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Early Patient-Reported Outcomes in a Randomized Phase II Trial of HDR Monotherapy in Low and Intermediate Risk Prostate Cancer
Abstracts / Brachytherapy 15 (2016) S21eS204 Reference [1] Hoskin PJ, Rojas AM, Bownes PJ, Lowe GJ, Ostler PJ, Bryant L. Randomised trial of external beam radiotherapy alone or combined with high-dose-rate brachytherapy boost for localised prostate cancer. Radiother Oncol. 2012 May;103(2):217-22. http://dx.doi.org/ 10.1016/j.radonc.2012.01.007. Epub 2012 Feb 16.
Figure 1. CD34 as a predictive biomarker for benefit from HDR brachytherapy boost in terms of Biochemical Relapse Free Survival (BRFS). The left panel shows the Kaplan-Meier survival plot for patients negative for CD34 and the right panel for patients positive for CD34. The blue line represents the HDR Brachytherapy boost arm and the red line the EBRT arm (HR 3.37 for EBRT compared to HDR-BTb, CI 1.47-7.69, p50.003).
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(5%). One patient experienced Grade 3 hematuria. Ten patients (6%) had urinary retention during the acute phase, but only 4 (2.5%) required use of a catheter for longer than 2 days. There was no difference in rate of Grade 2 toxicity between treatment arms; the only factor associated with grade 2 urinary retention on univariate and multivariate analysis was prostate volume (p50.0038). Mean IPSS was 5.5 at baseline, 10.4 at week 6, 7.4 at month 3, 7.6 at month 6 and 6.5 at months 9 and 12. Values within the first 6 months were significantly different from baseline (p !0.001). Patients treated on the 2-fraction arm had significantly higher IPSS scores within the first 3-months than those on the 1-fraction arm (p50.033). Mean EPIC urinary domain score for all patients decreased from 91.4 at baseline to 86.8 at 6 months and 87.7 at 12 months (p50.0003). Mean sexual domain score decreased from 63.0 at baseline to 46.7 at 6 months and 51.5 at 12 months (p!0.0001). Bowel and hormonal domain scores were unchanged at any time point. No difference was found in EPIC domain scores by treatment arm (Figure 1). Conclusions: HDR 19 Gy x 1 or 13.5 Gy x 2 is very well tolerated with no acute bowel toxicity and mild urinary toxicity. Patients treated on the 2-fraction arm reported more acute urinary symptoms. Mean EPIC urinary domain score decreased by less than 4 points at 12 months, with a greater decline in sexual domain score. No difference was found in acute toxicity or health-related quality of life within the first year between treatment arms.
PP54 Presentation Time: 8:18 AM Early Patient-Reported Outcomes in a Randomized Phase II Trial of HDR Monotherapy in Low and Intermediate Risk Prostate Cancer Gerard Morton, MD1, Hans T. Chung, MD1, Merrylee McGuffin, MRT2, Laura D’Alimonte, MRT2, Liying Zhang, PhD3, Ananth Ravi, PhD4, Joelle Helou, MD1, Andrew Loblaw, MD1. 1Radiation Oncology, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada; 2Radiation Therapy, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada; 3Biostatistics, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada; 4Medical Physics, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada. Purpose: Evidence supports the use of High Dose-Rate Brachytherapy (HDR) as monotherapy for selected patients with low and intermediate risk prostate cancer when given in schedules of 3 or more fractions. There is limited data on the safety and efficacy of HDR monotherapy given in one or two fractions. Our purpose is to report on acute toxicity (within 3 months) and early changes in health-related quality of life in a randomized trial comparing a single and a 2-fraction protocol. Materials and Methods: Eligible patients had NCCN low or intermediate risk disease, a prostate volume ! 60 cc, International Prostate Symptom Score (IPSS) of 18 or lower, no previous prostate surgery and no use of androgen deprivation therapy. Following informed consent, patients were randomized to receive either 19 Gy HDR as a single fraction (1F), or 27 Gy in 2 fractions one week apart (2F). Treatment was delivered using an out-patient ultrasound-based technique with the patient under general anaesthesia. Follow-up assessment was with CTCAE v4 and IPSS at 6 weeks, 12 weeks, every 3 months for the first year and then every 6 months. Health related quality of life was assessed using the Expanded Prostate Composite Index (EPIC) at baseline and every 6 months. Results: A total of 170 patients were randomized between June 2013 and April 2015: 87 to 1F and 83 to 2F arms. Median age was 65 years, median prostate volume was 35 cc, median PSA was 6.3 ng/ml, 72% had Gleason 7 cancer and 77% had intermediate risk disease, with no significant difference between arms. Median follow-up is 14 months, with 110 (65%) followed for over 1 year. Only 4 patients (2.4%) experienced any acute Grade 2 GI toxicity. The percentage of acute Grade 2 GU toxicities is as follows: retention (50%), frequency (21%), urgency
Figure 1. Mean EPIC Domain over time by treatment arm.
