{"entity":{"id":"mpact","kind":"trial","name":"MPACT","aka":["CA046","Metastatic Pancreatic Adenocarcinoma Clinical Trial"],"tldr":"MPACT established the second modern first-line regimen for advanced pancreatic cancer: adding albumin-bound paclitaxel to gemcitabine lengthened median survival from 6.7 to 8.5 months and doubled two-year survival, with more neuropathy and neutropenia; it is the option for people not fit enough for FOLFIRINOX and the control arm of most trials since.","summary":"MPACT randomised 861 patients (431 to nab-paclitaxel plus gemcitabine, 430 to gemcitabine) between 2009 and 2012. Median overall survival was 8.5 against 6.7 months (hazard ratio 0.72, 95 percent confidence interval 0.62 to 0.83; p below 0.001), one-year survival 35 against 22 percent and two-year survival 9 against 4 percent; median progression-free survival 5.5 against 3.7 months (hazard ratio 0.69) and independently reviewed response 23 against 7 percent. Grade 3 or worse neutropenia was 38 against 27 percent, fatigue 17 against 7 percent and peripheral neuropathy 17 against 1 percent, the neuropathy improving to grade 1 or less in a median 29 days after interruption; febrile neutropenia 3 against 1 percent. The long-term update (JNCI 2015) gave 8.7 against 6.6 months with 4 percent of the combination arm alive beyond three years and none on gemcitabine, and found high CA 19-9 and neutrophil-to-lymphocyte ratio prognostic. The FDA approved the combination in September 2013 and the EMA the same year (Abraxane product information); in England NICE TA476 (2017) restricts it to people for whom other combination chemotherapies are unsuitable and who would otherwise have gemcitabine alone. No UK sites took part.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00844649","url":"https://clinicaltrials.gov/study/NCT00844649"},{"label":"Von Hoff et al., increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine (NEJM 2013)","url":"https://doi.org/10.1056/NEJMoa1304369"},{"label":"Goldstein et al., MPACT long-term survival (JNCI 2015)","url":"https://doi.org/10.1093/jnci/dju413"},{"label":"Abraxane label (openFDA): adenocarcinoma of the pancreas study section","url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ABRAXANE%22"}],"tags":[],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine-nab-paclitaxel","nab-paclitaxel","gemcitabine"],"companies":["bms"],"institutions":[],"pathways":[],"terms":["peripheral-neuropathy","neutropenia","ca19-9"],"trials":[],"people":["daniel-von-hoff"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00844649","phase":"3","setting":"Untreated metastatic pancreatic adenocarcinoma with Karnofsky performance status 70 or more at 151 sites in 11 countries: nab-paclitaxel 125 mg/m2 followed by gemcitabine on days 1, 8 and 15 of 28 against gemcitabine alone, with overall survival as the primary endpoint","sponsor":"Celgene (Bristol Myers Squibb)","result":"Median overall survival 8.5 months with nab-paclitaxel plus gemcitabine against 6.7 months with gemcitabine (hazard ratio 0.72, 95 percent confidence interval 0.62 to 0.83; p below 0.001); progression-free survival 5.5 against 3.7 months; response 23 against 7 percent.","yearReported":2013,"enrolled":861,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Nab-paclitaxel + gemcitabine","n":431,"value":8.5,"note":"95% CI 7.9 to 9.5"},{"name":"Gemcitabine","n":430,"value":6.7,"note":"95% CI 6.0 to 7.2"}],"hr":0.72,"ci":[0.62,0.83],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1304369"},{"endpoint":"Progression-free survival (independent review)","unit":"months","arms":[{"name":"Nab-paclitaxel + gemcitabine","value":5.5},{"name":"Gemcitabine","value":3.7}],"hr":0.69,"ci":[0.58,0.82],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1304369"},{"endpoint":"Grade 3 or worse peripheral neuropathy","unit":"%","arms":[{"name":"Nab-paclitaxel + gemcitabine","value":17},{"name":"Gemcitabine","value":1}],"source":"https://doi.org/10.1056/NEJMoa1304369"}]},"route":"/trials/mpact/","neighbours":{"cancer":[{"id":"metastatic-pdac","kind":"cancer","name":"Metastatic pancreatic ductal adenocarcinoma","route":"/cancers/metastatic-pdac/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"drug":[{"id":"gemcitabine","kind":"drug","name":"Gemcitabine","route":"/drugs/gemcitabine/"},{"id":"gemcitabine-nab-paclitaxel","kind":"drug","name":"Gemcitabine + nab-paclitaxel","route":"/drugs/gemcitabine-nab-paclitaxel/"},{"id":"nab-paclitaxel","kind":"drug","name":"Nab-paclitaxel","route":"/drugs/nab-paclitaxel/"}],"company":[{"id":"bms","kind":"company","name":"Bristol Myers Squibb","route":"/companies/bms/"}],"term":[{"id":"ca19-9","kind":"term","name":"CA 19-9","route":"/terms/ca19-9/"},{"id":"neutropenia","kind":"term","name":"Neutropenia","route":"/terms/neutropenia/"},{"id":"peripheral-neuropathy","kind":"term","name":"Peripheral neuropathy (chemotherapy-induced)","route":"/terms/peripheral-neuropathy/"}],"person":[{"id":"daniel-von-hoff","kind":"person","name":"Daniel D. Von Hoff","route":"/people/daniel-von-hoff/"}],"trial":[{"id":"napoli-3","kind":"trial","name":"NAPOLI 3","route":"/trials/napoli-3/"},{"id":"panova-3","kind":"trial","name":"PANOVA-3","route":"/trials/panova-3/"},{"id":"nct07491445","kind":"trial","name":"Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma","route":"/trials/nct07491445/"}]}}