培美曲塞联合卡铂作为可切除的非鳞状非小细胞肺癌患者的辅助化疗。
Pemetrexed plus carboplatin as adjuvant chemotherapy in patients with curative resected non-squamous non-small cell lung cancer.
机构信息
Department of Thoracic Surgery, Sun Yat-sen University Cancer Center Guangzhou, Guangdong Province, China; State Key Laboratory of Oncology in South China Guangzhou, Guangdong Province, China.
出版信息
Thorac Cancer. 2014 Jan;5(1):50-6. doi: 10.1111/1759-7714.12058. Epub 2014 Jan 2.
BACKGROUND
Cisplatin-based adjuvant chemotherapy provided a significant advantage in the overall survival (OS) of patients with stage II and III non-small cell lung cancer (NSCLC). However, the compliance and toxicity in cisplatin-based treatment were not always satisfactory. Pemetrexed plus carboplatin (PC) had better chemotherapy compliance and efficiency in advanced non-squamous NSCLC patients. The aim of our study was to investigate the feasibility and efficacy of PC as adjuvant chemotherapy in patients with completely resected non-squamous NSCLC.
METHODS
Eighty-two eligible non-squamous NSCLC patients operated on with pathological stage II or IIIA were enrolled in this trial. Adjuvant chemotherapy was initiated between one and four weeks after surgery, and consisted of four cycles of pemetrexed (500 mg/m2) plus carboplatin (AUC = 5) every three weeks. The primary endpoint was the compliance of the regimen and the second endpoint was disease-free survival (DFS).
RESULTS
Patient demographics were median age 58 years (range 32 to 78) and gender ratio 68.3% male/31.7% female. Forty-eight (58.5%) of the patients were at stage II, and the other thirty-four (41.5%) patients were at stage IIIA. Seventy patients (85.4%) received four cycles of therapy over a 12-week period. Reasons for discontinuing therapy included: patient's refusal (n = 10); severe adverse events (n = 1); and surgical complications (n = 1). The primary grade 3 to 4 adverse reaction was hematologic toxicity: neutropenia (13.4%); leucopenia (7.3%); anemia (3.7%); and thrombocytopenia (2.4%). Non-hematological adverse events were mild. No treatment related deaths were observed. Median DFS for stage II and IIIA patients were 38.0 months (95% confidence interval (CI): 28.1 to 47.9 months) and 21.0 months (95%CI: 13.7 to 28.3 months), respectively.
CONCLUSION
Adjuvant PC chemotherapy was an acceptable regimen in resected non-squamous NSCLC patients.
背景
顺铂为基础的辅助化疗在 II 期和 III 期非小细胞肺癌（NSCLC）患者的总生存（OS）中提供了显著优势。然而，顺铂治疗的依从性和毒性并不总是令人满意。培美曲塞加卡铂（PC）在晚期非鳞状 NSCLC 患者中具有更好的化疗依从性和效率。我们的研究目的是探讨 PC 作为完全切除的非鳞状 NSCLC 患者辅助化疗的可行性和疗效。
方法
本试验纳入了 82 例符合条件的行手术治疗且病理分期为 II 期或 IIIA 期的非鳞状 NSCLC 患者。辅助化疗在手术后 1 至 4 周内开始，每 3 周进行 4 个周期的培美曲塞（500mg/m2）加卡铂（AUC=5）。主要终点是方案的依从性，次要终点是无病生存期（DFS）。
结果
患者的中位年龄为 58 岁（范围 32 至 78 岁），性别比例为 68.3%男性/31.7%女性。48 例（58.5%）患者分期为 II 期，34 例（41.5%）患者分期为 IIIA 期。70 例（85.4%）患者在 12 周内完成了 4 个周期的治疗。停止治疗的原因包括：患者拒绝（n=10）；严重不良事件（n=1）；和手术并发症（n=1）。主要的 3 至 4 级不良反应为血液学毒性：中性粒细胞减少症（13.4%）；白细胞减少症（7.3%）；贫血（3.7%）；血小板减少症（2.4%）。非血液学不良反应较轻。未观察到治疗相关死亡。II 期和 IIIA 期患者的中位 DFS 分别为 38.0 个月（95%置信区间（CI）：28.1 至 47.9 个月）和 21.0 个月（95%CI：13.7 至 28.3 个月）。
结论
在接受手术治疗的非鳞状 NSCLC 患者中，辅助 PC 化疗是一种可接受的方案。
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