The First Clinical Trial to Incorporate Patient Quality of Life Measures

Comparing Continuous vs Intermittent Chemotherapy Treatment for Advanced Breast Cancer

In the early 1980’s chemotherapy was widely used in the treatment of metastatic breast cancer and while it produced remission in some cases, chemotherapy was not a curative treatment and the optimal duration of chemotherapy was undefined.

Standard treatment involved long periods of chemotherapy and previous research showed that continued treatment until the maximum tolerable dosage had been reached, produced unwanted side effects for patients and was unpopular.

Researchers wanted to investigate if patients could benefit from intermittent chemotherapy treatment, while still maintaining control of the disease, so that patients could enjoy periods without the side effects of chemotherapy and improve their quality of life.

The ANZ8101 clinical trial compared continuous chemotherapy with intermittent therapy, whereby treatment was stopped after three cycles and then repeated for three more cycles only when there was evidence of disease progression.

In what was landmark research, it was the first time that a breast cancer clinical trial incorporated patient reported outcomes or quality of life measures.

Intermittent therapy resulted in a significantly worse response, a significantly shorter time to disease progression and a trend toward shorter survival. It was also associated with worse scores for physical well-being, mood and appetite, and for a quality-of-life index as indicated by the patient.

Researchers concluded that continuous chemotherapy was better than intermittent chemotherapy in controlling the disease and women with advanced disease could be assured that the standard treatment was the best available.

The results were published in the New England Journal of Medicine and 308 patients participated in the study across Australia and New Zealand.

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Professor Alan Coates AM

Professor Alan Coates was the Breast Cancer Trials Study Chair of the ANZ8101 Clinical Trial.