Late toxicity described using patient reported outcomes measures (PROMS) in men treated with salvage radiation following primary high intensity focal ultrasound (HIFU) for localized prostate cancer.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 131-131 ◽  
Author(s):  
Reena Davda ◽  
Clement Orczyk ◽  
Mark Prentice ◽  
Aylin Sarova ◽  
Manit Arya ◽  
...  

131 Background: In primary treatment of localised prostate cancer, minimally invasive ablative therapies such as HIFU aim to achieve cancer control whilst offering a potentially favourable toxicity profile. At 5 years median follow up, 12% of patients treated with focal HIFU require salvage therapy. PROMS using Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC‐CP) provide a validated and clinically relevant tool to assess and quantify side effects from pelvic radiotherapy. There is limited data on late toxicity using PROMs with salvage radiotherapy in this setting. Methods: Retrospective analysis from prospectively collected data of 28 patients who received salvage radiotherapy at our institution 2010-2018 was performed. Late bowel and urinary toxicity measured by EPIC-CP is reported. Results: Gleason score at diagnosis: 3+3 4/28; 3+4 22/28; 4+3 2/28. HIFU treatment received: focal: 9/28; whole gland: 6/28; focal and redo focal: 7/28; focal and redo whole gland: 1/28; whole gland and redo: 5/28. All patients had mpMRI and biopsy proven recurrence with median PSA 6.6 ng/ml (0.57- 30.89). Median age at radiation was 67 years (55-80). Patients received 74 Gy to the prostate and 4 patients received additional pelvic lymph node irradiation. Three men received conformal radiotherapy (multiphase technique) and 25 arcing intensity modulated radiotherapy with hormone therapy as per risk stratification. Cumulative incidence of toxicity is reported at median follow-up of 43 months (7-99). Overall urinary function: no problem 8/28; very small problem 4/28; small problem 7/28; moderate problem 5/28; big problem 4/28 Urinary Incontinence Symptom Score: 2.5/12 (0-12) Urinary Irritation /Obstructive Symptom Score: 3.1/12 (0-12) Bowel Symptom Score: 3.5/12 (0-11) Biochemical relapse has occurred in 2/28 patients. Conclusions: Functional and oncological outcomes for a greater number of patients treated with minimally invasive ablative therapies followed by salvage radiation are required, however this data suggests radiation is a well-tolerated and effective salvage option following primary HIFU.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 2-2 ◽  
Author(s):  
David P. Dearnaley ◽  
Isabel Syndikus ◽  
Helen Mossop ◽  
Alison J. Birtle ◽  
DJ Bloomfield ◽  
...  

2 Background: We aimed to explore the dose response relationship for two 3 Gray (Gy) hypofractionated radiotherapy (hRT) schedules for localised prostate cancer (PCa). Methods: hRT schedules of 60Gy/20 fractions (f) and 57Gy/19f were compared with conventional RT (cRT) 74Gy/37f; iso-effective for alpha-beta ratios of 2.5Gy and 1.5Gy respectively. The trial was powered to demonstrate non-inferiority between each hRT schedule and cRT, with 3,213 patients (pt) needed to rule out 5% inferiority (80% power, 1-sided alpha 5%) assuming 70% event-free rate in cRT, corresponding to a critical hazard ratio (HR) of 1.21. The trial was not formally powered to directly compare the two hRT schedules. Pt with N0 T1b-T3a localised PCa were randomized (1:1:1 ratio). The primary endpoint was PCa progression (freedom from biochemical failure by Phoenix consensus guidelines or PCa recurrence). Acute toxicity was assessed up to 18 weeks post treatment and late side effects to 5 years (yr) by RTOG, LENT-SOM and patient reported outcomes (PROs). Results: 3,216 pts were randomized between 2002 and 2011; 1,065 (74Gy), 1,074 (60Gy), 1,077 (57Gy). Baseline characteristics were well balanced across groups: median age 69 yr; NCCN risk group 15% low, 73% intermediate, 12% high. With median follow up 5.2yr, 5yr progression-free rate (95% CI) was 74Gy: 88.3% (86.0%, 90.2%); 60Gy: 90.6% (88.5%, 92.3%), 57Gy: 85.9 (83.4, 88.0); HR60/74: 0.83, 90% CI (0.68, 1.03), HR57/74: 1.20, 90% CI (0.99, 1.45). Significantly more events were observed with 57Gy compared to 60Gy; HR57/60: 1.44, 90% CI (1.18, 1.75), log-rank p=0.003. No significant difference in acute RTOG bladder or bowel toxicity was observed between hRT schedules. Late toxicity profile was favorable; with grade 2+ RTOG bladder (60Gy: 16/960 (1.7%); 57Gy: 11/962 (1.1%), p=0.34) and bowel (60Gy: 28/960 (2.9%); 57Gy: 17/962 (1.8%), p=0.10) toxicity at 2yr. Analysis of LENT-SOM and PROs supported these results. Conclusions: With 5 yr follow-up treatment with a 3Gy schedule of 60Gy/20f shows improved treatment efficacy compared to 57Gy/19f and is non-inferior to 74Gy/37f with a similar low level of acute and late normal tissue damage. Clinical trial information: ISRCTN97182923.


