Randomized Clinical Trial of adjuvant chemotherapy with paclitaxel and carboplatin following resection in Stage IB Non-Small Cell Lung Cancer (NSCLC): Report of Cancer and Leukemia Group B (CALGB) Protocol 9633.
Randomized Clinical Trial of adjuvant chemotherapy with paclitaxel and carboplatin following resection in Stage IB Non-Small Cell Lung Cancer (NSCLC): Report of Cancer and Leukemia Group B (CALGB) Protocol 9633.
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DOI：
10.1200/jco.2004.22.14_suppl.7019
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发表时间：
2004-07
期刊：
影响因子：
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通讯作者：
G. Strauss;J. Herndon;M. Maddaus;D. Johnstone;Elizabeth A. Johnson;D. Watson;D. Sugarbaker;R. Schilsky;M. Green
中科院分区：
文献类型：
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作者：
G. Strauss;J. Herndon;M. Maddaus;D. Johnstone;Elizabeth A. Johnson;D. Watson;D. Sugarbaker;R. Schilsky;M. Green
7019 背景：辅助化疗在可切除肺癌中的价值仍存在争议。国际辅助肺试验 (IALT) 报告称，在 IA 至 III 期 NSCLC 中，基于顺铂的辅助化疗具有适度但具有统计学意义的生存优势。另一方面，意大利辅助肺项目（ALPI）未能证明辅助化疗对相似阶段的患者有益处。 CALGB 9633 旨在测试 T2N0M0、IB 期 NSCLC 患者辅助化疗的有效性。 NCCTG 和 RTOG 也参加了。方法 在切除后 4-8 周内，患者被随机接受紫杉醇 200 mg/m2 3 小时内辅助化疗和卡铂 AUC 6，每三周第一天给药，持续四个周期，或观察。资格：年龄 > 18 岁，组织学记录为 NSCLC、T2 原发灶、肺叶切除术或全肺切除术、手术或纵隔镜检查时 N1 或 N2 淋巴结中无肿瘤。所有 p 值都是两侧的。结果 96 年 9 月 15 日至 2003 年 11 月 26 日期间，344 名患者被随机分组。目前中位随访时间为 34 个月。中位年龄为 61 岁（范围 34-81 岁），其中 64% 为男性。各组在年龄、性别、人种、民族、组织学、肿瘤分化和切除类型方面非常平衡。 80% 的患者在手术前接受了纵隔镜检查。 89% 的患者进行了肺叶切除术。辅助化疗耐受性良好，没有发生化疗相关的中毒性死亡。 36% 发生 III 级或 IV 级中性粒细胞减少症。化疗组 173 名患者中有 36 例因任何原因死亡，而观察组 171 名患者中有 52 例死亡（HR=0.62；95% CI：0.41-0.95，p=0.028）。化疗组和观察组的 4 年总生存率分别为 71%（95% CI：62%-81%）和 59%（95% CI：50%-69%）。化疗组在无失败生存方面也具有显着优势（HR=0.69；95% CI：0.48-0.98；p=0.035）。关于肺癌死亡率，化疗组有19例肺癌死亡，对照组有34例死亡（HR=0.51；95% CI：0.29-0.89；p=0.018）。 4 年时，化疗组和对照组的肺癌死亡率分别为 15%（95% CI：8%-21%）和 26%（95% CI：18%-34%）。结论 辅助化疗可显着降低 IB 期 NSCLC 的全因死亡率和肺癌死亡率。这是第一个随机试验，证明基于卡铂的辅助化疗方案在非小细胞肺癌统一人群中显着提高了生存率。 [表：见正文]。
7019 Background: The value of adjuvant chemotherapy in resectable lung cancer remains controversial. The International Adjuvant Lung Trial (IALT) reported a modest but statistically significant survival advantage with cisplatin-based adjuvant chemotherapy in stages IA to III NSCLC. On the other hand, Adjuvant Lung Project Italy (ALPI) failed to demonstrate benefit for adjuvant chemotherapy in patients of similar stage. CALGB 9633 was designed to test the effectiveness of adjuvant chemotherapy in patients with T2N0M0, stage IB NSCLC. NCCTG and RTOG also participated. METHODS Within 4-8 weeks of resection, patients were randomized to adjuvant chemotherapy with paclitaxel 200 mg/m2 over 3 hours and carboplatin AUC 6, each administered on day one every three weeks for four cycles, or to observation. Eligibility: age >18 years, histologically documented NSCLC, T2 primary lesion, lobectomy or pneumonectomy, absence of tumor in N1 or N2 nodes sampled at surgery or mediastinoscopy. All p-values are two-sided. RESULTS Between 9/15/96 and 11/26/03, 344 patients were randomized. Median follow-up is currently 34 months. Median age was 61 years (range 34-81 years), and 64% were male. Groups were well balanced with regard to age, gender, race, ethnicity, histology, tumor differentiation, and resection type. 80% underwent mediastinoscopy prior to surgery. Lobectomy was performed in 89%. Adjuvant chemotherapy was well tolerated, and there were no chemotherapy-related toxic deaths. Grade III or IV neutropenia occurred in 36%. There have been 36 deaths from any cause among 173 patients in the chemotherapy group compared to 52 deaths among 171 patients in the observation group (HR=0.62; 95% CI: 0.41-0.95, p=0.028). Overall survival at 4 years is 71% (95% CI: 62%-81%) and 59% (95% CI: 50%-69%) in chemotherapy and observation groups, respectively. There was also a significant advantage in failure-free survival favoring the chemotherapy group (HR=0.69; 95% CI: 0.48-0.98; p=0.035). With regard to lung cancer mortality, there have been 19 lung cancer deaths in the chemotherapy group and 34 deaths in the control group (HR=0.51; 95% CI: 0.29-0.89; p=0.018). At 4 years, lung cancer mortality was 15% (95% CI: 8%-21%) and 26% (95% CI: 18%-34%) in chemotherapy and control groups, respectively. CONCLUSIONS Adjuvant chemotherapy significantly reduces all-cause and lung cancer mortality in stage IB NSCLC. This is the first randomized trial to demonstrate significantly improved survival for a carboplatin-based adjuvant chemotherapy regimen in a uniform population with NSCLC. [Table: see text].