Maintenance Bacillus Calmette-Guerin Immunotherapy for Recurrent Ta, T1 and Carcinoma in Situ Transitional Cell Carcinoma of the Bladder: A Randomized Southwest Oncology Group Study

Lamm, Donald L.; Blumenstein, Brent A.; Crissman, John D.; Montie, James E.; Gottesman, James E.; Lowe, Bruce A.; Sarosdy, Michael F.; Bohl, Robert D.; Grossman, H. Barton; Beck, Thomas M.; Leimert, Joseph T.; Crawford, E. David

doi:10.1016/s0022-5347(05)67707-5

Cited by 1,090 publications

(746 citation statements)

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“…The reported progression rates have varied according to the definition of progression. For example, if the criteria for worsening of disease outlined by Lamm et al 23 were used, the 11 patients who underwent cystectomy because of high-grade disease or CIS would be included among those with recurrence, and the progression rate would have been 6.5%. Our view, however, is that the term "progression" should be limited to the development of muscleinvasive disease rather than encompassing an increase in grade.…”

Section: Commentmentioning

confidence: 99%

“…Although recurrence does not imply progression, some investigators have emphasized the importance of the data relating to recurrence. 3,4,10,20,23 Holmang et al 21 demonstrated that patients with Ն10 recurrences had a high risk of metastatic bladder cancer and a significant risk of dying of this disease, even if the initial diagnosis had been Stage TaG1. These data on recurrence have confirmed an earlier observation reported by Parmar et al 4 for the British Medical Research Council subgroup on non-muscle invasive bladder cancer.…”

Section: Commentmentioning

confidence: 99%

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Recurrence at Three Months and High-grade Recurrence as Prognostic Factor of Progression in Multivariate Analysis of T1G2 Bladder Tumors

Palou

Rodríguez-Rubio

Millán

et al. 2009

Urology

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OBJECTIVESTo evaluate the risk factors for disease progression in the frequent subgroup of Stage T1G2 (World Health Organization 1973) bladder tumors using an analysis of a large cohort of patients with Stage T1G2 disease. METHODSA cohort of 616 patients with Stage T1G2 were treated with transurethral resection and random bladder biopsies. The mean follow-up was 4.2 years. Univariate and multivariate analyses were done using Cox regression analysis. The independent variables were multiplicity, association with carcinoma in situ (CIS), tumor size, tumor recurrence at 3 or 6 months, tumor grade, and association with CIS at first recurrence. The dependent variable was progression to muscleinvasive disease. RESULTSProgression to muscle-invasive disease was identified in 28 of the 616 patients (4.5%). On multivariate analysis, when considering recurrence at 3 months, this factor was the principal prognostic factor, with a relative risk of 4.0 (95% confidence interval 1.2-13.3), followed by the presence of high-grade disease or CIS at first recurrence (relative risk 2.8, 95% confidence interval 1.3-5.8) and CIS associated with the primary tumor (relative risk 1.8, 95% confidence interval 1.1-2.9). When considering recurrence at 6 months, more prognostic factors were involved for progression, including as multiple tumors, CIS associated with the primary tumor, recurrence at 6 months, and the presence of high-grade disease or CIS at the first recurrence. CONCLUSIONSIn primary urothelial T1G2 bladder cancer, recurrence at 3 months was the main prognostic factor related to progression. Additional factors were the association of CIS with the primary tumor and the presence of high-grade disease and/or CIS at first recurrence. UROLOGY 73: 1313UROLOGY 73: -1317UROLOGY 73: , 2009

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Section: Commentmentioning

confidence: 99%

Section: Commentmentioning

confidence: 99%

Recurrence at Three Months and High-grade Recurrence as Prognostic Factor of Progression in Multivariate Analysis of T1G2 Bladder Tumors

Palou

Rodríguez-Rubio

Millán

et al. 2009

Urology

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“…Ten to 22% of patients who fail an initial induction course of BCG may be salvaged with a second induction course [2,3]. Recently, the addition of a single 3 week maintenance course of BCG increased the complete response rate at 6 months from 68% to 84% compared to patients who receive only a 6-week induction course [4]. The addition of interferon alpha may augment the response to BCG and Phase II studies suggest that salvage of high risk patients who have failed BCG is possible in over one half of patients treated with this combination [5,6].…”

Section: Introductionmentioning

confidence: 99%

“…SWOG 8507 is one of the largest prospective trials of intravesical BCG with a median follow-up of 7.5 years [4]. This randomized trial tested the hypothesis that the addition of maintenance BCG would be associated with lower recurrence and progression rates compared to an induction course alone.…”

Section: Introductionmentioning

confidence: 99%

Failure to achieve a complete response to induction BCG therapy is associated with increased risk of disease worsening and death in patients with high risk non-muscle invasive bladder cancer