2020 ◽  
Vol 61 (6) ◽  
pp. 908-919
Author(s):  
Hitoshi Ishikawa ◽  
Keiko Higuchi ◽  
Takuya Kaminuma ◽  
Yutaka Takezawa ◽  
Yoshitaka Saito ◽  
...  

Abstract The feasibility and efficacy of hypofractionated salvage radiotherapy (HS-RT) for prostate cancer (PC) with biochemical recurrence (BR) after prostatectomy, and the usefulness of prostate-specific antigen (PSA) kinetics as a predictor of BR, were evaluated in 38 patients who received HS-RT without androgen deprivation therapy between May 2009 and January 2017. Their median age, PSA level and PSA doubling time (PSA-DT) at the start of HS-RT were 68 (53–74) years, 0.28 (0.20–0.79) ng/ml and 7.7 (2.3–38.5) months, respectively. A total dose of 60 Gy in 20 fractions (three times a week) was three-dimensionally delivered to the prostate bed. After a median follow-up of 62 (30–100) months, 19 (50%) patients developed a second BR after HS-RT, but only 1 patient died before the last follow-up. The 5-year overall survival and BR-free survival rates were 97.1 and 47.4%, respectively. Late grade 2 gastrointestinal and genitourinary morbidities were observed in 0 and 5 (13%) patients, respectively. The PSA level as well as pathological T-stage and surgical margin status were regarded as significant predictive factors for a second BR by multivariate analysis. BR developed within 6 months after HS-RT in 11 (85%) of 13 patients with a PSA-DT < 10 months compared with 1 (17%) of 6 with a PSA-DT ≥ 10 months (median time to BR: 3 vs 14 months, P < 0.05). Despite the small number of patients, our HS-RT protocol seems feasible, and PSA kinetics may be useful for predicting the risk of BR and determining the appropriate follow-up schedule.


2019 ◽  
Author(s):  
Cheng Zhu ◽  
Min Wang ◽  
Qian Hao

Abstract Background: Abernethy malformation is a kind of congenital malformation of portal vein system caused by abnormal portacaval anastomosis. It can be in combination with other congenital malformations. The major therapy of Abernethy malformation is surgery. There has been a limited number of patients since the first patient reported, leading to a limited view towards this kind of disease until now.Results: In August 2018 we treated a patient diagnosed with typeII Abernethy malformation complicated with both congenital polydactyly and enlargement of all cardiac chambers, which is extremely rare and can be a supplementary to the existing cases. Besides, the low white blood cell and platelet, the arrested megakaryocytic maturation and the positive platelet autoantibody in serum may result in misdiagnosis as immune thrombocytopenia, so we analyze the differential points between these two diseases. We treated this patient with silybin orally and advised him to make follow-up visits because of his mild liver function disorder, normal cardiac function and no other malformations or complications complicated. At the latest follow-up, we knew the condition of the patient was generally satisfactory, whether in terms of laboratory test results or his daily life experience.Conclusions: Because of some changes of spleen in form and function secondary to Abernethy malformation, in some cases, this disease has similarities with a part of blood diseases, which we should take into consideration for differential diagnosis, especially when other congenital malformations are found in combination at the same time. This case also suggests that simply conservative treatment with regular follow-up visits can be suitable for certain patients.


2021 ◽  
Vol 108 (Supplement_7) ◽  
Author(s):  
Hannah Elkadi ◽  
Eleanor Dodd ◽  
Theodore Poulton ◽  
William Bolton ◽  
Joshua Burke ◽  
...  

