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Primary Chemotherapy in Resectable Oral Cavity Squamous Cell Cancer: A Randomized Controlled Trial

Lisa Licitra, Cesare Grandi, Marco Guzzo, Luigi Mariani, Salvatore Lo Vullo, Francesca Valvo, Pasquale Quattrone, Pinuccia Valagussa, Gianni Bonadonna, Roberto Molinari, Giulio Cantù

From the Istituto Nazionale Tumori, Milan, Italy.

Address reprint requests to Lisa Licitra, Istituto Nazionale Tumori, Via Venezian 1, 20133 Milan, Italy; email: lisa.licitra{at}istitutotumori.mi.it.

Purpose: Prognosis of patients with advanced oral cavity cancer is worth improving. Chemotherapy has been reported to be especially active in oral cavity tumors. Here we repeat the results of a randomized, multicenter trial enrolling patients with a resectable, stage T2–T4 (> 3 cm), N0–N2, M0 untreated, squamous cell carcinoma of the oral cavity.

Patients and Methods: Patients were randomly assigned to three cycles of cisplatin and fluorouracil followed by surgery (chemotherapy arm) or surgery alone (control arm). In both arms, postoperative radiotherapy was reserved to high-risk patients, and surgery was modulated depending on the tumor’s closeness to the mandible. Patients’ accrual was opened in 1989 and closed in 1999. It included 195 patients.

Results: In the chemotherapy arm, three toxic deaths were recorded. No significant difference in overall survival was found. Five-year overall survival was, for both arms, 55%. Postoperative radiotherapy was administered in 33% of patients in the chemotherapy arm, versus 46% in the control arm. A mandible resection was performed in 52% of patients in the control arm, versus 31% in the chemotherapy arm.

Conclusion: The addition of primary chemotherapy to standard surgery was unable to improve survival. However, in this study, primary chemotherapy seemed to play a role in reducing the number of patients who needed to undergo mandibulectomy and/or radiation therapy. Variations in the criteria used to select patients for these treatment options may make it difficult to generalize these results, but there appears to be room for using preoperative chemotherapy to spare demolitive surgery and/or radiation therapy in patients with advanced, resectable oral cavity cancer.

Supported in part by CNR-ACRO, Grant no. 92.02336.pf39, and AIRC (Associazione Italiana Ricerca Cancro).

Both L.L. and C.G. contributed equally to this work.

Participating institutions and investigators: Ospedale Niguarda Ca Granda, Milan, Italy: E. Colombo, G. Gelosa; Melegnano Hospital, Milan, Italy: F. Zibordi; Centro di Riferimento Oncologico, Aviano Pordenone, Italy: L. Barzan.

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