Correspondence
Quality of Life and Satisfaction with Outcome among Prostate-Cancer Survivors
N Engl J Med 2008; 359:200-202July 10, 2008
- Article
To the Editor:
The quality of life is an important consideration in treatment for prostate cancer. The study by Sanda et al. (March 20 issue)1 provides valuable information regarding this aspect of treatment. Unfortunately, the abstract highlights two of the least relevant observations made in this study. First, although the authors show that hormone therapy diminishes the quality of life, class I evidence supports its use in intermediate-risk and high-risk patients receiving radiotherapy.2-5 Highlighting a small effect on the quality of life, given the survival advantages, seems inappropriate. Second, the decision to offer nerve-sparing radical prostatectomy is usually dictated more by efforts to control disease than by quality-of-life concerns. Finally, as shown in Figure 1 of the article, at 24 months, the mean sexual score for patients undergoing prostatectomy was similar to that for patients receiving radiotherapy or brachytherapy, even though the patients in the prostatectomy group started with a higher mean sexual score and were 5 to 10 years younger. The relative decline in sexual function was significantly worse in the patients who underwent prostatectomy, even with the use of nerve-sparing techniques. This finding should have been emphasized in the abstract and should be considered in making informed treatment decisions.
5 ReferencesJennifer S. Yu, M.D., Ph.D.
Mack Roach, III, M.D.
University of California, San Francisco, San Francisco, CA 94115
mroach@radonc.ucsf. edu 1
Sanda MG ,Dunn RL ,Michalski J , et al. Quality of life and satisfaction with outcome among prostate-cancer survivors. N Engl J Med 2008;358:1250-1261
Full Text | Web of Science | Medline2
Pilepich MV ,Winter K ,Lawton CA , et al. Androgen suppression adjuvant to definitive radiotherapy in prostate carcinoma -- long-term results of phase III RTOG 85-31. Int J Radiat Oncol Biol Phys 2005;61:1285-1290
CrossRef | Web of Science | Medline3
Bolla M ,Collette L ,Blank L , et al. Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial. Lancet 2002;360:103-106
CrossRef | Web of Science | Medline4
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;292:821-827
CrossRef | Web of Science | Medline5
Roach M III ,Lu J ,Pilepich MV , et al. Predicting long-term survival, and the need for hormonal therapy: a meta-analysis of RTOG prostate cancer trials. Int J Radiat Oncol Biol Phys 2000;47:617-627
CrossRef | Web of Science | Medline
To the Editor:
Sanda and colleagues report on the quality of life and satisfaction with the outcome among prostate-cancer survivors who were treated with prostatectomy, radiotherapy, or brachytherapy. However, one issue (and perhaps a potential source of bias) was not addressed: the use of sildenafil (Viagra), vardenafil (Levitra), or tadalafil (Cialis) for treatment-related erectile dysfunction. Were patients in the study asked about the use of these drugs? If so, was there any detectable effect on the sexual score within each different treatment group? Similar lines of questioning may also apply to topical administration of drugs such as alprostadil (Caverject) or surgical implantation of prosthetic devices.
Wadih Arap, M.D., Ph.D.
University of Texas M.D. Anderson Cancer Center, Houston, TX 77030
warap@mdanderson.org To the Editor:
Sanda et al. present a robust data set on the quality of life after radical prostatectomy, external-beam radiotherapy, and brachytherapy. In quality-of-life research, the definition of the threshold difference in the quality-of-life score that represents a clinically meaningful change has varied. For the European Organization for Research and Treatment of Cancer (EORTC) quality-of-life questionnaires, a change by at least 10 points (on a scale from 0 to 100) has been rated by patients to be at least “moderate.”1 For the quality-of-life instrument now used, the Expanded Prostate Cancer Index Composite (EPIC-26), the authors define a clinically relevant change from baseline by a difference in mean scores of at least half the standard deviation of the pretreatment value. This appears to be problematic. On the basis of the raw quality-of-life data presented, a 10-point change from baseline in one quality-of-life score might thus be considered clinically relevant in one treatment group but not in another. Other current studies with the EPIC instrument are showing much larger standard deviations,2 suggesting that the definition used by Sanda et al. cannot be universally applied.
