Phase II Clinical Study of Nab-paclitaxel Combined with Cisplatin Concurrent Radiotherapy in the Treatment of Advanced Cervical Cancer

다국어 초록 (Multilingual Abstract)

Purpose – To explore the maximum tolerated dose of nab-paclitaxel in patients with advanced cervical cancer during
concurrent radiotherapy and chemotherapy.
Design/Methodology/Approach – This study adopted a 3+3 design, with a fixed cisplatin dose of 40 mg/m2, and
escalation of nab-paclitaxel for injection. The initial dose was 10 mg/m2, with at least 3 subjects in each dose group.
radiotherapy was used 6 MV X-ray pelvic three-dimensional conformal radiotherapy, the dose is 180 cGy/time, 5
times/week, lasting 4-6 weeks，Combined intracavitary brachytherapy 30-36gy/5-6 times. Such as DLT, enter the
next dose group until the MTD is obtained, and regularly evaluate the efficacy and adverse reactions.
Findings – A total of 21 patients were enrolled, including 3 cases in the 10 mg/m2 group, 3 cases in the 20 mg/m2
group, 6 cases in the 30 mg/m2 group, 6 cases in the 50 mg/m2 group, and 4 cases in the 70 mg/m2 group. There
were 2 cases of DLT in the 70 mg/m2 group, so the MTD was determined to be 50 mg/m2. The 3-month ORR was
100% (20/20), the 6-month ORR was 94. 12% (16/17), and the 1-year ORR was 87. 5 % (12/14). The most common
occurrence of grade 3-4 treatment-related adverse reactions is bone marrow suppression.
Research Implications – The maximum tolerated dose of nab-paclitaxel in the treatment of advanced cervical cancer
with concurrent radiotherapy and chemotherapy is 50 mg/m2. This program has reliable efficacy and good safety.