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Stereotactic Body Radiation Therapy for Prostate Cancer: What Is the Appropriate Patient-Reported Outcome for Clinical Trial Design?
Poster Viewing Abstracts S705
Volume 90 Number 1S Supplement 2014
3256 Long-Term Trajectory of Quality of Life in Nasopharyngeal Cancer Patients A. Kiang, K.N. Cheung, V.K. Weinberg, E. Shugard, J.M. Quivey, and S.S. Yom; Department of Radiation Oncology, University of California, San Francisco, San Francisco, CA Purpose/Objectives(s): There are limited data on the long-term side effects of intensity-modulated radiation therapy (IMRT), especially past the 5-year range of follow-up. The purpose of this study was to quantify and compare quality of life (QOL) among <1-16 year survivors of nasopharyngeal carcinoma (NPC) who received IMRT. We hypothesized that certain disease-specific QOL domains, such as cognitive deficits, would uniquely affect long-term survivors. To our knowledge this is the longest QOL series of IMRT that has been performed. Materials/Methods: This was a cross-sectional cohort study offered to all living patients who received curative-intent IMRT for Stage I-IVB NPC. Two questionnaires, FACT-NP and FACT-Cog, were used in this study and were completed once by each patient at the most recent post-radiation follow-up. FACT-NP is comprised of a general QOL measure (FACT-G) plus an NPC-subscale (NPCS) that measures disease-specific symptoms. Responses were collected between May and November 2013 by phone, mail, or e-mail, per patient preference. Results: 46 surviving patients agreed to participate in the study, and were divided into quartiles of time since end of IMRT. Overall, median time since treatment was 5.7 years (range: <1-16 years) with lower and upper quartiles 2.6 and 10.8 years, respectively. Among the quartiles, a significant difference was observed by 1-way analysis of variance in FACT-G total (p Z 0.005) and NPCS scores (p Z 0.02). Newman-Keuls post-hoc tests showed that FACT-G total was significantly lower in the 1st quartile compared all other groups (p Z 0.01 for each). The NPCS score was significantly lower in the 1st (p Z 0.04) and 4th quartile (p Z 0.02) when compared to the 2nd quartile. In terms of cognitive QOL, the overall difference in the FACT-Cog total score was of borderline statistical significance (p Z 0.06). There were significant quadratic effects defined by linear contrasts for the ANOVA models in which FACT-G, NPCS, and FACT-Cog all increased after about 3 years and then decreased with longterm follow-up (p0.01 for each). Age at time of study participation was not significantly different among the groups (p Z 0.83) and was not correlated with FACT-G, NPCS, or FACT-Cog scores (Pearson’s correlation: p Z 0.39, 0.75, 0.31, respectively). Conclusions: Based on FACT-G scores, general QOL improved starting 2.6 years after IMRT and this is maintained above the initial quartile over the long-term. Meanwhile, all outcomes demonstrated a quadratic effect in which scores increased initially but decreased over the long-term at about 10 years. This study indicates that long-term QOL changes are observed with the use of both general and disease-specific assessments. Due to the small sample size, however, further investigation is warranted to control for the potential effect of IMRT technological evolution and to better specify the level of change in cognitive QOL over time. Author Disclosure: A. Kiang: None. K.N. Cheung: None. V.K. Weinberg: A. Employee; University of California, San Francisco. E. Shugard: A. Employee; University of California, San Francisco. J.M. Quivey: A. Employee; University of California, San Francisco. S.S. Yom: A. Employee; University of California, San Francisco. S. Leadership; Scientific Program Chair, American Radium Society, Chair, Appropriateness Committee-Head and Neck, American College of Radiology, Senior Editor, International Journal of Radiation Oncology Biology Physics.
