High risk prostate fractionation

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  • Tolerance doses for late adverse events after hypofractionated radiotherapy for prostate cancer on trial RTOG 0415
  • Radiother Oncol. 2019 June ; 135: 19–24
  • doi:10.1016/j.radonc.2019.02.014
  • “presence of acute GI toxicity was a candidate predictor for late GI toxicity”
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  • RTOG 0415
  • TOLERANCE DOSES FOR LATE ADVERSE EVENTS AFTER HYPOFRACTIONATED RADIOTHERAPY FOR PROSTATE CANCER ON TRIAL RTOG 0415
  • Radiother Oncol. 2019 June ; 135: 19–24
  • doi:10.1016/j.radonc.2019.02.014
  • “presence of acute GI toxicity was a candidate predictor for late GI toxicity”
  • “AT A MEDIAN FOLLOW-UP OF 5.9 YEARS, THE CRUDE LATE ≥GRADE 2 GI AND GU TOXICITIES WERE 19% AND 29%, RESPECTIVELY.”
  • “OF NOTE, THE LATE GI TOXICITY RATE IS AN ORDER OF MAGNITUDE HIGHER THAN THAT OBSERVED AFTER HIGH DOSE CONVENTIONAL RADIATION THERAPY REGIMENS FOR THE SAME DISEASE AND STAGE, E.G., 19% VS. 2%”
"AN ORDER OF MAGNITUDE HIGHER"!*****
 
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I treat high risk conventionally unless patient has transportation issues. Need to the keep therapists employed and I have seen worse acute urinary side effects. In training, we used 1.8 and maybe only 1/3 men needed flomax.
 
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  • THE PROFIT TRIAL
  • Late grades 2 and 3 GI adverse events were approximately 60% more likely in men who were assigned to treatment with Moderate Hypofractionation.
  • significant increase in acute Grade ≥2 toxicity in the MH arm.
 
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  • HYPRO TRIAL
  • incidence for acute Grade ≥2 GI toxicity was significantly higher (OR 1.6; P = 0.0015) in the MH arm (42%, 95% CI 37.2%–46.9%) compared to control (31.2%, 95% CI 26.6%–35.8%)
  • NOT NONINFERIOR WITH REGARDS TO ACUTE TOXICITY.
  • HYPRO TRIAL 2016
  • Hypofractionated versus conventionally fractionated radiotherapy for patients with prostate cancer (HYPRO): late toxicity results from a randomised, non-inferiority, phase 3 trial
  • http://dx.doi.org/10.1016/ S1470-2045(15)00567-7
  • Lancet 2016
  • NEGATIVE TRIAL***
  • NOT NONINFERIOR WITH REGARDS TO LATE TOXICITY
  • “we could not confirm non-inferiority of hypofractionation for cumulative late gastrointestinal toxicity”
  • “Cumulative grade 3 or worse late genitourinary toxicity was significantly higher in the hypofractionation group than in the standard fractionation group (19·0% [95% CI 15·2–23·2] vs 12·9% [9·7–16·7], respectively; p=0·021), but there was no significant difference between cumulative grade 3 or worse late gastrointestinal toxicity (2·6% [95% CI 1·2–4·7]) in the standard fractionation group and 3·3% [1·7–5·6] in the hypofractionation group; p=0·55)”
  • Lancet comment box:
  • “Implication of all available evidence Together with previous findings that were unable to show non-inferiority of hypofractionation for both acute gastrointestinal and genitourinary toxicity, and the recorded significant increase in incidence of acute gastrointestinal toxicity, the findings of late toxicity question the added value of hypofractionation.”
  • “Interpretation: Our data could not confirm that hypofractionation was non-inferior for cumulative late genitourinary and gastrointestinal toxicity compared with standard fractionation. Before final conclusions can be made about the utility of hypofractionation, efficacy outcomes need to be reported.”
  • “Whether hypofractionation can be incorporated into routine clinical practice will depend on the toxicity and outcome results of continuing studies with long follow-up.”
  • We currently do not have long enough followup.
 
