Adjuvant vs. progression-triggered treatment with gemcitabine in platinum-ineligible high-risk bladder cancer patients: Long-term follow-up of a randomized phase 3 trial.
Urol Oncol
; 41(8): 356.e19-356.e30, 2023 08.
Article
in En
| MEDLINE
| ID: mdl-37198025
ABSTRACT
BACKGROUND:
Cisplatin-based chemotherapy (ChT) is the preferred perioperative treatment in muscle-invasive urothelial carcinoma of the urinary bladder (UCUB). Nevertheless, a certain number of patients are ineligible for platinum-based ChT. This trial compared immediate adjuvant vs. delayed gemcitabine ChT at progression in platinum-ineligible patients with high-risk UCUB.METHODS:
High-risk platinum-ineligible UCUB patients (nâ¯=â¯115) were randomized 11 to adjuvant gemcitabine (nâ¯=â¯59) or gemcitabine at progression (nâ¯=â¯56). Overall survival was analyzed. Additionally, we analyzed progression-free survival (PFS), toxicity and quality of life (QoL).RESULTS:
After a median follow-up of 3.0 years (inter quartile range [IQR] 1.3-11.6), adjuvant ChT did not significantly prolong overall survival (OS) (HR 0.84; 95% CI 0.57-1.24; P = 0.375), with 5-year OS of 44.1% (95% CI 31.2-56.2) and 30.4% (95% CI 19.0-42.5), respectively. We noted no significant difference in PFS (HR 0.76; 95% CI 0.49-1.18; P = 0.218), with 5-year PFS of 36.2% (95% CI 22.8-49.7) in the adjuvant group and 22.2% (95% CI 11.5%-35.1%) when treated at progression. Patients with adjuvant treatment showed a significantly worse QoL. The trial was prematurely closed after recruitment of 115 of the planned 178 patients.CONCLUSIONS:
There was no statistically significant difference in terms of OS and PFS for patients with platinum-ineligible high-risk UCUB receiving adjuvant gemcitabine compared to patients treated at progression. These findings underline the importance of implementing and developing new perioperative treatments for platinum-ineligible UCUB patients.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Urinary Bladder Neoplasms
/
Carcinoma, Transitional Cell
Type of study:
Clinical_trials
/
Etiology_studies
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Aspects:
Patient_preference
Limits:
Humans
Language:
En
Journal:
Urol Oncol
Journal subject:
NEOPLASIAS
/
UROLOGIA
Year:
2023
Document type:
Article