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APACT

Adjuvant nab-paclitaxel plus gemcitabine in resected pancreatic ductal adenocarcinoma (APACT)

Phase 3N = 866NCT01964430

Population
Treatment-naive patients with resected pancreatic ductal adenocarcinoma, ECOG performance status 0 or 1, CA 19-9 below 100 U/mL; 866 randomised 1:1 (432 nab-paclitaxel plus gemcitabine, 434 gemcitabine).
Design
Randomised, open-label phase 3 trial. Treatment-naive patients with resected pancreatic ductal adenocarcinoma received nab-paclitaxel 125 mg/m2 plus gemcitabine 1,000 mg/m2, or gemcitabine alone, on days 1, 8 and 15 of six 28-day cycles. Primary endpoint independently assessed disease-free survival; additional endpoints investigator-assessed DFS, overall survival and safety. Overall survival and safety were secondary end points; investigator-assessed DFS was a prespecified sensitivity analysis. All efficacy analyses were in the intention-to-treat population (full text). 160 sites in 21 countries; EudraCT 2013-003398-91.
Primary endpoint
DFS
Arms
  • Gemcitabine (control, n = 434): Gemcitabine 1,000 mg/m2, days 1, 8, 15 of six 28-day cycles
  • nab-Paclitaxel plus gemcitabine (experimental, n = 432): nab-Paclitaxel 125 mg/m2 plus gemcitabine 1,000 mg/m2, days 1, 8, 15 of six 28-day cycles
People
Tempero MA
DFSHR 0.880 (95% CI 0.729–1.063)Δ median DFS+0.6 monthsDFSHR 0.820 (95% CI 0.694–0.965)Δ median DFS+2.9 monthsOSHR 0.820 (95% CI 0.680–0.996)Δ median OS+4.3 months
Show the numbers
Results reported for APACT
EndpointAnalysisnab-Paclitaxel plus gemcitabineGemcitabineEffect
DFSprimarymedian follow-up 38.5 monthsTempero 2023median 19.4 monthsmedian 18.8 monthsHR 0.880 (95% CI 0.729–1.063)P=.18Independently assessed DFS, the primary endpoint; the authors state it was not met.
DFSexploratorymedian follow-up 38.5 monthsTempero 2023median 16.6 monthsmedian 13.7 monthsHR 0.820 (95% CI 0.694–0.965)P=.02Investigator-assessed DFS, a prespecified sensitivity analysis; the full text considers comparisons descriptive because the primary endpoint was not met. The abstract gives interquartile ranges rather than confidence intervals for the medians.
OSinterimmedian follow-up 38.5 monthsTempero 2023median 40.5 monthsmedian 36.2 monthsHR 0.820 (95% CI 0.680–0.996)P=.045427 of 630 target events (68% mature), so labelled interim; the abstract gives interquartile ranges for the medians (nab-paclitaxel plus gemcitabine 20.7 to not reached; gemcitabine 17.7-53.3 months). OS was a secondary end point.
OSlong term-updatemedian follow-up 63.2 monthsTempero 2023median 41.8 monthsmedian 37.7 monthsHR 0.800 (95% CI 0.678–0.947)P=.0091555 events (88% mature); a cutoff of 3 April 2020 (511 events) gave the same medians, HR 0.82 (95% CI 0.687 to 0.973; P = .0232).
Results reported for APACT
EndpointAnalysisnab-Paclitaxel plus gemcitabineGemcitabineEffect
DFSprimarymedian follow-up 38.5 monthsTempero 2023median 19.4 monthsmedian 18.8 monthsHR 0.880 (95% CI 0.729–1.063)P=.18Independently assessed DFS, the primary endpoint; the authors state it was not met.
DFSexploratorymedian follow-up 38.5 monthsTempero 2023median 16.6 monthsmedian 13.7 monthsHR 0.820 (95% CI 0.694–0.965)P=.02Investigator-assessed DFS, a prespecified sensitivity analysis; the full text considers comparisons descriptive because the primary endpoint was not met. The abstract gives interquartile ranges rather than confidence intervals for the medians.
OSinterimmedian follow-up 38.5 monthsTempero 2023median 40.5 monthsmedian 36.2 monthsHR 0.820 (95% CI 0.680–0.996)P=.045427 of 630 target events (68% mature), so labelled interim; the abstract gives interquartile ranges for the medians (nab-paclitaxel plus gemcitabine 20.7 to not reached; gemcitabine 17.7-53.3 months). OS was a secondary end point.
OSlong term-updatemedian follow-up 63.2 monthsTempero 2023median 41.8 monthsmedian 37.7 monthsHR 0.800 (95% CI 0.678–0.947)P=.0091555 events (88% mature); a cutoff of 3 April 2020 (511 events) gave the same medians, HR 0.82 (95% CI 0.687 to 0.973; P = .0232).
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
DFSDFSOSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
DFS0.880.729–1.063
DFS0.820.694–0.965
OS0.820.68–0.996
OS0.80.678–0.947
Illustrative — modelled from reported values, not trial data. DFS, primary.
0%25%50%75%100%010203040Months (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%
1265.1%64.2%
2442.4%41.3%
3627.6%26.5%
4917.4%16.4%
Illustrative — modelled from reported values, not trial data. DFS, exploratory.
0%25%50%75%100%010203040Months (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%
1065.9%60.3%
2141.6%34.6%
3127.4%20.8%
4217.3%11.9%
Primary publication: Tempero MA, Pelzer U, O'Reilly EM, Winter J, Oh DY, Li CP, et al. Adjuvant nab-Paclitaxel + Gemcitabine in Resected Pancreatic Ductal Adenocarcinoma: Results From a Randomized, Open-Label, Phase III Trial. J Clin Oncol. 2023;41(11):2007-2019. PubMedDOI

Appears in

Sources

  1. Tempero MA, Pelzer U, O'Reilly EM, Winter J, Oh DY, Li CP, et al. Adjuvant nab-Paclitaxel + Gemcitabine in Resected Pancreatic Ductal Adenocarcinoma: Results From a Randomized, Open-Label, Phase III Trial. J Clin Oncol. 2023;41(11):2007-2019.

    PubMedDOI