Intensity-modulated radiation therapy (IMRT)-based concurrent chemoradiotherapy (CCRT) with Endostar in patients with pelvic locoregional recurrence of cervical cancer: Results from a hospital in the Qinghai-Tibet Plateau

The treatment of recurrent cervical cancer, especially pelvic locoregional recurrence, is very challenging for gynecologic oncologists. This study investigated the efficacy and safety of intensity-modulated radiation therapy (IMRT)-based concurrent chemoradiotherapy (CCRT) with Endostar, a novel modified recombinant human endostatin, in patients with pelvic locoregional recurrence of cervical cancer following surgical treatment.This phase 2 study was conducted between May 2018 and May 2019 at a single center in the Qinghai-Tibet Plateau and enrolled 31 patients with pelvic locoregional recurrence of cervical cancer following surgical treatment. All patients were treated with IMRT-based CCRT for 6 weeks and intravenous infusions of Endostar (15 mg/m(2)), which were administered on days 1 to 7 of CCRT, followed by rest for 4 weeks. After resting, chemotherapy with cisplatin (70 mg/m(2)) plus paclitaxel (135–175 mg/m(2)) was given every 3 weeks for a total of 4 treatments.Thirty-one patients were evaluable for the primary endpoint. The mean age was 50.03 years (SD 7.72). The objective response rate was 67.74% and the disease control rate was 83.87% (48.39% achieved a complete response, 19.35% a partial response, 16.13% had disease stabilization, and 16.13% had progressive disease). The most common adverse events were nausea, vomiting, alopecia, neutropenia, and leukopenia; most events were grade 1 or 2 in intensity. Grade 3 toxicities included thrombocytopenia and neutropenia in 2 patients each, and leukopenia in 4 patients. No cases of grade 4 acute toxicity were observed. IMRT-based CCRT with Endostar infusions is effective and safe. Our results support the use of this treatment for patients with pelvic locoregional recurrence of cervical cancer following surgical treatment.