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The study covered in this summary was published on ssrn.com as a preprint and has not yet been peer reviewed.

Key Takeaway

  • Neoadjuvant immunochemotherapy appears safe and effective for patients with locally advanced and resectable oral squamous cell carcinoma (SCC).

Why This Matters

  • This prospective, single-arm trial is the first to investigate the use of a PD-1 inhibitor with chemotherapy for neoadjuvant treatment of locally advanced and resectable oral SCC.

  • On the basis of the safety profile and major pathologic response rate, the investigators recommend conducting a larger, randomized trial.

Study Design

  • The investigators treated 20 patients with stage III and IVA locally advanced and resectable oral SCC with intravenous paclitaxel (260 mg/m2), cisplatin (75 mg/m2), and toripalimab (240 mg) on days 1 and 22 for two cycles, followed by radical surgery and risk-adapted adjuvant (chemo)radiotherapy.

  • The primary endpoint was major pathologic response, venlafaxine high erowid defined as ≤10% residual viable tumor cells in the primary tumor bed after neoadjuvant treatment.

Key Results

  • The major pathologic response rate was 60% (12/20); six patients (30%) had pathologic complete response.

  • Tumors in nine patients (45%) were downstaged.

  • During 22 months’ median follow-up, disease-free survival was 90% and overall survival was 95%.

  • Grade 3/4 adverse events (AEs) occurred in three patients (15%) and included neutropenia, leukopenia, hypokalemia, vomiting, and rash.

  • No AEs led to study discontinuation, dose reduction, surgery delay, or death.

  • Major pathologic response rates were higher for patients with higher tumor mutation burden and more immune activation cells on biopsy.

  • Major pathologic response was achieved in the four patients with combined positive PD-L1 scores >10.

  • Major pathologic response with the combination was substantially higher than previously reported rates of <8% with neoadjuvant PD-1 inhibitors alone.

Limitations

  • This was a single-arm trial with a small number of patients and a short follow-up.

  • No conclusions can be drawn about later toxicities or long-term survival.

Disclosures

  • The work was funded by the National Natural Science Foundation of China and others.

  • The investigators didn’t report any financial relationships.

This is a summary of a preprint research study, “Neoadjuvant Immunochemotherapy for Locally Advanced Resectable Oral Squamous Cell Carcinoma: A Prospective Single-Arm Trial,” led by Ying-ying Huang of Shanghai Jiao Tong University, China, provided to you by Medscape. The study has not been peer reviewed. The full text can be found at ssrn.com.

M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who has worked for several major news outlets before joining Medscape and also an MIT Knight Science Journalism fellow. Email: [email protected]

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