3257 Stereotactic Body Radiation Therapy for Prostate Cancer: What Is the Appropriate Patient-Reported Outcome for Clinical Trial Design? J.A. Woo,1 L.N. Chen,1 H. Wang,2 J.S. Kim,1 T.M. Yung,1 S. Lei,1 B.T. Collins,1 S. Suy,1 A. Dritschilo,1 and S.P. Collins1; 1Georgetown University Department of Radiation Medicine, Washington, DC, 2 Georgetown University Department of Biostatistics, Washington, DC
Purpose/Objective(s): Stereotactic body radiation therapy (SBRT) is increasingly utilized as primary treatment for clinically localized prostate cancer. Consensus regarding what are the appropriate patient-reported outcome (PRO) endpoints for clinical trials is lacking. This study presents PROs over a 36-month period following SBRT for clinically localized prostate cancer. Materials/Methods: Between Feb. 2008 and Dec. 2010, 174 hormonenaı¨ve patients with clinically localized prostate cancer were treated with 35-36.25 Gy SBRT (robotic SBRT) delivered in 5 fractions. Patients completed the validated Expanded Prostate Cancer Index Composite (EPIC)-26 questionnaire at baseline, 1 month post-treatment, then every 6 months for the next three years. The proportion of patients developing a clinically significant decline in each EPIC domain score was determined. The minimally important difference (MID) was defined as a change of onehalf standard deviation from the baseline. Per RTOG 0938, we also examined the percentage of patients who experienced a decline in EPIC urinary domain summary score of >2 points (unacceptable toxicity defined as > 60% of all patients reporting this degree of decline) and EPIC bowel domain summary score of >5 points (unacceptable toxicity defined as > 55% of all patients reporting this degree of decline) from baseline to one year. Results: A total of 174 patients at a median age of 69 years received SBRT with a minimum follow-up of 36 months. The proportion of patients reporting a clinically significant decline (MID for urinary/bowel are 5.5/ 4.4) in EPIC urinary/bowel domain scores was 34%/30% at 6 months, 40%/32.2% at 12 months and 32.8%/21.5% at 36 months. The percentage of patients reporting a decrease in the EPIC urinary domain summary score of >2 points was 43.2% (CI: 33.7%, 54.6%) at 6 months, 51.6% (CI: 43.4%, 59.7%) at 12 months and 41.8% (CI: 33.3%, 50.6%) at 36 months. The percentage of patients reporting a decrease in the EPIC bowel domain summary score of >5 points was 29.6% (CI: 21.9%, 39.3%) at 6 months, 29% (CI: 22%, 36.8%) at 12 months and 22.4% (CI: 15.7%, 30.4%) at 36 months. Conclusions: Following prostate SBRT, clinically significant urinary symptoms are more common than bowel symptoms. Our prostate SBRT treatment protocol meets the RTOG 0938 criteria for moving forward to a Phase III trial comparing it to conventionally fractionated radiation therapy. Notably, between 12 and 36 months, the proportion of patients reporting a significant decrease in both EPIC urinary and bowel domain scores declined, suggesting a late improvement in these symptom domains. Further investigation is needed to elucidate 1) which EPIC domains bear the greatest influence on post-treatment quality of life and 2) at what time point PRO endpoints should be assessed. Author Disclosure: J.A. Woo: None. L.N. Chen: None. H. Wang: None. J.S. Kim: None. T.M. Yung: None. S. Lei: None. B.T. Collins: G. Consultant; Accuray. S. Suy: None. A. Dritschilo: None. S.P. Collins: G. Consultant; Accuray.
