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

• Published in: International journal of clinical oncology 2022-04, Vol.27 (4), p.676-683
• Main Authors: Oizumi, Satoshi, Takamura, Kei, Harada, Toshiyuki, Tachihara, Motoko, Morikawa, Naoto, Honda, Ryoichi, Watanabe, Satoshi, Asao, Tetsuhiko, Kunisaki, Mamoru, Fukuhara, Tatsuro, Noro, Rintaro, Kikuchi, Eiki, Tsutani, Yasuhiro, Tenma, Toshiyuki, Kobayashi, Kunihiko, Dosaka-Akita, Hirotoshi
• Format: Article
• Language: English
• Subjects: Antineoplastic Combined Chemotherapy Protocols - adverse effects; Bevacizumab; Bevacizumab - adverse effects; Cancer Research; Carboplatin; Carboplatin - adverse effects; Carcinoma; Carcinoma - drug therapy; Chemotherapy; Clinical trials; Cytotoxicity; Disease control; Hematology; Humans; Lung cancer; Lung carcinoma; Lung Neoplasms - drug therapy; Lung Neoplasms - pathology; Medicine; Medicine & Public Health; Monoclonal antibodies; Oncology; Original Article; Paclitaxel; Paclitaxel - adverse effects; Patients; Prospective Studies; Surgical Oncology; Survival; Targeted cancer therapy; Tumors; UMIN; UMIN000008707
• ISSN: 1341-9625; 1437-7772
• DOI: 10.1007/s10147-021-02113-5

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).