Late toxicity and quality of life from GETUG-AFU 22 study.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 331-331
Author(s):  
Igor Latorzeff ◽  
Stephane Guerif ◽  
Sandra Pelissier ◽  
Emmanuel Meyer ◽  
Julien Fraisse ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Late Toxicity ◽  
Localized Prostate Cancer ◽  
Efficacy Analysis ◽  
Prostate Bed ◽  
Gu Toxicity ◽  
Significant Difference ◽  
Grade 3

331 Background: Radical prostatectomy (RP) is recommended as a standard treatment for localized prostate cancer. However no recommendations exist for pts with immediate detectable PSA after RP. Methods: Pts with localized prostate cancer, treated by RP (R0 or R1), with a PSA level post-RP ≥0.2 ng/mL and ≤2 ng/mL at randomization and N0 M0 on imaging were included. Pts were randomized (1:1) to radiotherapy (RT) alone (RT arm) or 6 months degarelix hormone therapy (HT) with RT (RT+HT arm). RT consisted of pelvic irradiation (46 Gy in 23 Fr) with a boost on the prostate bed (66 Gy in 33 Fr). The primary endpoint was event-free survival (EFS). Acute and late toxicities were evaluated as secondary endpoints and scored using CTCAE V4.0 scale. Quality of life (QOL) was assessed with QLQ-C30 and QLQ-PR25 questionnaires at 12 and 24 months. Late toxicity was reported at 24 months. Results: From Jan-2013 to Sept-2015, 125 pts were included (RT arm: 64 pts; RT+HT arm: 61). Median follow up is 38 months (31.4; 44). The baseline characteristics are well-balanced between two arms: median age was 66 yrs (50-77), all men having an ECOG ≤1 (ECOG 0 in 92%), a median Gleason score of 7 (3-9), a median PSA of 0.3 ng/mL (0.09-1.82) post-RP and 0.6 ng/mL (0.12-3.65) at randomization. All pts received 33 Fr of RT. In the RT+HT arm 98.4% of pts received the 6 months of HT planned. All pts were eligible for safety analysis. At 24 months, no difference in late genitourinary (GU) or gastrointestinal (GI)toxicity was observed between the two arms (p=0.145) Grade 3 late toxicities were reported for 15/125 pts (12%): 8/64 pts (6.5%) in the RT arm and 7/61 pts (5.5%) in RT+HT arm (NS) and no toxicity grade >3 was observed. Evaluation of QOL was assessable at 12 and 24 months of FU for 80%/89% pts and 59%/77% pts in RT/RT-HT arms respectively. At 12 months QLQ-PR25 HT related symptoms was significantly more important in the RT-HT arm (p=0.04). At 24 months no significant difference in QLQC-30 or QLQ-PR25 analysis was reported. Conclusions:, At 24 months in this phase II trial no significant difference in GI/GU toxicity and.QOL was observed between the two arms. GETUG-AFU 22 efficacy analysis is still pending. Clinical trial information: NCT01994239.

Patient-reported quality of life in men with TURP undergoing proton therapy for prostate cancer.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 220-220 ◽  
Author(s):  
Derek Lee ◽  
Bradford S. Hoppe ◽  
Tamara L. Smith ◽  
Christopher G. Morris ◽  
Romaine Charles Nichols ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Proton Therapy ◽  
Toxicity Assessment ◽  
Gu Toxicity ◽  
Significant Difference ◽  
Patient Reported ◽  
Grade 3