Abstract Aims Despite being the most common surgical procedure, there is wide variation that exists in the management of simple subcutaneous abscesses with no national guideline describing best practice. During the COVID-19 Pandemic national guidelines promoted the use of regional or local anaesthetic (LA) instead of general anaesthesia (GA) to avoid aerosol generating intubation associated with GA. This study aimed to assess the impact of anaesthetic choice in outcomes following incision and drainage of subcutaneous abscesses. Methods Two cohorts of patients undergoing abscess incision and drainage at St. James’ University Hospital Leeds were retrospectively identified over a 14-week period before and after the introduction of the new COVID-19 anaesthetic guidelines. Wound healing surrogate endpoints were used: i) total number of follow up appointments and ii) attendance to healthcare services after 30 days from I&D. Result 133 patients were included. Significantly more procedures were performed under LA after the intervention (84.1% vs 5.7%; p < 0.0001) with a significant reduction in wound packing (68.3% vs 87.1%. p=0.00473). Follow up data found no significant difference in the average number of follow-up appointments (7.46 vs 5.11; p = 0.0731) and the number of patients who required ongoing treatment after 30 days (n = 14 vs n = 14, p = 0.921). Conclusion Drainage of simple subcutaneous abscess under 5 cm is safe under local anaesthetic with no significant difference in surrogate endpoints of wound healing observed in this patient cohort. Recurrent packing may not be required. Future work should explore patient reported measures such as pain management and the health economics of this intervention.


2019 ◽  
Vol 5 (22;5) ◽  
pp. E451-E456
Author(s):  
Kyung-Hoon Kim

Background: Lumbar intraspinal synovial cyst (LISC) refers to a cyst that arises from the zygapophyseal joint capsule of the lumbar spine and contains serous or gelatinous fluid. In cases of LISCs resistant to conservative treatments, various minimally invasive percutaneous spinal techniques (MIPSTs) may be applied prior to open surgery. Objectives: The outcomes of 3-staged MIPSTs for the treatment of symptomatic LISCs resistant to conservative treatments were evaluated. Study Design: An institutional review board approved retrospective chart review. Setting: University hospital inpatients referred to our pain clinic. Methods: Review of charts of all patients who underwent MIPSTs for symptomatic LISCs resistant to conservative treatments during a time period of 13 years at a university hospital pain clinic. Patients with symptomatic LISCs resistant to conservative treatments were treated with 3-staged MIPSTs, including image-guided intraarticular aspiration, cyst distention and rupture, and injection of corticosteroids (ARI), endoscopic cyst enucleation (ECE), and endoscopic superior facetectomy (ESF) by a single pain specialist. A symptom-free period after each intervention was evaluated. Recurrence was defined as the same recurrent symptomatic radicular pain with confirmation of the LISC on magnetic resonance imaging. All patients with a minimum follow-up time of 3 years were included. Results: Of the 40 patients who underwent ARI, 3 patients failed to complete a follow-up and 19 patients (51.4%) who had recurring symptoms received ECE. Ten patients (52.6%) who had rerecurring symptoms after ECE received ESF. There was no recurrence after ESF. Limitations: This retrospective and observational study with a limited number of patients does not represent a high level of evidence. Conclusions: This information provided the recurrence rate after each intervention. Half of the patients who went on to receive ARI experienced recurrence, whereas half of the patients with recurrence who received ECE experienced re-recurrence. ESF treatment resulted in no recurrence within the 3-year study period. Key words: Conservative treatment, endoscopic surgical procedures, facet joint, intraarticular injection, minimally invasive surgical procedures, needle biopsy, nerve root compression, radiculopathy, synovial cysts


2018 ◽  
Vol 21 (5) ◽  
pp. 449-455 ◽  
Author(s):  
Julio D. Montejo ◽  
Joaquin Q. Camara-Quintana ◽  
Daniel Duran ◽  
Jeannine M. Rockefeller ◽  
Sierra B. Conine ◽  
...  

