2764 - The Efficacy and Safety of Lobaplatin vs. Cisplatin in Concurrent Chemoradiotherapy for Elderly Patients with Cervical Cancer: An Open-Label,Prospective Phase 2 Study

Purpose/Objective(s): The standard treatment for local advanced cervical cancer is cisplatin based concurrent chemoradiotherapy, while the most common adverse reactions of cisplatin are gastrointestinal reactions and renal toxicity. Elderly patients with cervical cancer are mostly accompanied by medical complications and have poor tolerance to treatment-related adverse reactions. The purpose of this study is to observe the efficacy and safety of lobaplatin versus cisplatin in concurrent chemoradiotherapy for elderly patients with cervical cancer.

Materials/Methods: A total of 64 elderly patients with stage IB - IIIC cervical cancer, =65 years old, were admitted to Affiliated Cancer Hospital of Guizhou Medical University from January 2020 to December 2023. They were divided into two groups. The lobaplatin group (30mg/m²,q3w x 2cycles) included 31 patients, and the cisplatin group (40mg/m², qw x 5cycles) included 33 patients. The radiotherapy regimen included external beam radiotherapy (PCTV 50.4Gy, 28 fractions, PGTVnd 60.2Gy, 28 fractions) combined with high dose rate intracavitary brachytherapy (HR-CTV 30Gy, 6 fractions). To observe the efficacy and adverse reactions of two groups.

Results: There was a significantly higher completion rate in the lobaplatin group, 26 patients (83.9%) completed 2 cycles lobaplatin chemotherapy, while 18 patients (54.5%) completed 4-5 cycles cisplatin chemotherapy (P = 0.011). The total radiotherapy time was =8 weeks in 25 patients (80.6%) in the lobaplatin group and 28 patients (84.8%) in the cisplatin group (P=0.66). ORR of the lobaplatin group and the cisplatin group was 93.5% and 93.9%, and DCR was 96.8% and 97.0%. There was no significant difference between the two groups (P > 0.05). The 1-year and 4-year OS was 96.3% and 78.1%, the 1-year and 4-year PFS was 89.7% and 70%. Among them, the 1-year OS of the lobaplatin group and the cisplatin group was 96.0% vs. 96.6%, the 4-year OS was 79.3% vs. 77.2% (P=0.56),the 1-year PFS was 88.9% vs. 90.5%, and the 4-year PFS was 67.0% vs 73.3% (P=0.38).The incidence of leukopenia, lower gastrointestinal reaction, and urinary system reaction were similar between the two groups, while the incidence of grade III-IV thrombocytopenia was higher in the lobaplatin group but without statistical significance,16.1% and 6.1% respectively. The incidence of grade II - III upper gastrointestinal reaction was higher in the cisplatin group, 30.3% and 12.9% respectively (P=0.059). The incidence of renal damage was significantly lower in the lobaplatin group, 9.7% and 39.4% respectively(P=0.006).

Conclusion: Compared with cisplatin, lobaplatin has similar efficacy in the treatment of concurrent chemoradiotherapy for elderly patients with cervical cancer, with tolerable adverse reactions and lower upper gastrointestinal reaction and renal toxicity. It can be clinically recommended for elderly patients with cervical cancer who have renal insufficiency or intolerable gastrointestinal reactions.