High dose methotrexate with and without BCG therapy in advanced head and neck malignancy

Area of Science:

• Oncology
• Immunotherapy
• Pharmacology

Background:

• Advanced recurrent head and neck carcinoma presents significant treatment challenges.
• High-dose methotrexate (HDMTX) with leucovorin rescue is a treatment option.
• The role of chemoimmunotherapy combining HDMTX with bacilli Calmette Guerin (BCG) requires further investigation.

Purpose of the Study:

• To evaluate the efficacy of HDMTX alone versus HDMTX/BCG in patients with advanced recurrent head and neck carcinoma.
• To assess the impact of escalating HDMTX doses on treatment response.
• To determine if BCG enhances response rates, duration, or survival compared to HDMTX alone.

Main Methods:

• Randomized trial comparing HDMTX and HDMTX/BCG in 23 patients.
• An additional 8 patients received escalating doses of HDMTX.
• Response rates, duration of response, and survival were monitored.

Main Results:

• HDMTX group (12 patients): 1 complete response (CR), 2 partial responses (PR).
• HDMTX/BCG group (11 patients): 1 CR, 2 PR.
• Escalating dose group (8 patients): 1 PR.
• Responses were brief, with no significant difference in duration or survival across groups.
• Tolerable toxicity was observed in all treatment arms.

Conclusions:

• BCG did not improve response rate, duration of response, or survival in advanced recurrent head and neck cancer.
• Responses to HDMTX therapy were consistently brief.
• The combination of HDMTX/BCG chemoimmunotherapy offers questionable clinical benefit for this patient population due to limited response duration and high cost.