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groups with respect to mortality from cancer but increases harms among men with low-risk
was 1.1 percentage points when we used a higher- disease or those who are older than 65 years of
certainty cause-of-death definition. Results sug- age. We encourage physicians and guideline groups
gest modest reductions in all-cause mortality to recommend initial observation for these men.
among younger men and those with intermediate- For younger, healthy men with intermediate-risk
risk disease. or high-risk disease, treatment decisions should
In reply to Sharma and Karnes: adherence to include balancing benefits with harms.
radical treatment in PIVOT was similar to that in TimothyJ. Wilt, M.D., M.P.H.
other studies.2,3 Adherence to observation was Minneapolis Veterans Affairs Health Care System
superior to adherence to nonradical treatment in Minneapolis, MN
the Prostate Testing for Cancer and Treatment tim.wilt@va.gov
(ProtecT) trial.3 Although per-protocol analyses GeraldL. Andriole, M.D.
may slightly alter effect estimates, the results of Washington University School of Medicine
St. Louis, MO
previous nonrandomized trials led to the uncer-
tainty that gave rise to these randomized trials. MichaelK. Brawer, M.D.
Myriad Genetics Laboratories
Contemporary prostate-specific antigenSalt Lake City, UT
detected cancers have a better prognosis with Since publication of their article, the authors report no fur-
observation than the cancers in PIVOT.3 Refine- ther potential conflict of interest.
ments in surgery and radiation therapy cost more 1. Maurice MJ, Abouassaly R, Kim SP, Zhu H. Contemporary
and provide modest, if any, improvement in tu- nationwide patterns of active surveillance use for prostate cancer.
mor control or reduction in treatment harms JAMA Intern Med 2015;175:1569-71.
Bill-Axelson A, Holmberg L, Garmo H, et al. Radical prosta-
than observation.4 In addition, new chemothera- 2. tectomy or watchful waiting in early prostate cancer. N Engl J
pies for disseminated prostate cancer yield larg- Med 2014;370:932-42.
er reductions in mortality than surgery for local- 3. Hamdy FC, Donovan JL, Lane JA, et al. 10-Year outcomes
ized disease, and these agents are associated with after monitoring, surgery, or radiotherapy for localized prostate
cancer. N Engl J Med 2016;375:1415-24.
acceptable harms. Therefore, men who currently 4. Wilt TJ, Dahm P. Value of prostate cancer care: new informa-
5
undergo surgery or receive radiation therapy tion on new therapies suggest less is more. Eur Urol 2017 May 29
probably have smaller mortality benefits than (Epub ahead of print).
5. James ND, de Bono JS, Spears MR, et al. Abiraterone for
those in our trial and probably have similar prostate cancer not previously treated with hormone therapy.
harms. Multiple randomized trials now show N Engl J Med 2017;377:338-51.
that early treatment does not decrease mortality DOI: 10.1056/NEJMc1710384
1. Sotos-Prieto M, Bhupathiraju SN, Mattei J, et al. Association period was consistently associated with a de-
of changes in diet quality with total and cause-specific mortality.
creased risk of death. We pooled data from our
N Engl J Med 2017;377:143-53.
2. Ejima K, Li P, Smith DL Jr, et al. Observational research own randomized, controlled trials1-4 that evalu-
rigour alone does not justify causal inference. Eur J Clin Invest ated the effect of the Mediterranean diet on sur-
2016;46:985-93.
rogate biomarkers of longevity5 among men and
3. Shepherd R, Shepherd R. Resistance to changes in diet. Proc
Nutr Soc 2002;61:267-72. women who were followed for up to 8 years and
DOI: 10.1056/NEJMc1710523 had both baseline and final values available. The
102 participants who had a higher score with re-
spect to diet quality (a median or greater intake
To the Editor: The approach of the study by of whole grain, fruit, olive oil, nuts, and legumes)
Sotos-Prieto et al. is informative; however, we were compared with the 98 who had a lower
think that an approach that considered the tra- score (intake lower than median). Participants
jectories of diet quality over 12 years would have who consumed a higher-quality diet had lower
added considerable value to this work. Our con- levels of glucose and insulin, higher levels of
cern is that the group with an improved diet adiponectin (indicating higher insulin sensitiv-
quality includes several distinct diet improve- ity), and lower plasma levels of total 8-iso-prosta-
ment profiles, including those whose diet im- glandin F2 (indicating decreased oxidative stress)
proved progressively during the 12-year study than those who consumed a lower-quality diet.
