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Thread: (H) Radiation Treatment

  1. #131
    Major Complications and Adverse Events Related to the Injection of the SpaceOAR® Hydrogel System Before Radiotherapy for Prostate Cancer



    The SpaceOAR® is a Food and Drug Administration-approved hydrogel injection used to create space between the prostate and rectum during prostate radiotherapy. It has shown to significantly reduce the rectal radiation dose with lower rates of rectal toxicity. Despite a high safety performance in initial trials, the SpaceOAR® remains in early clinical use. Thus, we examined emerging safety reports as the system becomes more widely utilized.

    We reviewed the SpaceOAR® manufacturer website for the safety profile and complications associated with the SpaceOAR® hydrogel. We then compared this with reports submitted to the Manufacturer and User Facility Device Experience (MAUDE) database.

    The manufacturer website reported risks including pain, needle penetration and/or gel injection into a nearby organ or blood vessel, local inflammation, infection, urinary retention and local rectal injury or symptoms. There were 22 unique reports discussing 25 patient cases in the MAUDE database from 2015 to 3/2019, with an increasing number of reports each year up through 2018. Unique major complications including acute pulmonary embolism, severe anaphylaxis, prostatic abscess and sepsis, purulent perineal drainage, rectal wall erosion and recto-urethral fistula were reported.

    Despite well documented clinical benefits of the SpaceOAR® System, there are a number of severe and debilitating complications recently reported in close proximity to gel injection. This highlights the need for further study of device complications in light of its increasing clinical use.
    [Emphasis mine]

    Late toxicities of prostate cancer radiotherapy with and without hydrogel SpaceAOR insertion [2019]



    To investigate whether the implantation of a hydrogel spacer (SpaceOAR) reduces long‐term rectal toxicity for prostate cancer patients treated with intensity‐modulated radiotherapy (IMRT).

    Patients with localised prostate cancer treated with 81 Gy in 45 fx of IMRT over 9 weeks were retrospectively compared: 65 patients with SpaceOAR and 56 patients without SpaceOAR. Planning aims restricted rectal doses to V40 Gy < 35%, V65 Gy < 17%, V75 Gy < 10%. Toxicities were evaluated between 3 months and 3 years after the completion of radiotherapy and were based on the common terminology criteria for adverse events (CTCAE) assessment tool for diarrhoea, haemorrhoids, faecal incontinence and proctitis.

    The cumulative incidence of low‐grade diarrhoea (G1) was significantly higher in the non‐SpaceOAR group (21.4% vs 6.2%; P = 0.016). The cumulative incidence of proctitis (grades G1 and G2) was also higher in the non‐SpaceOAR group (26.7% vs 9.2%; P = 0.015); the cumulative incidence of G2 proctitis was higher in the latter group (P = 0.043). There were no differences between the treatment groups for cumulative incidences of faecal incontinence and/or haemorrhoids. Three years after IMRT, diarrhoea and proctitis were higher in the non‐SpaceOAR group, without reaching statistical significance. This finding was unchanged after correcting for baseline symptoms.

    SpaceOAR is of benefit in reducing the cumulative incidence of low‐grade diarrhoea and proctitis for up to 3 years after intensity‐modulated radiotherapy.
    Last edited by DjinTonic; 09-17-2019 at 12:23 PM.

  2. #132
    Hypofractionation for clinically localized prostate cancer
    [2019, Review]



    Using hypofractionation (fewer, larger doses of daily radiation) to treat localized prostate cancer may improve convenience and resource use. For hypofractionation to be feasible, it must be at least as effective for cancer-related outcomes and have comparable toxicity and quality of life outcomes as conventionally fractionated radiation therapy.

    To assess the effects of hypofractionated external beam radiation therapy compared to conventionally fractionated external beam radiation therapy for men with clinically localized prostate cancer.

    We searched CENTRAL, MEDLINE (Ovid), Embase (Ovid) and trials registries from 1946 to 15 March 2019 with reference checking, citation searching and contact with study authors. Searches were not limited by language or publication status. We reran all searches within three months (15th March 2019) prior to publication.

