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Current and recent clinical trials for perioperative systemic therapy for muscle invasive bladder cancer: a systematic review.

Vashistha V, Quinn DI, Dorff TB, Daneshmand S - BMC Cancer (2014)

Bottom Line: Although Muscle Invasive Bladder Cancer (MIBC) is increasing in incidence, treatment has largely remained limited to radical cystectomy with or without cisplatin-based neoadjuvant and/or adjuvant chemotherapy.An overview of perioperative MIBC management was conducted initially using MEDLINE.Systematic MEDLINE searches had no phase restrictions.

View Article: PubMed Central - PubMed

Affiliation: Department of Urology, USC/Norris Comprehensive Cancer Center, USC Institute of Urology, 1441 Eastlake Abe, Suite 7416, Los Angeles, CA 90089, USA. daneshma@med.usc.edu.

ABSTRACT

Background: Although Muscle Invasive Bladder Cancer (MIBC) is increasing in incidence, treatment has largely remained limited to radical cystectomy with or without cisplatin-based neoadjuvant and/or adjuvant chemotherapy. We reviewed the current and recent clinical trials evaluating perioperative chemotherapy, targeted therapy, and novel therapeutic regimens for MIBC patients undergoing radical cystectomy.

Methods: An overview of perioperative MIBC management was conducted initially using MEDLINE. The Clinical Trials Registry and MEDLINE were further searched specifically for perioperative MIBC chemotherapy, targeted therapy, and other novel therapeutic approaches. Trials involving non-perioperative management, operative management other than radical cystectomy, multiple tumors, or purely superficial or metastatic disease were excluded from selection. These criteria were not specifically fulfilled for mTOR inhibitor and immune therapy trials. Only phase III chemotherapy and phase II targeted therapy trials found in the Clinical Trials Registry were selected. MEDLINE searches of specific treatments were limited to January 2009 to January 2014 whereas the Clinical Trials Registry search had no timeline. Systematic MEDLINE searches had no phase restrictions. Trials known by the authors to fulfill search criteria but were not found via searches were also selected.

Results: Twenty-five trials were selected from the Clinical Trials Registry including 7 phase III chemotherapy trials, 11 Phase II targeted therapy trials, 3 immune therapy trials, 1 mammalian target of rapamycin (mTOR) inhibitor trial, and 3 gene and vaccine therapy trials. Nine trials have been completed and 5 have been terminated early or withdrawn. Nine trials have data available when individually searched using MEDLINE and/or Google. Systematic searches of MEDLINE separately found 12 trials in the past 5 years. Two phase III chemotherapy trials were selected based on knowledge by the authors. No phase III trials of targeted therapy have been registered or published.

Conclusions: New trials are currently being conducted that may revolutionize MIBC treatment preceding or following cystectomy. Head-to-head phase III trials of perioperative chemotherapy and further phase II and phase III trials of targeted therapy and other therapeutic approaches are necessary before the current cisplatin-based perioperative chemotherapy paradigm is altered.

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Related in: MedlinePlus

Flow-chart of current management paradigm for patients with MIBC. RCT = Randomized Controlled Trial.
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Fig1: Flow-chart of current management paradigm for patients with MIBC. RCT = Randomized Controlled Trial.

Mentions: The current treatment paradigm for MIBC management is conveyed in Figure 1. Outcomes from meta-analyses of previous phase III perioperative chemotherapy trials are reported in Table 2. The current and recent perioperative clinical trials for MIBC are identified below based on drug class. The classes include perioperative chemotherapy (Table 3), targeted therapy (Table 4), mTOR inhibition (Table 5), immune therapy (Table 5), gene therapy (Table 6), and vaccine therapy (Table 6).Figure 1


Current and recent clinical trials for perioperative systemic therapy for muscle invasive bladder cancer: a systematic review.

Vashistha V, Quinn DI, Dorff TB, Daneshmand S - BMC Cancer (2014)

Flow-chart of current management paradigm for patients with MIBC. RCT = Randomized Controlled Trial.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4301463&req=5

Fig1: Flow-chart of current management paradigm for patients with MIBC. RCT = Randomized Controlled Trial.
Mentions: The current treatment paradigm for MIBC management is conveyed in Figure 1. Outcomes from meta-analyses of previous phase III perioperative chemotherapy trials are reported in Table 2. The current and recent perioperative clinical trials for MIBC are identified below based on drug class. The classes include perioperative chemotherapy (Table 3), targeted therapy (Table 4), mTOR inhibition (Table 5), immune therapy (Table 5), gene therapy (Table 6), and vaccine therapy (Table 6).Figure 1

Bottom Line: Although Muscle Invasive Bladder Cancer (MIBC) is increasing in incidence, treatment has largely remained limited to radical cystectomy with or without cisplatin-based neoadjuvant and/or adjuvant chemotherapy.An overview of perioperative MIBC management was conducted initially using MEDLINE.Systematic MEDLINE searches had no phase restrictions.

View Article: PubMed Central - PubMed

Affiliation: Department of Urology, USC/Norris Comprehensive Cancer Center, USC Institute of Urology, 1441 Eastlake Abe, Suite 7416, Los Angeles, CA 90089, USA. daneshma@med.usc.edu.

ABSTRACT

Background: Although Muscle Invasive Bladder Cancer (MIBC) is increasing in incidence, treatment has largely remained limited to radical cystectomy with or without cisplatin-based neoadjuvant and/or adjuvant chemotherapy. We reviewed the current and recent clinical trials evaluating perioperative chemotherapy, targeted therapy, and novel therapeutic regimens for MIBC patients undergoing radical cystectomy.

Methods: An overview of perioperative MIBC management was conducted initially using MEDLINE. The Clinical Trials Registry and MEDLINE were further searched specifically for perioperative MIBC chemotherapy, targeted therapy, and other novel therapeutic approaches. Trials involving non-perioperative management, operative management other than radical cystectomy, multiple tumors, or purely superficial or metastatic disease were excluded from selection. These criteria were not specifically fulfilled for mTOR inhibitor and immune therapy trials. Only phase III chemotherapy and phase II targeted therapy trials found in the Clinical Trials Registry were selected. MEDLINE searches of specific treatments were limited to January 2009 to January 2014 whereas the Clinical Trials Registry search had no timeline. Systematic MEDLINE searches had no phase restrictions. Trials known by the authors to fulfill search criteria but were not found via searches were also selected.

Results: Twenty-five trials were selected from the Clinical Trials Registry including 7 phase III chemotherapy trials, 11 Phase II targeted therapy trials, 3 immune therapy trials, 1 mammalian target of rapamycin (mTOR) inhibitor trial, and 3 gene and vaccine therapy trials. Nine trials have been completed and 5 have been terminated early or withdrawn. Nine trials have data available when individually searched using MEDLINE and/or Google. Systematic searches of MEDLINE separately found 12 trials in the past 5 years. Two phase III chemotherapy trials were selected based on knowledge by the authors. No phase III trials of targeted therapy have been registered or published.

Conclusions: New trials are currently being conducted that may revolutionize MIBC treatment preceding or following cystectomy. Head-to-head phase III trials of perioperative chemotherapy and further phase II and phase III trials of targeted therapy and other therapeutic approaches are necessary before the current cisplatin-based perioperative chemotherapy paradigm is altered.

Show MeSH
Related in: MedlinePlus