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20 september 2017: lees ook deze artikelen: https://kanker-actueel.nl/NL/protonenbestraling-wordt-in-amerika-steeds-vaker-toegepast-en-ook-vergoed-astro-publiceert-nieuwe-richtlijnen-voor-gebruikvan-protonenbestraling.html

en deze: 

https://kanker-actueel.nl/NL/protonenbestraling-geeft-uitstekende-resultaten-op-overleving-veroorzaakt-door-prostaatkanker-met-veel-minder-bijwerkingen-bij-prostaatkankerpatienten-met-hoog-en-middelhoog-risico.html

5 maart 2014: Bron: Int J Radiat Oncol Biol Phys. 2014;88:596-602

Protonenbestraling geeft extreem goede resultaten op 5 jaars overleving en ziektevrije tijd bij prostaatkankerpatiënten in vergelijking met de meest gebruikte fotonen IMRT bestraling (intensity-modulated radiation therapy). Ook al een verbeterde versie van de klassieke bestraling, 3- dimensionale externe radiotherapie ( 3D XRT ) die overigens nog steeds veel wordt uitgevoerd ondanks de ernstigere bijwerkingen daarvan dan bij een IMRT bestraling.  

De resultaten voor 5-jaars overleving met protonenbestraling waren voor de drie risicogroepen resp. 93 % voor de laag risico groep, 88% voor de intermediair risico groep en 90 % voor de hoog risicogroep. Voor de ziektevrije tijd op 5 jaars meting waren de cijfers respectievelijk: 99 % in de groep van laag risico patiënten , 99 % in de groep van intermediair risico patiënten en 76 % in de groep van hoog risico patiënten.

Dit blijkt uit drie postpectieve studies met totaal 211 patiënten (89 patiënten met laag risico, 82 patiënten met intermediair risico en 40 patiënten hoog risico) en uitgevoerd aan de universiteit van het Florida Proton Therapy Institute in Jacksonville met een follow-up tijd van 5,2 jaar.

Deze resultaten zijn ook in lijn met de gerandomiseerde PROG-9509 protonen veiligheidstudie met oplopende bestralingsintensiteit, uitgevoerd bij totaal 393 patiënten. zie Patient-reported long-term outcomes after conventional and high-dose combined proton and photon radiation for early prostate cancer 

Studieresultaten:
De studiegegevens zijn ook te vergelijken met de resultaten van een 5,5 jaar durende studie in het Memorial Sloan-Kettering Cancer Center (MSKCC) met prostaatkankerpatiënten met vergelijkbaar risico profiel. Daarvan waren de resultaten op de ziektevrije tijd op 5 jaar respectievelijk:  97 % voor laag risico patiënten , 85 % voor intermediair - risico patiënten en 67 % voor hoog risico patiënten.
De overall ziektevrije tijd na 5 jaar was voor de protonenbestraling 76% tegenover 67% voor de IMRT studie.

Ook de bijwerkingen waren voor de protonenbestraling gunstig: Graad 3 darmklachten en urologische toxiciteit waren respectievelijk 1.0% (0.5%) en 5.4% (1.0%), binnen 5 jaar opgemaakt volgens de Common Terminology Criteria for Adverse Events (CTCAE), de algemene standaard bijwerkingen meting voor prostaatkanker. Deze studiegegevens van protonenbestraling zijn ook gunstig in vergelijking met de beste gepubliceerde resultaten van radicale prostatectomie + brachytherapie en IMRT.

De protonenbestraling werd uitgevoerd met een intensiteit van de zogeheten 78 cobalt gray equivalent (CGE) in 39 fractions voor laag riscio patiënten, 78 to 82 CGE for intermediair risico patiënten, en 78 CGE met daarnaast chemotherapie met docetaxel gevolgd door een hormoontherapie voor hoog risico patiënten.

Kosten:

Protonenbestraling is een duurdere vorm van bestralen dan IMRT bestraling tenminste als er vergeleken wordt wat de bestraling op zichzelf kost. Echter wanneer in acht genomen wordt dat met protonenbestraling 15% betere resultaten worden geboekt op ziektevrije tijd en overleving en de kosten voor herhalingsbehandelingen enz. worden meegenomen dan kan protonenbestraling (veel) goedkoper uitvallen dan IMRT. En door de geringe bijwerkingen ook veel beter voor de patiënt.

Het volledige studieverslag van de Five-Year Outcomes from 3 Prospective Trials of Image-Guided Proton Therapy for Prostate Cancer is tegen betaling in te zien. Hieronder het abstract.

Daaronder het abstract van de Patient-Reported Long-term Outcomes After Conventional and High-Dose Combined Proton and Photon Radiation for Early Prostate Cancer waarvan het volledige studierapport wel gratis is in te zien.

