DOI: 10.1097/01.OTU.0000394173.78754.f9
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Issn Print: 1742-8009
Publication Date: 2010/08/01
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Excerpt
Data collected through clinical assessments and laboratory investigations can be applied to predict the risk of toxicity from chemotherapy for elderly cancer patients, according to the results of two studies reported at the ASCO Annual Meeting.
‘These two groundbreaking studies put to task key clinical and treatment variables, simple and commonly used laboratory values, and geriatric assessment parameters to predict “chemotoxicity”,’ said the studies’ Discussant Dr Hyman Muss, professor of medicine and director of geriatric oncology at the University of North Carolina Lineberger Comprehensive Cancer Center.
‘They took advantage of data that we all have readily available and added geriatric assessment parameters as well to develop simple scales to predict toxicity.’
Chemotherapy can improve outcomes for older patients with cancer, he explained, but the toxicity in these patients is greater because they have less organ reserve and more co-morbidities. Predicting the risk of toxicity is the key to minimising functional loss and maximising quality of life.
‘The immediate solution is to develop simple scales that are fast, with minimal data collection, that are generic for tumour types and stages, and adjustable for treatment’, said Dr Muss.
Researchers at the H Lee Moffitt Cancer Center & Research Institute set out to build a predictive score that would be valid across several chemotherapy regimens and take into account chemotherapy and patient variables. Dr Martine Extermann established the Max 2 index that summarises the risk of Grade 4 haematological toxicity and Grade 3-4 non-haematological toxicity.
‘These endpoints were chosen because they are associated with instructions to modify the dosage of regimens in most clinical trials’, said Dr Lodovico Balducci, programme leader in senior adult oncology at the Moffitt Centre.
The researchers observed the correlation between toxicity and several patient variables and tested them in 2,564 patients in four Eastern Cooperative Oncology Group trials. Regimens were stratified into low-, intermediate-, and high-risk Max 2 scores. Most toxicity occurred early in treatment during the first cycle of chemotherapy, Dr Balducci said.
The researchers then conducted a comprehensive analysis of variables in a prospective, multi-centre fashion. ‘We focused on reliable collection of toxicity data in order to create and validate an independent predictive score with the potential for clinical application, and ominously called it CRASH – Chemotherapy Risk Assessment Scale for High-Age Patients.’
Patients were recruited from seven community cancer centres in Florida, including the Moffitt centre. Variables were limited to those that could be routinely obtained in geriatric oncology practices, including age, sex, body mass index, diastolic blood pressure, and co-morbidity. Variables related to cancer included the stage of disease, marrow invasion, pre-treatment with chemotherapy, and tumour response.
The study included 518 patients, median age of 76, who were eligible for analysis. A total of 337 patients came from Moffitt and 181 from the affiliates. The patients had very similar baseline characteristics. They had 23 tumour types and had received 111 chemotherapy regimens.
The CRASH score showed that 32% of patients had Grade 4 haematological toxicity and 56% had Grade 3-4 non-haematological toxicity. The median time to toxicity was 22 days. Levels of haemoglobin, creatine clearance, and albumin, as well as co-morbidity, were significantly associated with severe toxicity. ‘This approach meets the conservative estimate of our predictive model’, Dr Balducci said.
In conclusion, Dr Balducci said: ‘Geriatric instruments are helpful in oncology. Several key impairments might be captured by shorter screens. A global approach is sound, given the striking number of chemotherapy regimens we give to older cancer patients.