3258 High-Precision Conformal Radiation Therapy in Head-Neck Cancers: Longitudinal Changes in Quality-of-Life and Temporal Time-Trends S. Rathod, T. Gupta, S. Laskar, V. Murthy, A. Budrukkar, and J. Agarwal; Tata Memorial Centre, Mumbai, India Purpose/Objective(s): To report longitudinal changes in quality-of-life (QOL) and temporal time-trends in a cohort of head-neck cancer (HNC) patients treated with high-precision radiation therapy i.e. three-dimensional conformal radiation therapy (3D-CRT) and intensity-modulated radiation therapy (IMRT). Materials/Methods: One hundred nineteen HNC patients treated on two randomized controlled trials comparing 3D-CRT and IMRT were included. QOL was assessed by the European Organization for Research & Treatment of Cancer (EORTC) quality-of-life questionnaire (QLQ-C30) with its head-neck module (H&N35) at baseline (pre-treatment) and subsequently at 3, 6 & 12-months post-treatment. Mean score for each QOL domain was evaluated longitudinally. Magnitude of deterioration in QOL scores was graded in 3 groups (>20 points-major, 10-20 points-moderate & <10
Volume 90 Number 1S Supplement 2014
3256 Long-Term Trajectory of Quality of Life in Nasopharyngeal Cancer Patients A. Kiang, K.N. Cheung, V.K. Weinberg, E. Shugard, J.M. Quivey, and S.S. Yom; Department of Radiation Oncology, University of California, San Francisco, San Francisco, CA Purpose/Objectives(s): There are limited data on the long-term side effects of intensity-modulated radiation therapy (IMRT), especially past the 5-year range of follow-up. The purpose of this study was to quantify and compare quality of life (QOL) among <1-16 year survivors of nasopharyngeal carcinoma (NPC) who received IMRT. We hypothesized that certain disease-specific QOL domains, such as cognitive deficits, would uniquely affect long-term survivors. To our knowledge this is the longest QOL series of IMRT that has been performed. Materials/Methods: This was a cross-sectional cohort study offered to all living patients who received curative-intent IMRT for Stage I-IVB NPC. Two questionnaires, FACT-NP and FACT-Cog, were used in this study and were completed once by each patient at the most recent post-radiation follow-up. FACT-NP is comprised of a general QOL measure (FACT-G) plus an NPC-subscale (NPCS) that measures disease-specific symptoms. Responses were collected between May and November 2013 by phone, mail, or e-mail, per patient preference. Results: 46 surviving patients agreed to participate in the study, and were divided into quartiles of time since end of IMRT. Overall, median time since treatment was 5.7 years (range: <1-16 years) with lower and upper quartiles 2.6 and 10.8 years, respectively. Among the quartiles, a significant difference was observed by 1-way analysis of variance in FACT-G total (p Z 0.005) and NPCS scores (p Z 0.02). Newman-Keuls post-hoc tests showed that FACT-G total was significantly lower in the 1st quartile compared all other groups (p Z 0.01 for each). The NPCS score was significantly lower in the 1st (p Z 0.04) and 4th quartile (p Z 0.02) when compared to the 2nd quartile. In terms of cognitive QOL, the overall difference in the FACT-Cog total score was of borderline statistical significance (p Z 0.06). There were significant quadratic effects defined by linear contrasts for the ANOVA models in which FACT-G, NPCS, and FACT-Cog all increased after about 3 years and then decreased with longterm follow-up (p0.01 for each). Age at time of study participation was not significantly different among the groups (p Z 0.83) and was not correlated with FACT-G, NPCS, or FACT-Cog scores (Pearson’s correlation: p Z 0.39, 0.75, 0.31, respectively). Conclusions: Based on FACT-G scores, general QOL improved starting 2.6 years after IMRT and this is maintained above the initial quartile over the long-term. Meanwhile, all outcomes demonstrated a quadratic effect in which scores increased initially but decreased over the long-term at about 10 years. This study indicates that long-term QOL changes are observed with the use of both general and disease-specific assessments. Due to the small sample size, however, further investigation is warranted to control for the potential effect of IMRT technological evolution and to better specify the level of change in cognitive QOL over time. Author Disclosure: A. Kiang: None. K.N. Cheung: None. V.K. Weinberg: A. Employee; University of California, San Francisco. E. Shugard: A. Employee; University of California, San Francisco. J.M. Quivey: A. Employee; University of California, San Francisco. S.S. Yom: A. Employee; University of California, San Francisco. S. Leadership; Scientific Program Chair, American Radium Society, Chair, Appropriateness Committee-Head and Neck, American College of Radiology, Senior Editor, International Journal of Radiation Oncology Biology Physics.
