Marcus J Daniels1, Emily Barry2, Mark Schoenberg2, Donald L Lamm3, Trinity J Bivalacqua4, Alex Sankin2, Max Kates4. 1. James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions, Baltimore, MD. Electronic address: mdanie56@jhmi.edu. 2. Department of Urology, Montefiore Medical Center, Albert Einstein College of Medicine, New York, NY. 3. BCG Oncology, Phoenix, AZ. 4. James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions, Baltimore, MD.
Abstract
PURPOSE: According to the 2016 American Urological Association (AUA) guidelines for nonmuscle invasive bladder cancer (NMIBC), clinicians should offer a 2nd intravesical induction course of Bacillus Calmette-Guérin (BCG) to patients with persistent or recurrent Ta or CIS disease after a 1st BCG induction course. However, evidence for a 2nd course is limited, and some patients forego a 2nd induction of BCG in favor of a clinical trial or alternate intravesical therapy. We sought to investigate contemporary oncologic outcomes of a 2nd induction course of BCG in a multi-institutional cohort. MATERIALS AND METHODS: Three hundred fifty-three patients who received full induction BCG for NMIBC since 2001 at 2 institutions were identified. Patients were categorized as receiving primary 6-week induction therapy or subsequent 2nd 6-week induction therapy for patients who recurred or persisted. The baseline differences in demographic and tumor characteristics were compared between the 2 groups, and Kaplan-Meier curves were constructed to assess high-grade recurrence free survival (HgRFS) among both groups. Univariable logistic regression was used to determine factors associated with recurrence after 2nd course BCG RESULTS: A total of 353 patients received 1st induction BCG (BCG1) and 116 patients received a 2nd induction course (BCG2). Maintenance therapy was given to 117 (33.1%) patients after BCG1 and 43 (37.1%) patients after BCG2. Both cohorts were similar in demographics including age, sex, and race. Pathologic stage before treatment differed as BCG1 patients were more likely to have T1 (40.8% vs. 25%) and less likely to have CIS (13.9% vs. 33.6%) (P < 0.001). Complete response (CR) 3 months after BCG1 was observed in 276 patients (78.2%) and 104 patients (89.7%) after BCG2. Responses remained durable, with 36-month CR of 54.7% in BCG1 and 65.6% in BCG2. Progression to MIBC was identified in 1.4% of BCG1 patients vs. 3.4% in BCG2 patients (P = 0.17). Pathologic stage before BCG2 does not predict progression to MIBC (P = 0.21) after BCG2. The time interval between the 1st and 2nd induction of BCG was not significantly associated with response to 2nd induction BCG (P = 0.47). Maintenance therapy after BCG2 was associated with decreased recurrence after 2nd induction course of BCG. CONCLUSION: A 2nd course of BCG is efficacious with a durable HgRFS, validating the recommendations of the 2016 AUA guidelines.
PURPOSE: According to the 2016 American Urological Association (AUA) guidelines for nonmuscle invasive bladder cancer (NMIBC), clinicians should offer a 2nd intravesical induction course of Bacillus Calmette-Guérin (BCG) to patients with persistent or recurrent Ta or CIS disease after a 1st BCG induction course. However, evidence for a 2nd course is limited, and some patients forego a 2nd induction of BCG in favor of a clinical trial or alternate intravesical therapy. We sought to investigate contemporary oncologic outcomes of a 2nd induction course of BCG in a multi-institutional cohort. MATERIALS AND METHODS: Three hundred fifty-three patients who received full induction BCG for NMIBC since 2001 at 2 institutions were identified. Patients were categorized as receiving primary 6-week induction therapy or subsequent 2nd 6-week induction therapy for patients who recurred or persisted. The baseline differences in demographic and tumor characteristics were compared between the 2 groups, and Kaplan-Meier curves were constructed to assess high-grade recurrence free survival (HgRFS) among both groups. Univariable logistic regression was used to determine factors associated with recurrence after 2nd course BCG RESULTS: A total of 353 patients received 1st induction BCG (BCG1) and 116 patients received a 2nd induction course (BCG2). Maintenance therapy was given to 117 (33.1%) patients after BCG1 and 43 (37.1%) patients after BCG2. Both cohorts were similar in demographics including age, sex, and race. Pathologic stage before treatment differed as BCG1 patients were more likely to have T1 (40.8% vs. 25%) and less likely to have CIS (13.9% vs. 33.6%) (P < 0.001). Complete response (CR) 3 months after BCG1 was observed in 276 patients (78.2%) and 104 patients (89.7%) after BCG2. Responses remained durable, with 36-month CR of 54.7% in BCG1 and 65.6% in BCG2. Progression to MIBC was identified in 1.4% of BCG1 patients vs. 3.4% in BCG2 patients (P = 0.17). Pathologic stage before BCG2 does not predict progression to MIBC (P = 0.21) after BCG2. The time interval between the 1st and 2nd induction of BCG was not significantly associated with response to 2nd induction BCG (P = 0.47). Maintenance therapy after BCG2 was associated with decreased recurrence after 2nd induction course of BCG. CONCLUSION: A 2nd course of BCG is efficacious with a durable HgRFS, validating the recommendations of the 2016 AUA guidelines.
Authors: Stephen A Boorjian; Mehrdad Alemozaffar; Badrinath R Konety; Neal D Shore; Leonard G Gomella; Ashish M Kamat; Trinity J Bivalacqua; Jeffrey S Montgomery; Seth P Lerner; Joseph E Busby; Michael Poch; Paul L Crispen; Gary D Steinberg; Anne K Schuckman; Tracy M Downs; Robert S Svatek; Joseph Mashni; Brian R Lane; Thomas J Guzzo; Gennady Bratslavsky; Lawrence I Karsh; Michael E Woods; Gordon Brown; Daniel Canter; Adam Luchey; Yair Lotan; Tracey Krupski; Brant A Inman; Michael B Williams; Michael S Cookson; Kirk A Keegan; Gerald L Andriole; Alexander I Sankin; Alan Boyd; Michael A O'Donnell; David Sawutz; Richard Philipson; Ruth Coll; Vikram M Narayan; F Peter Treasure; Seppo Yla-Herttuala; Nigel R Parker; Colin P N Dinney Journal: Lancet Oncol Date: 2020-11-27 Impact factor: 41.316
Authors: Harry Herr; Emily A Vertosick; Guido Dalbagni; Eugene K Cha; Robert Smith; Nicole Benfante; Daniel D Sjoberg; John P Sfakianos Journal: Urology Date: 2021-07-15 Impact factor: 2.633