Source: DGNews  |  Posted 3 years ago

By Ed Susman

SAN FRANCISCO -- January 19, 2009 -- Patients who were prescribed oral capecitabine for treatment of breast or gastrointestinal (GI) cancer appear to be highly compliant in taking the oral medication, according to a study conducted in Switzerland.

"While oral therapy has increased convenience with a reduced risk of venous access complications compared with intravenous drug administration, compliance with intravenous drugs can be assumed, but the same is not true for oral therapy," said Ralph Winterhalder, MD, Kantonsspital Lucerne, Lucerne, Switzerland.

He presented the study results here on January 17 at the American Society of Clinical Oncology's 6th Gastrointestinal Cancers Symposium (ASCO-GI), cosponsored by the American Gastrointestinal Association Foundation, the American Society for Radiation Oncology, and the Society of Surgical Oncology.

For the study, patients receiving capecitabine either as monotherapy or in combination with other chemotherapeutic agents recorded their daily capecitabine intake and any adverse effects on a diary. After completion of therapy for a maximum of 8 cycles, the data were transferred to a questionnaire in which the reasons for discontinuation were also collected. Differences in compliance rates were also analysed according to age, Eastern Cooperative Oncology Group performance status, tumour type, and disease stage.

In their study, Dr. Winterhalder and colleagues evaluated 143 patients with GI tumours and 34 with breast cancer. The 90 men and 87 women in the study were a mean of 66 years old. About 90% of patients had a good (0-1) performance status.

Of the overall cohort, 91% took capecitabine as prescribed for the entire course of treatment. Reasons for interrupting therapy included forgetting to take treatment (56%), adverse effects (25%), and misunderstanding instructions (19%).

Patients with GI or metastatic tumours made more intake errors (9%) than patients with breast cancer (3%). Patients with metastatic disease (10%) had more intake errors than those receiving adjuvant treatments (5%).

Dr. Winterhalder said that the 16 patients who did make compliance errors included 9 instances in which the patients forgot to take the medicine. He said that despite the impressive compliance figures seen in the study, there are ways to improve the compliance further.

"Patient management systems such as patient diaries may further improve compliance and adherence with treatment," he said during his poster presentation. "Compliance may be further improved by educating patients about how to recognise and manage treatment toxicities."

The researchers analysed compliance outcomes based on age and found little differences for available data. Compliance was 92.3% among the 13 patients older than 80 years, 91.5% among the 47 patients who were 70 to 80 years of age, and 90.9% among the 110 patients younger than 70 years.

Performance status, similarly, had no impact on compliance, Dr. Winterhalder reported. However, the appearance of adverse effects did predict compliance failure. About 95% of those with no reported adverse events remained compliant, but among patients with 3 or more adverse effects, compliance dipped to 66.7%.

About 52% of patients reported diarrhoea, 32.5% reported hand-foot syndrome, 30.8% experienced nausea or vomiting, 7.7% experienced stomatitis, and 6.8% reported neuropathy, he said.

The study received funding support from Roche Pharma (Schweiz) AG.

[Presentation title: Compliance With Capecitabine: Findings From a Prospective Cohort Analysis. Abstract 420]