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TCC indicates transitional cell carcinoma; Tis, tumor in situ; PI, perioperative instillation; G3, grade 3; MMC, mitomycin C; THP, (2″R)-4′- O -tetrahydropyranyl-doxorubicin; MRC, Medical Research Council.

*

Includes 2 patients with G3 disease who were excluded from analysis.

†

Forty-six patients had T0/Tis/T2/T3 disease or non-TCC within the bladder. Others were excluded for tumor ‘outside of bladder’ or ‘previous carcinoma.’ Only 129 PI treated patients of 397 total patients had follow-up information at publication in 1988; however, in 1996, it was indicated that 149 PI treated patients out of 452 total patients were analyzed. The latter group was used in the meta-analysis by Sylvester et al and, thus, was used here.

‡

PI exclusions were calculated as follows: 46 total exclusions from the PI group times 66 of the 81 patients (81%) who were excluded for inappropriate initial pathologic evaluation. PI G3 numbers were estimated as follows: the proportion of initial PI patients with G3 disease (24 of 205 patients) times the number of PI patients who had follow-up and were used in the analysis (194 patients).

§

This study also had an interferon alpha PI group that demonstrated no benefit and, thus, was excluded from the PI group analysis.

∥

Because of the loss of 2 patients to follow-up, these values were estimated in a manner similar to that used for estimating G3 patients for the Oosterlinck study, as described above.

ASC indicates ambulatory surgical center; PI, perioperative instillation; TUR, transurethral resection (of bladder tumor); CPT, Current Procedural Terminology; Pro, professional; Tech, technical; N/A, not applicable; MMC, mitomycin C; Path, pathologic evaluation; Drug, drug therapy.

*

All values shown are rounded to the nearest whole number, but calculations were performed using dollar fractions for greater numerical accuracy.

†

When instillation is performed perioperatively, a 50% multiple-procedure deduction is taken for this procedure, which is reflected in this table.

‡

Technical fees are bundled: These values include hospital and anesthesia technical reimbursements.

