Interferon-alfa as a comparative treatment for clinical trials of new therapies against advanced renal cell carcinoma Journal Article
| Authors: | Motzer, R. J.; Bacik, J.; Murphy, B. A.; Russo, P.; Mazumdar, M. |
| Article Title: | Interferon-alfa as a comparative treatment for clinical trials of new therapies against advanced renal cell carcinoma |
| Abstract: | Purpose: To define outcome data and prognostic criteria for patients with metastatic renal cell carcinoma (RCC) treated with interferon-alfa as initial systemic therapy. The data can be applied to design and interpretation of clinical trials of new agents and treatment programs against this refractory malignancy. Patients and Methods: Four hundred sixty-three patients with advanced RCC administered interferon-α as first-line systemic therapy on six prospective clinical trials were the subjects of this retrospective analysis. Three risk categories for predicting survival were identified on the basis of five pretreatment clinical features by a stratified Cox proportional hazards model. Results: The median overall survival time was 13 months. The median time to progression was 4.7 months. Five variables were used as risk factors for short survival: low Karnofsky performance status, high lactate dehydrogenase, low serum hemoglobin, high corrected serum calcium, and time from initial RCC diagnosis to start of interferon-α therapy of less than one year. Each patient was assigned to one of three risk groups: those with zero risk factors (favorable risk), those with one or two (intermediate risk), and those with three or more (poor risk). The median time to death of patients deemed favorable risk was 30 months. Median survival time in the intermediate-risk group was 14 months. In contrast, the poor-risk group had a median survival time of 5 months. Conclusion: Progression-free and overall survival with interferon-α treatment can be compared with new therapies in phase II and III clinical investigations. The prognostic model is suitable for risk stratification of phase III trials using interferon-α as the comparative treatment arm. © 2001 by American Society of Clinical Oncology. |
| Keywords: | adult; cancer survival; aged; aged, 80 and over; disease-free survival; middle aged; survival rate; retrospective studies; major clinical study; clinical trial; cancer risk; antineoplastic agents; alpha interferon; antineoplastic agent; reproducibility of results; cancer immunotherapy; metastasis; phase 2 clinical trial; proportional hazards models; risk factors; calcium; hemoglobin; calcium blood level; retrospective study; kidney carcinoma; kidney neoplasms; vinblastine; models, theoretical; carcinoma, renal cell; neoplasm metastasis; lactate dehydrogenase; multivariate analysis; isotretinoin; lactate dehydrogenase blood level; clinical trials; interferon-alpha; hemoglobin determination; humans; prognosis; human; male; female; priority journal; article |
| Journal Title: | Journal of Clinical Oncology |
| Volume: | 20 |
| Issue: | 1 |
| ISSN: | 0732-183X |
| Publisher: | American Society of Clinical Oncology |
| Date Published: | 2002-01-01 |
| Start Page: | 289 |
| End Page: | 296 |
| Language: | English |
| DOI: | 10.1200/jco.20.1.289 |
| PUBMED: | 11773181 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Export Date: 14 November 2014 -- Source: Scopus |
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