Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine
October 16, 2013DOI: 10.1056/NEJMoa1304369
- Abstract
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Background
In a phase 1–2 trial of albumin-bound paclitaxel (nab-paclitaxel) plus gemcitabine, substantial clinical activity was noted in patients with advanced pancreatic cancer. We conducted a phase 3 study of the efficacy and safety of the combination versus gemcitabine monotherapy in patients with metastatic pancreatic cancer.Methods
We randomly assigned patients with a Karnofsky performance-status score of 70 or more (on a scale from 0 to 100, with higher scores indicating better performance status) to nab-paclitaxel (125 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks or gemcitabine monotherapy (1000 mg per square meter) weekly for 7 of 8 weeks (cycle 1) and then on days 1, 8, and 15 every 4 weeks (cycle 2 and subsequent cycles). Patients received the study treatment until disease progression. The primary end point was overall survival; secondary end points were progression-free survival and overall response rate.Results
A total of 861 patients were randomly assigned to nab-paclitaxel plus gemcitabine (431 patients) or gemcitabine (430). The median overall survival was 8.5 months in the nab-paclitaxel–gemcitabine group as compared with 6.7 months in the gemcitabine group (hazard ratio for death, 0.72; 95% confidence interval [CI], 0.62 to 0.83; P<0 .001="" 0.58="" 0.69="" 0.82="" 1="" 22="" 23="" 27="" 29="" 2="" 3.7="" 35="" 3="" 4="" 5.5="" 7="" 95="" 9="" a="" according="" adverse="" and="" as="" at="" ci="" common="" compared="" days.="" death="" disease="" events="" fatigue="" febrile="" for="" gemcitabine="" grade="" group="" groups.="" groups="" hazard="" higher="" improved="" in="" independent="" lower="" median="" months="" most="" nab-paclitaxel="" neuropathy="" neutropenia="" occurred="" of="" or="" p="" patients="" progression-free="" progression="" rate="" ratio="" response="" review="" survival="" the="" to="" two="" versus="" vs.="" was="" were="" with="" year="" years.=""> 0>Conclusions
In patients with metastatic pancreatic adenocarcinoma, nab-paclitaxel plus gemcitabine significantly improved overall survival, progression-free survival, and response rate, but rates of peripheral neuropathy and myelosuppression were increased. (Funded by Celgene; ClinicalTrials.gov number, NCT00844649.)
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