Stage I and II Pancreatic Cancer
The United States Gastrointestinal Intergroup has reported the results of a randomized phase III trial (RTOG-9704) that included 451 patients with resected pancreatic cancers who were assigned to receive either postoperative infusional 5-FU plus infusional 5-FU and concurrent radiation or adjuvant gemcitabine plus infusional 5-FU and concurrent radiation. The primary endpoints were OS for all patients and OS for patients with pancreatic head cancers. 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 = 0.82; 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.[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. 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).[Level of evidence: 1iiDii]
Although the available data do not resolve the controversy of the optimal adjuvant therapy strategy for patients with resected pancreatic cancer, the results of CONKO-001 and RTOG-9704 suggest that a gemcitabine-containing platform represents an appropriate choice for current management and may be considered as a building block for future clinical trials.
Additional trials are still warranted to determine more effective adjuvant therapy for this disease.
Standard treatment options:
- 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.[17,18]
- Radical pancreatic resection with or without postoperative 5-FU chemotherapy and radiation therapy.[9,10,11,12,13]
Treatment options under clinical evaluation:
- For patients with resected tumors, postoperative radiation therapy with other chemotherapeutic agents.
- For patients with resected tumors, postoperative chemotherapy alone. The RLUH-NCRI-ESPAC-3V2 trial evaluated postoperative chemotherapy with either 5-FU/leucovorin or gemcitabine versus no additional treatment. Results are pending.
Current Clinical Trials
Check for U.S. clinical trials from NCI's list of cancer clinical trials that are now accepting patients with stage I pancreatic cancer and stage II pancreatic cancer. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.