Assessment of hematologic effects and fatigue in cancer patients with chemotherapy-induced anemia given darbepoetin alfa every two weeks.

Saroj Vadhan-Raj, Barry Mirtsching, Veena Charu, Dixon Terry, Gregory Rossi, Dianne Tomita, William P. McGuire

Research output: Contribution to journalArticle

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Abstract

The objective of this ongoing trial is to study the ability of darbepoetin alfa to reverse chemotherapy-induced anemia in cancer patients, and to relate improvement in hemoglobin with changes in fatigue and functional capacity. Eligible subjects had a nonmyeloid malignancy, were receiving multicycle chemotherapy, and were anemic, as defined by a screening hemoglobin < or = 11 g/dL. Darbepoetin alfa was administered at a starting dosage of 3 microg/kg every 2 weeks for up to eight doses (16 weeks) in an open-label, noncomparative setting. A total of 194 oncology practices contributed 1,173 subjects to this interim analysis. The mean increase in hemoglobin was 1.7 g/dL (95% CI: 1.6, 1.8) to last value on study (intent-to-treat analysis) and 2.1 g/dL (95% CI: 1.9, 2.2) for those patients receiving the full 16 weeks of therapy.The Kaplan-Meier estimate of the proportion of subjects with a hematopoietic response (increase in hemoglobin > or = 2 g/dL and/or hemoglobin value > or = 12 g/dL) was 84% (95% CI:81,86).Subjects in the lower baseline hemoglobin category (< 10 g/dL) tended to have a greater hemoglobin response during treatment. The Functional Assessment of Cancer Therapy-Fatigue (FACT-Fatigue) subscale score increased by a mean of 6.8 points (26%) during the study, and improvements in fatigue paralleled the increases observed in hemoglobin. Study treatment-related toxicity was minimal, with the most common event being injection-site pain, seen in 2% of subjects. Experience to date with an every-2-week regimen of darbepoetin alfa indicated efficacy comparable to historical experience with weekly and 3-times-weekly regimens of epoetin alfa in treating chemotherapy-induced anemia in cancer subjects.

Original languageEnglish (US)
Pages (from-to)131-138
Number of pages8
JournalThe journal of supportive oncology.
Volume1
Issue number2
StatePublished - Jul 2003

Fingerprint

Fatigue
Anemia
Hemoglobins
Drug Therapy
Neoplasms
Epoetin Alfa
Aptitude
Darbepoetin alfa
Therapeutics
Pain
Injections

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Vadhan-Raj, S., Mirtsching, B., Charu, V., Terry, D., Rossi, G., Tomita, D., & McGuire, W. P. (2003). Assessment of hematologic effects and fatigue in cancer patients with chemotherapy-induced anemia given darbepoetin alfa every two weeks. The journal of supportive oncology., 1(2), 131-138.

Assessment of hematologic effects and fatigue in cancer patients with chemotherapy-induced anemia given darbepoetin alfa every two weeks. / Vadhan-Raj, Saroj; Mirtsching, Barry; Charu, Veena; Terry, Dixon; Rossi, Gregory; Tomita, Dianne; McGuire, William P.

In: The journal of supportive oncology., Vol. 1, No. 2, 07.2003, p. 131-138.

Research output: Contribution to journalArticle

Vadhan-Raj, S, Mirtsching, B, Charu, V, Terry, D, Rossi, G, Tomita, D & McGuire, WP 2003, 'Assessment of hematologic effects and fatigue in cancer patients with chemotherapy-induced anemia given darbepoetin alfa every two weeks.', The journal of supportive oncology., vol. 1, no. 2, pp. 131-138.
Vadhan-Raj, Saroj ; Mirtsching, Barry ; Charu, Veena ; Terry, Dixon ; Rossi, Gregory ; Tomita, Dianne ; McGuire, William P. / Assessment of hematologic effects and fatigue in cancer patients with chemotherapy-induced anemia given darbepoetin alfa every two weeks. In: The journal of supportive oncology. 2003 ; Vol. 1, No. 2. pp. 131-138.
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abstract = "The objective of this ongoing trial is to study the ability of darbepoetin alfa to reverse chemotherapy-induced anemia in cancer patients, and to relate improvement in hemoglobin with changes in fatigue and functional capacity. Eligible subjects had a nonmyeloid malignancy, were receiving multicycle chemotherapy, and were anemic, as defined by a screening hemoglobin < or = 11 g/dL. Darbepoetin alfa was administered at a starting dosage of 3 microg/kg every 2 weeks for up to eight doses (16 weeks) in an open-label, noncomparative setting. A total of 194 oncology practices contributed 1,173 subjects to this interim analysis. The mean increase in hemoglobin was 1.7 g/dL (95{\%} CI: 1.6, 1.8) to last value on study (intent-to-treat analysis) and 2.1 g/dL (95{\%} CI: 1.9, 2.2) for those patients receiving the full 16 weeks of therapy.The Kaplan-Meier estimate of the proportion of subjects with a hematopoietic response (increase in hemoglobin > or = 2 g/dL and/or hemoglobin value > or = 12 g/dL) was 84{\%} (95{\%} CI:81,86).Subjects in the lower baseline hemoglobin category (< 10 g/dL) tended to have a greater hemoglobin response during treatment. The Functional Assessment of Cancer Therapy-Fatigue (FACT-Fatigue) subscale score increased by a mean of 6.8 points (26{\%}) during the study, and improvements in fatigue paralleled the increases observed in hemoglobin. Study treatment-related toxicity was minimal, with the most common event being injection-site pain, seen in 2{\%} of subjects. Experience to date with an every-2-week regimen of darbepoetin alfa indicated efficacy comparable to historical experience with weekly and 3-times-weekly regimens of epoetin alfa in treating chemotherapy-induced anemia in cancer subjects.",
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