3257 Stereotactic Body Radiation Therapy for Prostate Cancer: What Is the Appropriate Patient-Reported Outcome for Clinical Trial Design? J.A. Woo,1 L.N. Chen,1 H. Wang,2 J.S. Kim,1 T.M. Yung,1 S. Lei,1 B.T. Collins,1 S. Suy,1 A. Dritschilo,1 and S.P. Collins1; 1Georgetown University Department of Radiation Medicine, Washington, DC, 2 Georgetown University Department of Biostatistics, Washington, DC
Purpose/Objective(s): Stereotactic body radiation therapy (SBRT) is increasingly utilized as primary treatment for clinically localized prostate cancer. Consensus regarding what are the appropriate patient-reported outcome (PRO) endpoints for clinical trials is lacking. This study presents PROs over a 36-month period following SBRT for clinically localized prostate cancer. Materials/Methods: Between Feb. 2008 and Dec. 2010, 174 hormonenaı¨ve patients with clinically localized prostate cancer were treated with 35-36.25 Gy SBRT (robotic SBRT) delivered in 5 fractions. Patients completed the validated Expanded Prostate Cancer Index Composite (EPIC)-26 questionnaire at baseline, 1 month post-treatment, then every 6 months for the next three years. The proportion of patients developing a clinically significant decline in each EPIC domain score was determined. The minimally important difference (MID) was defined as a change of onehalf standard deviation from the baseline. Per RTOG 0938, we also examined the percentage of patients who experienced a decline in EPIC urinary domain summary score of >2 points (unacceptable toxicity defined as > 60% of all patients reporting this degree of decline) and EPIC bowel domain summary score of >5 points (unacceptable toxicity defined as > 55% of all patients reporting this degree of decline) from baseline to one year. Results: A total of 174 patients at a median age of 69 years received SBRT with a minimum follow-up of 36 months. The proportion of patients reporting a clinically significant decline (MID for urinary/bowel are 5.5/ 4.4) in EPIC urinary/bowel domain scores was 34%/30% at 6 months, 40%/32.2% at 12 months and 32.8%/21.5% at 36 months. The percentage of patients reporting a decrease in the EPIC urinary domain summary score of >2 points was 43.2% (CI: 33.7%, 54.6%) at 6 months, 51.6% (CI: 43.4%, 59.7%) at 12 months and 41.8% (CI: 33.3%, 50.6%) at 36 months. The percentage of patients reporting a decrease in the EPIC bowel domain summary score of >5 points was 29.6% (CI: 21.9%, 39.3%) at 6 months, 29% (CI: 22%, 36.8%) at 12 months and 22.4% (CI: 15.7%, 30.4%) at 36 months. Conclusions: Following prostate SBRT, clinically significant urinary symptoms are more common than bowel symptoms. Our prostate SBRT treatment protocol meets the RTOG 0938 criteria for moving forward to a Phase III trial comparing it to conventionally fractionated radiation therapy. Notably, between 12 and 36 months, the proportion of patients reporting a significant decrease in both EPIC urinary and bowel domain scores declined, suggesting a late improvement in these symptom domains. Further investigation is needed to elucidate 1) which EPIC domains bear the greatest influence on post-treatment quality of life and 2) at what time point PRO endpoints should be assessed. Author Disclosure: J.A. Woo: None. L.N. Chen: None. H. Wang: None. J.S. Kim: None. T.M. Yung: None. S. Lei: None. B.T. Collins: G. Consultant; Accuray. S. Suy: None. A. Dritschilo: None. S.P. Collins: G. Consultant; Accuray.
3258 High-Precision Conformal Radiation Therapy in Head-Neck Cancers: Longitudinal Changes in Quality-of-Life and Temporal Time-Trends S. Rathod, T. Gupta, S. Laskar, V. Murthy, A. Budrukkar, and J. Agarwal; Tata Memorial Centre, Mumbai, India Purpose/Objective(s): To report longitudinal changes in quality-of-life (QOL) and temporal time-trends in a cohort of head-neck cancer (HNC) patients treated with high-precision radiation therapy i.e. three-dimensional conformal radiation therapy (3D-CRT) and intensity-modulated radiation therapy (IMRT). Materials/Methods: One hundred nineteen HNC patients treated on two randomized controlled trials comparing 3D-CRT and IMRT were included. QOL was assessed by the European Organization for Research & Treatment of Cancer (EORTC) quality-of-life questionnaire (QLQ-C30) with its head-neck module (H&N35) at baseline (pre-treatment) and subsequently at 3, 6 & 12-months post-treatment. Mean score for each QOL domain was evaluated longitudinally. Magnitude of deterioration in QOL scores was graded in 3 groups (>20 points-major, 10-20 points-moderate & <10