In an Indian single-institution phase II study reported in the Journal of Clinical Oncology, Chaukar et al found that neoadjuvant chemotherapy was associated with mandibular preservation in approximately half of previously untreated patients undergoing surgery for squamous cell carcinoma of the oral cavity.
In the open-label trial, 68 patients at Tata Memorial Hospital, Mumbai, with disease (cT2–T4 and N0/N1, M0) requiring resection of the mandible were randomly assigned to upfront segmental resection (n = 34) or neoadjuvant chemotherapy with two cycles of docetaxel, cisplatin, and fluorouracil at 3-week intervals followed by surgery based on disease extent (n = 34). All patients in the neoadjuvant chemotherapy group received adjuvant chemoradiotherapy, and patients in the upfront surgery group received treatment based on final histopathology findings.
Key Findings
Median follow-up was 3.6 years (interquartile range = 0.95–7.05 years). Mandibular preservation was achieved in 16 (47%, 95% confidence interval [CI] = 31%–63%) of 34 patients in the neoadjuvant chemotherapy group.
No difference in locoregional control was observed between groups (P = .71). Median disease-free survival was 3.8 years (range = 0.04–9.38 years) in the neoadjuvant chemotherapy group vs 3.4 years (range = 0.13–8.74 years) in the upfront surgery group (hazard ratio [HR] = 0.91, 95% CI = 0.52–1.61, P = .715). Median overall survival was 4.1 years (range = 0.12–9.38 years) in the neoadjuvant chemotherapy group vs 3.4 years (range = 0.29–8.74 years) in the upfront surgery group (HR = 0.90, 95% CI = 0.51–1.59, P = .747).
Surgical complications were observed in two patients in the neoadjuvant chemotherapy group and none in the upfront surgery group. Toxicity associated with neoadjuvant chemotherapy included grade III and grade IV adverse events in 14 patients (41%) and 11 patients (32%), respectively.
The investigators concluded, “Neoadjuvant chemotherapy plays a potential role in mandibular preservation in oral cancers, with acceptable toxicities and no compromise in survival. However, this needs to be validated in a larger phase III randomized trial.”
Devendra Chaukar, MBBS, MS, of Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by intramural funds from Tata Memorial Hospital. For full disclosures of the study authors, visit ascopubs.org.
