Service d'Endocrinologie, Maladies Métaboliques et Nutrition, Centre Hospitalier Universitaire Rangueil-Larrey, Université Paul Sabatier, Institut CardioMet et INSERM U1037, Toulouse, France.
Service d'endocrinologie, Centre Hospitalier Universitaire de Lille, Lille, France.
Horm Cancer. 2018 Feb;9(1):62-69. doi: 10.1007/s12672-017-0313-6. Epub 2017 Oct 25.
A partial response (PR) has been proposed as a surrogate for overall survival in advanced adrenocortical carcinoma (ACC). The primary endpoint of the study was to characterize the time until a PR in patients with metastatic ACC treated with a standard therapy is achieved. Long-term survivors were selected to allow evaluation of delayed tumor response to mitotane. Records from patients with metastatic ACC that survived for > 24 months were retrieved. Tumor response was analyzed according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Time until a tumor response, after treatment initiation or therapeutic plasma mitotane level, was analyzed. Sixty-eight patients were analyzed. The first-line systemic therapy was mitotane as a monotherapy (M) (n = 57) or cytotoxic polychemotherapy plus/minus mitotane (PC ± M) (n = 11). The second-line therapy was M (n = 2) or PC ± M (n = 41). Thirty-two PRs occurred in 30/68 patients (44.1%): this was obtained for 13 (40.6%) during M and during PC ± M for 19/32 responders (59.4%). PRs were observed within 6 months of starting M or PC ± M in 76.9 and 94.7% of responses, respectively, within 6 months of therapeutic plasma mitotane being first observed in 88.9% of responses with M and in 53.3% of responses with PC ± M. All PRs (but one) occurred within 1 year after initiating treatment. To conclude, Most patients with metastatic ACC and long survival times had PRs within the first 6 months of standard systemic therapy, and almost all within the first year. The absence of response after that period could be considered as a treatment failure. Maintenance of mitotane therapy in non-responders after 1 year should be questioned in future randomized trials.
部分缓解(PR)已被提议作为晚期肾上腺皮质癌(ACC)总生存的替代指标。该研究的主要终点是确定接受标准治疗的转移性 ACC 患者达到 PR 的时间。选择长期存活者以评估米托坦对肿瘤的延迟反应。检索了转移性 ACC 存活时间超过 24 个月的患者的记录。根据实体瘤反应评估标准(RECIST)1.1 标准分析肿瘤反应。分析了从开始治疗或治疗性血浆米托坦水平后肿瘤反应的时间。共分析了 68 例患者。一线全身治疗是米托坦单药治疗(M)(n=57)或细胞毒性联合化疗加/减米托坦(PC±M)(n=11)。二线治疗是米托坦(n=2)或细胞毒性联合化疗加/减米托坦(n=41)。32 例患者(30/68 例,44.1%)出现 PR:M 治疗期间 13 例(40.6%),PC±M 治疗期间 19/32 例(59.4%)。在开始 M 或 PC±M 后 6 个月内,分别有 76.9%和 94.7%的患者出现缓解,在开始 M 或 PC±M 后 6 个月内首次观察到治疗性血浆米托坦后,分别有 88.9%和 53.3%的患者出现缓解。所有 PR(除 1 例外)均发生在开始治疗后 1 年内。总之,大多数转移性 ACC 患者和长期存活者在标准全身治疗的前 6 个月内出现 PR,几乎所有患者都在 1 年内出现 PR。在此期间后无反应可被视为治疗失败。在未来的随机试验中,应考虑在 1 年后对无反应者继续使用米托坦治疗。