Tislelizumab and GP regimen neoadjuvant therapy followed by concurrent chemoradiotherapy with nimotuzumab in patients with stage IVA nasopharyngeal carcinoma: a retrospective study.

Objective: We aimed to retrospectively evaluate the safety and efficacy of tislelizumab combined with the gemcitabine and cisplatin (GP) regimen as neoadjuvant therapy followed by nimotuzumab with concurrent chemoradiotherapy (CCRT) for locoregionally advanced nasopharyngeal carcinoma (LANPC).

Methods: From March 2021 to January 2022, 44 patients were included in our hospital. Tislelizumab and the GP regimen were given every three weeks for 1-4 cycles, followed by nimotuzumab with chemoradiotherapy, which included lobaplatin and intensity-modulated radiation therapy (IMRT). All patients were analyzed for tumor response at regular intervals during induction therapy, chemoradiotherapy, and follow-up visits.

Results: Forty-one (93%) patients completed 4 cycles of GP and tislelizumab during neoadjuvant treatment. Forty-one patients (93%) finished two cycles of lobaplatin treatment, and forty-two patients (95%) finished six weeks of nimotuzumab treatment during concurrent chemoradiotherapy. Of the patients, twenty (46%) had a complete response, and twenty-four (55%) had a partial response prior to CCRT. After chemoradiotherapy, 91% of patients (40 out of 44) and 98% of patients (43 out of 44) had complete responses, respectively, at three and six months. With 34 months of median follow-up time, overall survival and progression-free survival were not reached. The 2-year overall survival rate was 93% (95% CI, 0.803-0.977), and the 2-year progression-free survival rate was 91% (95% CI, 0.776-0.965). Of the patients, 43% had treatment-related adverse events, and 9.1% had immune-related adverse events (irAEs) from grades 3-4.

Conclusions: Tislelizumab plus induction chemotherapy followed by nimotuzumab with chemoradiotherapy significantly improved tumor response, superior progression-free survival, and manageable safety for high-risk LANPC. However, our study demonstrates the potential benefits of combining nimotuzumab with chemoradiotherapy after neoadjuvant chemotherapy in high-risk LANPC patients; the findings are preliminary and must be validated by larger, more rigorously designed trials.