American Society of Clinical Oncology: Oral Fluoropyrimidine for Metastatic Colon Cancer
Speaker: Joseph J. McKendrick, MD, Director of Medical Oncology, Department of Clinical Hematology and Clinical Oncology, Box Hill Hospital, Melbourne, Victoria, Australia.
Adjuvant chemotherapy with oral capecitabine (Xeloda®, Roche), an oral fluoropyrimidine preferentially activated to 5-fluorouracil (5-FU) in tumors by enzymatic action, was more cost-effective than the standard Mayo Clinic regimen of IV 5-FU and leucovorin (LV) in the adjuvant treatment of meta-static colon cancer.
Medical resource utilization (MRU) data were evaluated from the Xeloda in Adjuvant Colon Cancer Therapy (X-ACT) study, a large, phase III randomized clinical trial that compared capecitabine and the Mayo Clinic regimen as adjuvant treatment for patients with stage III colon cancer. A total of 1,987 patients with metastatic colorectal cancer were randomly assigned to receive 24 weeks of treatment with either oral capecitabine 1,250 mg/m2 twice daily on the first to 14th days of a three-week cycle or an IV bolus 5-FU/LV (425 mg/m2/ 20 mg/m2) on the first to fifth days, repeated every 28 days.
The primary endpoint—to demonstrate that disease-free survival with oral capecitabine was at least equivalent to IV 5-FU/LV in patients with metastatic colon cancer—was successfully met.
Relapse-free survival rates for capecitabine—a secondary endpoint—were statistically superior to those for 5-FU/LV, with a 14% reduction in the risk of relapse in favor of capecitabine.
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IV administration, a major inconvenience for patients, is not needed with oral capecitabine. The Mayo Clinic Regimen typically requires at least 30 clinic visits over the 24-week treatment course; only eight visits are necessary with capecitabine, one visit at the beginning of each cycle.
Treatment for drug-related ADEs was considerably more costly for patients receiving 5-FU/LV; higher-priced drugs (e.g., antidiarrheal agents, analgesics, and antifungal agents) were necessary. Patients receiving capecitabine took more low-cost vitamins and emollients.
Finally, patients both younger and older than 65 years of age tolerated treatment with capecitabine quite well. Both age groups experienced a similar low incidence of severe toxicities. This finding was important because colon cancer is most often diagnosed in older patients, who generally do not receive optimal treatment for this disease.
Overall, adjuvant chemotherapy for stage III colon cancer with oral capecitabine yielded substantial savings in MRU because the administrative costs of IV therapy could be avoided and because of substantial indirect cost savings in terms of patient time saved. The added value of equivalent disease-free survival and superior relapse-free survival rates make oral capecitabine a cost-effective alternative to the Mayo Clinic regimen, the present standard of care for the adjuvant treatment of stage III colon cancer.
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Taxane-Based Chemotherapy in Hormone-Refractory Prostate Cancer
Speaker: Mario Eisenberger, MD, R. Dale Hughes Professor of Oncology and Urology, Johns Hopkins Kimmel Cancer Center, Baltimore, Maryland.
Docetaxel (Taxotere®, Aventis), a well-known taxane chemotherapeutic agent for patients with metastatic breast cancer, provided a significant survival benefit when administered to patients with hormone-resistant prostate cancer, and it reduced the chance of dying by 24% while offering markedly improved quality of life.
The researchers randomly assigned 1,006 patients to receive docetaxel 30 mg/m2 weekly, docetaxel 75 mg/m2 once every three weeks, or mitoxantrone (Novantrone®, Immunex) 12 mg/m2 once every three weeks. All of the patients also received 5 mg of oral prednisone daily. (The latter approach is the established standard of care as initial treatment to relieve pain in patients with advanced hormone-refractory cancer.)
The planned duration for all three arms was 30 weeks, and the primary study endpoint was survival. Secondary endpoints included pain response, measurable tumor responses, a decline in prostate-specific antigen (PSA) values, and improved quality of life over baseline measures.
At a median follow-up of 20.7 months, the men receiving higher-dose docetaxel every three weeks had a survival rate of 18.9 months; those receiving low-dose docetaxel weekly survived for 17.4 months; and those receiving mitoxantrone plus prednisone survived for 16.5 months. On average, therefore, patients who received higher-dose docetaxel every three weeks survived 2.4 months longer than those receiving mitox-antrone.
For the men who received higher-dose docetaxel every three weeks, PSA levels declined by 45%; for the patients receiving the lower dose of docetaxel, the levels were reduced by 48%; and for those receiving mitoxantrone plus prednisone, the levels were decreased by 32%. buy antibiotics no prescription
Of equal importance, more men who received higher-dose docetaxel every three weeks experienced significantly greater pain relief (35%) than men who received low-dose docetaxel (31%) or mitoxantrone plus prednisone (22%) every three weeks.
Finally, the docetaxel patients experienced marked improvement in quality of life over baseline values compared with patients taking mitoxantrone. These improvements were observed in 22% of patients on the docetaxel three-times-weekly arm, in 23% on the docetaxel once-weekly arm, and in 13% of the men on the mitoxantrone and prednisone regimen.