220 Background: We report on quality of life (QOL) and early toxicity following proton therapy (PT) among men with prostate cancer who underwent transurethral resection of the prostate (TURP) prior to treatment. Methods: Between 2006 and 2010, 1,540 patients were treated definitively with PT for prostate cancer at UFPTI and enrolled on a prospective IRB-approved outcomes protocol. One hundred of the men had received a TURP before PT. Baseline comorbidities, medications, expanded prostate index composite (EPIC) score, international prostate symptom score (IPSS), and CTCAE vs.3 toxicity assessment were collected prospectively. The Kaplan-Meier product limit method was used to estimate freedom from toxicity. Results: Men who had TURP prior to PT had lower EPIC scores at baseline and at all followup points for urinary function, urinary incontinence, and urinary summary (Table). The TURP group also had lower EPIC bowel bother, bowel function, and bowel summary at baseline, 6-month, and 1-year followup. EPIC urinary bother, urinary irritation/obstruction, and subscales did not show a statistically significant difference at baseline, but they did show lower scores for the TURP group at variable follow-up time points. The IPSS scores among the TURP group did not show a statistical difference from the non-TURP group, except at the 6-month follow-up time point. Toxicity assessment showed that the 2-year and 3-year cumulative incidence of grade 3 GU toxicity rate in the pretreatment TURP group were 14% and 18%, respectively. Conclusions: Pretreatment TURP was associated with both a high incidence of physician-assessed toxicity and inferior patient-reported QOL scores both before and after PT treatment. Studies investigating QOL and toxicity after specific prostate cancer therapies should stratify patients by pretreatment TURP. Longer follow-up and further evaluation of risk factors for grade 3 GU toxicity among this cohort are needed. [Table: see text]

Stereotactic body radiotherapy as a monotherapy for localized prostate cancer: Late toxicity and quality of life

2016 ◽  
Vol 15 (13) ◽  
pp. e1596
Author(s):  
G. Beltramo ◽  
Zanetti I. Bossi ◽  
A. Bergantin ◽  
A.S. Martinotti ◽  
I. Redaelli ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Stereotactic Body Radiotherapy ◽  
Late Toxicity ◽  
Localized Prostate Cancer

The acute toxicity results of the GETUG-AFU 22 study: A multicenter randomized phase II trial comparing the efficacy of a short hormone therapy in combination with radiotherapy to radiotherapy alone as a salvage treatment for patients with detectable PSA after radical prostatectomy.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 16-16 ◽  
Author(s):  
Stephane Gilles Guerif ◽  
Igor Latorzeff ◽  
Lise Roca ◽  
Djelila Allouache ◽  
Stephane Supiot ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Radical Prostatectomy ◽  
Acute Toxicity ◽  
Hormone Therapy ◽  
Primary Endpoint ◽  
Late Toxicity ◽  
Localized Prostate Cancer ◽  
Free Survival ◽  
Prostate Bed ◽  
Grade 3

16 Background: Radical prostatectomy (RP) is recommended as a standard treatment for localized prostate cancer. However no recommendations exist for pts with detectable PSA after RP. Methods: Pts with localized prostate cancer, treated by RP (R0 or R1), with a PSA level post-RP ≥ 0.2 ng/mL and ≤ 2 ng/mL at randomization and N0 M0 on imaging were included. Pts were randomized (1:1) to radiotherapy (RT) alone (RT arm) or 6 months degarelix hormone therapy (HT) with RT (RT+HT arm). RT consisted of pelvic irradiation (46 Gy in 23 Fr) with a boost on the prostate bed (66 Gy in 33 Fr). The primary endpoint is the event-free survival (EFS). Secondary endpoints are: 5-yr EFS and metastases-free survival, 5 and 10-yr OS, acute and late toxicity (CTCAE V4.0), and QOL. With 122 patients, the probability of selecting the most effective arm is over 80% for a 20% reduction in the HR = 0.80. Results: From Dec-2012 to Sept-2015, 125 pts were included (RT arm: 64 pts; RT+HT arm: 61). Median follow up is 14.7 months (6.2; 33.5). The baseline characteristics are well-balanced: median age was 66 yrs (50-77), all men having an ECOG ≤ 1 (ECOG 0 in 92%), a median Gleason score of 7 (3-9), a median PSA of 0.3 ng/mL (0.09-1.82) post-RP and 0.6 ng/mL (0.12-3.65) at randomization. All pts received 33 Fr of RT. In the RT+HT arm 98.4% of pts received the 6 months of HT planned. All pts were eligible for safety analysis. No grade 4 toxicity or toxic death was reported. Grade 3 acute toxicity, occurring within 6 months of RT, were reported for 11/125 pts (9%): 3/64 pts (5%) in the RT arm and 8/61 pts (13%) in RT+HT arm (NS). Regarding grade 3 toxicities, the following occurred only in the RT+HT arm: erectile dysfunction (3 pts) and urinary incontinence (2 pts); in contrast, dysuria/pollakiuria (2 pts) occurred only in the RT arm. In the RT+HT arm, grade 2 toxicities included hot flushes (8 pts) and decreased libido (7 pts). Conclusions: In terms of acute toxicities the RT+HT arm is well tolerated with the observed toxicities usually expected with concomitant HT. The primary endpoint analysis is expected for 2018. Clinical trial information: NCT01994239.

