ASCO advises adjuvant gemcitabine/capecitabine in potentially curable resected pancreatic cancer

Last Updated: 2017-04-20

By Reuters Staff

NEW YORK (Reuters Health) - Patients with pancreatic cancer who have undergone R0 or R1 resection and did not receive preoperative therapy should be offered six months of adjuvant chemotherapy in the absence of contraindications, says an updated guideline from the American Society of Clinical Oncology (ASCO).

For these patients, the doublet regimen of gemcitabine and capecitabine is “preferred in the absence of concerns for toxicity or tolerance,” the authors say. Monotherapy with gemcitabine or fluorouracil plus folinic acid can be offered as an alternative.

Adjuvant therapy should be started within eight weeks of surgery, assuming complete recovery.

Dr. Alok Khorana and an ASCO expert panel first published guidelines on treatment for potentially curable pancreatic cancer in the Journal of Clinical Oncology in May 2016.

Their update, online April 11 in the same journal, focuses exclusively on new evidence that pertains to clinical question 4 of the guideline: What is the appropriate adjuvant regimen for patients with pancreatic cancer who have undergone an R0 or R1 resection of their primary tumor? (The remaining recommendations from the original guideline are unchanged)

Results of the ESPAC-4 study, published in the Lancet in January 2017, triggered the update on question 4, given the “high quality of the reported evidence and the potential for its clinical impact,” Dr. Khorana and colleagues note in their update.

ESPAC-4 was an international, open-label randomized controlled phase III trial comparing adjuvant chemotherapy with gemcitabine plus capecitabine to gemcitabine alone in more than 700 patients with resected pancreatic ductal adenocarcinoma.

In the trial, median overall survival was improved in the combination arm to 28.0 months versus 25.5 months for gemcitabine alone (hazard ratio, 0.82; p=0.032).

Grade 3 and 4 adverse events were similar in both arms, although higher rates of hand-foot syndrome and diarrhea occurred in patients randomly assigned to gemcitabine plus capecitabine.

Based on these data, “the combination of gemcitabine and capecitabine is a new option for adjuvant therapy in this setting,” the new guideline says.

SOURCE: http://bit.ly/2ot8mQY

J Clin Oncol 2017.