Sforza Vincenzo, Martinelli Erika, Cardone Claudia, Martini Giulia, Napolitano Stefania, Vitiello Pietro Paolo, Vitale Pasquale, Zanaletti Nicoletta, Reginelli Alfonso, Bisceglie Maurizio Di, Latiano Tiziana Pia, Bochicchio Anna Maria, Cecere Fabiana, Selvaggi Francesco, Ciardiello Fortunato, Troiani Teresa
Oncologia Medica, Dipartimento di Internistica Clinica e Sperimentale "F. Magrassi", Università degli Studi della Campania Luigi Vanvitelli, Naples, Italy.
Department of Radiology, Università degli Studi della Campania Luigi Vanvitelli, Naples, Italy.
ESMO Open. 2017 Sep 21;2(4):e000229. doi: 10.1136/esmoopen-2017-000229. eCollection 2017.
TAS-102 improves overall survival (OS) in patients with metastatic colorectal cancer (mCRC) refractory to standard treatments. However, predictive biomarkers of efficacy are currently lacking.
We treated a cohort of 43 chemorefractory mCRC patients treated with TAS-102, in a single institution expanded access, compassionate use programme. We stratified patients in two groups according to number of cycles received (<6 cycles and ≥6 cycles). OS, progression-free survival (PFS) and safety were evaluated.
Thirteen out of 43 patients (30%) obtained a clinically relevant disease control with TAS-102 therapy. Eleven of them were treated for ≥6 cycles with TAS-102, reaching a median PFS of 7.5 months (95% CI 5.8 to 9.2 months) and a median OS of 11.2 months (95% CI range not reached yet). A trend towards significance (p=0.08) between a good performance status and response to TAS-102 was observed. Further, 7 out of the 11 TAS-102 long-treated patients achieved a clinical benefit from a previous treatment with regorafenib. A significant correlation between regorafenib and TAS-102 clinical efficacy was observed (p=0.008). Six out 13 regorafenib-naïve patients were treated with regorafenib after progression from TAS-102. All these patients achieved SD with a median duration of treatment with regorafenib of 6.1 months (range, 1.6-6.7).
Patients with mCRC in good clinical conditions, even though having been heavily pretreated with all the available treatment options, could obtain a significant clinical benefit from treatment with TAS-102. Moreover, a previous clinical benefit obtained with regorafenib is potentially predictive of clinical efficacy of subsequent TAS-102 treatment.
TAS-102可改善对标准治疗耐药的转移性结直肠癌（mCRC）患者的总生存期（OS）。然而，目前尚缺乏疗效预测生物标志物。
我们在一项单机构扩大准入的同情用药计划中，对43例接受TAS-102治疗的化疗难治性mCRC患者进行了治疗。我们根据接受的疗程数（<6个疗程和≥6个疗程）将患者分为两组。评估了总生存期（OS）、无进展生存期（PFS）和安全性。
43例患者中有13例（30%）通过TAS-102治疗获得了具有临床意义的疾病控制。其中11例接受TAS-102治疗≥6个疗程，中位无进展生存期为7.5个月（95%CI 5.8至9.2个月），中位总生存期为11.2个月（95%CI范围尚未达到）。观察到良好的体能状态与对TAS-102的反应之间存在显著趋势（p=0.08）。此外，11例接受TAS-102长期治疗的患者中有7例从先前的瑞戈非尼治疗中获得了临床益处。观察到瑞戈非尼与TAS-102临床疗效之间存在显著相关性（p=0.008）。13例未接受过瑞戈非尼治疗的患者中有6例在TAS-102进展后接受了瑞戈非尼治疗。所有这些患者均达到疾病稳定，瑞戈非尼治疗的中位持续时间为6.1个月（范围1.6 - 6.7）。
临床状况良好的mCRC患者，即使已接受了所有可用治疗方案的大量预处理，仍可从TAS-102治疗中获得显著的临床益处。此外，先前从瑞戈非尼获得的临床益处可能预测后续TAS-102治疗的临床疗效。