period and those who had poor diet (possibly Thus, we would note that in controlled dietary
suboptimal with respect to guidelines) during trials, the increased quality of a Mediterranean
the first 9 years but an improved diet during the diet was associated with more favorable biomark-
last 3 years. Such heterogeneity may lead to an ers of longevity in men and women who were
underestimation of the effect of improving diet obese or had newly diagnosed type 2 diabetes.
quality during the 12-year period. Adjusting for Katherine Esposito, M.D., Dr.P.H.
the initial diet-quality score may not be sufficient Dario Giugliano, M.D.
to address this issue. MariaI. Maiorino, M.D., Dr.P.H.
If diet changes at different time points were University of Campania Luigi Vanvitelli
considered, the trajectory approach1 would be Naples, Italy
more suitable for capturing the association of dario.giugliano@unicampania.it
diet quality with risk of death. By classifying No potential conflict of interest relevant to this letter was re-
ported.
participants into distinct, exclusive trajectory
groups, such an approach would allow for close 1. Esposito K, Marfella R, Ciotola M, et al. Effect of a Mediter-
scrutiny of population heterogeneity in diet- ranean-style diet on endothelial dysfunction and markers of vas-
cular inflammation in the metabolic syndrome: a randomized
quality changes during the 12-year period and trial. JAMA 2004;292:1440-6.
would permit a direct comparison of outcomes 2. Esposito K, Giugliano F, Di Palo C, et al. Effect of lifestyle
across these groups. changes on erectile dysfunction in obese men: a randomized
controlled trial. JAMA 2004;291:2978-84.
Bamba Gaye, Ph.D. 3. Esposito K, Pontillo A, Di Palo C, et al. Effect of weight loss
Xavier Jouven, M.D., Ph.D. and lifestyle changes on vascular inflammatory markers in
obese women: a randomized trial. JAMA 2003;289:1799-804.
JeanP. Empana, M.D., Ph.D. 4. Esposito K, Maiorino MI, Ciotola M, et al. Effects of a Med-
Paris Descartes University iterranean-style diet on the need for antihyperglycemic drug
Paris, France therapy in patients with newly diagnosed type 2 diabetes: a ran-
bamba.gaye@inserm.fr domized trial. Ann Intern Med 2009;151:306-14.
No potential conflict of interest relevant to this letter was re- 5. Heilbronn LK, de Jonge L, Frisard MI, et al. Effect of 6-month
ported. calorie restriction on biomarkers of longevity, metabolic adapta-
tion, and oxidative stress in overweight individuals: a random-
1. Song M, Hu FB, Wu K, et al. Trajectory of body shape in ized controlled trial. JAMA 2006;295:1539-48.
early and middle life and all cause and cause specific mortality: DOI: 10.1056/NEJMc1710523
results from two prospective US cohort studies. BMJ 2016;353:
i2195.
DOI: 10.1056/NEJMc1710523
The authors reply: We agree with Lee and Shin
that a causal relationship cannot be established
solely from observational studies. However, our
To the Editor: Sotos-Prieto and colleagues re- data are consistent with strong evidence from
port that improved diet quality during a 12-year many well-designed observational studies and
arrhythmia developed after he took the first No potential conflict of interest relevant to this letter was re-
ported.
dose. Subsequent investigation, including coro-
nary angiography, led to the diagnosis of giant- 1. Jani SM, Nallamothu BK, Cooper LT, Smith A, Fazel R. Beat-
cell myocarditis. Nuclear perfusion imaging with ing, fast and slow. N Engl J Med 2017;377:72-8.