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MPACT

Phase 3 study of nab-paclitaxel plus gemcitabine versus gemcitabine in metastatic pancreatic adenocarcinoma (MPACT)

Phase 3N = 861NCT00844649

Population
Metastatic pancreatic adenocarcinoma, Karnofsky performance status 70 or more
Design
Randomised comparison of nab-paclitaxel 125 mg/m2 followed by gemcitabine 1000 mg/m2 (days 1, 8, 15 every 4 weeks) with gemcitabine alone in metastatic pancreatic cancer, Karnofsky performance status 70 or more; treatment until progression. Phase 3 per the abstract and ClinicalTrials.gov NCT00844649.
Primary endpoint
OS
Arms
  • Nab-paclitaxel plus gemcitabine (experimental, n = 431): Nab-paclitaxel 125 mg/m2 then gemcitabine 1000 mg/m2 on days 1, 8, 15 every 4 weeks
  • Gemcitabine (control, n = 430): Gemcitabine 1000 mg/m2 weekly for 7 of 8 weeks (cycle 1), then days 1, 8, 15 every 4 weeks
People
Von Hoff DD
OSHR 0.72 (95% CI 0.62–0.83)Δ median OS+1.8 monthsΔ 12-month OS+13 pointsPFSHR 0.69 (95% CI 0.58–0.82)Δ median PFS+1.8 monthsΔ ORR+16 points
Show the numbers
Results reported for MPACT
EndpointAnalysisNab-paclitaxel plus gemcitabineGemcitabineEffect
OSITT (all randomly assigned patients, 861)primaryVon 2013median 8.5 months; 35% at 12 mo; 9% at 2 ymedian 6.7 months; 22% at 12 mo; 4% at 2 yHR 0.72 (95% CI 0.62–0.83)P<0.001
PFSITT (all randomly assigned patients, 861)primaryVon 2013median 5.5 monthsmedian 3.7 monthsHR 0.69 (95% CI 0.58–0.82)P<0.001Secondary endpoint.
ORRITT (all randomly assigned patients, 861)Response rate according to independent review (secondary endpoint)primaryVon 201323%7%P<0.001
OSITT (all randomly assigned patients, 861)long term-updateGoldstein 2015median 8.7 monthsmedian 6.6 monthsHR 0.72 (95% CI 0.62–0.83)P<0.001Post hoc update with longer follow-up (efficacy data collected through 9 May 2013). Long-term survivors (more than three years) were identified in the nab-paclitaxel plus gemcitabine arm only (4%).
Results reported for MPACT
EndpointAnalysisNab-paclitaxel plus gemcitabineGemcitabineEffect
OSITT (all randomly assigned patients, 861)primaryVon 2013median 8.5 months; 35% at 12 mo; 9% at 2 ymedian 6.7 months; 22% at 12 mo; 4% at 2 yHR 0.72 (95% CI 0.62–0.83)P<0.001
PFSITT (all randomly assigned patients, 861)primaryVon 2013median 5.5 monthsmedian 3.7 monthsHR 0.69 (95% CI 0.58–0.82)P<0.001Secondary endpoint.
ORRITT (all randomly assigned patients, 861)Response rate according to independent review (secondary endpoint)primaryVon 201323%7%P<0.001
OSITT (all randomly assigned patients, 861)long term-updateGoldstein 2015median 8.7 monthsmedian 6.6 monthsHR 0.72 (95% CI 0.62–0.83)P<0.001Post hoc update with longer follow-up (efficacy data collected through 9 May 2013). Long-term survivors (more than three years) were identified in the nab-paclitaxel plus gemcitabine arm only (4%).
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSPFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.720.62–0.83
PFS0.690.58–0.82
OS0.720.62–0.83
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Nab-paclitaxel plus gemcitabine (experimental)
  • Gemcitabine (control)
Data table (modelled values)
MonthsNab-paclitaxel plus gemcitabineGemcitabine
0100.0%100.0%
665.1%57.3%
1331.5%18.4%
1917.9%8.5%
269.0%4.0%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%024681012Months (modelled)
  • Nab-paclitaxel plus gemcitabine (experimental)
  • Gemcitabine (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsNab-paclitaxel plus gemcitabineGemcitabine
0100.0%100.0%
368.5%57.0%
741.4%26.9%
1028.4%15.4%
1417.1%7.3%
Primary publication: Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013;369(18):1691-703. PubMedDOI

Appears in

Sources

  1. Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013;369(18):1691-703.

    PubMedDOI

  2. Goldstein D, El-Maraghi RH, Hammel P, Heinemann V, Kunzmann V, Sastre J, et al. nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: long-term survival from a phase III trial. J Natl Cancer Inst. 2015;107(2).

    PubMedDOI