The Italian Collaborative Group sets a standard for the treatment of locally advanced head and neck cancer

The role of induction chemotherapy (IC) in locally advanced squamous cell carcinoma of the head/neck (LA-SCCHN) continues to be a controversial. While randomized trials have established that cisplatin/5-FU (PF) IC is equivalent to surgery followed by radiation therapy and may improve survival compared with chemoradiotherapy (CRT) for organ preservation, a definitive answer in locally advanced disease, outside of organ preservation, has been elusive [1–3]. The DeCIDE and Paradigm trials are considered to be negative IC trials exploring taxotere/cisplatin/5-FU (TPF) as IC, however both trials were inconclusive. They accrued poorly and failed to meet planned enrollment goals. Hence, the studies were underpowered and the results indeterminate [4, 5]. The GSTTC Italian Collaborative Group study in this issue of the Annals of Oncology is the first well-designed, multi-institutional, randomized phase III study comparing overall survival (OS) between a sequential approach of IC followed by concurrent CRT versus CRT alone, which fully completed. This trial is noteworthy of its innovation, management, robust analysis and adequate follow-up. The improvements in OS (HR 0.74, P <0.031), progression-free survival (PFS) (HR 0.72, P <0.013) and local regional control (LRC) (HR 0.74, P <0.036) were significant and consistently favored sequential treatment over CRT. It is notable that an improvement in LRC accounted for a great deal of the survival advantage and confirms the results of the Tax 324 study of TPF sequential therapy where the experimental TPF IC improved LRC compared with the PF control arm [6].

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