  • FROM GERMAN WORKING GROUP
  • Prostate Cancer Expert Panel of the German Society of Radiation Oncology (DEGRO) and the Working Party Radiation Oncology of the German Cancer Society (DKG-ARO)
  • Hypofractionated Radiotherapy for Localized Prostate Cancer
  • DOI 10.1007/s00066-016-1041-5
  • Strahlenther Onkol (2017) 193:1–12
  • “there might be a trend for increased short-term and possibly even long-term toxicity”
  • “Until the results on long-term follow-up of several well-designed phase 3 trials become available, moderate hypofractionation should not be used in routine practice”
  • REGARDING HYPRO, FROM GERMAN WORKING GROUP (same publication)
  • “In the HYPRO study, cumulative acute gastrointestinal (GI) toxicity grade 2 and worse was significantly increased (42 % vs. 31.2 %, p = 0.0015) in the hypofractionated arm, leading to the statement that hypofractionated radiotherapy was not non-inferior in terms of acute side effects [14].
  • “In the gastrointestinal subitems evaluated, there was a marked difference with respect to increased stool frequency ≥6 times a day (15 % vs. 8 %, p = 0.0035) and in pain needing drugs (9 %vs. 5 %, p = 0.021).
  • “In genitourinary (GU) toxicity there was no difference in general but in the subitem increased frequency at night more than 7 times (grade 3) there again was a significant increase in the hypofractionation group (12 % vs. 7 %, p = 0.019).
  • “Late toxicity of the HYPRO study has been recently reported [13].
  • “Grade 2 or worse GU toxicity at 3 years was increased (hazard ratio HR 1.16) from 39.0 % to 41.3 % and grade 2 or worse gastrointestinal toxicity at 3 years increased from 17.7 % to 21.9 % (HR 1.19).
  • “Especially cumulative grade 3 or worse late GU toxicity was significantly higher with an increase from 12.9 % to 19.0 % (p = 0.021).
  • “The subitems that were of special concern were nycturia ≥6 (1 % vs. 6 %, p = 0.0005), incontinence (14 % vs. 20 %, p = 0.04) and stool frequency ≥6 (3 % vs. 7 %, p = 0.034).
  • “Thus, the authors again had to state that with respect to late toxicity non-inferiority could not be shown.”
 
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  • HYPRO TRIAL 2021
  • Patient-reported outcomes in the acute phase of the randomized hypofractionated irradiation for prostate cancer (HYPRO) trial
  • Redirecting
  • significantly higher rates of moderate-severe painful defecation (HF 10.8%, SF 5.3%), any mucus discharge (HF 47.1%, SF 37.4%), any rectal blood loss (HF 16.1%, SF 9.3%),increased daily stool frequency ≥4 and ≥6 (HF 34.6%/13.8%, SF25.6%/7.0%), and any urinary straining (HF 69.9%, SF 58.0%).
  • The increased patient-reported acute rectal symptoms with HF confirmed the previously reported results on acute grade >=2 rectal toxicity.
  • “Our study revealed a higher increase with HF for symptoms of acute proctitis like stool frequency, urge, painful defecation, and rectal bleeding which requires more attention by the physician (30)”
  • The increased bladder symptoms with HF was not identified previously.
  • ***These observations contradict the NTD 2Gy calculations.*******
  • Despite the similar dose-rate and the calculated lower NTD2Gy, we still observed considerable increased rectal toxicity rates.
  • These observations from physician-reported and patient-reported toxicity contradict the per protocol NTD 2Gy calculations and similar dose-rate per week, which predicted that the acute toxicity with the HF schedule should be at a similar level and probably less.
  • the NTD 2Gy calculation with an an α/β ratio of 10 Gy resulted in an equivalent dose of 72.1 Gy for the HF schedule.
  • ***Therefore this observation in the XXXX trial is quite puzzling since it cannot be explained by existing models in the literature on underlying radiobiological mechanisms.
  • It suggests that the α/β ratio for acute GI toxicity is much lower, i.e. that the acute rectal mucosa response is much more sensitive to fraction size then hypothesized, based on animal studies (16).
  • “QUITE PUZZLING”!!***** -- I haven't seen those words used in many publications...
 
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  • ITALY REVIEW, 2021
  • Critical Reviews in Oncology / Hematology
  • Redirecting
  • “Of course, mature data about toxicity rate after 5 years are needed to have a reliable assessment about late toxicity comparison. Data from the pooled analysis may raise concern about the 9.8 % acute GI toxicity increase after moderate hypofractionation.”
 
  • MODERATE HYPOFX INCREASES RISK OF LATE URINARY INCONTINENCE
  • Patient-reported urinary incontinence after radiotherapy for prostate cancer: Quantifying the dose–effect
  • doi:10.1016/j.radonc.2017.07.029
  • Radiother Oncol. 2017
  • "Conclusions: LPRUI after RT for PCa dramatically depends on EQD2 and few clinical factors. Results are consistent with a ***larger than expected impact of moderate hypo-fractionation on the risk of LPRUI (late patient-reported urinary incontinence).*** As expected, baseline symptoms, as captured by ICIQ-SF, are associated to an increased risk of LPRUI.
  • "Urgency and incontinence are among the most clinically relevant urinary symptoms: they may occur even years after the treatment and influence the patients’ daily health-related quality of life (HRQoL), often permanently.
  • "importantly, for most of the commonly delivered conventionally fractionated schedules (i.e.: 74–78 Gy, 2 Gy/fr), severe incontinence is rare (<3%).
  • "More in general, our results suggest that bladder is much more sensitive to fractionation than previously believed.
  • "The increased response related to the higher daily doses of hypofractionated regimens could ultimately lead to a stronger acute inflammation, though often sub-clinical, ultimately resulting in an enhanced ‘‘consequential” component of the damage, generating a more severe fibrotic process.
  • In particular, a previous TURP increased the risk of objective symptoms of a factor between 3 and 10.
  • A previously suggested low alpha–beta value (0.8 Gy) better fitted the data, consistently with a high sensitivity of incontinence to fractionation.
 
