PMID- 25847373 OWN - NLM STAT- MEDLINE DCOM- 20160831 LR - 20201224 IS - 1097-0142 (Electronic) IS - 0008-543X (Print) IS - 0008-543X (Linking) VI - 121 IP - 13 DP - 2015 Jul 1 TI - 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. PG - 2156-63 LID - 10.1002/cncr.29337 [doi] AB - 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. CI - (c) 2015 American Cancer Society. FAU - Viswanathan, Akila N AU - Viswanathan AN AD - Department of Radiation Oncology, Brigham and Women's Hospital, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts. FAU - Moughan, Jennifer AU - Moughan J AD - NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania. FAU - Miller, Brigitte E AU - Miller BE AD - Carolinas Healthcare System NorthEast, Levine Cancer Institute, Concord, North Carolina. FAU - Xiao, Ying AU - Xiao Y AD - Thomas Jefferson University Hospital, Philadelphia, Pennsylvania. FAU - Jhingran, Anuja AU - Jhingran A AD - The University of Texas MD Anderson Cancer Center, Houston, Texas. FAU - Portelance, Lorraine AU - Portelance L AD - University of Miami Miller School of Medicine, Miami, Florida. FAU - Bosch, Walter R AU - Bosch WR AD - Washington University, St. Louis, Missouri. FAU - Matulonis, Ursula A AU - Matulonis UA AD - Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA. FAU - Horowitz, Neil S AU - Horowitz NS AD - Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Brigham and Women's Hospital, Boston, MA. FAU - Mannel, Robert S AU - Mannel RS AD - University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma. FAU - Souhami, Luis AU - Souhami L AD - McGill University, Montreal, Quebec, Canada. FAU - Erickson, Beth A AU - Erickson BA AD - Medical College of Wisconsin, Milwaukee, Wisconsin. FAU - Winter, Kathryn A AU - Winter KA AD - NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania. FAU - Small, William Jr AU - Small W Jr AD - Loyola University, Chicago, Illinois. FAU - Gaffney, David K AU - Gaffney DK AD - University of Utah Health Science Center, Salt Lake City, Utah. LA - eng GR - U10 CA180868/CA/NCI NIH HHS/United States GR - UG1 CA189867/CA/NCI NIH HHS/United States GR - U10CA180822/CA/NCI NIH HHS/United States GR - U24 CA081647/CA/NCI NIH HHS/United States GR - UG1 CA233178/CA/NCI NIH HHS/United States GR - R21 CA167800/CA/NCI NIH HHS/United States GR - U10CA37422/CA/NCI NIH HHS/United States GR - UG1 CA233180/CA/NCI NIH HHS/United States GR - U10 CA180818/CA/NCI NIH HHS/United States GR - U10 CA037422/CA/NCI NIH HHS/United States GR - U10 CA021661/CA/NCI NIH HHS/United States GR - U24 CA180803/CA/NCI NIH HHS/United States GR - U10CA21661/CA/NCI NIH HHS/United States GR - U10 CA180822/CA/NCI NIH HHS/United States GR - U10 CA180798/CA/NCI NIH HHS/United States GR - U24CA180803/CA/NCI NIH HHS/United States GR - U10CA180868/CA/NCI NIH HHS/United States GR - U10 CA180867/CA/NCI NIH HHS/United States GR - U24CA81647/CA/NCI NIH HHS/United States PT - Clinical Trial, Phase II PT - Journal Article PT - Research Support, N.I.H., Extramural DEP - 20150406 PL - United States TA - Cancer JT - Cancer JID - 0374236 RN - 2S9ZZM9Q9V (Bevacizumab) RN - P88XT4IS4D (Paclitaxel) RN - Q20Q21Q62J (Cisplatin) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use MH - Bevacizumab/administration & dosage MH - Chemoradiotherapy, Adjuvant MH - Cisplatin/administration & dosage MH - Disease-Free Survival MH - Endometrial Neoplasms/*drug therapy/pathology/*radiotherapy/surgery MH - Female MH - Humans MH - Hysterectomy MH - Lymph Node Excision MH - Middle Aged MH - Paclitaxel/administration & dosage MH - Postoperative Period MH - Radiotherapy, Intensity-Modulated PMC - PMC4685031 MID - NIHMS738420 OTO - NOTNLM OT - bevacizumab OT - chemotherapy OT - endometrial cancer OT - intensity-modulated radiotherapy (IMRT) OT - radiation EDAT- 2015/04/08 06:00 MHDA- 2016/09/01 06:00 PMCR- 2016/07/01 CRDT- 2015/04/08 06:00 PHST- 2014/12/29 00:00 [received] PHST- 2015/02/04 00:00 [accepted] PHST- 2015/04/08 06:00 [entrez] PHST- 2015/04/08 06:00 [pubmed] PHST- 2016/09/01 06:00 [medline] PHST- 2016/07/01 00:00 [pmc-release] AID - 10.1002/cncr.29337 [doi] PST - ppublish SO - Cancer. 2015 Jul 1;121(13):2156-63. doi: 10.1002/cncr.29337. Epub 2015 Apr 6.