OBJECTIVELumbar disc herniation (LDH) in the pediatric population is rare and exhibits unique characteristics compared with adult LDH. There are limited data regarding the safety and efficacy of minimally invasive surgery (MIS) using tubular retractors in pediatric patients with LDH. Here, the outcomes of MIS tubular microdiscectomy for the treatment of pediatric LDH are evaluated.METHODSTwelve consecutive pediatric patients with LDH were treated with MIS tubular microdiscectomy at the authors’ institution between July 2011 and October 2015. Data were gathered from retrospective chart review and from mail or electronic questionnaires. The Macnab criteria and the Oswestry Disability Index (ODI) were used for outcome measurements.RESULTSThe mean age at surgery was 17 ± 1.6 years (range 13–19 years). Seven patients were female (58%). Prior to surgical intervention, 100% of patients underwent conservative treatment, and 50% had epidural steroid injections. Preoperative low-back and leg pain, positive straight leg raise, and myotomal leg weakness were noted in 100%, 83%, and 67% of patients, respectively. The median duration of symptoms prior to surgery was 9 months (range 1–36 months). The LDH level was L5–S1 in 75% of patients and L4–5 in 25%. The mean ± SD operative time was 90 ± 21 minutes, the estimated blood loss was ≤ 25 ml in 92% of patients (maximum 50 ml), and no intraoperative or postoperative complications were noted at 30 days. The median hospital length of stay was 1 day (range 0–3 days). The median follow-up duration was 2.2 years (range 0–5.8 years). One patient experienced reherniation at 18 months after the initial operation and required a second same-level MIS tubular microdiscectomy to achieve resolution of symptoms. Of the 11 patients seen for follow-up, 10 patients (91%) reported excellent or good satisfaction according to the Macnab criteria at the last follow-up. Only 1 patient reported a fair level of satisfaction by using the same criteria. Seven patients completed an ODI evaluation at the last follow-up. For these 7 patients, the mean ODI low-back pain score was 19.7% (SEM 2.8%).CONCLUSIONSTo the authors’ knowledge, this is the longest outcomes study and the largest series of pediatric patients with LDH who were treated with MIS microdiscectomy using tubular retractors. These data suggest that MIS tubular microdiscectomy is safe and efficacious for pediatric LDH. Larger prospective cohort studies with longer follow-up are needed to better evaluate the long-term efficacy of MIS tubular microdiscectomy versus other open and MIS techniques for the treatment of pediatric LDH.


2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 64-64
Author(s):  
Andrey Soares ◽  
Diogo Assed Bastos ◽  
Fabio A. B. Schutz ◽  
Eduardo Cronemberger ◽  
Murilo Luz ◽  
...  

64 Background: LACOG0415 is a 3-arm randomized trial evaluating ADT with abiraterone acetate plus prednisone (ADT+AAP), apalutamide alone (APA) or apalutamide with AAP (APA+AAP) for patients with locally-advanced, high-risk biochemical recurrence or metastatic castration-sensitive prostate cancer (ASCO 2020). In this trial, ADT+AAP and APA+AAP achieved the primary endpoint of percentage of patients with PSA ≤ 0.2 ng/mL at week 25. Apalutamide alone showed a high PSA decline > 50% rate, but did not achieve the pre-specified PSA threshold. Here we report patient-reported outcome data using Functional Assessment of Cancer Therapy-Prostate (FACT-P). Methods: HRQoL was measured in the overall population using the FACT-P questionnaire, comprising 5 subscales: physical wellbeing (PWB), functional wellbeing (FWB), emotional wellbeing (EWB), social/family wellbeing (SFWB), and prostate cancer subscale (PCS). Scores for each patient were measured at baseline and every four weeks until week 25. Questionnaire completion was defined as ≥ 1 question answered at an assessment time point. Analysis of HRQoL change from baseline and deterioration included only patients with baseline and ≥ 1 postbaseline score. Differences greater than 10-points in FACT-P total score and differences greater than 3-points in PWB, FWB, EWB, SFWB, and PCS scores were considered clinically significant. The time-to-event endpoint was estimated by Kaplan-Meier method and compared by stratified log-rank test. Results: 128 patients were included in LACOG0415 trial and 122 of them completed the HRQoL assessments (ranging from 95.3% at baseline to 79.7% at week 25). FACT-P and all subscales scores were similar for all three arms at baseline. There were no meaningful differences in FACT-P scores at baseline and at week 25 between the 3 arms. The subscales scores also showed no statistically differences at baseline and at week 25. Time to FACT-P deterioration did not show any statistically difference between three arms ( P=0.3371). Conclusions: ADT free alternatives with APA alone or APA+AAP did not show meaningful differences in HRQoL in patients with advanced castration-sensitive prostate cancer compared to ADT+AAP. The short follow-up period limited the ability to explore differences in HRQoL after 25 weeks. Larger studies with longer follow-up are needed to further evaluate HRQoL with ADT-free strategies. Clinical trial information: NCT02867020. [Table: see text]


2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Salvina Barra ◽  
Stefano Vagge ◽  
Michela Marcenaro ◽  
Gladys Blandino ◽  
Giorgia Timon ◽  
...  

