United BioSource Corporation, Bethesda, MD 20814, USA.
Health Qual Life Outcomes. 2012 Jun 13;10:66. doi: 10.1186/1477-7525-10-66.
In an international, randomized Phase III trial ipilimumab demonstrated a significant overall survival benefit in previously treated advanced melanoma patients. This report summarizes health-related quality of life (HRQL) outcomes for ipilimumab with/without gp100 vaccine compared to gp100 alone during the clinical trial's 12 week treatment induction period.
The Phase III clinical trial (MDX010-20) was a double-blind, fixed dose study in 676 previously treated advanced unresectable stage III or IV melanoma patients. Patients were randomized 3:1:1 to receive either ipilimumab (3 mg/kg q3w x 4 doses) + gp100 (peptide vaccine; 1 mg q3w x 4 doses; ipilimumab plus gp100, n = 403); gp100 vaccine + placebo (gp100 alone, n = 136); or ipilimumab + placebo (ipilimumab alone, n = 137). The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) assessed HRQL. Baseline to Week 12 changes in EORTC QLQ-C30 function, global health status, and symptom scores were analyzed for ipilimumab with/without gp100 vaccine compared to gp100 alone. Mean change in scores were categorized "no change" (0-5), "a little" (5-10 points), "moderate" (10-20 points), and "very much" (>20).
In the ipilimumab plus gp100 and ipilimumab alone groups, mean changes from baseline to Week 12 generally indicated "no change" or "a little" impairment across EORTC QLQ-C30 global health status, function, and symptom subscales. Significant differences in constipation, favoring ipilimumab, were observed (p < 0.05). For ipilimumab alone arm, subscales with no or a little impairment were physical, emotional, cognitive, social function, global health, nausea, pain, dyspnea, constipation, and diarrhea subscales. For the gp100 alone group, the observed changes were moderate to large for global health, role function, fatigue, and for pain.
Ipilimumab with/without gp100 vaccine does not have a significant negative HRQL impact during the treatment induction phase relative to gp100 alone in stage III or IV melanoma patients.
Clinicaltrials.gov identification number NCT00094653.
在一项国际性、随机的 III 期临床试验中，伊匹单抗在先前治疗的晚期黑色素瘤患者中表现出显著的总生存获益。本报告总结了在临床试验的 12 周治疗诱导期内，与单独使用 gp100 相比，伊匹单抗联合/不联合 gp100 疫苗治疗的健康相关生活质量（HRQL）结果。
III 期临床试验（MDX010-20）是一项在 676 例先前治疗的不可切除的 III 期或 IV 期晚期黑色素瘤患者中进行的双盲、固定剂量研究。患者按 3:1:1 的比例随机分配至以下三组：接受伊匹单抗（3mg/kg，每 3 周 1 次，共 4 次）+ gp100（肽疫苗；1mg，每 3 周 1 次，共 4 次；伊匹单抗联合 gp100，n=403）；gp100 疫苗+安慰剂（gp100 组，n=136）；或伊匹单抗+安慰剂（伊匹单抗组，n=137）。欧洲癌症研究与治疗组织生活质量问卷（EORTC QLQ-C30）评估了 HRQL。分析了伊匹单抗联合/不联合 gp100 疫苗与单独使用 gp100 相比，在基线至第 12 周时 EORTC QLQ-C30 功能、总体健康状况和症状评分的变化。评分的平均变化分为“无变化”（0-5）、“略有”（5-10 分）、“中度”（10-20 分）和“非常大”（>20 分）。
在伊匹单抗联合 gp100 和伊匹单抗单独治疗组中，与基线相比，第 12 周时 EORTC QLQ-C30 总体健康状况、功能和症状子量表的平均变化通常表明“无变化”或“略有”受损。与伊匹单抗相比，便秘显著改善（p<0.05）。在伊匹单抗单独治疗组中，无或轻度受损的子量表包括身体、情绪、认知、社会功能、总体健康、恶心、疼痛、呼吸困难、便秘和腹泻。对于 gp100 组，观察到总体健康状况、角色功能、疲劳和疼痛的变化为中度至重度。
与单独使用 gp100 相比，在 III 期或 IV 期黑色素瘤患者中，伊匹单抗联合/不联合 gp100 疫苗在治疗诱导期内不会对 HRQL 产生显著的负面影响。
Clinicaltrials.gov 标识符 NCT00094653。
