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Potentially Curable Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update
Alok A Khorana1, Pamela B Mangu1, Jordan Berlin1
1Alok A. Khorana and Marc Shapiro, Cleveland Clinic, Cleveland, OH; Pamela B. Mangu, American Society of Clinical Oncology, Alexandria, VA; Jordan Berlin, Vanderbilt University, Nashville, TN; Anitra Engebretson, Pancreatic Cancer Action Network, Manhattan Beach, CA; Theodore S. Hong, Massachusetts General Hospital, Boston, MA; Anirban Maitra and Matthew H.G. Katz, The University of Texas MD Anderson Cancer Center, Houston, TX; Supriya G. Mohile, University of Rochester, Rochester, NY; Matthew Mumber, Harbin Clinic, Rome, GA; Richard Schulick, University of Colorado at Denver, Denver, CO; Susan Urba, University of Michigan, Ann Arbor, MI; and Herbert J. Zeh, University of Pittsburgh, Pittsburgh, PA.
Abstract:
Purpose To update the Potentially Curable Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline published on May 31, 2016. The October 2016 update focuses solely 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? Methods The recently published results of a randomized phase III study prompted an update of this guideline. The high quality of the reported evidence and the potential for its clinical impact prompted the Expert Panel to revise one of the guideline recommendations. Results The ESPAC-4 study, a multicenter, international, open-label randomized controlled phase III trial of adjuvant combination chemotherapy compared gemcitabine and capecitabine with gemcitabine monotherapy in 730 evaluable patients with resected pancreatic ductal adenocarcinoma. Median overall survival was improved in the doublet arm to 28.0 months (95% CI, 23.5 to 31.5 months) versus 25.5 months (95% CI, 22.7 to 27.9 months) for gemcitabine alone (hazard ratio, 0.82; 95% CI, 0.68 to 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. Recommendations 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 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. The remaining recommendations from the original 2016 ASCO guideline are unchanged.
Insights
Adjuvant chemotherapy with gemcitabine and capecitabine improves survival for resected pancreatic cancer patients. This combination is preferred over gemcitabine monotherapy, with similar safety profiles.
Area of Science:
- Oncology
- Clinical Practice Guidelines
- Surgical Oncology
Background:
- The American Society of Clinical Oncology (ASCO) published guidelines for potentially curable pancreatic cancer in 2016.
- An update was prompted by new evidence regarding adjuvant chemotherapy regimens for resected pancreatic cancer.
Purpose of the Study:
- To update the 2016 ASCO Clinical Practice Guideline for potentially curable pancreatic cancer.
- Specifically address the optimal adjuvant chemotherapy regimen following R0 or R1 resection for pancreatic ductal adenocarcinoma.
Main Methods:
- The update was based on results from the ESPAC-4 study, a randomized phase III trial.
- This trial compared adjuvant combination chemotherapy (gemcitabine and capecitabine) with gemcitabine monotherapy in 730 patients.
Main Results:
- Median overall survival was significantly improved with the combination regimen (28.0 months) compared to gemcitabine monotherapy (25.5 months).
- Adverse events were comparable between arms, though the doublet regimen had higher rates of hand-foot syndrome and diarrhea.
Conclusions:
- Six months of adjuvant chemotherapy is recommended for all resected pancreatic cancer patients without contraindications.
- The combination of gemcitabine and capecitabine is the preferred adjuvant regimen, with gemcitabine or fluorouracil/folinic acid as alternatives.
- Adjuvant treatment should commence within 8 weeks post-surgery, contingent on full recovery.