Guideline endorses doublet therapy after pancreatic cancer surgery in chemo-naive patients

FROM THE JOURNAL OF CLINICAL ONCOLOGY

A recommendation on postop adjuvant chemotherapy has been updated in the Potentially Curable Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline, according to an article published online on April 11 in the Journal of Clinical Oncology.

In the absence of medical or surgical contraindications, all patients who have resected pancreatic cancer and did not receive preoperative therapy should be offered 6 months of adjuvant chemotherapy, according to the new recommendation. “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. Adjuvant treatment should be initiated within 8 weeks of surgical resection, assuming complete recovery,” Alok A. Khorana, MD , of the Cleveland Clinic, and members of the guideline committee wrote .

The recommendation was based on results of the ESPAC-4 study , a multicenter, international, open-label randomized controlled phase III trial (Lancet. 2017;389:1011-24). ESPAC-4 compared adjuvant combination chemotherapy of gemcitabine and capecitabine with gemcitabine monotherapy in 730 evaluable patients with resected pancreatic ductal adenocarcinoma.

Median overall survival was 28 months (95% confidence interval, 23.5-31.5 months) in the doublet arm and 25.5 months (95% CI, 22.7 to 27.9 months) for gemcitabine alone (hazard ratio, 0.82; 95% CI, 0.68-0.98; P = .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 the doublet arm.

The remaining recommendations from the original 2016 ASCO guideline are unchanged.

The revised guideline is available at this link .

mdales@frontlinemedcom.com

On Twitter @maryjodales

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