Julio Hajdenberg, MD
In patients with locally advanced prostate cancer, does endocrine therapy plus radiotherapy reduce disease-specific mortality more than endocrine therapy alone?
Randomized controlled trial (SPCG-7/SFUO-3 trial). Current Controlled Trials ISRCTN01534787.
Median 7.6 years.
47 centers in Norway, Sweden, and Denmark.
880 men < 76 years of age who had histologically confirmed clinical stage T1b–T2, G2–G3, or T3, G1-3 prostate cancer (1992 TNM classification, World Health Organization grade), prostate-specific antigen (PSA) level ≤ 70 ng/mL (≤ 70 µg/L), no metastases on bone scan and pulmonary radiography, good performance status, and life expectancy > 10 years. Patients with nodal disease were excluded.
Endocrine therapy alone (n = 439) or with radiotherapy (n = 436). Endocrine therapy consisted of total androgen blockade (leuprorelin, 3.75 mg/mo or 11.25 mg/3 mo, and flutamide, 250 mg 3 times/d) for 3 months, then flutamide until progression or death. Standard 3-dimensional conformal radiotherapy was started at 3 months and consisted of 50 Gy to the prostate and seminal vesicles and ≥ 20 Gy boost to the prostate.
Prostate-cancer–specific mortality. Secondary outcomes were all-cause mortality, PSA recurrence, and quality of life (European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire).
99% (mean age 66 y, intention-to-treat analysis).
At 10 years, endocrine therapy plus radiotherapy reduced disease-specific mortality, overall mortality, and PSA recurrence more than endocrine therapy alone (Table). At 4 years, groups did not differ for quality of life (P = 0.059); moderate or severe diarrhea was more frequent in the radiotherapy group (12% vs 10%, P = 0.003).
In locally advanced prostate cancer, adding radiotherapy to endocrine therapy reduced disease-specific and overall mortality.
Endocrine therapy with vs without radiotherapy (RT) in locally advanced prostate cancer†
†PSA = prostate-specific antigen; other abbreviations defined in Glossary. RRR, NNT, and CI calculated from data in article.
‡10-year data estimated from Cox proportional-hazard models.
Hajdenberg J. Adding radiotherapy to endocrine therapy improved survival in locally advanced prostate cancer. Ann Intern Med. ;150:JC6–6. doi: 10.7326/0003-4819-150-12-200906160-02006
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Published: Ann Intern Med. 2009;150(12):JC6-6.
Hematology/Oncology, Prostate Cancer.
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