Epoetin alfa in platinum-treated ovarian cancer patients: results of a multinational, multicentre, randomised trial

Abstract

This multicentre, open-label, controlled clinical trial assessed the effects of epoetin alfa treatment on haematologic and quality of life (QOL) parameters in 182 anaemic (Hb< or = 12 g dl(-1)) ovarian cancer patients receiving platinum chemotherapy. Patients were randomised 2 : 1 to receive epoetin alfa 10,000-20 000 IU three times weekly plus best standard treatment (BST) or BST only. Main study end points were changes from baseline in haemoglobin (Hb) level, transfusion requirements, and QOL. For the epoetin alfa group, mean Hb increased by 1.8 g dl(-1) by weeks 4-6 and was significantly increased from baseline through study end (P<0.001). The mean change in Hb from baseline was significantly (P<0.001) greater for epoetin alfa than BST patients at all post-baseline evaluations. Significantly fewer epoetin alfa than BST patients required transfusion(s) after the first 4 weeks of treatment (7.9 vs 30.5%; P<0.001). Also, significant (P< or = 0.04) differences favouring the epoetin alfa group over the BST group were found for all three median CLAS scores (Energy Level, Ability to Do Daily Activities, Overall QOL) and the median average CLAS score during chemotherapy. These findings support use of epoetin alfa to increase Hb levels, reduce transfusion use, and improve QOL in anaemic ovarian cancer patients receiving platinum chemotherapy.

Figure 1

Mean haemoglobin levels±s.e. over time (epoetin alfa vs best standard treatment).

Figure 2

Box and whisker plots summarising the distribution of haemoglobin values for all patients in the two study groups during the treatment period. Bottom and top edges of the boxes correspond to the 25th and 75th percentiles of the sample, respectively. The central solid lines represent the median values, and the dotted lines represent the mean values. The bars at the ends of the vertical lines or ‘whiskers’ mark the 5 and 95% values. Any values more extreme than these are indicated by solid black circles.

Figure 3

Change in Cancer Linear Analog Scale (CLAS, also known as Linear Analog. Scale Assessment (LASA)) scores from baseline after 12 weeks and at study end (epoetin alfa vs best standard treatment).