Department of Surgery, Tochigi Cancer Center, Utsunomiya, Tochigi, Japan.
Department of Gastric Surgery, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
J Gastrointest Cancer. 2024 Sep;55(3):1125-1133. doi: 10.1007/s12029-024-01061-3. Epub 2024 May 4.
Post-operative infectious complication (IC) is a well-known negative prognostic factor, while showing neoadjuvant chemotherapy (NAC) may cancel out the negative influence of IC. This analysis compared the clinical impacts of IC according to the presence or absence of NAC in gastric cancer patients enrolled in the phase III clinical trial (JCOG0501) which compared upfront surgery (arm A) and NAC followed by surgery (arm B) in type 4 and large type 3 gastric cancer.
The subjects were 224 patients who underwent R0 resection out of 316 patients enrolled in JCOG0501. The prognoses of the patients with or without ICs in each arm were investigated by univariable and multivariable Cox regression analyses.
There were 21 (20.0%) IC occurrences in arm A and 15 (12.6%) in arm B. In arm A, the overall survival (OS) of patients with ICs was slightly worse than those without IC (3-year OS, 57.1% in patients with ICs, 79.8% in those without ICs; adjusted hazard ratio (95% confidence interval), 1.292 (0.655-2.546)). In arm B, patients with ICs showed a trend of better survival than those without ICs (3-year OS, 80.0% in patients with IC, 74.0% in those without IC; adjusted hazard ratio, 0.573 (0.226-1.456)).
This study could not indicate the negative prognostic influence of ICs in gastric cancer patients receiving NAC, which might be canceled by NAC. To build exact evidence, further investigation with prospective and large numbers of data might be expected.
术后感染并发症(IC)是一个众所周知的预后不良因素,但新辅助化疗(NAC)的显示可能会抵消 IC 的负面影响。本分析比较了 III 期临床试验(JCOG0501)中接受 NAC 的胃癌患者与未接受 NAC 的患者的 IC 存在与否的临床影响,该试验比较了直接手术(A 组)和 NAC 后手术(B 组)在 4 型和大型 3 型胃癌中的疗效。
JCOG0501 共入组 316 例患者,其中 224 例患者行 R0 切除。通过单变量和多变量 Cox 回归分析,研究了各臂中有无 IC 的患者的预后。
A 组中 IC 发生率为 21.0%(21/100),B 组为 12.6%(15/119)。在 A 组中,IC 患者的总生存期(OS)略差于无 IC 患者(3 年 OS,IC 患者为 57.1%,无 IC 患者为 79.8%;调整后的危险比(95%置信区间)为 1.292(0.655-2.546))。在 B 组中,IC 患者的生存情况好于无 IC 患者(3 年 OS,IC 患者为 80.0%,无 IC 患者为 74.0%;调整后的危险比为 0.573(0.226-1.456))。
本研究不能表明接受 NAC 的胃癌患者 IC 的预后不良影响可能被 NAC 抵消。为了建立确切的证据,可能需要进行前瞻性和大数据量的进一步研究。