Division of Hematology and Oncology, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Department of Pharmacy, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Oncologist. 2021 Jan;26(1):49-55. doi: 10.1002/onco.13561. Epub 2020 Nov 8.
As indications for immune checkpoint inhibitor (ICI) therapy have increased in recent years, so has the proportion of patients eligible for this type of therapy. However, a lack of data exists about the risks and benefits of ICI therapy in hospitalized patients, who tend to be frailer and sicker than patients enrolled in clinical trials.
We conducted a retrospective cohort study among hospitalized patients with metastatic solid tumors who received ICI therapy at a large academic cancer center over the course of 4 years. We analyzed the characteristics and outcomes of these patients and identified demographic and clinical factors that could be used to predict mortality.
During the 4-year study period, 106 patients were treated with ICI therapy while admitted to the hospital; 70 (66%) had Eastern Cooperative Oncology Group Performance Status ≥2, which would have prevented them from enrolling in most clinical trials of ICIs. Fifty-two patients (49%) died either during admission or within 30 days of discharge; median overall survival was 1.0 month from discharge, and 16 patients (15%) were alive 6 months after discharge. Independent predictors of death following receipt of inpatient ICI included a diagnosis of non-small cell lung cancer relative to melanoma and prior treatment with two or more lines of therapy.
The poor overall outcomes observed in this study may give clinicians pause when considering ICI therapy for hospitalized patients, particularly those with characteristics that are associated with a greater risk of mortality.
Immunotherapy strategies for patients with cancer are rapidly evolving and their use is expanding, but not all patients will develop a response, and secondary toxicity can be significant and challenging. This is especially evident in hospitalized patients, where the economic cost derived from inpatient immune checkpoint inhibitor (ICI) administration is important and the clinical benefit is sometimes unclear. The poor overall outcomes evidenced in the ICI inpatient population in this study highlight the need to better identify the patients that will respond to these therapies, which will also help to decrease the financial burden imposed by these highly priced therapies.
近年来，免疫检查点抑制剂（ICI）治疗的适应证不断增加，因此适合这种治疗的患者比例也有所增加。然而，关于住院患者接受 ICI 治疗的风险和获益的数据尚缺乏，这些患者往往比临床试验入组患者更为脆弱和病重。
我们对在一家大型学术癌症中心接受 ICI 治疗的 4 年内住院的转移性实体瘤患者进行了回顾性队列研究。我们分析了这些患者的特征和结局，并确定了可用于预测死亡率的人口统计学和临床因素。
在 4 年的研究期间，有 106 例住院患者接受了 ICI 治疗；其中 70 例（66%）的东部肿瘤协作组体能状态评分≥2，这会使他们无法入组大多数 ICI 的临床试验。52 例（49%）患者在住院期间或出院后 30 天内死亡；中位总生存期为出院后 1 个月，出院后 6 个月时仍有 16 例（15%）患者存活。接受住院 ICI 治疗后死亡的独立预测因素包括与黑色素瘤相比诊断为非小细胞肺癌和先前接受过 2 线或更多线治疗。
本研究观察到的总体预后较差可能会使临床医生在考虑为住院患者使用 ICI 治疗时犹豫不决，特别是对于那些具有更高死亡率风险特征的患者。
癌症患者的免疫治疗策略正在迅速发展，其应用范围也在扩大，但并非所有患者都会产生反应，并且继发性毒性可能会很明显且具有挑战性。这在住院患者中尤为明显，因为住院免疫检查点抑制剂（ICI）给药带来的经济成本很重要，而且临床获益有时并不明确。本研究中 ICI 住院患者的总体预后较差，突出了需要更好地识别那些对这些治疗有反应的患者，这也将有助于降低这些高价位治疗带来的经济负担。
