Bone Marrow-sparing Intensity Modulated Radiation Therapy With Concurrent Cisplatin For Stage IB-IVA Cervical Cancer: An International Multicenter Phase II Clinical Trial (INTERTECC-2)
详细信息 查看全文
- 作者：Loren K. Mell ; MD&lowast ; ; lmell@ucsd.edu ; Igor Sirá ; k ; MD ; PhD&dagger ; ; Lichun Wei ; MD&Dagger ; ; Rafal Tarnawski ; MD ; PhD§ ; ; Umesh Mahantshetty ; MD‖ ; Catheryn M. Yashar ; MD&lowast ; ; Michael T. McHale ; MD¶ ; ; Ronghui Xu ; PhD¶ ; ; Gordon Honerkamp-Smith ; PhD¶ ; ; Ruben Carmona ; MD¶ ; ; Mary Wright ; BS¶ ; ; Casey W. Williamson ; MD&lowast ; ; Linda Kasaová ; PhD&dagger ; ; Nan Li ; PhD&lowast ; ; Stephen Kry ; PhD# ; Jeff Michalski ; MD&lowast ; &lowast ; ; Walter Bosch ; PhD&lowast ; &lowast ; ; William Straube ; MS&lowast ; &lowast ; ; Julie Schwarz ; MD ; PhD&dagger ; &dagger ; ; Jessica Lowenstein ; PhD¶ ; ; Steve B. Jiang ; PhD¶ ; ; Cheryl C. Saenz ; MD¶ ; ; Steve Plaxe ; MD¶ ; ; John Einck ; MD&lowast ; ; Chonlakiet Khorprasert ; MD&Dagger ; &Dagger ; ; Paul Koonings ; MD§ ; § ; ; Terry Harrison ; MD§ ; § ; ; Mei Shi ; MD&Dagger ; ; A.J. Mundt ; MD&lowast ; ; for the INTERTECC Study Group
- 刊名：International Journal of Radiation Oncology*Biology*Physics
- 出版年：2017
- 出版时间：1 March 2017
- 年：2017
- 卷：97
- 期：3
- 页码：536-545
- 全文大小：1294 K
- 卷排序：97
文摘
To test the hypothesis that intensity modulated radiation therapy (IMRT) reduces acute hematologic and gastrointestinal (GI) toxicity for patients with locoregionally advanced cervical cancer.Methods and MaterialsWe enrolled patients with stage IB-IVA cervical carcinoma in a single-arm phase II trial involving 8 centers internationally. All patients received weekly cisplatin concurrently with once-daily IMRT, followed by intracavitary brachytherapy, as indicated. The primary endpoint was the occurrence of either acute grade ≥3 neutropenia or clinically significant GI toxicity within 30 days of completing chemoradiation therapy. A preplanned subgroup analysis tested the hypothesis that positron emission tomography-based image-guided IMRT (IG-IMRT) would lower the risk of acute neutropenia. We also longitudinally assessed patients' changes in quality of life.ResultsFrom October 2011 to April 2015, 83 patients met the eligibility criteria and initiated protocol therapy. The median follow-up was 26.0 months. The incidence of any primary event was 26.5% (95% confidence interval [CI] 18.2%-36.9%), significantly lower than the 40% incidence hypothesized a priori from historical data (P=.012). The incidence of grade ≥3 neutropenia and clinically significant GI toxicity was 19.3% (95% CI 12.2%-29.0%) and 12.0% (95% CI 6.7%-20.8%), respectively. Compared with patients treated without IG-IMRT (n=48), those treated with IG-IMRT (n=35) had a significantly lower incidence of grade ≥3 neutropenia (8.6% vs 27.1%; 2-sided χ2P=.035) and nonsignificantly lower incidence of grade ≥3 leukopenia (25.7% vs 41.7%; P=.13) and any grade ≥3 hematologic toxicity (31.4% vs 43.8%; P=.25).ConclusionsIMRT reduces acute hematologic and GI toxicity compared with standard treatment, with promising therapeutic outcomes. Positron emission tomography IG-IMRT reduces the incidence of acute neutropenia.