NRG Oncology/RTOG 0921: A phase 2 study of postoperative intensity-modulated radiotherapy with concurrent cisplatin and bevacizumab followed by carboplatin and paclitaxel for patients with endometrial cancer.

Authors

Akila N. Viswanathan, Harvard Medical School
Jennifer Moughan, NRG Oncology Statistics and Data Management CenterFollow
Brigitte E. Miller, Levine Cancer Institute
Ying Xiao, Thomas Jefferson UniversityFollow
Anuja Jhingran, The University of Texas MD Anderson Cancer Center
Lorraine Portelance, University of Miami Miller
Walter R. Bosch, Washington University in St. LouisFollow
Ursula A. Matulonis, Dana-Farber Cancer Institute
Neil S. Horowitz, Brigham and Women's Hospital
Robert S S. Mannel, University of OklahomaFollow
Luis Souhami, McGill UniversityFollow
Beth A. Erickson, Medical College of WisconsinFollow
Kathryn A. Winter, NRG Oncology Statistics and Data Management CenterFollow
William Small, Loyola University
David K. Gaffney, University of Utah

Document Type

Article

Publication Date

7-1-2015

Comments

This article has been peer reviewed. It is the authors' final version prior to publication in Cancer

Volume 121, Issue 13, July 2015, Pages 2156-2163.

The published version is available at DOI: 10.1002/cncr.29337Copyright © American Cancer Society

Abstract

BACKGROUND: The current study was conducted to assess acute and late adverse events (AEs), overall survival (OS), pelvic failure, regional failure, distant failure, and disease-free survival in a prospective phase 2 clinical trial of bevacizumab and pelvic intensity-modulated radiotherapy (IMRT) with chemotherapy in patients with high-risk endometrial cancer.

METHODS: Patients underwent a hysterectomy and lymph node removal, and had ≥1 of the following high-risk factors: grade 3 carcinoma with >50% myometrial invasion, grade 2 or 3 disease with any cervical stromal invasion, or known extrauterine extension confined to the pelvis. Treatment included pelvic IMRT and concurrent cisplatin on days 1 and 29 of radiation and bevacizumab (at a dose of 5 mg/kg on days 1, 15, and 29 of radiation) followed by adjuvant carboplatin and paclitaxel for 4 cycles. The primary endpoint was grade ≥3 AEs occurring within the first 90 days (toxicity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0]).

RESULTS: A total of 34 patients were accrued from November 2009 through December 2011, 30 of whom were eligible and received study treatment. Seven of 30 patients (23.3%; 1-sided 95% confidence interval, 10.6%-36.0%) developed grade ≥3 treatment-related nonhematologic toxicities within 90 days; an additional 6 patients experienced grade ≥3 toxicities between 90 and 365 days after treatment. The 2-year OS rate was 96.7% and the disease-free survival rate was 79.1%. No patient developed a within-field pelvic failure and no patients with International Federation of Gynecology and Obstetrics stage I to IIIA disease developed disease recurrence after a median follow-up of 26 months.

CONCLUSIONS: Postoperative bevacizumab added to chemotherapy and pelvic IMRT appears to be well tolerated and results in high OS rates at 2 years for patients with high-risk endometrial carcinoma.

Recommended Citation

Viswanathan, Akila N.; Moughan, Jennifer; Miller, Brigitte E.; Xiao, Ying; Jhingran, Anuja; Portelance, Lorraine; Bosch, Walter R.; Matulonis, Ursula A.; Horowitz, Neil S.; Mannel, Robert S S.; Souhami, Luis; Erickson, Beth A.; Winter, Kathryn A.; Small, William; and Gaffney, David K., "NRG Oncology/RTOG 0921: A phase 2 study of postoperative intensity-modulated radiotherapy with concurrent cisplatin and bevacizumab followed by carboplatin and paclitaxel for patients with endometrial cancer." (2015). Department of Radiation Oncology Faculty Papers. Paper 75.
https://jdc.jefferson.edu/radoncfp/75

PubMed ID

25847373