Outcomes in Patients with Muscle-invasive Bladder Cancer Treated with Neoadjuvant Chemotherapy Followed by (Chemo)radiotherapy in the BC2001 Trial.
Loading...
Embargo End Date
Authors
Hussain, SA
Porta, N
Hall, E
Salawu, A
Lewis, R
Sreenivasan, T
Wallace, J
Crundwell, M
Jenkins, P
Tremlett, J
Huddart, R
James, ND
BC2001 Investigators,
Porta, N
Hall, E
Salawu, A
Lewis, R
Sreenivasan, T
Wallace, J
Crundwell, M
Jenkins, P
Tremlett, J
Huddart, R
James, ND
BC2001 Investigators,
Document Type
Journal Article
Date
2021-02-01
Date Accepted
2020-11-19
Abstract
BACKGROUND: BC2001 demonstrated improved local control with the addition of chemotherapy to radiotherapy in 360 patients with muscle-invasive bladder cancer. OBJECTIVE: To establish whether such benefit remained in BC2001 patients who received prior neoadjuvant chemotherapy. DESIGN, SETTING, AND PARTICIPANTS: A total of 117 patients (33%) received neoadjuvant chemotherapy and were randomised to radiotherapy with (48%) or without (52%) concomitant chemotherapy. Patients were recruited between August 2001 and April 2008 from 28 UK centres. INTERVENTION: Platinum-based neoadjuvant chemotherapy, followed by radiotherapy with (cRT) or without (RT) synchronous 5-fluorouracil and mitomycin-C. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Toxicity, locoregional control (LRC), overall survival (OS), and quality of life (QoL) were measured. RESULTS AND LIMITATIONS: Of the patients, 74% received gemcitabine plus cisplatin or carboplatin. Compliance rates with full-dose radiotherapy were cRT 93% and RT 92%. An excess of grade ≥3 toxicities while on (chemo)radiation occurred for cRT 33% versus RT 22%, although nonstatistically significant (p = 0.16). With 110 mo median follow-up for survival (interquartile range 96-123), cRT showed improved LRC though not statistically significant (adjusted hazard ratio [aHR] = 0.64, 95% confidence interval [CI] 0.33-1.23, p = 0.18). No differences in OS (aHR = 0.95, 95% CI 0.57-1.57, p = 0.8) were observed. No significant detriment in QoL was observed between cRT and RT in this subgroup of patients. CONCLUSIONS: Neoadjuvant chemotherapy does not compromise the delivery of radical curative treatment. Although underpowered due to a small sample size, the benefit of chemoradiotherapy to improve local control in this group of patients receiving neoadjuvant chemotherapy is consistent with that observed in the main trial. Although a nonsignificant excess of toxicity was observed, there was no evidence of impaired QoL. PATIENT SUMMARY: Chemotherapy before radical chemo(radiotherapy) is feasible and well tolerated.
Citation
European urology, 2021, 79 (2), pp. 307 - 315
Rights
Source Title
Publisher
ELSEVIER
ISSN
0302-2838
eISSN
1873-7560
Collections
Research Team
Clinical Trials & Statistics Unit
ICR-CTSU Urology and Head and Neck Trials Team
Clinical Academic Radiotherapy (Huddart)
Prostate and Bladder Cancer Research
ICR-CTSU Urology and Head and Neck Trials Team
Clinical Academic Radiotherapy (Huddart)
Prostate and Bladder Cancer Research