• Something wrong with this record ?

Positron Emission Tomography-Guided Bone Marrow-Sparing Radiation Therapy for Locoregionally Advanced Cervix Cancer: Final Results From the INTERTECC Phase II/III Trial

CW. Williamson, I. Sirák, R. Xu, L. Portelance, L. Wei, R. Tarnawski, U. Mahantshetty, ES. Heide, CM. Yashar, MT. McHale, W. Bosch, J. Lowenstein, CC. Saenz, S. Plaxe, R. Eskander, J. Einck, AJ. Mundt, J. Mayadev, LK. Mell

. 2022 ; 112 (1) : 169-178. [pub] 20210820

Language English Country United States

Document type Clinical Trial, Phase II, Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural

Persistent link   https://www.medvik.cz/link/bmc22011498

Grant support
R01 CA197059 NCI NIH HHS - United States
R21 CA162718 NCI NIH HHS - United States

PURPOSE: To test effects of positron emission tomography (PET)-based bone marrow-sparing (BMS) image-guided intensity modulated radiation therapy (IG-IMRT) on efficacy and toxicity for patients with locoregionally advanced cervical cancer. METHODS AND MATERIALS: In an international phase II/III trial, patients with stage IB-IVA cervical carcinoma were treated with either PET-based BMS-IG-IMRT (PET-BMS-IMRT group) or standard image-guided IMRT (IMRT group), with concurrent cisplatin (40 mg/m2 weekly), followed by brachytherapy. The phase II component nonrandomly assigned patients to PET-BMS-IMRT or standard IMRT. The phase III trial randomized patients to PET-BMS-IMRT versus IMRT, with a primary endpoint of progression-free survival (PFS) but was closed early for futility. Phase III patients were analyzed separately and in combination with phase II patients, comparing acute hematologic toxicity, cisplatin delivery, PFS, overall survival (OS), and patterns of failure. In a post-hoc exploratory analysis, we investigated the association between pretreatment absolute lymphocyte count (ALC) and OS. RESULTS: In total, 101 patients were enrolled on the phase II/III trial, including 29 enrolled in phase III (PET-BMS-IMRT group: 16; IMRT group: 13) before early closure. Median follow-up was 33 months for phase III patients and 39 months for all patients. PFS and OS at 5 years for all patients were 73.6% (95% confidence interval [CI], 64.9%-84.3%) and 84% (95% CI, 76%-92.9%]), respectively. There were no differences in number of cisplatin cycles, OS, PFS, or patterns of failure between groups for the combined cohort. The incidence of acute grade ≥ 3 neutropenia was significantly lower in the PET-BMS-IMRT group compared with IMRT for randomized patients (19% vs 54%, χ2P = .048) and in the combined cohort (13% vs 35%, χ2P = .01). Patients with pretreatment ALC ≤ 1.5 k/μL had nonsignificantly worse OS on multivariable analysis (HR 2.85; 95% CI, 0.94-8.62; adjusted P = .216), compared with patients with ALC > 1.5 k/μL. There was no difference in posttreatment ALC by treatment group. CONCLUSIONS: PET-BMS-IMRT significantly reduced acute grade ≥3 neutropenia, but not treatment-related lymphopenia, compared with standard IMRT. We found no evidence that PET-BMS-IMRT affected chemotherapy delivery or long-term outcomes, and weak evidence of an association between pretreatment ALC and OS.