    Randomized controlled comparisons which included men with clinically localized prostate adenocarcinoma where hypofractionated radiation therapy (external beam radiation therapy) to the prostate using hypofractionation (greater than 2 Gy per fraction) compared with conventionally fractionated radiation therapy to the prostate delivered using standard fractionation (1.8 Gy to 2 Gy per fraction).

    We used standard Cochrane methodology. Two authors independently assessed trial quality and extracted data. We used Review Manager 5 for data analysis and meta-analysis. We used the inverse variance method and random-effects model for data synthesis of time-to-event data with hazard ratios (HR) and 95% confidence intervals (CI) reported. For dichotomous data, we used the Mantel-Haenzel method and random-effects model to present risk ratios (RR) and 95% CI. We used GRADE to assess evidence quality for each outcome.

    We included 10 studies with 8278 men in our analysis comparing hypofractionation with conventional fractionation to treat prostate cancer.Primary outcomesHypofractionation may result in little or no difference in prostate cancer-specific survival [PC-SS] (HR 1.00, 95% CI 0.72 to 1.39; studies = 8, participants = 7946; median follow-up 72 months; low-certainty evidence). For men in the intermediate-risk group undergoing conventional fractionation this corresponds to 976 per 1000 men alive after 6 years and 0 more (44 fewer to 18 more) alive per 1000 men undergoing hypofractionation.We are uncertain about the effect of hypofractionation on late radiation therapy gastrointestinal (GI) toxicity (RR 1.10, 95% CI 0.68 to 1.78; studies = 4, participants = 3843; very low-certainty evidence).Hypofractionation probably results in little or no difference to late radiation therapy genitourinary (GU) toxicity (RR 1.05, 95% CI 0.93 to 1.18; studies = 4, participants = 3843; moderate-certainty evidence). This corresponds to 262 per 1000 late GU radiation therapy toxicity events with conventional fractionation and 13 more (18 fewer to 47 more) per 1000 men when undergoing hypofractionation.Secondary outcomesHypofractionation results in little or no difference in overall survival (HR 0.94, 95% CI 0.83 to 1.07; 10 studies, 8243 participants; high-certainty evidence). For men in the intermediate-risk group undergoing conventional fractionation this corresponds to 869 per 1000 men alive after 6 years and 17 fewer (54 fewer to 17 more) participants alive per 1000 men when undergoing hypofractionation.Hypofractionation may result in little to no difference in metastasis-free survival (HR 1.07, 95% CI 0.65 to 1.76; 5 studies, 4985 participants; low-certainty evidence). This corresponds to 981 men per 1000 men metastasis-free at 6 years when undergoing conventional fractionation and 5 more (58 fewer to 19 more) metastasis-free per 1000 when undergoing hypofractionation.Hypofractionation likely results in a small, possibly unimportant reduction in biochemical recurrence-free survival based on Phoenix criteria (HR 0.88, 95% CI 0.68 to 1.13; studies = 5, participants = 2889; median follow-up 90 months to 108 months; moderate-certainty evidence). In men of the intermediate-risk group, this corresponds to 804 biochemical-recurrence free men per 1000 participants at six years with conventional fractionation and 42 fewer (134 fewer to 37 more) recurrence-free men per 1000 participants with hypofractionationHypofractionation likely results in little to no difference to acute GU radiation therapy toxicity (RR 1.03, 95% CI 0.95 to 1.11; 4 studies, 4174 participants at 12 to 18 weeks' follow-up; moderate-certainty evidence). This corresponds to 360 episodes of toxicity per 1000 participants with conventional fractionation and 11 more (18 fewer to 40 more) per 1000 when undergoing hypofractionation.

    These findings suggest that moderate hypofractionation (up to a fraction size of 3.4 Gy) results in similar oncologic outcomes in terms of disease-specific, metastasis-free and overall survival. There appears to be little to no increase in both acute and late toxicity.

