Abstract
5532 Background: In 1986, the Gruppo di Studio sui Tumori Testa e Collo (GSTTC) started a multicenter randomized trial comparing induction CT with Cisplatin and 5Fluorouracil 120h c.i. (PF) followed by locoregional treatment (Surgery+RT or RT alone) (Group A) versus locoregional therapy (LRT) alone (Group B) in resectable or unresectable stage III-IVM0 H&N Squamous Cell Carcinoma. Our previous report (J Natl Cancer Inst 86: 265–72,1994), showed that 4 cycles of PF before LRT improved local control, decreased the incidence of distant metastases and increased Disease-Free-Survival (DFS) and Overall Survival (OS) in the subgroup of inoperable patients. Methods: From March 1986 to February 1990, 237 patients with stage III-IVM0 were randomized to 4 neoadjuvant PF followed by LRT or LRT alone. After a minimum follow-up of 10 years, the two treatments were compared in univariate and multivariate analysis for OS. Results: Of the 237 patients, 118 group A and 119 group B, 92% and 90% respectively were male, 25% and 28% hypopharynx, 59% and 54% oropharynx, 15% and 16% oral cavity. KPS ≥70 in 95% and 92%; stage III 35% and 37%. Inoperable 71% and 73%. The OS for the entire group of patients at 5 and 10 years was 23% and 19% for Group A and 16% and 9% for Group B (p=0.13). No difference was observed in operable patients. In inoperable patients, the OS at 5 and 10 years was 21% and 16% for Group A and 8% and 6% for RT arm (p=0.04). With Cox analysis applied to all randomized patients, the HR and p values were respectively 1.251 and 0.292 for site; 3.28 and 0.002 for T; 1.66 and 0.036 for N; 0.92 and 0.56 for treatment arm. Conclusion: The analyses at 10 years has confirmed all the previously reported data. Four cycles of neoadjuvant CT remains a promising approach for advanced H&N cancer with a significant OS advantage in inoperable patients. No significant financial relationships to disclose.
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