ESMO Congress 2024 | OncologyPRO

Abstract 888P

Background

Concurrent chemoradiotherapy (CCRT) with cisplatin (DDP) is the backbone for locoregionally advanced NPC (LA-NPC). However, patients with IV LA-NPC had a high risk of recurrence and metastasis. Concurrent DDP chemotherapy may be inadequate. Paclitaxel combined with platinum (TP) has yielded satisfactory results in many cancers. We performed a randomized, open-label Phase II trial to prove that the TP-based concurrent chemoradiotherapy regimen was superior to the DDP-based regimen for high-risk NPC.

Methods

Patients with stage IV LA-NPC were randomly assigned 1:1 to receive concurrent TP- or DDP-based chemoradiotherapy. The patients in the TP group were treated with paclitaxel with cisplatin every 4 weeks for two cycles. The patients in the DDP group were treated with cisplatin every 3 weeks for three cycles. The radiotherapy dose was 68-70 Gy delivered in 30-33 fractions. Primary endpoint was 3-year progression-free survival (PFS) in the intention-to-treat population.

Results

Between February 2017 and September 2019, 184 patients were enrolled, with 92 patients in each arm. After a median follow-up of 47.6 months, estimated 3-year PFS rates were 68.2% in the TP group (95% CI 58.6–77.8) and 72.8% (95% CI 63.8–81.8) in the DDP group (stratified HR 0.86, 95% CI 0.71–1.90; P log-rank = 0.56). The two groups showed no differences in terms of PFS, OS, or cumulative incidence of locoregional relapse and distant metastasis. Significantly higher incidence rates of any grade gastrointestinal toxicity (including nausea, vomiting, anorexia, and constipation) and any grade of thrombocytopenia were observed in the DDP group compared to TP group (P<0.05). No significant differences were observed in grade 3-4 acute toxicities and any grade or grade 3–4 late toxicities.

Conclusions

The TP regimen did not significantly prolong the PFS compared with the standard DDP regimen in CCRT in patients with stage IV LA-NPC. DDP regimen remains the backbone for CCRT.