The Royal Marsden National Health Service Foundation Trust, London, UK.
European Organization for Resesarch and Treatment of Cancer Headquarters, Brussels, Belgium.
Oncologist. 2018 Oct;23(10):1250-1259. doi: 10.1634/theoncologist.2017-0598. Epub 2018 Apr 12.
Almost half of patients diagnosed with soft tissue sarcoma (STS) are older than 65 years; however, the outcomes of elderly patients with metastatic disease are not well described.
An elderly cohort of patients aged ≥65 years was extracted from the European Organization for Research and Treatment of Cancer (EORTC) Soft Tissue and Bone Sarcoma Group database of patients treated with first-line chemotherapy for advanced STS within 12 EORTC clinical trials. Endpoints were overall survival (OS), progression-free survival (PFS), and response rate (RR).
Of 2,810 participants in EORTC trials, there were 348 elderly patients (12.4%, median 68 years; interquartile range [IQR], 67-70; maximum 84 years) and 2,462 patients aged <65 years (median 49 years; IQR, 39-57). Most elderly patients had a performance status of 0 ( = 134; 39%) or 1 ( = 177; 51%). Leiomyosarcoma ( = 130; 37%) was the most common histological subtype. Lung metastases were present in 181 patients (52%) and liver metastases in 63 patients (18%). Overall, 126 patients (36%) received doxorubicin, 114 patients (33%) doxorubicin + ifosfamide, 43 patients (12%) epirubicin, 39 patients (11%) trabectedin, and 26 patients (7%) ifosfamide. Overall RR was 14.9% ( = 52), median PFS was 3.5 months (95% confidence interval [CI], 2.7-4.3), and median OS was 10.8 months (95% CI, 9.43-11.83). In patients aged <65 years, overall RR was 20.3% ( = 501), median OS was 12.3 months (95% CI, 11.9-12.9), and median PFS was 4.3 months (95% CI, 3.9-4.6).
Elderly patients with metastatic STS treated with first-line chemotherapy were largely underrepresented in these EORTC STS trials. Their outcomes were only slightly worse than those of younger patients. Novel trials with broader eligibility criteria are needed for elderly patients. These trials should incorporate geriatric assessments and measurements of age-adjusted health-related quality of life.
This analysis demonstrates that elderly patients with advanced soft tissue sarcoma are underrepresented in clinical trials of first-line chemotherapy by the European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Furthermore, the elderly participants were generally of excellent performance status, which is not representative of an unselected elderly population. These data provide rationale for development of novel trials for elderly patients that are not only for "elite" patients but include comprehensive geriatric assessments for risk stratification. Because chemotherapy for advanced soft tissue sarcomas is largely given with palliative intent, incorporation of health-related quality of life measures with traditional endpoints will provide a more holistic approach to future clinical trials.
大约一半的软组织肉瘤（STS）患者年龄大于 65 岁；然而，转移性疾病老年患者的预后情况尚不清楚。
从欧洲癌症研究与治疗组织（EORTC）软组织和骨肉瘤组数据库中提取年龄≥65 岁的老年患者队列，这些患者在 12 项 EORTC 临床试验中接受了一线化疗治疗晚期 STS。终点是总生存期（OS）、无进展生存期（PFS）和缓解率（RR）。
在 EORTC 试验的 2810 名参与者中，有 348 名老年患者（12.4%，中位数 68 岁；四分位距 [IQR]，67-70；最大 84 岁）和 2462 名年龄<65 岁的患者（中位数 49 岁；IQR，39-57）。大多数老年患者的体能状态为 0（=134；39%）或 1（=177；51%）。平滑肌肉瘤（=130；37%）是最常见的组织学亚型。181 名患者（52%）存在肺转移，63 名患者（18%）存在肝转移。总体而言，126 名患者（36%）接受了多柔比星，114 名患者（33%）接受了多柔比星+异环磷酰胺，43 名患者（12%）接受了表柔比星，39 名患者（11%）接受了替莫唑胺，26 名患者（7%）接受了异环磷酰胺。总的 RR 为 14.9%（=52），中位 PFS 为 3.5 个月（95%置信区间 [CI]，2.7-4.3），中位 OS 为 10.8 个月（95% CI，9.43-11.83）。在年龄<65 岁的患者中，总的 RR 为 20.3%（=501），中位 OS 为 12.3 个月（95% CI，11.9-12.9），中位 PFS 为 4.3 个月（95% CI，3.9-4.6）。
在接受一线化疗治疗的转移性 STS 老年患者中，在这些 EORTC STS 试验中代表性严重不足。他们的结果略逊于年轻患者。需要为老年患者开展更广泛纳入标准的新试验。这些试验应纳入老年评估和年龄调整后的健康相关生活质量的测量。
这项分析表明，欧洲癌症研究与治疗组织（EORTC）软组织和骨肉瘤组的一线化疗临床试验中，老年患者的代表性严重不足。此外，老年参与者的体能状态通常非常好，这与未选择的老年人群并不相符。这些数据为老年患者制定新的临床试验提供了依据，这些临床试验不仅针对“精英”患者，还包括全面的老年评估进行风险分层。由于晚期软组织肉瘤的化疗主要是姑息性的，因此将健康相关生活质量指标与传统终点结合使用，将为未来的临床试验提供更全面的方法。
