PURPOSE: A prospective multicenter phase II trial was undertaken to define the activity of a low-dose subcutaneous regimen of interleukin-2 (IL-2) and interferon alfa-2a (IFN) in patients with metastatic renal cancer. PATIENTS AND METHODS: Between December 1990 and October 1991, 42 patients with metastatic renal cancer who had received no prior immunotherapy were treated with IL-2 (4 x 10(6) U) days 1 through 4 and IFN (9 x 10(6) U) day 1 and 4 each week of a 4-week treatment course followed by a 2-week rest period. Maximum duration of therapy was 1 year. Concomitant therapy with acetaminophen, diphenhydramine, and indomethacin was recommended. Treatment was administered on an outpatient basis. RESULTS: With a median follow-up duration of 18 months, responses occurred in five of 42 patients (12%; 95% confidence interval [Cl], 2% to 22%). One pathologic complete remission, one surgical complete remission, and three partial remissions occurred. Toxicity was modest, with a symptom complex of rash, fever, anorexia, fatigue, mild weight loss, lymphocytosis, and eosinophilia occurring in 85% to 90% of patients. Renal dysfunction (creatinine > 2 mg/dL) occurred in 19% of patients, while three patients (7%) refused further IL-2 and IFN. No toxic deaths occurred. The median survival duration was 14.5 months. CONCLUSION: This outpatient low-dose subcutaneous regimen induced mild toxicity, a modest response rate, and an excellent median survival duration in previously untreated patients. Phase III trials are now needed to compare IL-2 plus IFN with IL-2 alone or to various IL-2/IFN regimens. However, the major task is to identify unique new agents with activity in renal cancer.
PURPOSE: A prospective multicenter phase II trial was undertaken to define the activity of a low-dose subcutaneous regimen of interleukin-2 (IL-2) and interferon alfa-2a (IFN) in patients with metastatic renal cancer. PATIENTS AND METHODS: Between December 1990 and October 1991, 42 patients with metastatic renal cancer who had received no prior immunotherapy were treated with IL-2 (4 x 10(6) U) days 1 through 4 and IFN (9 x 10(6) U) day 1 and 4 each week of a 4-week treatment course followed by a 2-week rest period. Maximum duration of therapy was 1 year. Concomitant therapy with acetaminophen, diphenhydramine, and indomethacin was recommended. Treatment was administered on an outpatient basis. RESULTS: With a median follow-up duration of 18 months, responses occurred in five of 42 patients (12%; 95% confidence interval [Cl], 2% to 22%). One pathologic complete remission, one surgical complete remission, and three partial remissions occurred. Toxicity was modest, with a symptom complex of rash, fever, anorexia, fatigue, mild weight loss, lymphocytosis, and eosinophilia occurring in 85% to 90% of patients. Renal dysfunction (creatinine > 2 mg/dL) occurred in 19% of patients, while three patients (7%) refused further IL-2 and IFN. No toxic deaths occurred. The median survival duration was 14.5 months. CONCLUSION: This outpatient low-dose subcutaneous regimen induced mild toxicity, a modest response rate, and an excellent median survival duration in previously untreated patients. Phase III trials are now needed to compare IL-2 plus IFN with IL-2 alone or to various IL-2/IFN regimens. However, the major task is to identify unique new agents with activity in renal cancer.
Authors: M Donini; S Buti; S Lazzarelli; R Bozzetti; L Rivoltini; C Camisaschi; C Castelli; A Bearz; C Simonelli; G Lo Re; R Mattioli; C Caminiti; R Passalacqua Journal: Target Oncol Date: 2014-09-19 Impact factor: 4.493
Authors: Jacob A Klapper; Stephanie G Downey; Franz O Smith; James C Yang; Marybeth S Hughes; Udai S Kammula; Richard M Sherry; Richard E Royal; Seth M Steinberg; Steven Rosenberg Journal: Cancer Date: 2008-07-15 Impact factor: 6.860
Authors: James C Yang; Richard M Sherry; Seth M Steinberg; Suzanne L Topalian; Douglas J Schwartzentruber; Patrick Hwu; Claudia A Seipp; Linda Rogers-Freezer; Kathleen E Morton; Donald E White; David J Liewehr; Maria J Merino; Steven A Rosenberg Journal: J Clin Oncol Date: 2003-08-15 Impact factor: 44.544
Authors: Amy C Peterson; Helena Harlin; Theodore Karrison; Nicholas J Vogelzang; James A Knost; John W Kugler; Eric Lester; Everett Vokes; Thomas F Gajewski; Walter M Stadler Journal: Invest New Drugs Date: 2006-03 Impact factor: 3.850
Authors: N Verra; R Jansen; G Groenewegen; H Mallo; M J Kersten; A Bex; F A Vyth-Dreese; J Sein; W van de Kasteele; W J Nooijen; M de Waal; S Horenblas; G C de Gast Journal: Br J Cancer Date: 2003-05-06 Impact factor: 7.640