[ad_1]
February 15, 2019
Postoperative radiotherapy with adjuvant chemotherapy has prolonged disease-free survival and overall survival in patients with locally advanced urothelial carcinoma.
Adjuvant chemotherapy added to postoperative radiotherapy (PORT) improves outcomes in patients undergoing radical cystectomy for locally advanced urothelial carcinoma of the bladder, according to study findings presented at the Genitourinary Symposium 2019.
Compared to PORT alone, PORT plus sequential adjuvant chemotherapy extended disease-free survival (DFS) and overall survival (OS) in a study of 81 patients with locally advanced bladder UC, according to Brian C. Baumann, MD , who presented the results.
The 81 patients were part of a group of 153 patients with locally advanced bladder cancer, included in a randomized phase 3 trial (ClinicalTrials.gov Identifier: NCT01734798) comparing oral treatment to sequential chemotherapy plus treatment with PORT. The eligibility criteria of the study, headed by Mohamed S. Zaghloul, MD, of the Egyptian National Cancer Institute of Cairo, included pT3b disease or higher, a grade 3 cancer or positive lymph nodes, as well as negative surgical margins after RC plus dissection of pelvic ganglia.
Of the 81 UC patients, 40 received PORT alone and 41 received chemotherapy and PORT therapy. The PORT consisted of 3D conformal radiotherapy of the pelvis up to a dose of 45 Gy administered in fractions of 1.5 Gy twice a day. Chemotherapy recipients received 2 cycles of gemcitabine and cisplatin before and after radiotherapy. Patients were followed every two months for the first two years and then every six months. Computed tomography was performed every six months for the first two years and then annually thereafter.
The median age of patients in the combined modality group and the PORT only group was 54 and 55, respectively. The median duration of follow-up was 21 months for the chemotherapy-PORT group and 15 months for the PORT group.
The two-year DFS rates for the chemotherapy-PORT and treatment-only groups were 62% (95% CI, 53% to 71%) and 48% (95% CI, 39% to 58%), respectively. The two-year OS rates were 71% (95% CI, 63% to 80%) and 51% (95% CI, 40% to 61%), respectively. On a multivariate badysis, the chemotherapy-PORT group had a significantly reduced 58% risk of disease progression [HR]0.42; 95% CI, 0.21-0.85; P = 0.016) and a 55% decrease in the risk of death (HR, 0.45, 95% CI, 0.21-0.96; P = .039) compared to the group consisting only of PORT.
In the entire cohort, late gastrointestinal grade 3 or greater toxicity was observed in 5 patients in the PORT group plus chemotherapy (7%) and 6 patients in the PORT alone group (8%).
"I think these findings strongly suggest that adjuvant treatments play a role in the treatment of local and distant disease in patients with locally advanced bladder cancer," said Dr. Baumann during the course of the year. presentation.
The improvement of disease-free survival and overall survival with adjuvant chemotherapy in this relatively small cohort is "somewhat surprising," he said, adding that previous large-scale trials do not have the same effect. had not resulted in such a profit.
Dr. Baumann thinks that adjuvant radiation is changing the pattern of failure into a more distant relapse, "which could be treated more effectively by chemotherapy."[therapy]. "Previous adjuvant chemotherapy trials," he explained, "did not include local adjuvant therapy to treat the local problem of failure. Therefore, the benefit of DFS in these trials may have been limited to patients who were otherwise intended for relapsing only at a distance.
"Our hypothesis is that the use of adjuvant radiation, which greatly improves local control, has a synergistic effect with chemotherapy.[therapy], improve the effectiveness of chemo[therapy] to prevent the recurrence of the disease. "
Read more from Cancer Therapy AdvisorThe coverage of the 2019 Symposium on Genitourinary Cancer by visiting the conference page.
Reference
- Zaghloul MS, Christodouleas JP, Hwang WT et al. Randomized phase III trial of adjuvant sequential chemotherapy with radiotherapy versus adjuvant radiotherapy alone for locally advanced bladder cancer after radical cystectomy: subgroup badysis of urothelial carcinoma. Data presented at: 2019 Symposium on Genitourinary Cancer; San Francisco, California; February 14-16. Summary 351.
[ad_2]
Source link
