NEW YORK (Reuters Health) - A meta-analysis using individual patient data "clearly confirmed" the efficacy of a single instillation of chemotherapy immediately following resection of superficial bladder cancer in reducing risk of recurrence, European investigators say.
However, the data also indicate that single postoperative instillation (SPI) of chemotherapy should be avoided in patients at high risk of recurrence due to its lack of efficacy in this subgroup, report Dr. Richard J. Sylvester, from the European Organization for Research and Treatment of Cancer (EORTC) Headquarters, Brussels, Belgium, and colleagues.
"The European Association of Urology non-muscle-invasive bladder cancer (NMIBC) guidelines recommend that all low- and intermediate-risk patients receive a single immediate instillation of chemotherapy after transurethral resection of the bladder (TURB), but its use remains controversial," they point out in their European Urology online report.
"The limited use of SPI in daily practice remains a problem," writes J. Alfred Witjes, from Radboud University Nijmegen Medical Center, the Netherlands, in a linked editorial. "I hope that the data presented by Sylvester et al will convince urologists to use SPI, at least in all low-risk patients, which should improve the quality of care and patient outcomes and reduce health care costs."
To identify which NMIBC patients benefit from SPI of chemotherapy, Dr. Sylvester's group identified 13 relevant randomized controlled trials. They obtained individual patient data from 11 studies involving 2278 patients with pTa-pT1 tumors who underwent TURB alone or with SPI of chemotherapy (epirubicin, mitomycin C, pirarubicin or thiotepa). Altogether, there were 1128 recurrences, 108 progressions, and 460 deaths (59 due to bladder cancer).
SPI of chemotherapy after surgery reduced the risk of recurrence by 35% (P<0 .001="" 14="" 44.8="" 58.8="" absolute="" at="" five="" from="" in="" p="" recurrence="" reduction="" the="" to="" was="" years="">
However, SPI did not reduce the recurrence rate in higher risk patients - those with more than one prior recurrence per year and those with a EORTC recurrence score 5 or greater. This subgroup was mainly composed of patients with multiple tumors (51%), tumors 3 cm or larger (70%), and T1 tumors (76%), the authors say.
Exploratory analyses suggest that SPI "may be associated with an increase in the risk of death in patients at high risk of recurrence in whom the instillation is not effective or recommended," Dr. Sylvester and colleagues report.
In his editorial, Dr Witjes notes that, "Except for thiotepa, the chemotherapeutic drugs studied showed similar efficacy. In addition, "better efficacy was seen when the instillation was given within 2 h after surgery. Although this finding is not based on randomized comparison, it certainly makes sense and is something that should be kept in mind."
The study had no commercial funding and the authors have no relevant disclosures. They did not respond to requests for comment by press time.
SOURCE: http://bit.ly/1LaMm49 and http://bit.ly/1N7GmMy
Eur Urol 2015.
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