PURPOSE
To 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 MATERIALS
Between 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.
RESULTS
A 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.
CONCLUSIONS
In 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.
Background
There is conflicting evidence regarding the benefit of post-mastectomy radiation therapy (PMRT) for pathologic stage T3N0M0 breast cancers. We analyzed data from the Surveillance, Epidemiology, and End Results (SEER) database to investigate the benefit of PMRT in these patients.
Methods
We queried the SEER database for T3N0M0 breast cancer patients diagnosed from 2000–2010 who underwent modified radical mastectomy. We excluded males, patients with unknown radiation timing/type, other primary tumors, or survival <6 months. 2525 patients were included in this analysis. We performed univariate and multivariate statistical analysis using Chi-squared tests, log rank test, and Cox proportional hazards regression. Primary endpoints were overall survival (OS) and breast cancer-specific survival (CSS).
Results
Of the 2525 patients identified, 1063 received PMRT. The median follow-up was 56 months (range: 6–131).
On univariate analysis, PMRT improved OS (76.5% vs. 61.8%, p<0.01) and CSS (85.0% vs. 82.4%, p<0.01) at 8 years. The use of PMRT remained significant on multivariate analysis: PMRT improved OS (HR 0.63, p<0.001) and CSS (HR 0.77, p=0.045). Low tumor grade (p<0.01) and marital status "married" (p=0.01) also predicted for improved CSS on multivariate analysis.
Conclusion(s)
PMRT was associated with significant improvements in both CSS and OS in patients with T3N0M0 breast cancers treated with modified radical mastectomy from 2000 to 2010. PMRT should be strongly considered in T3N0M0 patients.
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