Lobaplatin versus cisplatin in concurrent chemoradiotherapy for elderly cervical cancer: randomized controlled phase II study

OBJECTIVE: This phase II study compared the efficacy and safety of lobaplatin vs. cisplatin in concurrent chemoradiotherapy (CCRT) for elderly cervical cancer patients. METHODS: Elderly cervical cancer patients aged ≥65 years were randomly assigned (1:1) to lobaplatin-based (2 cycles of lobaplatin 30 mg/m² every 3 weeks) or cisplatin-based (5 cycles of cisplatin 40 mg/m² every week) CCRT. Radiotherapy included external beam radiotherapy (50.4 Gy in 28 fractions) and intracavitary brachytherapy (30 Gy in 5 fractions). RESULTS: From January 1, 2020, to December 31, 2023, 64 patients were enrolled: 31 were randomly assigned to the lobaplatin group and 33 to the cisplatin group. The lobaplatin group showed higher chemotherapy completion rates compared to the cisplatin group (83.9% vs. 54.5%, p=0.011). The objective response rate and disease control rate were comparable between 2 groups (93.5% vs. 93.9%, 96.8% vs. 97.0%). The 1- and 2-year overall survival rates of the lobaplatin group and the cisplatin group were 96.0% vs. 96.6%, 90.7% vs. 96.6%, respectively (p=0.558). The lobaplatin group had a lower incidence of nephrotoxicity (39.4% vs. 9.7%, p=0.006), and there was also a trend of lower grade 2-3 gastrointestinal toxicity (30.3% vs. 12.9%, p=0.059), although the incidence of grade 3-4 thrombocytopenia was higher (16.1% vs. 6.1%, p=0.295), the difference was not statistically significant. CONCLUSION: Lobaplatin-based CCRT demonstrates comparable efficacy to cisplatin in elderly cervical cancer patients, with superior renal safety and improved gastrointestinal tolerability, establishing it as a viable alternative for cisplatin-intolerant populations.