Department of Chemotherapy, Center of Pulmonology and Chemotherapy, 58-580, Szklarska Poręba, Poland.
Department of Pathomorphology, Medical University of Gdańsk, 80-214, Gdańsk, Poland.
BMC Cancer. 2021 May 10;21(1):529. doi: 10.1186/s12885-021-08183-y.
Oxaliplatin-based therapy with FOLFOX-4 or CAPOX administered over 6 months remains the standard adjuvant treatment for stage III colon cancer (CC) patients. However, many patients experience dose reduction or early termination of chemotherapy due to oxaliplatin toxicity, which may increase the risk of early recurrence. The objective of this study was to analyze the relationship between the relative dose intensity of oxaliplatin (RDI-O) and early recurrence among stage III CC patients.
The study included 365 patients treated at five oncology centers in Poland between 2000 and 2014. Survival analysis was performed using the Kaplan-Meier method. Univariate analysis was performed using the Cox proportional hazard model; multivariate analysis was performed with the stepwise forward approach. For all analyses the α level of 0.05 was employed.
The median follow-up was 51.8 months (range 8.2-115.1). Early recurrence < 36 months after surgery occurred in 130 patients (37.8%). In this group 51 (39.2%) and 87 (66.9%) of patients were low and high-risk, respectively. Receipt < 60% of RDI-O was associated with early recurrence within 18 months after surgery (OR = 2.05; 95%CI: 1.18-3.51; p = 0.010), especially in low-risk group (HR = 1.56 (95%CI: 0.96-2.53), p = 0.07). In the multivariate analysis early recurrence was correlated with grade (OR = 2.47; 95% CI: 1.25-4.8; p = 0.008), pN (OR = 2.63; 95% CI: 1.55-4.54; p < 0.001), the number of lymph nodes harvested (OR = 0.51; 95% CI: 0.29-0.86; p = 0.013) and RDI-O (OR = 1.91; 95%CI: 1.06-3.39; p = 0.028). The early vs. late recurrence negatively correlated with OS regardless of the RDI-O (HR = 22.9 (95%CI: 13.9-37.6; p < 0.001).
RDI-O < 60% in adjuvant therapy among stage III CC (especially in low-risk group) increases the risk of early recurrence within 18 months of surgery. Patients with early recurrence showed worse overall survival regardless of the RDI-O.
奥沙利铂为基础的 FOLFOX-4 或 CAPOX 治疗方案,持续 6 个月,仍然是 III 期结肠癌(CC)患者的标准辅助治疗。然而,由于奥沙利铂毒性,许多患者经历剂量减少或化疗提前终止,这可能增加早期复发的风险。本研究的目的是分析 III 期 CC 患者奥沙利铂相对剂量强度(RDI-O)与早期复发之间的关系。
本研究纳入了 2000 年至 2014 年间在波兰五家肿瘤中心接受治疗的 365 名患者。采用 Kaplan-Meier 法进行生存分析。使用 Cox 比例风险模型进行单因素分析;使用逐步向前法进行多因素分析。所有分析均采用 α 水平为 0.05。
中位随访时间为 51.8 个月(范围 8.2-115.1)。术后 36 个月内发生早期复发<36 个月的患者有 130 例(37.8%)。在该组中,51 例(39.2%)和 87 例(66.9%)患者分别为低危和高危。接受<60% RDI-O 的患者在术后 18 个月内发生早期复发的风险更高(OR=2.05;95%CI:1.18-3.51;p=0.010),尤其是在低危组(HR=1.56(95%CI:0.96-2.53),p=0.07)。在多因素分析中,早期复发与肿瘤分级(OR=2.47;95%CI:1.25-4.8;p=0.008)、pN 分期(OR=2.63;95%CI:1.55-4.54;p<0.001)、淋巴结清扫数目(OR=0.51;95%CI:0.29-0.86;p=0.013)和 RDI-O(OR=1.91;95%CI:1.06-3.39;p=0.028)相关。早期复发与晚期复发相比,与 OS 呈负相关,无论 RDI-O 如何(HR=22.9(95%CI:13.9-37.6;p<0.001)。
III 期 CC(尤其是低危组)辅助治疗中 RDI-O<60%,会增加术后 18 个月内早期复发的风险。早期复发患者的总生存情况更差,无论 RDI-O 如何。