  3. #133
    Results of 15 Gy HDR-BT boost plus EBRT in intermediate-risk prostate cancer: Analysis of over 500 patients



    • 5-year FFBF was 92% in patients with intermediate risk prostate cancer treated with 15 Gy HDR boost.

    • 5-year MFS was 96% in patients with intermediate risk prostate cancer treated with 15 Gy HDR boost.

    To report biochemical control associated with single fraction 15 Gy high-dose-rate brachytherapy (HDR-BT) boost followed by external beam radiation (EBRT) in patients with intermediate-risk prostate cancer.

    Materials and methods
    A retrospective chart review of all patients with intermediate-risk disease treated with a real-time ultrasound-based 15 Gy HDR-BT boost followed by EBRT between 2009 and 2016 at a single quaternary cancer center was performed. Freedom from biochemical failure (FFBF), cumulative incidence of androgen deprivation therapy use for biochemical or clinical failure post-treatment (CI of ADT) and metastasis-free survival (MFS) outcomes were measured.

    518 patients met the inclusion criteria for this study. Median age at HDR-BT was 67 years (IQR 61–72). 506 (98%) had complete pathologic information available. Of these, 146 (28%) had favorable (FIR) and 360 (69%) had unfavorable (UIR) intermediate-risk disease. 83 (16%) received short course hormones with EBRT + HDR.

    Median overall follow-up was 5.2 years. FFBF was 91 (88–94)% at 5 years. Five-year FFBF was 94 (89–99)% and 89 (85–94)% in FIR and UIR patients, respectively (p = 0.045). CI of ADT was 4 (2–6)% at 5 years. Five-year CI of ADT was 1 (0–3)% and 5 (2–8 )% in FIR and UIR patients, respectively (p = 0.085). MFS was 97 (95–98 )% at 5 years. Five-year MFS was 100 (N/A-100)% and 95 (92–98 )% in FIR and UIR patients, respectively (p = 0.020).

    In this large cohort of intermediate-risk prostate cancer patients, 15 Gy HDR-BT boost plus EBRT results in durable biochemical control and low rates of ADT use for biochemical failure.

  4. #134
    Treatment patterns of high-dose-rate and low-dose-rate brachytherapy as monotherapy for prostate cancer



    Monotherapy with high-dose-rate (HDR) or low-dose-rate (LDR) brachytherapy are both recommended modalities for prostate cancer. The choice between HDR and LDR is dependent on patient, physician, and hospital preferences. We sought to identify treatment patterns and factors associated with receipt of HDR or LDR monotherapy.

    We queried the National Cancer Database (NCDB) for patients with localized low- or intermediate-risk prostate cancer treated with HDR or LDR monotherapy. Descriptive statistics were used to analyze patterns of HDR vs. LDR. Patient characteristics were correlated with HDR vs. LDR using multivariable logistic regression.

    We identified 50,326 patients from 2004-2014: LDR 37,863 (75.2%) vs. HDR 12,463 (24.8%). Median follow-up was 70.3 months. The overall use of monotherapy declined over time. HDR application declined relative to LDR. In 2004, 27.0% of cases were HDR compared to 19.2% in 2014. Factors associated with increased likelihood of HDR on multivariable analysis included: increasing age (OR: 1.01, 95% CI: 1.01-1.01), cT2c disease (OR: 1.25, 95% CI: 1.11-1.41), treatment at an academic center (OR: 2.45, 95% CI: 2.24-2.65), non-white race (OR: 1.34, 95% CI: 1.27-1.42), and income > $63,000 (OR: 1.73, 95% CI: 1.59-1.88 ). LDR was more common in 2010-2014 (OR: 0.59, 95% CI: 0.54-0.65), Charlson-Deyo comorbidity index > 0 (OR: 0.89, 95% CI: 0.84-0.95), and for patients receiving hormone therapy (OR: 0.88, 95% CI: 0.83-0.93). No difference in prostate-specific antigen (PSA) or Gleason score and receipt of HDR vs. LDR was observed. Mean overall survival was 127.0 months for HDR and 125.4 for LDR, and was not statistically different.