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  • A NOVEL METHOD FOR PREDICTING LATE GENITOURINARY TOXICITY AFTER PROSTATE RADIATION THERAPY AND THE NEED FOR AGE-BASED RISK ADAPTED DOSE CONSTRAINTS
  • Int J Radiat Oncol Biol Phys. 2013 July 15; 86(4)
  • doi:10.1016/j.ijrobp.2013.03.020
  • Age >68 years was associated with late grade ≥2 GU toxicity, which suggests that risk-adapted dose constraints based on age should be explored.
  • Latency is a very important issue to consider when studying late GU toxicity. The present study examined late grade ≥2 toxicity. For many patients, GU disease processes may demonstrate a very long latent period before clinical manifestations develop.
  • *** GU toxicity does not always occur immediately after the cessation of RT; rather, it may often take 2 years or longer to develop, and rates increase over time. Thus, long-term follow-up should be considered an integral aspect of any thorough investigation of late chronic GU toxicity
  • 1659809770649.png
  • Fig. 2 (above). Crude rates of grade ≥2 genitourinary (GU) toxicity in different age groups. The mean age for patients in this study was 68. Older patient age groups had greater rates of toxicity. The number of patients in each age group is indicated by numbers above the data points. A rapid rise in toxicity rates is seen for age groups 70 and older.


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Fig. 4 (above). Late genitourinary (GU) toxicity as a function of time.



1659809842630.png

Fig. 5 (above). Rates of grade ≥2 genitourinary (GU) toxicity in different age groups and long-term followup.
 
  • FECAL INCONTINENCE
  • Predicting Late Fecal Incontinence Risk After Radiation Therapy for Prostate Cancer: New Insights From External Independent Validation
  • Int J Radiation Oncol Biol Phys, Vol. 102, No. 1, pp. 127e136, 2018
  • Redirecting
  • “The observed rate of mean FI grade >1 in the first 2 years after radiation therapy completion was 10.9% (25/229 patients): 8.1% and 17.4% in the conventional fractionated and hypofractionated subpopulations, respectively (z-test for proportions, P = .04”
  • “The observed rate of mean FI grade >1 in the first 2 years after radiation therapy completion was 10.9% (25/229 patients): 8.1% and 17.4% in the conventional fractionated and hypofractionated subpopulations, respectively (z-test for proportions, P = .04”).”
  • “The model exclusively including mean dose and that including abdominal surgery as dose-response modifying factor showed both a clear trend (ie, increasing observed toxicity rates with increased predicted risk), but the absolute toxicity rates were underestimated (ie, absolute predicted rates were always lower than corresponding absolute observed rates).”
  • “It may be hypothesized that this result could be related to a hidden effect of hypofractionation beyond the standard linear quadratic correction. As a matter of fact, hypofractionation results to be a risk factor in the validation population with OR = 2.4 (range: 1.6-3.7), FI rates 8.1% vs 17.4%, in convenventionally treated group vs hypofractionated patients.”

As a matter of fact, hypofractionation results to be a risk factor in the validation population with OR = 2.4 (range: 1.6-3.7), Fecal Incontinence rates 8.1% vs 17.4%, in convenventionally treated group vs hypofractionated patients.”

Hypofractionation itself was a risk factor for fecal incontinence...
 
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  • Faecal Incontinence in Prostate Cancer Survivors Treated With Radiotherapy
  • Currently enrolling
  • Start date July 2022
  • clinicaltrials.gov

    Faecal Incontinence in Prostate Cancer Survivors Treated Whith Radiotherapy - Full Text View - ClinicalTrials.gov

    Faecal Incontinence in Prostate Cancer Survivors Treated Whith Radiotherapy - Full Text View.
    clinicaltrials.gov clinicaltrials.gov
  • “The safe dose of irradiation of the anal sphincter with radiotherapy modern techniques (volumetric modulated arc therapy with moderately hypofracctionation) is unknown.
  • "Urgency and faecal incontinence greatly affects the quality of life of these patients.
 
SpaceOAR? No thank you as I already have an excellent treatment with minimal toxicities.

