Division of Clinical Trials and Biostatistics, Mayo Clinic, Rochester, Minnesota.
Division of Medical Oncology, Mayo Clinic, Phoenix, Arizona.
J Natl Compr Canc Netw. 2023 Aug;21(8):841-850.e4. doi: 10.6004/jnccn.2023.7028.
For patients with resected stage III colon cancer, 6 months of adjuvant fluoropyrimidine-based chemotherapy has been the standard of care. The IDEA collaboration aimed to evaluate whether 3 months of adjuvant chemotherapy was noninferior to 6 months. Despite failing to meet its primary endpoint, the subgroup analyses demonstrated noninferiority based on regimen and treatment duration when a risk-stratified approach was used.
To evaluate the impact of the results of the IDEA collaboration, we evaluated adjuvant chemotherapy prescribing practice patterns, including planned adjuvant treatment regimen and duration from January 1, 2016, to January 31, 2021. The time period was selected to evaluate chemotherapy prescribing patterns prior to the abstract presentation of the IDEA collaboration in June 2017 and after full manuscript publication in March 2018.
A total of 399 patients with stage III colon cancer who received adjuvant chemotherapy were included in the analysis. A significant increasing trend for use of 3 months of adjuvant chemotherapy was observed after presentation of the IDEA abstract (P<.001). A significant change in CAPOX (capecitabine/oxaliplatin) prescribing was also observed, increasing from 14% of patients prior to presentation of the IDEA abstract to 48% after presentation (P<.001). Comparing 3 months of CAPOX with 6 months of FOLFOX (fluorouracil/leucovorin/oxaliplatin), 3 months of CAPOX use also steadily increased over time (adjusted odds ratio [aOR], 1.28; 95% CI, 1.20-1.37; P<.001). Among subgroups of interest, no differences in adoption of CAPOX were observed. The adoption of 3 months of CAPOX was similar in patients with low-risk cancer (aOR, 1.27; 95% CI, 1.17-1.37) and those with high-risk cancer (aOR, 1.31; 95% CI, 1.16-1.47).
Despite the IDEA collaboration failing to demonstrate noninferiority of 3 months' duration of adjuvant therapy compared with 6 months, the findings have influenced practice prescribing patterns, favoring CAPOX and a shorter duration of planned adjuvant treatment.
对于接受 III 期结肠癌根治术的患者，6 个月的辅助氟嘧啶类化疗一直是标准治疗方法。IDEA 合作旨在评估 3 个月的辅助化疗是否不劣于 6 个月。尽管未能达到主要终点，但亚组分析表明，采用风险分层方法时，基于方案和治疗持续时间，该方案具有非劣效性。
为了评估 IDEA 合作的结果，我们评估了辅助化疗的处方实践模式，包括从 2016 年 1 月 1 日至 2021 年 1 月 31 日的计划辅助治疗方案和持续时间。选择这段时间是为了评估在 2017 年 6 月 IDEA 合作摘要公布之前和 2018 年 3 月全文发表之后的化疗处方模式。
共纳入 399 例接受辅助化疗的 III 期结肠癌患者。在公布 IDEA 摘要后，3 个月辅助化疗的使用率呈显著上升趋势（P<.001）。卡培他滨/奥沙利铂（CAPOX）的处方也有显著变化，从 IDEA 摘要公布前的 14%增加到公布后的 48%（P<.001）。比较 3 个月的 CAPOX 与 6 个月的 FOLFOX（氟尿嘧啶/亚叶酸钙/奥沙利铂），3 个月的 CAPOX 使用率也随着时间的推移而稳步增加（调整优势比[aOR]，1.28；95%置信区间[CI]，1.20-1.37；P<.001）。在感兴趣的亚组中，没有观察到 CAPOX 采用率的差异。在低危癌症患者（aOR，1.27；95%CI，1.17-1.37）和高危癌症患者（aOR，1.31；95%CI，1.16-1.47）中，采用 3 个月 CAPOX 的情况相似。
尽管 IDEA 合作未能证明 3 个月辅助治疗与 6 个月相比不劣效，但这些发现已影响实践处方模式，有利于 CAPOX 和计划辅助治疗持续时间更短。
