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World J Respirol. Mar 28, 2014; 4(1): 1-7
Published online Mar 28, 2014. doi: 10.5320/wjr.v4.i1.1
Phase II trial of carboplatin/docetaxel in patients with resected NSCLC
Hidetaka Uramoto, Ryoichi Nakanishi, Akihiko Uchiyama, Masaaki Inoue, Masakazu Sugaya, Teruo Iwata, Noriyuki Ebi, Takeshi Hanagiri, Fumihiro Tanaka
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
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.
