3928 - Chemotherapy (CT)-induced anaemia in patients (pts) treated with dose-dense regimen: Results of the prospectively randomised anaemia substudy from the neoadjuvant GeparOcto study

Background

Use of parenteral (IV) ferric carboxymaltose (FCM) has been shown to be an efficient treatment of iron deficiency anaemia that can prevent blood transfusion. This substudy compared use of FCM with physician’s choice (PhCh) anaemia therapy in breast cancer (BC).

Methods

In GeparOcto trial pts with primary BC were randomised to receive sequential, intensified, dose-dense epirubicin, paclitaxel, and cyclophosphamide (iddEPC) or weekly paclitaxel/liposomal doxorubicin +/- carboplatin (PM(Cb)) (Schneeweiss et al. Eur J Cancer). Pts with anaemia grade ≥2 (haemoglobin (Hb)<10g/dl), transferrin saturation (TSAT) ≤20% and serum ferritin <300ng/ml (amended to < 600ng/ml) were randomised to receive weekly FCM or PhCh (no treatment, oral iron, erythropoiesis-stimulating agent, or both) anaemia therapy. Stratification factors were CT arm (iddEPC vs PM(Cb)) and planned PhCh. Primary objective compared the frequency of pts achieving Hb ≥ 11g/dl at 6 wks of therapy between both arms. Main secondary objectives were median time to achieve Hb ≥ 11g/dl and changes in iron parameters at baseline vs different time points. It was planned to include 184 pts per arm using 2-sided exact Fisher test, with α = 0.05 and power 80%.

Results

Less than anticipated pts had CT-induced anaemia. 125 pts were randomised (62 in FCM, 63 in PhCh arm). Median age was 46 years (range 26-66); median levels of Hb, serum ferritin and TSAT were 9.6 (7.6-11.8)g/dl, 201 (3.0-551)ng/ml and 14.0% (4.0%-76.0%), respectively. After 6 wks, overall 40 (32.0%) pts (22 in FCM and 18 in PhCh arm; p = 0.447) reached Hb ≥ 11g/dl. Median time to achieve Hb ≥ 11g/dl was 9.0 wks with FCM vs 10.6 wks by PhCh. Median Hb changes vs baseline were comparable in both arms during the treatment. 2 pts in FCM and 5 in PhCh arm (p = 0.246) received blood transfusions until 6 wks of therapy.

Conclusions

This is the first study investigating IV iron treatment for dose-dense CT-induced anaemia in BC. 32% of pts reached Hb ≥ 11g/dl at 6 wks. FCM treatment was not different than PhCh for anaemia therapy.

Clinical trial identification

NCT02125344.

Editorial acknowledgement

Legal entity responsible for the study

German Breast Group (GBG).

Funding

The anaemia supportive treatment substudy was financially supported by Vifor Pharma Ltd and the GeparOcto trial by Amgen, Roche and TEVA.

