Uramoto H, Nakanishi R, Uchiyama A, Inoue M, Sugaya M, Iwata T, Ebi N, Hanagiri T, Tanaka F. Phase II trial of carboplatin/docetaxel in patients with resected NSCLC. World J Respirol 2014; 4(1): 1-7 [DOI: 10.5320/wjr.v4.i1.1]
Corresponding Author of This Article
Hidetaka Uramoto, MD, PhD, Second Department of Surgery, School of Medicine, University of Occupational and Environmental Health, 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555, Japan. hidetaka@med.uoeh-u.ac.jp
Research Domain of This Article
Oncology
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Prospective Study
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Mar 28, 2014 (publication date) through Feb 13, 2026
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Publication Name
World Journal of Respirology
ISSN
2218-6255
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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA
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Uramoto H, Nakanishi R, Uchiyama A, Inoue M, Sugaya M, Iwata T, Ebi N, Hanagiri T, Tanaka F. Phase II trial of carboplatin/docetaxel in patients with resected NSCLC. World J Respirol 2014; 4(1): 1-7 [DOI: 10.5320/wjr.v4.i1.1]
Hidetaka Uramoto, Takeshi Hanagiri, Fumihiro Tanaka, Second Department of Surgery, School of Medicine, University of Occupational and Environmental Health, Kitakyushu 807-8555, Japan
Ryoichi Nakanishi, Department of Thoracic Surgery, Shin-Kokura Hospital, Federation of National Public Service Personnel Mutual Aid Associations, Kokurakita-ku, Kitakyushu 803-0816, Japan
Akihiko Uchiyama, Department of Surgery, Kyushu Kouseinenkin Hospital, Kitakyushu 806-8501, Japan
Masaaki Inoue, Department of Chest Surgery, Shimonoseki City Hospital, Shimonoseki 750-8520, Japan
Masakazu Sugaya, Department of Chest Surgery, Chubu Rosai Hospital, Nagoya 455-0018, Japan
Teruo Iwata, Department of Thoracic Surgery, Niigata Rousai Hospital, Niigata 942-0071, Japan
Noriyuki Ebi, Department of Respiratory Medicine, Iizuka Hospital, Iizuka 820-8505, Japan
Author contributions: All the authors contributed to this work.
Supported by JPJS KAKENHI, No. 25462202; A UOEH Research Grant for Promotion of Occupational Health; Uramoto H, Hanagiri T and Tanaka F received a research grant that belongs to the institute from Sanofi-Aventis, Inc.
Correspondence to: Hidetaka Uramoto, MD, PhD, Second Department of Surgery, School of Medicine, University of Occupational and Environmental Health, 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555, Japan. hidetaka@med.uoeh-u.ac.jp
Telephone: +81-93-6917442 Fax: +81-93-6924004
Received: October 31, 2013 Revised: February 15, 2014 Accepted: February 18, 2014 Published online: March 28, 2014 Processing time: 147 Days and 2.3 Hours
Abstract
AIM: To investigate the development of a safer chemotherapeutic regimen with better compliance, a total of 67 patients were enrolled as a single arm in a two-stage multi-center phase II study.
METHODS: The patients received chemotherapy with carboplatin (CBDCA) with an area under the curve (AUC) of 5, and docetaxel (DTX) at 60 mg/m2 tri-weekly for three cycles after surgery. The primary endpoint of this study was compliance, while the secondary endpoints were the adverse events (AE) and recurrence-free survival (RFS).
RESULTS: Sixty-one patients were treated in this study arm. The patients were 43 males and 18 females, with a median age of 64.6 years. Fifty-one patients (83.6%) completed all three cycles of therapy. The presence of Grade 3 and 4 neutropenia was noted in 25% and 66% of the patients, respectively. The non-hematological AE were less frequently reported, and no treatment-related death was registered. The two-year RFS and OS rates of the 61 patients were 69.8% and 88.3%, respectively.
CONCLUSION: A tri-weekly schedule of CBDCA and DTX as adjuvant chemotherapy showed a favorable feasibility.
Core tip: Adjuvant chemotherapy with a tri-weekly schedule of carboplatin and docetaxel was feasible in Japanese non-small cell lung cancer patients. In clinical practice, this regimen represents a potential treatment option that may be superior to other regimens. The main limitation associated with this study is the small number of patients enrolled. Therefore, it is important to employ a reference arm for any future randomized clinical trials evaluating this treatment regimen.