Hot off the press:



Model Number SO-2101
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Fever (1858); Fistula (1862); Unspecified Infection (1930); Pain (1994); Sepsis (2067); Ulcer (2274); Swelling/ Edema (4577)
Event Date 06/01/2022
Event Type Injury
Event Description
It was reported to boston scientific corporation that spaceoar was implanted during a spaceoar placement procedure performed on an unknown date. Fiducial markers were placed during the same procedure. The patient received four treatments of standard fractionated intensity-modulated radiation therapy (imrt) a few weeks after the spaceoar procedure. The patient started complaining of pain in the abdominal area, swelling in the groin and testicular areas. The patient had multiple emergency room (er) visits and was diagnosed as septic. The physician evaluated the patient and was able to locate a large fistula starting in the rectum, through the prostate and into the bladder. The patient was treated with a permanent colostomy and was advised to undergo a colonoscopy. The patient was admitted to a hospital beyond the standard of care. The patient's outcome was reported to be disability and permanent damage. Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Manufacturer Narrative
The exact date of the event is unknown. The provided event date, (b)(6) 2022, was chosen as a best estimate based on the date that the manufacturer became aware of the event, 17jun2022. The complainant was unable to provide the suspect device lot number. Therefore, the manufacture date and expiration date are unknown. (b)(4). The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental mdr will be filed.
 
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BRB, I have to go update my SpaceOAR notes that I give to patients.

Once they see these reports they universally decide they are not interested in SpaceOAR.
 
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Speaking of SpaceOAR, here are the toxicities that were reported last month - I bet the house that there are many many more out there that have not been reported:

MAUDE JULY 2022

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I can't help it:

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPACEOAR VUE WAS IMPLANTED DURING A SPACEOAR VUE PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PROCEDURE WAS DONE UNDER GENERAL ANESTHESIA. ON (B)(6) 2022, THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND A RECTAL ULCER WAS CONFIRMED. THE PATIENT WAS PLACED ON HORMONE THERAPY AND RADIATION TREATMENT WAS DELAYED. Manufacturer Narrative: (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A PROBLEM ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.


IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPACEOAR DEVICE WAS IMPLANTED DURING A SPACEOAR PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. FIDUCIAL MARKERS WERE PLACED DURING THE SAME PROCEDURE. A WEEK AFTER THE SPACEOAR PROCEDURE, THE PATIENT EXPERIENCED RECTAL URGENCY AND URINARY RETENTION. THE PATIENT EXPERIENCED THE FEELING OF GOING TO THE BATHROOM BUT ONLY PASSING A PENCIL-LIKE STOOL. THE PATIENT WAS INSTRUCTED TO TAKE IBUPROFEN FOR PAIN, BUT THE PATIENT EXPERIENCED BLEEDING AND WAS ADVISED TO SWITCH TO EXTRA-STRENGTH TYLENOL. ON( B)(6) 2022, THE PATIENT WENT TO THE EMERGENCY ROOM FOR URINARY RETENTION, HAD A BLADDER SCAN, AND WAS FOUND TO HAVE 469CC OF URINE RETAINED. THE PATIENT WAS TREATED WITH A FOLEY CATHETER FOR ONE WEEK. THE PATIENT WAS ALSO TAKING FLOMAX TO LESSEN THE SYMPTOMS. THE PATIENT HAD A FOLLOW UP APPOINTMENT WITH THE PHYSICIAN ON (B)(6) 2022. ON JULY 4, 2022, ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT WAS PASSING A CLEAR YELLOW SUBSTANCE WITH A FOUL SMELL AND WAS REFERRED TO A GASTROINTESTINAL SPECIALIST (GI) BECAUSE THE RECTAL URGENCY WAS STILL PERSISTING. Manufacturer Narrative: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MDR WILL BE FILED.


IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPACEOAR WAS IMPLANTED DURING SPACEOAR PLACEMENT PROCEDURE ON (B)(6) 2022. THE PROCEDURE WAS DONE UNDER LOCAL ANESTHESIA. SEVERAL HOURS AFTER THE SPACEOAR PROCEDURE, THE PATIENT WENT TO THE EMERGENCY ROOM (ER) DUE TO INABILITY TO URINATE AND HAS SINCE BEEN CATHETER DEPENDENT. A WEEK LATER, THE PATIENT UNDERWENT TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) IN ORDER TO IMPROVE THE SYMPTOMS. HOWEVER, IT DID NOT HELP. THE PATIENT IS STILL UNABLE TO URINATE FOR 3 TO 4 WEEKS. THE PATIENT WAS TREATED WITH FLOMAX. THE PHYSICIAN RECOMMENDED PELVIC MAGNETIC RESONANCE IMAGING (MRI) AND STEROID TAPERING. Manufacturer Narrative: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MDR WILL BE FILED.


IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPACEOAR WAS IMPLANTED DURING A SPACEOAR PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. THE PROCEDURE WAS DONE UNDER LOCAL ANESTHESIA. APPROXIMATELY FIVE MONTHS AFTER THE SPACEOAR IMPLANTATION, THE PATIENT UNDERWENT COLONOSCOPY AS A POSTOPERATIVE FOLLOW-UP AND A RECTAL PERFORATION WAS CONFIRMED. THE PATIENT CONDITION WAS MONITORED AND THERE WERE NO SYMPTOMS AT THAT TIME. THE PATIENT WENT TO THE HOSPITAL DUE TO ABDOMINAL PAIN AND FEVER. A COMPUTED TOMOGRAPHY SCAN SHOWED THAT THERE WAS AIR SPACE AT THE SPACER PLACEMENT. THE PATIENT WAS UNDER OBSERVATION AND THE RECTAL PERFORATION WAS TREATED WITH ARTIFICIAL ANUS CONSTRUCTION. THE PATIENT RECEIVED EXTERNAL BEAM RADIATION THERAPY (EBRT) WITH SBRT (40 GY/5FR) AND VOLUMETRIC-MODULATED ARC THERAPY (VMAT). Manufacturer Narrative: EVENT DATE: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE, (B)(6) 2022, WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT, (B)(6) 2022. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A PROBLEM ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.


IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPACEOAR VUE WAS IMPLANTED DURING A SPACEOAR VUE PLACEMENT PROCEDURE PERFORMED IN (B)(6) 2021. FIDUCIAL MARKERS WERE PLACED TRANSPERINEALLY DURING THE SAME PROCEDURE. THE PATIENT BEGAN INTENSITY MODULATED RADIATION THERAPY (IMRT) IN (B)(6) 2021 AND COMPLETED IT IN (B)(6) 2022. IN (B)(6) 2022, THE PATIENT NOTED TO THE PLACING PHYSICIAN THAT HE WAS EXPERIENCING RECTAL FREQUENCY, RECTAL URGENCY AND RECTAL PAIN. THE PATIENT'S SYMPTOMS BEGAN DURING THE SECOND HALF OF HIS RADIATION THERAPY. THE PATIENT'S PROSTATE SPECIFIC ANTIGEN (PSA) HAD FALLEN TO 0.2 OR 0.3. DUE TO SEVERE RECTAL PAIN AND FECAL INCONTINENCE, THE PATIENT WENT TO THE EMERGENCY ROOM. THE PATIENT POSSIBLY EXPERIENCED FEVERS AT HOME. A FLUID COLLECTION BETWEEN THE PROSTATE AND THE RECTUM WAS VISIBLE ON A COMPUTED TOMOGRAPHY (CT) SCAN AND WAS DIAGNOSED AS AN ABSCESS. RECTAL EXAMINATION REVEALED TENDERNESS BUT NOTHING WAS FLUCTUANT. TRANSRECTAL ULTRASONOGRAPHY (TRUS) WAS PERFORMED ON THE PATIENT TWO DAYS LATER IN THE OFFICE, AND IT REVEALED A SOLID HETEROGENEOUS LESION. THE TRANSPERINEAL BIOPSY OF THIS TUMOR BY THE PHYSICIAN REVEALED FIBROSIS AND INFLAMMATION BUT NO FINDINGS THAT WERE INDICATIVE OF PROSTATE CANCER. WHEN THE NEEDLE WAS INSERTED TRANSPERINEALLY, NO FLUID WAS FOUND. THE PATIENT WAS TREATED WITH PERCOCET FOR PAIN. A FLEXIBLE SIGMOIDOSCOPY WILL BE PERFORMED. MAGNETIC RESONANCE IMAGING (MRI) WILL BE PERFORMED AND THE PATIENT WILL BE TREATED TO MANAGE SYMPTOMS. Manufacturer Narrative: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE, (B)(6) 2022, WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT, 10JUN2022. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER. THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. CLINICAL CODE (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A PROBLEM ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

EDIT: I missed some...

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPACEOAR WAS IMPLANTED DURING A SPACEOAR PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. THE PATIENT EXPERIENCED PAIN AND BLOODY STOOL IMMEDIATELY FOLLOWING SPACEOAR IMPLANTATION. ENDOSCOPY OF THE GASTROINTESTINAL TRACT CONFIRMED AN ULCER HAD FORMED. IT WAS NOTED THE POSSIBLE CAUSE OF THE ULCER FORMATION WAS THE HYDROGEL PENETRATING INTO THE INTRINSIC MUSCULAR LAYER OF THE RECTUM. THE PATIENT HAD NO SIGNS OF INFECTION AND WAS TREATED CONSERVATIVELY. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. Manufacturer Narrative: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE, (B)(6) 2022, WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT, (B)(6) 2022. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A PROBLEM ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.


IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPACEOAR VUE WAS IMPLANTED DURING A SPACEOAR VUE PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. THE PATIENT HAD ACUTE RECTAL SYMPTOMS AND APPEARED TO HAVE A RECTAL WALL INFILTRATION THAT WAS NOTED BY THE FOURTH WEEK OF RADIATION TREATMENT. PAIN, FISTULA, AND AN ULCER WERE CONFIRMED VIA SCOPE. THE PATIENT WAS TREATED WITH HYPERBARIC OXYGEN TREATMENTS. ADDITIONALLY, THE PATIENT COMPLETED RADIATION TREATMENT AND THE FISTULA IS ALREADY SHRINKING, ALTHOUGH THERE WAS STILL SOME PAIN. Manufacturer Narrative: EVENT DATE: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE, (B)(6) 2022, WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT, (B)(6) 2022. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER. THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4). INITIAL REPORTER: HEALTHCARE PROFESSIONAL WAS ESTIMATED TO YES BASED OFF EVENT DETAILS. THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A PROBLEM ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.


IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPACEOAR VUE WAS IMPLANTED DURING A SPACEOAR VUE PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. A COMPUTED TOMOGRAPHY SCAN (CT) REVEALED NO EVIDENCE OF GEL IN THE RECTUM. HOWEVER, IT WAS NOT DEFINITIVE WITHOUT MAGNETIC RESONANCE IMAGING (MRI). THE PATIENT EXPERIENCED SEVERE PAIN AND WAS TREATED WITH HYDROCODONE. THE PATIENT DEVELOPED A DEEP RECTAL ULCER AFTER RADIATION THERAPY. THE PATIENT HAD RADIATION TREATMENT OF 70/28 FRACTIONS. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. Manufacturer Narrative: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE, (B)(6) 2021, WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT, (B)(6) 2021. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A PROBLEM ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
 
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SneakyBooger said:
  • ITALY REVIEW, 2021
  • Critical Reviews in Oncology / Hematology
  • Redirecting
  • “Of course, mature data about toxicity rate after 5 years are needed to have a reliable assessment about late toxicity comparison. Data from the pooled analysis may raise concern about the 9.8 % acute GI toxicity increase after moderate hypofractionation.”
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Easy to just quote the ASTRO/AUA prostate hypofx guidelines which mention this.

Evilcore started trying to push hypofx last year and that went away pretty quickly once they started seeing their decisions appealed and overturned by third parties based on the guidelines and data. Now they don't even try to push back against conventional.

I still hypofx but i am pretty adamant about counseling about the acute gi effects which are no joke... Some patients are still happy to finish quicker, a couple have wished they had just come in the few extra weeks
 
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medgator said:
Easy to just quote the ASTRO/AUA prostate hypofx guidelines which mention this.

Evilcore started trying to push hypofx last year and that went away pretty quickly once they started seeing their decisions appealed and overturned by third parties based on the guidelines and data
Click to expand...
So Im about to sim a high risk patient (officially due to Gleason score) with ece and loss of the plane bt prostate and rectum on MRI. No evidence of rectal invasion on exam. Most here would conventionally fractionate?
 
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Ray D. Ayshun said:
So Im about to sim a high risk patient (officially due to Gleason score) with ece and loss of the plane bt prostate and rectum on MRI. No evidence of rectal invasion on exam. Most here would conventionally fractionate?
Click to expand...
Assuming he lives nearby, why take a risk?
 
Ray D. Ayshun said:
So Im about to sim a high risk patient (officially due to Gleason score) with ece and loss of the plane bt prostate and rectum on MRI. No evidence of rectal invasion on exam. Most here would conventionally fractionate?
Click to expand...
70/28 has worked fine for me if pt wants to finish quicker and understands the tradeoffs. I treat nodes
 
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Ray D. Ayshun said:
So Im about to sim a high risk patient (officially due to Gleason score) with ece and loss of the plane bt prostate and rectum on MRI. No evidence of rectal invasion on exam. Most here would conventionally fractionate?
Click to expand...
I would offer conventional with unfailing enthusiasm. I would even go knock on Dan Spratt's door and tell him I'm doing it, too.

THAT BEING SAID, agree with the folks above. 70/28 is fine, especially for someone with travel issues.

I also treat nodes for high risk patients. I like 45/25 for pelvic ENI, and I don't care who knows about it.
 
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I vote for SneakerBooger for SDN poster of the year for promoting arthritis treatment and now leading the 'resistance' against the ridiculous NCCN and ASTRO crusade against effective and safe conventionally fractionated radiation for prostate cancer. In addition to the compelling evidence presented, I would add that conventionally fractionated radiation to 74 Gy in 37 fractions was shown in the ProtecT trial to be equally effective and less toxic compared to radical prostatectomy with 10 year follow-up.

I 'wonder' why NCCN and ASTRO would so aggressively promote a treatment which is certainly not more effective than the previous standard of care and is possibly more toxic.
 
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theradiator said:
I vote for SneakerBooger for SDN poster of the year for promoting arthritis treatment and now leading the 'resistance' against the ridiculous NCCN and ASTRO crusade against effective and safe conventionally fractionated radiation for prostate cancer. In addition to the compelling evidence presented, I would add that conventionally fractionated radiation to 74 Gy in 37 fractions was shown in the ProtecT trial to be equally effective and less toxic compared to radical prostatectomy with 10 year follow-up.