2 ReferencesDirk Vordermark, M.D.
Martin Luther University Halle-Wittenberg, 06110 Halle/Saale, Germany
dirk.vordermark@medizin. uni-halle. de 1
Osoba D ,Rodrigues G ,Myles J ,Zee B ,Pater J . Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol 1998;16:139-144
Web of Science | Medline2
Ferrer M, Suárez JF, Guedea F, et al. Health-related quality of life 2 years after treatment with radical prostatectomy, prostate brachytherapy, or external beam radiotherapy in patients with clinically localized prostate cancer. Int J Radiat Oncol Biol Phys (in press).
Author/Editor Response
We agree with Yu and Roach that detriments in health-related quality of life should be considered a lower priority than possible survival benefits in decisions regarding the use of hormone therapy. For patients with high-risk prostate cancer similar to that in participants in trials wherein class I evidence supported adjuvant androgen-suppression therapy, our findings are intended to better inform the patients of adverse consequences of such therapy, rather than to provide a rationale for eschewing such therapy altogether. However, adjuvant androgen-suppression therapy is given to many patients to reduce prostate size before radiotherapy, or it is given to patients who have intermediate-risk disease, for which class I evidence is not uniformly supportive.1 Our abstract highlights the patient-reported effects of hormone therapy because these effects have not been addressed in prior multicenter studies, and the prevalence of moderate or worse distress with respect to vitality and hormonal concerns had an unexpected magnitude, which was similar to that of urinary or bowel problems.
Arap points to a need for characterizing the use of medications or devices for erectile dysfunction. Such an analysis of this cohort is ongoing. We and others have previously explored the use of medications or devices in cross-sectional analyses of single-institution cohorts,2,3 and it would not have been possible to address this complex subtopic of sexuality with sufficient detail in the context of the article's broader overview across multiple health-related quality-of-life domains. Subtopics in other health-related quality-of-life domain outcomes in our cohort also warrant more focused analyses.
We recognize that defining clinical relevance is open to different interpretations, as Vordermark points out. There is no standard for setting thresholds of clinical relevance. We opted to use the half–standard deviation of each domain score for our analyses because this approach has analytic validity4 and does not assume that scales for different health-related quality-of-life domains have identical sensitivity to different clinical problems (as would be required for applying the same threshold — e.g., a 10-point change — across multiple health-related quality-of-life subscales that measure different health-related quality-of-life concerns).
4 ReferencesMartin G. Sanda, M.D.
Beth Israel Deaconess Medical Center, Boston, MA 02215
msanda@bidmc.harvard. edu Howard M. Sandler, M.D.
John T. Wei, M.D.
University of Michigan Medical Center, Ann Arbor, MI 481051
Denham JW ,Steigler A ,Lamb DS , et al. Short-term androgen deprivation and radiotherapy for locally advanced prostate cancer: results from the Trans-Tasman Radiation Oncology Group 96.01 randomised controlled trial. Lancet Oncol 2005;6:841-850
CrossRef | Web of Science | Medline2
Schover LR ,Fouladi RT ,Warneke CL , et al. The use of treatments for erectile dysfunction among survivors of prostate carcinoma. Cancer 2002;95:2397-2407
CrossRef | Web of Science | Medline3
Miller DC ,Wei JT ,Dunn RL , et al. Use of medications or devices for erectile dysfunction among long-term prostate cancer treatment survivors: potential influence of sexual motivation and/or indifference. Urology 2006;68:166-171
CrossRef | Web of Science | Medline4
Norman GR ,Sloan JA ,Wyrwich KW . Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care 2003;41:582-592
CrossRef | Web of Science | Medline
- Citing Articles (3)
Citing Articles
1
Chunyu Li, Donatus U. Ekwueme, Sun Hee Rim, Florence K. Tangka. (2010) Years of Potential Life Lost and Productivity Losses From Male Urogenital Cancer Deaths—United States, 2004. Urology 76:3, 528-535
CrossRef2
D Wittmann, J E Montie, D A Hamstra, H Sandler, D P Wood. (2009) Counseling patients about sexual health when considering post-prostatectomy radiation treatment. International Journal of Impotence Research 21:5, 275-284
CrossRef3
Linda Vignozzi, Sandra Filippi, Annamaria Morelli, Mirca Marini, Aravinda Chavalmane, Benedetta Fibbi, Enrico Silvestrini, Rosa Mancina, Marco Carini, G. Barbara Vannelli, Gianni Forti, Mario Maggi. (2009) Cavernous Neurotomy in the Rat is Associated with the Onset of an Overt Condition of Hypogonadism. Journal of Sexual Medicine 6:5, 1270-1283
CrossRef
