Drug intelligence / Profile preview

Fluorouracil and Interleukin-2

Development stage
Unknown
Lead developer
Roche
Modality
Vaccines & Immunotherapeutics, Classical Binding Small Molecules → Small Molecules, Covalent Small Molecules → Small Molecules, Nucleic Acid-Directed Small Molecules → Small Molecules
Administration
Intravenous, Subcutaneous
01

Overview

The combination of fluorouracil and interleukin-2 is a therapeutic regimen that has been studied primarily for the treatment of advanced cancers, particularly renal cell carcinoma and colorectal cancer. Based on the search results, I can provide the following information about this drug combination: ## Drug Information The combination therapy consists of two distinct agents: 1. **Fluorouracil (5-FU)**: A chemotherapeutic agent that interferes with DNA synthesis and cell division. 2. **Interleukin-2 (IL-2)**: A cytokine that stimulates the immune system, particularly T-cell proliferation and activation. ## Clinical Applications This combination has been investigated in several clinical settings: - **Metastatic Renal Cell Carcinoma**: Multiple studies have evaluated the efficacy of this combination, sometimes with the addition of interferon-alpha. Response rates in these studies ranged from approximately 19% to 48.6%[1][6][8]. - **Colorectal Cancer**: A phase II study in patients with progressive metastatic colorectal cancer who had failed first-line chemotherapy showed a 36% response rate[2]. - **Cutaneous Squamous Cell Carcinoma**: The combination has been studied as part of a regimen including cyclophosphamide[5]. ## Administration Protocol The typical administration protocol varies across studies but generally includes: - **5-Fluorouracil**: Usually administered intravenously at doses ranging from 500-750 mg/m² weekly or as continuous infusion[1][2][6][8]. - **Interleukin-2**: Administered subcutaneously at various doses (e.g., 5-20 MU/m² three times weekly)[1][8] or as continuous infusion[3]. In many protocols, these agents are given sequentially rather than simultaneously, and treatment cycles typically last 4-8 weeks[1][6][8]. ## Efficacy and Outcomes The efficacy of this combination therapy varies by cancer type: - In renal cell carcinoma, objective response rates ranged from 19% to 48.6%, with complete responses observed in 9-11.4% of patients[1][6][8]. - Response duration was reported as 7+ months in one study[1] and 12.5 months in another[8]. - The SCAPP II trial, however, failed to confirm the favorable results previously reported, with a 19% objective response rate[6]. ## Toxicity Profile The combination therapy is associated with various side effects: - Common adverse events include fever, nausea, vomiting, elevated liver enzymes, hypotension, and skin toxicity[2]. - Toxicity was described as "mild to moderate" in some studies[1], while others reported "severe toxicity" requiring dose reductions or treatment delays[6]. - The outpatient subcutaneous administration protocol appears to have a more favorable toxicity profile compared to high-dose intravenous IL-2[1][8]. This combination represents an approach that combines traditional chemotherapy with immunotherapy, aiming to enhance antitumor effects through potential synergistic mechanisms.

Other names
5-FU and IL-2
02

Targets

TS (Thymidylate synthase)IL-2R (Interleukin-2/interleukin-15 receptor complex)

Beyond the preview

Go deeper on Fluorouracil and Interleukin-2.

Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.

Clinical trials

Full profile access

Follow clinical development from study design and recruitment through results.

  • Trial phase
  • Status
  • Readouts

Indications & development

Full profile access

Explore development by indication, patient population, and geography.

  • Indications
  • Development status
  • Countries

Licensing & deals

Full profile access

Trace asset ownership, licensing agreements, and commercial partnerships.

  • Partners
  • Deal terms
  • Milestones

Patents & exclusivity

Full profile access

Explore the patent landscape and regulatory exclusivity around an asset.

  • Patents
  • Expiration dates
  • Exclusivity

Competitive landscape

Full profile access

Compare development programs by target, modality, and indication.

  • Competing assets
  • Targets
  • Development stage

Research & analysis

Full profile access

Connect source evidence and development news to your research questions.

  • Publications
  • News
  • Analysis

Bring the full picture into focus.

See how Gosset can support your research on Fluorouracil and Interleukin-2.

Explore the full profile

Gosset Free

Get started with Gosset.

Enter your work email and we’ll be in touch with next steps.

Work email preferred.

Book a call