Department of Oncology and Haematology, Klinikum Oldenburg, Oldenburg, Germany.
Department of Hematology and Oncology, Städtisches Klinikum München, Munich, Germany.
Drugs R D. 2019 Sep;19(3):267-275. doi: 10.1007/s40268-019-0278-8.
Data from a trial of first-line panitumumab plus FOLFIRI (folinic acid, infusional 5-fluorouracil and irinotecan) in metastatic colorectal cancer were retrospectively analysed to investigate the effects of primary tumour location and early tumour shrinkage on outcomes.
Patients with RAS wild-type metastatic colorectal cancer from a single-arm, open-label phase II study (NCT00508404) were included. Tumours located from the splenic flexure to rectum and in the caecum to transverse colon were defined as left- and right-sided, respectively. Baseline characteristics were summarised by primary tumour location and the effects of primary tumour location on outcomes-including objective response rate, resection rate, depth of response, duration of response and progression-free survival-were analysed. Progression-free survival and objective response rate were analysed by early tumour shrinkage status.
Primary tumour location was determined in 52/69 (75%) patients with RAS wild-type metastatic colorectal cancer; 45 (87%) had left-sided disease. Median progression-free survival was longer in patients with left-sided tumours (11.2 vs. 7.2 months for right-sided disease) and more of these patients experienced early tumour shrinkage ≥ 30% (53% vs. 29%). Early tumour shrinkage ≥ 30% was associated with improved progression-free survival irrespective of tumour location. More patients with early tumour shrinkage ≥ 30% achieved a partial or complete response. Objective response rate, duration of response, depth of response and resection rates were similar in patients with left- and right-sided tumours.
This analysis has confirmed a prognostic effect of primary tumour location in patients with RAS wild-type metastatic colorectal cancer receiving first-line panitumumab plus FOLFIRI. Early tumour shrinkage was associated with improved progression-free survival irrespective of tumour location. In right-sided disease, early tumour shrinkage may identify a subgroup of patients who might respond to panitumumab. CLINICALTRIALS.
NCT00508404.
对一线帕尼单抗联合 FOLFIRI（亚叶酸、持续输注氟尿嘧啶和伊立替康）治疗转移性结直肠癌的临床试验数据进行回顾性分析，以探讨原发肿瘤位置和早期肿瘤退缩对结局的影响。
纳入来自一项单臂、开放标签的 II 期研究（NCT00508404）的 RAS 野生型转移性结直肠癌患者。肿瘤位于脾曲至直肠和盲肠至横结肠之间的定义为左侧和右侧。根据原发肿瘤位置总结基线特征，并分析原发肿瘤位置对结局的影响，包括客观缓解率、切除率、缓解深度、缓解持续时间和无进展生存期。根据早期肿瘤退缩情况分析无进展生存期和客观缓解率。
52/69（75%）例 RAS 野生型转移性结直肠癌患者确定了原发肿瘤位置；45 例（87%）为左侧肿瘤。左侧肿瘤患者的中位无进展生存期较长（11.2 个月 vs. 右侧疾病的 7.2 个月），且更多患者出现早期肿瘤退缩≥30%（53% vs. 29%）。无论肿瘤位置如何，早期肿瘤退缩≥30%均与无进展生存期的改善相关。更多早期肿瘤退缩≥30%的患者获得部分或完全缓解。左侧和右侧肿瘤患者的客观缓解率、缓解持续时间、缓解深度和切除率相似。
本分析证实了 RAS 野生型转移性结直肠癌患者接受一线帕尼单抗联合 FOLFIRI 治疗时原发肿瘤位置的预后影响。早期肿瘤退缩与无进展生存期的改善相关，与肿瘤位置无关。在右侧疾病中，早期肿瘤退缩可能可以识别出可能对帕尼单抗有反应的患者亚组。临床试验.gov 标识符：NCT00508404。
