9 juni 2010: Bron ASCO 2010 - Citation: J Clin Oncol 28:7s, 2010 (suppl; abstr CRA4504)

Bestraling toegevoegd aan hormoonkuur bij prostaatkankerpatienten met een Gleasonscore van 8 of meer en een PSA van meer dan 40 maar zonder uitzaaiingen op afstand hebben beduidend grotere kans om hun prostaatkanker te overleven en de ziektevrije tijd te vergroten dan met alleen een hormoonkuur. Na 7 jaar bleek dat nog 74% van de 603 mannen die behandeld werden met ADT (hormoonkuur) plus externe bestraling nog in leven waren, vergeleken met 66% van de 602 mannen die alleen ADT hadden gekregen.

De combinatietherapie verminderde ook het risico te sterven aan prostaatkanker met 43%, vergeleken met ADT alleen. De algemene verwachting is dat op 10 jaar er ca. 15% zullen zijn overleden in de combinatiegroep en 23% in de groep die alleen hormoontherapie krijgt. De studie was een fase III studie met ca. 1200 prostaatkankerpatienten over een periode van 10 jaar, 1995 tot 2005 en werd gepresenterd op ASCO 2010.

Intergroup randomized phase III study of androgen deprivation therapy (ADT) plus radiation therapy (RT) in locally advanced prostate cancer (CaP) (NCIC-CTG, SWOG, MRC-UK, INT: T94-0110; NCT00002633).

Citation: J Clin Oncol 28:7s, 2010 (suppl; abstr CRA4504)

Author(s): P. R. Warde, M. D. Mason, M. R. Sydes, M. K. Gospodarowicz, G. P. Swanson, P. Kirkbride, E. Kostashuk, J. Hetherington, K. Ding, W. Parulekar, NCIC CTG PR.3/ MRC PRO7/ SWOG JPR3 investigators; Department of Radiation Oncology, Princess Margaret Hospital and University of Toronto, Toronto, ON, Canada; Velindre Hospital, Cardiff, United Kingdom; Clinical Trials Unit, Medical Research Council, London, United Kingdom; University of Texas Health Science Center at San Antonio, San Antonio, TX; Weston Park Hospital, Sheffield, United Kingdom; British Columbia Cancer Agency, Surrey, BC, Canada; Castle Hill Hospital, Hull, United Kingdom; NCIC Clinical Trials Group, Kingston, ON, Canada

 

Background: The impact of radiotherapy on overall survival (OS) in men with locally advanced CaP is unclear. The SPCG-7 trial recently showed a benefit to RT for CaP specific mortality. Our primary objective was to assess the effect of RT on OS when added to lifelong ADT in men with locally advanced CaP. 

Methods: Patients with T3/T4 (1057) or T2, PSA > 40 µg/l (119) or T2 PSA > 20 µg/l and Gleason ≥ 8 (25) and N0 /NX, M0 prostate adenocarcinoma were randomized to lifelong ADT (bilateral orchiectomy or LHRH agonist) with or without RT (65-69 Gy to prostate ± seminal vesicles with or without 45Gy to pelvic nodes). The primary endpoint was OS and secondary endpoints included disease specific survival (DSS), time to disease progression and quality of life. 

Results: 1205 patients were randomized from 1995 to 2005, 602 to ADT and 603 to ADT+RT (well balanced with respect to baseline characteristics). A protocol specified second interim analysis on OS was performed in Aug 2009 (data cut-off Dec 31 2008). The DSMC recommended release of the results to the Trial Committee for publication. The median follow-up is 6.0 years and 320 patients have died (175 ADT and 145 ADT+RT). 10% of patients had no follow-up data beyond 2006. The addition of RT to ADT significantly reduced the risk of death (hazard ratio 0.77, 95% CI 0.61-0.98, p=0.033). 140 patients died of disease and/or treatment (89 on ADT and 51 on ADT+RT) The disease specific survival HR was 0.57 (95% CI 0.41-0.81, p=0.001) favoring ADT+RT. The 10 year cumulative disease specific death rates were estimated at 15% with ADT+ RT and 23% with ADT alone. Grade ≥2 late GI toxicity rates were similar in both arms (proctitis, 1.3% ADT alone, 1.8% ADT+RT).

Conclusions: The trial results indicate a substantial overall survival and disease specific survival benefit for the combined modality approach (ADT+RT) in the management of patients with locally advanced prostate cancer with no significant increase in late treatment toxicity. In view of this data combined modality therapy (ADT+RT) should be the standard treatment approach for these patients. Supported by NCI-US Grant #5U10CA077202-12, CCSRI Grant #15469.

  


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