En het studierapport: Long-term Survival and Toxicity in Patients Treated With High-Dose Intensity Modulated Radiation Therapy for Localized Prostate Cancer is alleen tegen betaling in te zien.

Voor alle studies geldt:  U kunt ook proberen via http://www.openaccessbutton.org/ het volledige artikel gratis in te zien.

Hier achtereenvolgens de abstracten van vernoemde studies:

Five-year clinical outcomes with image-guided proton therapy included extremely high efficacy, minimal physician-assessed toxicity, and excellent patient-reported outcomes.

International Journal of Radiation Oncology * Biology * Physics
Volume 88, Issue 3 , Pages 596-602, 1 March 2014

Five-Year Outcomes from 3 Prospective Trials of Image-Guided Proton Therapy for Prostate Cancer

  • Nancy P. Mendenhall, MD

    Affiliations

    • University of Florida Proton Therapy Institute, Jacksonville, Florida
    • Corresponding Author InformationReprint requests to: Nancy Price Mendenhall, MD, University of Florida Proton Therapy Institute, 2015 North Jefferson St, Jacksonville, FL 32206. Tel: (904) 588-1800
  • ,
  • Bradford S. Hoppe, MD

    Affiliations

    • University of Florida Proton Therapy Institute, Jacksonville, Florida
  • ,
  • Romaine C. Nichols, MD

    Affiliations

    • University of Florida Proton Therapy Institute, Jacksonville, Florida
  • ,
  • William M. Mendenhall, MD

    Affiliations

    • University of Florida Proton Therapy Institute, Jacksonville, Florida
  • ,
  • Christopher G. Morris, MS

    Affiliations

    • University of Florida Proton Therapy Institute, Jacksonville, Florida
  • ,
  • Zuofeng Li, DSc

    Affiliations

    • University of Florida Proton Therapy Institute, Jacksonville, Florida
  • ,
  • Zhong Su, PhD

    Affiliations

    • University of Florida Proton Therapy Institute, Jacksonville, Florida
  • ,
  • Christopher R. Williams, MD

    Affiliations

    • Division of Urology, College of Medicine, University of Florida, Jacksonville, Florida
  • ,
  • Joseph Costa, DO

    Affiliations

    • Division of Urology, College of Medicine, University of Florida, Jacksonville, Florida
  • ,
  • Randal H. Henderson, MD, MBA

    Affiliations

    • University of Florida Proton Therapy Institute, Jacksonville, Florida

    Purpose

    To report 5-year clinical outcomes of 3 prospective trials of image-guided proton therapy for prostate cancer.

    Methods and Materials

    A total of 211 prostate cancer patients (89 low-risk, 82 intermediate-risk, and 40 high-risk) were treated in institutional review board-approved trials of 78 cobalt gray equivalent (CGE) in 39 fractions for low-risk disease, 78 to 82 CGE for intermediate-risk disease, and 78 CGE with concomitant docetaxel therapy followed by androgen deprivation therapy for high-risk disease. Toxicities were graded according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Median follow-up was 5.2 years.

    Results

    Five-year rates of biochemical and clinical freedom from disease progression were 99%, 99%, and 76% in low-, intermediate-, and high-risk patients, respectively. Actuarial 5-year rates of late CTCAE, version 3.0 (or version 4.0) grade 3 gastrointestinal and urologic toxicity were 1.0% (0.5%) and 5.4% (1.0%), respectively. Median pretreatment scores and International Prostate Symptom Scores at >4 years posttreatment were 8 and 7, 6 and 6, and 9 and 8, respectively, among the low-, intermediate-, and high-risk patients. There were no significant changes between median pretreatment summary scores and Expanded Prostate Cancer Index Composite scores at >4 years for bowel, urinary irritative and/or obstructive, and urinary continence.

    Conclusions

    Five-year clinical outcomes with image-guided proton therapy included extremely high efficacy, minimal physician-assessed toxicity, and excellent patient-reported outcomes. Further follow-up and a larger patient experience are necessary to confirm these favorable outcomes.

Among men with clinically localized prostate cancer, treatment with higher-dose radiation compared with standard dose was not associated with an increase in patient-reported prostate cancer symptoms after a median of 9.4 years

JAMA. 2010 Mar 17;303(11):1046-53. doi: 10.1001/jama.2010.287.

Patient-reported long-term outcomes after conventional and high-dose combined proton and photon radiation for early prostate cancer.

Author information

  • 1Center for Outcomes Research, MGH Cancer Center, Massachusetts General Hospital, Boston, Massachusetts, USA. jtalcott@partners.org

Erratum in

  • JAMA. 2010 Apr 7;303(13):1257.

Abstract

CONTEXT:

Increased radiation doses improve prostate cancer control but also increase toxicity to adjacent normal tissue. Proton radiation may attenuate adverse effects.

