Prospective Phase II Open-Label Randomized Controlled Trial to Compare Mandibular Preservation in Upfront Surgery...

Area of Science:

• Oncology
• Surgical Oncology
• Chemotherapy

Background:

• Oral cancer treatment often involves extensive surgery, including mandible resection.
• Mandibular preservation is crucial for maintaining quality of life and function.
• Neoadjuvant chemotherapy (NACT) is being explored as a strategy to reduce tumor burden and potentially spare the mandible.

Purpose of the Study:

• To evaluate the efficacy of NACT in achieving tumor shrinkage for mandibular preservation in oral cancer.
• To compare the outcomes of NACT followed by surgery with upfront surgical treatment.
• To assess the safety and toxicity profiles of NACT in this context.

Main Methods:

• A single-center, randomized phase II trial was conducted on patients with advanced oral squamous cell carcinoma requiring mandibular resection.
• Patients were randomized to either standard upfront surgery (standard arm) or two cycles of NACT (docetaxel, cisplatin, fluorouracil) followed by surgery (intervention arm).
• The primary endpoint was the rate of mandible preservation, with secondary endpoints including disease-free survival and toxicity.

Main Results:

• Mandibular preservation was achieved in 47% of patients who received NACT.
• Disease-free survival and overall survival rates were similar between the NACT and standard surgery arms.
• While complications were comparable, NACT led to significant chemotherapy-induced toxicities (grade III/IV in 73.6% of patients).

Conclusions:

• NACT demonstrates a potential role in facilitating mandibular preservation for oral cancer patients.
• This approach appears to offer similar survival outcomes compared to conventional surgery without NACT.
• Further validation in larger phase III trials is warranted due to observed toxicities.