艰难的数据解读之路：III 期结肠癌患者需要接受 3 或 6 个月的辅助化疗？
The hard road to data interpretation: 3 or 6 months of adjuvant chemotherapy for patients with stage III colon cancer?
机构信息
Department of Medical Oncology, IRCCS San Martino Hospital, Genoa, Italy.
Division of Medical Oncology, Mayo Clinic Cancer Center, Rochester, USA.
出版信息
Ann Oncol. 2018 May 1;29(5):1099-1107. doi: 10.1093/annonc/mdy064.
BACKGROUND
Six months of adjuvant oxaliplatin-based chemotherapy is standard for patients with stage III colon cancer following surgery. However, oxaliplatin is associated with peripheral neurotoxicity which worsens over treatment duration. Consequently, a shorter treatment duration, if equally effective, would be extremely beneficial. A pooled analysis of data for 12 834 stage III colon cancer patients, from six randomised phase III trials of adjuvant therapy, the International Duration Evaluation of Adjuvant chemotherapy study, was carried out and the results presented at the ASCO Annual Meeting 2017. To clarify the potential impact of these results on clinical practice, ESMO decided to sponsor a special session at their 2017 Annual Meeting dedicated to achieving a more meaningful interpretation of the results.
METHODS
Medical oncologists from Europe, the United States and Asia selected for their involvement in the trials, together with an independent statistician and an independent clinician, were invited to provide their independent interpretations of the results and contribute to a moderated panel discussion. The pooled analysis evaluated the non-inferiority of 3 versus 6 months of adjuvant FOLFOX/CAPOX therapy but not the non-inferiority of 3 months CAPOX versus 6 months FOLFOX therapy.
RESULTS
There was strong evidence of an interaction between the choice of regimen (CAPOX or FOLFOX) and duration of treatment. Patients were classified as either 'fighters' or 'fatalists', and 3-month CAPOX was considered standard for patients classified as fatalists even if they had high-risk disease. However, patients classified as 'fighters' would only receive 3 months of CAPOX if they had low-risk disease but would always receive 6 months of CAPOX/FOLFOX if they had T4 disease. The panel was split on whether they would advocate 3 or 6 months CAPOX therapy based on high-risk N2 disease.
CONCLUSIONS
The main drivers of the duration of treatment were choice of regimen and patient attitude, with risk, based mainly on T4 stage, having less influence.
背景
手术后，III 期结肠癌患者的标准辅助治疗是接受 6 个月奥沙利铂为基础的化疗。然而，奥沙利铂与周围神经毒性相关，且随着治疗时间的延长而恶化。因此，如果治疗时间更短且同样有效，将会带来极大的益处。一项针对来自六个辅助治疗随机 III 期试验的 12834 例 III 期结肠癌患者的数据的汇总分析，即国际辅助化疗持续时间评估研究，在 2017 年 ASCO 年会上进行了报告。为了阐明这些结果对临床实践的潜在影响，欧洲肿瘤内科学会决定在其 2017 年年会上举办一个特别会议，专门对这些结果进行更有意义的解读。
方法
来自欧洲、美国和亚洲的参与这些试验的肿瘤内科医生，以及一名独立的统计学家和一名独立的临床医生，应邀对结果进行独立解读，并为一个有争议的小组讨论做出贡献。该汇总分析评估了辅助 FOLFOX/CAPOX 治疗 3 个月与 6 个月的非劣效性，但不评估 3 个月 CAPOX 与 6 个月 FOLFOX 治疗的非劣效性。
结果
治疗方案（CAPOX 或 FOLFOX）和治疗持续时间之间存在很强的相互作用的证据。患者被分为“斗士”或“宿命论者”，对于被归类为宿命论者的患者，即使他们患有高危疾病，也认为 3 个月 CAPOX 是标准治疗。然而，对于被归类为“斗士”的患者，如果他们患有低危疾病，他们只会接受 3 个月的 CAPOX 治疗，但如果他们患有 T4 疾病，他们将始终接受 6 个月的 CAPOX/FOLFOX 治疗。小组成员对于是否根据高危 N2 疾病而主张接受 3 个月或 6 个月的 CAPOX 治疗存在分歧。
结论
治疗持续时间的主要驱动因素是治疗方案的选择和患者的态度，而主要基于 T4 分期的风险则影响较小。
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