    We observed an overall decrease in brachytherapy (BT) monotherapy use since 2004 for localized prostate cancer. Despite similar survival outcomes, the use of HDR monotherapy declined relative to LDR.

  5. #135
    Comparative toxicity outcomes of proton-beam therapy versus intensity-modulated radiotherapy for prostate cancer in the postoperative setting



    Despite increasing utilization of proton-beam therapy (PBT) in the postprostatectomy setting, no data exist regarding toxicity outcomes relative to intensity-modulated radiotherapy (IMRT). The authors compared acute and late genitourinary (GU) and gastrointestinal (GI) toxicity outcomes in patients with prostate cancer (PC) who received treatment with postprostatectomy IMRT versus PBT.

    With institutional review board approval, patients with PC who received adjuvant or salvage IMRT or PBT (70.2 gray with an endorectal balloon) after prostatectomy from 2009 through 2017 were reviewed. Factors including combined IMRT and PBT and/or concurrent malignancies prompted exclusion. A case-matched cohort analysis was performed using nearest-neighbor 3-to-1 matching by age and GU/GI disorder history. Logistic and Cox regressions were used to identify univariate and multivariate associations between toxicities and cohort/dosimetric characteristics. Toxicity-free survival (TFS) was assessed using the Kaplan-Meier method.

    Three hundred seven men (mean ± SD age, 59.7 ± 6.3 years; IMRT, n = 237; PBT, n = 70) were identified, generating 70 matched pairs. The median follow-up was 48.6 and 46.1 months for the IMRT and PBT groups, respectively. Although PBT was superior at reducing low-range (volumes receiving 10% to 40% of the dose, respectively) bladder and rectal doses (all P ≤ .01), treatment modality was not associated with differences in clinician-reported acute or late GU/GI toxicities (all P ≥ .05). Five-year grade ≥2 GU and grade ≥1 GI TFS was 61.1% and 73.7% for IMRT, respectively, and 70.7% and 75.3% for PBT, respectively; and 5-year grade ≥3 GU and GI TFS was >95% for both groups (all P ≥ .05).

    Postprostatectomy PBT minimized low-range bladder and rectal doses relative to IMRT; however, treatment modality was not associated with clinician-reported GU/GI toxicities. Future prospective investigation and ongoing follow-up will determine whether dosimetric differences between IMRT and PBT confer clinically meaningful differences in long-term outcomes.

  6. #136
    Comparison of 5-Year Outcomes of Stereotactic Body Radiotherapy for African American and white Men Treated for Low Risk Prostate Cancer


    Several studies have demonstrated that African American Men (AAM) with Low Risk Prostate Cancer may harbor higher grade disease not detected on pre-treatment biopsy and have a higher rate of biochemical recurrence after definitive therapies. Stereotactic Body Radiotherapy (SBRT) is a well characterized treatment option for men with low risk disease. Despite this, there is a paucity of data that describes treatment related outcomes after SBRT between AAM and white Men (CM).

    Between April 7, 2006 and January 6, 2018, 405 patients with low risk prostate cancer (PC) were treated with definitive robotic-based SBRT at a large academic practice. 17.3% of these patients self-identified as African American. The median prescription dose was 3500 cGy (3500-3625) delivered in 5 fractions. Pearson Chi-Square was utilized to assess differences in baseline parameters. Biochemical failure was evaluated using the Phoenix definition and long-term urinary and rectal toxicity was characterized as occurring ≥6 months post radiation. Estimates of biochemical relapse free survival (bRFS), and freedom from urinary and rectal toxicity were calculated using the Kaplan-Meier method.

