PDF(Pubmed)
Abstract：
UNASSIGNED: Patients with small cell lung cancer (SCLC) often respond to first-line chemoimmunotherapy. However, relapse is inevitable and is associated with a poor prognosis. Treatments for relapsed SCLC, such as lurbinectedin and topotecan, are limited by modest efficacy and significant hematologic adverse events, leaving a need for newer therapeutic agents or regimens. The combination of gemcitabine and nab-paclitaxel is active and safe in other types of malignancies, such as pancreatic cancer.
UNASSIGNED: We conducted a phase II trial evaluating the efficacy and safety of gemcitabine and nab-paclitaxel in patients with relapsed/refractory SCLC. The primary endpoint was objective response rate (ORR), defined as the proportion of patients with confirmed complete or partial response. Secondary endpoints included time to progression (TTP), progression-free survival (PFS), overall survival (OS), and safety.
UNASSIGNED: Between October 2016 and May 2021, 32 patients were enrolled. Patients were followed for a median of 9.3 months (range 1.8-65.2). Median age was 65 years (range 48-81). Fifty percent of patients were female. Fifty-three percent of patients had platinum-resistant/refractory relapsed SCLC. The ORR was 28.1% (95% confidence interval [CI] 15.5-100%). Median PFS was 2.9 months (95% CI 2.4-3.6), and median OS was 9.3 months (95% CI 5.2-12.4). Seven patients (21.9%) developed grade 3 or 4 neutropenia.
UNASSIGNED: Our study showed that the combination of gemcitabine and nab-paclitaxel led to encouraging outcomes in relapsed/refractory SCLC. Further studies are needed to compare this combination with other treatments used for relapsed SCLC, including lurbinectedin, temozolomide, and topotecan.
UNASSIGNED: https://clinicaltrials.gov/study/NCT02769832?cond=NCT02769832&rank=1, identifier NCT02769832.
UNASSIGNED: We conducted a phase II trial evaluating the efficacy and safety of gemcitabine and nab-paclitaxel in patients with relapsed/refractory SCLC. The primary endpoint was objective response rate (ORR), defined as the proportion of patients with confirmed complete or partial response. Secondary endpoints included time to progression (TTP), progression-free survival (PFS), overall survival (OS), and safety.
UNASSIGNED: Between October 2016 and May 2021, 32 patients were enrolled. Patients were followed for a median of 9.3 months (range 1.8-65.2). Median age was 65 years (range 48-81). Fifty percent of patients were female. Fifty-three percent of patients had platinum-resistant/refractory relapsed SCLC. The ORR was 28.1% (95% confidence interval [CI] 15.5-100%). Median PFS was 2.9 months (95% CI 2.4-3.6), and median OS was 9.3 months (95% CI 5.2-12.4). Seven patients (21.9%) developed grade 3 or 4 neutropenia.
UNASSIGNED: Our study showed that the combination of gemcitabine and nab-paclitaxel led to encouraging outcomes in relapsed/refractory SCLC. Further studies are needed to compare this combination with other treatments used for relapsed SCLC, including lurbinectedin, temozolomide, and topotecan.
UNASSIGNED: https://clinicaltrials.gov/study/NCT02769832?cond=NCT02769832&rank=1, identifier NCT02769832.
摘要：
■小细胞肺癌（SCLC）患者通常对一线化学免疫疗法有反应。然而,复发是不可避免的，并且与不良预后相关。复发性SCLC的治疗，比如lurbinectedin和topotecan,受到适度疗效和显著血液学不良事件的限制，留下需要更新的治疗剂或方案。吉西他滨和nab-紫杉醇的组合在其他类型的恶性肿瘤中具有活性和安全性，比如胰腺癌。
■我们进行了一项II期试验，评估了吉西他滨和nab-紫杉醇对复发/难治性SCLC患者的疗效和安全性。主要终点是客观缓解率（ORR），定义为确认完全或部分缓解的患者比例。次要终点包括进展时间（TTP），无进展生存期（PFS），总生存期（OS），和安全。
■在2016年10月至2021年5月期间，共招募了32名患者。随访患者的中位数为9.3个月（范围1.8-65.2）。中位年龄为65岁（范围48-81）。50%的患者是女性。53％的患者患有铂耐药/难治性复发性SCLC。ORR为28.1%（95%置信区间[CI]15.5-100%）。中位PFS为2.9个月（95%CI2.4-3.6），中位OS为9.3个月（95%CI5.2-12.4）。7名患者（21.9%）出现3或4级中性粒细胞减少症。
■我们的研究表明，吉西他滨和nab-紫杉醇的组合导致复发/难治性SCLC的令人鼓舞的结果。需要进一步的研究来比较这种组合与其他用于复发性SCLC的治疗方法。包括lurbinectedin,替莫唑胺,还有托普替康.
■https://clinicaltrials.gov/study/NCT02769832?cond=NCT02769832&rank=1，标识符NCT02769832。
■我们进行了一项II期试验，评估了吉西他滨和nab-紫杉醇对复发/难治性SCLC患者的疗效和安全性。主要终点是客观缓解率（ORR），定义为确认完全或部分缓解的患者比例。次要终点包括进展时间（TTP），无进展生存期（PFS），总生存期（OS），和安全。
■在2016年10月至2021年5月期间，共招募了32名患者。随访患者的中位数为9.3个月（范围1.8-65.2）。中位年龄为65岁（范围48-81）。50%的患者是女性。53％的患者患有铂耐药/难治性复发性SCLC。ORR为28.1%（95%置信区间[CI]15.5-100%）。中位PFS为2.9个月（95%CI2.4-3.6），中位OS为9.3个月（95%CI5.2-12.4）。7名患者（21.9%）出现3或4级中性粒细胞减少症。
■我们的研究表明，吉西他滨和nab-紫杉醇的组合导致复发/难治性SCLC的令人鼓舞的结果。需要进一步的研究来比较这种组合与其他用于复发性SCLC的治疗方法。包括lurbinectedin,替莫唑胺,还有托普替康.
■https://clinicaltrials.gov/study/NCT02769832?cond=NCT02769832&rank=1，标识符NCT02769832。
