Background: This pilot study was conducted to evaluate the feasibility, activity, and safety of an induction dose of epoetin a in cancer patients with moderate or severe anemia who were receiving chemotherapy. Patients and methods: Thirty patients with solid tumors and hemoglobin (Hb) levels <11.0 g/dl were enrolled. Patients received single s.c. injections of epoetin a, 40 000 IU for three consecutive days, and were then observed for the following 30 days. The primary efficacy variable was the response rate (Hb increase ‡1 g/dl) at day 15. Secondary efficacy variables included the proportion of patients given blood transfusions between baseline and the end of study, the duration of response (Hb level ‡1 g/dl), and ability to maintain the planned chemotherapy dose (dose intensity). Results: At day 15, 23 of 30 (77%) patients had achieved increases in Hb levels of at least 1 g/dl. The mean Hb increase in responders was 2.0 g/dl [95% confidence interval (CI) = 1.7–2.3 g/dl]. The Hb increase was 2.3 ± 0.7 g/dl in responders with baseline Hb levels <9.5 g/dl (median Hb value), and 1.7 ± 0.6 g/dl in those with higher Hb levels (P = 0.012). The median duration of response was 6.1 weeks (95% CI = 1.6–10.6 weeks). Hematologic parameters were not significantly changed in nonresponders. Multivariate analysis detected no significant differences in Hb increase at day 15 on the basis of age, sex, weight, baseline Hb levels, type or stage of tumor, or treatment with platinum-based chemotherapy. No serious adverse event related to epoetin a treatment was observed. Conclusions: We conclude that a higher initial dosing of epoetin a appears to be an efficient schedule for treating anemia in cancer patients undergoing chemotherapy, conferring higher response rates than those seen with standard doses. Further evaluation of these and other epoetin a dosage regimens is warranted.
An induction dose of epoietin alpha of 40.000 IU daily for three consecutive days increases and mantains hemoglobin levels in anemic cancer patients undergoing chemotherapy.
MUSTACCHI, GIORGIO;
2006-01-01
Abstract
Background: This pilot study was conducted to evaluate the feasibility, activity, and safety of an induction dose of epoetin a in cancer patients with moderate or severe anemia who were receiving chemotherapy. Patients and methods: Thirty patients with solid tumors and hemoglobin (Hb) levels <11.0 g/dl were enrolled. Patients received single s.c. injections of epoetin a, 40 000 IU for three consecutive days, and were then observed for the following 30 days. The primary efficacy variable was the response rate (Hb increase ‡1 g/dl) at day 15. Secondary efficacy variables included the proportion of patients given blood transfusions between baseline and the end of study, the duration of response (Hb level ‡1 g/dl), and ability to maintain the planned chemotherapy dose (dose intensity). Results: At day 15, 23 of 30 (77%) patients had achieved increases in Hb levels of at least 1 g/dl. The mean Hb increase in responders was 2.0 g/dl [95% confidence interval (CI) = 1.7–2.3 g/dl]. The Hb increase was 2.3 ± 0.7 g/dl in responders with baseline Hb levels <9.5 g/dl (median Hb value), and 1.7 ± 0.6 g/dl in those with higher Hb levels (P = 0.012). The median duration of response was 6.1 weeks (95% CI = 1.6–10.6 weeks). Hematologic parameters were not significantly changed in nonresponders. Multivariate analysis detected no significant differences in Hb increase at day 15 on the basis of age, sex, weight, baseline Hb levels, type or stage of tumor, or treatment with platinum-based chemotherapy. No serious adverse event related to epoetin a treatment was observed. Conclusions: We conclude that a higher initial dosing of epoetin a appears to be an efficient schedule for treating anemia in cancer patients undergoing chemotherapy, conferring higher response rates than those seen with standard doses. Further evaluation of these and other epoetin a dosage regimens is warranted.Pubblicazioni consigliate
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