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A randomized, controlled phase III trial of nab-Paclitaxel versus dacarbazine in chemotherapy-naïve patients with metastatic melanoma
- Source :
- Annals of oncology : official journal of the European Society for Medical Oncology. 26(11)
- Publication Year :
- 2014
-
Abstract
- The efficacy and safety of nab-paclitaxel versus dacarbazine in patients with metastatic melanoma was evaluated in a phase III randomized, controlled trial.Chemotherapy-naïve patients with stage IV melanoma received nab-paclitaxel 150 mg/m(2) on days 1, 8, and 15 every 4 weeks or dacarbazine 1000 mg/m(2) every 3 weeks. The primary end point was progression-free survival (PFS) by independent radiologic review; the secondary end point was overall survival (OS).A total of 529 patients were randomized to nab-paclitaxel (n = 264) or dacarbazine (n = 265). Baseline characteristics were well balanced. The majority of patients were men (66%), had an Eastern Cooperative Oncology Group status of 0 (71%), and had M1c stage disease (65%). The median PFS (primary end point) was 4.8 months with nab-paclitaxel and 2.5 months with dacarbazine [hazard ratio (HR), 0.792; 95.1% confidence interval (CI) 0.631-0.992; P = 0.044]. The median OS was 12.6 months with nab-paclitaxel and 10.5 months with dacarbazine (HR, 0.897; 95.1% CI 0.738-1.089; P = 0.271). Independently assessed overall response rate was 15% versus 11% (P = 0.239), and disease control rate (DCR) was 39% versus 27% (P = 0.004) for nab-paclitaxel versus dacarbazine, respectively. The most common grade ≥3 treatment-related adverse events were neuropathy (nab-paclitaxel, 25% versus dacarbazine, 0%; P0.001), and neutropenia (nab-paclitaxel, 20% versus dacarbazine, 10%; P = 0.004). There was no correlation between secreted protein acidic and rich in cysteine (SPARC) status and PFS in either treatment arm.nab-Paclitaxel significantly improved PFS and DCR compared with dacarbazine, with a manageable safety profile.
- Subjects :
- Adult
Male
medicine.medical_specialty
Skin Neoplasms
Paclitaxel
Dacarbazine
Gastroenterology
Disease-Free Survival
law.invention
Young Adult
Randomized controlled trial
law
Internal medicine
Albumins
medicine
Clinical endpoint
Humans
Progression-free survival
Antineoplastic Agents, Alkylating
Melanoma
Aged
Aged, 80 and over
business.industry
Hazard ratio
Hematology
Original Articles
Middle Aged
medicine.disease
Chemotherapy regimen
Confidence interval
Surgery
Oncology
Female
business
medicine.drug
Subjects
Details
- ISSN :
- 15698041
- Volume :
- 26
- Issue :
- 11
- Database :
- OpenAIRE
- Journal :
- Annals of oncology : official journal of the European Society for Medical Oncology
- Accession number :
- edsair.doi.dedup.....6435264d855bffa8943826dbe68c61cd