Pancreatic Cancer Treatment (PDQ®): Treatment - Health Professional Information [NCI] - Stage I and Stage II Pancreatic Cancer Treatment
The EORTC/U.S. Gastrointestinal Intergroup RTOG-0848 phase III adjuvant trial evaluating the impact of chemoradiation after completion of a full course of gemcitabine with or without erlotinib is currently enrolling patients.
Evidence (postoperative chemotherapy):
- Charité Onkologie (CONKO)-001: 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 receive six cycles of adjuvant gemcitabine versus observation.[Level of evidence: 1iiDii] 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 arm (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 arm (median 20.2 months, 95% CI, 17–23.4).
- 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%).
- ESPAC-3: 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 leucovorin (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.[Level of evidence: 1iiA]
- Median OS was 23.0 months (95% CI, 21.1– 25.0) for patients treated with 5-FU plus leucovorin 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).
Additional trials are still warranted to determine more effective adjuvant therapy for this disease.
Treatment Options Under Clinical Evaluation for Stages I and II Pancreatic Cancer
Treatment options under clinical evaluation include the following:
- Gemcitabine and capecitabine (ESPAC-4).
- Gemcitabine and erlotinib (CONKO-005).
- Gemcitabine and erlotinib with or without 5-FU/capecitabine-based chemoradiation (RTOG-0848).
- Preoperative chemotherapy and/or radiation therapy.