Department of Biostatistics, Boston University School of Public Health, Boston, USA.
Department of Global Health, Boston University School of Public Health, Boston, USA.
Ann Oncol. 2018 Jul 1;29(7):1582-1587. doi: 10.1093/annonc/mdy138.
Obesity is a risk factor for numerous cancer types, and may influence cancer treatment outcomes. Underrepresentation of obese patients in obesity-related cancer randomized controlled trials (RCTs) may affect generalizability of results. We aimed to assess the reporting of information about eligibility and enrollment of obese participants in obesity-related cancer RCTs.
We conducted a systematic review of RCTs of 10 obesity-related cancer types (esophagus, colon/rectum, liver, gallbladder, pancreas, postmenopausal breast, endometrium, ovary, kidney, and thyroid cancer). We selected RCTs published between 2013 and 2016 in five major journals. For each trial, we examined the article, the protocol, and the registration record. We assessed if eligibility criteria limiting the enrollment of obese participants were reported, the proportion of obese participants that were enrolled, and if a subgroup analysis according to obesity status was reported. We systematically contacted corresponding authors and asked for information about eligibility of obese participants and the proportion of obese participants.
We included 76 RCTs. Colon/rectum (n = 20), postmenopausal breast (n = 11), and kidney (n = 11) cancers were the most frequent types. Based on publicly available sources, information on the eligibility of obese participants was available in 5 (7%) trials. The proportion of obese participants could be estimated in 9 (12%) trials only. We found a subgroup analysis in only one RCT. When considering unpublished information, the eligibility of obese participants was explicitly stated in 31 (41%) trials but it was unclear if the remaining 59% trials considered obese participants as eligible and what proportion of obese participants was included. Across 22 trials, the median proportion of obese participants included was 18% (Q1-Q3 11-23).
Information on the eligibility and enrollment of obese participants in cancer RCTs is dramatically underreported. More transparency is needed to understand the applicability of obesity-related cancer RCT results to obese patients with cancer.
肥胖是多种癌症类型的危险因素，可能影响癌症治疗结果。肥胖相关癌症随机对照试验（RCT）中肥胖患者代表性不足可能会影响结果的普遍性。本研究旨在评估肥胖相关癌症 RCT 中关于肥胖参与者入选资格和纳入的信息报告情况。
我们对 10 种肥胖相关癌症类型（食管、结肠/直肠、肝、胆囊、胰腺、绝经后乳腺癌、子宫内膜癌、卵巢癌、肾癌和甲状腺癌）的 RCT 进行了系统综述。我们选择了 2013 年至 2016 年在五个主要期刊上发表的 RCT。对于每个试验，我们检查了文章、方案和注册记录。我们评估了是否报告了限制肥胖参与者纳入的入选标准、纳入的肥胖参与者的比例，以及是否根据肥胖状况进行了亚组分析。我们系统地联系了相应的作者，并询问了肥胖参与者的入选资格和肥胖参与者的比例信息。
我们纳入了 76 项 RCT。结肠/直肠（n=20）、绝经后乳腺癌（n=11）和肾癌（n=11）是最常见的癌症类型。根据公开来源的信息，仅有 5（7%）项试验提供了肥胖参与者入选资格的信息。仅有 9（12%）项试验可以估计肥胖参与者的比例。我们仅在 1 项 RCT 中发现了亚组分析。当考虑未发表的信息时，有 31（41%）项试验明确说明了肥胖参与者的入选资格，但尚不清楚其余 59%的试验是否认为肥胖参与者符合入选条件，以及纳入了多少肥胖参与者。在 22 项试验中，纳入的肥胖参与者的中位数比例为 18%（Q1-Q3 11-23）。
癌症 RCT 中肥胖参与者入选资格和纳入的信息报告严重不足。需要提高透明度，以了解肥胖相关癌症 RCT 结果对患有癌症的肥胖患者的适用性。
