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Phase II study of human lymphoblastoid interferon in patients with advanced renal carcinoma
Abstract:
Twenty-two patients with measurable metastatic renal carcinoma were treated with human alpha lymphoblastoid interferon (Wellferon) (3 million units/m2 of body surface area) im three times a week for 6 weeks; 21 were evaluable for response and toxicity. One patient had a partial regression of disease lasting 39 weeks and another had a minor response. Six patients had partial or minor response in one area but no change in the disease elsewhere (mixed response); they were classified as having stable disease. An additional seven patients had no change in measurable disease and in six the disease progressed. The tumor regressions by metastatic site were four of 14 patients, pulmonary; three of four, soft tissue; one of nine, bone (? soft tissue); none of three, mediastinal; none of four, renal; none of five, liver; and none of ten, other abdominal sites of tumor. The side effects were fever (101 degrees F-103 degrees F), chills, malaise, anorexia, minor (10%-20%) decrease in performance status, and weight loss. We concluded that interferon had some activity against metastatic renal carcinoma, although clinically useful responses were quite infrequent. While lung metastases appeared to be more responsive than those at other sites, careful examination of the data suggests that this simply reflects differences in the bulk of the metastatic disease. Smaller metastases appear more likely to respond than bulky metastases.
Insights
Human alpha lymphoblastoid interferon showed limited activity in metastatic renal carcinoma patients. While some lung metastases responded, overall clinically useful responses were infrequent, with smaller tumors showing more promise.
Area of Science:
- Oncology
- Immunotherapy
- Pharmacology
Background:
- Metastatic renal carcinoma (kidney cancer) has limited treatment options.
- Interferon-alpha has been explored as a potential therapy for various cancers.
Purpose of the Study:
- To evaluate the efficacy and toxicity of human alpha lymphoblastoid interferon in patients with measurable metastatic renal carcinoma.
Main Methods:
- Twenty-two patients with metastatic renal carcinoma received human alpha lymphoblastoid interferon (3 million units/m2) intramuscularly three times weekly for 6 weeks.
- Response and toxicity were assessed in 21 evaluable patients.
Main Results:
- One patient achieved a partial regression, and another had a minor response. Six patients had mixed responses (stable disease). Seven patients had no change, and six experienced disease progression.
- Tumor regression was observed in pulmonary (4/14), soft tissue (3/4), and bone (1/9) metastases. No responses were seen in mediastinal, renal, liver, or other abdominal sites.
- Common side effects included fever, chills, malaise, anorexia, decreased performance status, and weight loss.
Conclusions:
- Human alpha lymphoblastoid interferon demonstrated some activity against metastatic renal carcinoma, but clinically useful responses were infrequent.
- Lung metastases appeared more responsive, potentially due to differences in metastatic bulk; smaller metastases were more likely to respond than bulky ones.