A Randomized Phase III Trial Observed the Feasibility and Safety of Loplatin Combination Regimen of Sequential Loplatin in Locally Advanced Head and Neck SCC

Abstract

<h3>Purpose/Objective(s)</h3> To compare the toxicity and efficacy of TL (docetaxel + lobaplatin (LBP)) regimen induction chemotherapy combined with LBP concurrent chemoradiotherapy (CRT) and TPF (docetaxel + cisplatin (DDP) + 5-fluorouracil) regimen induction chemotherapy combined with DDP concurrent CRT in the treatment of locally advanced head and neck squamous cell carcinoma (HNSCC). <h3>Materials/Methods</h3> Between August 2016 and October 2019, 87 patients with locally advanced HNSCC who were pathologically confirmed and met the enrollment criteria were randomly assigned to the experimental group and the control group. All patients adopted the chrono-chemotherapy mode. In the experimental group, TL regimen induction chemotherapy combined with LBP concurrent CRT was used. The control group received TPF induction chemotherapy combined with DDP concurrent CRT. Adjuvant chemotherapy regimen was the same as induction chemotherapy, for a total of two cycles. The endpoints of the study were the toxic and adverse effects, and overall survival (OS). <h3>Results</h3> The median follow-up was 35 months (19-57 months). (1) There was no significant difference in short-term objective response rate (ORR) between the TL group and the TPF group (p=0.208). (2) During induction chemotherapy, the incidence of nausea/vomiting of grade 1-2, hyperbilirubinemia and hyponatremia in the TL group and the TPF group was 10% vs. 51% (p<0.001), 14% vs. 36% (p=0.023) and 21% vs. 71% (p<0.001). The incidence of absolute neutrophil count reduction of grade 3-4 was 17% and 51% (p=0.001). During concurrent CRT, the incidence of creatinine elevation of grade 1-2, hyponatremia and hypokalemia in the TL group and the TPF group was 2% vs. 20% (p=0.010), 14% vs. 69% (p<0.001), 19% vs.62% (p<0.001). The incidence of thrombocytopenia of grade 3-4 was 24% and 4% (p=0.009). The 2-year OS of the TL group and the TPF group were 54.3% and 66.7% (p=0.342), and the 2-year progression-free survival rates (PFS) were 61.1% and 71.4% (p=0.200). <h3>Conclusion</h3> For locally advanced HNSCC, LBP combined regimen induction chemotherapy followed by LBP concurrent CRT may be a new choice for second-line treatment. LBP regimen had obvious advantages in reducing toxic and adverse effects, and the efficacy needs further follow-up verification.