NEOADJUVANT ORGAN-PRESERVING CHEMOTHERAPY IN THE MANAGEMENT OF LOCALLY ADVANCED ORAL CAVITY AND OROPHARYNX CANCER - A TENTATIVE QUANTITATIVE-EVALUATION OF ORGAN PRESERVATION AND CLINICAL-RESPONSE

We designed an open, non-randomized clinical study to assess as the fi rst endpoint the feasibility of sparing surgery and of preserving orga n/function by using neo-adjuvant chemotherapy (NAG) in oral cavity and oropharynx cancer patients, and, as the second endpoint, the clinical response to this treatment approach and its duration. Moreover, an at tempt was made to scale the extent of surgery by means of an Arbitrary Scale assigning different percentages to the different extents of sur gical resection. Twenty-five patients with primary oral cavity and oro pharynx cancer (stage III-TV) were enrolled in the study and were assi gned to either the classical Al-Sarrafs regimen (1) (n=15) or to a reg imen (2) consisting of cisplatin 80 mg/m(2) i.v. on day 1, 5-FU 600 mg /m(2) on days 2-5 and vinorelbine 20 mg/m(2) on days 2 and 8 (n=10). T he 25 patients were all evaluable for response to NAC and 20 of them w ere evaluable for organ preservation. The overall response (OR) rate w as 86.6% (13/15 patients) for regimen 1 (cisplatin + 5-FU) and 80% (8/ 10 patients) for regimen 2 (cisplatin + 5-FU + vinorelbine). The media n follow-up duration was 20.6 months. 5/20 (25%) patients completely a voided surgery, 5/20 (25%) patients had a reduced extent of surgical r esection, while: 10/20 (50%) patients received the previously planned surgical resection. Altogether, 10/20 (50%) patients treated with NAC either avoided or achieved a reduction in the previously planned surgi cal resection. Moreover, organ function was evaluated to support the a ssessment of treatment outcome in our patients. For this purpose we se lected the Performance Status Scale for Head and Neck Cancer Patients: as expected, no significant impairment was detected in the area of co mprehensibility of speech, but we were rather surprised that no signif icant impairment was found in the two areas of eating in public and no rmalcy of diet. NAG-associated toxicity was moderate and similar in th e two chemotherapy regimens. The most relevant contributions offered b y our study are represented by i) a Scale aimed at measuring as precis ely as possible the reduction of surgical resection made possible by N AC compared to surgery planned before NAC and ii) an attempt to suppor t the results with an assessment of treatment outcome.