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  Table of Contents 
EDITORIAL
Year : 2019  |  Volume : 35  |  Issue : 2  |  Page : 92-93
 

Round up


Department of Urology, Christian Medical College, Vellore, Tamil Nadu, India

Date of Web Publication1-Apr-2019

Correspondence Address:
Santosh Kumar
Department of Urology, Christian Medical College, Vellore, Tamil Nadu
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/iju.IJU_92_19

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How to cite this article:
Kumar S. Round up. Indian J Urol 2019;35:92-3

How to cite this URL:
Kumar S. Round up. Indian J Urol [serial online] 2019 [cited 2019 Sep 17];35:92-3. Available from: http://www.indianjurol.com/text.asp?2019/35/2/92/255325


Among men offered curative therapy for localized disease, those with, high-risk prostate cancer are at highest risk of disease progression. Radiation with androgen suppression is frequently used in the treatment at this stage. The effect of addition of adjuvant docetaxel chemotherapy to radiation with androgen suppression was studied in a randomized trial on 612 patients.[1] The overall survival (OS) and clinical outcomes were evaluated. The median follow-up was 5.7 years. Addition of adjuvant docetaxel chemotherapy was well tolerated. The 4-year OS was 89% versus 93% favoring the adjuvant chemotherapy arm. At 6 years, the distant metastasis rate was 14% versus 9.1% again favoring a better metastasis-free survival in adjuvant chemotherapy arm. Six-year disease-free survival was 55% versus 65% in the chemotherapy arm. The addition of adjuvant docetaxel chemotherapy may benefit select patients with high-risk, localized prostate cancer at 6-year follow-up. It needs to be seen if the same makes a difference in the OS on long-term follow-up.

In another study, the effectiveness of radical prostatectomy (RP) was compared to external beam radiotherapy plus brachytherapy (EBRT + BT) in patients with high-risk localized cancer prostate.[2] The study was limited to healthy (Charlson comorbidity index = 0) young men (age <65 years) from the National Cancer Database from 2004 to 2015 to avoid the biases of the previous studies. The median follow-up was 92 months. Inverse probability of treatment weighting adjustment was done to balance baseline characteristics. EBRT + BT was associated with higher all-cause mortality compared to RP (hazard ration 1.22, confidence interval 1.05–1.43).

A multicenter, phase III, randomized placebo-controlled trial was conducted in mildly/asymptomatic men with chemonaive castrate-resistant prostate cancer with bone metastasis and good performance status and life expectancy of at least 6 months.[3] They were randomized to receive either radium 223 or placebo with abiraterone acetate plus prednisolone or prednisolone alone. The primary endpoint was symptomatic skeletal event-free survival. The study was unblinded prematurely and showed median symptomatic skeletal-free event of 22.3 months in radium group versus 26 months in the placebo group. Thus, the addition of radium 223 is not recommended in this group of patients.

Aquablation is a promising new minimally invasive therapy for the treatment of bladder outflow obstruction due to benign prostatic hyperplasia BPH. A double-blind, multicenter prospective randomized controlled trial involving 181 patients with moderate-to-severe lower urinary tract symptoms LUTS due to BPH was done to evaluate the safety and efficacy of aquablation versus TURP.[4] Both procedures reduced international prostate symptom score IPSS by 15 points after 1 year. The mean Qmax improved by over 10 ml/s in each group. The retreatment rates were 1.5% for TURP and 2.6% in aquablation. The rate of late complication was low with no procedure-related adverse event after 6 months. Long-term results are awaited to see if the same results are sustained over time. A similar randomized controlled study on 188 subjects using the water vapor thermal therapy (Rezum) with normal controls (who were crossed over to treatment arm after 1 year) showed sustained results over 4 years with a retreatment rate of 4.4%.[5]

In patients with advanced renal cell carcinoma (RCC), there are many options for treatment now compared to a decade back. In patients with primarily untreated advanced RCC, a phase III trial compared the combination of Avelumab with Axitinib versus the standard-of-care Sunitinib.[6] A total of 866 patients were randomized. The primary endpoint was progression-free survival (PFS) and OS in patients with programmed death ligand 1 (PD-L1)-positive tumors. In PD-L1-positive patients, the median PFS was 13.8 months with combination versus 7.2 months with Sunitinib alone. Similarly, in PD-L1-positive tumors, the objective response rate was 55.2 versus 25.5% in favor of the combination. The adverse events were 99.5% versus 99.3% in each group, respectively, with 71.2 versus 71.5% events being of greater than grade 3 toxicity.

