A phase II study of bevacizumab in combination with definitive radiotherapy and cisplatin chemotherapy in untreated patients with locally advanced cervical carcinoma: preliminary results of RTOG 0417 Journal Article

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Authors: Schefter, T. E.; Winter, K; Kwon, J. S.; Stuhr, K.; Balaraj, K.; Yaremko, B. P.; Small, W., Jr; Gaffney, D. K.
Article Title: A phase II study of bevacizumab in combination with definitive radiotherapy and cisplatin chemotherapy in untreated patients with locally advanced cervical carcinoma: preliminary results of RTOG 0417
Abstract: PURPOSE: Concurrent cisplatin-based chemoradiotherapy (CRT) is the standard treatment for locally advanced cervical cancer. RTOG 0417 was a Phase II study exploring the safety and efficacy of the addition of bevacizumab to standard CRT. METHODS AND MATERIALS: Eligible patients with bulky tumors (Stage IB-IIIB) were treated with once-weekly cisplatin (40 mg/m(2)) chemotherapy and standard pelvic radiotherapy and brachytherapy. Bevacizumab was administered at 10 mg/kg intravenously every 2 weeks for three cycles. Treatment-related serious adverse event (SAE) and other adverse event (AE) rates within the first 90 days from treatment start were determined. Treatment-related SAEs were defined as any Grade >/= 4 vaginal bleeding or thrombotic event or Grade >/= 3 arterial event, gastrointestinal (GI) bleeding, or bowel/bladder perforation, or any Grade 5 treatment-related death. Treatment-related AEs included all SAEs and Grade 3 or 4 GI toxicity persisting for >2 weeks despite medical intervention, Grade 4 neutropenia or leukopenia persisting for >7 days, febrile neutropenia, Grade 3 or 4 other hematologic toxicity, and Grade 3 or 4 GI, renal, cardiac, pulmonary, hepatic, or neurologic AEs. All AEs were scored using the National Cancer Institute Common Terminology Criteria (CTCAE) v 3.0 (MedDRA version 6.0). RESULTS: A total of 60 patients from 28 institutions were enrolled between 2006 and 2009, and of these, 49 patients were evaluable. The median follow-up was 12.4 months (range, 4.6-31.4 months).The median age was 45 years (range, 22-80 years). Most patients had FIGO Stage IIB (63%) and were of Zubrod performance status of 0 (67%). 80% of cases were squamous. There were no treatment-related SAEs. There were 15 (31%) protocol-specified treatment-related AEs within 90 days of treatment start; the most common were hematologic (12/15; 80%). 18 (37%) occurred during treatment or follow-up at any time. 37 of the 49 patients (76%) had cisplatin and bevacizumab administered per protocol, and 46 of the 49 (94%) had both external beam and brachytherapy administered per protocol or with acceptable variation. CONCLUSION: Bevacizumab in addition to standard pelvic chemoradiotherapy for locally advanced cervical cancer is feasible and safe with respect to the protocol-specified treatment-related SAEs and AEs.
Journal Title: International journal of radiation oncology, biology, physics
Volume: 83
Issue: 4
ISSN: 1879-355X; 0360-3016
Publisher: Elsevier Inc  
Journal Place: United States
Date Published: 2012
Start Page: 1179
End Page: 1184
Language: eng
DOI/URL:

10.1016/j.ijrobp.2011.10.060
Notes: LR: 20131121; CI: Copyright (c) 2012; GR: U10 CA21661/CA/NCI NIH HHS/United States; GR: U10 CA37422/CA/NCI NIH HHS/United States; JID: 7603616; 0 (Antibodies, Monoclonal, Humanized); 2S9ZZM9Q9V (bevacizumab); Q20Q21Q62J (Cisplatin); 2011/08/25 [received]; 2011/10/24 [revised]; 2011/10/25 [accepted]; 2012/02/16 [aheadofprint]; ppublish