OBJECTIVE 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. METHODS 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. RESULTS 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. CONCLUSIONS 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. GOV IDENTIFIER NCT00508404.

中文翻译：

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一线FOLFIRI加Panitumumab后RAS野生型转移性结直肠癌患者的原发肿瘤位置和早期肿瘤缩小对结果的影响。

目的回顾性分析一线帕尼单抗联合FOLFIRI（亚叶酸，5-氟尿嘧啶和伊立替康）在转移性结直肠癌中的试验数据，以研究原发肿瘤位置和早期肿瘤缩小对预后的影响。方法纳入单臂开放标签II期研究（NCT00508404）的RAS野生型转移性结直肠癌患者。从脾曲至直肠以及盲肠至横结肠的肿瘤分别定义为左侧和右侧。通过原发肿瘤的位置以及原发肿瘤的位置对结局的影响总结了基线特征，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。通过早期肿瘤缩小状态分析无进展生存期和客观缓解率。结果确定了52/69（75％）RAS野生型转移性结直肠癌患者的原发肿瘤位置；45（87％）人患有左侧疾病。左侧肿瘤患者的中位无进展生存期更长（右侧疾病为11.2 vs. 7.2个月），并且这些患者中有更多经历了早期肿瘤缩小≥30％（53％vs. 29％）。早期肿瘤缩小≥30％与改善无进展生存期无关，而与肿瘤位置无关。早期肿瘤缩小≥30％的患者获得了部分或完全缓解。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。结论该分析证实了接受一线帕尼单抗联合FOLFIRI治疗的RAS野生型转移性结直肠癌患者的原发肿瘤位置预后。早期肿瘤缩小与改善的无进展生存期无关，而与肿瘤位置无关。在右侧疾病中，早期肿瘤缩小可能会确定可能对帕尼单抗有反应的患者亚组。临床试验。GOV标识符NCT00508404。临床试验。GOV标识符NCT00508404。临床试验。GOV标识符NCT00508404。