Phase II study of carboplatin-paclitaxel alone or with bevacizumab in advanced sarcomatoid carcinoma of the lung: HOT1201/NEJ024
Phase II study of carboplatin-paclitaxel alone or with bevacizumab in advanced sarcomatoid carcinoma of the lung: HOT1201/NEJ024
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DOI：
10.1007/s10147-021-02113-5
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发表时间：
2022-01-29
影响因子：
3.3
通讯作者：
Dosaka-Akita, Hirotoshi
中科院分区：
文献类型：
--
作者：
Oizumi, Satoshi;Takamura, Kei;Dosaka-Akita, Hirotoshi
只有少数前瞻性研究对肺肉瘤样癌（PSCs）患者进行全身化疗的有效性和安全性进行了研究。因此，迫切需要开发新的治疗策略来治疗这种罕见的肿瘤。组织学证实的PSCs首次接受化疗的患者被分配接受卡铂/紫杉醇单独（CP）或贝伐单抗（CPB），随后接受贝伐单抗维持。主要终点是总缓解率（ORR）。次要终点包括总生存期（OS）、无进展生存期（PFS）和安全性。结果由于患者累积缓慢，本研究在积累预期病例数之前就结束了。最终，16名患者入组。总有效率为25.0%，疾病控制率为56.3%。所有4例患者均给予CPB治疗，客观缓解[部分缓解（PR）]；4例PR中2例为多形性癌，2例为癌肉瘤。所有入组患者的中位PFS和中位生存时间（MST）分别为2.6个月和8.8个月。CP组的中位PFS为1.2个月，CPB组为4.2个月。CP组MST为7.9个月，CPB组MST为11.2个月。血液学和非血液学不良事件是常见的和可逆的，尽管在CPB组中各发生一例肠梗阻（4级）和鼻出血（3级）。结论CPB可作为PSCs的一线治疗方法。需要进一步的研究来阐明细胞毒性化疗在这种罕见的侵袭性肿瘤中的作用。
Objectives Only a few prospective studies have been conducted to examine the efficacy and safety of systemic chemotherapy for patients with pulmonary sarcomatoid carcinomas (PSCs). There is, thus, a crucial need to develop novel treatment strategies for this rare tumor. Patients and methods Chemotherapy-naive patients with histologically confirmed PSCs were assigned to receive either carboplatin/paclitaxel alone (CP) or with bevacizumab (CPB) followed by bevacizumab maintenance. The primary endpoint was overall response rate (ORR). Secondary endpoints included overall survival (OS), progression-free survival (PFS), and safety. Results This study was closed before accumulating the expected number of cases due to slow patient accrual. Eventually, 16 patients were enrolled. The ORR was 25.0% and disease control rate was 56.3%. CPB was administered in all four patients with an objective response [partial response (PR)]; among the four PR cases, two patients had pleomorphic carcinoma, and two had carcinosarcoma. Median PFS and median survival time (MST) in all the enrolled patients were 2.6 months and 8.8 months, respectively. Median PFS was 1.2 months in the CP group and 4.2 months in the CPB group. In addition, MST was 7.9 months in the CP group and 11.2 months in the CPB group. Hematological and non-hematological adverse events were common and reversible, although ileus (grade 4) and nasal bleeding (grade 3) occurred in one case each in the CPB group. Conclusions CPB might be effective as first-line treatment for PSCs. Further study is warranted to clarify the role of cytotoxic chemotherapy for this rare and aggressive tumor.