| Methods |
Prospective, multicenter, open‐label, randomized, controlled study Study length = 6 weeks Study conducted during: not reported |
| Participants |
Eligibility: Hb ≤ 105g/dL; Ferritin ≤ 450pmol/L or ≤ 450pmol/L ; TSAT ≤ 19%; ECOG PS ≤ 2 Sex (number enrolled): female (65), male (92); Mean age: 64.7 years; Experimental arm: ESAs + iron dextran total dose infusion (TDI): enrolled 41, analyzed 41 Control arm: ESAs only: enrolled 36, analyzed 36 Mean baseline S. Ferritin range (207 to 194 pmol/L); Mean baseline TSAT saturation range (14 to 19%) |
| Interventions |
Esperimental arm: ESAs + iron dextran TDI Control: ESAs only: rHuEPO 40,000 U SC (dose escalation or reduction was not permitted) |
| Outcomes |
|
| Notes |
This is a four‐armed study and the references (Auerbach 2004b) Auerbach2004b and (Auerbach 2004c) Auerbach2004c refer to the same study. Hematopoietic response defined as increase in Hb level of ≥2g/dL or achievement of Hb level of ≥12g/dL without transfusion during study The number of patients "receiving transfusions" were reported (no separate reporting of RBCs versus other types of transfusions) QOL was measured using: LASA, ADL and Overall QOL index The total dose of iron dextran was calculated using the formula to reach a desired Hb level of 140 g/L: dose (mL)0.0442 (desired Hb–observed Hb)xLBW(0.26LBW) whereLBWis the patient’s lean body weight in kilograms. All patients received iron dextran as INFeD (Watson Pharmaceuticals, Morristown, NJ) except for two patients who received iron dextran as DexFerrum (American Regent Laboratories, Shirley, NY) during a brief period when the first formulation was not available. Participants randomly assigned to TDI received methylprednisolone 125 mg before and following the infusion. Patients then received a 25mg test dose given by IV push.One hour after the test dose was administered, patients received the calculated total iron dextran dose in 500 mL of 0.9% NaCl solution administered at a rate of 175 mL/h. This was an industry funded trial. COI statement included: Acted as a consultant within the last 2 years: Michael Auerbach, Watson Pharmaceuticals; J. Richard Trout, Watson Pharmaceuticals. Received more than $2,000 a year from a company for either of the last 2 years: Michael Auerbach, Watson Pharmaceuticals; J. Richard Trout, Watson Pharmaceuticals; Marilyn McIlwain, Watson Pharmaceuticals. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
High risk |
Trial authors described the study as “randomized controlled” and reported that “patients were centrally randomly assigned…”, however, this information is insufficient to permit judgment about the sequence generation process because details of how sequence was generated are not provided. |
| Allocation concealment (selection bias) |
Low risk |
“patients were centrally randomly assigned” |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
There was no blinding (study described as “open‐label”) yet outcome measurement was likely to be influenced by lack of blinding. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Trial authors reported that efficacy data were analyzed according to the "modified ITT principle". Withdrawals and drop‐outs were adequately |
| Selective reporting (reporting bias) |
Low risk |
One of outcomes of interest in the review (RBC transfusion) was not reported, however, it was reported that the study was not powered to detect differences in RBC transfusion requirements. |
| Other bias |
Low risk |
Pre‐specified values of sample size, alpha and beta errors and delta were provided |
