Phase III trial of docetaxel cisplatin 5‐fluorouracil induction chemotherapy for resectable oral cancer suggests favorable pathological response as a surrogate endpoint for good therapeutic outcome

Due to the limited sample size of the clinical N2 group, our retrospective subgroup analyses were not sufficient to guide further treatment plan until further demonstrated by convincing studies. Besides clinical indicators, we also focused on the predictive effect of pathological response after induction chemotherapy. The pCR rate was consistent with another trial investigating split TPF induction chemotherapy regimen in oral and oropharyngeal squamous cell cancer, in which pCR rate was 31.5% (17/54) [ 6]. Since the pCR rate of induction chemotherapy was relatively low, major pathological response (MPR) or FPR, which were both defined as ≤10% of residual viable tumor after induction chemotherapy, were used as surrogate criteria of pathological response evaluation and endpoints for survival [ 3]. No significant difference in baseline characteristics, including the T stage or TNM stage, was observed between patients with and without FPR, suggesting that FPR could be considered as a prognostic predictor for induction chemotherapy in OSCC. [...]increasing the FPR rate of OSCC patients receiving induction treatment is crucial. Attempts to intensify TPF with cetuximab to increase efficacy on HNSCC demonstrated no significant effectiveness but was rather toxic [ 7]. Since immunotherapy demonstrated efficacy in HNSCC and some other cancers, such as esophageal squamous cell carcinoma and triple-negative breast cancer, with excellent tolerability, it has been currently tested in combination with chemotherapy [ 8, 9].