Can bleomycin toxicity in the treatment of testis cancer be batch related?
Bleomycin is an antibiotic complex derived from Streptomyces verticullis culture and excreted by the kidneys. Bleomycin toxicity, predominately skin and pulmonary, has been described since the drug’s introduction into testicular cancer management in the 1960s [1]. Previous data from the Royal Marsden have described a 6.8% rate of pulmonary toxicity in an 835-patient series, with increased risk occurring in patients >40 years old, those with impaired glomerular filtration rate (GFR) (<80 ml/min) or with stage IV disease, or if a cumulative dose >300 000 IU was given [2]. No relation to bleomycin batch has been described previously. At the end of 2003/early 2004, we encountered a number of patients with bleomycin toxicity and decided to investigate whether there was an identifiable cause. We identified 19 patients treated at least in part from the same bleomycin batch (435000 Kyowa). Cumulative bleomycin dose, schedule, prognostic group and bleomycin risk factors were reviewed. Five out
