6/28/23, 11:19 PM MPACT Pathway Feedback Search Clinical Topics Home Studies MPACT MPACT Disease Pancreatic cancer 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 N = 861 58.0% male 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)) https://web.pathway.md/studies/recrKKROCZfx4sK0d 1/2 6/28/23, 11:19 PM MPACT Pathway Primary outcome Median overall survival 8.5 months 8.5 6.7 6.4 months 4.3 months 2.1 months Significant increase 0.0 months Nab-paclitaxel plus gemcitabine Gemcitabine monotherapy 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 https://web.pathway.md/studies/recrKKROCZfx4sK0d 2/2