Instituto Nacional de Cancerología - Colombia, Calle 1 # 9-85, Bogota, 110111, Colombia.
Centro de tratamiento e investigación sobre cáncer (CTIC), Calle 168 # 14 -49, Bogota, 110131, Colombia.
BMC Cancer. 2023 Aug 23;23(1):786. doi: 10.1186/s12885-023-11305-3.
It is unknown if participation in a cancer clinical trial confers clinical benefits to patients. There is not enough scientific evidence in this regard and the available publications are scarce and provide ambiguous and limited information.
Compare overall and progression-free survival and response to treatment among those who met the eligibility criteria and accepted to participate and those who refused to participate in cancer clinical trials.
An observational cross-sectional study with an analytical component was carried out, which included patients diagnosed with cancer who participated in phase III clinical trials and patients who, being eligible, refused to participate. The patients were cared for at the National Institute of Cancerology in Colombia between 2019 and 2022. Analysis of differences in proportions and means of sociodemographic and clinical variables was included; overall survival and progression-free survival time were described and the survival curves between groups were compared. Variables related to survival were determined using a Cox regression model and Hazard Ratios were calculated.
62 women and 50 men were included. In the women group, we found a statistical association between clinical trial participation and non-serious events adverse and progression. The stable disease and complete response were higher in participants than in refusers. The median progression-free survival for refusers was 7,4 m meantime for participants the median was not reached and 74,1% remained without progression at 28 months. In the men group, we also found a statistical association between clinical trial participation and the occurrence of non-serious events adverse meanwhile there were no significant differences in overall response, progression, and death, even though the proportion of progression was minor in participants 20% vs. refusers 26% respectively. The median survival was not reached for any group, even though in the participants group 55,2% were still alive at month 20 and in the refusers group still alive at 56,8% at month 45. Covariables included for the multivariate Cox regression only age had a statistical association with overall survival in the women's group and the men group any covariables reached statistical association.
It can be considered that participation in clinical trials could give participants a better response to treatment, without increasing the probability of death and with the probability of decreasing the progression of the disease. Participation in trials could improve the outcomes of clinical response rates, no change in overall survival, and progression-free.
参与癌症临床试验是否能给患者带来临床获益尚不清楚。这方面的科学证据不足，现有的出版物也很少，提供的信息模糊且有限。
比较符合入组条件并同意参加与拒绝参加癌症临床试验患者的总生存和无进展生存以及治疗反应。
这是一项具有分析部分的观察性横断面研究，纳入了在哥伦比亚国家癌症研究所参加 III 期临床试验的癌症患者和符合条件但拒绝参加的患者。研究对象为 2019 年至 2022 年期间入组的患者。分析了社会人口统计学和临床变量的比例和平均值的差异；描述了总生存和无进展生存时间，并比较了组间生存曲线。使用 Cox 回归模型确定与生存相关的变量，并计算了风险比。
共纳入 62 名女性和 50 名男性患者。在女性组中，我们发现临床试验参与与非严重不良事件和进展之间存在统计学关联。与拒绝者相比，参与者的疾病稳定和完全缓解更高。拒绝者的中位无进展生存时间为 7.4 个月，而参与者的中位无进展生存时间未达到，28 个月时 74.1%的患者无进展。在男性组中，我们还发现临床试验参与与非严重不良事件的发生之间存在统计学关联，尽管参与者的总缓解率、进展率和死亡率没有显著差异，尽管参与者的进展比例较小，分别为 20%和 26%。任何一组的中位生存时间都未达到，尽管在参与者组中，20 个月时仍有 55.2%的患者存活，而在拒绝者组中，45 个月时仍有 56.8%的患者存活。多变量 Cox 回归分析中仅纳入的年龄与女性组和男性组的总生存有统计学关联，任何协变量均未达到统计学关联。
可以认为，参与临床试验可能会使参与者对治疗有更好的反应，而不会增加死亡的概率，并降低疾病进展的概率。参与试验可以提高临床反应率的结果，对总生存和无进展生存没有影响。
