A phase 2 study of nanoparticle albumin-bound paclitaxel plus nedaplatin for patients with advanced, recurrent, or metastatic cervical carcinoma.

BACKGROUND

Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) and nedaplatin (NDP) are used for the treatment of patients with cervical cancer. However, to the authors' knowledge, the use of this combination regimen among patients with advanced, recurrent, or metastatic cervical cancer has rarely been reported.

METHODS

Patients with pathologically confirmed, stage IVB (FIGO staging 2009), recurrent or metastatic cervical cancer were eligible. Nab-paclitaxel at a dose of 175 mg/m2 plus NDP at a dose of 80 mg/m2 was administered intravenously every 3 weeks. The primary endpoint of the current study was the objective response rate (ORR). The secondary endpoints were progression-free survival, overall survival, and safety.

RESULTS

A total of 27 patients were included (5 with late-stage and 22 with recurrent or metastatic disease). The mean age of the patients was 48.26 ± 9.21 years. Of these 27 patients, 25 had squamous cell carcinoma (92.6%). A total of 26 patients completed 92 cycles of chemotherapy, with an average of 3.4 cycles per patient. The ORR was 50.0% (13 of 26 patients). The overall survival was 16.6 months (95% confidence interval, 12.6-20.6 months) and the progression-free survival was 9.1 months (95% confidence interval, 2.4-15.8 months).The ORR of patients with an interval of >12 months from receipt of prior chemotherapy was significantly higher than that of those with a shorter interval (71.4% vs 25.0%; P = .034). The most common adverse effects reported were myelosuppression, gastrointestinal reactions, fatigue, and peripheral neuropathy. The incidence of grade 3 neutropenia was 33.3% (adverse effects were graded on a scale from 0 to 4 according to the National Cancer Institute's Common Terminology Criteria for Adverse Events [version 3.0]). The incidence of grade 3 thrombocytopenia and anemia was 7.4% and 18.5%, respectively. The incidence of grade 1 to 2 peripheral neuropathy was reported to be as high as 51.9%. No case of hypersensitivity was observed.

CONCLUSIONS

The combination of nab-paclitaxel plus NDP for the treatment of patients with late-stage, recurrent, or metastatic cervical cancer appears to be active and tolerable. Cancer 2017;123:420-425. © 2016 American Cancer Society.