The hard road to data interpretation: 3 or 6 months of adjuvant chemotherapy for patients with stage III colon cancer?
The hard road to data interpretation: 3 or 6 months of adjuvant chemotherapy for patients with stage III colon cancer?
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DOI：
10.1093/annonc/mdy064
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发表时间：
2018-05-01
影响因子：
50.5
通讯作者：
Cervantes, A.
中科院分区：
文献类型：
--
作者：
Sobrero, A.;Grothey, A.;Cervantes, A.
背景：6个月的奥沙利铂辅助化疗是III期结肠癌术后患者的标准治疗方案。然而，奥沙利铂与周围神经毒性有关，随着治疗时间的延长而恶化。因此，较短的治疗时间，如果同样有效，将是非常有益的。对来自6项辅助治疗随机III期试验的12834名III期结肠癌患者的数据进行了汇总分析，国际辅助化疗持续时间评估研究，并在2017年ASCO年会上公布了结果。为了阐明这些结果对临床实践的潜在影响，ESMO决定在其2017年年会上举办一次特别会议，致力于对这些结果进行更有意义的解释。方法：来自欧洲、美国和亚洲的医学肿瘤学家被选中参与试验，与一名独立的统计学家和一名独立的临床医生一起，被邀请提供他们对结果的独立解释，并参与主持的小组讨论。合并分析评估了3个月与6个月FOLFOX/CAPOX辅助治疗的非劣效性，但没有评估3个月CAPOX与6个月FOLFOX治疗的非劣效性。结果：有强有力的证据表明，方案的选择（CAPOX或FOLFOX）和治疗时间之间存在相互作用。患者被分类为“战士”或“宿命论者”，3个月CAPOX被认为是被分类为宿命论者的标准，即使他们患有高风险疾病。然而，被归类为“战士”的患者如果患有低风险疾病，则只接受3个月的CAPOX，但如果患有T4疾病，则总是接受6个月的CAPOX/FOLFOX。该小组在是否提倡基于高风险N2疾病的3个月或6个月CAPOX治疗方面存在分歧。结论：影响治疗持续时间的主要因素是治疗方案的选择和患者态度，其中以T4分期为主的风险影响较小。
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.