A phase III Egyptian trial presented by Mohamad S. Zaghloul, MD, et al at the 2019 Genitourinary Cancers Symposium focused on the benefit of adjuvant chemotherapy in patients with locally advanced bladder cancer treated with postoperative radiotherapy.1 Researchers compared postoperative radiotherapy alone vs sequential chemotherapy plus postoperative radiotherapy after radical cystectomy in locally advanced bladder cancer.
Mohamad S. Zaghloul, MD
Study Methods
A TOTAL OF 153 patients were enrolled from 2002 to 2008 at the National Cancer Institute in Cairo. Patients with at least one of the following factors—≥ pT3b, grade 3 disease, or positive nodes—with negative margins after radical cystectomy plus pelvic node dissection were eligible. Radiotherapy was delivered using three-dimensional conformal radiotherapy to the pelvis to 45 Gy in 1.5 Gy twice a day. The arm receiving chemotherapy plus radiotherapy received two cycles of gemcitabine/cisplatin before and after radiotherapy.
The primary endpoint was disease-free survival.
Findings
Median follow-up was 21 months for chemotherapy plus postoperative radiotherapy and 15 months for radiotherapy alone.
There were two local failures in the radiotherapy alone arm and none in the chemotherapy plus radiotherapy arm. Two-year disease-free survival for chemotherapy plus radiotherapy was 62% vs 48%, and 2-year overall survival was 71% vs 51%, respectively.
On multivariable analysis, chemotherapy plus radiotherapy was a significant predictor of improved disease-free survival (hazard ratio [HR] = 0.42; confidence interval [CI] = 0.21–0.85, P = .016) and overall survival (HR = 0.45, 95% CI = 0.21–0.96, P = .039).
Late-grade gastrointestinal toxicity was observed in five chemotherapy-plus-radiotherapy patients and six radiotherapy patients.
The authors concluded, “The addition of adjuvant chemotherapy to postoperative radiotherapy improved [disease-free survival] and [overall survival] for [patients with] locally advanced bladder cancer after radical cystectomy with acceptable late gastrointestinal toxicity. The results suggest a role for adjuvant therapies to address both local and distant disease.” ν
DISCLOSURE: Dr. Zaghloul reported no conflicts of interest. For disclosures of all study authors, visit https://coi.asco.org/Report/ViewAbstractCOI?id=244665.
REFERENCE
1. Zaghloul MS, Christodouleas JP, Hwang WT, et al: Randomized phase III trial of adjuvant sequential chemotherapy plus radiotherapy versus adjuvant radiotherapy alone for locally advanced bladder cancer after radical cystectomy: Urothelial carcinoma subgroup analysis. 2019 Genitourinary Cancers Symposium. Abstract 351. Presented February 15, 2019.
