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Quality of Life in Operable Colon Cancer Patients Receiving Oral Compared With Intravenous Chemotherapy: Results From National Surgical Adjuvant Breast and Bowel Project Trial C-06

Jacek A. Kopec, Greg Yothers, Patricia A. Ganz, Stephanie R. Land, Reena S. Cecchini, H. Samuel Wieand, Barry C. Lembersky, Norman Wolmark

From the National Surgical Adjuvant Breast and Bowel Project Operations and Biostatistical Centers, Pittsburgh, PA; University of British Columbia, Vancouver, BC, Canada; Schools of Medicine and Public Health and the Jonsson Comprehensive Cancer Center, University of California Los Angeles, Los Angeles, CA; University of Pittsburgh Medical Center Cancer Center at Magee-Women's Hospital, Pittsburgh, PA; and Allegheny General Hospital, Pittsburgh, PA
Deceased.

Address reprint requests to Jacek Kopec, ARC, 895 West 10th Ave, Vancouver, BC, Canada V5Z 1L7; e-mail: jkopec{at}arthritisresearch.ca

Purpose: We compared health-related quality of life (HRQL), symptoms, and convenience of care (COC) in patients with stage II/III carcinoma of the colon who received either oral uracil/ftorafur (UFT) plus leucovorin (LV) or standard intravenous (IV) fluorouracil (FU) plus LV as adjuvant chemotherapy.

Patients and Methods: We measured HRQL with the Functional Assessment of Cancer Therapy–Colorectal (FACT-C) questionnaire, Short Form-36 Vitality Scale (SF-36), and a Quality of Life Rating Scale (QLRS) at baseline, once during chemotherapy, and at 1 year. We used the Symptom Distress Scale (SDS) and treatment-specific Symptom Checklist (SCL) to assess symptoms and a modified Burden of Care form to assess COC at baseline, on day 1 of each treatment cycle, and at 1 year. Repeated measures analyses controlling for demographic variables and baseline scores were used for statistical comparisons.

Results: The study accrued 1,608 patients, 803 to the FU arm and 805 to the UFT arm. There were no differences between the arms in overall FACT-C scores, FACT-C scores within the subscales of colon-specific, physical, emotional, social, and functional health, or QLRS scores. Patients taking UFT reported substantially higher COC. Statistically significant but small differences were observed for SF-36, favoring FU, and for SDS and SCL, both favoring UFT.

Conclusion: Patients perceive adjuvant treatment with UFT + LV as more convenient than standard IV treatment with FU + LV. Both regimens are well tolerated and do not differ in their impact on HRQL.

Supported by Public Health Service Grants No. U10CA-12027, P-U10CA-37377, U10CA-69651, U10CA-69974 from the National Cancer Institute, Department of Health and Human Services; Bristol-Myers Squibb Pharmaceutical Research Institute, Wallingford, CT; and Taiho Pharmaceutical Co, Lts, Tokyo, Japan.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.