Despite evidence that fit, elderly patients respond similarly to younger patients in terms of efficacy and toxicity of chemotherapy treatments, false assumptions about the ability of elderly patients to tolerate aggressive treatment may result in them missing out on optimum treatment and not being included in clinical trials. Age alone should not be regarded as sufficient criterion to make evidence-based treatment decisions in the management of haematological disorders. These were the key conclusions from an eminent panel of international speakers at a symposium sponsored by Hospira at the 15th Congress of the European Haematology Association (EHA), Barcelona.
Haematological disorders and solid tumours predominantly affect people over the age of 651, however due to the under-representation of this population group in clinical trials there is often a lack of clear guidance in treatment.
The management of haematological disorders, such as leukaemia, neutropenia and anaemia present challenges in the elderly. The median age of onset of patients with hairy cell leukaemia, a rare, chronic, lymphoproliferative disorder is 52 years and old age is negatively correlated with the outcome of hairy cell leukaemia. However, if treatment is optimised, older patients can be successfully treated. Professor Michael Grever, Chair of the Department of Internal Medicine and Professor of Internal Medicine and Pharmacology at The Ohio State University Medical Center, Columbus, USA commented: “Optimising the dosing schedule of drugs such as pentostatin (Nipent) may minimise adverse events whilst still maintaining clinical activity. This could be important to those of advanced age.”
Similarly there are issues to be considered when preventing febrile neutropenia (FN) in an older population as studies have shown that haematopoietic reserves decline progressively with age, resulting in increased chemotherapy-related haematological toxicity. Furthermore, patients aged 65 or over are at an increased risk of FN. Granulocyte colony-stimulating factor (G-CSF), such as NivestimTM (filgrastim), has been shown to reduce the duration of chemotherapy-induced neutropenia, and reduce the occurrence of FN in elderly patients, demonstrating that the administration of recombinant G-CSF remains a prophylactic as well as a therapeutic option in this age group. Current clinical practice guidelines include specific statements for the use of G-CSF in patients receiving chemotherapy for cancer treatment.
Anaemia, which is commonly associated with fatigue and poor quality of life, is particularly prevalent in older adults. In adults older than 50 years, the incidence of anaemia increases with age, and can range from >20% in community-dwelling adults aged 85 and older to 48–63% of those living in nursing home accommodation. Erythropoiesis stimulating agents (ESAs) are indicated for the treatment of chemotherapy induced-anaemia and anaemia associated with chronic kidney disease (CKD). A phase III study in anaemic patients with end-stage renal failure who were undergoing chronic haemodialysis, demonstrated that epoetin zeta (Hospira’s Retacrit) and epoetin alfa (Janssen-Cilag’s Eprex) effectively maintained haemoglobin levels in patients irrespective of age (≤65 vs >65 years). In addition, epoetin alfa therapy has been shown to be equally effective in patients irrespective of age, is well tolerated and led to an improvement in quality of life in patients ≥ 65 years.
Professor Emili Montserrat, Professor of Medicine at the Institute of Haematology and Oncology Hospital Clinic, University of Barcelona, Spain, said: “People across the world are living longer and physically in better condition; therefore there is a need for more inclusion of older patients in clinical trials to give us the tools to tailor treatments and thus improve outcomes.”
The mean age of the global population is rising and the consequences of under representing older people in clinical trials results in a lack of data on the efficacy and safety of drugs in this growing population, limiting the ability to make treatment decisions on evidence-based medicine.
“As part of Hospira’s continued commitment to haematology we support the inclusion of older people in clinical trials to ensure that treatments developed reflect and take into account the health and needs of older people,” said Dr Helen Phillips, Hospira’s Medical Director for Europe, Middle East and Africa.