Hypofractionated VMAT IGRT in localized prostate cancer. Acute and late toxicity, quality of life and early results

2013 ◽  
Vol 18 ◽  
pp. S320-S321
Author(s):  
J. Salinas Ramos ◽  
A. Iglesias Aguera ◽  
M. Gómez Aparicio ◽  
P. Escolar Perez ◽  
E. Martinez Lerma
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Late Toxicity ◽  
Localized Prostate Cancer ◽  
Early Results

A randomized trial of 79.2Gy versus 70.2Gy radiation therapy (RT) for localized prostate cancer.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 4-4 ◽  
Author(s):  
Jeff M. Michalski ◽  
Jennifer Moughan ◽  
James Purdy ◽  
Walter Bosch ◽  
Jean-Paul Bahary ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Dose Escalation ◽  
Late Toxicity ◽  
Phase Iii ◽  
Localized Prostate Cancer ◽  
Rank Test ◽  
High Dose ◽  
Local Progression ◽  
Gu Toxicity ◽  
Grade 3

4 Background: RTOG 0126 is a phase III trial for localized prostate cancer (PC) testing whether dose escalation to 79.2Gy with 3DCRT or IMRT will improve overall survival (OS). Methods: Stage cT1b-T2b with Gleason Score (GS) 2-6 and PSA ≥ 10 and <20 or GS 7 and PSA <15 were eligible and randomized to receive 79.2Gy or 70.2Gy. No androgen withdrawal was used. Treatment was 3DCRT or IMRT to 79.2Gy in 44 fractions or 70.2Gy in 39 fractions. The objective was to detect a 23% reduction in mortality hazard (HR=0.77) for 79.2Gy. ASTRO and Phoenix definition was used for biochemical failure (BF). Time to local progression (LP), distant metastases (DM), PC death, and late GI/GU toxicity was calculated from date of registration. OS was estimated by Kaplan Meier and arms compared with log rank test. BF, LP, DM, time to late GI/GU, and PC death were estimated by cumulative incidence method and arms compared with Gray’s test. Results: 1,532 men were randomized, 763 to 79.2Gy and 769 to 70.2Gy. 1,499 were eligible, 751 and 748 in the 79.2Gy and 70.2Gy arms respectively. Median age was 69, 70% had PSA < 10 ng/ml, 84% with GS 7, 57% had T1 disease, and 66% used 3D-CRT. With a median of 7.0 years follow up, the 5 and 10-yr rates of OS are 88% and 67% with 79.2Gy and 89% and 66% with 70.2Gy (p=0.87; HR (95%CI)=0.98 (0.79,1.21)). The ASTRO (Phoenix) BF rates at 5 and 10 yr are 25% (16%) and 30% (26%) with 79.2Gy and 40% (21%) and 45% (43%) with 70.2Gy (both p<0.0001). The 5 and 10-yr rates of LP are 1% and 4% with 79.2Gy and 2% and 8% with 70.2Gy (p=0.0059; HR (95%CI)=0.46 (0.27,0.81)). The 5 and 10 yr rates of DM are 2% and 5% with 79.2Gy and 3% and 8% with 70.2Gy (p=0.026; HR (95%CI)=0.57 (0.35,0.94)). The high dose arm had lower rate of salvage therapy, 13.5% vs 21%, p=0.0002. The 10 yr rates for time to late grade ≥ 2 GI/GU are 22%/15% with 79.2Gy and 16%/10% with 70.2Gy (p=0.0063/p=0.001). Time to late grade ≥ 3 GI was higher for the 79.2Gy arm (p=0.035) but time to late grade ≥ 3 GU toxicity was not (p=0.14). Conclusions: Despite significant improvement in BF, DM, and LP rates, dose escalation did not improve OS. Patients receiving high dose radiation experience more late toxicity. Clinical trial information: NCT00033631.

