Induction chemotherapy failed to improve survival in OSCC
Patients with oral squamous cell carcinoma who received an induction chemotherapy regimen had similar survival outcomes as those who did not receive chemotherapy, according to results of a prospective, open-label phase 3 trial.
The researchers conducted the investigation to assess whether induction chemotherapy with docetaxel, cisplatin and fluorouracil (TPF) followed by surgery and postoperative radiotherapy is comparable to up-front surgery and postoperative radiotherapy in patients with locally advanced resectable oral squamous cell carcinoma (OSCC).
Eligible participants had untreated stage III or IVA locally advanced disease.
Patients in the chemotherapy group underwent two cycles of TPF induction chemotherapy (docetaxel 75 mg/m2 on day 1, cisplatin 75 mg/m2 on day 1, and fluorouracil 750 mg/m2 on days 1 to 5) followed by radical surgery and postoperative radiotherapy (54 Gy to 66 Gy). Patients in the other cohort underwent up-front radical surgery and postoperative radiotherapy.
OS served as the primary endpoint. Secondary endpoints included local control and safety. The median follow-up duration was 30 months.
The final analysis included 222 patients who received the full treatment protocol.
No unexpected toxicities occurred. Chemotherapy was not associated with an increase in perioperative morbidity, according to the results.
Induction chemotherapy was linked to a clinical response rate of 80.6%.
At follow-up, researchers observed no significant difference in OS (HR=0.977; 95% CI, 0.634-1.507) or DFS (HR=0.974; 95% CI, 0.654-1.45) between the two groups.
The researchers observed superior OS and locoregional and distant control in patients in the induction chemotherapy arm who had a clinical or favorable pathologic response (≤10% viable tumor cells).
“This may warrant prospective confirmation in future studies,” the researchers wrote. “Assessment of molecular markers may also be useful in identifying patients most likely to benefit from induction chemotherapy.”
Disclosure: See study for a full list of financial disclosures.