1Department of Oncology, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, and.
2Division of Biostatistics and Bioinformatics, Department of Oncology, Johns Hopkins University, Baltimore, Maryland.
J Natl Compr Canc Netw. 2021 Jan 21;19(6):686-692. doi: 10.6004/jnccn.2020.7646.
Patients participating in phase I trials represent a population with advanced cancer and symptoms, with quality-of-life implications arising from both disease and treatment. Transitions to end-of-life care for these patients have received little attention. Good empirical data are needed to better understand the role of advance care planning and palliative care during phase I trial transitions. We investigated how physician-patient communication at the time of disease progression, patient characteristics, and patterns of care were associated with end-of-life care.
We conducted a retrospective chart review of all patients with solid tumors enrolled in phase I trials at a comprehensive cancer center from January 2015 to December 2017. We captured physician-patient communication during disease progression. Among patients who died, we assessed palliative care referral, advance care planning, place of death, healthcare use in the final month of life, hospice enrollment, and hospice length of stay (LOS). Factors independently associated with a short hospice LOS (defined as ≤3 days) were estimated from a multivariable model building approach.
Among 207 participants enrolled in phase I intervention studies at Johns Hopkins Hospital, the median age was 61 years (range, 31-91 years), 48% were women, 21% were members of racial minority groups, and 41.5% were referred from an outside institution. At the time of disease progression, 53% had goals of care documented, 47% were previously referred to palliative care, and 41% discussed hospice with their oncologist. A total of 82% of decedents died within 1 year of study enrollment, and 85% enrolled in hospice. Among the 147 participants who enrolled in hospice, 22 (15%) had a short LOS (≤3 days). Factors independently associated with an increased risk of short hospice LOS in the multivariable model included age >65 years (odds ratio [OR], 1.12; 95% CI, 1.01-1.24; P=.04), whereas remaining at the same institution (OR, 0.72; 95% CI, 0.65-0.80; P<.001) and referral to palliative care before progression (OR, 0.83; 95% CI, 0.75-0.92; P<.001) were associated with a decreased risk of short hospice LOS.
Reported data support the benefit of palliative care for patients in phase I trials and the risks associated with healthcare transitions for all patients, particularly older adults, regardless of care received. Leaving a clinical trial is a time when clear communication is paramount. Phase I studies will continue to be vital in advancing cancer treatment. It is equally important to advance the support provided to patients who transition off these trials.
参加 I 期临床试验的患者代表了患有晚期癌症和症状的人群,其生活质量受到疾病和治疗的双重影响。这些患者向临终关怀的过渡受到的关注很少。需要良好的经验数据来更好地了解在 I 期试验过渡期间预先护理计划和姑息治疗的作用。我们研究了疾病进展时的医患沟通、患者特征以及护理模式如何与临终关怀相关。
我们对 2015 年 1 月至 2017 年 12 月期间在一家综合癌症中心参加 I 期试验的所有实体瘤患者进行了回顾性图表审查。我们记录了疾病进展期间的医患沟通。在死亡的患者中,我们评估了姑息治疗转诊、预先护理计划、死亡地点、生命最后一个月的医疗保健使用、临终关怀入院和临终关怀住院时间(LOS)。从多变量模型构建方法中估计了与短 LOS(定义为≤3 天)独立相关的因素。
在约翰霍普金斯医院参加 I 期干预研究的 207 名参与者中,中位年龄为 61 岁(范围为 31-91 岁),48%为女性,21%为少数族裔,41.5%来自其他机构。在疾病进展时,53%的患者有记录的治疗目标,47%之前被转诊到姑息治疗,41%与肿瘤学家讨论过临终关怀。82%的死亡患者在研究入组后 1 年内死亡,85%的患者入组了临终关怀。在 147 名入组临终关怀的参与者中,有 22 名(15%)的 LOS 较短(≤3 天)。多变量模型中与短 LOS 风险增加相关的因素包括年龄>65 岁(比值比[OR],1.12;95%置信区间[CI],1.01-1.24;P=.04),而留在同一机构(OR,0.72;95%CI,0.65-0.80;P<.001)和在疾病进展前转诊到姑息治疗(OR,0.83;95%CI,0.75-0.92;P<.001)与短 LOS 风险降低相关。
报告的数据支持姑息治疗对 I 期试验患者的益处,以及对所有患者,特别是老年患者的医疗保健过渡的风险,无论他们接受何种治疗。离开临床试验是进行明确沟通的重要时刻。I 期研究将继续为推进癌症治疗发挥重要作用。同样重要的是,要为从这些试验中过渡的患者提供支持。