Machida Nozomu, Okumura Takehiro, Boku Narikazu, Kishimoto Junji, Nishina Tomohiro, Suyama Koichi, Ohde Yasuhisa, Shinozaki Katsunori, Baba Hideo, Tokunaga Shinya, Kawakami Hisato, Tsuda Takashi, Kotaka Masahito, Okuda Hiroyuki, Yasui Hisateru, Yamazaki Kentaro, Hironaka Shuichi, Muro Kei, Hyodo Ichinosuke
Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Sunto-gun, Shizuoka, Japan.
Department of Surgery, University Hospital Mizonokuchi, Teikyo University School of Medicine, Kawasaki City, Kanagawa, Japan.
Cancer. 2025 Apr 1;131(7):e35807. doi: 10.1002/cncr.35807.
BACKGROUND: The clinical significance of adjuvant chemotherapy after lung metastasectomy for colorectal cancer remains unknown. This phase 2 study evaluated adjuvant chemotherapy with modified 5-fluorouracil/leucovorin and oxaliplatin (mFOLFOX6) after lung metastasectomy. METHODS: Eligibility criteria included colorectal adenocarcinoma, first curative resection of ≤4 lung metastases, and no prior chemotherapy. Treatment consisted of 12 cycles of mFOLFOX6. The primary endpoint was the 5-year overall survival (OS) rate, with the expectation of 50% (threshold, 35%) and a planned sample size of 100 (90% power; alpha error, 5%). RESULTS: Fifty-two patients were enrolled between July 2011 and July 2014; patient enrollment was closed prematurely because of slow accrual. Excluding four ineligible patients, the characteristics of the 48 patients in the efficacy analysis set were a median age of 62 years (range, 43-75 years), Eastern Cooperative Oncology Group performance status of 0 in 45 patients, prior resection of extrathoracic metastasis in four patients, and postoperative carcinoembryonic antigen within normal range in 43 patients; the status of lung metastasis was single in 34 patients, unilateral in 40 patients, and metachronous in 41 patients; and a disease-free interval between primary tumor resection and diagnosis of lung metastasis of <2 years in 33 patients. The 5-year OS rate was 85.2% (95% confidence interval [CI], 71.4%-92.6%), and the 5-year disease-free survival rate was 60.2% (95% CI, 44.9%-72.4%). Forty-one of the 52 patients (78.8%) in the safety analysis set completed 12 cycles of mFOLFOX6. Grade ≥3 adverse events were neutropenia (50.0%), fatigue (7.7%), peripheral sensory neuropathy (7.7%), and other (<5%). CONCLUSIONS: Adjuvant chemotherapy with mFOLFOX6 is feasible, and may be effective after lung metastasectomy for colorectal cancer.
背景：结直肠癌肺转移灶切除术后辅助化疗的临床意义尚不清楚。本2期研究评估了肺转移灶切除术后采用改良氟尿嘧啶/亚叶酸钙和奥沙利铂（mFOLFOX6）进行辅助化疗的效果。 方法：纳入标准包括结肠腺癌、首次根治性切除≤4个肺转移灶且未接受过化疗。治疗方案为12个周期的mFOLFOX6。主要终点为5年总生存率（OS），预期为50%（阈值为35%），计划样本量为100例（检验效能90%；α错误概率5%）。 结果：2011年7月至2014年7月共纳入52例患者；由于入组缓慢，患者入组提前结束。排除4例不符合条件的患者后，疗效分析集中48例患者的特征为：中位年龄62岁（范围43 - 75岁），45例患者东部肿瘤协作组体能状态评分为0，4例患者有胸外转移既往史，43例患者术后癌胚抗原在正常范围内；肺转移状态为单发34例，单侧40例，异时性41例；33例患者原发肿瘤切除至肺转移诊断的无病间期<2年。5年OS率为85.2%（95%置信区间[CI]，71.4% - 92.6%），5年无病生存率为60.2%（95% CI，44.9% - 72.4%）。安全性分析集中52例患者中的41例（78.8%）完成了12个周期的mFOLFOX6。≥3级不良事件为中性粒细胞减少（50.0%）、疲劳（7.7%）、周围感觉神经病变（7.7%）以及其他（<5%）。 结论：mFOLFOX6辅助化疗是可行的，对于结直肠癌肺转移灶切除术后可能有效。
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