to hospital control difficulties of patients with HNC, a phase II with oral fluoropyrimidines was conducted. Oral administration of 5-FU itself is not feasible owing to the high activity of dihydropyridine dehydrogenase (DPD) in the gut wall. To bypass this problem, oral fluoropyrimidine derivatives were developed in the form of 5-FU prodrugs. This phase II Trial focuses on the oral 5-FU prodrug tegafur to allow similar responses and toxicities. On the other hand a secondary objective was to correlate the effect of CDDP that induces renal injury through multiple pathways. For that reason, the correlation between Mg/Cr and Toxicity was studied. Methods: From 2006 to 2011 seventeen patients with locally advanced head and neck carcinomas were treated in our institution. A phase II clinical trial was conducted as neoadjuvant treatment [docetaxel 75 m2 d-1, cisplatin 75 mgm2 d-1, and tegafur 800 mg twice daily for 14 days, administered every 21 days with GCSF support]. If tumor response, patients received radiotherapy (RT) 70 Gy concomitant with weekly cisplatin 25mg/m2. If no response, palliative surgery or RT or/second line of chemotherapy was administered.) Results: Sixteen were male, one female, three died (2 sepsis secondary to neutropenia grade IV/ 1 secondary to direct tumor complication after 1st course of chemotherapy). Only 14 patients were evaluable for response [mean age was 54,24]. Toxicity grade >2 was present in a range [13,33-21,43%]. Partial responses (PR) were present in 9 patients (52,94%), complete response or no evidence of disease in 3 (17,63%). After RT witth weekly cisplatin the diseas control was 70,57%. An association trend was detected between hypomagnesaemia and a greater toxicity. Conclusions: The implementation of an oral chemotherapy regimen has been feasible and effective with similar results to other studies. The idiosyncrasy of patients with HNC have kept their prized autonomy and independence. A new study is in progress to assess more accurately magnesium levels as predictors of severe toxicities when platinum is used.