Clinical trialPhase 3Pancreatic cancer

Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine

N Engl J Med · 2013861 patients (431 nab-paclitaxel + gemcitabine, 430 gemcitabine)

Von Hoff DD, Ervin T, Arena FP, et al. N Engl J Med. 2013. 369:1691-1703

Study type: Clinical trial
Study name: MPACT
Phase: Phase 3
Design: Randomised, open-label, international multicentre trial (1:1 randomisation)
Sample size: 861 patients (431 nab-paclitaxel + gemcitabine, 430 gemcitabine)
Source: N Engl J Med · 2013
Trial registration: NCT00844649

In plain words

This study showed that adding the drug nab-paclitaxel to gemcitabine in pancreatic cancer that has spread lengthens patients' lives by about two months on average, and raises the number of patients alive after one year from about 22% to 35%. Its main side effects are tingling and numbness in the hands and feet (neuropathy) and a drop in white blood cells, which usually get better when the drug is paused. This regimen is usually chosen for patients who cannot tolerate four-drug regimens or for whom those are not preferred.

Key results

8.5 vs 6.7 months

Median overall survival

HR for death 0.72 (95% CI 0.62–0.83); P<0.001

35% vs 22%

1-year survival

2-year survival: 9% vs 4%

5.5 vs 3.7 months

Median progression-free survival

HR 0.69 (95% CI 0.58–0.82); P<0.001

23% vs 7%

Response rate (independent review)

P<0.001

Drugs in this study:Gemcitabine (Gemzar)Paclitaxel (Taxol)

Dose and schedule cards

Gemcitabine + nab-paclitaxel (MPACT)

First-line metastatic disease (in MPACT, Karnofsky ≥70); or second-line after FOLFIRINOXCycle length: Every 28 daysOn the page “Pancreatic cancer” · Metastatic disease: first-line, maintenance and later lines

First-line metastatic disease (in MPACT, Karnofsky ≥70); or second-line after FOLFIRINOX

Drug	Dose	Route	Schedule
Nab-paclitaxel	125 mg/m²	IV over 30 to 40 minutes	Days 1, 8 and 15
Gemcitabine (immediately after nab-paclitaxel)	1000 mg/m²	IV over 30 minutes	Days 1, 8 and 15

Cycle length: Every 28 days
Duration: Until disease progression or unacceptable toxicity

Doses from the nab-paclitaxel FDA label and MPACT.

Do not administer if the neutrophil count is below 1500/µL, and frequent blood counts are required; not recommended in pancreatic cancer with moderate to severe hepatic impairment; peripheral neuropathy may require dose reduction.

On the page “Pancreatic cancer” · Metastatic disease: first-line, maintenance and later lines

Gem/nab-P

Metastatic pancreatic cancer, first lineCycle length: Every 28 daysOn the page “Gemcitabine with nab-paclitaxel: dose and schedule”

Metastatic pancreatic cancer, first line

Drug	Dose	Route	Schedule
Nab-paclitaxel	125 mg/m²	IV over 30 to 40 minutes	Days 1, 8 and 15
Gemcitabine	1000 mg/m²	IV over 30 minutes, after nab-paclitaxel	Days 1, 8 and 15

Cycle length: Every 28 days
Duration: Until progression or toxicity

Doses as in the MPACT study. In older patients, many centres use a day 1 and 15 every 28 days schedule.

On the page “Gemcitabine with nab-paclitaxel: dose and schedule”

Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.

Treatment arms and regimens

1Nab-paclitaxel + gemcitabine

Nab-paclitaxel 125 mg/m² followed by gemcitabine 1000 mg/m², on days 1, 8 and 15 every 4 weeks, until disease progression.

2Gemcitabine alone (control group)

Gemcitabine 1000 mg/m² weekly for 7 of 8 weeks (cycle 1), then on days 1, 8 and 15 every 4 weeks (cycle 2 onwards), until disease progression.

Source of the regimen details: Abstract of the NEJM 2013 paper (dose and schedule for both arms)

Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.

Study population

Metastatic pancreatic adenocarcinoma with no prior treatment for metastatic disease.
Karnofsky performance status (KPS) 70 or higher.

Endpoints

Primary outcome: overall survival.

Secondary outcomes: progression-free survival and overall response rate (by independent review).

Safety and side effects

The most common grade 3 or higher adverse events with nab-paclitaxel–gemcitabine versus gemcitabine: neutropenia 38% versus 27%, fatigue 17% versus 7% and neuropathy 17% versus 1%. Febrile neutropenia 3% versus 1%. Grade 3 or higher neuropathy in the combination group improved to grade 1 or lower in a median of 29 days.

Clinical significance and place in guidelines

Based on MPACT, nab-paclitaxel with gemcitabine was approved by the FDA in 2013 for first-line treatment of metastatic pancreatic adenocarcinoma and is also licensed in Europe. NCCN (version 4.2026) considers this combination a category 1 preferred option for metastatic disease. In the ESMO Express Update 2025, the combination is recommended for patients with ECOG 0 to 1 at level [I, B] (ESMO-MCBS score 3).

Limitations

The study was open-label and quality of life was not assessed as a planned endpoint. The absolute survival benefit was modest (about 1.8 months in median), and the comparator was gemcitabine alone, not FOLFIRINOX.

Original article (DOI)PubMed ClinicalTrials.gov

This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.