進行性腎細胞癌に対するインターフェロン療法の現況と展望

Abstract

1)連日筋注で300万単位のHLBIを投与した25例の第二相試験で, CR 3例, PR 3例であった。奏効症例は全例前治療に腎摘を受けており, PSも非奏効症例に比べ良好であった。2)無作為比較試験で16例に300万単位を投与し, 15例に100万単位を投与した。300万単位群の奏効率は33.1%, 100万単位群の奏効率は20.0%と有意差を認めなかった。抗腫瘍効果が見られた転移部位は全例肺であった。副作用としての血液毒性の頻度は300万単位群43.8%, 100万単位群13.3%

To determine the effect of human lymphoblastoid interferon (HLBI) on metastatic renal cell carcinoma (MRCC), we performed two clinical trials. First, between 1982 and 1984, we performed a phase II study using 3 mega-units (MU) of HLBI daily in 25 eligible patients with MRCC. Six patients (24.0%) showed objective responses, including 2 with complete response (CR) and 4 with partial response (PR). Patients with a prior nephrectomy or with a good performance status were likely to respond to the therapy. Based on the above observation, we performed a prospective randomized trial to compare 2 different doses of HLBI following nephrectomy. Treatment consisted of HLBI, 3 MU intramuscularly 6 days a week in arm A and 1 MU intramuscularly 6 days a week in arm B. Treatments were started within 4 weeks after the nephrectomy and patients were evaluated every week for 1 month, and every month thereafter. Between 1985 and 1991, 16 patients were enrolled in arm A and 15 patients in arm B. Responses were seen in 5 (31.3%) of the 16 arm A patients (4 CRs and 1 PR) and 3 (20.0%) of the 15 arm B patients (1 CR and 2 PRs). Most responses occurred in patients with lung metastasis and favorable PS. There was no statistical difference in efficacy between the two arms. Hematologic toxicity was more frequent in arm A (43.8%) than arm B (13.3%). We conclude that further studies are needed to secure the clinical efficacy of HLBI for MRCC.