Outcomes in Patients with Muscle-invasive Bladder Cancer Treated with Neoadjuvant Chemotherapy Followed by (Chemo)radiotherapy in the BC2001 Trial.

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.

• Authors: Syed A Hussain, Nuria Porta, Emma Hall, Abdulazeez Salawu, Rebecca Lewis, Thiagarajan Sreenivasan, Jan Wallace, Malcolm Crundwell, Peter Jenkins, Jean Tremlett, Robert Huddart, Nicholas D James, BC2001 Investigators
• Journal: European urology (Eur Urol) Vol. 79 Issue 2 Pg. 307-315 (02 2021) ISSN: 1873-7560 [Electronic] Switzerland
• PMID: 33293079 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2020 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Topics

• Aged
• Aged, 80 and over
• Chemoradiotherapy
• Chemotherapy, Adjuvant
• Female
• Humans
• Male
• Middle Aged
• Neoadjuvant Therapy
• Neoplasm Invasiveness
• Prospective Studies
• Treatment Outcome
• Urinary Bladder Neoplasms (pathology, therapy)