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ESMOPharma 2013 (ECC 2013): Dr Florian Scotté
Erythropoiesis Stimulating Agents: Back to the Future
The return of studies on erythropoetins to the 2013 ECC is surprising. In fact, there are several studies on biosimilar products and their comparative studies.
The first was conducted by comparing a biosimilar version of epoetin alfa in daily administration at 40,000 units to darbepoetin alfa administered every 3 weeks at 500 units. This retrospective observational study included 95 patients in the biosimilar epoetin alfa arm (85% of breast cancers) and 50 patients in the darbepoetin alfa arm (82% of breast cancers). The comparative results presented in the following table demonstrate no real difference between the two cohorts.
500 μg/3 weeks (N=50)
|Biosimilar epoetin alfa40,000 IU/week (n=95)|
|Average duration of ESA treatment (weeks)||4.28||4.66|
|Average haemoglobin value at the start of ESA treatment (g/dl)||9.92||9.85|
|Average haemoglobin value at the end of ESA treatment (g/dl)||11.93||11.91|
|Number of patients requiring transfusion of red blood cells during ESA treatment period||3 (6.0%)||4 (4.2%)|
The methodological absence of the definitions of various criteria, the absence of comparison between the two cohorts and the oral administration of iron in each arm that did not correspond to current references are regrettable. However, it is interesting to analyse the prescription habits with a haemoglobin level at initiation of treatment of 9.92 and 9.85 g/dl in the darbepoetin and biosimilar epoetin alfa cohorts, respectively, and a target at 11.93 and 11.91 between each of the arms, respectively.
Another amusing study [2013 ECC, Abs 1320] was conducted retrospectively in Spain among 284 patients at a single centre. Without any comparative data being (or having been) evaluated, the results place various products in direct competition (see the following table).
|ESA||Average duration of ESA treatment (weeks)||Average value of haemoglobin at the start of ESA treatment (g/dl)||Average value of haemoglobin at the end of ESA treatment (g/dl)|
300 µg/2 weeks
500 µg/3 weeks
|Biosimilar epoetin alfa 30,000 IU/week||4.57||9.1||10.4|
|Biosimilar epoetin alfa 40,000 IU/week||4.20||9.3||10.7|
The main result of this study was the evaluation of tumour sites included in the observational study emphasizing primary sites treated using an ESA first and foremost:
·Non-small cell lung cancer = 30%
·Breast cancer = 12%
·Head and neck cancer = 7%
·Ovarian cancer = 6%
A third observational study [2013 ECC, Abs 1312], this time a national French study, was conducted on the prescription of biosimilar epoetin alfa in the treatment for chemotherapy-induced anaemia (OncoBOS observational study). Among the 444 patients included in 75 French centres, 344 had solid tumours (lung 22.1% then breast 13.4%) and 100 had malignant haemopathy (non-Hodgkin's lymphoma 55%, multiple myeloma 24.0%). The values of the haemoglobin levels were compared at start of treatment (9.6 +/- 0.9 g/dl), at 3-4 weeks (10.6 +/- 1.4 g/dl) then at 12 weeks (11.2 +/- 1.5 g/dl) after patient inclusion. The difference between values was significantly in favour of efficacy of use of the biosimilar epoetin alfa to increase the haemoglobin level. Only 3 patients (0.7%) would have presented with a treatment-related reaction, essentially one case of hallucinations and two cases of thrombosis without serious event.
To close, some data on biosimilar GCSFs. The observational Monitor study was presented at the 2013 ECC [Abs 1386]. It concerned an international, prospective, observational, open-label, pharmaco-epidemiological study with the primary objective of describing patient populations at risk for presenting febrile neutropenia and treated prophylactically with a biosimilar filgrastim. Another primary objective was to evaluate the consistency of prescriptions with the 2010 EORTC recommendations  and to describe the various risk levels of these patients.
In total, 48.8% of patients correctly received the primary or secondary treatment with respect to the EORTC recommendations. The recommendations were not followed in primary prophylaxis for 23% of the patients with a risk factor for febrile neutropenia that was >20%, and for 30% of those with a risk of between 10 and 20% but with personal risk criteria of ≥ 3, normally indicating recourse to prophylactic GCSF.
In comparing the malignant haemopathy and solid tumour patient populations, it is apparent that the patients treated for solid tumours had earlier administration of GCSF (within 24 to 72 hours following chemotherapy administration) corresponding with the recommendations, compared to those with malignant haemopathies (60.0% vs. 29.6%; p<0.0001).
 Aapro MS, et al. EORTC guidelines. Eur J Cancer 2011;47:8-32. Updated by Flowers CR, et al. J Clin Oncol. 2013;31(6):794-810.)