(ChemotherapyAdvisor) – Induction chemotherapy with docetaxel, cisplatin, and fluorouracil followed by surgery failed to improve survival vs up-front surgery in patients with locally advanced resectable oral squamous cell carcinoma, a study in the Journal of Clinical Oncology online November 5 has found.
Although this first prospective, randomized phase 3 study of induction chemotherapy “failed to demonstrate a benefit…it is possible that a subset of patients may indeed have more favorable outcomes when exposed to chemotherapy before surgery,” noted Zhi-yuan Zhang, PhD, MD, Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. A post hoc exploratory analysis suggested a survival benefit with chemotherapy induction in patients with cN2, which “may warrant prospective confirmation in future studies.”
Study patients received two cycles of induction chemotherapy—docetaxel 75mg/m2 on day 1, cisplatin 75mg/m2 on day 1, and fluorouracil 750mg/m2 on days 1 to 5 followed by radical surgery and postoperative radiotherapy (54 to 66 Gy) vs up-front radical surgery and postoperative radiotherapy. Primary end point was overall survival (OS).
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Of the 256 patients enrolled, 222 completed the study. After a median follow-up of 30 months, no significant difference was observed between patients treated with or without induction chemotherapy, either in OS (HR 0.977; 95% CI, 0.634–1.507; P=0.918) or disease-free survival (HR 0.974; 95% CI, 0.654–1.45; P=0.897). The clinical response rate to induction chemotherapy was 80.6%.
“Patients in the induction chemotherapy arm with a clinical response or favorable pathologic response (≤10% viable tumor cells) had superior OS and locoregional and distant control,” they found.
No unexpected toxicities were found and induction chemotherapy did not increase perioperative morbidity.
“If future studies are to be designed for evaluation of induction chemotherapy in this setting, we suggest incorporation of biologic agents to the regimen, coupled with an effort to identify and/or select patients who are more likely to benefit from induction treatment by using either clinical and/or biomarker criteria,” the authors concluded.
Link to abstract:
http://jco.ascopubs.org/content/early/2012/11/05/JCO.2012.43.8820.abstract