PP55 Presentation Time: 8:27 AM Low and Intermediate Risk Prostate Cancer Treated with Single Fraction 19 Gy High Dose Rate Brachytherapy as Monotherapy: Outcomes Comparison to Multi-Fraction Regimens Daniel Krauss, MD1, Hong Ye, MS1, Beth Mitchell, RN1, Michelle Wallace, RN1, Alvaro Martinez, MD2, Michel Ghilezan, MD2, Gary Gustafson, MD3. 1Radiation Oncology, Oakland University William Beaumont School of Medicine, Royal Oak, MI, USA; 221st Century Oncology, Pontiac, MI, USA; 3Radiation Oncology, Oakland University William Beaumont School of Medicine, Sterling Heights, MI, USA. Purpose: To evaluate the outcomes and toxicity of high dose rate (HDR) brachytherapy delivered in a single fraction of 19 Gy relative to historical multi-fraction HDR regimens. Materials and Methods: Between 1999 and 2015, patients at a single institution with low- and intermediate-risk prostate cancer were treated as part of an IRB-approved, prospective, non-randomized trial of HDR brachytherapy as monotherapy. The initial protocol phase treated a prescription dose of 38 Gy in 4 treatment fractions (single interstitial
Figure 1. CD34 as a predictive biomarker for benefit from HDR brachytherapy boost in terms of Biochemical Relapse Free Survival (BRFS). The left panel shows the Kaplan-Meier survival plot for patients negative for CD34 and the right panel for patients positive for CD34. The blue line represents the HDR Brachytherapy boost arm and the red line the EBRT arm (HR 3.37 for EBRT compared to HDR-BTb, CI 1.47-7.69, p50.003).
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(5%). One patient experienced Grade 3 hematuria. Ten patients (6%) had urinary retention during the acute phase, but only 4 (2.5%) required use of a catheter for longer than 2 days. There was no difference in rate of Grade 2 toxicity between treatment arms; the only factor associated with grade 2 urinary retention on univariate and multivariate analysis was prostate volume (p50.0038). Mean IPSS was 5.5 at baseline, 10.4 at week 6, 7.4 at month 3, 7.6 at month 6 and 6.5 at months 9 and 12. Values within the first 6 months were significantly different from baseline (p !0.001). Patients treated on the 2-fraction arm had significantly higher IPSS scores within the first 3-months than those on the 1-fraction arm (p50.033). Mean EPIC urinary domain score for all patients decreased from 91.4 at baseline to 86.8 at 6 months and 87.7 at 12 months (p50.0003). Mean sexual domain score decreased from 63.0 at baseline to 46.7 at 6 months and 51.5 at 12 months (p!0.0001). Bowel and hormonal domain scores were unchanged at any time point. No difference was found in EPIC domain scores by treatment arm (Figure 1). Conclusions: HDR 19 Gy x 1 or 13.5 Gy x 2 is very well tolerated with no acute bowel toxicity and mild urinary toxicity. Patients treated on the 2-fraction arm reported more acute urinary symptoms. Mean EPIC urinary domain score decreased by less than 4 points at 12 months, with a greater decline in sexual domain score. No difference was found in acute toxicity or health-related quality of life within the first year between treatment arms.
