"Nab-Paclitaxel plus Gemcitabine for Metastatic Pancreatic Cancer". The New England Journal of Medicine. 2013.
Links to original sources: Wiki Journal Post Full Journal Article
In patients with metastatic pancreatic cancer, does the addition of nab-paclitaxel to gemcitabine improve survival compared with gemcitabine monotherapy?
In patients with metastatic pancreatic adenocarcinoma, the addition of nab-paclitaxel to gemcitabine resulted in significantly enhanced overall survival, progression-free survival, and response rate, albeit with elevated rates of peripheral neuropathy and myelosuppression.
A phase 3 study showed that the combination of nab-paclitaxel and gemcitabine led to a notable survival advantage for patients with metastatic pancreatic cancer over treatment with gemcitabine alone. Key findings included improved median overall survival by 1.8 months and a doubling in the 2-year survival rate with the combination therapy.
As of 2013, there are no specific guidelines that reference the results of this trial.
- Multicenter, open-label, randomized, phase 3 trial. - N=861 patients with metastatic pancreatic cancer. - Nab-paclitaxel plus gemcitabine (n=431) versus gemcitabine (n=430). - Setting: 151 community and academic centers in 11 countries. - Enrollment: May 2009 to April 2012. - Analysis: Intention-to-treat. - Primary outcome: Overall survival.
- Adults (≥18 years) with metastatic adenocarcinoma of the pancreas. - Karnofsky performance-status score of 70 or more required. - Patients had not previously received chemotherapy for metastatic disease.
- Nab-paclitaxel (125 mg per square meter) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks. - Gemcitabine monotherapy (1000 mg per square meter) weekly for 7 of 8 weeks (cycle 1) and on days 1, 8, and 15 every 4 weeks (cycle 2 and subsequent cycles).
- Median overall survival: Nab-paclitaxel–gemcitabine group 8.5 months, gemcitabine group 6.7 months (HR 0.72, 95% CI, 0.62 to 0.83; P<0.001). - Median progression-free survival: 5.5 months in the nab-paclitaxel–gemcitabine group versus 3.7 months in the gemcitabine group (HR 0.69, 95% CI, 0.58 to 0.82; P<0.001). - Overall response rate (independent review): 23% in the nab-paclitaxel–gemcitabine group versus 7% in the gemcitabine group (P<0.001).
- Quality of life was not measured. - The study's open-label design might have influenced assessments.
Supported by Celgene.
The New England Journal of Medicine, published on October 16, 2013, at NEJM.org.