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白蛋白结合型紫杉醇联合卡铂作为潜在可切除肺鳞状细胞癌新辅助治疗的疗效和安全性:一项真实世界回顾性队列研究。

The efficacy and safety of albumin-bound paclitaxel plus carboplatin as neoadjuvant therapy for potentially resectable lung squamous cell carcinoma: a real-world retrospective cohort study.

作者信息

Jiang Wenjuan, Zhou Yuling, Zeng Liang, Xiong Yi, Liu Li, Zhou Chunhua, Yang Haiyan, Guo Hui, Minervini Fabrizio, Bongiolatti Stefano, Yang Nong, Zhang Yongchang, Tao Min

机构信息

Department of Oncology, The First Affiliated Hospital of Soochow University, Suzhou, China.

Department of Oncology, Dushu Lake Hospital Affiliated to Soochow University, Suzhou, China.

出版信息

Transl Lung Cancer Res. 2022 Apr;11(4):647-655. doi: 10.21037/tlcr-22-252.

Abstract

BACKGROUND

In early and locally advanced stage non-small-cell lung cancer (NSCLC), surgery is the cornerstone of curative-intent treatments. And the addition of neoadjuvant or adjuvant chemotherapy can prolong overall survival (OS), albumin-bound paclitaxel plus carboplatin (ab-PC) as neoadjuvant therapy (NAT) has showed favorable effect for resectable lung squamous cell carcinoma (LSCC) with IIIA. However, to date, no study has investigated the efficacy of ab-PC as neoadjuvant chemotherapy in potentially resectable LSCC with IIIA-IIIB. This study aimed to evaluate the efficacy and safety of the regimen in potentially resectable LSCC.

METHODS

Enrolled patients with stage IIIA and IIIB potentially resectable LSCC treated with neoadjuvant albumin-bound paclitaxel (nab-P; 100 mg/m, days 1, 8, and 15) and carboplatin (6 mg/mL/min, day 1) for two 21-day cycles at the Hunan Cancer Hospital between December 2017 and December 2019. The primary endpoint was the surgery conversion rate (SCR). Secondary endpoints included objective response rate (ORR), margin-free (R0) resection, major pathological response (mPR), and safety.

RESULTS

In total, 49 patients were included in the study, with an overall response rate (ORR) of 67% (33/49). The SCR was 67% (33/49). Only 31 patients underwent surgery eventually, and R0 resection was achieved in 30 patients. Further, 4 (13%) and 11 (35%) of the 31 patients had a pathological complete response (pCR) and mPR, respectively. In total, 23 patients experienced treatment-related adverse events (TRAEs). The most common TRAE was liver disfunction (9 patients, 18%). Only 1 patient (2%) experienced a grade ≥3 TRAE of leukopenia. There were no treatment-related deaths or treatment discontinuations.

CONCLUSIONS

In this study, we found a high SCR (67%) and mPR (35%) after ab-PC treatment for stage IIIA and IIIB potentially resectable LSCC. ab-PC maybe considered a neoadjuvant chemotherapy option for potentially resectable LSCC patients.

摘要

背景

在早期和局部晚期非小细胞肺癌(NSCLC)中,手术是根治性治疗的基石。新辅助或辅助化疗的加入可延长总生存期(OS),白蛋白结合型紫杉醇联合卡铂(ab-PC)作为新辅助治疗(NAT)已显示出对可切除的IIIA期肺鳞状细胞癌(LSCC)有良好疗效。然而,迄今为止,尚无研究调查ab-PC作为新辅助化疗在潜在可切除的IIIA-IIIB期LSCC中的疗效。本研究旨在评估该方案在潜在可切除的LSCC中的疗效和安全性。

方法

纳入2017年12月至2019年12月在湖南省肿瘤医院接受新辅助白蛋白结合型紫杉醇(nab-P;100mg/m²,第1、8和15天)和卡铂(6mg/mL/min,第1天)治疗两个21天周期的IIIA期和IIIB期潜在可切除LSCC患者。主要终点是手术转化率(SCR)。次要终点包括客观缓解率(ORR)、无瘤(R0)切除、主要病理缓解(mPR)和安全性。

结果

本研究共纳入49例患者,总缓解率(ORR)为67%(33/49)。SCR为67%(33/49)。最终仅31例患者接受了手术,其中30例实现了R0切除。此外,31例患者中分别有4例(13%)和11例(35%)达到病理完全缓解(pCR)和mPR。共有23例患者发生了治疗相关不良事件(TRAEs)。最常见的TRAEs是肝功能障碍(9例,18%)。仅1例患者(2%)发生了≥3级的白细胞减少TRAEs。没有治疗相关死亡或治疗中断。

结论

在本研究中,我们发现ab-PC治疗后,IIIA期和IIIB期潜在可切除LSCC的SCR(67%)和mPR(35%)较高。ab-PC可被视为潜在可切除LSCC患者的一种新辅助化疗选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d460/9073738/640de9b4d8cc/tlcr-11-04-647-f1.jpg

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