Background. UFT is a fixed‐ratio combination of uracil and Ftorafur, a prodrug that is absorbed orally and metabolized in vivo to 5‐fluorouracil (5‐FU). Uracil potentiates 5‐FU through interference with its catabolism. The combination of UFT and leucovorin in patients with advanced incurable colorectal cancer, to evaluate preliminary activity and toxicity in this patient population. Methods. Twenty‐one patients were treated. Twenty patients were evaluable for toxicity and response. Patients received UFT 350 mg/m2/day divided every 8 hours. Patients took a 5 mg tablet of leucovorin every 8 hours, concurrent with each UFT dose. Treatment was continued for 28 consecutive days, followed by a 7‐day rest. Results. Five major objective responses (one complete and four partial) were observed. Toxicity was mild, with no dose‐limiting myelosuppression. Four patients experienced grade 3 diarrhea or higher, and two patients experienced dose‐limiting mucositis. Conclusion. UFT and low dose leucovorin is a well tolerated, orally administered regimen with activity in colorectal cancer. A randomized comparison of this regimen with conventional parenteral regimens is warranted. Cancer 1995;75:782‐5.

BACKGROUND Pegylated liposomal doxorubicin is a new formulation with activity against epithelial ovarian carcinoma (EOC). The authors sought to determine patient characteristics that may predict for response to this treatment and favorable time to failure as well as survival. METHODS Eight patients in a Phase I study and 44 patients in two consecutive Phase II studies who were treated with pegylated liposomal doxorubicin (40–60 mg/m2 every 3 weeks for the first two cycles and 40 mg/m2 every 4 weeks thereafter) after failing initial platinum‐based chemotherapies for ovarian carcinoma were analyzed. Associations were sought for response, time to failure (TTF), and survival after the treatment and various pretreatment characteristics. RESULTS Treatment with pegylated liposomal doxorubicin yielded 23% objective responses in measurable disease and 31% overall responses, including serum CA 125‐defined responses. The median TTF was 5.2 months (95% confidence interval, 4.1–6.9 months) in all patients, and the median response duration in all responders was 13.2 months (95% confidence interval, 11.9–18.5 months). The overall median survival was 15 months (95% confidence interval, 11–40 months). The main predictive factors were tumor size and baseline hemoglobin level for TTF, and these plus Karnofsky performance status were the main predictive factors for survival. CONCLUSIONS Pegylated liposomal doxorubicin is an effective drug when it is given as secondary therapy to patients with EOC. Lack of bulky disease is the major predictor for a favorable response, TTF, and survival. The role of this treatment in combination with other effective drugs should be explored in both previously treated and untreated patients with ovarian carcinoma. Cancer 2001;91:90–100. © 2001 American Cancer Society.

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