The Spanish Head and Neck Cancer Cooperative Group (TTCC) announced today that Induction Chemotherapy (IC) delivered prior to standard ChemoRadiotherapy (CRT), a treatment paradigm defined as sequential therapy, compared to upfront CRT alone, significantly prolonged Time-to-Treatment Failure (TTF) for patients with unresectable Locally Advanced Head and Neck Cancer (LAHNC).
The endpoint of Time-to-Treatment Failure was defined as a composite of time-to-disease progression, -to-surgery or other cancer-related treatments, -to-drop-out due to an adverse event, and to death from any cause.
Final results (abstract #6009) from the Phase 3 randomized study were presented by Prof. Ricardo Hitt, of the University Hospital 12 de Octubre, Madrid, in an oral presentation at the 2009 annual meeting of the American Society of Clinical Oncology (ASCO). The results of this study have also been selected for inclusion in the Best of ASCO program. The Best of ASCO is an educational initiative that condenses highlights from ASCO's Annual Meeting, with the objective of increasing global access to cutting-edge science that is relevant and significant in oncology today.
This study enrolled 439 patients with Locally Advanced Head and Neck Cancer with good performance status, who were randomly assigned to receive standard CRT (cisplatin and fractionated radiation) versus the same treatment preceded by IC, which consisted of cisplatin plus 5-fluorouracil (5-FU) with or without Taxotere (docetaxel) Injection Concentrate.
The study was designed to compare the results of those patients who received IC prior to CRT (sequential therapy) and patients who received CRT alone.
The sequential therapy of adding IC to CRT improved Time-to-Treatment Failure (TTF) from 5.0 months to 12.5 months (p< 0.0001), a 7.5 month increase. Furthermore, a secondary endpoint of loco-regional control, was observed in 61.5% of the patients treated with the sequential strategy (IC+CRT) compared to 44.5% of those patients treated with CRT alone (p=0.002).
The most frequent severe (grade 3-4) adverse reactions were stomatitis (44% for IC+CRT vs. 31% for CRT) and febrile neutropenia (10% for IC+CRT vs. 1% for CRT). Other adverse events included neutropenia and asthenia.