Satoshi Oizumi1,2, Kei Takamura3, Toshiyuki Harada4, Motoko Tachihara5, Naoto Morikawa6, Ryoichi Honda7, Satoshi Watanabe8, Tetsuhiko Asao9, Mamoru Kunisaki10, Tatsuro Fukuhara11, Rintaro Noro12, Eiki Kikuchi13, Yasuhiro Tsutani14, Toshiyuki Tenma15, Kunihiko Kobayashi16, Hirotoshi Dosaka-Akita13. 1. Department of Respiratory Medicine, National Hospital Organization Hokkaido Cancer Center, 3-54 Kikusui 4-2 Shiroishi-ku, Sapporo, 003-0804, Japan. soizumi@hokkaido.med.or.jp. 2. Hokkaido University Graduate School of Medicine, Sapporo, Japan. soizumi@hokkaido.med.or.jp. 3. Obihiro Kousei Hospital, Obihiro, Japan. 4. JCHO Hokkaido Hospital, Sapporo, Japan. 5. Kobe University Graduate School of Medicine, Kobe, Japan. 6. Iwate Medical University School of Medicine, Morioka, Japan. 7. Sapporo Higashi Tokusyukai Hospital, Sapporo, Japan. 8. Niigata University Medical and Dental Hospital, Niigata, Japan. 9. Juntendo University, Graduate School of Medicine, Tokyo, Japan. 10. Department of Respiratory Medicine, National Hospital Organization Hokkaido Cancer Center, 3-54 Kikusui 4-2 Shiroishi-ku, Sapporo, 003-0804, Japan. 11. Miyagi Cancer Center, Natori, Japan. 12. Nippon Medical School, Graduate School of Medicine, Tokyo, Japan. 13. Hokkaido University Graduate School of Medicine, Sapporo, Japan. 14. Hiroshima University, Hiroshima, Japan. 15. Asahikawa Medical University Hospital, Asahikawa, Japan. 16. Saitama Medical University International Medical Center, Hidaka, Japan.
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).
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).
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