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Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, Ohio
Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, Ohio
Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, Ohio
Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, Ohio
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Level-1 evidence has demonstrated decreased recurrence of low-grade bladder tumors when initial transurethral resection (TUR) is followed by perioperative instillation (PI) of chemotherapy. A meta-analysis determined that the number needed to treat (NNT) was 8.5 patients to prevent 1 recurrence. No benefit was demonstrated for tumors classified as T0, tumor in situ, or T2; thus, patients with those tumors were excluded from the analysis, which potentially may have resulted in underestimating the true NNT. Economic benefits were suggested, but cost calculations were not presented. The objectives of the current analysis were to recalculate the NNT considering patients who previously were excluded and to examine the economic implications based on various management alternatives for tumor recurrence.
For each study that was included in the current meta-analysis, the number of patients excluded because of ‘inappropriate’ pathology results was determined. A potentially more accurate NNT was calculated, and pertinent Medicare reimbursements were obtained to estimate costs.
The added cost for 8.5 patients who underwent inpatient TUR to receive PI was $1711. Inpatient TUR ($7025) was extremely costly compared with hospital outpatient TUR ($2666), ambulatory surgery center TUR ($2113), and physician office fulguration ($1167). Although the inclusion of patients who previously were excluded resulted in a recalculated NNT of 9.6 patients, the authors used a more conservative NNT if 8.5 patients to estimate the economic impact of the ‘best-case scenario.’
Routine PI significantly lowered the overall cost if recurrences were managed in the inpatient setting, but these benefits were offset mostly or completely by outpatient management in the United States. Thus, the authors concluded that the decision to use routine PI of chemotherapy should be based on clinical effects and not on presumed economic benefits. Cancer 2009. © 2009 American Cancer Society.
Several recent publications have supported the use of routine perioperative instillation (PI) of intravesical chemotherapy in the management of nonmuscle-invasive bladder cancer. Nearly all reports have demonstrated a reduced recurrence rate of low-grade tumors. It is hypothesized that PI prevents the implantation of suspended tumor cells at sites of mucosal irritation after surgical manipulation. 1 - 4
This concept has been received enthusiastically by some clinicians, at least in part because it is 1 of the few examples of clear Level-1 evidence in the urologic literature. According to a meta-analysis by Sylvester et al, PI decreases the tumor recurrence rate by 11.7% overall, from a rate of 48.4% after transurethral resection (TUR) alone to 36.7% after the addition of a single postoperative dose of intravesical chemotherapy. 3 A decrease in recurrence was demonstrated for patients who had tumors classified (according to International Union Against Cancer criteria 5 ) as Ta and T1 with both single lesions (11.5% decrease) and multiple lesions (17%), although the authors concluded that this treatment was inadequate for the latter tumors. A more recent meta-analysis of 2 studies was performed by the American Urological Association (AUA) Bladder Cancer Clinical Guideline Update Panel, and the recurrence rate after PI of mitomycin C (MMC) reportedly was 17% lower than that of TUR alone. 6
Despite the overall decrease in recurrence, the impact appears to be limited primarily to small, so-called ‘nuisance tumors.’ 7 A recent study indicated that the tumors prevented by PI were limited to the smaller low-grade tumors, and no impact was reported on the recurrence of tumors that measured >5 mm in greatest dimension. 8 Finally, there is little or no evidence of a benefit from intravesical chemotherapy immediately after TUR for bladder tumors (TURBT) in patients with high-grade disease, 9 including carcinoma in situ (CIS), or for patients with detrusor-invasive disease (≥T2). 10 , 11 Possibly in relation to these limitations, previous studies also failed to demonstrate any impact on overall progression or survival, although the studies were powered inadequately for those outcomes. 3 , 6 Moreover, although the presence of malignancy and pathologic stage/grade of tumors often can be predicted based on cystoscopic examination, they are not known definitively at the time of initial TURBT, and a subset of tumors (approximately 7%) are high grade although they appear to be papillary and low grade. 12 Thus, the routine use of PI accrues costs and risks potential side effects both in patients with high-grade disease and in those with benign pathologic findings, although neither of these groups receives any proven benefit.
In the absence of a demonstrable impact on disease progression or mortality, supporters of routine PI have touted another theoretical benefit: that a decrease in recurrences inevitably leads to a decreased cost of repeat TUR procedures. The meta-analysis calculation that a single recurrence would be prevented by every 8.5 PIs (the number needed to treat [NNT]), it is suggested that routine treatment with PI after initial TURBT should be economically beneficial. 3 It is worth noting that this conclusion was made based on the presumption that TUR costs probably are >8.5 times the cost of a single PI dose 3 , 12 ; however, to our knowledge, no publication has considered the actual costs involved. Moreover, the NNT calculations excluded patients who received treatment despite having disease that had demonstrated no benefit from the chemotherapy, including patients with T0, T2, and T3 tumors, or high-grade disease, and some patients with multifocal disease. In fact, up to 28% of the patients were excluded from the larger studies, mostly because of these pathologic findings. 8 Thus, the NNT in clinical practice probably would be greater than the previously suggested number, which appears to represent the ‘best-case scenario’ regarding the benefits of PI.
Most recurrences are small and can be managed in an outpatient setting. It has been reported that office-based fulguration is a viable alternative to operative TURBT, and it is listed as an ‘option’ in the 2007 AUA guidelines. 6 , 13 Expectant management also may be appropriate for some small, low-grade, recurrent tumors. 14 The use of these options in lieu of hospital inpatient-based intervention for recurrences probably would diminish further any calculated advantage of routine PI. Given all of these issues, we sought to recalculate the NNT with consideration of patients who previously were excluded from analysis and to evaluate the actual cost impact of routine chemotherapeutic PI for all patients undergoing their first TURBT.
Seven randomized clinical trials were included in the meta-analysis of PI by Sylvester et al. We reviewed those publications to recalculate the total number of patients treated and the total decrease in recurrence from PI. From these data, a revised NNT to prevent 1 recurrence was determined.
In 2 of the studies, the number of treated patients who were excluded because of ‘inappropriate pathology’ was provided. 10 , 15 In the studies that did not provide this information, 9 , 16 - 22 this number was estimated by multiplying the study's total number of patients who were excluded for tumors categorized as T0/tumor in situ (Tis)/T2/T3 by the fraction of included patients in the PI group. This method assumed a random distribution of patients with these pathologic diagnoses among study groups.
In the United States, MMC is the most common PI agent. 6 , 23 , 24 With guidance from our reimbursement team, we examined United States Medicare reimbursement for MMC drug costs and instillation charges and for the management of recurrences by TUR (in hospital inpatient, hospital outpatient, and ambulatory surgery center [ASC] settings) or fulguration (in the office setting).
According to the analysis by Sylvester et al, 100 patients receivin
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