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In this study we aimed to assess the maximum-tolerated dose (MTD) of nab-paclitaxel (Keaili ^®) in combination with a fixed dose of cisplatin when given concurrently with radiotherapy to patients for locally advanced cervical cancer (LACC).

Chemotherapy: Patients firstly receive an escalating dose of weekly nab-paclitaxel starting at 10 mg/m² up to 70 mg/m², Patients secondly receive weekly cisplatin (40 mg/m²). Treatment repeats every week until the disease recurrence or unacceptable toxicity, death or begin a novel therapeutic. Concurrent chemotherapy is a weekly regimen during radiotherapy. Patients will complete at least 4 cycles of concurrent chemoradiotherapy, until the MTD appeared.

Radiation therapy: Patients also receive pelvic radiation therapy once daily (Monday-Friday) for a total of 28 fractions and intracavitary brachytherapy twice a week for a total 5 fractions. Complete radiotherapy within 55 days. (ClinicalTrials.gov Identifier: NCT04017377)

This study was initiated in September, 2019, and enrollment ended in October, 2021. Eighteen patients with stage ⅠB2-ⅣA cervical cancer were enrolled in this study. Five levels of nab-paclitaxel were studied with three, three, three, six and three patients enrolled, respectively. The MTD of nab-paclitaxel was found at 50 mg/m²/week. At level 4, 1 patient experienced DLT because of grade 3 right upper extremity edema. At level 5, two DLTs (grade 3 rash and grade 3 perineal edema) were observed in two patients. Other major side effects included leukopenia, neutropenia, hypochromia, fatigue and nausea. Sixteen patients were evaluable for response: two complete and fourteen partial responses were obtained with an overall response rate of 100%.

      Based on the results obtained from this study, weekly administration of 50 mg/m² nab-paclitaxel when associated to cisplatin 40 mg/m²/week and concurrent radiotherapy can be considered a tolerable and safe dose for the treatment of locally advanced cervical cancer.