|
Use of adjuvant chemotherapy following cystectomy in patients with deep muscle-invasive transitional cell carcinoma of the bladder |
Segal R, Winquist E, Lukka H, Chin J, Brundage M, Markman B, Genitourinary Cancer Disease Site Group |
|
|
CRD summary The review aimed to determine the role of adjuvant chemotherapy following surgery for the treatment of bladder cancer. Although the authors' conclusion, that available evidence did not support the routine use of adjuvant chemotherapy in this population, appeared consistent with the results obtained, small sample sizes and poor reporting of the review process may restrict interpretation.
Authors' objectives To determine the role of post-operative adjuvant chemotherapy in the treatment of deep muscle-invasive transitional cell carcinoma (TCC) of the bladder.
Searching MEDLINE (1985 to October 2002), Cancerlit (1985 to October 2002) and the Cochrane Library (Issue 4, 2002) were searched for articles in English; the search terms were reported. PDQ was searched for new or ongoing trials. Personal files and bibliographic references of relevant articles and reviews were also searched. Abstracts, letters and editorials were excluded.
Study selection Study designs of evaluations included in the reviewRandomised controlled trials (RCTs) were included in the review.
Specific interventions included in the reviewStudies that compared post-operative adjuvant chemotherapy with observation were eligible. Studies comparing different chemotherapy regimens were also considered.
Participants included in the reviewAdults who had undergone cystectomy for the treatment of deep muscle-invasive TCC of the bladder (pT2b or pT3 or pT4 and pN0-pN2 only) were eligible for inclusion. Adults with superficial muscle invasion (pT2a) were not considered.
Outcomes assessed in the reviewStudies that evaluated overall survival, disease-free survival, adverse effects and quality of life were eligible.
How were decisions on the relevance of primary studies made?Three reviewers assessed articles for relevance. The authors did not state whether this was conducted independently, or how any disagreements were resolved.
Assessment of study quality The validity of the primary studies was evaluated in terms of randomisation, intention-to-treat analysis, withdrawal, duration of follow-up, number of participants not enrolled, evidence of balancing of prognostic factors, and other non-specific criteria. The authors did not state how the validity of the primary studies was assessed, or how many reviewers performed the validity assessment.
Data extraction The authors did not state how the data were extracted for the review, or how many reviewers performed the data extraction.
Methods of synthesis How were the studies combined?A narrative synthesis of the primary studies was undertaken.
How were differences between studies investigated?No formal test of heterogeneity was used, although individual study differences were described in the body of the text.
Results of the review Four RCTs (at least 275 participants) were included in the review.
All four trials failed to detect an overall survival benefit with post-operative adjuvant chemotherapy.
All three trials reporting data on disease-free survival found a statistically significant benefit in favour of post-operative adjuvant chemotherapy compared with observation. The median follow-up time ranged from 32 to 69 months.
A substantial number of adverse effects were reported in participants receiving chemotherapy. These included nausea and vomiting, dehydration, peripheral neuropathy and impaired renal function, gastrointestinal toxicities, and death from neutropenic sepsis. Of the two trials reporting data on lymph node involvement and survival outcomes, patients with greater lymph node involvement were shown to be at greater risk of recurrence of death. Subgroup analyses from one trial based on nodal status indicated that post-surgical adjuvant chemotherapy benefited all groups, although the magnitude and duration of the benefit appeared to vary according to the degree of lymph node involvement.
No trials directly comparing different chemotherapy regimens were identified.
Authors' conclusions The available evidence did not support the routine use of post-surgical adjuvant chemotherapy in patients with deep muscle-invasive TCC of the bladder.
CRD commentary The review question was supported by clear inclusion and exclusion criteria. Several electronic databases were searched, although the search strategy was restricted to published, English language studies; publication bias was not assessed. Procedures implemented for the data extraction and validity assessment were not reported, thus the likelihood of reviewer error or bias at these stages could not be assessed. The methodological quality of the primary studies was assessed, and the results reported. Given the clinical differences between the primary studies in terms of disease stage, duration of follow-up and treatment regimen, the use of a narrative summary was appropriate. The authors' conclusions appear consistent with the results obtained, but are perhaps too firm if the small sample sizes of the included studies and corresponding limited statistical power, and poor reporting of the review process are considered.
Implications of the review for practice and research Practice: The authors stated that post-surgical adjuvant therapy should not be routinely offered for the treatment of deep muscle-invasive TCC of the bladder, but that adjuvant chemotherapy could be offered to high-risk patients for whom an improvement in disease-free survival is important. The authors recommended that the possible benefits and associated risks, including toxicities, are fully discussed with any patient for whom adjuvant chemotherapy is being considered. The use of a cisplatin-based combination chemotherapy regimen from one of the identified RCTs is recommended if chemotherapy is opted for.
Research: The authors did not state any implications for future research.
Funding Cancer Care Ontario; Ontario Ministry of Health and Long-term Care.
Bibliographic details Segal R, Winquist E, Lukka H, Chin J, Brundage M, Markman B, Genitourinary Cancer Disease Site Group. Use of adjuvant chemotherapy following cystectomy in patients with deep muscle-invasive transitional cell carcinoma of the bladder. Cancer Care Ontario Practice Guidelines Initiative 2003. Available at: https://www.cancercare.on.ca/common/pages/UserFile.aspx?fileId=14054 Accessed April, 2014 This paper is produced by Cancer Care Ontario Practice Guidelines Initiative. The series is published on the Internet and regularly updated. To ensure that you are viewing the most up to date version, go to the Cancer Care Ontario website at: http://www.cancercare.on.ca/english/toolbox/qualityguidelines/pebc/
This abstract is based on the web version accessed on 13/10/2005 Other publications of related interest 1. Browman GP, Levine MN, Mohide EA, Hayward RS, Pritchard KI, Gafni A, et al. The practice guidelines development cycle: a conceptual tool for practice guidelines development and implementation. J Clin Oncol 1995;13:502-12. 2. Segal R, Winquist E, Lukka H, Chin JL, Brundage M, Markman BR. Adjuvant chemotherapy for deep muscle-invasive transitional cell bladder carcinoma - a practice guideline. Can J Urol 2002;9:1625- 33.
Indexing Status Subject indexing assigned by CRD MeSH Antineoplastic Combined Chemotherapy Protocols /therapeutic use; Chemotherapy, Adjuvant; Cystectomy; Urinary Bladder Neoplasms /drug therapy /surgery AccessionNumber 12003008440 Date bibliographic record published 30/04/2006 Date abstract record published 30/04/2006 Record Status This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn. |
|
|
|