Alternating chemotherapy: gemcitabine and cisplatin with concurrent radiotherapy for treatment of advanced head and neck cancer.

BACKGROUND: Many studies have shown gemcitabine and cisplatin are radiosensitizers. Concurrent chemoradiation seems to be an efficient approach for treatment of advanced head and neck cancer (HNC), but toxicity is significant. OBJECTIVE: To evaluate safety and explore efficacy of alternating chemotherapy with gemcitabine and cisplatin concurrent with radiotherapy in patients with advanced non-metastatic HNC. PATIENTS AND METHODS: Twenty-eight patients diagnosed with advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN) in stages III (28%), IVa (36%), and IVb (36%) were treated with gemcitabine: 100mg/m(2) alternating with cisplatin: 50mg/m(2) concurrent with radiotherapy at doses of 2 Gy/day until completing 70 Gy. While awaiting for concurrent treatment, eleven patients received induction chemotherapy with cisplatin: 100mg/m(2) and 5-FU: 1000 mg/m(2). Toxicity, especially in relation to mucositis, xerostomy, dysphagia, leucopenia and radiodermitis was evaluated. RESULTS: 5-year progression-free survival was 27.8 ± 17.2% (CI-95: 0-61.5) and overall survival was 55.9 ± 11% (CI: 34.4-77.5). Overall response rate was 93%; complete response was 64.3% and partial response was 28.6%. Extensive surgery for primary site was avoided in 19 patients (70.4%). Grade 3-4 adverse events were mucositis (46.4%), leucopenia (14.2%), dysphagia (25%), xerostomy (10.7%) and radiodermitis (3.6%). Response rates and toxicity were not significantly different among those patients with and without induction chemotherapy, but survival was higher in patients receiving induction. CONCLUSIONS: Gemcitabine alternating with cisplatin concurrent with radiotherapy is an active and safe treatment that deserves further study.

Cetuximab concomitant with gemcitabine and radiotherapy in advanced squamous cell carcinomas of upper aerodigestive tract: a pilot study

PURPOSE: To explore the response and toxicity of advanced non-metastatic squamous cell carcinomas of upper aerodigestive tract (SCC-UADT) to a combination of cetuximab concomitant with gemcitabine and radiotherapy. METHODS: We managed patients with concomitant treatment of cetuximab (400 mg/m(2) as uploading dose, then 250 mg/m(2), IV) concomitant with gemcitabine (50 mg/m(2)) weekly for seven courses, and radiotherapy in classical fractionation until completion of 70 Gy. Primary endpoints were complete response (CR) to treatment and toxicity. We evaluated patients for toxicity on a weekly basis; evaluation of response included physical examination, endoscopy, computed tomography (CT) scan and biopsy when indicated, and was performed 6 weeks after completion of radiotherapy. Additional evaluations were done every 3 months to document disease status. Between November 2004 and November 2005, 20 patients were included. RESULTS: CR was 82.4%, overall response was 100%. Neck disease reached CR in 61.5% and partial in 38.5% of patients. The main toxicities were nausea, lymphopenia, neutropenia and mucositis. Grade 3 and 4 side effects were presented in 70.6% of patients, but mucositis, and lymphopenia without clinical repercussions, occurred in 88.2% of patients. Gastrostomy was required in 11.8% of patients to maintain nutrition. Radioepithelitis developed in 76.5%, but only three of these (23.1%) were grade III. Median overall survival was 53 months (range 6-55 months) and median progression-free survival has not yet been reached at the time of evaluation. CONCLUSIONS: Although toxicity is important, this approach has interesting activity and deserves further investigation (AU)