Patients with resected pancreatic cancer who did not receive preoperative therapy should be offered 6 months of adjuvant chemotherapy in the absence of medical or surgical contraindications, according to an updated ASCO clinical practice guideline published in Journal of Clinical Oncology.
A combination of gemcitabine and capecitabine is the preferred adjuvant treatment in the absence of concerns for toxicity or tolerance. Alternatively, patients can receive monotherapy with gemcitabine or fluorouracil plus folinic acid.
Alok A. Khorana
ASCO revised its May 2016 guideline to focus specifically on the appropriate adjuvant regimen for patients with pancreatic cancer who have undergone an R0 or R1 resection of their primary tumor.
“The recent report of a new randomized trial demonstrating survival improvement in patients with pancreas cancer after resection with a doublet regimen over standard-of-care single-agent gemcitabine necessitated the recent update to ASCO’s guideline, as part of ASCO’s commitment to rapidly updating our guidelines in response to emerging data,” Alok A. Khorana, MD, FACP, professor of medicine at Cleveland Clinic Lerner College of Medicine, vice chair for clinical services of Taussig Cancer Institute and co-chair of ASCO’s expert panel on guidelines for pancreatic cancer, told HemOnc Today. “We hope that this update to the guideline will highlight the results of this new trial and enable greater utilization of adjuvant therapy in the setting of potentially curable pancreas cancer after resection.”
The randomized phase 3 ESPAC-4 study evaluated the efficacy and safety of the addition of capecitabin to gemcitabine in 730 patients with resected pancreatic ductal adenocarcinoma. Of the study population, 40% had poorly differentiated histology, 60% had R1 resection and 80% had involved nodes.
Median OS improved from 25.5 months (95% CI, 22.7-27.9) with gemcitabine alone to 28 months (95% CI, 23.5-31.5) with gemcitabine combined with capecitabine (HR = 0.82; 95% CI, 0.68-0.98).
Both arms had similar grade 3 and grade 4 adverse events, although higher rates of hand–foot syndrome and diarrhea occurred in patients randomly assigned to gemcitabine with capecitabine.
“Adjuvant treatment should be initiated within 8 weeks of surgical resection, assuming complete recovery,” Khorana and colleagues wrote. “The remaining recommendations from the original 2016 ASCO guidelines are unchanged.” – by Chuck Gormley
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Alok A. Khorana, MD, can be reached at email@example.com.
Disclosure: Khorana reports research finding from Amgen, consultant/advisory roles with Halozyme, Janssen, Leo Pharma, Pfizer and Sanofi; and honoraria from Bayer AG, Halozyme, Janssen, Leo Pharma, Pfizer and Sanofi. Please see the full study for a list of all other authors’ relevant financial disclosures.