caa a22 4500 605491267 CHVBK 20210128100509.0 cr unu---uuuuu 210128e20150801xx s 000 0 eng 10.1007/s10147-014-0755-6 doi (NATIONALLICENCE)springer-10.1007/s10147-014-0755-6 Phase II study of carboplatin, docetaxel and bevacizumab for chemotherapy-naïve patients with advanced non-squamous non-small cell lung cancer [Elektronische Daten] [Yuichi Takiguchi, Shunichiro Iwasawa, Koichi Minato, Yosuke Miura, Akihiko Gemma, Rintaro Noro, Kozo Yoshimori, Masato Shingyoji, Mitsunori Hino, Masahiro Ando, Hiroaki Okamoto] Purpose: To evaluate a 3-drug combination of carboplatin, docetaxel and bevacizumab as a front-line chemotherapy for patients with advanced non-squamous non-small cell carcinoma (NSCLC), a single arm phase II study was conducted. Methods: Patients with stage IIIB/IV or postoperative recurrent non-squamous NSCLC were treated with carboplatin (targeted area under the curve of 6mgh/L), docetaxel (60mg/m2), and bevacizumab (15mg/kg) on day 1, repeated every 3weeks for 4 to 6 cycles, followed by maintenance with bevacizumab every 3weeks until disease progression or occurrence of predefined toxicity. The planned patient number was 40, and the primary endpoint was progression free survival (PFS) as assessed by independent reviewers. Results: One patient refused the treatment after enrollment; thus, 39 patients were treated and analyzed. The 3-drug therapy was delivered for a median of 4 cycles, and 54% of the patients proceeded to the maintenance therapy for a median of 4 cycles. The overall response rate was 74.4% (29/39), with a 95% confidence interval (CI) of 60.0 to 88.7%. The median PFS and overall survival (OS) were 6.2months (95% CI, 4.8-8.5months) and 22.4months (95% CI, 11.3-26.2months), respectively. Toxicities of grade 3 or higher included neutropenia in 71.8%, febrile neutropenia in 23.1%, and hypertension in 38.5% of the patients, but they were transient and manageable. Conclusion: The primary endpoint was met. The regimen yielded promising results with an excellent overall response rate, PFS, and OS for chemotherapy-naïve patients with advanced non-squamous NSCLC. Further studies are warranted. Japan Society of Clinical Oncology, 2014 Non-squamous nationallicence Non-small cell lung carcinoma nationallicence Bevacizumab nationallicence Docetaxel nationallicence Carboplatin nationallicence Phase II study nationallicence Takiguchi Yuichi Department of Medical Oncology, Graduate School of Medicine, Chiba University, 1-8-1, Inohana, 260-8670, Chuo-ku, Chiba, Japan aut Iwasawa Shunichiro Department of Medical Oncology, Graduate School of Medicine, Chiba University, 1-8-1, Inohana, 260-8670, Chuo-ku, Chiba, Japan aut Minato Koichi Department of Respiratory Medicine, Gunma Prefectural Cancer Center, 617-1, Takabayashinishi, 373-8550, Ohta, Japan aut Miura Yosuke Department of Respiratory Medicine, Gunma Prefectural Cancer Center, 617-1, Takabayashinishi, 373-8550, Ohta, Japan aut Gemma Akihiko Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, 1-1-5, Sendagi, 113-8602, Bunnkyo-ku, Tokyo, Japan aut Noro Rintaro Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, 1-1-5, Sendagi, 113-8602, Bunnkyo-ku, Tokyo, Japan aut Yoshimori Kozo Department of Respiratory Medicine, Anti-tuberculosis Association Fukujuji Hospital, 3-1-24, Matsuyama, 204-8522, Kiyose, Tokyo, Japan aut Shingyoji Masato Department of Thoracic Disease, Chiba Cancer Center, 666-2, Nitona, 260-8717, Chuo-ku, Chiba, Japan aut Hino Mitsunori Respiratory Disease Center, INBAHITEC Medical Center, Nippon Medical School Chiba Hokusoh Hospital, 1715, Kamagari, 270-1694, Inzai, Chiba, Japan aut Ando Masahiro Division of Cancer Chemotherapy, Tsuboi Cancer Center Hospital, 1-10-13, Nagakubo, Azumi, 963-0197, Kouriyama, Japan aut Okamoto Hiroaki Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, 56, Okazawa, Hodogaya-ku, 240-8555, Yokohama, Japan aut International Journal of Clinical Oncology Springer Japan 20/4(2015-08-01), 659-667 1341-9625 20:4<659 2015 20 10147 https://doi.org/10.1007/s10147-014-0755-6 text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s10147-014-0755-6 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Takiguchi Yuichi Department of Medical Oncology, Graduate School of Medicine, Chiba University, 1-8-1, Inohana, 260-8670, Chuo-ku, Chiba, Japan aut NATIONALLICENCE 700 1- Iwasawa Shunichiro Department of Medical Oncology, Graduate School of Medicine, Chiba University, 1-8-1, Inohana, 260-8670, Chuo-ku, Chiba, Japan aut NATIONALLICENCE 700 1- Minato Koichi Department of Respiratory Medicine, Gunma Prefectural Cancer Center, 617-1, Takabayashinishi, 373-8550, Ohta, Japan aut NATIONALLICENCE 700 1- Miura Yosuke Department of Respiratory Medicine, Gunma Prefectural Cancer Center, 617-1, Takabayashinishi, 373-8550, Ohta, Japan aut NATIONALLICENCE 700 1- Gemma Akihiko Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, 1-1-5, Sendagi, 113-8602, Bunnkyo-ku, Tokyo, Japan aut NATIONALLICENCE 700 1- Noro Rintaro Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, 1-1-5, Sendagi, 113-8602, Bunnkyo-ku, Tokyo, Japan aut NATIONALLICENCE 700 1- Yoshimori Kozo Department of Respiratory Medicine, Anti-tuberculosis Association Fukujuji Hospital, 3-1-24, Matsuyama, 204-8522, Kiyose, Tokyo, Japan aut NATIONALLICENCE 700 1- Shingyoji Masato Department of Thoracic Disease, Chiba Cancer Center, 666-2, Nitona, 260-8717, Chuo-ku, Chiba, Japan aut NATIONALLICENCE 700 1- Hino Mitsunori Respiratory Disease Center, INBAHITEC Medical Center, Nippon Medical School Chiba Hokusoh Hospital, 1715, Kamagari, 270-1694, Inzai, Chiba, Japan aut NATIONALLICENCE 700 1- Ando Masahiro Division of Cancer Chemotherapy, Tsuboi Cancer Center Hospital, 1-10-13, Nagakubo, Azumi, 963-0197, Kouriyama, Japan aut NATIONALLICENCE 700 1- Okamoto Hiroaki Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, 56, Okazawa, Hodogaya-ku, 240-8555, Yokohama, Japan aut NATIONALLICENCE 773 0- International Journal of Clinical Oncology Springer Japan 20/4(2015-08-01), 659-667 1341-9625 20:4<659 2015 20 10147