TY - JOUR
T1 - Bone Marrow-sparing Intensity Modulated Radiation Therapy With Concurrent Cisplatin For Stage IB-IVA Cervical Cancer
T2 - An International Multicenter Phase II Clinical Trial (INTERTECC-2)
AU - for the
AU - INTERTECC Study Group
AU - Mell, Loren K.
AU - Sirák, Igor
AU - Wei, Lichun
AU - Tarnawski, Rafal
AU - Mahantshetty, Umesh
AU - Yashar, Catheryn M.
AU - McHale, Michael T.
AU - Xu, Ronghui
AU - Honerkamp-Smith, Gordon
AU - Carmona, Ruben
AU - Wright, Mary
AU - Williamson, Casey W.
AU - Kasaová, Linda
AU - Li, Nan
AU - Kry, Stephen
AU - Michalski, Jeff
AU - Bosch, Walter
AU - Straube, William
AU - Schwarz, Julie
AU - Lowenstein, Jessica
AU - Jiang, Steve B.
AU - Saenz, Cheryl C.
AU - Plaxe, Steve
AU - Einck, John
AU - Khorprasert, Chonlakiet
AU - Koonings, Paul
AU - Harrison, Terry
AU - Shi, Mei
AU - Mundt, A. J.
N1 - Publisher Copyright:
© 2016 Elsevier Inc.
PY - 2017/3/1
Y1 - 2017/3/1
N2 - Purpose 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 Materials We 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. Results From 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 χ2 P=.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). Conclusions IMRT 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.
AB - Purpose 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 Materials We 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. Results From 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 χ2 P=.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). Conclusions IMRT 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.
UR - http://www.scopus.com/inward/record.url?scp=85009986044&partnerID=8YFLogxK
U2 - 10.1016/j.ijrobp.2016.11.027
DO - 10.1016/j.ijrobp.2016.11.027
M3 - Article
C2 - 28126303
AN - SCOPUS:85009986044
SN - 0360-3016
VL - 97
SP - 536
EP - 545
JO - International Journal of Radiation Oncology Biology Physics
JF - International Journal of Radiation Oncology Biology Physics
IS - 3
ER -