Pectasides Dimitrios, Karavasilis Vasilios, Papaxoinis George, Gourgioti Georgia, Makatsoris Thomas, Raptou Georgia, Vrettou Eleni, Sgouros Joseph, Samantas Epaminontas, Basdanis George, Papakostas Pavlos, Bafaloukos Dimitrios, Kotoula Vassiliki, Kalofonos Haralambos P, Scopa Chrisoula D, Pentheroudakis George, Fountzilas George
Oncology Section, Second Department of Internal Medicine, "Hippokration" Hospital, Athens, 11527, Greece.
Department of Medical Oncology, "Papageorgiou" Hospital, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece.
BMC Cancer. 2015 May 10;15:384. doi: 10.1186/s12885-015-1406-7.
The aim of the trial was to compare two active adjuvant chemotherapy regimens in patients with early stage colorectal cancer (CRC).
Patients were assigned to oxaliplatin, leucovorin and 5-FU for 12 cycles (group A, FOLFOX6) or oxaliplatin and capecitabine for eight cycles (group B, CAPOX). Primary endpoint was disease-free survival (DFS). Tumors were classified as mismatch repair proficient (pMMR) or deficient (dMMR) according to MLH1, PMS2, MSH2 and MSH6 protein expression. KRAS exon two and BRAF V600E mutational status were also assessed.
Between 2005 and 2008, 441 patients were enrolled, with 408 patients being eligible. After a median follow-up of 74.7 months, 3-year DFS was 79.8 % (95 % CI 76.5-83.4) in the FOLFOX group and 79.5 % (95 % CI 75.9-83.1) in the CAPOX group (p = 0.78). Three-year OS was 87.2 % (95 % CI 84.1-91.1) in the FOLFOX and 86.9 % (95 % CI 83.4-89.9) in the CAPOX group (p = 0.84). Among 306 available tumors, 11.0 % were dMMR, 34.0 % KRAS mutant and 4.9 % BRAF mutant. Multivariate analysis showed that primary site in the left colon, earlier TNM stage and the presence of anemia at diagnosis were associated with better DFS and overall survival (OS), while grade one-two tumors were associated with better OS. Finally, a statistically significant interaction was detected between the primary site and MMR status (p = 0.010), while KRAS mutated tumors were associated with shorter DFS. However, the sample was too small for safe conclusions.
No significant differences were observed in the efficacy of FOLFOX versus CAPOX as adjuvant treatment in high-risk stage II or stage III CRC patients, but definitive conclusions cannot be drawn because of the small sample size.
ANZCTR 12610000509066 . Date of Registration: June 21, 2010.
该试验的目的是比较两种活性辅助化疗方案用于早期结直肠癌（CRC）患者的疗效。
患者被分配接受12个周期的奥沙利铂、亚叶酸钙和5-氟尿嘧啶治疗（A组，FOLFOX6方案）或8个周期的奥沙利铂和卡培他滨治疗（B组，CAPOX方案）。主要终点是无病生存期（DFS）。根据MLH1、PMS2、MSH2和MSH6蛋白表达将肿瘤分类为错配修复功能正常（pMMR）或缺陷（dMMR）。还评估了KRAS第2外显子和BRAF V600E的突变状态。
2005年至2008年期间，共纳入441例患者，其中408例符合条件。中位随访74.7个月后，FOLFOX组的3年DFS为79.8%（95%CI 76.5 - 83.4），CAPOX组为79.5%（95%CI 75.9 - 83.1）（p = 0.78）。FOLFOX组的3年总生存期（OS）为87.2%（95%CI 84.1 - 91.1），CAPOX组为86.9%（95%CI 83.4 - 89.9）（p = 0.84）。在306个可获得的肿瘤中，11.0%为dMMR，34.0%为KRAS突变型，4.9%为BRAF突变型。多因素分析显示，左半结肠癌的原发部位、较早的TNM分期以及诊断时存在贫血与更好的DFS和总生存期（OS）相关，而一至二级肿瘤与更好的OS相关。最后，检测到原发部位与MMR状态之间存在统计学显著的相互作用（p = 0.010），而KRAS突变型肿瘤与较短的DFS相关。然而，样本量过小，无法得出可靠结论。
在高危II期或III期CRC患者中，作为辅助治疗，FOLFOX与CAPOX的疗效未观察到显著差异，但由于样本量小，无法得出明确结论。
ANZCTR 12610000509066。注册日期：2010年6月21日。
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