Intratumoral Injection of H101 in Combination With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer
Abstract BackgroundTo evaluate the clinical benefit of concurrent chemoradiotherapy in combination with H101 injection for the treatment of locally advanced cervical cancer (LACC) patients.MethodsThe patients, all diagnosed with stage IIB or III cervical cancer according to The International Federation of Gynecology and Obstetrics (FIGO) stage (2009) with tumor length ≥6cm were enrolled at Zhejiang Cancer Hospital from July 2015 to April 2017. All patients received concurrent chemoradiotherapy (CCRT) in combination with intratumoral H101 injection before and during external beam radiotherapy (EBRT). The parameters recorded and analyzed included progression-free survival (PFS), overall survival (OS), tumor regression after EBRT and side effects, which were compared to another group of patients with similar characteristics treated with CCRT alone.ResultsTwenty patients were treated with CCRT in combination with intratumoral H101 injection and another group of 20 patients treated with CCRT alone was selected as control. The median follow-up time was 38 months (range 10-58 months). The 3-year local, regional, and overall PFS rates were 95% vs 66.6%(p = 0.02), 95% vs 62.5%(p = 0.029), and 65% vs 43.8%(p = 0.19), for H101 group and control group respectively. The 3-year (OS) was 74.3% vs 54.5%(p = 0.098), respectively. The median reduction of tumor length and volume for H101 group and control group were 37.7% vs 28.7%(p = 0.016) and 75.1% vs 62.4%(p = 0.001), respectively. The major adverse event related to H101 was fever.ConclusionCCRT in combination with intratumoral H101 injection is effective in treating LACC, and has an acceptable safety profile.Trial registrationThe study was registered at Chinese Clinical Trail Registry (ChiCTR-OPC-15006142).