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Oral Capecitabine Is Attractive Alternative to Continuous- Infusion Regimens

Oral Capecitabine Is Attractive Alternative to Continuous- Infusion Regimens

BIRMINGHAM, ALABAMA- "Capecitabine can replace continuous infusion in regimens to treat colorectal cancer," Scott Cole, MD, and colleagues at the University of Alabama at Birmingham concluded after reviewing data on 3,224 patients in phase I or II studies (abstract 3591). The studies were published or available from 1997 to 2004 from the American Society of Clinical Oncology, the European Society for Medical Oncology, and the European Cancer Conference. The safety and efficacy of capecitabine (Xeloda)-based regimens were compared with those of continuousinfusion fluorouracil (5-FU)-based regimens, such as FOLFOX (5-FU, leucovorin, oxaliplatin [Eloxatin]) and FOLFIRI (5-FU, leucovorin, irinotecan [Camptosar]). Treatment could have been first line or second line and administered alone or with radiation therapy, oxaliplatin, or irinotecan. The studies included 1,409 patients taking capecitabine and 1,815 patients receiving 5-FU. The mean age was 62 years (range, 18-88 years). An average of 61% of patients per study had an Eastern Cooperative Oncology Group (ECOG) performance status of 0. "Our conclusions are limited by the lack of randomized controlled trials directly comparing capecitabinebased therapies with continuous-in- fusion 5-FU-based therapies for the treatment of colorectal cancer," the investigators acknowledged. "Nonetheless, these comparisons have shown that capecitabine therapies, as monotherapy or combination regimens, provide the following advantages": Advantages

  • Capecitabine offers a superior toxicity profile and at least equivalent response rates, time to progression, and survival compared with continuous- infusion treatment when used alone or in combination with other agents or radiation therapy in colorectal cancer (first-line, adjuvant, neoadjuvant);
  • Capecitabine has demonstrated a better toxicity profile than regimens based on continuous-infusion 5-FU, except for a higher incidence of hand-foot syndrome, which is manageable by treatment delay and dose reduction as appropriate.
  • Using oral dosing may lead to superior medical resource utilization.
In background information, the investigators noted that although "the low level of myelosuppression associated with continuous infusion makes it an attractive regimen for combining with other agents," continuousinfusion therapies "require an indwelling catheter, which can lead to infections and the need for ancillary care, potentially raising costs and reducing patient quality of life." Efficacy and Safety Overall response rates were similar for patients taking oral capecitabine and those receiving intravenous continuous infusion 5-FU, 34% vs 39% (overall response rate odds ratio, 0.7917; 95% confidence interval [CI], 0.6784 to 0.9239; P = .999). Average survival figures were similar: 14.2 months for capecitabine and 14.9 months for intravenous continuousinfusion 5-FU (see Table 1). Safety was assessed by determining the proportion of patients who experienced grade 3/4 adverse events (see Table 2). The reviewers found that grade 3/4 hematologic toxicity was more frequent in patients on intravenous continuous-infusion 5-FU than in patients on capecitabine (16.31% vs 3.40%, P < .0001). Hand-foot syndrome was more frequent in patients receiving capecitabine (9.30% vs 6.34%, P < .999). Capecitabine was associated with a significantly lower incidence of grade 3/4 neutropenia (4.79% vs 27.7%), leading to significantly less grade 3/4 neutropenic fevers (1.16% vs 7.72%). Although thromboses were observed in 8% of patients receiving intravenous continuous-infusion 5-FU, none was reported for patients taking capecitabine.
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