Methotrexate compared with placebo in lung cancer

Area of Science:

• Medical Oncology
• Pulmonology

Background:

• Bronchogenic carcinoma, or lung cancer, presents significant treatment challenges, especially in inoperable cases.
• Methotrexate is a chemotherapy agent with potential antineoplastic effects.

Purpose of the Study:

• To evaluate the efficacy and safety of different doses of methotrexate compared to placebo in patients with inoperable bronchogenic carcinoma.
• To determine the dose-response relationship of methotrexate in terms of objective tumor regression and survival.

Main Methods:

• A randomized trial involving 239 patients with inoperable bronchogenic carcinoma.
• Patients received intramuscular injections of high-dose methotrexate (0.06 mg/kg), low-dose methotrexate (0.2 mg/kg), or placebo twice weekly for four months.
• Objective response was defined as ≥50% tumor regression.

Main Results:

• Objective response rates were dose-dependent: 21% for high-dose, 11% for low-dose, and 6% for placebo.
• For epidermoid carcinoma, response rates were 35% (high-dose), 9% (low-dose), and 0% (placebo).
• Responders in methotrexate groups experienced a 3-4 fold increase in median survival; non-responders had similar survival to placebo.

Conclusions:

• High-dose methotrexate demonstrated a potentially useful role in the temporary palliation of epidermoid carcinoma of the lung.
• The study suggests a dose-response relationship for methotrexate efficacy in this patient population.
• All regimens were well-tolerated, with no life-threatening toxicity observed.