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Efficacy and Quality-of-Life Data Are Related in a Phase II Trial of Oral Chemotherapy in Previously Untreated Patients With Metastatic Colorectal Carcinoma

From the Mayo Clinic and Mayo Foundation, Rochester, and Duluth Community Clinical Oncology Program (CCOP), Duluth, MN; Illinois Oncology Research Association CCOP, Peoria, IL; Scottsdale CCOP, Scottsdale, AZ; Missouri Valley Cancer Consortium, Omaha, NE; Saskatoon Cancer Centre, Saskatoon, and Allan Blair Cancer Centre, Regina, Saskatchewan, Canada; Sioux Community Cancer Consortium, Sioux Falls, SD; and Toledo Community Hospital Oncology Program CCOP, Toledo, OH.

Address reprint requests to Timothy J. Hobday, MD, Division of Oncology, Mayo Clinic, 200 First St SW, Rochester, MN 55905; email: hobday.timothy{at}mayo.edu

PURPOSE: To evaluate quality of life (QOL) and tumor response after administration of an oral chemotherapy regimen in patients with previously untreated metastatic colorectal cancer.

PATIENTS AND METHODS: Seventy-eight patients received a mean number of 5.8 cycles of therapy. QOL data were analyzed at baseline, after every two cycles of therapy, and at the time of treatment discontinuation. The Uniscale and the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 were both utilized.

RESULTS: The confirmed response rate was 26% (95% confidence interval [CI], 17% to 37%). Median survival was 11.3 months (95% CI, 9.6 to 15.1 months). Global QOL scores were unchanged over the course of therapy by either tool. Only the physical function subscale score had worsened at the end of therapy. In an analysis of responding patients, significant and durable improvements in both global QOL measures as well as select subscale scores were observed. Diarrhea and physical function QOL scores had declined at the time of treatment discontinuation. Patients who did not respond to therapy had preserved QOL scores when they were evaluated after two cycles of therapy.

CONCLUSION: This oral treatment strategy preserved QOL in treated patients. Global QOL measures as well as several QOL subscale scores significantly improved in patients with a documented response to therapy. The profile of improved QOL components indicated that patient well-being was related to tumor response in specific and perceivable ways. Nonresponding patients reported preserved QOL during the first two cycles of therapy. QOL analysis was feasible and informative in this moderately sized multicenter phase II trial.

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