早期治疗和奥沙利铂停药对III期结肠癌患者的预后影响：ACCENT/IDEA对11项辅助试验的汇总分析
Prognostic Impact of Early Treatment and Oxaliplatin Discontinuation in Patients With Stage III Colon Cancer: An ACCENT/IDEA Pooled Analysis of 11 Adjuvant Trials.
作者信息
Gallois Claire, Shi Qian, Meyers Jeffrey P, Iveson Timothy, Alberts Steven R, de Gramont Aimery, Sobrero Alberto F, Haller Daniel G, Oki Eiji, Shields Anthony Frank, Goldberg Richard M, Kerr Rachel, Lonardi Sara, Yothers Greg, Kelly Caroline, Boukovinas Ioannis, Labianca Roberto, Sinicrope Frank A, Souglakos Ioannis, Yoshino Takayuki, Meyerhardt Jeffrey A, André Thierry, Papamichael Demetris, Taieb Julien
机构信息
Paris-Cité University, Department of Gastroenterology and Digestive Oncology, Georges Pompidou European Hospital, SIRIC CARPEM, Paris, France.
Department of Health Science Research, Mayo Clinic, Rochester, MN.
出版信息
J Clin Oncol. 2023 Feb 1;41(4):803-815. doi: 10.1200/JCO.21.02726. Epub 2022 Oct 28.
PURPOSE
Oxaliplatin-based adjuvant chemotherapy in patients with stage III colon cancer (CC) for 6 months remains a standard in high-risk stage III patients. Data are lacking as to whether early discontinuation of all treatment (ETD) or early discontinuation of oxaliplatin (EOD) could worsen the prognosis.
MATERIALS AND METHODS
We studied the prognostic impact of ETD and EOD in patients with stage III CC from the ACCENT/IDEA databases, where patients were planned to receive 6 months of infusional fluorouracil, leucovorin, and oxaliplatin or capecitabine plus oxaliplatin. ETD was defined as discontinuation of treatment and EOD as discontinuation of oxaliplatin only before patients had received a maximum of 75% of planned cycles. Association between ETD/EOD and overall survival and disease-free survival (DFS) were assessed by Cox models adjusted for established prognostic factors.
RESULTS
Analysis of ETD and EOD included 10,447 (20.9% with ETD) and 7,243 (18.8% with EOD) patients, respectively. Compared with patients without ETD or EOD, patients with ETD or EOD were statistically more likely to be women, with Eastern Cooperative Oncology Group performance status ≥ 1, and for ETD, older with a lower body mass index. In multivariable analyses, ETD was associated with a decrease in disease-free survival and overall survival (hazard ratio [HR], 1.61, < .001 and HR, 1.73, < .001), which was not the case for EOD (HR, 1.07, = .3 and HR, 1.13, = .1). However, patients who received < 50% of the planned cycles of oxaliplatin had poorer outcomes.
CONCLUSION
In patients treated with 6 months of oxaliplatin-based chemotherapy for stage III CC, ETD was associated with poorer oncologic outcomes. However, this was not the case for EOD. These data favor discontinuing oxaliplatin while continuing fluoropyrimidine in individuals with significant neurotoxicity having received > 50% of the planned 6-month chemotherapy.
目的
对于III期结肠癌（CC）患者，基于奥沙利铂的辅助化疗6个月仍是高危III期患者的标准治疗方案。关于提前终止所有治疗（ETD）或提前终止奥沙利铂（EOD）是否会使预后恶化，目前尚缺乏相关数据。
材料与方法
我们从ACCENT/IDEA数据库中研究了ETD和EOD对III期CC患者预后的影响，该数据库中的患者计划接受6个月的氟尿嘧啶持续静脉输注、亚叶酸钙和奥沙利铂或卡培他滨加奥沙利铂治疗。ETD定义为在患者接受的计划周期数最多达到75%之前终止治疗，EOD定义为仅提前终止奥沙利铂治疗。通过针对既定预后因素进行调整的Cox模型评估ETD/EOD与总生存期和无病生存期（DFS）之间的关联。
结果
对ETD和EOD的分析分别纳入了10447例（20.9%为ETD）和7243例（18.8%为EOD）患者。与未发生ETD或EOD的患者相比，发生ETD或EOD的患者在统计学上更可能为女性且东部肿瘤协作组体能状态≥1，对于ETD患者，年龄更大且体重指数更低。在多变量分析中，ETD与无病生存期和总生存期降低相关（风险比[HR]，1.61，P <.001和HR，1.73，P <.001），而EOD并非如此（HR，1.07，P =.3和HR，1.13，P =.1）。然而，接受奥沙利铂计划周期数<50%的患者预后较差。
结论
对于接受基于奥沙利铂的化疗6个月的III期CC患者，ETD与较差的肿瘤学结局相关。然而，EOD并非如此。这些数据支持在接受计划6个月化疗>50%且有明显神经毒性的个体中，在继续使用氟嘧啶的同时停用奥沙利铂。
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