Thebault Eric, Piperno-Neumann Sophie, Tran Diep, Pacquement Hélène, Marec-Berard Perrine, Lervat Cyril, Castex Marie-Pierre, Cleirec Morgane, Bompas Emmanuelle, Vannier Jean-Pierre, Plantaz Dominique, Saumet Laure, Verite Cecile, Collard Olivier, Pluchart Claire, Briandet Claire, Monard Laure, Brugieres Laurence, Le Deley Marie-Cécile, Gaspar Nathalie
Department of Oncology for Child and Adolescent, Gustave Roussy, Paris-Saclay University, 94800 Villejuif, France.
Medical Oncology Department, Institut Curie, 75005 Paris, France.
Cancers (Basel). 2021 Apr 2;13(7):1683. doi: 10.3390/cancers13071683.
The purpose was to describe first and subsequent relapses in patients from the OS2006/Sarcome-09 trial, to help future trial design. We prospectively collected and analysed relapse data of all French patients included in the OS2006/Sarcome-09 trial, who had achieved a first complete remission. 157 patients experienced a first relapse. The median interval from diagnosis to relapse was 1.7 year (range 0.5-7.6). The first relapse was metastatic in 83% of patients, and disease was not measurable according to RECIST 1.1 criteria in 23%. Treatment consisted in systemic therapy (74%) and surgical resection (68%). A quarter of the patients were accrued in a phase-II clinical trial. A second complete remission was obtained for 79 patients. Most of them had undergone surgery (76/79). The 3-year progression-free and overall survival rates were 21% and 37%, respectively. In patients who achieved CR2, the 3y-PFS and OS rates were 39% and 62% respectively. Individual correlation between subsequent PFS durations was poor. For osteosarcoma relapses, we recommend randomised phase-II trials, open to patients from all age categories (children, adolescents, adults), not limited to patients with measurable disease (but stratified according to disease status), with PFS as primary endpoint, response rate and surgical CR as secondary endpoints.
目的是描述OS2006/Sarcome - 09试验患者的首次复发及后续复发情况，以助力未来的试验设计。我们前瞻性地收集并分析了OS2006/Sarcome - 09试验中所有达到首次完全缓解的法国患者的复发数据。157例患者经历了首次复发。从诊断到复发的中位间隔时间为1.7年（范围0.5 - 7.6年）。83%的患者首次复发时出现转移，23%的患者根据RECIST 1.1标准疾病不可测量。治疗包括全身治疗（74%）和手术切除（68%）。四分之一的患者入组了一项II期临床试验。79例患者获得了第二次完全缓解。其中大多数患者接受了手术（76/79）。3年无进展生存率和总生存率分别为21%和37%。在达到CR2的患者中，3年无进展生存率和总生存率分别为39%和62%。后续无进展生存期之间的个体相关性较差。对于骨肉瘤复发，我们建议开展随机II期试验，纳入所有年龄段（儿童、青少年、成人）的患者，不限于疾病可测量的患者（但根据疾病状态进行分层），以无进展生存期作为主要终点，缓解率和手术完全缓解作为次要终点。