Virtual HDR SBRT for localized prostate carcinoma: Efficacy and quality-of-life assessment.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 45-45 ◽  
Author(s):  
Donald B. Fuller ◽  
Reza Shirazi ◽  
John Naitoh ◽  
George Mardirossian
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Disease Free Survival ◽  
Life Assessment ◽  
Intermediate Risk ◽  
Gu Toxicity ◽  
Gi Toxicity ◽  
Grade 3

45 Background: We designed a CyberKnife (CK) prostate Stereotactic Body Radiotherapy (SBRT) method to recapitulate HDR fractionation and target volume coverage (“Virtual HDR”). We report 4 year efficacy, toxicity and quality of life (QoL) outcomes. Methods: Eligible patients had low- (Gleason < 6, PSA < 10 ng/mL, < T2bN0) or intermediate-risk (Gleason < 6 with PSA 10.01 – 20 ng/mL or Gleason 7 with PSA < 10 ng/mL, < T2bN0) prostate cancer. A dose of 38 Gy/4 fractions was given to > 95% of the PTV; with “HDR-like” bladder, urethral and rectal dose constraints, and “HDR-like” dose escalation in the PTV. Toxicities were assessed using CTCAE3.0 criteria. QoL was assessed using the Expanded Prostate Cancer Index Composite (EPIC). Results: Since July 2006, 59 patients were treated. Two were lost to follow-up and 6 have been followed < 6 months, leaving 51 (32 low- and 19 intermediate-risk) patients for analysis. Median f/u is 42 months (range, 6-60). 4-year actuarial biochemical-disease free survival is 98% (ASTRO, Phoenix). Freedom from local and distant relapse is 100% and 98%. Median baseline PSA of 6.3 ng/mL (range 1.0 – 14.1) decreased to 0.1 ng/mL by 48 months. Acute grade 2 GU and GI toxicity rates were 22% and 4%, respectively (0% Grade 3+). Three (6%) late Grade 3 GU toxicities occurred at 18, 48 and 48 months. No grade 3+ GI toxicity occurred. Late grade 2 GU and GI toxicity rates were 18% and 2%, respectively. Only 2 patients (4%) had ongoing late > grade 2 GU toxicity at last follow-up (0% GI). Mean EPIC urinary and bowel scores decreased at 2 months, with subsequent improvement and stability to 48 months. Mean EPIC sexual scores gradually declined to 48 months. Of patients potent at baseline, 63% were potent at 3 years, including 100% < age 60, 64% age 61-70 and 60% > age 70. Conclusions: To 4 years, HDR-like CK SBRT for low- and intermediate-risk prostate cancer results in a very low PSA nadir and relapse rate, minimal toxicity and a favorable QoL outcome, with an age-dependent potency preservation rate. The occasional occurrence of late grade 3 urethral stricture can likely be reduced by better patient selection (caution re: patients with significant pre-existing uropathy). Acute and late grade 2 GU toxicity usually resolves with conservative management.

The impact of simultaneous dose escalation VMAT to the focal lesion micro boost of localized prostate cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e16592-e16592
Author(s):  
Radwa Fawzy Saleh Ahmed ◽  
Raafat Ragaie Abdel Malek ◽  
Mohamed Metwaly ◽  
Omar Abdel Aziz ◽  
Samy Al sirafy ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Dose Escalation ◽  
Localized Prostate Cancer ◽  
Focal Lesion ◽  
Rectal Toxicity ◽  
Gu Toxicity ◽  
Gi Toxicity

