Aims

The approach to potentially resectable non-small cell lung cancer (NSCLC) remains controversial. There is a benefit of neoadjuvant chemotherapy (NACT), but the ideal regimen is unknown. We evaluated the efficacy and safety of dose-dense NACT in potentially resectable NSCLC in this phase II trial.

Materials and methods

Paclitaxel at 80 mg/m² on days 1, 8 and 15 with AUC-6 carboplatin on day 1, 3 weekly for four cycles was evaluated as NACT. Patients with Eastern Cooperative Oncology Group performance status 0–2, stage IIB and IIIA (with only non-bulky N2 nodes) were included. The primary end point was the objective response rate. Secondary end points included toxicity, progression-free survival, recurrence-free survival, complete resection rate and overall survival. The relative dose intensity (RDI) was calculated to define tolerability (CTRI/2016/05/006916).

Results

In total, 37 patients were enrolled (median age 55 years). Most (78.8%) were smokers. Most patients had adenocarcinoma (57.6%) and stage IIIA disease (81.0%) according to the seventh American Joint Committee on Cancer staging system. Seventy-eight per cent of patients completed four cycles. The objective response rate was 75.6% with a complete response in 10.8%. The mean RDI of paclitaxel was 88.61%, with 68.0% of patients able to maintain an RDI ≥85.0%. In total, 187 toxicity events were recorded (120 grade 1, 64 grade 2 and three grade 3 events). Common toxicities were peripheral neuropathy (20.3%), myalgia (19.8%), nausea (15.7%) and neutropenia (10.2%). There were no treatment-related deaths. Seventeen patients underwent surgery (lobectomy 82.4%). After a median follow-up of 47 months (95% confidence interval 27–50.7 months), the median progression-free survival was 9.6 months (7.4–17.4) and overall survival was 29.2 months (16.0–37.2).

Conclusion

Dose-dense paclitaxel–carboplatin is feasible, safe and efficacious and should be evaluated further in potentially resectable NSCLC.

中文翻译：

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高剂量紫杉醇和卡铂作为 IIB/IIIA 期非小细胞肺癌的新辅助化疗——一项 II 期试验

宗旨

潜在可切除的非小细胞肺癌 (NSCLC) 的方法仍然存在争议。新辅助化疗 (NACT) 有好处，但理想的方案尚不清楚。我们在这项 II 期试验中评估了剂量密集型 NACT 在可能可切除的 NSCLC 中的疗效和安全性。

材料和方法

在第1、8 和 15 天使用80 mg/m ^{2 的}紫杉醇和在第 1、3 周、4 个周期的第 1 天使用 AUC-6 卡铂评估为 NACT。东部肿瘤协作组体能状态为 0-2、IIB 和 IIIA 期（仅具有非大块 N2 淋巴结）的患者被包括在内。主要终点是客观反应率。次要终点包括毒性、无进展生存期、无复发生存期、完全切除率和总生存期。计算相对剂量强度 (RDI) 以定义耐受性 (CTRI/2016/05/006916)。

结果

总共招募了 37 名患者（中位年龄 55 岁）。大多数（78.8%）是吸烟者。根据第七届美国癌症联合委员会分期系统，大多数患者患有腺癌 (57.6%) 和 IIIA 期疾病 (81.0%)。78% 的患者完成了四个周期。客观反应率为 75.6%，完全反应率为 10.8%。紫杉醇的平均 RDI 为 88.61%，68.0% 的患者能够维持 RDI ≥ 85.0%。总共记录了 187 起毒性事件（120 起 1 级、64 起 2 级和 3 起 3 级事件）。常见的毒性为周围神经病变 (20.3%)、肌痛 (19.8%)、恶心 (15.7%) 和中性粒细胞减少 (10.2%)。没有与治疗相关的死亡。17 名患者接受了手术（肺叶切除术 82.4%）。中位随访 47 个月后（95% 置信区间 27-50.7 个月），

结论

剂量密集型紫杉醇-卡铂是可行的、安全的和有效的，应在可能可切除的 NSCLC 中进一步评估。