MULTI-ISTITUTIONAL CONTROLLED STUDIES DO NO REFLECT THE PATIENT’S COMPLIANCE TO BCG ENCOUNTERED IN CLINICAL PRACTICE. RESULTS ON 411 PATIENTS

Vincenzo Serretta, Cristina Scalici Gesolfo, Vincenza Alonge

Risultato della ricerca: Other

Abstract

INTRODUCTION AND OBJECTIVESBCG maintenance for at least one year is advocated by urological guidelines as the best intravesical regimen in high-risk non muscle invasive bladder cancer (NMIBC), conservatively treated. Noteworthy, a relevant percentage of patients does not complete the planned treatment. The aim of this study was to analyze the reasons for treatment interruption and low compliance.METHODSConsecutive patients affected by T1HG NMIBC undergoing conservative management with adjuvant BCG entered the study. The Connaught BCG strain was administered intravesically according to the South West Oncology Group schedule for one year, 81mg diluted in 50 ml of saline solution, starting 21-30 days after TUR. Toxicity and causes of treatment interruption were recorded.RESULTSBetween 2000 and 2012, intravesical BCG with 1-year maintenance regimen was proposed to 411 patients. Out of them, 380 (92,5%) completed the induction cycle and 308 (81%) started the maintenance. A total of 215 (52.3%) completed the scheduled one-year treatment. Toxicity requiring treatment interruption was recorded in 25 (6.1%) patients only. In 60 patients (14.6%) a delay of one or more instillations was necessary. Grade-I toxicity, not requiring therapy interruption or delay, was recorded in 193 (46.9%) cases. In our experience, the patient's compliance registered during the induction cycle reached 92%, confirming the low toxicity and the good patients' acceptance of the 6-week induction. However, between the end of the induction course and the first maintenance instillation, 50 patients (13%) became reluctant to treatment for many personal reasons unrelated to toxicity and 22 (6%) were excluded for suspicious bladder lesion at cystoscopy. Moreover, patients' compliance to maintenance decreased from 81% at 3 months to 56.6% at 12 months. Surprisingly, the rate of drop-out (15%) remained stable at 6 and 12 months. Mild toxicity and social discomfort were the mean reasons for dropout during maintenance (60%).CONCLUSIONSSevere toxicity caused BCG interruption in a limited amount of cases. Almost 60% of treatment interruptions was attributable to low grade toxicity, inadequately considered by the urologists. The personal difficulties related to the prolonged treatment and the limited patients' awareness of the therapeutic value of maintenance were other important reasons. A structured periodical counseling and a timely recognition and therapy of mild but persistent symptoms, might significantly ameliorate patients' acceptance of BCG maintenance.
Lingua originaleEnglish
Pagine300-300
Numero di pagine1
Stato di pubblicazionePublished - 2015

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