e16592 Background: Dose Escalation to the prostate is showing promising results of increasing local control. The study aims to assess biochemical failure free survival (BFF) after dose escalation to the prostate 78Gy with simultaneous integrated boost (SIB) 87Gy to the focal lesion. Genito-urinary (GU) & gastro-intestinal (GI) toxicity was assessed by comparing investigational toxicity score & patient outcome reports. Methods: Thirty intermediate & high risk localized prostate cancer patients were treated with dose escalated VMAT protocol of 78 Gy/35 fractions to prostate & 87Gy boost to focal lesion detected by baseline multi-parametric MRI & TRUS as well. Neo-adjuvant, Concurrent & adjuvant hormonal therapy was applied. Risk structures dose statistics were matched to modified Quantec with EQD2 equation. For each patient, daily online fiducial markers image guided verification was done. Toxicity profile was assessed by RTOG for subjective assessment and FACIT quality of life protocol for objective assessment during the radiotherapy course & follow up period. Results: About 80% of patients received the pre-determined protocol, however three patients received 76Gy to prostate & 84Gy to the focal lesion to comply with the risk structure constrains. At median follow up period of 18 months-BFF was 93.3 %. By the end of radiotherapy, 80% developed G3 GU toxicity while 30% developed G2 GI toxicity. Correlation between bladder V40 (≥or≤ 40%) & GU toxicity (≤ G3 vs G3) was of border line statistical significance (P = 0.05). After radiotherapy, GU toxicity dropped to 17.2% G2 & 13% G3 at the 3rd month while 0 % G3 afterwards. Three patients developed G4 rectal toxicity (bleeding per rectum); one at 9th month of ending treatment & two at 12th month; two of them needed cautery for angio-dysplasia as post radiation sequelae confirmed by colonoscopy. However, the correlation between V40 of the rectum ≥ 40% was significant with rectal toxicity (G0 vs G4) (P = 0.02). Comparing FACIT assessment during radiotherapy or in follow up showed no significant difference affecting the quality of life. Conclusions: Dose Escalation with SIB should be done using advanced technique like VMAT with image guidance. Re-validation of risk structure & rectal dose constrains should be considered especially for dose escalation ≥ 72Gy. Clinical trial information: NCT03384199.

scholarly journals Slowly resorbable biosynthetic mesh: 2-year results in VHWG grade 3 hernia repair

Hernia ◽  
2021 ◽  
Author(s):  
M. M. J. Van Rooijen ◽  
T. Tollens ◽  
L. N. Jørgensen ◽  
T. S. de Vries Reilingh ◽  
G. Piessen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Hernia Repair ◽  
Hernia Recurrence ◽  
Recurrence Rates ◽  
Elective Repair ◽  
Significant Difference ◽  
Grade 3

Abstract Introduction Information on the long-term performance of biosynthetic meshes is scarce. This study analyses the performance of biosynthetic mesh (Phasix™) over 24 months. Methods A prospective, international European multi-center trial is described. Adult patients with a Ventral Hernia Working Group (VHWG) grade 3 incisional hernia larger than 10 cm2, scheduled for elective repair, were included. Biosynthetic mesh was placed in sublay position. Short-term outcomes included 3-month surgical site occurrences (SSO), and long-term outcomes comprised hernia recurrence, reoperation, and quality of life assessments until 24 months. Results Eighty-four patients were treated with biosynthetic mesh. Twenty-two patients (26.2%) developed 34 SSOs, of which 32 occurred within 3 months (primary endpoint). Eight patients (11.0%) developed a hernia recurrence. In 13 patients (15.5%), 14 reoperations took place, of which 6 were performed for hernia recurrence (42.9%), 3 for mesh infection (21.4%), and in 7 of which the mesh was explanted (50%). Compared to baseline, quality of life outcomes showed no significant difference after 24 months. Despite theoretical resorption, 10.7% of patients reported presence of mesh sensation in daily life 24 months after surgery. Conclusion After 2 years of follow-up, hernia repair with biosynthetic mesh shows manageable SSO rates and favorable recurrence rates in VHWG grade 3 patients. No statistically significant improvement in quality of life or reduction of pain was observed. Few patients report lasting presence of mesh sensation. Results of biosynthetic mesh after longer periods of follow-up on recurrences and remodeling will provide further valuable information to make clear recommendations. Trial registration Registered on clinicaltrials.gov (NCT02720042), March 25, 2016.

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