Japanese Journal of Clinical Oncology Advance Access originally published online on August 14, 2009
Japanese Journal of Clinical Oncology 2009 39(11):720-726; doi:10.1093/jjco/hyp089
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© The Author (2009). Published by Oxford University Press. All rights reserved
Multicenter Phase II Trial of Combination Therapy with Meloxicam, a COX-2 Inhibitor, and Natural Interferon-
for Metastatic Renal Cell Carcinoma
1 Department of Renal and Genitourinary Surgery, Graduate School of Medicine, Hokkaido University
2 Department of Urology, Teine Keijinkai Hospital, Sapporo
3 Department of Urology, Asahikawa City Hospital, Hokkaido, Japan
For reprints and all correspondence: Nobuo Shinohara, Department of Renal and Genitourinary Surgery, Hokkaido University Graduate School of Medicine, North-15, West-7, Kitaku, Sapporo 060-8638, Japan. E-mail: nozomis{at}mbj.nifty.com
Received May 10, 2009; accepted July 7, 2009
Objective: We conducted a Phase II trial to investigate the efficacy of combined therapy with meloxicam, a cyclooxygenase-2 inhibitor and natural interferon (IFN)-
in renal cell carcinoma patients with distant metastasis.
Methods: The subjects of this study were patients with untreated renal cell carcinoma who were diagnosed from the results of imaging or pathological studies and who had measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST). Patients could be enrolled in the study irrespective of whether nephrectomy had been performed. Treatment involved the subcutaneous injection of natural IFN- at 3 x 106 or 5 x 106 U three times weekly plus oral administration of meloxicam at 10 mg once daily.
Results: A total of 43 patients were enrolled in the present study, included 11 patients without nephrectomy, 23 patients with a high C-reactive protein (CRP) level and 23 patients with extrapulmonary metastasis. Four patients of complete response and 12 patients of partial response were confirmed, given an overall response rate of 37.2% (95% confidence interval, 23.0–53.3%). Stable disease for 6 months or longer was also obtained in 14 patients. The median time to progression was 14 months. Adverse events (AEs) observed were mainly flu-like symptoms due to cytokine. Although the Grade 3 or 4 AEs were fatigue, hepatic dysfunction, arthritis and gastric ulcer, all but one (gastric ulcer) were immediately improved by discontinuation of this combined therapy.
Conclusions: The combination of meloxicam and natural IFN- is considered to be an active regimen with tolerable toxicities as a first-line treatment of metastatic renal cell carcinoma.
Key Words: renal cell carcinoma • IFN- • COX-2 inhibitor • CRP • clinical trial