    A higher percentage of AAM were younger than age 65 compared to CM (71.4% vs. 41.5%, p<.0001). There was no significant difference between the mean number of Gleason 6 cores between AAM and CM (3.1 and 2.8, p=.272), nor in pre-treatment PSA (5.51ng/ml and 5.46ng/ml, p=.843) between groups. A similar percentage of AAM and CM had first degree relatives diagnosed with PC (14.3% and 15.7%, p=.699) and there was no difference between the groups in previous Active Surveillance, T1c vs. T2a disease, ADT use, or in SBRT dose. CM were more likely to receive SBRT within 4 months of prostate biopsy compared to AAM (47.9% vs. 28.6%, p=.014). While there was no difference in 5-year biochemical relapse free survival (bRFS) between AAM and CM (100% and 98.6%, p=.352), CM experienced a lower PSA nadir (0.58ng/ml vs. 0.76ng/ml, p=.05). There was no difference in 5-year freedom from grade 2+ urinary toxicity between AAM and CM (98.1% and 97.5%, p=.144) nor from grade 2+ rectal toxicity in this cohort (100% and 97.1%, p=.337).

    With modest follow-up, SBRT appears to be equally effective for AAM and CM with low risk prostate cancer, with no significant difference in low grade 2+ urinary or rectal toxicity. In this series, AAM were diagnosed at a younger age and longer after biopsy than CM. Despite comparable 5-year bRFS, AAM had a higher PSA nadir than CM. Longer follow-up is warranted to assess for durability of these encouraging findings.

  7. #137
    External beam radiotherapy (EBRT) and high-dose rate (HDR) brachytherapy for intermediate and high-risk prostate cancer: the impact of EBRT volume



    Whole pelvis radiotherapy (WPRT) may improve clinical outcomes over prostate-only radiotherapy (PORT)in high-risk prostate cancer patients by sterilization of micrometastatic nodal disease provided there is optimal control of the primary site.

    A prospective multicentre cohort study of eligible patients (stage ≥T2c, Gleason score ≥7 or presenting prostate-specific antigen (pPSA) ≥10) treated between 2009 and 2013 were enrolled in a UK national protocol deliveringcombined EBRT and HDR BT. Centres elected to deliver WPRT, 46Gy in 23 fractions or PORT 37.5Gy in 15 fractions with 15Gy single dose HDR BT. The primary endpoint was biochemical progression-free survival (bPFS). Secondary endpoints were overall survival (OS), genitourinary and gastrointestinal toxicity. This was not a randomised comparison and therefore subject to bias and the findings are therefore hypothesis generating but not conclusive.

    812 patients were entered; 401 received WPRT and 411 received PORT. With a median follow- up of 4.7 years, five-year bPFS rates for WPRT versus PORT arms were 89% vs 81% (p = 0.007) for all patients and 84% vs 77% (p = 0.001) for high-risk patients. Differences in bPFS remained significant after accounting for Gleason score, pPSA, T stage and androgen deprivation therapy duration as co-variates. There was no difference in OS. The overall post treatment toxicities across both cohorts were low with no greater than 1.5% of ≥ grade 3 toxicities at any follow-up time point. WPRT increased both prevalence and cumulative incidence of acute genitourinary toxicity (p = 0.004) and acute gastrointestinal toxicity (p = 0.003). No difference in late radiation toxicity was observed.

    A significant improvement in 5-year bPFS was seen in intermediate and high-risk prostate cancer treated with WPRT compared to PORT in a combined EBRT and BT schedule with no increase in late radiation toxicity.

  8. #138
    Stereotactic body radiation therapy for prostate cancer: systematic review and meta-analysis of prospective trials
    [2019, Review, Full Text]

    http://www.oncotarget.com/index.php?journal=oncotarget&page=article&op=view& path[]=27177&path[]=87262


