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Definition |
Neoadjuvant hormonal therapy (NHT) is defined as therapy given before definitive local curative treatment.
Since PCa is an androgen-dependent tumour, NHT is an appealing concept. A recent review and meta-analysis
studied the role of NHT and prostatectomy. NHT significantly reduced positive margin rates (RR = 0.49
p < 0.00001), extra-prostatic extension (RR = 1.63; p < 0.0001) and lymph node invasion (RR = 0.49; 0.42-0.56;
p < 0.02). However, this was not associated with improved OS or disease-free survival (DFS).
Regarding adjuvant HT, a Cochrane review has been published: the pooled data showed a
non-significant 5-year OS benefit (OR: 1.50 [95% CI: 0.79-2.84]) and no 10-year OS benefit (with again a trend
favouring the adjuvant approach). The pooled data for DFS gave an overall OR of 3.73 (95% CI: 2.3-6.03). The
overall effect estimate was highly significant (p < 0.00001) in favour of the HT arm. The Early Prostate Cancer
Trialists’ Group (EPC) trial using bicalutamide 150 mg daily could not be included in the Cochrane review
due to missing information. After a median follow-up of 7.2 years, there was a significant improvement in
objective PFS that was only significant in the locally advanced disease group (HR: 0.75; 95% CI: 0.61-0.91).
There was an OS decrease trend in the localised disease group (HR: 1.16; 95% CI: 0.99-1.37). No OS benefit
was observed in both localised and locally advanced groups.
The main limitations of the above data are the mixing of pN0 and pN1 populations. For pN+ patients, 2 RCT are
available and drive the main conclusion of the Cochrane review, even if non RCT suggest that the benefit might
not be so large in all patients. Regarding pN0 / N0 stages, the only RCT is the EPC project. Using
more conventional HT, a large retrospective data base with a median follow up of 10 years suggests that
adjuvant HT might be linked to an increased specific, but not OS benefit.
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