Lobaplatin-based treatment is as effective as, but less toxic than, cisplatin-based therapy for patients with locoregional advanced nasopharyngeal carcinoma (NPC), according to a phase 3 trial published in The Lancet Oncology.
Cisplatin-based induction plus concurrent chemoradiotherapy is the current standard treatment for patients with stage II-IVB NPC, according to National Comprehensive Cancer Network Guidelines. However, cisplatin is associated with significant toxic side effects, according to the study authors.
They noted that lobaplatin is a third-generation platinum drug that previously showed encouraging antitumor activity against several cancers, with fewer toxic effects than cisplatin.
Based on these results, the authors conducted a randomized, phase 3 trial to compare lobaplatin-based therapy and cisplatin-based treatment in patients with stage III-IVB NPC.
The study enrolled 502 patients. They were randomly assigned 1:1 to receive induction with lobaplatin plus fluorouracil (n=252) or cisplatin plus fluorouracil (n=250), both followed by concurrent chemoradiotherapy (either lobaplatin- or cisplatin-based).
The median follow-up duration for the intention-to-treat population was 75.3 months. In this group, the 5-year progression-free survival (PFS) rate was 75.0% for the lobaplatin arm and 75.5% for the cisplatin arm (hazard ratio [HR], 0.98; 95% CI, 0.69-1.39; log-rank P =.92). The difference between the arms was 0.5% (95% CI, -7.1 to 8.1; Pnoninferiority =.0070).
In the per-protocol population, the 5-year PFS rate was 74.8% in the lobaplatin arm and 76.4% in the cisplatin arm (HR, 1.04; 95% CI, 0.73-1.49; log-rank P =.83). The difference between the arms was 1.6% (95% CI, -6.1 to 9.3; Pnoninferiority =.016).
Grade 1 to 2 adverse events (AEs) that were significantly more common in the cisplatin arm than in the lobaplatin arm were nausea (75% vs 42%; P <.0001), vomiting (60% vs 21%; P <.0001), nephrotoxicity (37% vs 21%; P <.0001), and weight loss (66% vs 32%; P <.0001).
The rate of grade 3-4 AEs was 73% in the cisplatin arm and 63% in the lobaplatin arm. The most common grade 3-4 AEs (in the cisplatin and lobaplatin arms, respectively) were mucositis (40% vs 41%), leucopenia (23% vs 16%), and neutropenia (24% vs 10%).
There were no serious AEs or treatment-related deaths reported during the study.
“The results of our trial indicate that lobaplatin-based induction chemotherapy plus concurrent chemoradiotherapy might be a promising alternative regimen to cisplatin-based treatment in patients with locoregional, advanced nasopharyngeal carcinoma,” the study authors wrote.
“Future studies to enhance the potency of lobaplatin (eg, combination with other chemotherapy drugs, targeted therapy, or immunotherapy) are required to better understand its efficacy.”
Disclosures: This research was supported by the National Science and Technology Pillar Program and other sources. The study authors declared no conflicts of interest. Please see the original reference for a full list of disclosures.
Lv X, Cao X, Xia W-X, et al. Induction chemotherapy with lobaplatin and fluorouracil versus cisplatin and fluorouracil followed by chemoradiotherapy in patients with stage III–IVB nasopharyngeal carcinoma: an open-label, non-inferiority, randomised, controlled, phase 3 trial. Lancet Oncol. 2021;22(5):716-726. doi:10.1016/S1470-2045(21)00075-9