Protracted venous infusion 5-fluorouracil in combination with subcutaneous interleukin-2 and alpha-interferon in patients with metastatic renal cell cancer: a phase II study

Abstract

Our purpose was to assess the activity of alpha-interferon (IFN-α), interleukin-2 (IL-2) and 5 fluorouracil (5FU) administered by protracted venous infusion (PVI) as opposed to bolus injection. 55 patients with advanced renal cell cancer were treated as follows: IL-2 and IFN-α according to the schedule originally described by Atzpodien, with PVI 5FU 200 mg m–2 day–1 during weeks 5–9. 42 patients (76%) were of moderate or poor prognosis as defined by previous studies. The response rate by intention to treat was 31% (17 of 55, three complete response, 14 partial response; 95% CI = 19–45%) and in evaluable patients (completed one cycle, n = 42), it was 40% (95% CI = 26–57%). In addition, 24% (13 of 55) patients achieved disease stabilization. The overall median survival was 11 months with a 1-year survival of 45%. The median survival for evaluable patients was 18 months with 1- and 2-year survivals of 60% and 40% respectively. The median survival of responding patients was 31 months and the three patients achieving complete response remain progression-free at 14+, 18+ and 23+ months. Evaluable patients with poor prognostic features achieved a response rate of 54% and median survival of 18 months. Toxicity was significant yet manageable with 12 patients unable to complete one cycle due to side-effects and 36% experiencing grade 3–4 toxicities. The three on-treatment deaths were considered unlikely to be due to toxicity. The schedule of IFN-α, IL-2 and PVI 5FU has significant activity in advanced renal cell cancer with manageable toxicity. It is of particular interest that this regimen appears to have high activity in fit patients with poor prognostic features. © 2000 Cancer Research Campaign

Subcutaneous interleukin-2, interferon alpha-2b and 5-fluorouracil in metastatic renal cell carcinoma as second-line treatment after failure of previous immunotherapy: a phase II trial

“…This protocol is closely related to the schedule designed for other clinical research trials with IL-2, IFNa and 75-FU within the framework of the French Immunotherapy Group Négrier et al, 2000). These large studies showed an unexpectedly low response rate Négrier et al, 2000) like the present study, compared to more promising results obtained by others (Atzpodien et al, 1993;Hofmockel et al, 1996;Joffe et al, 1996;Ellerhorst et al, 1997;Tourani et al, 1998;Allen et al, 2000;Dutcher et al, 2000;Elias et al, 2000;van Herpen et al, 2000).…”

Noncardiogenic Pulmonary Edema: An Unusual and Serious Complication of Anticancer Therapy

“…This biological response modifier is currently employed in the management of metastatic melanoma and renal cell carcinoma, alone or in combination with chemotherapy or biotherapy [18][19][20][21].…”

Phase II clinical trial of capecitabine and gemcitabine chemotherapy in patients with metastatic renal carcinoma

“…However, some patients have good quality responses with prolonged disease-free survival, and for this reason immunotherapy has remained the standard first-line treatment for this disease (Medical Research Council Renal Cancer Collaborators, 1999). Combinations of immunotherapy and 5-fluorouracil (5-FU) chemotherapy have produced consistently higher response rates of 20 -39% in previously untreated patients, but at the expense of additional toxicity Lopez Hanninen et al, 1995;Tourani et al, 1998;Allen et al, 2000;van Herpen et al, 2000). As yet there is no randomised evidence supporting the superiority of this approach over standard immunotherapy.…”