The addition of capecitabine to adjuvant gemcitabine following resection significantly improved overall survival compared with adjuvant gemcitabine alone among patients with pancreatic ductal carcinoma, according to a study published in The Lancet.1
The ESPAC-3 study demonstrated that adjuvant gemcitabine is associated with similar survival to, and less toxicity than, adjuvant fluorouracil plus leucovorin among patients with resected pancreatic cancer, making gemcitabine the standard of care in this setting.
Because previous reports showed improved survival and tumor response with gemcitabine and capecitabine vs gemcitabine alone in advanced or metastatic pancreatic cancer, investigators evaluated the efficacy and safety of adjuvant gemcitabine in combination with capecitabine compared with gemcitabine monotherapy after resection.
For the international, open-label, phase 3 ESPAC-4 trial (EudraCT Identifier: 2007-004299-38), investigators enrolled 732 adult patients who underwent complete macroscopic resection for pancreatic ductal adenocarcinoma. Participants were randomly assigned 1:1 within 12 weeks of resection to receive gemcitabine once weekly for 3 weeks of each 4-week cycle plus capecitabine for 21 days followed by a 7-day rest during each cycle for 6 cycles, or to receive gemcitabine alone.
Patients treated with combination gemcitabine and capecitabine had an 18% reduced risk of death compared with those treated with gemcitabine alone (hazard ratio, 0.82; 95% CI, 0.68-0.98; P = .032).
Median overall survival was 28.0 months (95% CI, 23.5-31.5) and 25.5 months (95% CI, 22.7-27.9) with combination therapy and gemcitabine monotherapy, respectively.
About 63% of patients treated with gemcitabine and capecitabine had grade 3 to 4 adverse events vs about 54% in the gemcitabine arm.
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The authors concluded that this adjuvant combination regimen should be considered the new standard of care following resection among patients with pancreatic ductal adenocarcinoma.
- Neoptolemos JP, Palmer DH, Ghaneh P, et al. Comparison of adjuvant gemcitabine and capecitabine with gemcitabine monotherapy in patients with resected pancreatic cancer (ESPAC-4): a multicentre, open-label, randomised, phase 3 trial. Lancet. 2017 Jan 24. doi: 10.1016/S0140-6736(16)32409-6 [Epub ahead of print]