The quality of the statistics used in clinical research is poor. It is even worse in surgical literature and Urology is no exception. Seventy-one percent of the papers published during 1 month in 2005 in the leading urology journals, namely European Urology, The Journal of Urology, BJU International, and Urology, had at least one statistical flaw.[7] In the March issue, the statistical team from the four above journals have put together a set of guidelines for reporting statistics for clinical research in Urology.[8] Abiding by these guidelines will hopefully improve the quality of statistics reported in the urology literature and also enhance the authors understanding on this subject.

The results of radical cystectomy have improved in recent decades, and perioperative complications have decreased. Perioperative nutrition and parenteral nutrition have been a matter of debate. In a prospective randomized controlled pilot trial, the effect of perioperative oral nutritional supplementation was studied on body composition and clinical outcomes.[9] Sixty-one patients were randomized to oral nutritional supplement or multivitamin and multi-mineral supplement twice a day for 8 weeks in the perioperative period. The primary outcome measured was difference in 30-day hospital-free days. Patients with an oral nutritional supplement perioperatively had reduced prevalence of sarcopenia (reduced skeletal muscle index) and fewer and less severe complications and readmissions. The time of waiting before these major surgeries should be used to build up these patients nutritionally using cheap and simple means.

Active surveillance has been increasingly used in the management of patients with organ localized, low-risk carcinoma prostate. The concept is being stretched to the favorable risk patients in the intermediate group also. Survival outcomes in Danish men with localized carcinoma prostate managed on active surveillance has been reported.[10] A total of 936 men were enrolled from 2002 to 2012. The cancer was very low risk in 223 men, low risk in 436, intermediate risk in 259, and high risk in 18. The 10-year figure for curative treatment-free survival was 62.8%, hormonal therapy-free survival was 92.2%, castrate-resistant prostate cancer-free survival was 97.2%, and cause-specific survival was 99.6%. The study supports the use of active surveillance in favorable, intermediate-risk prostate cancer.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
   References Top

1.
Rosenthal SA, Hu C, Sartor O, Gomella LG, Amin MB, Purdy J, et al. Effect of chemotherapy with docetaxel with androgen suppression and radiotherapy for localized high-risk prostate cancer: The randomized phase III NRG oncology RTOG 0521 trial. J Clin Oncol 2019:JCO1802158.  Back to cited text no. 1
    
2.
Berg S, Cole AP, Krimphove MJ, Nabi J, Marchese M, Lipsitz SR, et al. Comparative effectiveness of radical prostatectomy versus external beam radiation therapy plus brachytherapy in patients with high-risk localized prostate cancer. Eur Urol 2019;75:552-5.  Back to cited text no. 2
    
3.
Smith M, Parker C, Saad F, Miller K, Tombal B, Ng QS, et al. Addition of radium-223 to abiraterone acetate and prednisone or prednisolone in patients with castration-resistant prostate cancer and bone metastases (ERA 223): A randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol 2019;20:408-19.  Back to cited text no. 3
    
4.
Gilling PJ, Barber N, Bidair M, Anderson P, Sutton M, Aho T, et al. Randomized controlled trial of aquablation versus transurethral resection of the prostate in benign prostatic hyperplasia: One-year outcomes. Urology 2019;125:169-73.  Back to cited text no. 4
    
5.
McVary KT, Rogers T, Roehrborn CG. Rezūm water vapor thermal therapy for lower urinary tract symptoms associated with benign prostatic hyperplasia: 4-year results from randomized controlled study. Urology 2019. pii: S0090-4295(19)30070-6.  Back to cited text no. 5
    
6.
Motzer RJ, Penkov K, Haanen J, Rini B, Albiges L, Campbell MT, et al. Avelumab plus axitinib versus sunitinib for advanced renal-cell carcinoma. N Engl J Med 2019. [doi: 10.1056/NEJMoa1816047].  Back to cited text no. 6
    
7.
Scales CD Jr., Norris RD, Peterson BL, Preminger GM, Dahm P. Clinical research and statistical methods in the urology literature. J Urol 2005;174:1374-9.  Back to cited text no. 7
    
8.
Assel M, Sjoberg D, Elders A, Wang X, Huo D, Botchway A, et al. Guidelines for reporting of statistics for clinical research in urology. BJU Int 2019;123:401-10.  Back to cited text no. 8
    
9.
Ritch CR, Cookson MS, Clark PE, Chang SS, Fakhoury K, Ralls V, et al. Perioperative oral nutrition supplementation reduces prevalence of sarcopenia following radical cystectomy: Results of a prospective randomized controlled trial. J Urol 2019;201:470-7.  Back to cited text no. 9
    
10.
Thomsen FB, Jakobsen H, Langkilde NC, Borre M, Jakobsen EB, Frey A, et al. Active surveillance for localized prostate cancer: Nationwide observational study. J Urol 2019;201:520-7.  Back to cited text no. 10
    




 

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