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Article of the week: Prostate cancer treatments: How much do you want to spend?

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Every week the Editor-in-Chief selects the Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video of Matthew Cooperberg discussing his paper.

If you only have time to read one article this week, it should be this one.

Primary treatments for clinically localised prostate cancer: a comprehensive lifetime cost-utility analysis

Matthew R. Cooperberg, Naren R. Ramakrishna†, Steven B. Duff*, Kathleen E. Hughes‡, Sara Sadownik‡, Joseph A. Smith§ and Ashutosh K. Tewari

Departments of Urology and Epidemiology and Biostatistics, UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, *Veritas Health Economics Consulting, Inc., Carlsbad, CA, †Department of Radiation Oncology, MD Anderson Cancer Center, Orlando, FL, ‡Avalere Health LLC, Washington, DC, §Department of Urologic Surgery, Vanderbilt University, Nashville, TN, and Department of Urology, Cornell University, New York, NY, USA

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OBJECTIVE

• To characterise the costs and outcomes associated with radical prostatectomy (open, laparoscopic, or robot-assisted) and radiation therapy (RT: dose-escalated three-dimensional conformal RT, intensity-modulated RT, brachytherapy, or combination), using a comprehensive, lifetime decision analytical model.

PATIENTS AND METHODS

• A Markov model was constructed to follow hypothetical men with low-, intermediate-, and high-risk prostate cancer over their lifetimes after primary treatment; probabilities of outcomes were based on an exhaustive literature search yielding 232 unique publications.

• In each Markov cycle, patients could have remission, recurrence, salvage treatment, metastasis, death from prostate cancer, and death from other causes.

• Utilities for each health state were determined, and disutilities were applied for complications and toxicities of treatment.

• Costs were determined from the USA payer perspective, with incorporation of patient costs in a sensitivity analysis.

RESULTS

• Differences across treatments in quality-adjusted life years across methods were modest, ranging from 10.3 to 11.3 for low-risk patients, 9.6–10.5 for intermediate-risk patients and 7.8–9.3 for high-risk patients.

• There were no statistically significant differences among surgical methods, which tended to be more effective than RT methods, with the exception of combined external beam + brachytherapy for high-risk disease.

• RT methods were consistently more expensive than surgical methods; costs ranged from $19 901 (robot-assisted prostatectomy for low-risk disease) to $50 276 (combined RT for high-risk disease).

• These findings were robust to an extensive set of sensitivity analyses.

CONCLUSIONS

• Our analysis found small differences in outcomes and substantial differences in payer and patient costs across treatment alternatives.

• These findings may inform future policy discussions about strategies to improve efficiency of treatment selection for localised prostate cancer.

 

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Article of the Week: Does tadalafil improve ejaculatory dysfunction?

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Every week the Editor-in-Chief selects the Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video of  Darius Paduch discussing his paper.

If you only have time to read one article this week, it should be this one.

Effects of 12 weeks of tadalafil treatment on ejaculatory and orgasmic dysfunction and sexual satisfaction in patients with mild to severe erectile dysfunction: integrated analysis of 17 placebo-controlled studies

Darius A. Paduch*†, Alexander Bolyakov*†, Paula K. Polzer‡ and Steven D. Watts‡

*Department of Urology and Reproductive Medicine,Weill Cornell Medical College, New York, NY, †Consulting Research Services, Inc., Red Bank, NJ, and ‡Lilly Research Laboratories, Eli Lilly, Indianapolis, IN, USA

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Weill Cornell Medical College Press Release

OBJECTIVES

• To compare effects of tadalafil on ejaculatory and orgasmic function in patients presenting with erectile dysfunction (ED).

• To determine the effects of post-treatment ejaculatory dysfunction (EjD) and orgasmic dysfunction (OD) on measures of sexual satisfaction.

PATIENTS AND METHODS

• Data from 17 placebo-controlled 12-week trials of tadalafil (5, 10, 20 mg) as needed in patients with ED were integrated.

• EjD and OD severities were defined by patient responses to the International Index of Erectile Function, question 9 (IIEF-Q9; ejaculation) and IIEF-Q10 (orgasm), respectively.

• Satisfaction was evaluated using the intercourse and overall satisfaction domains of the IIEF and Sexual Encounter Profile question 5.

