Review of Bolla Paper

American Society of Clinical Oncology Abstracts Prostate Cancer Key Abstracts Proc Am Soc Clin Oncol 15: 1996.
Bolla M, Gonzalez D, Warde P et al: Immediate hormonal therapy improves locoregional control and survival in patients with locally advanced prostate cancer. Results of a randomized phase III clinical trial of the EORTC radiotherapy and genitourinary tract cancer cooperative groups. Proc Am Soc Clin Oncol 15:238, 1996.

This European study group randomized patients with T1 or T2 clinical stage disease Gleason's scores of 8- 10 as well as patients with T3 or T4 lesions who were N0 Nx M0 into 2 treatment groups: Arm 1 received RT alone and Arm 2 received hormone blockade therapy commencing at the start of RT. The regimen for androgen deprivation (AD) used Cyproterone acetate (Androcur) for one month only at 150 mg per day orally along with Goserelin acetate (Zoladex) 3.6 mg intramuscularly with this drug used for a total of 3 years. Both treatment arms received 50 Gy to the pelvis in 5 weeks given as 5 fractions per week, along with 20 Gy as a prostatic boost in 2 weeks. The total dose to the prostate is therefore 70 Gy or 7000 cGy. A preliminary evaluation with a median of 33 months of follow-up involved 385 patients. At entry to the study the median age was 71 years (range 51-80); the ECOG performance status was 0 in 79% of the patients. The results are shown in the table below and are expressed as 5-years Kaplan-Meier estimates(%) along with confidence intervals (95% c.i.).

This is a significant paper with a key issue being: how important was the use of AD for 36 months in affecting this survival data in patients followed for a median of 33 months. If Labrie's data showed a crude survival of 82% at 3 years in patients with minimal D-2 disease receiving combination hormone blockade then a 78% crude survival using monotherapy with an LHRH agonist at essentially 3 years would not be at all surprising in lesser staged patients. Therefore is the survival benefit really a contribution of AD? It would also be important to look at biochemical progression-free survival using PSA, along with PAP and CGA and also report the cause-specific survival data along with crude- survival.

 

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