The combination of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) and nedaplatin showed promising activity and was relatively well tolerated in a small phase II trial.
The combination of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) and nedaplatin showed promising activity and was relatively well tolerated in a small phase II trial of patients with advanced cervical cancer.
“Among the advantages of nab-paclitaxel are the lack of a need for anti-allergic premedication and a shorter administration time” than standard paclitaxel, wrote study authors led by Rong Zhang, MD, of the Cancer Hospital of Peking Union Medical College, China. Nab-paclitaxel and nedaplatin have demonstrated efficacy with few adverse effects in single-agent studies of cervical cancer, but the combination had not yet been tested.
The new study included 27 patients with late-stage, metastatic, or recurrent cervical cancer; 25 of these had squamous cell carcinoma. Patients received nab-paclitaxel at a dose of 175 mg/m2 plus nedaplatin at a dose of 80 mg/m2 intravenously every 3 weeks. The results were published online ahead of print in Cancer.
Patients underwent an average of 3.4 cycles of the treatment, and 26 of 27 completed at least 1 cycle. Of those 26, the objective response rate was 50%; there were 2 complete responses (7.7%), 11 partial responses (42.3%), and 6 patients had progressive disease (23.1%).
The median follow-up period was 12 months, and the cohort had a median progression-free survival of 9.1 months. The median overall survival was 16.6 months.
On a univariate analysis, the only factor significantly associated with response rate was the time interval since last chemotherapy. Patients whose last treatment was more than 12 months before the study began had a response rate of 71.4%, compared with 20% in those with more recent chemotherapy (P = .034). This was not, however, associated with median progression-free survival or median overall survival; the only factor associated with those survival outcomes was ECOG performance status at baseline.
The most common grade 3 adverse events included neutropenia in 33.3% of patients, anemia in 18.5% of patients, and thrombocytopenia in 7.4% of patients. There was one case each of grade 3 neutropenic fever, fatigue, and pain. Most patients experienced vomiting (81.5%) and fatigue of lower grades (88.9%).
The authors cautioned that this was only a single-center, open-label study, and will require validation in larger trials. There was also no long-term follow-up available from the study. Still, this regimen may offer some advantages, such as a lower rate of hypersensitivity compared with solvent paclitaxel, they wrote.