    Background: Despite the increasing worldwide utilization of stereotactic body radiation therapy (SBRT) for prostate cancer, there are no known summative data regarding its safety and efficacy. To address this knowledge gap, we conducted a PRISMA-guided systematic review and meta-analysis of prospective prostate SBRT trials. Results: Fourteen trials with a total of 2,038 patients were included. Median follow-up was 37 months (range 6-55 months). Most patients had cT1-T2a, Gleason ≤7 disease with median pre-treatment PSAs of 5-10; 1,042 (51%) were low-risk, 744 (37%) were intermediate-risk, 158 (8%) were high-risk, and the remainder were unreported. Doses ranged from 33.5-50.0 Gy, most typically in 5 fractions, with nearly all studies delivering nondaily fractionation with some type of daily image guidance. Outcomes were converted into counts at the end of one year. The pooled rate of FFBF was 98% [95% confidence interval, 97-98%]. The pooled rate of late grade ≥3 gastrointestinal and genitourinary toxicities were 1% [0-5%] and 2% [1-3%], respectively. Methods: PubMed and Google Scholar were queried for prospective studies evaluating survival and/or toxicity outcomes in SBRT (≤5 fractions) for localized prostate cancer. Pooled rates of freedom from biochemical failure (FFBF) and late grades ≥3 gastrointestinal (GI) and genitourinary (GU) toxicities were assessed. Meta-analysis of proportions was logit transformed and pooled using generalized linear mixed models (both fixed and random effects) and subsequently back transformed to standard proportions. Conclusions: Despite the lack of long-term follow-up and heterogeneity of the available evidence, prostate SBRT affords appropriate biochemical control with few high-grade toxicities. These data have implications for ongoing worldwide utilization of prostate SBRT as well as ongoing prospective investigations.

  9. #139
    This type of wording amazes me.

    "No known summative data regarding its safety and efficacy"

    "prospective prostate SBRT trials"

    "lack of long-term follow-up and heterogeneity of the available evidence"

    This presentation implies that SBRT is some experimental treatment, with little known about its effects.

    The fact is that SBRT for the treatment of prostate cancer was approved in 2001, less than a year after the DaVinci robotic surgery system. There are several ten year reports of patient outcomes.

    Sorry, Djin, and this is not your fault, but this labeling of non-surgical treatments as some types of risky jump-into-the-dark non-standard choices is a pet peeve of mine.

    Yes, the conclusion was very positive. But you had to get through all the uncertainties to reach it.
    DOB: May 1944
    In Active Surveillance program at Johns Hopkins
    Strict protocol of tests, including PHI, DRE, MRI, and biopsy.
    Six biopsies from 2009 to 2019. Numbers 1, 2, and 5 were negative. Numbers 3,4, and 6 were positive with 5% Gleason(3+3) found. Last one was Precision Point transperineal.
    PSA has varied up and down from 3 to 10 over the years. Is 4.0 as of September 2019.
    Hopefully, I can remain untreated. So far, so good.

  10. #140
    Quote Originally Posted by ASAdvocate View Post
    This type of wording amazes me.

    "No known summative data regarding its safety and efficacy"

    "prospective prostate SBRT trials"

    "lack of long-term follow-up and heterogeneity of the available evidence"

    This presentation implies that SBRT is some experimental treatment, with little known about its effects.

    The fact is that SBRT for the treatment of prostate cancer was approved in 2001, less than a year after the DaVinci robotic surgery system. There are several ten year reports of patient outcomes.

    Sorry, Djin, and this is not your fault, but this labeling of non-surgical treatments as some types of risky jump-into-the-dark non-standard choices is a pet peeve of mine.

    Yes, the conclusion was very positive. But you had to get through all the uncertainties to reach it.
    I know your view, ASA. I can only report the studies -- and we can all comment on them. (I started a thread with this study in the Main Forum -- perhaps you'd like to copy your post there for wider viewing and comments?)

    Some (including my uro/surgeon) aren't very impressed by 10-year studies and are interested in what they consider long-term, 20 and 25 years. This doesn't mean they will always push the goalposts (to 30 and 35 years), but rather that younger men should know what the future holds. Perhaps ask yourself why you are seeing this hedging by authors of basically favorable results.

    Last edited by DjinTonic; 10-15-2019 at 08:36 PM.


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