PP54 Presentation Time: 8:18 AM Early Patient-Reported Outcomes in a Randomized Phase II Trial of HDR Monotherapy in Low and Intermediate Risk Prostate Cancer Gerard Morton, MD1, Hans T. Chung, MD1, Merrylee McGuffin, MRT2, Laura D’Alimonte, MRT2, Liying Zhang, PhD3, Ananth Ravi, PhD4, Joelle Helou, MD1, Andrew Loblaw, MD1. 1Radiation Oncology, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada; 2Radiation Therapy, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada; 3Biostatistics, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada; 4Medical Physics, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada. Purpose: Evidence supports the use of High Dose-Rate Brachytherapy (HDR) as monotherapy for selected patients with low and intermediate risk prostate cancer when given in schedules of 3 or more fractions. There is limited data on the safety and efficacy of HDR monotherapy given in one or two fractions. Our purpose is to report on acute toxicity (within 3 months) and early changes in health-related quality of life in a randomized trial comparing a single and a 2-fraction protocol. Materials and Methods: Eligible patients had NCCN low or intermediate risk disease, a prostate volume ! 60 cc, International Prostate Symptom Score (IPSS) of 18 or lower, no previous prostate surgery and no use of androgen deprivation therapy. Following informed consent, patients were randomized to receive either 19 Gy HDR as a single fraction (1F), or 27 Gy in 2 fractions one week apart (2F). Treatment was delivered using an out-patient ultrasound-based technique with the patient under general anaesthesia. Follow-up assessment was with CTCAE v4 and IPSS at 6 weeks, 12 weeks, every 3 months for the first year and then every 6 months. Health related quality of life was assessed using the Expanded Prostate Composite Index (EPIC) at baseline and every 6 months. Results: A total of 170 patients were randomized between June 2013 and April 2015: 87 to 1F and 83 to 2F arms. Median age was 65 years, median prostate volume was 35 cc, median PSA was 6.3 ng/ml, 72% had Gleason 7 cancer and 77% had intermediate risk disease, with no significant difference between arms. Median follow-up is 14 months, with 110 (65%) followed for over 1 year. Only 4 patients (2.4%) experienced any acute Grade 2 GI toxicity. The percentage of acute Grade 2 GU toxicities is as follows: retention (50%), frequency (21%), urgency
Figure 1. Mean EPIC Domain over time by treatment arm.
PP55 Presentation Time: 8:27 AM Low and Intermediate Risk Prostate Cancer Treated with Single Fraction 19 Gy High Dose Rate Brachytherapy as Monotherapy: Outcomes Comparison to Multi-Fraction Regimens Daniel Krauss, MD1, Hong Ye, MS1, Beth Mitchell, RN1, Michelle Wallace, RN1, Alvaro Martinez, MD2, Michel Ghilezan, MD2, Gary Gustafson, MD3. 1Radiation Oncology, Oakland University William Beaumont School of Medicine, Royal Oak, MI, USA; 221st Century Oncology, Pontiac, MI, USA; 3Radiation Oncology, Oakland University William Beaumont School of Medicine, Sterling Heights, MI, USA. Purpose: To evaluate the outcomes and toxicity of high dose rate (HDR) brachytherapy delivered in a single fraction of 19 Gy relative to historical multi-fraction HDR regimens. Materials and Methods: Between 1999 and 2015, patients at a single institution with low- and intermediate-risk prostate cancer were treated as part of an IRB-approved, prospective, non-randomized trial of HDR brachytherapy as monotherapy. The initial protocol phase treated a prescription dose of 38 Gy in 4 treatment fractions (single interstitial