Updated 4-Year Results for NRG Oncology/RTOG 0921: A Phase 2 Study of Postoperative Intensity Modulated Radiation Therapy With Concurrent Cisplatin and Bevacizumab Followed by Carboplatin and Paclitaxel for Patients With Endometrial Cancer International Journal of Radiation Oncology, Biology, Physics ORAL SCIENTIFIC SESSION| VOLUME 96, ISSUE 2, SUPPLEMENT , S49-S50, OCTOBER 01, 2016
Date
10/01/2016Abstract
Purpose/Objective(s)
To report 4-year outcome results including late adverse events (AEs) >1 year from treatment start, overall survival (OS), para-aortic failure (PaF), distant failure (DF), and disease-free survival (DFS) in a prospective Phase II clinical trial of bevacizumab (Bev) and pelvic intensity modulated radiation therapy (IMRT) with chemotherapy in high-risk endometrial-cancer patients.
Materials/Methods
Patients had a hysterectomy, lymph node removal, and ≥1 of the following high-risk factors: grade 3 carcinoma with >50% myometrial invasion (n = 15); grade 2 or 3 disease with any cervical stromal invasion (n = 10); or known extrauterine extension confined to the pelvis (n = 13). Treatment included pelvic IMRT and concurrent cisplatin on days 1 and 29 of radiation and Bev (5 mg/kg on days 1, 15, and 29 of radiation) followed by adjuvant carboplatin and paclitaxel for 4 cycles. Univariate OS and DFS estimates were obtained using the Kaplan-Meier method and PF and DF rates were determined by the cumulative incidence method.
Results
Thirty-four patients were accrued from November 2009 through December 2011, 30 of whom were eligible and received study treatment. The median follow up is 3.92 years (min-max: 1.13-4.96). There were 5 patients with reported grade 3 or 4 AEs > 1 year from treatment start as follows: grade 3 diarrhea/ vomiting/ low lymphocyte count/ dyspnea/ acute kidney injury; grade 3 hematuria; grade 3 vaginismus; grade 3 skin/pelvic infection; and grade 4 low lymphocyte/neutrophil count. Four-year OS was 86.7% (95% CI = 68.3-94.8), DFS was 73.2% (95% CI = 53.4-85.6), para-aortic failure (2 patients) was 6.7% (95% CI = 1.1-19.5) and DF (7 patients) was 23.5% (95% CI = 10.2-39.9). No patient had recurrent disease in the pelvis throughout the duration of follow-up.
Conclusion
Postoperative Bevacizumab added to chemotherapy and pelvic IMRT was well tolerated and resulted in high overall survival rates with no pelvic recurrences at 4 years for patients with high-risk endometrial carcinoma. This combination of RT, cisplatin and bevacizumab may be considered for future clinical trials. Supported by NCI grants U10CA21661, U10CA180868, U10CA180822, U10CA37422, U24CA81647, and U24CA180803.
Author List
A.N. Viswanathan K. Winter B.E. Miller Y. Xiao A. Jhingran L. Portelance W.R. Bosch U. Matulonis N. Horowitz R. Mannel L. Souhami B.A. Erickson W. Small Jr. D.K. GaffneyAuthor
Beth A. Erickson MD Professor in the Radiation Oncology department at Medical College of WisconsinView Online
