Inventi Impact: Clinical Research

Inventi:pcr/23288/17

Safety and Efficacy of Lobaplatin Combined with 5-Fluorouracil as First-Line Induction\nChemotherapy Followed by Lobaplatin-Radiotherapy in Locally Advanced Nasopharyngeal\nCarcinoma: Preliminary Results of a Prospective Phase II Trial

Background: Due to improvements in imaging and radiological techniques as well as the use of chemotherapy,\ndistant metastasis has become the predominant mode of treatment failure in patients with locally advanced\nnasopharyngeal carcinoma (LA-NPC). Platinum-based systemic chemotherapy has shown survival benefits and is\nnow the standard strategy for systemic therapy in patients with LA-NPC. Notably, the third-generation platinum\nreagent lobaplatin has shown anti-tumor effects in several solid tumors with lower incidences of gastrointestinal,\nhepatic and renal toxicity relative to other platinum drugs. However, the safety and efficacy of lobaplatin as a\nfirst-line regimen in patients with LA-NPC are undetermined.\nMethods: Patients with stage IIIââ?¬â??IVa-b NPC received lobaplatin at a dose of 30 mg/m2 on days 1 and 22 combined\nwith a continuous 120-h intravenous injection of 5-fluorouracil at a dose of 4 g/m2 followed by lobaplatin at a\ndose of 50 mg/m2 on days 43 and 64 concomitant with intensity-modulated radiation therapy. Objective response\nrates and acute toxicity were assessed based on RECIST (1.1) and CTCAE v.3.0, respectively. Kaplan-Meier analysis\nwas used to calculate survival rates.\nResults: Fifty-nine patients were enrolled, and 44 patients (74.6%) received allocated cycles of chemotherapy.\nThe objective response rates were 88.1% (95% confidence interval [CI], 0.77 to 0.95) and 100% after induction\nchemotherapy (ICT) and concurrent chemoradiotherapy (CRT), respectively. With a median follow-up period of\n44 months, the 3-year estimated progression-free survival and overall survival were 86.4% (95% CI, 69.8 to 98.8)\nand 94.9% (95% CI, 89.5 to 100), respectively. The most common grade 3ââ?¬â??4 toxicities were neutropenia (8.5%)\nand thrombocytopenia (40.7%) after ICT and CRT, respectively.\nConclusion: Lobaplatin combined with 5-fluorouracil followed by lobaplatin-RT treatment showed encouraging\nanti-tumor effects with tolerable toxicities in patients with LA-NPC. Randomized controlled trials of lobaplatin in\npatients with LA-NPC are warranted.