Department of Behavioral Science, College of Medicine, Markey Cancer Center, University of Kentucky, 467 Healthy Kentucky Research Building, 760 Press Avenue, Lexington, KY, 40508, USA.
Dana-Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA, USA.
Qual Life Res. 2023 Jan;32(1):183-196. doi: 10.1007/s11136-022-03226-8. Epub 2022 Aug 27.
Trial E1609 demonstrated superior overall survival with ipilimumab 3 mg/kg (ipi3) compared to high-dose interferon (HDI) for patients with resected high-risk melanoma. To inform treatment tolerability, we compared health-related quality of life (HRQoL), gastrointestinal (GI), and treatment-specific physical and cognitive/emotional symptoms. We also compared treatment-specific concerns between all arms.
We assessed HRQoL using the Functional Assessment of Cancer Therapy-General, physical and cognitive/emotional concerns using the FACT-Biologic Response Modifier subscale, and GI symptoms with the Functional Assessment of Chronic Illness Therapy-Diarrhea subscale pre-treatment and every 3 months. The primary outcome was the difference in HRQoL at 3 months between ipi3/ipi10 vs. HDI.
549 patients (n = 158 ipi3; n = 191 ipi10; n = 200 HDI) were analyzed. 3-month completion was 58.7%. Compared to HDI, ipilimumab patients reported better HRQoL (ipi3 = 87.5 ± 14.6 vs. HDI = 74.7 ± 15.4, p < .001; ipi10 = 84.9 ± 16.5 vs. HDI, p < .001) and fewer physical (ipi3 = 22.3 ± 4.6 vs. HDI = 17.1 ± 5.4, p < .001; ipi10 = 21.8 ± 5.0 vs. HDI p < .001) and cognitive/emotional (ipi3 = 18.6 ± 4.4 vs. HDI = 15.0 ± 5.3, p < .001; ipi10 = 17.7 ± 4.8 vs. HDI p < .001) concerns, but worse GI symptoms (ipi3 = 40.8 ± 5.0 vs. HDI = 42.2 ± 2.9, p = .011; ipi10 = 39.5 ± 7.0 vs. HDI, p < .001). Fewer ipilimumab patients reported worsening treatment-specific concerns (e.g., 52% of ipi3 and 58% of ipi10 reported worsening fatigue vs. 82% HDI, p's < .001).
PROs demonstrated less toxicity of ipi3 compared to HDI and ipi10. Priorities for symptom management among patients receiving ipilimumab include GI toxicities, fatigue, weakness, appetite loss, arthralgia, and depression.
NCT01274338, January 11, 2011 (first posted date) https://clinicaltrials.gov/ct2/show/NCT01274338?term=NCT01274338&draw=2&rank=1 .
试验 E1609 显示，与高剂量干扰素（HDI）相比，伊匹单抗 3mg/kg（ipi3）可显著提高切除高风险黑色素瘤患者的总生存期。为了说明治疗耐受性，我们比较了健康相关生活质量（HRQoL）、胃肠道（GI）以及特定于治疗的身体和认知/情绪症状。我们还比较了所有组之间的特定于治疗的担忧。
我们使用功能性评估癌症治疗 - 一般（FACT-G）评估 HRQoL，使用 FACT 生物学反应调节剂子量表评估身体和认知/情绪担忧，使用慢性病治疗 - 腹泻子量表评估 GI 症状，在治疗前和每 3 个月评估一次。主要结局是 ipi3/ipi10 与 HDI 相比，3 个月时 HRQoL 的差异。
共分析了 549 名患者（n=158 ipi3；n=191 ipi10；n=200 HDI）。3 个月的完成率为 58.7%。与 HDI 相比，接受伊匹单抗治疗的患者报告了更好的 HRQoL（ipi3=87.5±14.6 与 HDI=74.7±15.4，p<0.001；ipi10=84.9±16.5 与 HDI，p<0.001）和更少的身体（ipi3=22.3±4.6 与 HDI=17.1±5.4，p<0.001；ipi10=21.8±5.0 与 HDI，p<0.001）和认知/情绪（ipi3=18.6±4.4 与 HDI=15.0±5.3，p<0.001；ipi10=17.7±4.8 与 HDI，p<0.001）担忧，但 GI 症状更严重（ipi3=40.8±5.0 与 HDI=42.2±2.9，p=0.011；ipi10=39.5±7.0 与 HDI，p<0.001）。较少的伊匹单抗患者报告治疗相关担忧恶化（例如，52%的 ipi3 和 58%的 ipi10 报告疲劳恶化，而 82%的 HDI，p<0.001）。
与 HDI 和 ipi10 相比，PRO 显示 ipi3 的毒性较小。接受伊匹单抗治疗的患者的症状管理重点包括 GI 毒性、疲劳、虚弱、食欲减退、关节痛和抑郁。
NCT01274338，2011 年 1 月 11 日（首次发布日期）https://clinicaltrials.gov/ct2/show/NCT01274338?term=NCT01274338&draw=2&rank=1。
