Safety and efficacy of nimotuzumab and concurrent intensity-modulated radiation therapy and chemotherapy for locally advanced cervical squamous cell cancer.

Abstract

5532 Background: To evaluate the safety and efficacy of nimotuzumab plus concurrent intensity-modulated radiation therapy (IMRT) and chemotherapy for the treatment of locally advanced cervical squamous cell cancer (LACSCC). Methods: From December 2013 to March 2017, 31 patients with stage (FIGO 2009) IB2-IVA cervical squamous cell cancer were enrolled in this single-arm clinical trial at an academic medical center and received concurrent chemoradiotherapy plus nimotuzumab. All patients underwent at least 1 year of follow-up. The prescription radiation dose was 50.4 Gy/28 F on the pelvic field with or without extended-field radiation. An additional 30-36 Gy to Point A was delivered with high-dose-rate techniques. Cisplatin 40 mg/m2 and nimotuzumab 200 mg were infused intravenously once weekly during radiotherapy. The main and secondary outcome measures were toxicity evaluated using CTCAE 4.0., and the short-term outcome evaluated by RECIST 1.1. Results: The median follow-up duration was 29.7 months (13.3-61.2 months). All patients received external beam radiotherapy, brachytherapy, and nimotuzumab six times. Twenty-seven patients received six cycles of chemotherapy while four received only 4-5 cycles. There was no life-threatening toxicity. The incidence of acute grade 3 bone marrow depression was 51.6% (16/31) and grade 3 gastrointestinal tract reaction was 9.7% (3/31). The incidence of late toxicities was 22.6% (7/31), and these included vaginal-rectal fistula, intestinal obstruction, rectal hemorrhage, hematuria, and vaginal stenosis. Complete response was achieved in 30 cases (96.8%). The 1-year disease-free survival (DFS), local progression-free survival (LPFS), and overall survival (OS) rates were 87.1%, 90.3%, and 100%, respectively. The corresponding 3-year values were 74.8%, 90.3%, and 86.7%. Conclusions: Nimotuzumab plus concurrent IMRT and chemotherapy may represent a well-tolerated and effective treatment regimen in patients with LACSCC.