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Stage I and II Pancreatic Cancer


The median OS for the 388 patients with pancreatic head tumors was 20.5 months in the gemcitabine arm versus 16.9 months in the 5-FU arm; 3-year survival was 31% versus 22%, respectively (P = .09; hazard ratio [HR], 0.82; 95% confidence interval [CI], 0.65–1.03). OS for all patients was not reported in the publication; however, median survival estimates extrapolated from the presented survival curve were approximately 19 months for the gemcitabine group and 17 months for the 5-FU group.[15][Level of evidence: 1iiA]

Results have also been reported from CONKO-001, a multicenter, phase III trial of 368 patients with resected pancreatic cancer who were randomly assigned to six cycles of adjuvant gemcitabine versus observation.[16] In contrast to the previous trials, the primary endpoint was disease-free survival (DFS). Median DFS was 13.4 months in the gemcitabine arm (95% CI, 11.4–15.3) and 6.9 months in the observation group (95% CI, 6.1–7.8; P < .001). However, there was no significant difference in OS between the gemcitabine arm (median 22.1 months, 95% CI, 18.4–25.8) and the control group (median 20.2 months, 95% CI, 17–23.4).[16][Level of evidence: 1iiDii] At the American Society of Clinical Oncology annual meeting in 2008, the investigators, with longer follow-up, reported a significant improvement in OS that favored gemcitabine (median survival 22.8 months vs. 20.2 months, P = .005; 5-year survival 21% vs. 9%).[17]

The ESPAC-3 (NCT00058201) trial randomly assigned 1,088 patients who had undergone complete macroscopic resection to either 6 months of 5-FU (425 mg/m2) and folinic acid (20 mg/m2) on days 1 to 5 every 28 days or 6 months of gemcitabine (1,000 mg/m2) on days 1, 8, and 15 every 28 days.[18] Median OS was 23.0 months (95% CI, 21.1– 25.0) for patients treated with 5-FU plus folinic acid and 23.6 months (95% CI, 21.4–26.4) for those treated with gemcitabine (HR, 0.94, 95% CI, 0.81–1.08, P = .39).[18][Level of evidence: 1iiA]

Additional trials are still warranted to determine more effective adjuvant therapy for this disease.

Standard treatment options:

  1. Radical pancreatic resection:
    • Whipple procedure (pancreaticoduodenal resection).
    • Total pancreatectomy when necessary for adequate margins.
    • Distal pancreatectomy for tumors of the body and tail of the pancreas.[19,20]
  2. Radical pancreatic resection with postoperative chemotherapy (gemcitabine or 5-FU/folinic acid).[18]
  3. Radical pancreatic resection with postoperative 5-FU chemotherapy and radiation therapy.[9,10,11,12,13]

Treatment options under clinical evaluation:

  1. Gemcitabine and capecitabine (ESPAC-4).
  2. Gemcitabine and erlotinib (CONKO-005).
  3. Gemcitabine and erlotinib with or without 5-FU/capecitabine-based chemoradiation (RTOG-0848).
  4. Preoperative chemotherapy and/or radiation therapy.

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