Neoadjuvant Chemotherapy plus Cystectomy Compared with Cystectomy Alone for Locally Advanced Bladder Cancer
- Study type
- Clinical trial
- Design
- Randomised controlled trial, stratified by age and disease stage
- Sample size
- 317 patients enrolled; 10 were ineligible and 307 patients were analysed (154 in the surgery-alone group and 153 in the combined-treatment group)
- Source
- N Engl J Med · 2003
In plain words
In this study, patients with bladder cancer that had grown into the bladder muscle either had only surgery to remove the bladder, or received three cycles of chemotherapy with a combination of four drugs (MVAC) before surgery. In the group that had chemotherapy before surgery, the removed bladder more often showed no cancer left (38% versus 15%). Median survival was also longer in this group (77 months versus 46 months), although this difference just missed the threshold of statistical significance (P=0.06). The decision about chemotherapy before surgery should be made with the treating doctor.
Key results
Treatment arms and regimens
Radical cystectomy without neoadjuvant chemotherapy (154 patients).
Three cycles of methotrexate, vinblastine, doxorubicin and cisplatin (MVAC) followed by radical cystectomy (153 patients). The dose and daily schedule of each drug are not given in the abstract or in the freely available sources (the ClinicalTrials.gov record and secondary analyses of SWOG 8710), and the full text of the NEJM paper was not available to us.
Source of the regimen details: Abstract of the paper; eligibility criteria of the original SWOG 8710 trial from ClinicalTrials.gov NCT02756637 (secondary analysis) and enrolment period from PMC5319875; the doses of the MVAC drugs are not given in the available sources
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Patients with muscle-invasive transitional cell carcinoma of the bladder, stage T2 to T4a, N0, M0 (AJCC 4th edition), scheduled for radical cystectomy; SWOG performance status 0 or 1; adequate organ function (white cell count above 4000 per cubic millimetre, platelets above 150,000 per cubic millimetre, creatinine below 1.5 mg/dL in men or below 1.3 mg/dL in women, and liver tests below 2 times the upper limit of normal). No age limit; another malignancy (except basal cell skin cancer), prior pelvic radiotherapy and metastatic or incurable disease were exclusion criteria. Stratification by age (under 65 years versus 65 years or older) and stage (superficial muscle invasion versus more extensive disease); enrolment from 1987 to 1998.
Endpoints
The abstract does not explicitly state the primary endpoint. Reported outcomes include overall survival (median survival, intention-to-treat analysis) and the absence of residual disease in the cystectomy specimen.
Safety and side effects
Safety and adverse event data are not reported in the abstract, and the full text of the paper was not available to us.
Clinical significance and place in guidelines
Based on the abstract, MVAC-based neoadjuvant chemotherapy before radical cystectomy increased the likelihood of no residual disease in the surgical specimen and was associated with improved survival, although the difference in median survival in the intention-to-treat analysis did not reach the threshold of significance (P=0.06). The status of this approach in current guidelines and its place relative to newer regimens should be checked separately; the abstract gives no information on this.
Limitations
Based on the abstract: the difference in median survival in the intention-to-treat analysis was not statistically significant (P=0.06). The abstract gives no information on adverse events or the primary endpoint. Enrolment took 11 years, and 10 patients were ineligible. Other limitations should be checked in the full text of the paper.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.