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Title: Intralesional Bacille Calmette-Guerin Injection Effective for Melanoma but Underused: Presented at ACS

"Intralesional Bacille Calmette-Guerin Injection Effective for Melanoma but Underused: Presented at ACS"

By Crystal Phend SAN FRANCISCO, CA -- October 24, 2005 -- Although intralesional injections of bacilli Calmette-Guerin (BCG) have fallen into disuse for melanoma, they are effective and have manageable toxicity, according to results of a 40-year prospective study. Mark B. Faries, MD, Surgical Oncologist and Director of Translational Tumor Immunology, John Wayne Cancer Institute, Santa Monica, California, United States, presented the findings here October 19[^th at the American College of Surgeons (ACS) annual meeting.

"Intralesional BCG generates a vigorous immune response, good local control and complete [disease] regression in 80% [of patients]," Dr. Faries said. "Systemic immunity may also develop in these patients."

This treatment was first used nearly 35 years ago, but due to early concerns of systemic infection and two reported deaths, alternative approaches such as isolated limb perfusion and systemic therapy are used more commonly.

Dr. Faries and colleagues examined records of 547 melanoma patients treated with intralesional BCG in a prospectively collected clinical database and also conducted a retrospective assessment of records from 52 recently treated patients.

In the total cohort, almost half of patients had clinical stage III melanoma (47%) while 28% had stage I/II disease and 25% had stage IV disease.

These patients had a median survival of 15.4 months and a 5-year survival rate of 20%. BCG treatment alone achieved a local control rate of 56%. Local control was attained with simple excision or ablation in 19% and after conversion to intralesional interferon alpha in 4% of patients.

Eighty percent of the lesions with evaluable responses regressed completely with BCG and another 11% stabilized or partially regressed and were excised; 9% progressed.

Immunological response as measured by purified protein derivative conversion was a significant predictor of overall survival.

The cohort had mostly stage III melanoma (73%) with phase I/II accounting for about 12% of patients and stage IV disease for about 15%.

The researchers found that dose was dependent on PPD status, typically about 0.1 to 0.2 cc per lesion.

Toxicity was typically erythema, induration and ulceration. Fever occurred in 22% of the 52 cases reviewed, flu-like symptoms in 10%, cellulitis in 4% and cough in 2%.

One patient (2%) required hospitialization for suspected disseminated BCG infection (BCGosis) and two patients treated at other centers had systemic infections. All recovered with antitubercular medication.

The researchers acknowledged that a limitation of their study is that dosing changed throughout the 40-year study period, among other possible confounders.

More detailed investigations of systemic immunity with BCG treatment are needed, Dr. Faries said, but concluded, "In our experience, intralesional BCG has been very safe and effective."

[Presentation title: Intralesional Bacillus Calmette-Guerin Immunotherapy in Metastatic Melanoma: An Effective but Underutilized Therapy. General Session 63]

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