ASCO Updates Pancreatic Cancer Guideline to Include Doublet Chemotherapy

April 24, 2017
Dave Levitan
Dave Levitan

ASCO updated a 2016 guideline regarding resected pancreatic cancer to include treatment with adjuvant chemotherapy with gemcitabine and capecitabine.

The American Society of Clinical Oncology (ASCO) updated a 2016 guideline regarding potentially curable pancreatic cancer based on recent study results. Patients who have undergone resection should be offered adjuvant chemotherapy, preferably with a doublet regimen containing gemcitabine and capecitabine.

ASCO published a clinical practice guideline on potentially curable pancreatic cancer in May 2016. The update, published in the Journal of Clinical Oncology, is based largely on results of the ESPAC-4 trial, published in January in the Lancet. The trial was a phase III, open-label, multicenter, randomized study including 730 patients, 366 of whom received gemcitabine monotherapy and 364 of whom received gemcitabine plus capecitabine.

The doublet regimen yielded a median overall survival of 28.0 months, compared with 25.5 months with monotherapy, for a hazard ratio of 0.82 (95% CI, 0.68–0.98; P = .032). The adverse event profiles of the two groups were similar, though there were higher rates of hand-foot syndrome and diarrhea in patients randomized to the combination therapy.

Based on those results, ASCO has updated its practice guideline: “All 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,” wrote guideline authors led by Alok A. Khorana, MD, of the Cleveland Clinic. “The doublet regimen of gemcitabine and capecitabine is preferred in the absence of concerns for toxicity or tolerance; alternatively, monotherapy with gemcitabine or fluorouracil plus folinic acid can be offered.”

The authors added that the adjuvant chemotherapy should be initiated within 8 weeks of the surgical resection, assuming recovery from surgery is complete. The evidence quality is considered “high,” and the recommendations are considered “strong.” The remainder of the 2016 ASCO guideline is unchanged by this update; the guideline includes recommendations on imaging for pancreatic cancer, preoperative therapy, primary surgical resection, ongoing supportive care, and other important segments of treatment for this malignancy.

The ASCO guideline confirms what the study authors wrote, that “in patients with resected pancreatic cancer, the results of ESPAC-4 indicate that adjuvant gemcitabine plus capecitabine is the new standard of care.”