Disclosure

H. Tesch: Honoraria (self): Vifor; Honoraria (self): Roche; Honoraria (self): Amgen. S. Loibl: Honoraria (institution), Research grant / Funding (institution): Roche; Honoraria (institution), Research grant / Funding (institution): Amgen GmbH; Honoraria (institution), Research grant / Funding (institution): AstraZeneca; Honoraria (institution), Research grant / Funding (institution): Celgene; Honoraria (institution), Research grant / Funding (institution): Novartis; Honoraria (institution), Research grant / Funding (institution): Pfizer; Honoraria (institution), Research grant / Funding (institution): Seattle Genetics; Honoraria (institution), Research grant / Funding (institution): Teva; Honoraria (institution), Research grant / Funding (institution): Vifor; Honoraria (institution), Research grant / Funding (institution): PRIME; Honoraria (institution), Research grant / Funding (institution): Daiichi; Licensing / Royalties: EP14153692.0 pending. V. Möbus: Honoraria (self): Amgen; Honoraria (self): Celgene; Honoraria (self): Myelotherapeutics; Honoraria (self): AstraZeneca. M. Untch: Honoraria (institution), Non-remunerated activity/ies: Abbvie; Honoraria (institution), Non-remunerated activity/ies: Amgen GmbH; Honoraria (institution), Non-remunerated activity/ies: AstraZeneca; Honoraria (institution): BMS; Honoraria (institution), Non-remunerated activity/ies: Celgene GmbH; Honoraria (institution), Non-remunerated activity/ies: Daiji Sankyo; Honoraria (institution), Non-remunerated activity/ies: Eisai GmbH; Honoraria (institution), Non-remunerated activity/ies: Janssen Cilag; Honoraria (institution), Non-remunerated activity/ies: Lilly; Honoraria (institution), Non-remunerated activity/ies: MSD Merck; Honoraria (institution), Non-remunerated activity/ies: Mundipharma; Honoraria (institution), Non-remunerated activity/ies: Myriad Genetics; Honoraria (institution), Non-remunerated activity/ies: Odonate; Honoraria (institution), Non-remunerated activity/ies: Pfizer GmbH; Honoraria (institution): PUMA Biotechnology; Honoraria (institution), Non-remunerated activity/ies: Novartis; Honoraria (institution), Non-remunerated activity/ies: Roche Pharma AG; Honoraria (institution), Non-remunerated activity/ies: Sanofi Aventis Deutschland GmbH; Honoraria (institution), Non-remunerated activity/ies: Sividon Diagnostics; Honoraria (institution), Non-remunerated activity/ies: TEVA Pharmaceuticals Ind Ltd. C. Hanusch: Honoraria (self): Roche; Honoraria (self): Pfizer; Honoraria (self): Novartis; Honoraria (self): Celgene; Honoraria (self): Lilly; Honoraria (self): AstraZeneca. S. Seiler: Honoraria (self), presentations: Roche; Honoraria (self), Advisory / Consultancy: Amgen GmbH; Honoraria (self), Advisory / Consultancy: Hexal; Honoraria (self), Advisory / Consultancy: Mundipharma; Advisory / Consultancy: Novartis. P.A. Fasching: Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Biontech; Honoraria (self): Novartis; Honoraria (self): Roche; Honoraria (self): Pfizer; Honoraria (self): Celgene; Honoraria (self): Daiichi-Sankyo; Honoraria (self): TEVA; Honoraria (self): AstraZeneca; Honoraria (self): Merck Sharp & Dohme; Honoraria (self): Myelo Therapeutics; Honoraria (self): Macrogenics; Honoraria (self): Eisai; Honoraria (self): PUMA; Research grant / Funding (institution): Cepheid. K. Rhiem: Honoraria (self): Tesaro; Honoraria (self): AstraZeneca; Honoraria (self): Pfizer. J. Huober: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Lilly; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy: Hexal; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: MSD Oncology; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Celgene; Honoraria (self), Travel / Accommodation / Expenses: Abbvie. C. Denkert: Shareholder / Stockholder / Stock options: Sividon Diagnostics; Honoraria (self): Teva; Honoraria (self): Novartis; Honoraria (self): Pfizer; Honoraria (self): Roche; Honoraria (self), Advisory / Consultancy: Amgen; Advisory / Consultancy: MSD Oncology; Advisory / Consultancy: Daiichi Sankyo; Licensing / Royalties: VMScope digital pathology software; Licensing / Royalties: Patent application: EP18209672 - cancer immunotherapy; Licensing / Royalties: Patent application EP20150702464 - therapy response; Licensing / Royalties: Patent application EP20150702464 - therapy response. T. Link: Honoraria (self): Amgen; Non-remunerated activity/ies: AstraZeneca; Honoraria (self), Non-remunerated activity/ies: Pfizer; Non-remunerated activity/ies: Pharma Mar; Non-remunerated activity/ies: Daiichi Sankyo; Honoraria (self): MSD Oncology; Honoraria (self): Novartis; Honoraria (self): Teva; Honoraria (self): Tesaro; Honoraria (self), Non-remunerated activity/ies: Roche. A. Schneeweiss: Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Celgene; Honoraria (self), Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Research grant / Funding (institution): AbbVie; Research grant / Funding (institution): Molecular Partner; Honoraria (self), Speaker Bureau / Expert testimony: AstraZeneca; Honoraria (self), Travel / Accommodation / Expenses: Pfizer; Honoraria (self): MSD Oncology; Honoraria (self): Tesaro; Honoraria (self): Lilly. All other authors have declared no conflicts of interest.