Department of Medical Oncology, Institut Curie, 26, rue d'Ulm, 75248 Paris Cedex 05, France.
Br J Cancer. 2012 Feb 28;106(5):854-7. doi: 10.1038/bjc.2012.10. Epub 2012 Jan 26.
Treatment effect is categorised into four classes by RECIST based on the evolution of the size of target lesions and the occurrence of new lesions, irrespective of tumour growth kinetics before treatment. This study aimed at evaluating the added value of tumour growth kinetics assessment to RECIST in patients treated with molecularly targeted agents (MTAs).
On-study imaging, along with pre-baseline imaging, of patients treated with MTA(s) in clinical trials at Institut Curie were centrally reviewed. The tumour growth ratio (TGr), defined as the ratio of the slope of tumour growth before treatment and the slope of tumour growth on treatment between the nadir and disease progression, was calculated for each patient.
A total of 50 patients included in 18 trials were eligible for the study. Among the 44 patients who withdrew from the study because of disease progression according to the investigators' assessment, 18 patients (41%) had a TGr <0.9. Among these 18 patients, 5 had disease progression according to RECIST 1.1 based on our retrospective reassessment of on-study imaging and occurrence of no new lesion during study treatment.
Our preliminary results suggest that a substantial proportion of patients treated with MTAs have discontinued treatment although being potentially benefitted from them.
RECIST 根据目标病灶大小的变化和新病灶的出现,将治疗效果分为四类,而不考虑治疗前肿瘤生长动力学。本研究旨在评估肿瘤生长动力学评估对接受分子靶向药物(MTA)治疗的患者的 RECIST 的附加价值。
对居里研究所临床试验中接受 MTA 治疗的患者的研究期间成像以及基线前成像进行中心审查。为每位患者计算肿瘤生长比(TGr),定义为治疗前肿瘤生长斜率与治疗期间从最低点到疾病进展的肿瘤生长斜率之比。
共有 18 项试验中的 50 名患者符合入选标准。在因研究者评估的疾病进展而退出研究的 44 名患者中,18 名患者(41%)的 TGr<0.9。在这 18 名患者中,有 5 名根据我们对研究期间成像的回顾性重新评估和研究治疗期间无新病灶出现,根据 RECIST 1.1 判定为疾病进展。
我们的初步结果表明,尽管可能从 MTA 中受益,但相当一部分接受 MTA 治疗的患者已停止治疗。