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Randomized phase III study of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic adenocarcinoma of the pancreas (MPACT).
Oral Abstract Session: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract (eQ&A)
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).
Background: nab-Paclitaxel (nab-P, 130 nm albumin-bound paclitaxel) provides tumor selective localization via transcytosis across the endothelium, potential tumor uptake via macropinocytosis, and improved pharmacokinetics vs cremophor-paclitaxel. In vitro, nab-P increased tumoral gemcitabine (G) levels, and in a phase I/II study in metastatic pancreatic cancer (mPC) nab-P + G showed promising activity. Methods: Patients (pts) with mPC were randomized to nab-P 125 mg/m2, followed by G 1000 mg/m2 on days 1, 8, and 15 every 4 weeks or G 1000 mg/m2 weekly for 7 weeks (cycle 1), then on days 1, 8, and 15 every 4 weeks (≥ cycle 2). For the primary endpoint of overall survival (OS), 608 events from 842 patients provided a power of 0.9 to detect a HR of 0.769 (2-side α = 0.049). Results: 861 pts received therapy. Baseline pt characteristics were well balanced. Median age was 63 years, Karnofsky performance status was 90-100 in 60% and ≤80 in 40% of pts, 43% had head of pancreas lesions, 84% had liver and 39% had lung metastases, and 52% of pts had CA19-9 ≥59 x ULN. Treatment duration was 4 vs 3 months in nab-P + G vs G. The relative protocol G dose was 75% vs 85% in nab-P + G vs G; nab-P dose was 81%. OS, progression-free survival (PFS), time to treatment failure (TTF), and overall response rate (ORR) were significantly improved in the nab-P + G arm (Table). Most common grade ≥3 AEs were neutropenia (38% vs 27%), fatigue (17% vs 7%), and neuropathy (17% vs 1%) in the nab-P + G vs G arms. Grade ≥3 neuropathy improved to grade ≤1 in 29 days. Febrile neutropenia was reported in 3% (nab-P + G) vs 1% (G) pts. Conclusions: In this multinational, multiinstitutional study, nab-P + G was well tolerated and superior to G with statistically significant and clinically meaningful results in all endpoints and across subgroups. Clinical trial information: NCT00844649.
n = 431
n = 430
|OS, median mo||8.5||6.7||0.72||0.000015|
|1-yr survival, %||35||22||(0.617–0.835)||0.000200|
|2-yr survival, %||9||4||0.021234|
|PFS, median mo||5.5||3.7||0.69||0.000024|
|1-yr PFS, %||16||9||(0.581–0.821)||0.031876|
|TTF, median mo||5.1||3.6||0.70
|Response rate ratio
(Pnab-P+G / PG)
|ORR, n (%)||99||31||3.19||1.1x10-10|
|ORR, n (%)||(23)||(7)||(2.178–4.662)|
Abstracts by Daniel D. Von Hoff:
Effect of baseline carbohydrate antigen 19-9 (CA19-9) level on overall survival (OS) in NAPOLI-1 trial: A phase III study of MM-398 (nal-IRI), with or without 5-fluorouracil and leucovorin (5-FU/LV), versus 5-FU/LV in metastatic pancreatic cancer (mPAC) previously treated with gemcitabine-based therapy.Meeting: 2016 Gastrointestinal Cancers Symposium | Abstract No: 425
Outcome of second-line treatment (2L Tx) following nab-paclitaxel (nab-P) + gemcitabine (G) or G alone for metastatic pancreatic cancer (MPC).Meeting: 2016 Gastrointestinal Cancers Symposium | Abstract No: 333
Updated overall survival analysis of NAPOLI-1: Phase III study of nanoliposomal irinotecan (nal-IRI, MM-398), with or without 5-fluorouracil and leucovorin (5-FU/LV), versus 5-FU/LV in metastatic pancreatic cancer (mPAC) previously treated with gemcitabine-based therapy.Meeting: 2016 Gastrointestinal Cancers Symposium | Abstract No: 417
Presentations by Daniel D. Von Hoff:
Randomized phase III study of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic adenocarcinoma of the pancreas (MPACT)Meeting: 2013 Gastrointestinal Cancers Symposium Abstract No: LBA148Session: Oral Abstract Session: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract (eQ&A) (Oral Abstract Session)
Integrating molecular profiling into cancer treatment decision making: Experience with over 35,000 cases.Meeting: 2013 ASCO Annual Meeting Abstract No: 11001Session: Tumor Biology (Oral Abstract Session)