Intravesical 4'-epi-doxorubicin (epirubicin) versus bacillus Calmette-Guérin. A controlled prospective study on the prophylaxis of superficial bladder cancer.

Abstract

BACKGROUND:

The selection of the most appropriate antineoplastic agent and optimal treatment schedule for the prophylaxis of superficial bladder cancer against tumor recurrences is the subject of continual investigations.

METHODS:

A controlled prospective trial involving 161 patients evaluated and compared the efficacy of intravesical epirubicin and bacillus Calmette-Guérin (BCG) administration as prophylaxis against recurrences after complete transurethral resection of superficial bladder cancer. The treatment schedule, consisting of one 6- or 8-week course of instillations (50 mg epirubicin or 150 mg BCG per instillation) followed by single maintenance doses to the responders at follow-up examinations, was modified for those of the initial responders who were at high risk for recurrence and who received an additional separate 4-week course of treatment 6 months after the start of therapy.

RESULTS:

Sixty percent of the patients treated with epirubicin, 68% of the patients treated with BCG, and 41% of the control subjects, who underwent resection only, remained free of recurrences for a mean follow-up of 32.9 months. The only significant difference was found between patients treated with BCG and control subjects, in favor of the former. Conversely, recurrence rate per 100 patient-months and mean interval to recurrence showed both drugs to be superior to resection alone regarding several tumor characteristics. However, a significant benefit in favor of BCG when compared with epirubicin was shown in those patients who had Stage T1 and Grade 3 tumors at presentation.

CONCLUSIONS:

Intravesical epirubicin and BCG were superior to transurethral resection alone in the prophylaxis of superficial bladder cancer, but with respect to superficially invasive and high-grade tumors, BCG demonstrated a remarkable advantage.

• Authors: M D Melekos, H S Chionis, G S Paranychianakis, H H Dauaher
• Journal: Cancer (Cancer) Vol. 72 Issue 5 Pg. 1749-55 (Sep 01 1993) ISSN: 0008-543X [Print] United States
• PMID: 8348504 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)

Chemical References

• BCG Vaccine
• Epirubicin

Topics

• Administration, Intravesical
• Aged
• BCG Vaccine (administration & dosage, adverse effects, therapeutic use)
• Carcinoma in Situ (prevention & control, surgery)
• Carcinoma, Transitional Cell (prevention & control, surgery)
• Combined Modality Therapy
• Cystitis (chemically induced, etiology)
• Epirubicin (administration & dosage, adverse effects, therapeutic use)
• Female
• Follow-Up Studies
• Humans
• Male
• Neoplasm Invasiveness
• Neoplasm Recurrence, Local (prevention & control)
• Neoplasm Staging
• Prospective Studies
• Remission Induction
• Urinary Bladder Neoplasms (prevention & control, surgery)