Phase II trial of docetaxel in previously untreated advanced non-small-cell lung cancer: a Japanese cooperative study.

PURPOSE: This phase II study was conducted to evaluate the efficacy and toxicity of moderate-dose (60 mg/m2) docetaxel in Japanese patients with previously untreated advanced (stage IIIB or IV) non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Docetaxel 60 mg/m2 was administered intravenously over 1 to 2 hours to patients with previously untreated stage IIIB or IV NSCLC. Treatment was repeated every 3 weeks. No routine premedication was given. The patients' median age was 67 years (range, 40 to 80). Forty-four patients (59%) had adenocarcinoma and 55 (73%) had stage IV disease. The median Eastern Cooperative Oncology Group (ECOG) performance status (PS) was 1. RESULTS: Seventy-five patients were eligible and treated with docetaxel. Fourteen patients (19%) achieved a partial response (PR); response was not significantly affected by histology or clinical stage. The median survival time for all patients was 297 days. The predominant toxicity was neutropenia, with 87% of patients experiencing grade 3 or 4. Febrile neutropenia was seen in eight patients. Hypersensitivity and edema each occurred in only 4% of patients and were easily manageable. There was no possible treatment-related death of acute exacerbation of pneumonitis. CONCLUSION: Docetaxel 60 mg/m2 showed significant activity in advanced NSCLC, with a low incidence of hypersensitivity or peripheral edema. Further investigation of this agent in NSCLC is warranted, especially in combination with other active drugs.

[Late phase II trial of RP56976 (Docetaxel) in patients with non-small-cell lung cancer].

A late phase II trial on RP 56976 (Docetaxel) was carried out against stage IIIB or IV non-resectable non-small cell lung cancer as a multicenter cooperative trial. Of 78 enrolled patients, seventy five patients were eligible and 71 were evaluable for the response. The overall response rate was 19.7% (14/71): 27.9% (12/48) of patients with adenocarcinoma and 10.0% (2/20) of patients with squamous cell carcinoma responded to docetaxel. The response rate was 15.0% (3/20) in patients with stage III B disease and 21.6% (11/51) in patients with stage IV disease. Leukopenia (neutropenia) occurred frequently, but most tended to recover in a short period of time. Other adverse reactions included nausea/vomiting, anorexia, general malaise, alopecia, all of which were not severe. Severe hypersensitivity reactions occurred in 2 patients (2.7%). The results seemed to show usefulness of docetaxel for the treatment of patients with non-small cell lung cancer.

[A clinical phase III trial of ulinastatin (MR-20) for nephrotoxicity of cisplatin].

UNLABELLED: MR-20 was administered to 140 lung cancer patients who presented with nephrotoxicity due to cisplatin (CDDP) treatment at 59 institutions throughout Japan during the period from September 1992 through March 1994 to study its suppressive effect on the nephrotoxicity as well as its safety. The results are reported in this paper. METHODS: The efficacy and usefulness of MR-20 were studied in a placebo-controlled, double-blind manner. An efficacy rate of 58.7% was achieved in the MR-20 group, and 36.8% in the placebo group: MR-20 was significantly more effective for nephrotoxicity than placebo (U-test). Serum Cr, Ccr and FENa were prevented from significant variations in the MR-20 group, compared with the control group. It was considered that MR-20 is a safe drug, and that it is useful in suppressing the nephrotoxicity of CDDP treatment.