Chemotherapy alternating gemcitabine and cisplatin concomitant with radiotherapy in locally advanced (LA) squamous cell carcinoma of the head and neck (SCCHN)

Abstract

15514 Background: In the Pignon’s meta-analysis, the OS benefit was 8% with chemoradiation in LA SCCHN. Unfortunately it is still unclear what scheme is the best, cisplatin (CDDP) being the most widely used drug. Other drugs such as gemcitabine (GMZ) has promising results, although toxicity has been severe but tolerable. We have published an initial study using GMZ and radiotherapy (ann oncol. 2004;15:301). In the present study we wished to determine if a scheme in which GMZ is alternated with CDDP and concomitant radiotherapy reduced toxicity yet maintains our previously described therapeutic effectiveness. This is a preliminary report with a short follow-up period. Methods: Inclusion criteria: patients with SCCHN (EC: III, IVa and IVb ) or with recurring disease, and no sytemic metastases or patients rejection of surgery between 03/2003 and 09/2004. Chemotherapy scheme consisted of GMZ at 100 mg/m2 once a w, ws 1, 3, 5, 7 and CDDP at 50 mg/m2 once a w, ws 2, 4, y 6. Radiotherapy consisted of 2 Gy/day, for a total of 70 Gy during the 7 ws. Toxicity evaluation focused on mucositis, xerostomia, dysphagia y leukopenia. Results: 28 patients were treated. 7 (25%)/ stage III, 11 (39.3%) IVa, 10 (35.7%) IVb. The tumor sites distribution was as follows: 9 patients with oropharynx and larynx disease (32.1%), 6 patients with oral cavity disease (21.4%), 3 patients with paranasal sinus disease (10.7%), and 1 hypopharinx (3.5%). A CCR was observed in 21 patients (75%), a partial response was observed in 5 patients (17%). Organ preservation was achieved in 68% of the patients. Toxicity: mucositis Grade 3–4 was in 42% of patients, leucopenia grade III in 29%, dysphagia in 19% and xerostomia in 10%. 40%of the patients stopped treatment for one or two weeks due to toxicity without affecting the doses of both treatments. Conclusions: The scheme with alternating GMZ and CDDP concomitant with radiotherapy is safe and effective. We observed a lower incidence in mucositis and few systemic toxic effects. Our findings support further studies in which alternating chemotherapeutic schemes are utilized given that tumor response is increased without an increment in toxicity. No significant financial relationships to disclose.