Adding adjuvant nab-paclitaxel to gemcitabine improved long-term overall survival (OS) in patients with resected pancreatic cancer, according to results of the phase 3 APACT trial.1

The results were presented at the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer 2021 by Margaret Tempero, MD, of the University of California, San Francisco.

The APACT trial (ClinicalTrials.gov Identifier: NCT01964430) was designed to compare nab-paclitaxel and gemcitabine with gemcitabine alone in adults with resected pancreatic cancer. Eligible patients had received no prior radiation, neoadjuvant, or systemic therapy. They had an Eastern Cooperative Oncology Group score of 0 or 1 and no evidence of disease via CT at baseline.


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Previous results from the trial2 showed no significant between-arm difference in disease-free survival (DFS) by independent assessment (hazard ratio [HR], 0.88; 95% CI, 0.729-1.063; P =.1824). However, investigator assessment suggested there may be a DFS improvement with nab-paclitaxel (HR, 0.82; 95% CI, 0.694-0.965; P =.0168).

For the current analysis, Dr Tempero and colleagues assessed 5-year OS in the intent-to-treat population. At the data cutoff in April 2021, patients had been followed for at least 5 years or had discontinued the study. Data from 432 patients in the nab-paclitaxel arm and 434 patients in the gemcitabine-alone arm were included.

The median follow-up for OS was 63.2 months. The median OS was 41.8 months with nab-paclitaxel and 37.7 months with gemcitabine alone (HR, 0.80; 95% CI, 0.678-0.947; P =.0091). The 5-year OS rates in the nab-paclitaxel and gemcitabine arms were 38% and 31%, respectively.

“Although APACT did not meet its primary endpoint of independently assessed disease-free survival in the primary analysis, these overall survival data suggest improved outcomes with nab-paclitaxel plus gemcitabine,” Dr Tempero concluded.

Disclosures: This research was supported by Bristol Myers Squibb. Dr Tempero declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

References

  1. Tempero MA, O’Reilly EM, Van Cutsem E, et al. Phase 3 APACT trial of adjuvant nab-paclitaxel plus gemcitabine vs gemcitabine alone in patients with resected pancreatic cancer: updated 5-year overall survival. Presented at: ESMO World Congress on Gastrointestinal Cancer; June 30-July 3, 2021. Abstract LBA-1.
  2. Tempero MA, Reni M, Riess H, et al. APACT: phase III, multicenter, international, open-label, randomized trial of adjuvant nab-paclitaxel plus gemcitabine (nab-P/G) vs gemcitabine (G) for surgically resected pancreatic adenocarcinoma. J Clin Oncol. 2019;37; (suppl 15; abstr 4000). doi:10.1200/JCO.2019.37.15_suppl.4000

This article originally appeared on Cancer Therapy Advisor