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Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine

This week's issue of the New England Journal of Medicine examines the efficacy and safety of the combination versus gemcitabine monotherapy in patients with metastatic pancreatic cancer.

News image

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.

Dr Daniel Von Hoff and colleagues conducted a phase 3 study of the efficacy and safety of the combination versus gemcitabine monotherapy in patients with metastatic pancreatic cancer.

The researchers randomly assigned patients with a Karnofsky performance-status score of 70 or more to nab-paclitaxel followed by gemcitabine on days 1, 8, and 15 every 4 weeks or gemcitabine monotherapy weekly for 7 of 8 weeks, and then on days 1, 8, and 15 every 4 weeks.

Patients received the study treatment until disease progression.

The researchers' primary end point was overall survival.

Febrile neutropenia occurred in 3% versus 1% of the patients in the 2 groups
New England Journal of Medicine

Secondary end points were progression-free survival and overall response rate.

A total of 861 patients were randomly assigned to nab-paclitaxel plus gemcitabine or gemcitabine.

The research team's median overall survival was almost 9 months in the nab-paclitaxel–gemcitabine group as compared with 7 months in the gemcitabine group.

The team found that survival rate was 35% in the nab-paclitaxel–gemcitabine group versus 22% in the gemcitabine group at 1 year, and 9% versus 4% at 2 years.

The researchers observed that median progression-free survival was 6 months in the nab-paclitaxel–gemcitabine group, as compared with 4 months in the gemcitabine group.

The response rate according to independent review was 23% versus 7% in the 2 groups.

The most common adverse events of grade 3 or higher were neutropenia, fatigue, and neuropathy.

The team found that febrile neutropenia occurred in 3% versus 1% of the patients in the 2 groups.

In the nab-paclitaxel–gemcitabine group, neuropathy of grade 3 or higher improved to grade 1 or lower in a median of 29 days.

Dr Von Hoff's team concludes, "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."

NEJM 2013; 369: 1691-1703
05 November 2013

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