I 'wonder' why NCCN and ASTRO would so aggressively promote a treatment which is certainly not more effective than the previous standard of care and is possibly more toxic.
Click to expand...
Shorter fractionation schemes benefit academic centers that are often seeing and potentially treating out of towners, higher costs are never an issue in these studies and it's easier to be blissfully ignorant about the elephant in the room. Often these centers are treating at capacity so rather than turn patients away to centers closer to home, better to increase the throughout (same reason why you'll see interest in hypofrac studies in places like the UK, Canada etc)

Site-neutral bundles would obviously make all of this a moot point and level the playing field which is exactly why ASTRO opposed them for years, and likely still does (afaik they haven't come out and straight up called for PPS exempt to be included in a bundle or to remove the status at all)
 
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Idk man. You think 8.5 vs 5.5 weeks is helping Mdacc ??
 
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RealSimulD said:
Idk man. You think 8.5 vs 5.5 weeks is helping Mdacc ??
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Maybe 1-4 weeks is? I'm sure some might even take the 5.5 if they have family in the area.

You don't think 5-28 fx at a big name might change the calculus for some vs 20-40 fx at jo schmo cancer center in town? If insurance is in network at both places, in my experience, some will absolutely travel, esp if it is a shorter course and it is cost agnostic to the patient
 
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medgator said:
Maybe 1-4 weeks is? I'm sure some might even take the 5.5 if they have family in the area.

You don't think 5-28 fx at a big name might change the calculus for some vs 20-40 fx at jo schmo cancer center in town? If insurance is in network at both places, in my experience, some will absolutely travel, esp if it is a shorter course and it is cost agnostic to the patient
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I think for 5 fractions, sure. But 28, I am doubtful. Could be wrong for sure.
 
RealSimulD said:
I think for 5 fractions, sure. But 28, I am doubtful. Could be wrong for sure.
Click to expand...
So many factors... I've had patients leave for 44 of protons plus spaceoar. But also for sbrt at the big name. Hospitals around the country don't pay for MD Anderson affiliation for nothing. That name carries weight. Same holds true for many NCI CCs around the country

My point is that the big name center for treatment becomes more palatable as the number of weeks away from home decreases, esp for some higher SES patients who have a choice (Medicaid, HMO etc often don't)
 
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Palex80 said:
There are data for SCLC LD using 2.66-2.75 Gy daily in single daily fractions.
They did not look better (or worse actually) than 30 x 1.5 Gy, delivered twice per day.
Click to expand...
Would argue the feasibility of hypofx in this setting is very dependent on the distribution of disease
 
Lamount said:
Would argue the feasibility of hypofx in this setting is very dependent on the distribution of disease
Click to expand...
Since most people seem to be giving 30-33 Gy in 2Gy fractions for LD SCLC, I do not see any issues in delivering something like 45-50Gy in 2.5-2.75 Gy fractions instead.
55/2.75 is s.o.c. in the UK for stage III NSCLC. They manage to meet constraints too, somehow.
 
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Ray D. Ayshun said:
So Im about to sim a high risk patient (officially due to Gleason score) with ece and loss of the plane bt prostate and rectum on MRI. No evidence of rectal invasion on exam. Most here would conventionally fractionate?
Click to expand...
Will you treat nodes or not?
 
Ray D. Ayshun said:
So Im about to sim a high risk patient (officially due to Gleason score) with ece and loss of the plane bt prostate and rectum on MRI. No evidence of rectal invasion on exam. Most here would conventionally fractionate?
Click to expand...
Conventional.



Jens Overgaard –

“Personalised radiation therapy taking both the tumour and patient into consideration”

Redirecting

“These studies clearly point to improved outcome of cancer treatment if the basic radiobiological principles are considered [12,13]. But this lesson is not always learned – we are increasingly seeing a development where the tumour control is under challenge by attempts to de-escalate curative dose levels, not only in the primary treatment, but also in the adjuvant setting. The latter is not necessarily intentional, but often a consequence of the increasing use of hypofractionated regimes which de facto can result in a relatively poorer therapeutic ratio (more late damage relative to tumour control) [14]”
 
jondunn said:
Strange that some of you think SBRT is reserved for the Mecca?

Just ask me or @OTN
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Not the point I was making. The point I was making is that academic places are adopting SBRT more rapidly in prostate. It is impossible to infer the intentions of those practitioners but it is plausible that they are doing this to keep more of the second opinion patients. Plus they usually have higher negotiated rates.

