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)
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu klinické zkoušky, fáze II, časopisecké články, multicentrická studie, Research Support, N.I.H., Extramural
Grantová podpora
KL2 RR031978
NCRR NIH HHS - United States
UL1 TR000100
NCATS NIH HHS - United States
L30 CA135746
NCI NIH HHS - United States
PubMed
28126303
DOI
10.1016/j.ijrobp.2016.11.027
PII: S0360-3016(16)33485-X
Knihovny.cz E-zdroje
- MeSH
- adenokarcinom diagnostické zobrazování patologie terapie MeSH
- brachyterapie metody MeSH
- celková dávka radioterapie MeSH
- chemoradioterapie metody MeSH
- cisplatina terapeutické užití MeSH
- gastrointestinální trakt účinky záření MeSH
- incidence MeSH
- kostní dřeň * MeSH
- léčba šetřící orgány metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- nádory děložního čípku diagnostické zobrazování patologie terapie MeSH
- neutropenie epidemiologie prevence a kontrola MeSH
- protinádorové látky terapeutické užití MeSH
- radiosenzibilizující látky terapeutické užití MeSH
- radioterapie řízená obrazem metody MeSH
- radioterapie s modulovanou intenzitou metody MeSH
- spinocelulární karcinom diagnostické zobrazování patologie terapie MeSH
- studie proveditelnosti MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze II MeSH
- multicentrická studie MeSH
- Research Support, N.I.H., Extramural MeSH
- Názvy látek
- cisplatina MeSH
- protinádorové látky MeSH
- radiosenzibilizující látky MeSH
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 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). 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.
Chulalongkorn Hospital Bangkok Thailand
Department of Oncology and Radiotherapy University Hospital Hradec Kralove Czech Republic
Department of Radiation Oncology Washington University St Louis Missouri
Kaiser Permanente Medical Center San Diego California
Marie Sklodowska Cancer Center and Institute of Oncology Gliwice Poland
MD Anderson Cancer Center Houston Texas
Tata Memorial Centre Parel Mumbai India
University of California San Diego La Jolla California
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