References provided by Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc22011498
003      
CZ-PrNML
005      
20220506125954.0
007      
ta
008      
220425s2022 xxu f 000 0|eng||
009      
AR
024    7_
$a 10.1016/j.ijrobp.2021.08.019 $2 doi
035    __
$a (PubMed)34419564
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxu
100    1_
$a Williamson, Casey W $u Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California
245    10
$a Positron Emission Tomography-Guided Bone Marrow-Sparing Radiation Therapy for Locoregionally Advanced Cervix Cancer: Final Results From the INTERTECC Phase II/III Trial / $c CW. Williamson, I. Sirák, R. Xu, L. Portelance, L. Wei, R. Tarnawski, U. Mahantshetty, ES. Heide, CM. Yashar, MT. McHale, W. Bosch, J. Lowenstein, CC. Saenz, S. Plaxe, R. Eskander, J. Einck, AJ. Mundt, J. Mayadev, LK. Mell
520    9_
$a PURPOSE: To test effects of positron emission tomography (PET)-based bone marrow-sparing (BMS) image-guided intensity modulated radiation therapy (IG-IMRT) on efficacy and toxicity for patients with locoregionally advanced cervical cancer. METHODS AND MATERIALS: In an international phase II/III trial, patients with stage IB-IVA cervical carcinoma were treated with either PET-based BMS-IG-IMRT (PET-BMS-IMRT group) or standard image-guided IMRT (IMRT group), with concurrent cisplatin (40 mg/m2 weekly), followed by brachytherapy. The phase II component nonrandomly assigned patients to PET-BMS-IMRT or standard IMRT. The phase III trial randomized patients to PET-BMS-IMRT versus IMRT, with a primary endpoint of progression-free survival (PFS) but was closed early for futility. Phase III patients were analyzed separately and in combination with phase II patients, comparing acute hematologic toxicity, cisplatin delivery, PFS, overall survival (OS), and patterns of failure. In a post-hoc exploratory analysis, we investigated the association between pretreatment absolute lymphocyte count (ALC) and OS. RESULTS: In total, 101 patients were enrolled on the phase II/III trial, including 29 enrolled in phase III (PET-BMS-IMRT group: 16; IMRT group: 13) before early closure. Median follow-up was 33 months for phase III patients and 39 months for all patients. PFS and OS at 5 years for all patients were 73.6% (95% confidence interval [CI], 64.9%-84.3%) and 84% (95% CI, 76%-92.9%]), respectively. There were no differences in number of cisplatin cycles, OS, PFS, or patterns of failure between groups for the combined cohort. The incidence of acute grade ≥ 3 neutropenia was significantly lower in the PET-BMS-IMRT group compared with IMRT for randomized patients (19% vs 54%, χ2P = .048) and in the combined cohort (13% vs 35%, χ2P = .01). Patients with pretreatment ALC ≤ 1.5 k/μL had nonsignificantly worse OS on multivariable analysis (HR 2.85; 95% CI, 0.94-8.62; adjusted P = .216), compared with patients with ALC > 1.5 k/μL. There was no difference in posttreatment ALC by treatment group. CONCLUSIONS: PET-BMS-IMRT significantly reduced acute grade ≥3 neutropenia, but not treatment-related lymphopenia, compared with standard IMRT. We found no evidence that PET-BMS-IMRT affected chemotherapy delivery or long-term outcomes, and weak evidence of an association between pretreatment ALC and OS.
650    _2
$a kostní dřeň $x účinky záření $7 D001853
650    _2
$a cisplatina $x terapeutické užití $7 D002945
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a lidé $7 D006801
650    _2
$a pozitronová emisní tomografie $7 D049268
650    _2
$a radioterapie řízená obrazem $7 D061089
650    12
$a radioterapie s modulovanou intenzitou $x škodlivé účinky $x metody $7 D050397
650    _2
$a výsledek terapie $7 D016896
650    12
$a nádory děložního čípku $x diagnostické zobrazování $x farmakoterapie $x patologie $x radioterapie $7 D002583
655    _2
$a klinické zkoušky, fáze II $7 D017427
655    _2
$a klinické zkoušky, fáze III $7 D017428
655    _2
$a časopisecké články $7 D016428
655    _2
$a randomizované kontrolované studie $7 D016449
655    _2
$a Research Support, N.I.H., Extramural $7 D052061
700    1_
$a Sirák, Igor $u Department of Oncology and Radiotherapy, University Hospital, Hradec Kralove, Czech Republic
700    1_
$a Xu, Ronghui $u University of California San Diego, La Jolla, California
700    1_
$a Portelance, Lorraine $u University of Miami, Miami, Florida
700    1_
$a Wei, Lichun $u Xijing Hospital, Xian, China
700    1_
$a Tarnawski, Rafal $u Marie Sklodowska Cancer Center and Institute of Oncology, Gliwice, Poland
700    1_
$a Mahantshetty, Umesh $u Tata Memorial Centre, Parel, Mumbai, India
700    1_
$a Heide, Elena S $u University of California Irvine, Irvine, California
700    1_
$a Yashar, Catheryn M $u Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California
700    1_
$a McHale, Michael T $u University of California San Diego, La Jolla, California
700    1_
$a Bosch, Walter $u Department of Radiation Oncology, Washington University in St. Louis, St. Louis, Missouri
700    1_
$a Lowenstein, Jessica $u University of Texas MD Anderson Cancer Center, Houston, Texas
700    1_
$a Saenz, Cheryl C $u University of California San Diego, La Jolla, California
700    1_
$a Plaxe, Steve $u University of California San Diego, La Jolla, California
700    1_
$a Eskander, Ramez $u University of California San Diego, La Jolla, California
700    1_
$a Einck, John $u Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California
700    1_
$a Mundt, Arno J $u Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California
700    1_
$a Mayadev, Jyoti $u Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California; La Jolla Center for Precision Radiation Medicine, La Jolla, California
700    1_
$a Mell, Loren K $u Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California; La Jolla Center for Precision Radiation Medicine, La Jolla, California. Electronic address: lmell@ucsd.edu
773    0_
$w MED00002371 $t International journal of radiation oncology, biology, physics $x 1879-355X $g Roč. 112, č. 1 (2022), s. 169-178
856    41
$u https://pubmed.ncbi.nlm.nih.gov/34419564 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y p $z 0
990    __
$a 20220425 $b ABA008
991    __
$a 20220506125946 $b ABA008
999    __
$a ok $b bmc $g 1789215 $s 1162696
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2022 $b 112 $c 1 $d 169-178 $e 20210820 $i 1879-355X $m International journal of radiation oncology, biology, physics $n Int J Radiat Oncol Biol Phys $x MED00002371
GRA    __
$a R01 CA197059 $p NCI NIH HHS $2 United States
GRA    __
$a R21 CA162718 $p NCI NIH HHS $2 United States
LZP    __
$a Pubmed-20220425

Find record

Citation metrics

Archiving options