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UROSCAN
Year : 2010  |  Volume : 26  |  Issue : 2  |  Page : 321-323
 

Adjuvant radiotherapy with hormonal management for locally advanced carcinoma prostate-do we have a case?


Department of Urology, Christian Medical College, Vellore, India

Date of Web Publication12-Jul-2010

Correspondence Address:
John S Banerji
Department of Urology, Christian Medical College, Vellore
India
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Source of Support: None, Conflict of Interest: None


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How to cite this article:
Banerji JS, Kumar S. Adjuvant radiotherapy with hormonal management for locally advanced carcinoma prostate-do we have a case?. Indian J Urol 2010;26:321-3

How to cite this URL:
Banerji JS, Kumar S. Adjuvant radiotherapy with hormonal management for locally advanced carcinoma prostate-do we have a case?. Indian J Urol [serial online] 2010 [cited 2019 Nov 17];26:321-3. Available from: http://www.indianjurol.com/text.asp?2010/26/2/321/65422

Anders Widmark, Olbjorn Klepp, Arne Solberg, Jan-Erik Damber, Anders Angelsen, Per Fransson, Jo Asmund Lund,Ilker Tasdemir,Morten Hoyer,Fredrik Wiklund, Sophie D Fossa: Endocrine treatment, with or without radiotherapy, in locally advanced prostate cancer (SPCG-7/SFUO-3): an open, randomized Phase III trial: Scandinavian Prostate Cancer Group Study 7; Swedish Association for Urological Oncology 3. Endocrine treatment, with or without radiotherapy, in locally advanced prostate cancer (SPCG-7/SFUO-3): an open, randomized Phase III trial: Lancet. 2009 Jan 24; 373 (9660):301-8.



   Summary Top


This study by the Scandinavian Prostate Cancer Study Group highlights the importance of the addition of local radiotherapy to hormonal management in the treatment of high risk, non metastatic, prostate cancer.

A total of 875 patients from 47 centers in Norway, Sweden, and Denmark were diagnosed histologically with carcinoma prostate and if they were younger than 76 years old, had a good performance status, and a life expectancy of at least 10 years, were included in the study. Metastasis was ruled out with a bone scan and pulmonary roentgenogram. All patients with Prostate Specific Antigen (PSA) > 11 ng/ml, were subjected to a pelvic lymph node dissection and were included in the study only if the nodal status was negative. They were subsequently randomized using a block randomization system with a block size of 4.

All patients received maximum androgen blockade with an LHRH agonist, leuprorelin, and flutamide for 3 months. They continued on flutamide at a dose of 750 mg in three divided doses. This was continued until death or progression. A total of 20% of the patients had to be changed to bicalutamide due to intolerance to flutamide. At 3 months, the combination group received radiotherapy in addition to the endocrine management. The median dose of radiotherapy was 70 Gy. Follow-up was initially every 3 months for the first year and subsequently every 6 months. A thorough clinical examination, haemogram, PSA estimation, liver function tests, and recording of adverse effects constituted the follow-up.

The baseline characteristics were evenly matched. A total of 188 of the 875 patients had T2 tumors or smaller. The mean follow-up was 7.6 years.

The cumulative incidence of cancer specific mortality was significantly lower in the group receiving both hormonal manipulation and radiotherapy (11.9% as compared with 23.9% in the hormone alone group). This was highly statistically significant.

The cumulative incidence of death from other causes was also higher in the endocrine group. What was even more marked were the PSA recurrences at 7 and 10 years. This was 74.7% at 10 years in the endocrine group, as compared with 25.9% in the group with combination therapy (with a relative risk of 0.16 with statistical significance).

The quality of life scores were not very different, except for diarrhea, which was more in the group that received radiation.


   Comments Top


The study was an open-ended randomized study with a fairly large and comprehensive sample size. The authors have chosen only pathologically proved node negative subjects so that there can be some comparison with radical prostatectomy on a head to head basis. The strength of this study is the excellent follow-up with no drop-outs in either of the arms. The cancer-specific survival achieved was higher than was expected; hence, the randomization code was broken earlier than planned. Analysis was on an intention-to-treat basis. Although grants and funding for the study were received from various quarters, there was no bias in that the sponsors had no role in design, data collection, or interpretation.

Detailed quality of life scores incorporating both functioning scale and single symptom quality of life quotients reveal the close attention to detail, thus making this study attractive.

Similar results of improvement in outcome with combination therapy have been reported in various subsets of population.

Cellini and associates [1] showed that in T2-T3 disease, dose escalation of radiotherapy unti 70 Gy, along with hormonal manipulation, did improve biochemical disease-free survival.

An RTOG 8610 trial [2] further corroborated that neoadjuvant hormonal therapy was associated with a highly significant improvement in local control, reduction in disease progression, and overall survival.

The Canadian Phase III trial [3] showed that there was no difference in pattern of failure to treatment, when a longer period of neoadjuvant hormonal therapy was used (8 months versus 3 months). However, in the high-risk group, there was a statistically significant difference in 5 year survivals (71% as compared with 42%). The Harvard N and C and SAHT trial [4] was designed to determine whether there was a survival benefit when 3-dimensional conformal radiation therapy (3D-CRT) was administered alone or in combination with 6 months of neoadjuvant and concomitant hormonal therapy in patients with clinically localized intermediate-risk prostate cancer. Patients randomized to receive 3D-CRT plus neoadjuvant hormonal therapy had a significantly higher overall survival rate (P = 0.04) and a lower rate of death from prostate cancer (P = 0.02) despite a surprisingly short median follow-up of 4.52 years.

The dynamics of prostate cancer are such that there is a much lower impact on survival effect in patients with low-risk disease. Thus, there is less opportunity for improvement. In contrast, patients with intermediate- to high-risk disease experience the greatest risk of death. There is room for improvement thus, it is easier to see the benefits of neoadjuvant therapy. Therefore, this trial has laid to rest any speculation about the benefit of combination therapy in intermediate risk carcinoma prostate and is the standard of care at this time.

 
   References Top

1.Cellini N, Pompei L, Fortuna G, Ammaturo MV, De Paula U, Luzi S, et al. High-dose radiotherapy plus prolonged hormone therapy in clinical T2-3 prostatic carcinoma: is it useful? Tumori 2004;90:201-7.  Back to cited text no. 1      
2.Pilepich MV, Winter K, John MJ, Mesic JB, Sause W, Rubin P, et al. Phase III radiation therapy oncology group (RTOG) trial 86-10 of androgen deprivation adjuvant to definitive radiotherapy in locally advanced carcinoma of the prostate. Int J Radiat Oncol Biol Phys 2001;50:1243-52.  Back to cited text no. 2      
3.Crook J, Ludgate C, Malone S, Perry G, Eapen L, Bowen J, et al. Final report of multicenter Canadian Phase III randomized trial of 3 versus 8 months of neoadjuvant androgen deprivation therapy before conventional-dose radiotherapy for clinically localized prostate cancer. Int J Radiat Oncol Biol Phys 2009;73:327-33.  Back to cited text no. 3      
4.D'Amico AV, Manola J, Loffredo M, Renshaw AA, DellaCroce A, Kantoff PW. 6- month androgen suppression plus radiation therapy vs radiation therapy alone for patients with clinically localized prostate cancer: A randomized controlled trial. JAMA 2004;292:821-7.  Back to cited text no. 4      




 

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