Protein-bound paclitaxel/carboplatin compared to solvent-based paclitaxel/carboplatin in treatment of advanced stage of cervical cancer.

Abstract

e17529 Background: In Uzbekistan, women with cervical cancer are often diagnosed in advanced stages of the disease. Cervical cancer is the leading cause of death among patients with malignant tumors in Uzbekistan. In the randomized study comparing nab-paclitaxel\carboplatin scheme with solvent-based paclitaxel\carboplatin in our patients with metastatic cervical cancer. Protein-bound Paclitaxel\carboplatin demonstrated a significantly higher overall response rate than solvent-based paclitaxel\Carboplatin. The primary endpoint was investigator assessed overall response rate and assessment of safety and tolerability. Secondary endpoints included time to tumor progression (TTP), survival and pharmacokinetics. Methods: Seventy-six patients were randomized from 20 June 2015 through 10 August 2016. The median age was 50 years, 87 percent of participants were less than 65 years old and 64 percent of participants were postmenopausal. Protein-bound Paclitaxel and Carboplatin administered intravenously on days 1, 8, and 15 of each 28-day cycle, with a starting dose of 100 mg/m2. Results: Protein-bound paclitaxel\carboplatin significantly improved the investigator assessed overall response rate versus solvent-based paclitaxel\carboplatin (49% vs. 21%; P =0.001). The median time to progression was longer for nab-paclitaxel\carboplatin than for solvent-based paclitaxel\carboplatin, the difference was significant (13.3 months vs.6.2 months p=0.078). Protein-bound paclitaxel\carboplatin also achieved a 29 percent improvement in progression free survival when compared to solvent-based paclitaxel (8.7 months vs. 5.1 months; P = 0.118). Nab-paclitaxel\carboplatin arm was also superior in tolerability and safety. There were fewer adverse events in the protein-bound paclitaxel\carboplatin arm - 10.6 versus 17.2 percent with solvent-based paclitaxel\carboplatin. There were fewer infections with protein-bound paclitaxel\carboplatin - 1.3 versus 6.1 percent with solvent-based paclitaxel\carboplatin. In addition, hematologic toxicities were approximately the same about 15 percent in each arm. Conclusions: Chemotherapy for advanced stage of cervical cancer with protein-bound paclitaxel/carboplatin was associated with less toxicity and significant OR, TTP and survival superiority compared with solvent-based paclitaxel/carboplatin.