各位好！今天与大家分享一篇近期发表在Journal of Thoracic Oncology上的一篇文献，研究对JCOG0802 试验的局部复发数据进行了披露。肺段切除术方兴未艾的当下，哪些特征是术后局部复发的高危因素？基于RCT研究的事后分析能临床实践带来哪些启示？一起来看看
Risk factors for locoregional relapse after segmentectomy: Supplementary analysis of the JCOG0802/WJOG4607L trial
Kazuo Nakagawa, MD, Shun-ichi Watanabe, MD, Masashi Wakabayashi, MSC, Masaya Yotsukura, MD, Takahiro Mimae, MD, Aritoshi Hattori, MD, Tomohiro Miyoshi, MD, Mitsuhiro Isaka, MD, Makoto Endo, MD, Hiroshige Yoshioka, MD, Yasuhiro Tsutani, MD, Tetsuya Isaka, MD, Tomohiro Maniwa, MD, Ryu Nakajima, MD, Kenji Suzuki, MD, Keiju Aokage, MD, Hisashi Saji, MD, Masahiro Tsuboi, MD, Morihito Okada, MD, Hisao Asamura, MD, Yuta Sekino, MD, Kenichi Nakamura, MD, Haruhiko Fukuda, MD
Journal of Thoracic Oncology 6 October 2024
Introduction: The JCOG0802/WJOG4607L trial revealed superior overall survival in segmentectomy to lobectomy for small-peripheral non-small-cell lung cancer. However, locoregional relapse (LR) is a major issue for segmentectomy. An ad hoc supplementary analysis aimed to determine the risk factors for LR and the degree of advantages of segmentectomy based on primary tumor sites.
目的：JCOG0802/WJOG4607L 试验表明，对于小周围型非小细胞肺癌，肺段切除术的总生存率优于肺叶切除术。然而，局部区域复发 (LR) 是肺段切除术的主要问题。一项临时补充分析旨在确定 LR 的风险因素以及基于原发肿瘤部位的肺段切除术的优势程度。
Methods: Participants in multi-institutional and intergroup, open-label, phase 3 randomized controlled trial in Japan were enrolled from August 10, 2009, to October 21, 2014. Risk factors for LR after segmentectomy and clinical features following the primary tumor site were investigated.
方法：研究纳入了自2009 年 8 月 10 日至 2014 年 10 月 21 日，在日本招募了多机构、跨组、开放标签、 3 期随机对照试验的参与者。研究了肺段切除术后 LR 的危险因素和原发肿瘤部位的临床特征。
Results: Of 1105 patients, 576 and 529 underwent lobectomy and segmentectomy, respectively. The primary tumor site for segmentectomy was the left upper division, left lingular segment, left S6, left basal segment, right upper lobe, right S6, or right basal segment. Multivariable analysis in the segmentectomy group revealed that pure-solid appearance on thin-section computed tomography (odds ratio 3.230; 95% confidential interval [CI] 1.559–6.690; p = 0.0016), margin distance less than the tumor size (odds ratio 2.682; 95% CI 1.350–5.331; p = 0.0049), and male sex (odds ratio: 2.089; 95% CI: 1.047–4.169; p = 0.0366) were significantly associated with LR. Patients with left lingular segment tumors (odds ratio 4.815; 95% CI 1.580–14.672) tended to experience LR more frequently than those with left upper division tumors, although primary tumor sites were not statistically significant.
结果：1105 例患者中，分别有 576 例和 529 例接受了肺叶切除术和肺段切除术。肺段切除术的原发肿瘤部位是左上叶、左舌叶、左 S6、左基底叶、右上叶、右 S6 或右基底叶。肺段切除术组的多因素分析显示，薄层 CT 上的纯实体外观（比值比 3.230；95% 置信区间 [CI] 1.559–6.690；p = 0.0016）、边缘距离小于肿瘤大小（比值比 2.682；95% CI 1.350–5.331；p = 0.0049）和男性（比值比：2.089；95% CI：1.047–4.169；p = 0.0366）与 LR 显着相关。患有左舌段肿瘤（比值比 4.815；95% CI：1.580–14.672）的患者比患有左上其他段肿瘤的患者更容易出现 LR，尽管原发肿瘤部位无统计学意义。
Conclusions: Thin-section computed tomography findings and margin distance are important factors to avoid LR in segmentectomy.
结论：薄层 CT 表现和切缘距离是避免肺段切除术中 LR 的重要因素。
1.众所周知，在JCOG0201基础上，影像学非浸润性肺结节行肺段切除术/楔形切除术具有较好的可行性。但目前已有结果的III期RCT研究JCOG0802和CALGB140503都没有在研究方案中提出普适性的肺段切除淋巴结清扫策略。
2.上细节：
首先本文是基于JCOG0802的事后分析主要分析研究中出现的局部复发的情况，既往JCOG0802的事后分析是分析淋巴结转移的话题，研究结果发表在JTCVS上。两个话题相互相关，互有影响。
其次，文章主要的结果是展示了肺段组98 (18.5%) of 529 patients是切缘小于肿瘤直径并且可能与局部复发相关，这里的肿瘤直径应该是指的肿瘤最大径。这个数据还是挺令人震惊的，段切居然有这么高的切缘。右下叶的基底段是手术时间最长、失血量最多，注意这里的右肺下叶基底段特指（S6+S8, S6+9, S6+10, S7+8, S7+S9, S7+S10, S8+S9, S9+S10）。
第三，局部复发在早期肺癌中与肿瘤性质和切缘密切相关。但两组有限的事件数也使得后续深入分析变得捉襟见肘。因此在高危患者中肺段切除仍然需要面临的是切缘和潜在淋巴结转移的清扫问题。
3. 可手术I期NSCLC需要更加精细化的研究，期待能有针对肿瘤位置更精细可量化的位置描述图谱和肺段切除术质控手册。
目录
1. INTRODUCTION
2. Material and Methods
2.1 Patient eligibility criteria
2.2 Radiological evaluation of the primary tumor
2.3 Surgical procedures
2.4 Evaluation of surgical margin
2.5 Follow-up policy
2.6 Statistical analysis
3. Results (Table 1-4)
4. Discussion
— 图表汇总—
Table 1. Baseline Characteristics of the Study Population
Table 2. Univariable and Multivariable Analyses to Identify Risk Factors for Locoregional Relapse in the Segmentectomy Group
Table 3. Magin Status of Patients Undergoing Segmentectomy According to Primary Tumor Sites
Table 4. Details of 11 Patients with Locoregional Relapse at the Surgical Margin after Segmentectomy