• Analyses of covariance were performed to compare mean ejaculatory function and orgasmic function, and chi-squared tests evaluated differences in endpoint responses to IIEF-Q9 and IIEF-Q10.

RESULTS

• A total of 3581 randomized subjects were studied.

• Treatment with tadalafil 10 or 20 mg was associated with significant increases in ejaculatory and orgasmic function (vs placebo) across all baseline ED, EjD, and OD severity strata.

• In the tadalafil group, 66% of subjects with severe EjD reported improved ejaculatory function compared with 36% in the placebo group (P < 0.001).

• Similarly, 66% of the tadalafil-treated subjects (vs 35% for placebo; P < 0.001) with severe OD reported improvement.

• Residual severe EjD and OD after treatment had negative impacts on sexual satisfaction.

• Limitations of the analysis include its retrospective nature and the use of an instrument (IIEF) with as yet unknown performance in measuring treatment responses for EjD and OD.

CONCLUSIONS

• Tadalafil treatment was associated with significant improvements in ejaculatory function, orgasmic function and sexual satisfaction.

• Proportions of subjects reporting improved ejaculatory or orgasmic function were ª twofold higher with tadalafil than with placebo.

• These findings warrant corroboration in prospective trials of patients with EjD or OD (without ED).

 

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Article of the Week: The New Partin Tables

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Every week the Editor-in-Chief selects the Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying blog written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video of John Eifler and Alan Partin discussing their paper.

If you only have time to read one article this week, it should be this one.

 

An updated prostate cancer staging nomogram (Partin tables) based on cases from 2006 to 2011

John B. Eifler, Zhaoyang Feng, Brian M. Lin, Michael T. Partin, Elizabeth B. Humphreys, Misop Han, Jonathan I. Epstein, Patrick C. Walsh, Bruce J. Trock, Alan W. Partin

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OBJECTIVE

• To update the 2007 Partin tables in a contemporary patient population.

PATIENTS AND METHODS

The study population consisted of 5,629 consecutive men who underwent RP and staging lymphadenectomy at the Johns Hopkins Hospital between January 1, 2006 and July 30, 2011 and met inclusion criteria.

• Polychotomous logistic regression analysis was used to predict the probability of each pathologic stage category: organ-confined disease (OC), extraprostatic extension (EPE), seminal vesicle involvement (SV+), or lymph node involvement (LN+) based on preoperative criteria.

• Preoperative variables included biopsy Gleason score (6, 3+4, 4+3, 8, and 9–10), serum PSA (0–2.5, 2.6–4.0, 4.1–6.0, 6.1–10.0, greater than 10.0 ng/mL), and clinical stage (T1c, T2c, and T2b/T2c).

• Bootstrap re-sampling with 1000 replications was performed to estimate 95% confidence intervals for predicted probabilities of each pathologic state.

RESULTS

• The median PSA was 4.9 ng/mL, 63% had Gleason 6 disease, and 78% of men had T1c disease.

• 73% of patients had OC disease, 23% had EPE, 3% had SV+ but not LN+, and 1% had LN+ disease. Compared to the previous Partin nomogram, there was no change in the distribution of pathologic state.

• The risk of LN+ disease was significantly higher for tumors with biopsy Gleason 9–10 than Gleason 8 (O.R. 3.2, 95% CI 1.3–7.6).

• The c-indexes for EPE vs. OC, SV+ vs. OC, and LN+ vs. OC were 0.702, 0.853, and 0.917, respectively.

• Men with biopsy Gleason 4+3 and Gleason 8 had similar predicted probabilities for all pathologic stages.

• Most men presenting with Gleason 6 disease or Gleason 3+4 disease have <2% risk of harboring LN+ disease and may have lymphadenectomy omitted at RP.

CONCLUSIONS

• The distribution of pathologic stages did not change at our institution between 2000–2005 and 2006–2011.

• The updated Partin nomogram takes into account the updated Gleason scoring system and may be more accurate for contemporary patients diagnosed with prostate cancer.

Erratum:

A typographical error was identified in Table 2, for the cell corresponding to the probability for EPE in a man with clinical stage T1c, PSA >10, and biopsy Gleason 4+3. The cell should read “38 (32-45)” rather than “28 (32-45).” Also, in the third paragraph of the Results section, the fourth sentence should be changed to “In contrast, the predicted risk of LN+ is no more than 3% for T1c tumours with biopsy Gleason score <9 for an PSA below 10.”

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