|Year : 2006 | Volume
| Issue : 4 | Page : 385-386
Can androgen deprivation therapy be deferred in select group of patients with prostate cancer who are not suitable for curative local treatment?
A Karthikeyan, Nitin S Kekre
Department of Urology, Christian Medical College, Vellore, Tamil Nadu, India
Department of Urology, Christian Medical College, Vellore, Tamil Nadu
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Karthikeyan A, Kekre NS. Can androgen deprivation therapy be deferred in select group of patients with prostate cancer who are not suitable for curative local treatment?. Indian J Urol 2006;22:385-6
|How to cite this URL:|
Karthikeyan A, Kekre NS. Can androgen deprivation therapy be deferred in select group of patients with prostate cancer who are not suitable for curative local treatment?. Indian J Urol [serial online] 2006 [cited 2019 Jun 17];22:385-6. Available from: http://www.indianjurol.com/text.asp?2006/22/4/385/29138
Studer UE, Hauri D, Hanselmann S, Chollet D, Leisinger HJ, Gasser T, et al. Immediate versus deferred hormonal treatment for patients with prostate cancer who are not suitable for curative local treatment: Results of the randomized trial SAKK 08/88. J Clin Oncol 2004;22:4109-18.
| Summary|| |
Androgen deprivation is an effective palliative therapy in men with advanced prostate cancer. When to initiate androgen deprivation therapy in advanced prostate cancer has been controversial over the years. The authors have tried to analyze the outcome of early versus delayed treatment in men with newly diagnosed asymptomatic prostate cancer in a randomized control trial. They included those with advanced disease or with localized disease not suitable or unwilling for any reason to undergo definitive treatment. Patients with obstructive voiding symptoms were not excluded as palliative transurethral resection of the prostate can be performed at any time. Before randomization patients were stratified according to the performance status, tumor stage, lymph node status, distant metastasis and participating center. One hundred and ninety-seven men were randomized into two groups and the analysis was done with an intension to treat. Of the 100 men assigned to the immediate treatment group 91 had subcapsular orchidectomy and nine did not undergo orchidectomy. Of the 97 assigned to deferred orchidectomy five were ineligible. In the deferred orchidectomy group subcapsular orchidectomy was performed at the onset of symptoms due to metastasis or ureteric compression or new asymptomatic metastasis which are likely to cause pathological fractures and nerve compression. Biochemical progression, new hotspots, new visceral metastasis were not an indication for orchidectomy if they were asymptomatic in the deferred treatment group provided there was no deterioration of two or more points in the performance status. The primary end point was overall survival. The main secondary end point was posttreatment symptom-free survival. The power of the study was 90% with a hypothesized difference in survival of 15% at five years between the two groups. Both the groups were followed periodically with history, physical examination, performance status, pain score, blood biochemistry, chest X-ray, Ultrasound or IVU, CT of the pelvis and bone scan. None of them were lost to follow-up and more than 90% died during follow-up. Of the 92 patients in the deferred treatment group 42% never required orchidectomy. There was no difference in the overall survival, cancer-specific survival and pain-free survival. In the multivariate analysis they found that immediate treatment and absence of metastasis were the factors that had a significant beneficial effect on time to progression. Overall survival was significantly lower in patients with metastatic disease, node positive disease, concomitant cardiovascular disease and in those with a baseline hemoglobin of <14 g/dl.
| Comments|| |
Endocrine treatment delays progression in locally advanced and metastatic disease, but whether it translates into better survival outcome has been addressed by the Veterans Administration Research Service Cooperative Urological Research Group (VACURG) and Medical Research Council (MRC) trials. The VACURG trial was the first randomized trial to disprove the prior belief that early hormonal treatment improves survival in the immediate treatment group as compared to deferred treatment in those with asymptomatic metastatic disease. They also concluded that there is no difference in survival between Stage III and Stage IV. The MRC trial demonstrated an overall survival and cancer-specific survival benefit in the immediate treatment group. Pathological fractures, spinal cord compression and ureteric obstruction were twice more common in the deferred treatment group, however, during long-term follow-up there was no difference in overall survival. Both these trials were criticized for the lack of stringent protocol. The authors in the present trial had designed a strict protocol for follow-up and the majority were followed till death. Nearly 40% in the deferred group did not require orchidectomy. The median time to orchidectomy in the deferred group was 3.2 years. The complications associated with androgen deprivation can be avoided or delayed by offering delayed treatment. The pitfall in this trial was the inclusion of T1 and T2 tumors, which accounted for about one-third of the patients. Due to the small number of patients with advanced disease, subgroup analysis may not give a meaningful conclusion. In a select group of elderly patients with asymptomatic advanced stage disease deferred treatment is an effective alternative therapy if strict follow-up is feasible.
| References|| |
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