Abstract |
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), which were administered on days 1 to 7 of CCRT, followed by rest for 4 weeks. After resting, chemotherapy with cisplatin (70 mg/m) plus paclitaxel (135-175 mg/m) 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.
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Authors | Kuan Zhang, Huiping Wang, Zhenqing Wang, Fuqing Li, Ying Cui, Shengchun Ma, Rui Chen, Yuhui Wang, Shul Guo, Ying Wei |
Journal | Medicine
(Medicine (Baltimore))
Vol. 99
Issue 49
Pg. e21966
(Dec 04 2020)
ISSN: 1536-5964 [Electronic] United States |
PMID | 33285664
(Publication Type: Clinical Trial, Phase III, Journal Article)
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Chemical References |
- Endostatins
- Recombinant Proteins
- endostar protein
- Paclitaxel
- Cisplatin
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Topics |
- Adult
- Antineoplastic Combined Chemotherapy Protocols
(administration & dosage, adverse effects, therapeutic use)
- Chemoradiotherapy
(methods)
- Cisplatin
(therapeutic use)
- Endostatins
(administration & dosage, adverse effects, therapeutic use)
- Female
- Humans
- Middle Aged
- Neoplasm Recurrence, Local
(pathology)
- Paclitaxel
(therapeutic use)
- Radiotherapy, Intensity-Modulated
(methods)
- Recombinant Proteins
(administration & dosage, adverse effects, therapeutic use)
- Tibet
- Uterine Cervical Neoplasms
(pathology, therapy)
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