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)

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00179906%3A_____%2F17%3A10367401" target="_blank" >RIV/00179906:_____/17:10367401 - isvavai.cz</a>

Výsledek na webu

<a href="http://dx.doi.org/10.1016/j.ijrobp.2016.11.027" target="_blank" >http://dx.doi.org/10.1016/j.ijrobp.2016.11.027</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.ijrobp.2016.11.027" target="_blank" >10.1016/j.ijrobp.2016.11.027</a>

Jazyk výsledku

angličtina

Název v původním jazyce

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)

Popis výsledku v původním jazyce

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 &gt;= 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&apos; 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 &gt;= 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 &gt;= 3 neutropenia (8.6% vs 27.1%; 2-sided chi(2) P = .035) and nonsignificantly lower incidence of grade &gt;= 3 leukopenia (25.7% vs 41.7%; P = .13) and any grade &gt;= 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 IGIMRT reduces the incidence of acute neutropenia.

Název v anglickém jazyce

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)

Popis výsledku anglicky

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 &gt;= 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&apos; 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 &gt;= 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 &gt;= 3 neutropenia (8.6% vs 27.1%; 2-sided chi(2) P = .035) and nonsignificantly lower incidence of grade &gt;= 3 leukopenia (25.7% vs 41.7%; P = .13) and any grade &gt;= 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 IGIMRT reduces the incidence of acute neutropenia.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30204 - Oncology

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2017

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

International Journal of Radiation: Oncology, Biolology, Physics

ISSN

0360-3016

e-ISSN

—

Svazek periodika

97

Číslo periodika v rámci svazku

3

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

10

Strana od-do

536-545

Kód UT WoS článku

000393294900014

EID výsledku v databázi Scopus

2-s2.0-85009986044