Appendix 4Main Study Findings and Author’s Conclusions
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| Study, Year, Country, Design | Main Findings |
|---|
Chou et al., 2016
9
USA
SR and MA
| Risk of bias:
High
(4 RCTs)
Medium (11 RCTs)
Recurrence –
Short term (<3 months) |
| Intervention | No. studies | RR (95% CI) |
I
2
| Strength of evidence |
| Overall | 10 | 0.60 (0.37 to 0.88) | 67% | Low |
| ALA | 4 | 0.57 (0.28 to 1.16) | 84% | |
| HAL | 6 | 0.62 (0.38 to 1.00) | 51% | |
| Recurrence –
Intermediate term (3 months to <12 months) |
| Intervention | No. studies | RR (95% CI) |
I
2
| Strength of evidence |
| Overall | 6 | 0.70 (0.56 to 0.88) | 19% | Low |
| ALA | 1 | 0.56 (0.34 to 0.91) | NA | |
| HAL | 5 | 0.76 (0.62 to 0.93) | 7% | |
| Recurrence – Long term
(≥12 months) |
| Intervention | No. studies | RR (95% CI) |
I
2
| Strength of evidence |
| Overall | 12 | 0.81 (0.70 to 0.93) | 46% | Low |
| ALA | 5 | 0.86 (0.68 to 1.08) | 66% | |
| HAL | 7 | 0.75 (0.62 to 0.92) | 41% | |
| 3 (where performance bias was reduced) | 0.96 (0.79 to 1.18) | 36% | |
| Progression to muscle invasive
bladder cancer |
| Intervention | No. studies | RR (95% CI) |
I
2
| Strength of evidence |
| Overall | 9 | 0.74 (0.52 to 1.03) | 0% | Moderate |
| ALA | 5 | 0.86 (0.57 to 1.28) | 0% | |
| HAL | 4 | 0.51 (0.28 to 0.96) | 0% | |
| Mortality |
| Intervention | No. studies | RR (95% CI) |
I
2
| Strength of evidence |
| Overall | 3 | 1.28 (0.55 to 2.95) | 43% | Low |
| ALA | 1 | 1.22 (0.34 to 4.46) | NA | |
| HAL | 2 | 1.87 (0.29 to 12.22) | 71% | |
Harms:
No
difference between fluorescent cystoscopy and white light cystoscopy for
local adverse events such as hematuria, dysuria, urinary frequency or
urgency and bladder spasms occurred after cystoscopy (the frequency of
events was not reported). |
| Authors’ conclusions:
“Fluorescent cystoscopy was associated with a
reduced risk of recurrence vs white light cystoscopy, although there
were inconsistencies and our findings may have been affected by
performance bias or publication bias. Fluorescent cystoscopy with
HAL may be associated with a decreased risk of progression but more
studies with long-term follow-up are needed to better understand the
effects of photosensitizer used on progression. Evidence on the
effects of fluorescent cystoscopy on mortality is too sparse to
reach strong conclusions.”9 p.9 |
Gakis and Fahmy, 2016
10
Germany and Malaysia
SR and MA
| Risk of bias: low to
moderate
Progression to muscle invasive bladder cancer |
| Intervention | No. studies | %WL-TURBT vs % HAL-TURBT | OR (95% CI) |
I
2
|
| HAL | 5 | 10.7 vs 6.8 | 1.64 (0.28 to 0.96) | 0% |
| Authors’ conclusions:
“This meta-analysis supported the assumption that
the detection and resection of NMIBC with HAL-guided TURBT reduces
the risk of progression. Therefore, patients should receive
hexaminolevulinate- rather than white-light-guided TURBT at their
first resection as this might allow more patients at risk of
progression to be treated timely and
adequately.”10 p.299 |
ALA = 5-aminolevulinic acid; CI = confidence interval; HAL =
hexaminolevulinic acid; MA = meta-analysis; NA = not applicable; NMIBC =
non-muscle invasive bladder cancer; RCT = randomized controlled trial; RR =
relative risk; SR = systematic review; TURBT = transurethral bladder tumor
resection; vs = versus; WL = white light
