1497P - Lessons from the past: Long-term safety and efficacy outcomes of a prematurely terminated, randomized phase III trial of precautionary versus hemog...

Date 28 September 2014
Event ESMO 2014
Session Poster Display session
Topics Complications/Toxicities of Treatment
Supportive Measures
Presenter Giannis Mountzios
Citation Annals of Oncology (2014) 25 (suppl_4): iv517-iv541. 10.1093/annonc/mdu356
Authors G. Mountzios1, G. Aravantinos2, G. Kouvatseas3, M. Karina2, E. Samantas2, P. Papakostas4, D. Skarlos5, E. Galani6, H. Kalofonos7, T. Makatsoris8, D. Bafaloukos9, D.G. Pectasides10, G. Fountzilas11
  • 1Medical Oncology, 251 Airforce General Hospital, 115 25 - Athens/GR
  • 2Medical Oncology, Agii Anargiri Cancer Hospital, GR-145 64 - Athens/GR
  • 3Biostatistics, Health Data Office, Athens/GR
  • 42nd Department Of Medicine, Hippokration General Hospital, Athens/GR
  • 5Medical Oncology, Metropolitan Hospital, GR-11528 - Athens/GR
  • 6Medical Oncology, Metropolitan Hospital, GR-185 47 - Athens/GR
  • 7Dept. Of Medical Oncology, University Hospital Patras, 265 00 - Patras/GR
  • 8Dept. Of Internal Medicine, University Hospital Patras, GR-26 500 - Patras/GR
  • 91st Dept Of Medical Oncology, Metropolitan Hospital, 185 47 - Athens/GR
  • 102nd. Dep. Int. Medicine, Hippokration General Hospital, 115 27 - Athens/GR
  • 11Medical Oncology Clinic, Papageorgiou Hospital Aristotle University of Thessaloniki, 564 29 - Thessaloniki/GR



Prophylactic erythropoiesis-stimulating agent (ESA) administration for chemotherapy-induced anemia (CIA) is not supported by current guidelines. Long-term follow-up of patients that had been treated with EPO for CIA in the past may provide useful information.


In 2002 we undertook a prospective, randomized phase III trial of prophylactic versus hemoglobin (Hgb)-based (threshold: 12 mg/dl) ESA administration in patients with solid tumors and CIA, which was permanently suspended in 2005 in the view of published data at that time, while patient surveillance continued. Herein we present safety and efficacy outcomes after more than a decade of follow-up.


Among 630 evaluable patients, 40.1% were male, 50.9% had advanced cancer at diagnosis, 39.2% had Hgb levels <12 mg/dl at baseline and 49.8% received ESA prophylactically (1:1 randomization). Major tumor types were colorectal (36.0%), breast (21.5%), non-prostate GU (11.4%). After a median follow-up of 127 months, 339 patients had relapsed and 341 had died. Patients in the prophylactic ESA group, as compared to those in the Hgb-based one, exhibited significantly higher increase in median Hgb levels, especially in the subset of patients with non-metastatic disease (two-sided p < 0.01 for all comparisons). The former group also experienced a higher rate of deep venous thrombosis, acute coronary syndrome and stroke (p < 0.05 for all comparisons) but not of pulmonary embolism (p = 0.61). These differences were more prominent in the subset of patients who received adjuvant treatment, as compared to those who received first-line treatment (p < 0.01 for all comparisons). There were no significant differences in overall mortality and relapse/progression rates between the two groups. Detailed safety and efficacy outcomes in both the adjuvant and metastatic setting across various tumor types will be presented in the meeting.


Prophylactic administration of ESA for CIA in patients with solid tumors was associated with increased incidence of a composite of thrombosis-related adverse events, especially in patients receiving adjuvant treatment, but did not have a detrimental impact on relapse/progression and survival rates.


All authors have declared no conflicts of interest.