OBJECTIVE:

To determine long-term, patient-reported, dose-related toxicity.

DESIGN, SETTING, AND PATIENTS:

We performed a post hoc cross-sectional survey of surviving participants in the Proton Radiation Oncology Group (PROG) 9509--a randomized trial comparing 70.2 Gy vs 79.2 Gy of combined photon and proton radiation for 393 men with clinically localized prostate cancer (stage T1b-T2b, prostate-specific antigen <15 ng/mL, and no radiographic evidence of metastasis). The estimated 10-year biochemical progression rate for patients receiving standard dose was 32% (95% confidence interval, 26%-39%) compared with 17% (95% confidence interval, 11%-23%) for patients receiving high dose (P < .001). We surveyed 280 of the surviving 337 patients (83%) from April 2007 to September 2008.

MAIN OUTCOME MEASURES:

Prostate Cancer Symptom Indices, a validated measure of urinary incontinence, urinary obstruction and irritation, bowel problems, and sexual dysfunction, and related quality-of-life instruments.

RESULTS:

At a median of 9.4 years after treatment (range, 7.4-12.1 years), participants' demographic and clinical characteristics were similar. Patient-reported outcomes were reported as mean (SD) scale score for standard dose vs high dose: urinary obstruction/irritation (23.3 [13.7] vs 24.6 [14.0]; P = .36), urinary incontinence (10.6 [17.7] vs 9.7 [15.8]; P = .99), bowel problems (7.7 [7.8] vs 7.9 [9.1]; P = .70), sexual dysfunction (68.2 [34.6] vs 65.9 [34.7]; P = .65), and most other outcomes were also similar, although patients receiving standard dose whose cancers had more often progressed expressed less confidence that their cancers were under control (mean scale score for standard dose, 76.0 [25.4] vs high dose, 86.2 [17.9]; P < .001). Many patients characterized their urinary and bowel function as normal despite reporting symptoms that, for other prostate cancer patients before and early after cancer treatment, caused substantial distress.

CONCLUSION:

Among men with clinically localized prostate cancer, treatment with higher-dose radiation compared with standard dose was not associated with an increase in patient-reported prostate cancer symptoms after a median of 9.4 years.

Comment in

PMID:
20233822
[PubMed - indexed for MEDLINE]

Long-term Survival and Toxicity in Patients Treated With High-Dose Intensity Modulated Radiation Therapy for Localized Prostate Cancer

International Journal of Radiation Oncology * Biology * Physics
Volume 85, Issue 3 , Pages 686-692, 1 March 2013

This work will be presented in part at the 54th Annual Meeting of the American Society for Radiation Oncology (ASTRO), in Boston, MA, October 28-31, 2012.

Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, New York

Received 17 April 2012; received in revised form 11 May 2012; accepted 15 May 2012. published online 13 July 2012.

Purpose

To report long-term survival and toxicity outcomes with the use of high-dose intensity modulated radiation therapy (IMRT) to 86.4 Gy for patients with localized prostate cancer.

Methods and Materials

Between August 1997 and December 2008, 1002 patients were treated to a dose of 86.4 Gy using a 5-7 field IMRT technique. Patients were stratified by prognostic risk group based on National Comprehensive Cancer Network risk classification criteria. A total of 587 patients (59%) were treated with neoadjuvant and concurrent androgen deprivation therapy. The median follow-up for the entire cohort was 5.5 years (range, 1-14 years).

Results

For low-, intermediate-, and high-risk groups, 7-year biochemical relapse-free survival outcomes were 98.8%, 85.6%, and 67.9%, respectively (P<.001), and distant metastasis-free survival rates were 99.4%, 94.1%, and 82.0% (P<.001), respectively. On multivariate analysis, T stage (P<.001), Gleason score (P<.001), and >50% of initial biopsy positive core (P=.001) were predictive for distant mestastases. No prostate cancer-related deaths were observed in the low-risk group. The 7-year prostate cancer-specific mortality (PCSM) rates, using competing risk analysis for intermediate- and high-risk groups, were 3.3% and 8.1%, respectively (P=.008). On multivariate analysis, Gleason score (P=.004), percentage of biopsy core positivity (P=.003), and T-stage (P=.033) were predictive for PCSM. Actuarial 7-year grade 2 or higher late gastrointestinal and genitourinary toxicities were 4.4% and 21.1%, respectively. Late grade 3 gastrointestinal and genitourinary toxicity was experienced by 7 patients (0.7%) and 22 patients (2.2%), respectively. Of the 427 men with full potency at baseline, 317 men (74%) retained sexual function at time of last follow-up.

Conclusions

This study represents the largest cohort of patients treated with high-dose radiation to 86.4 Gy, using IMRT for localized prostate cancer, with the longest follow-up to date. Our findings indicate that this treatment results in excellent clinical outcomes with acceptable toxicity.


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