Surgical perspectives in gastrointestinal disease: a study of quality of life outcomes in esophageal, pancreatic, colon, and rectal cancers.

Outcomes assessment in surgery traditionally has included data regarding peri-operative mortality and morbidity, as well as long-term survival and recurrence in surgical oncology. However, quality of life (QOL) is another important patient-related outcome measure. QOL data can be used to tailor treatment and improve clinical outcomes by detecting physical or psychological problems in patients that otherwise might be overlooked, but which have profound implications for the effective delivery of care. We review several well-validated QOL instruments developed specifically for use in patients with gastrointestinal malignancies, including esophageal, pancreatic and colorectal cancers, and conclude that QOL assessment routinely should be included in clinical trials of novel treatments.

Phase II trial of weekly docetaxel/irinotecan combination in advanced pancreatic cancer.

BACKGROUND: Docetaxel and irinotecan have activity in pancreatic cancer. The combination of docetaxel and irinotecan is attractive because of preclinical evidence of synergy between the two drugs. We have previously demonstrated the safety of docetaxel 35 mg/m(2) and irinotecan 50 mg/m(2) given on days 1, 8, 15, and 21 of a 35-day schedule. PATIENTS AND METHODS: Patients who had unresectable or metastatic adenocarcinoma of the pancreas, bidimensionally measurable disease, Eastern Cooperative Oncology Group (ECOG) performance status 0-2, and normal bilirubin levels were eligible. Tumor assessment was performed with computed tomography, computed tomographic angiography, or magnetic resonance imaging every 2 cycles. Response was graded according to World Health Organization criteria. RESULTS: We enrolled 37 eligible patients. Principal grade 3/4 toxicities were diarrhea (21%), neutropenia (30%), and hyperglycemia (30%). There were 3 patients with febrile neutropenia and no toxic deaths. There were 4 early deaths. Among 36 evaluable patients, 9 (24%) attained a partial response and 1 (3%) attained a complete response for an objective response rate of 27%. One patient enrolled because she had been deemed to have unresectable disease but then underwent resection with negative margins after attaining a confirmed partial response. Median survival for all eligible patients is 9.4 months (range 0-68+ months) with minimum follow-up for surviving patients of 23.4 months. One-year survival is 43%. The patient who attained a complete response is alive with recurrent disease at 68 months. CONCLUSIONS: The docetaxel/irinotecan combination given on a weekly schedule is an active treatment for advanced pancreatic cancer.