Lerner

Tangen

Sucharew

et al. 2009

Urologic Oncology: Seminars and Original Investigations

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Purpose-The Southwest Oncology Group conducted a randomized trial of induction BCG with or without maintenance BCG. In these additional retrospective analyses, our goal was to evaluate the association of a complete response (CR) or remaining with no evidence of disease (NED) versus no CR during induction therapy with subsequent survival after adjusting for other potential confounders. Among all patients randomized to maintenance treatment, we also wanted to identify combinations of baseline covariates in order to define prognostic groups for subsequent worseningfree survival.Methods-Outcome measures of worsening-free and overall survival were assessed using Kaplan Meier estimates and proportional hazards regression models. For the Classification and Regression Tree (CART) analysis, 434 patients randomized to maintenance vs. no therapy with complete covariate information were included.Results-Of the 593 evaluable patients, 341 were not randomized to maintenance BCG. Patients who achieved a prior complete response during induction BCG had a 5-year survival probability of 77% compared to 62% for patients who did not [Hazard ratio (HR) 0.60; 95% confidence interval (CI) 0.44, 0.81; p= 0.0008]. Prior CR retained significance when adjusted for age, gender, prior intravesical chemotherapy, and papillary disease versus CIS (HR=0.63; 95% CI: .46, .86; p=0.003). CART analysis identified 4 prognostic groups. Older patients (≥ 62 years old) previously treated with intravesical chemotherapy who failed to achieve a CR had a 5-fold higher risk of a worsening event relative to those who are younger (< 67 years old) and achieve a CR (HR=5.09; 95% CI: 3.37, 7.68; p<0.0001). Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. Conclusion-Failure to achieve a complete response after induction BCG is associated with a significant risk of a worsening event and death for patients with CIS or Ta or T1 bladder cancer at increased risk of recurrence. NIH Public Access

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“…Recent data from the Southwest Oncology Group trial of maintenance bacillus Calmette-Guerin (BCG) demonstrated that cytology may convert to normal up to 6 months or longer after a single induction course of BCG. 15 Two of five patients who did not undergo biopsies subsequently developed bladder carcinoma. The first patient developed a Ta Grade 3 TCC 2 years later, and the second patient developed a Ta Grade 1 TCC only 7 months after inclusion in the study.…”

Section: Discussionmentioning

confidence: 99%

Urinary levels of urokinase‐type plasminogen activator and its receptor in the detection of bladder carcinoma

Casella

Shariat

Monoski

et al. 2002

Cancer

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Several studies have demonstrated that estrogen modulates brain‐derived neurotrophic factor (BDNF) mRNA and protein within the adult hippocampus and cortex. However, mechanisms underlying this regulation are unknown. Although an estrogen response element (ERE)‐like sequence has been identified within the BDNF gene, such a classical mechanism of estrogen‐induced transcriptional activation requires the colocalized expression of estrogen receptors within cells that produce BDNF. Developmental studies have demonstrated such a relationship, but to date no studies have examined colocalization of estrogen receptors and BDNF within the adult brain. By utilizing double‐label immunohistochemistry for BDNF, estrogen receptor‐α (ER‐α), and estrogen receptor‐β (ER‐β), we found only sparse colocalization between ER‐α and BDNF in the hypothalamus, amygdala, prelimbic cortex, and ventral hippocampus. Furthermore, ER‐β and BDNF do not colocalize in any brain region. Given the recent finding that cortical ER‐β is almost exclusively localized to parvalbumin‐immunoreactive GABAergic neurons, we performed BDNF/parvalbumin double labeling and discovered that axons from cortical ER‐β‐expressing inhibitory neurons terminate on BDNF‐immunoreactive pyramidal cells. Collectively, these findings support a potential transsynaptic relationship between estrogen state and cortical BDNF: By directly modulating GABAergic interneurons, estrogen may indirectly influence the activity and expression of BDNF‐producing cortical neurons. J. Comp. Neurol. 468:347–360, 2004. © 2003 Wiley‐Liss, Inc.

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Maintenance Bacillus Calmette-Guerin Immunotherapy for Recurrent Ta, T1 and Carcinoma in Situ Transitional Cell Carcinoma of the Bladder: A Randomized Southwest Oncology Group Study

Cited by 1,090 publications

References 24 publications

Recurrence at Three Months and High-grade Recurrence as Prognostic Factor of Progression in Multivariate Analysis of T1G2 Bladder Tumors

Recurrence at Three Months and High-grade Recurrence as Prognostic Factor of Progression in Multivariate Analysis of T1G2 Bladder Tumors

Failure to achieve a complete response to induction BCG therapy is associated with increased risk of disease worsening and death in patients with high risk non-muscle invasive bladder cancer

Urinary levels of urokinase‐type plasminogen activator and its receptor in the detection of bladder carcinoma

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