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Phase II Trial of Preoperative Chemoradiotherapy Followed by Surgical Resection in Patients With Superior Sulcus Non–Small-Cell Lung Cancers: Report of Japan Clinical Oncology Group Trial 9806

Hideo Kunitoh, Harubumi Kato, Masahiro Tsuboi, Taro Shibata, Hisao Asamura, Yukito Ichonose, Nobuyuki Katakami, Kanji Nagai, Tetsuya Mitsudomi, Akihide Matsumura, Ken Nakagawa, Hirohito Tada, Nagahiro Saijo

From the Department of Medical Oncology and Division of Thoracic Surgery, National Cancer Center Hospital; Department of Thoracic Surgery, Tokyo Medical University; Japan Clinical Oncology Group Data Center, Center for Cancer Control and Information Services, National Cancer Center; Department of Thoracic Surgery, Cancer Institute Hospital, Tokyo; Department of Chest Surgery, National Kyushu Cancer Center, Fukuoka; Pulmonary Unit, Kobe City Medical Center General Hospital, Kobe; Department of Thoracic Surgery, National Cancer Center Hospital East, Kashiwa; Department of Thoracic Surgery, Aichi Cancer Center Hospital, Nagoya; Department of Surgery, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai; and Department of Thoracic Surgery, Osaka City General Hospital, Osaka, Japan

Corresponding author: Hideo Kunitoh, MD, Department of Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan; e-mail: hkkunito{at}ncc.go.jp

Purpose: To evaluate the safety and efficacy of preoperative chemoradiotherapy followed by surgical resection for superior sulcus tumors (SSTs).

Patients and Methods: Patients with pathologically documented non–small-cell lung cancer with invasion of the first rib or more superior chest wall were enrolled as eligible; those with distant metastasis, pleural dissemination, and/or mediastinal node involvement were excluded. Patients received two cycles of chemotherapy every 4 weeks as follows; mitomycin 8 mg/m² on day 1, vindesine 3 mg/m² on days 1 and 8, and cisplatin 80 mg/m² on day 1. Radiotherapy directed at the tumor and the ipsilateral supraclavicular nodes was started on day 2 of each course, at the total dose of 45 Gy in 25 fractions, with a 1-week split. Thoracotomy was undertaken 2 to 4 weeks after completion of the chemoradiotherapy. Those with unresectable disease received boost radiotherapy.

Results: From May 1999 to November 2002, 76 patients were enrolled, of whom 20 had T4 disease; 75 patients were fully assessable. Chemoradiotherapy was generally well tolerated. Fifty-seven patients (76%) underwent surgical resection, and pathologic complete resection was achieved in 51 patients (68%). There were 12 patients with pathologic complete response. Major postoperative morbidity, including chylothorax, empyema, pneumonitis, adult respiratory distress syndrome, and bleeding, was observed in eight patients. There were three treatment-related deaths, including two deaths owing to postsurgical complications and one death owing to sepsis during chemoradiotherapy. The disease-free and overall survival rates at 3 years were 49% and 61%, respectively; at 5 years, they were 45% and 56%, respectively.

Conclusion: This trimodality approach is safe and effective for the treatment of patients with SSTs.

Supported by the Grant-in-Aid for Cancer Research from the Ministry of Health, Labour and Welfare of Japan (Grants No. 11S-2, 11S-4, 14S-2, 14S-4, 17S-2, and 17S-5).

Presented in part at the 39th Annual Meeting of the American Society of Clinical Oncology, May 31-June 3, 2003, Chicago, IL, and at the 11th World Conference on Lung Cancer, July 3-6, 2005, Barcelona, Spain.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.