Health-related quality of life of patients with metastatic melanoma treated with tumor-infiltrating lymphocytes compared with ipilimumab in a randomized phase III trial.

patients_and_methods

In a multicenter, randomized, phase III trial, patients with metastatic melanoma (unresectable stage IIIC-IV) were randomized to TIL-IMP or IPI treatment (NCT02278887).

在一个多中心、随机、III期临床试验中，不可切除的III C-IV期转移性黑色素瘤患者被随机分配接受TIL-IMP或IPI治疗（NCT02278887）。

HRQoL was measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative Care (EORTC QLQ-C15-PAL), EuroQol 5D-3L (EQ-5D), and the Impact of Event Scale (IES).

使用欧洲癌症研究与治疗组织生活质量问卷核心15姑息治疗(EORTC QLQ-C15-PAL)、欧洲五维健康量表(EQ-5D)和事件影响量表(IES)来测量健康相关生活质量(HRQoL)。

HRQoL outcomes were evaluated using a generalized estimating equations model.

使用广义估计方程模型来评估健康相关生活质量(HRQoL)的结果。

Sensitivity analyses were carried out to assess dropout assumptions.

进行了敏感性分析以评估脱落假设。

Results were interpreted for statistically and clinically significant differences.

结果被解释为统计学和临床上显著的差异。

Results

Of 168 patients randomized 1 : 1, n = 143 baseline HRQoL scores (85%) were calculated.

在168名随机分组的患者中，有143名（占85%）计算了基线健康相关生活质量（HRQoL）评分。

Of these, 75 (89%) were in the TIL-IMP group and 73 (87%) in the IPI group.

在这些患者中，75名（占89%）属于肿瘤浸润淋巴细胞免疫调节蛋白（TIL-IMP）组，73名（占87%）属于免疫原性蛋白（IPI）组。

TIL-IMP-treated patients reported higher global health status scores at week 24 compared with IPI-treated patients (78.2 versus 73.9; P < 0.05) and higher emotional functioning (85.9 versus 77.9; P < 0.05) scores.

接受TIL-IMP治疗的患者在第24周报告了比接受IPI治疗的患者更高的全球健康状况评分（78.2对比73.9；P < 0.05）以及更高的情感功能评分（85.9对比77.9；P < 0.05）

Patients treated with TIL-IMP had significantly lower fatigue (25.0 versus 32.4; P < 0.05) and pain (13.7 versus 17.6; P < 0.05) scores at week 24, but marginally higher nausea and vomiting (7.5 versus 5.2; P < 0.05) symptom scores.

在第24周，接受TIL-IMP治疗的患者的疲劳和疼痛评分显著低于接受IPI治疗的患者（疲劳：25.0对比32.4；P < 0.05；疼痛：13.7对比17.6；P < 0.05），但恶心和呕吐症状评分略高（7.5对比5.2；P < 0.05）

EQ-5D scores were also higher in the TIL-IMP group (0.89 versus 0.83; P < 0.05).

TIL-IMP组的EQ-5D评分也更高（0.89对比0.83；P<0.05）

These statistically significant differences were not considered clinically meaningful.

这些统计学上的显著差异被认为不具有临床意义。

The hypothesized higher impact of the more intensive TIL-IMP treatment compared with IPI was not observed, according to IES scores (11.8 versus 17.4; P < 0.05 at 24 weeks).

根据IES评分，未观察到更密集的TIL-IMP治疗相比IPI有更高的影响（24周时，11.8对比17.4；P < 0.05）。

Sensitivity analyses showed similar results.

敏感性分析显示了类似的结果。

Conclusions

Patients with metastatic melanoma treated with TIL-IMP experienced similar HRQoL compared with IPI monotherapy, with indications of better HRQoL outcomes over time.

接受肿瘤浸润淋巴细胞免疫疗法（TIL-IMP）治疗的转移性黑色素瘤患者与接受伊匹木单抗（IPI）单药治疗的患者相比，健康相关生活质量（HRQoL）相似，且随着时间的推移显示出更好的HRQoL结果。

Ongoing follow-up is essential to assess longer-term HRQoL and its generalizability to a larger patient population to help guide personalized treatment decisions.

持续的随访对于评估长期健康相关生活质量（HRQoL）及其在更广泛患者群体中的普遍性至关重要，以帮助指导个性化治疗决策。