Summary of findings from studies evaluating thresholds for initiating treatment from the AHRQ CER
| Study . | Randomly assigned (No.) . | Malignancy . | Drug and treatment duration . | Hb when EPO/DARB initiated . | Patients given EPO/DARB (%) . | Transfused (%) . | Between arm differences in Δ (FACT measures) from baseline . | Thromboembolic events (%) . | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| I . | D . | I . | D . | I . | D . | I . | D . | I . | D . | ||||
| Straus 200611 | 135 | 134 | Hematologic | Epoetin ≤ 16 wk | 11.1 ± 0.7* | <9 | 100 | 19.4 | 17.8 | 26.1 | FACT-An 8.22 (2.62) unadjusted mean, 6.67 (2.25) estimated mean†‡; FACT-fatigue 3.13 (1.16) unadjusted mean, 2.67 (0.94) estimated mean†‡ | 11.1 | 3† |
| Rearden 200412 | 102 | 102 | Mixed solid or hematologic | Darbepoetin 12 wk§ | 11.1 ± 0.07¶ | <10 | 100 | 62.7 | 17.2 | 26.5 | NS | 2 | 1 |
| Crawford 200710 | 109 | 107 | Non–small-cell lung cancer | Epoetin 16 wk (D group from first administration to end of study) | 13.1 ± 1.0* | ≤ 10‖ | 100 | 46.0 | 12.3 | 20.0 | NS | 12 | 15 |
| Study . | Randomly assigned (No.) . | Malignancy . | Drug and treatment duration . | Hb when EPO/DARB initiated . | Patients given EPO/DARB (%) . | Transfused (%) . | Between arm differences in Δ (FACT measures) from baseline . | Thromboembolic events (%) . | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| I . | D . | I . | D . | I . | D . | I . | D . | I . | D . | ||||
| Straus 200611 | 135 | 134 | Hematologic | Epoetin ≤ 16 wk | 11.1 ± 0.7* | <9 | 100 | 19.4 | 17.8 | 26.1 | FACT-An 8.22 (2.62) unadjusted mean, 6.67 (2.25) estimated mean†‡; FACT-fatigue 3.13 (1.16) unadjusted mean, 2.67 (0.94) estimated mean†‡ | 11.1 | 3† |
| Rearden 200412 | 102 | 102 | Mixed solid or hematologic | Darbepoetin 12 wk§ | 11.1 ± 0.07¶ | <10 | 100 | 62.7 | 17.2 | 26.5 | NS | 2 | 1 |
| Crawford 200710 | 109 | 107 | Non–small-cell lung cancer | Epoetin 16 wk (D group from first administration to end of study) | 13.1 ± 1.0* | ≤ 10‖ | 100 | 46.0 | 12.3 | 20.0 | NS | 12 | 15 |
Adapted from original work done by Seidenfeld et al.4
Abbreviations: AHRQ, Agency for Healthcare Research and Quality; CER, comparative effectiveness review; I, erythropoietic stimulant therapy begun immediately after random assignment; D, erythropoietic stimulant therapy delayed until Hb falls to threshold; Hb, hemoglobin; DARB, darbepoetin; EPO, epoetin; FACT, Functional Assessment of Cancer Therapy; NS, no significant difference; NR, not reported.
Mean ± standard deviation.
Statistically significant differences.
Estimated mean based on the treatment effect using a random coefficient linear growth curve model.
Transfusion data include 22 weeks follow-up as patients received chemotherapy throughout.
Mean ± standard error.
Included seven participants who recived EPO despite having Hb > 10 g/dL.