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Active Surveillance OK For Non-Muscle Invasive Bladder Cancer

Active Surveillance OK For Non-Muscle Invasive Bladder Cancer

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Action Points

  • Note that this observational study suggests that, for certain individuals with low-grade recurrent bladder cancer, active surveillance may be a viable alternative to transurethral resection of bladder tumor.
  • The study did not take into account certain genetic markers that may help to further risk-stratify patients in the future.

Active surveillance (AS) may give select patients with small, low-grade, recurrent non-muscle invasive bladder cancer (NMIBC) a safe, cost-effective way to avoid frequent surgeries without increasing the risk of progression, according to researchers.

In an ongoing prospective observational study of 122 patients on AS, 59 out of 146 events (40.4%) required treatment after a median of 11 months, said Massimo Lazzeri, MD, of Istituto Clinico Humanitas Istituto di Ricovero e Cura a Carattere Scientifico-Clinical and Research Hospital in Milan, Italy, and colleagues.

No cancer-related events were observed during AS and no significant complications resulted from repeat cystoscopy, except for five episodes of urinary tract infection, the team reported online in the Journal of Urology.

Recurrence-free survival appeared to be associated with age at the start of AS (HR 0.97, P=0.031) and the size of the lesion at the first transurethral resection (HR 1.55, P=0.025), the analysis showed. A total of 76 patients (62.3%) are still under observation.

“Our findings show that an AS protocol for recurrent NMIBC could be a reasonable clinical and cost-effective option in some elderly patients with comorbidities and in some young healthy patients as well who have small low-grade recurrent papillary bladder tumors after TURBT [transurethral resection of bladder tumor],” the study authors wrote.

“We believe that only patients with T1a tumors, which extend into the lamina propria but above the level of the muscularis mucosa, should be included in an AS program, since the risk of progression is low.”

Currently, AS is not included as an option in guidelines for the management of NIMBC issued by either the American Urological Association or the European Urological Association, Lazzeri and colleagues pointed out. In addition, AS is still associated with a failure rate of almost 50%.

“Such data document how poorly we are doing in selecting ideal candidates for AS,” the team said, adding that genetic testing could change all that. “New molecular urine marker testing could present tremendous promise for patient selection, opening the door to new tools to improve the success rate of AS or find progressive disease at an early and actively treatable stage.”

The Bladder Cancer Italian Active Surveillance project began in February 2008 to monitor patients with a history of pathologically confirmed stage pTa (grade 1-2) or pT1a (grade 2) non-muscle invasive bladder cancer, who experienced recurrence without hematuria and positive urine cytology during follow-up.

The mean age of the participants was 71, and 102 of the 122 patients (83.6%) were male. At study entry, there were 125 pTa (85.6%) and 21 pT1a lesions (14.4%), with grade 1 and 2 disease observed in 109 (74.7%) and 37 events (25.3%), respectively. All pT1a tumor events were grade 2 disease.

Although recurrence-free survival also appeared to be inversely related to the time from first transurethral resection and the start of AS (HR 0.99, P=0.027), this association could be “essentially meaningless clinically since it is close to 1,” the investigators pointed out.

A cost analysis showed that AS could reduce the lifetime cost of treatment for patients with small low-grade pTa/pT1a bladder tumors by €1,378 (approximately $1,700) for each TURBT avoided. Since the economic analysis was based on Italian National Health Service standards, however, the findings may not be applicable to other health systems, the investigators pointed out.

In an accompanying editorial, Mark S. Soloway, MD, of Memorial Hospital in Hollywood, FL, called AS or office fulguration of low-grade bladder tumors “an excellent option” that saves patients and clinicians a lot of time. He also said the cost differential between AS and TURBT was probably underestimated in this study.

“Compared to formal TURBT, which includes general or spinal anesthesia, this is a win-win scenario,” wrote Soloway, who first described the use of “expectant management” in NIMBC in 2003. “TURBT requires preoperative testing, medical clearance, and [there is] potential morbidity from anesthesia and TURBT.”

Currently, genetic testing is costly and underused by urologists for the management of NIMBC, the study authors noted. This will change in the future, and “it will become impossible to manage bladder cancer without molecular markers,” they predicted.

As previously reported by MedPage Today, the use of AS in other low-risk cancers varies widely. In indolent prostate cancer, for instance, the use of AS is “alarmingly low,” while in renal cancer, a small but growing number of patients with small renal masses have opted for AS. Not only was AS proven safe with adherence to well-defined criteria, but the researchers reported that cancer-specific survival was identical to immediate treatment.

In urological practice, many barriers remain to introducing AS, the investigators acknowledged. However, they continue to offer AS to patients with NIMBC, they said, emphasizing that patient counseling is “essential.”

The limitations of the study, the team said, include the fact that it did not have the power of a randomized, controlled trial and might have benefited from stage-based sub-analyses.

Lazzeri and co-authors reported having no conflicts of interest.

  • Reviewed by
    F. Perry Wilson, MD, MSCE Assistant Professor, Section of Nephrology, Yale School of Medicine and Dorothy Caputo, MA, BSN, RN, Nurse Planner


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