MPACT
Trial question
What is the role of nab-paclitaxel plus gemcitabine in patients with metastatic pancreatic cancer?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
42.0% female
58.0% male
N = 861
861 patients (359 female, 502 male).
Inclusion criteria: patients who had metastatic pancreatic disease with a Karnofsky performance status score ≥ 70.
Key exclusion criteria: receipt of cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting, islet-cell neoplasms or locally advanced disease.
Interventions
N=431 nab-paclitaxel plus gemcitabine (nab-paclitaxel (125 mg per square meter of body-surface area) followed by gemcitabine (1,000 mg per square meter) on days 1, 8, and 15 every 4 weeks).
N=430 gemcitabine monotherapy (1,000 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)).
Primary outcome
Median overall survival
8.5 months
6.7 months
8.5 months
6.4 months
4.3 months
2.1 months
0.0 months
Nab-paclitaxel plus
gemcitabine
Gemcitabine
monotherapy
Significant
increase ▲
Significant increase in median overall survival (8.5 months vs. 6.7 months; HR 1.38, 95% CI 1.2 to 1.61).
Secondary outcomes
Significant increase in median progression-free survival (5.5 months vs. 3.7 months; HR 1.44, 95% CI 1.22 to 1.72).
Significant increase in response (23% vs. 7%; RR 3.19, 95% CI 2.18 to 4.66).
Significant increase in rate of disease control (48% vs. 33%; RR 1.46, 95% CI 1.23 to 1.72).
Safety outcomes
No significant differences in anemia, thrombocytopenia, febrile neutropenia.
Significant differences in adverse events ≥grade 3, including neutropenia (38% vs. 27%), fatigue (17% vs. 7%), and neuropathy (17% vs. 1%).
Conclusion
In patients who had metastatic pancreatic disease with a Karnofsky performance status score ≥ 70, nab-paclitaxel plus gemcitabine was superior to gemcitabine monotherapy with respect to median overall survival.
Reference
Von Hoff DD, Ervin T, Arena FP et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703.
Open reference URL