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J Thorac Cardiovasc Surg 2002;123:695-699
© 2002 The American Association for Thoracic Surgery

General Thoracic Surgery (GTS)

A prematurely terminated phase III trial of intraoperative intrapleural hypotonic cisplatin treatment in patients with resected non-small cell lung cancer with positive pleural lavage cytology: The incidence of carcinomatous pleuritis after surgical intervention

From the National Kyushu Cancer Center,^a Fukuoka; National Cancer Center Hospital,^b Tokyo; Niigata Cancer Center Hospital,^c Niigata; Osaka Prefectural Habikino Hospital,^d Osaka; National Kure Hospital,^e Hiroshima; Osaka City General Hospital,^f Osaka; Kitazato University,^g School of Medicine, Kanagawa; Aichi Cancer Center Hospital,^h Aichi; Cancer Institute Hospital,ⁱ Tokyo; Tochigi Cancer Center,^j Tochigi; and Tokyo Medical University,^k Tokyo, Japan.

Supported by a Grant-in-Aid (S11-2) for Cancer Research from the Ministry of Health and Welfare, Japan.

Received for publication June 1, 2001. Revisions requested Aug 28, 2001; revisions received Sept 24, 2001. Accepted for publication Oct 2, 2001. Address for reprints: Yukito Ichinose, MD, Department of Chest Surgery, National Kyushu Cancer Center, 3-1-1, Notame, Minami-ku, Fukuoka 811-1395, Japan (E-mail: yichinos{at}nk-cc.go.jp).

Background: The prognosis of patients with resected non-small cell lung cancer without carcinomatous pleuritis whose intrapleural cancer cells were detected by means of a cytologic examination of pleural lavage fluid obtained immediately after a thoracotomy has been reported to be poor.
Methods: The Japan Clinical Oncology Group conducted a phase III trial for a 3-year period starting from October 1994 to determine whether intraoperative intrapleural hypotonic cisplatin treatment could effectively control pleural disease and thereby prolong the survival of these patients. The patients were randomized to receive either intraoperative intrapleural hypotonic cisplatin treatment or no treatment before closure of the open thorax. The intraoperative intrapleural hypotonic cisplatin treatment consisted of exposing the entire thorax to cisplatin (50 µg/mL) in distilled water for 15 minutes.
Results: Because of the slow registration pace, the study was prematurely terminated in January 1998. During the 41-month period from the start of the registration, 49 patients were entered into the study, and all were eligible. Twenty-five and 24 patients were randomly assigned to the treatment and control groups, respectively. No statistically significant difference in the overall survival and disease-free survival between the 2 groups was observed. However, the appearance of carcinomatous pleuritis was suppressed by the hypotonic cisplatin treatment (42% of the control group vs 8% of the treatment group, P = .008).
Conclusions: Although the randomized trial was prematurely terminated, the intraoperative intrapleural hypotonic cisplatin treatment was found to effectively suppress the appearance of carcinomatous pleuritis in resected patients who demonstrated a positive pleural lavage cytology finding.

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