Effect of a Behavioral Intervention to Increase Vegetable Consumption on Cancer Progression Among Men With Early-Stage Prostate Cancer,JAMA

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Effect of a Behavioral Intervention to Increase Vegetable Consumption on Cancer Progression Among Men With Early-Stage Prostate Cancer
JAMA ( IF 63.1 ) Pub Date : 2020-01-14 , DOI: 10.1001/jama.2019.20207
J Kellogg Parsons ₁ , David Zahrieh ₂ , James L Mohler ₃ , Electra Paskett ₄ , Donna E Hansel ₅ , Adam S Kibel ₆ , Heshan Liu ₂ , Drew K Seisler ₂ , Loki Natarajan ₇ , Martha White ₇ , Olwen Hahn ₈ , John Taylor ₈ , Sheri J Hartman ₉ , Sean P Stroup ₁₀ , Peter Van Veldhuizen ₁₁ , Lannis Hall ₁₂ , Eric J Small ₁₃ , Michael J Morris ₁₄ , John P Pierce ₉ , James Marshall ₁₅

Affiliation

Department of Urology, UC San Diego Moores Comprehensive Cancer Center and VA San Diego Healthcare System, La Jolla, California.
Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.
Department of Urology, Roswell Park Comprehensive Cancer Center, Buffalo, New York.
Comprehensive Cancer Center, Department of Medicine, The Ohio State University College of Medicine, Columbus.
Department of Pathology, University of California, San Diego, La Jolla.
Division of Urology, Dana-Farber/Brigham and Women's Cancer Center, Harvard Medical School, Boston, Massachusetts.
Division of Biostatistics and Bioinformatics, Department of Family Medicine and Public Health and UC San Diego Moores Comprehensive Cancer Center, La Jolla, California.
Alliance Central Protocol Operations, University of Chicago, Chicago, Illinois.
Moores Cancer Center, Department of Family Medicine and Public Health, University of California, San Diego, La Jolla.
Department of Urology, Naval Medical Center San Diego, San Diego, California.
Menorah Medical Center, Midwest Oncology Associates, Overland Park, Kansas.
Siteman Cancer Center, Department of Radiation Oncology, Washington University, St Peters, Missouri.
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California.
Memorial Sloan Kettering Cancer Center, New York, New York.
Department of Prevention and Population Sciences, Roswell Park Comprehensive Cancer Center, Buffalo, New York.

Importance Guidelines endorsing vegetable-enriched diets to improve outcomes for prostate cancer survivors are based on expert opinion, preclinical studies, and observational data. Objective To determine the effect of a behavioral intervention that increased vegetable intake on cancer progression in men with early-stage prostate cancer. Design, Setting, and Participants The Men's Eating and Living (MEAL) Study (CALGB 70807 [Alliance]) was a randomized clinical trial conducted at 91 US urology and medical oncology clinics that enrolled 478 men aged 50 to 80 years with biopsy-proven prostate adenocarcinoma (International Society of Urological Pathology grade group = 1 in those <70 years and ≤2 in those ≥70 years), stage cT2a or less, and serum prostate-specific antigen (PSA) level less than 10 ng/mL. Enrollment occurred from January 2011 to August 2015; 24-month follow-up occurred from January 2013 to August 2017. Interventions Patients were randomized to a counseling behavioral intervention by telephone promoting consumption of 7 or more daily vegetable servings (MEAL intervention; n = 237) or a control group, which received written information about diet and prostate cancer (n = 241). Main Outcomes and Measures The primary outcome was time to progression; progression was defined as PSA level of 10 ng/mL or greater, PSA doubling time of less than 3 years, or upgrading (defined as increase in tumor volume or grade) on follow-up prostate biopsy. Results Among 478 patients randomized (mean [SD] age, 64 [7] years; mean [SD] PSA level, 4.9 [2.1] ng/mL), 443 eligible patients (93%) were included in the primary analysis. There were 245 progression events (intervention: 124; control: 121). There were no significant differences in time to progression (unadjusted hazards ratio, 0.96 [95% CI, 0.75 to 1.24]; adjusted hazard ratio, 0.97 [95% CI, 0.76 to 1.25]). The 24-month Kaplan-Meier progression-free percentages were 43.5% [95% CI, 36.5% to 50.6%] and 41.4% [95% CI, 34.3% to 48.7%] for the intervention and control groups, respectively (difference, 2.1% [95% CI, -8.1% to 12.2%]). Conclusions and Relevance Among men with early-stage prostate cancer managed with active surveillance, a behavioral intervention that increased vegetable consumption did not significantly reduce the risk of prostate cancer progression. The findings do not support use of this intervention to decrease prostate cancer progression in this population, although the study may have been underpowered to identify a clinically important difference. Trial Registration ClinicalTrials.gov Identifier: NCT01238172.

中文翻译：

行为干预增加蔬菜摄入量对早期前列腺癌男性癌症进展的影响

支持富含蔬菜的饮食以改善前列腺癌幸存者预后的重要性指南是基于专家意见、临床前研究和观察数据。目的确定增加蔬菜摄入量的行为干预对早期前列腺癌男性癌症进展的影响。设计、设置和参与者男性饮食和生活 (MEAL) 研究 (CALGB 70807 [Alliance]) 是一项在美国 91 家泌尿外科和肿瘤内科诊所进行的随机临床试验，招募了 478 名 50 至 80 岁的男性，这些男性经活检证实为前列腺腺癌（国际泌尿病理学会分级组 = 1 小于 70 岁，≤ 2 小于 70 岁），cT2a 期或更低，血清前列腺特异性抗原 (PSA) 水平小于 10 ng/mL。入学时间为2011年1月至2015年8月；从 2013 年 1 月到 2017 年 8 月进行了 24 个月的随访。干预措施患者被随机分配到通过电话促进每天食用 7 份或更多蔬菜的咨询行为干预（膳食干预；n = 237）或对照组，后者接受书面有关饮食和前列腺癌的信息（n = 241）。主要结果和措施主要结果是进展时间；进展被定义为 PSA 水平为 10 ng/mL 或更高，PSA 倍增时间小于 3 年，或在随访前列腺活检时升级（定义为肿瘤体积或分级增加）。结果在随机分配的 478 名患者（平均 [SD] 年龄，64 [7] 岁；平均 [SD] PSA 水平，4.9 [2.1] ng/mL）中，443 名符合条件的患者 (93%) 被纳入主要分析。有 245 个进展事件（干预：124；控制：121）。进展时间没有显着差异（未调整的风险比，0.96 [95% CI，0.75 至 1.24]；调整后的风险比，0.97 [95% CI，0.76 至 1.25]）。干预组和对照组的 24 个月 Kaplan-Meier 无进展百分比分别为 43.5% [95% CI，36.5% 至 50.6%] 和 41.4% [95% CI，34.3% 至 48.7%]（差异， 2.1% [95% CI，-8.1% 至 12.2%]）。结论和相关性在接受主动监测的早期前列腺癌男性中，增加蔬菜摄入量的行为干预并未显着降低前列腺癌进展的风险。研究结果不支持使用这种干预来减少该人群的前列腺癌进展，尽管该研究可能不足以确定临床上的重要差异。试验注册 ClinicalTrials.gov 标识符：NCT01238172。

更新日期：2020-01-14

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