Lessons learned: Weekly nanoparticle albumin-bound-paclitaxel (75 mg/m2) in combination with carboplatin (area under the curve 6 mg/mL/min) in elderly patients with previously untreated, advanced non-small cell lung cancer showed favorable efficacy, was well tolerated, and showed less neuropathic toxicity.This modified regimen offers potential for the treatment of elderly patients.
Background: The CA031 trial suggested weekly nanoparticle albumin-bound-paclitaxel (nab-PTX) was superior in efficacy to paclitaxel (PTX) once every 3 weeks when combined with carboplatin (CBDCA) for advanced non-small cell lung cancer (NSCLC) patients; a subgroup analysis of elderly patients looked promising. In a multicenter phase II trial, we prospectively evaluated the efficacy and tolerability of modified CBDCA plus weekly nab-PTX for elderly patients with untreated advanced NSCLC.
Methods: Eligible patients received CBDCA (area under the curve [AUC] 6 mg/mL/min) on day 1 and nab-PTX (75 mg/m2) on days 1, 8, and 15 every 4 weeks. The primary endpoint was an overall response rate (ORR), and secondary endpoints were progression-free survival (PFS), overall survival (OS), and toxicity.
Results: Of 32 patients (median age of 78 years), 84% were male, 56% had stage IV NSCLC, and 56% had squamous cell carcinoma. ORR and disease control rates were 50% (95% confidence interval (CI): 33-67) and 94% (95% CI: 85-100), respectively. Median PFS and OS were 6.4 months (95% CI: 4.8-8.0) and 17.5 months (95% CI: 11.9-23.1), respectively. Grade ≥3 toxicities were neutropenia (47%), leukopenia (38%), anemia (34%), thrombocytopenia (25%), and anorexia (9%). Febrile neutropenia and treatment-related deaths were not observed.
Conclusion: Modified CBDCA plus weekly nab-PTX demonstrated significant efficacy and acceptable toxicities in elderly patients with advanced NSCLC.
经验总结
• 白蛋白结合型紫杉醇纳米颗粒（75 mg/m2）每周一次给药联合卡铂（曲线下面积6 mg/mL/min）治疗既往未经治疗的晚期非小细胞肺癌老年患者时疗效和耐受性良好, 且神经毒性较低。
• 这一改良方案在老年患者的治疗中具有潜在应用价值。
摘要
背景. CA031试验表明, 与卡铂（CBDCA）联合治疗晚期非小细胞肺癌（NSCLC）患者时, 白蛋白结合型紫杉醇纳米颗粒（nab‐PTX, 每周一次）的疗效优于紫杉醇（PTX, 每3周一次）；老年患者的亚组分析显示该方案前景良好。在一项多中心II期试验中, 我们前瞻性评价了CBDCA联合每周一次nab‐PTX改良方案治疗未经治疗的晚期NSCLC老年患者的疗效和耐受性。
方法. 合格患者在每4周的第1天接受CBDCA[曲线下面积（AUC）6 mg/mL/min], 并在第1、8和15天接受nab‐PTX（75 mg/m2）。主要终点为总缓解率（ORR）, 次要终点为无进展生存期（PFS）、总生存期（OS）和毒性。
结果. 32例患者（中位年龄78岁）中有84%为男性, 56%患有IV期NSCLC, 56%患有鳞状细胞癌。ORR和疾病控制率分别为50%[95%置信区间（CI）：33‐67]和94%（95% CI：85‐100）。中位PFS和OS分别为6.4个月（95% CI：4.8‐8.0）和17.5个月（95% CI：11.9‐23.1）。≥3级毒性包括中性粒细胞减少症（47%）、白细胞减少症（38%）、贫血（34%）、血小板减少症（25%）和厌食（9%）。未观察到发热性中性粒细胞减少症和治疗相关死亡。
结论. CBDCA联合每周一次nab‐PTX改良方案在晚期NSCLC老年患者中表现出显著的疗效和可接受的毒性。The Oncologist 2017;22:640–e59
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