Kolek Vítězslav, Grygárková Ivona, Koubková Leona, Skřičková Jana, Švecová Jiřina, Sixtová Dimka, Bartoš Jiří, Tichopád Aleš
Department of Respiratory Medicine, University Hospital, Olomouc, Czech Republic.
Department of Pneumology, University Hospital, Praha-Motol, Czech Republic.
PLoS One. 2017 Jul 21;12(7):e0181803. doi: 10.1371/journal.pone.0181803. eCollection 2017.
Adjuvant cisplatin-based chemotherapy is recommended for routine use in patients with Stage IIA, IIB or IIIA non-small cell lung cancer (NSCLC) after complete resection. Results obtained for Stage IB were not conclusive. While vinorelbine plus cisplatin is the preferred choice after resection, combining vinorelbine with carboplatin promises improved compliance and delivery of drugs due to lower toxicity. We evaluated the impact of this option on treatment compliance and survival under real-world conditions.
A prospective, single-arm, multicenter, non-interventional study evaluated the tolerability, dose intensity and survival resulting from adjuvant use of intravenous carboplatin (AUC 5 on day 1) with vinorelbine administered both intravenously (25 mg/m2 on day 1) and orally (60 mg/m2 on day 8) within four cycles of 21 days each. A total of 74 patients with a median age of 64 years were observed.
The mean number of accomplished cycles was 3.78, and 62 patients (83.7%) completed all four planned cycles. Relative dose intensity for carboplatin was 88.9%, for intravenous vinorelbine 93.1%, and for oral vinorelbine 83.2%. Median follow-up was 4.73 years. Median disease-specific survival (DSS) was 7.63 years, median overall survival (OS) was 5.90 years, median disease-free survival (DFS0) was 4.43 years, and five-year survival was 56.2%. TNM stage of disease significantly affected DSS and OS. Favorable survival was observed in females, nonsmokers, patients aged over 65 years, patient with prior lobectomy, patients with tumor of squamous histology, and those who finished the planned therapy, but the differences were non-significant.
Adjuvant carboplatin with vinorelbine switched from intravenous to oral administration was shown to be a favorable regimen with regard to tolerability and safety. Compliance to therapy was high, and survival parameters were promising, showing that applied regimen can be another potential option for adjuvant chemotherapy in patients with NSCLC.
对于完全切除后的IIA期、IIB期或IIIA期非小细胞肺癌（NSCLC）患者，推荐常规使用以顺铂为基础的辅助化疗。IB期患者的相关结果尚无定论。虽然长春瑞滨加顺铂是切除术后的首选方案，但由于毒性较低，将长春瑞滨与卡铂联合使用有望提高患者的依从性并改善药物递送。我们评估了这一方案在现实条件下对治疗依从性和生存率的影响。
一项前瞻性、单臂、多中心、非干预性研究评估了在21天为一个周期的四个周期内，静脉注射卡铂（第1天AUC 5）与长春瑞滨联合使用的耐受性、剂量强度和生存率，长春瑞滨分别通过静脉注射（第1天25 mg/m²）和口服（第8天60 mg/m²）给药。共观察了74例中位年龄为64岁的患者。
完成的平均周期数为3.78个，62例患者（83.7%）完成了所有四个计划周期。卡铂的相对剂量强度为88.9%，静脉注射长春瑞滨为93.1%，口服长春瑞滨为83.2%。中位随访时间为4.73年。中位疾病特异性生存期（DSS）为7.63年，中位总生存期（OS）为5.90年，中位无病生存期（DFS0）为4.43年，五年生存率为56.2%。疾病的TNM分期显著影响DSS和OS。在女性、不吸烟者、65岁以上患者、既往接受肺叶切除术的患者、鳞状组织学肿瘤患者以及完成计划治疗的患者中观察到较好的生存率，但差异无统计学意义。
辅助使用从静脉注射改为口服给药的卡铂与长春瑞滨联合方案，在耐受性和安全性方面表现良好。治疗依从性高，生存参数良好，表明该应用方案可能是NSCLC患者辅助化疗的另一种潜在选择。
