Overall side-effect bother consistently associated with early treatment discontinuation due to adverse events in four clinical trials with various cancer types and treatments.
Overall side-effect impact, the aggregated experience of multiple toxicities, can be captured with the single Functional Assessment of Cancer Therapy (FACT) item GP5 ("I am bothered by side effects of treatment"). The objective of this study was to evaluate the ability of item GP5 to indicate treatment tolerability by examining its association with early treatment discontinuation (ETD) due to adverse events (AEs) in four cancer trials.
The authors analyzed data from four clinical trials coordinated by the ECOG-ACRIN Cancer Research Group, covering breast cancer (E1Z11, all patients received anastrozole; E1Z03, compared anastrozole vs. exemestane), melanoma (E1609, compared ipilimumab vs. high-dose interferon α), and chronic lymphocytic leukemia (E1912, compared ibrutinib-rituximab bs. standard chemoimmunotherapy). In each trial, GP5 responses were categorized as severe bother (i.e., "very much"/"quite a bit") versus moderate/low bother ("somewhat"/"a little bit"/"not at all").
At 3 months, significant associations were observed in each trial, indicating approximately 2.8-6.8 times greater odds of ETD among patients reporting severe bother (E1Z03: adjusted odds ratio [aOR], 2.82; 95% confidence interval [95% CI], 1.10-7.28; E1Z11: aOR, 4.10; 95% CI, 1.69-10.00; E1609: aOR, 6.77; 95% CI, 2.88-15.92; E1912: aOR, 4.15; 95% CI, 1.64-10.49).
These results support prior research demonstrating an association between severe side-effect bother, as reported on responses to the GP5 item, and ETD among patients with newly diagnosed multiple myeloma. The consistent association between GP5 responses and ETD suggests the GP5's ability to capture how well patients tolerate treatment, especially when side-effect bother is observed early in the course of treatment, and signals an opportunity to develop interventions to promote treatment adherence.
The authors analyzed data from four clinical trials coordinated by the ECOG-ACRIN Cancer Research Group, covering breast cancer (E1Z11, all patients received anastrozole; E1Z03, compared anastrozole vs. exemestane), melanoma (E1609, compared ipilimumab vs. high-dose interferon α), and chronic lymphocytic leukemia (E1912, compared ibrutinib-rituximab bs. standard chemoimmunotherapy). In each trial, GP5 responses were categorized as severe bother (i.e., "very much"/"quite a bit") versus moderate/low bother ("somewhat"/"a little bit"/"not at all").
At 3 months, significant associations were observed in each trial, indicating approximately 2.8-6.8 times greater odds of ETD among patients reporting severe bother (E1Z03: adjusted odds ratio [aOR], 2.82; 95% confidence interval [95% CI], 1.10-7.28; E1Z11: aOR, 4.10; 95% CI, 1.69-10.00; E1609: aOR, 6.77; 95% CI, 2.88-15.92; E1912: aOR, 4.15; 95% CI, 1.64-10.49).
These results support prior research demonstrating an association between severe side-effect bother, as reported on responses to the GP5 item, and ETD among patients with newly diagnosed multiple myeloma. The consistent association between GP5 responses and ETD suggests the GP5's ability to capture how well patients tolerate treatment, especially when side-effect bother is observed early in the course of treatment, and signals an opportunity to develop interventions to promote treatment adherence.
Authors
Peipert Peipert, Ganatra Ganatra, Zhao Zhao, Lee Lee, Roydhouse Roydhouse, Ip Ip, O'Connell O'Connell, Carlos Carlos, Graham Graham, Smith Smith, Gareen Gareen, Tarhini Tarhini, Shanafelt Shanafelt, Stearns Stearns, Raper Raper, Cella Cella, Gray Gray, Wagner Wagner
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