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Clinical Trial
. 2022 Apr;27(4):676-683.
doi: 10.1007/s10147-021-02113-5. Epub 2022 Jan 29.

Phase II study of carboplatin-paclitaxel alone or with bevacizumab in advanced sarcomatoid carcinoma of the lung: HOT1201/NEJ024

Satoshi Oizumi  1   2 , Kei Takamura  3 , Toshiyuki Harada  4 , Motoko Tachihara  5 , Naoto Morikawa  6 , Ryoichi Honda  7 , Satoshi Watanabe  8 , Tetsuhiko Asao  9 , Mamoru Kunisaki  10 , Tatsuro Fukuhara  11 , Rintaro Noro  12 , Eiki Kikuchi  13 , Yasuhiro Tsutani  14 , Toshiyuki Tenma  15 , Kunihiko Kobayashi  16 , Hirotoshi Dosaka-Akita  13 ; North East Japan Study Group, Hokkaido Lung Cancer Clinical Study Group
Affiliations
Clinical Trial

Phase II study of carboplatin-paclitaxel alone or with bevacizumab in advanced sarcomatoid carcinoma of the lung: HOT1201/NEJ024

Satoshi Oizumi et al. Int J Clin Oncol. 2022 Apr.

Abstract

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-naïve 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.

Clinical trials registration: University Hospital Medical Information Network (UMIN) Clinical Trial Registry (UMIN000008707).

Keywords: Bevacizumab; Chemotherapy; Pleomorphic carcinoma; Prognosis; Sarcomatoid carcinoma.

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