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. Issue 13 (6th April 2015)

• Record Type: Journal Article
• Authors: 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.; Souhami, Luis; Erickson, Beth A.; Winter, Kathryn A.; Small, William; Gaffney, David K.
• Is Part Of: Cancer. Volume 121:Issue 13(2015)
• Page Start: 2156
• Page End: 2163
• Publication Date: 2015-04-06
• Subjects: Cancer -- Periodicals; Cancer -- Cytopathology -- Periodicals; 616.99405
• DOI: 10.1002/cncr.29337
• Languages: English
• ISSNs: 0008-543X

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="cncr29337-sec-0001" sec-type="section"> <title>BACKGROUND</title> <p>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.</p> </sec> <sec id="cncr29337-sec-0002" sec-type="section"> <title>METHODS</title> <p>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]).</p> </sec> <sec id="cncr29337-sec-0003" sec-type="section"> <title>RESULTS</title> <p>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.</p> </sec> <sec id="cncr29337-sec-0004" sec-type="section"> <title>CONCLUSIONS</title> <p>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. <bold><italic>Cancer</italic> 2015;121:2156–2163.</bold> © <italic>2015 American Cancer Society</italic>.</p> </sec> </abstract>