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dc.contributor.authorDearnaley, David P
dc.contributor.authorSydes, Matthew R
dc.contributor.authorLangley, Ruth E
dc.contributor.authorGraham, John D
dc.contributor.authorHuddart, Robert A
dc.contributor.authorSyndikus, Isabel
dc.contributor.authorMatthews, John H L
dc.contributor.authorScrase, Christopher D
dc.contributor.authorJose, Chakiath C
dc.contributor.authorLogue, John P
dc.contributor.authorStephens, Richard J
dc.date.accessioned2009-06-09T16:30:28Z
dc.date.available2009-06-09T16:30:28Z
dc.date.issued2007-04
dc.identifier.citationThe early toxicity of escalated versus standard dose conformal radiotherapy with neo-adjuvant androgen suppression for patients with localised prostate cancer: results from the MRC RT01 trial (ISRCTN47772397). 2007, 83 (1):31-41 Radiother Oncolen
dc.identifier.issn0167-8140
dc.identifier.pmid17391791
dc.identifier.doi10.1016/j.radonc.2007.02.014
dc.identifier.urihttp://hdl.handle.net/10541/70035
dc.description.abstractBACKGROUND: Five-year disease-free survival rates for localised prostate cancer following standard doses of conventional radical external beam radiotherapy are around 80%. Conformal radiotherapy (CFRT) raises the possibility that radiotherapy doses can be increased and long-term efficacy outcomes improved, with safety an important consideration. METHODS: MRC RT01 is a randomised controlled trial of 862 men with localised prostate cancer comparing Standard CFRT (64Gy/32f) versus Escalated CFRT (74Gy/37f), both administered with neo-adjuvant androgen suppression. Early toxicity was measured using physician-reported instruments (RTOG, LENT/SOM, Royal Marsden Scales) and patient-reported questionnaires (MOS SF-36, UCLA Prostate Cancer Index, FACT-P). RESULTS: Overall early radiotherapy toxicity was similar, apart from increased bladder, bowel and sexual toxicity, in the Escalated Group during a short immediate post-radiotherapy period. Toxicity in both groups had abated by week 12. Using RTOG Acute Toxicity scores, cumulative Grade 2 bladder and bowel toxicity was 38% and 30% for Standard Group and 39% and 33% in Escalated Group, respectively. Urinary frequency (Royal Marsden Scale) improved in both groups from pre-androgen suppression to 6 months post-radiotherapy (p<0.001), but bowel and sexual functioning deteriorated. This pattern was supported by patient-completed assessments. Six months after starting radiotherapy the incidence of RTOG Grade > or = 2 side-effects was low (<1%); but there were six reports of rectal ulceration (6 Escalated Group), six haematuria (5 Escalated Group) and eight urethral stricture (6 Escalated Group). CONCLUSIONS: The two CFRT schedules with neo-adjuvant androgen suppression have broadly similar early toxicity profiles except for the immediate post-RT period. At 6 months and compared to before hormone therapy, bladder symptoms improved, whereas bowel and sexual symptoms worsened. These assessments of early treatment safety will be complemented by further follow-up to document late side-effects and efficacy.
dc.language.isoenen
dc.subjectProstate Canceren
dc.subject.meshAged
dc.subject.meshAndrogen Antagonists
dc.subject.meshGonadotropin-Releasing Hormone
dc.subject.meshHumans
dc.subject.meshMale
dc.subject.meshMiddle Aged
dc.subject.meshNeoadjuvant Therapy
dc.subject.meshProstatic Neoplasms
dc.subject.meshRadiation Injuries
dc.subject.meshRadiotherapy Dosage
dc.subject.meshRadiotherapy, Conformal
dc.subject.meshRectum
dc.subject.meshUrinary Bladder
dc.titleThe early toxicity of escalated versus standard dose conformal radiotherapy with neo-adjuvant androgen suppression for patients with localised prostate cancer: results from the MRC RT01 trial (ISRCTN47772397).en
dc.typeArticleen
dc.contributor.departmentInstitute of Cancer Research and Royal Marsden Hospitals, Sutton, UK. david.dearnaley@icr.ac.uken
dc.identifier.journalRadiotherapy and Oncologyen
html.description.abstractBACKGROUND: Five-year disease-free survival rates for localised prostate cancer following standard doses of conventional radical external beam radiotherapy are around 80%. Conformal radiotherapy (CFRT) raises the possibility that radiotherapy doses can be increased and long-term efficacy outcomes improved, with safety an important consideration. METHODS: MRC RT01 is a randomised controlled trial of 862 men with localised prostate cancer comparing Standard CFRT (64Gy/32f) versus Escalated CFRT (74Gy/37f), both administered with neo-adjuvant androgen suppression. Early toxicity was measured using physician-reported instruments (RTOG, LENT/SOM, Royal Marsden Scales) and patient-reported questionnaires (MOS SF-36, UCLA Prostate Cancer Index, FACT-P). RESULTS: Overall early radiotherapy toxicity was similar, apart from increased bladder, bowel and sexual toxicity, in the Escalated Group during a short immediate post-radiotherapy period. Toxicity in both groups had abated by week 12. Using RTOG Acute Toxicity scores, cumulative Grade 2 bladder and bowel toxicity was 38% and 30% for Standard Group and 39% and 33% in Escalated Group, respectively. Urinary frequency (Royal Marsden Scale) improved in both groups from pre-androgen suppression to 6 months post-radiotherapy (p<0.001), but bowel and sexual functioning deteriorated. This pattern was supported by patient-completed assessments. Six months after starting radiotherapy the incidence of RTOG Grade > or = 2 side-effects was low (<1%); but there were six reports of rectal ulceration (6 Escalated Group), six haematuria (5 Escalated Group) and eight urethral stricture (6 Escalated Group). CONCLUSIONS: The two CFRT schedules with neo-adjuvant androgen suppression have broadly similar early toxicity profiles except for the immediate post-RT period. At 6 months and compared to before hormone therapy, bladder symptoms improved, whereas bowel and sexual symptoms worsened. These assessments of early treatment safety will be complemented by further follow-up to document late side-effects and efficacy.


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