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Preoperative chemotherapy failed to improve survival in oral cavity cancer
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Patients with oral cavity squamous cell carcinoma who underwent preoperative chemotherapy demonstrated similar rates of locoregional relapse, metastasis development and OS as those who did not undergo preoperative chemotherapy, according to long-term phase 3 study results.
The analysis included 198 treatment-naive patients with stage T2 to T4 and N0 to N2 disease.
Researchers randomly assigned patients to upfront surgery or preoperative chemotherapy with three cycles of 100 mg/m2 cisplatin plus 1,000 mg/m2 fluorouracil every 21 days.
All patients with pathological risk features after surgery were offered radiation therapy.
Occurrence of locoregional or distant tumor relapse and death served as primary endpoints.
Median follow-up was 11.5 years.
Researchers observed similar rates for locoregional relapse (P=.6337), distant metastasis development (P=.1527) and OS (P=.3402) between the arms.
Ten-year OS was improved among patients who achieved a pathologic complete response (76.2% vs. 41.3%; P=.0004).
At a minimum follow-up of 60 months, researchers reported 42 incidents of late toxicities in each arm. Toxicities were similar between groups except for fibrosis (22% in the chemotherapy arm vs. 40% overall) and grade 2 dysphagia (5% in the chemotherapy arm vs. 14% overall).
“Data on preoperative chemotherapy in resectable oral cavity cancer are conflicting,” the researchers wrote in the study’s background information. “Long-term follow-up of this randomized trial confirmed the absence of survival benefit with preoperative chemotherapy in oral cavity cancer.”
Disclosure: See the study for a full list of the researchers’ relevant financial disclosures.
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