Aim. To evaluate the toxicity of a hypofractionated schedule for primary radiotherapy (RT) of prostate cancer as well as the value of the nadir PSA (nPSA) and time to nadir PSA (tnPSA) as surrogate efficacy of treatment.Material and Methods. Eighty patients underwent hypofractionated schedule by Helical Tomotherapy (HT). A dose of 70.2 Gy was administered in 27 daily fractions of 2.6 Gy. Acute and late toxicities were graded on the RTOG/EORTC scales. The nPSA and the tnPSA for patients treated with exclusive RT were compared to an equal cohort of 20 patients treated with conventional fractionation and standard conformal radiotherapy.Results. Most of patients (83%) did not develop acute gastrointestinal (GI) toxicity and 50% did not present genitourinary (GU) toxicity. After a median follow-up of 36 months only grade 1 of GU and GI was reported in 6 and 3 patients as late toxicity. Average tnPSA was 30 months. The median value of nPSA after exclusive RT with HT was 0.28 ng/mL and was significantly lower than the median nPSA (0.67 ng/mL) of the conventionally treated cohort (P=0.02).Conclusions. Hypofractionated RT schedule with HT for prostate cancer treatment reports very low toxicity and reaches a low level of nPSA that might correlate with good outcomes.


2020 ◽  
Vol 5 (4) ◽  
pp. 2473011420S0005
Author(s):  
Thomas L. Lewis ◽  
Robbie Ray ◽  
David Gordon

Category: Bunion Introduction/Purpose: The aim of this study was to explore the 2 year results of third generation (using screw fixation) Minimally Invasive Chevron and Akin osteotomies (MICA) for hallux valgus correction. There is a paucity of published data regarding the outcomes of this relatively new technique. We present the largest series in the literature, using three separate validated patient-reported outcome measures (EQ-5DL, VAS Pain and Manchester Oxford Foot Questionnaire (MOXFQ), for this time point. Methods: A single surgeon case series of patients with hallux valgus underwent primary third generation minimally invasive chevron and akin osteotomies for hallux valgus correction. Between August 2015 and January 2018, 290 MICAs were performed in 203 patients that were eligible for 2 year follow up. Baseline and 2 year post-operative patient reported outcomes were collected for 164 feet in 130 patients (124 females; 6 males). Paired t-tests were used to determine the statistical significance of the difference between pre- and post-operative scores. Results: The mean age was 56.6 (range 29.5-81.0, standard deviation (s.d.) 10.9). At two year follow up, mean MOXFQ scores improved for each domain: Pain; baseline 40.6 (range 0-100, s.d. 22.8), reduced to 11.3 (range 0-75, s.d. 16.0, p<0.001); Walking; 36.0 (range 0-100, s.d. 25.9) reduced to 8.2 (range 0-75.0, s.d. 16.0, p<0.001); Social interaction; 46.7 (range 0-100, s.d. 24.3), reduced to 7.7 (range 0-75.0, s.d. 13.9, p<0.001). Mean VAS Pain score improved from 30.4 (range 0.0-90.0, s.d. 23.6) to 9.4 (range 0.00-70.0, s.d. 15.6, p<0.001). Mean EQ-5D index score improved from 0.750 (range 0.066-1.000, s.d. 0.148) to 0.892 (range 0.410-1.000, s.d. 0.135, p<0.001). Mean EQ-5D VAS score did not significantly improve from 81.9 (range 0-100, s.d. 17.1) to 83.0 (range 0-100, s.d. 18.0, p=0.559). Conclusion: This is the largest prospective case series of short-term patient reported outcomes using a validated assessment method for hallux valgus, following third generation MICA to date. These data show that this technique is effective at improving foot and ankle specific patient reported outcomes at 2 years. This cohort is being followed over the longer term.


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