Long-term patient reported outcomes from a phase III randomized prospective trial of conventional versus hypofractionated radiotherapy for localized prostate cancer

Publication date: Available online 28 December 2016
Source:International Journal of Radiation Oncology*Biology*Physics
Author(s): Talha Shaikh, Tianyu Li, Elizabeth A. Handorf, Matthew E. Johnson, Lora S. Wang, Mark A. Hallman, Richard E. Greenberg, Robert A. Price, Robert G. Uzzo, Charlie Ma, David Chen, Daniel M. Geynisman, Alan Pollack, Eric M. Horwitz
PurposeTo assess the long-term quality of life (QoL) outcomes from a phase III trial comparing conventional (CIMRT) versus hypofractionated (HIMRT) IMRT in patients with localized prostate cancer.Methods and MaterialsBetween 2002 and 2006, 303 men with low- to high-risk prostate cancer were randomized to 76 Gy in 38 fractions (CIMRT) versus 70.2 Gy in 26 fractions (HIMRT). QoL was compared using the Expanded Prostate Cancer Index Composite (EPIC), International Prostate Symptom Score (IPSS), and EuroQoL (EQ5D) questionnaires. The primary outcome of the quality of life analysis was a minimum clinically important difference defined as a 0.5 standard deviation change from baseline for each respective QoL parameter. Treatment effects were evaluated using logistic mixed effects regression models.ResultsA total of 286, 299, and 218 patients had baseline EPIC, IPSS, or EQ5D data available and were included in the analysis. Overall, there was no statistically significant difference between the two treatment arms in terms of EPIC, IPSS, or EQ5D scores over time although there was a trend towards lower EPIC urinary incontinence scores in the HIMRT arm. More patients in the HIMRT arm had a lower EPIC urinary incontinence score relative to baseline versus patients in the CIMRT arm with long-term follow-up. On multivariable analysis, there was no association between radiation fractionation scheme and any QoL parameter. When examining other clinical factors, lymph node radiation was associated with worse EPIC hormonal scores versus patients receiving no lymph node radiation. In general, QoL outcomes were generally stable over time with the exception of EPIC hormonal and EQ5D scores.ConclusionsIn this randomized prospective study, there were stable QoL changes in patients receiving HIMRT or CIMRT. Our results add to the growing body of literature suggesting that HIMRT may be an acceptable treatment modality in clinically localized prostate cancer.

Teaser

There is no long-term randomized prospective data comparing quality of life outcomes of patients treated with conventional versus hypofractionated radiotherapy. In this randomized phase III trial, patients receiving hypofractionated radiotherapy appeared to have similar long-term quality of life outcomes versus patients receiving conventionally fractionated radiation. These long-term results suggest that hypofractionated radiation can be delivered effectively and safely in a select group of patients with prostate cancer.


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