Update to ASCO Clinical Practice Guideline on Potentially Curable Pancreatic Cancer
An ASCO clinical practice guideline update, reported by Khorana et al in the Journal of Clinical Oncology, includes the recommendation of gemcitabine-capecitabine doublet therapy as an adjuvant therapy option in potentially curable pancreatic cancer. The updated recommendation (4.1) modifies the corresponding recommendation in the ASCO guideline published in May 2016. The remaining recommendations from the original 2016 ASCO guideline are unchanged.
New Evidence
The ASCO guideline expert panel based the update on findings in the recently reported phase III ESPAC-4 study, in which 730 evaluable patients with resected pancreatic ductal adenocarcinoma were randomized to receive gemcitabine plus capecitabine or gemcitabine alone. Median overall survival was 28.0 months in the doublet group vs 25.5 months in the gemcitabine-alone group (hazard ratio = 0.82, P = .032). Grade 3 and 4 adverse events were similar in both groups, although the doublet group had higher rates of hand-foot syndrome and diarrhea.
The new evidence bears upon the guideline clinical question: What is the appropriate adjuvant regimen for patients with pancreatic cancer who have undergone an R0 or R1 resection of their primary tumor? In the guideline published in May 2016, Recommendation 4.1 stated that patients who had not received preoperative therapy “should be offered 6 months of adjuvant chemotherapy with either gemcitabine or fluorouracil plus folinic acid in the absence of medical or surgical contraindications.”
Updated Recommendation
The updated Recommendation 4.1 reads:
“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. The doublet regimen of gemcitabine and capecitabine is a new option; alternatively, monotherapy with gemcitabine alone or fluorouracil plus folinic acid can be offered if there are concerns about toxicity or tolerance. Adjuvant treatment should be initiated within 8 weeks of surgical resection, assuming complete recovery.” [Type (of recommendation): evidence-based, benefits outweigh harms; Evidence quality: high; Strength of recommendation: strong]
Pamela B. Mangu, MA, of ASCO, is the corresponding author of the Journal of Clinical Oncology article.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
