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Nab-Paclitaxel plus Gemcitabine Improves Survival in Pancreatic Cancer

Summary and Comment |
October 16, 2013

Nab-Paclitaxel plus Gemcitabine Improves Survival in Pancreatic Cancer

  1. David H. Ilson, MD, PhD

This combination therapy represents a new care standard and offers an alternative to FOLFIRINOX.

  1. David H. Ilson, MD, PhD

Little progress has been made in the treatment of metastatic pancreatic cancer. Numerous phase III trials of gemcitabine combination therapy have failed to improve survival compared to gemcitabine alone. FOLFIRINOX (oxaliplatin, irinotecan, fluorouracil, and leucovorin) chemotherapy did improve survival compared with gemcitabine in a recent phase III trial (NEJM JW Oncol Hematol May 11 2011), but toxicity limits its application to high-function patients.

Investigators now report results of an industry-sponsored, international, multicenter, randomized phase III trial (MPACT) of nab-paclitaxel plus gemcitabine in 861 patients with metastatic pancreatic cancer. Patients were randomized to gemcitabine (1000 mg/m2 weekly) for 7 of 8 weeks followed by weekly gemcitabine for 3 of 4 weeks each month versus gemcitabine (1000 mg/m2) plus nab-paclitaxel (125 mg/m2 weekly) for 3 of 4 weeks each month. The median ages of patients in the two groups were 62 and 63 years, and the majority of patients (92%) had Karnofsky performance scores of 80% to 100%, tumors of the pancreatic head or body (74%–75%), and liver metastases (84%–85%).

Median overall survival (OS, the primary endpoint) was significantly improved with the addition of nab-paclitaxel to gemcitabine (8.5 vs. 6.7 months; hazard ratio, 0.72; P<0.001; 1-year OS, 35% vs. 22%; P<0.001). Median progression-free survival was also improved with combination therapy (5.5 vs. 3.7 months; HR, 0.69; P< 0.001), as was the antitumor response rate (23% vs. 7%; P< 0.001). Therapy with nab-paclitaxel resulted in higher rates of grade 3 or 4 neutropenia, fatigue, and peripheral neuropathy.

Comment

The combination of nab-paclitaxel plus gemcitabine represents a new standard of care in metastatic pancreatic cancer. The tolerance of therapy makes this regimen an appealing therapy alternative to FOLFIRINOX, particularly in patients whose functional status may not permit three-drug combination therapy. However, the improvements in survival and response with nab-paclitaxel and gemcitabine versus gemcitabine appear to lag behind improvements with FOLFIRINOX versus gemcitabine. Which combination will move forward in future studies evaluating the addition of targeted and other drugs remains to be established.

  • Disclosures for David H. Ilson, MD, PhD at time of publication Consultant / Advisory board Clovis; Eli-Lilly; ImClone Speaker's bureau Genentech Grant / research support Bayer Editorial boards HemOnc Today; Journal of Clinical Oncology

Citation(s):

Reader Comments (1)

HENRY J. LOPEZ-ROMAN, MD Physician, Oncology, Oncology Hematology Associates. Victoria, TX

Great to know that this combination works

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