Best example

MSK Precise® Radiation Therapy

Learn more about MSK's approach to hypofractionated radiation therapy, called MSK Precise.
www.mskcc.org www.mskcc.org
 
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Chartreuse Wombat said:
Not the point I was making. The point I was making is that academic places are adopting SBRT more rapidly in prostate. It is impossible to infer the intentions of those practitioners but it is plausible that they are doing this to keep more of the second opinion patients. Plus they usually have higher negotiated rates.

Best example

MSK Precise® Radiation Therapy

Learn more about MSK's approach to hypofractionated radiation therapy, called MSK Precise.
www.mskcc.org www.mskcc.org
Click to expand...

Or maybe since many of them aren’t paid by productivity they don’t care and thus choose what they would likely offer themselves if they had prostate cancer?

To think an individual academic provider cares what negotiated rates are is silly. We already have talked about how most of them have no clue what it costs.
 
medgator said:
Really? The only places that flat out salary without any kind of productivity bonus that I'm aware of is CC and mayo
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Agree with gator on this one
The era of altruistic academics is over. Mskcc, mdacc, etc are almost assuredly in the business of stealing community patients. Mayo is one of few places where patients told that the local opinion is correct.

While we can’t say what the motives of individual providers are for sure, the rapid push to sbrt for almost everything suggests a desire to more easily pry away the out of town patients
 
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medgator said:
Really? The only places that flat out salary without any kind of productivity bonus that I'm aware of is CC and mayo
Click to expand...

Okay - then no matter what extended fractionation schemes always pay more. So what gives?

Again - negotiated rates have nothing to do with RVUs

See how the logic falls apart?

Also as an FYI - plenty and plenty of places in academics other than Mayo pay flat salaries
 
If you see patient for consult you only get em rvu if you treat them you get many more rvus

If you are on rvu you are incentivized to keep and treat every consult you see
 
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RadRadRad said:
If you see patient for consult you only get em rvu if you treat them you get many more rvus

If you are on rvu you are incentivized to keep and treat every consult you see
Click to expand...

No doubt shorter fractionation schemes help keep
Patients in major centers - but I just don’t think this is the majority of business. The majority of business is still people that are locoregional.

I agree MDA and MSK are unique in that sense they will have high flyers that want to come there. But even then - if you have people that are inclined to come - they’re yours anyways.

The amount of patients that will only come if you offer SBRT just isn’t that many - when you take ‘academics’ at large.


If you’re at Kansas - you’re the only name in town and it’s a small city anyways. The patients you mostly see are yours anyways. They’re in your insurance network already.

It’s simply not all that it’s being made out to be here.
 
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Simply put - at scale, the biggest factor on academic theft is hospital consolidation.

Treatment choice is a drop in the bucket.
 
jondunn said:
Okay - then no matter what extended fractionation schemes always pay more. So what gives?
Click to expand...
Nope.... Which fee schedule? Negotiated rates? PPS exempt? Unless you are talking about two exact centers, that's never true. And we most certainly aren't... We are talking local place vs big whig academic center. A patient is making a decision to stay local vs going to MDA msk based on how much they are charging the system. Did you forget your Adderall today?

SBRT at sloan or Anderson can easily cost more than 28-44 at a local community place.

KO on mednet long ago mentioned SBRT costing mid five figures at mayo.

A lot of places are putting productivity into salaries, I'm sure others on this forum can chime in... The only places I'm aware of not doing that are the VA, KP, CC and mayo
 
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medgator said:
Nope.... Which fee schedule? Negotiated rates? PPS exempt? Unless you are talking about two exact centers, that's never true. And we most certainly aren't... We are talking local place vs big whig academic center.

SBRT at sloan or Anderson can easily cost more than 28-44 at a local community place.

KO on mednet long ago mentioned SBRT costing mid five figures at mayo
Click to expand...

I’ve literally never met someone with less reading comprehension than you. Zero skills with context clues I guess?

Im not even going to tell you how badly you misread the post and missed the point. I’ll let you figure it out. RadRadRad did. I believe in you.
 
jondunn said:
I’ve literally never met someone with less reading comprehension than you. Zero skills with context clues I guess?

Im not even going to tell you how badly you misread the post and missed the point. I’ll let you figure it out. RadRadRad did. I believe in you.
Click to expand...
Projection is such an interesting thing, JD. Hopefully one day you get the help you need IRL. On to the Blocklist you go!
 
Chartreuse Wombat said:
Not the point I was making. The point I was making is that academic places are adopting SBRT more rapidly in prostate. It is impossible to infer the intentions of those practitioners but it is plausible that they are doing this to keep more of the second opinion patients. Plus they usually have higher negotiated rates.

Best example

MSK Precise® Radiation Therapy

Learn more about MSK's approach to hypofractionated radiation therapy, called MSK Precise.
www.mskcc.org www.mskcc.org
Click to expand...
JD struggles with reading comprehension.. not the first time, now he's employing a classic psych defense mechanism when called out on said BS. Best to ignore imo
 
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