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Observational Studies

Weinfurt, Castel, Li, Timbie, Glendenning & Schulman . Health-related quality of life among patients with breast cancer receiving zoledronic acid or pamidronate disodium for metastatic bone lesions. Medical care. 42(2). 2004.
Design: Prospective cohort study (prognosis),
Grade : 2−
Country: United States
Inclusion criteria:
Histologically confirmed BC
At least 1 bone metastasis confirmed by radiography
Ambulatory
Over 18 years
ECOG status 0–3
In receipt of anti-neoplastic therapy
Good clinical condition
Not more than 2nd line endocrine therapy unless combined with chemotherapy
Exclusion criteria:
Pregnancy
Treatment with bisphosphonates <12 months before 1st visit
Lymphangitic lung metastases
Symptomatic brain metastases
History of treatment non-compliance or unreliable behaviour
Grade III or IV heart disease
Population:
number of patients = 1124, mean age = 58 years.
Interventions:
Zoledronate at 4mg (n = 377) or 8mg (n = 360) as a 5 min iv infusion or pamidronate at 90mg (n = 387) by 90 min iv infusion every 3–4 weeks for 12 months in addition to current anti-cancer treatment.

At some unspecified point, patients were removed from the 8mg zoledronate dose and were put on 4mg as a 15 min iv infusion (8/4mg).
Outcomes:
Health related quality of life.
Follow up:
Baseline data collected included age, education, employment status, geographic region, current therapy, treatment group, previous SRE, days from initial cancer diagnosis to randomisation and days from first bone metastasis to randomisation.

Quality of life (QOL) was assessed by analysis of FATG questionnaires completed by patients at baseline and after 12, 24, 36 and 51 weeks on arrival at the clinic and before seeing the physician or receiving medication. Data were analysed on the intention to treat principle.

The percentage of patients completing the full course of treatment was 63% in the 4mg zoledronate arms and 60% in each of the other two arms. 30% of the drop-outs were due to adverse events and 26% to death.
Results:
The Authors concluded that over a 1 year period, the average patient on these treatments experienced a gradual improvement in overall, physical, functional and emotional wellbeing.

The results were illustrated by non-linear, 2nd or 3rd degree polynomial growth curves for FATG data: emotional and functional well-being - the lack of linearity was due to an initial increase followed by a plateau effect. These models did not fit data for the social/family well- being which was therefore un-interpretable.

There were significant variations among women in their experiences over time some of which were explained by differences in baseline status due to factors discussed above.

Women who had previously experienced a SRE before starting treatment began the study with significantly worse physical and functional well being. Authors conclude by saying that the positive mean change in health related QOL observed for patients treated with either regime was consistent with the notion that prevention of SREs could lead to a better QOL.
General comments:
This paper details a double blind, randomised controlled trial of two doses of zoledronate against pamidronate in patients with either multiple myeloma or stage IV breast cancer. The results for quality of life are reported here for only the latter group.

The trial was conducted at 207 centres in Canada, the USA, South America, Europe, Australia, New Zealand, Scandinavia and South Africa.

Health related QOL scores were analysed by conditional and unconditional models that took into account covariates that might explain variations between patients. These models appear to be complex but are thoroughly described. The covariates are as described by demographic data collected from each patient at baseline e.g. age, education etc. ECOG status was dichotomised and incorporated into the model.

This paper was predominantly based on testing the models to predict outcomes and contains little useful information on the treatment per se.

From: Chapter 6, Treatment Selection and Strategies

Cover of Metastatic Spinal Cord Compression
Metastatic Spinal Cord Compression: Diagnosis and Management of Patients at Risk of or with Metastatic Spinal Cord Compression.
NICE Clinical Guidelines, No. 75.
National Collaborating Centre for Cancer (UK).
Copyright © 2008, National Collaborating Centre for Cancer.

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