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ABCL-073 Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) Versus Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP) Therapy in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL): Results From the Phase III POLARIX Study
C. Flowers, H. Tilly, F. Morschhauser, LH. Sehn, JW. Friedberg, M. Trněný, JP. Sharman, C. Herbaux, JM. Burke, M. Matasar, S. Rai, K. Izutsu, N. Mehta-Shah, L. Oberic, A. Chauchet, W. Jurczak, Y. Song, R. Greil, L. Mykhalska, JM. Bergua-Burgués,...
Jazyk angličtina Země Spojené státy americké
Typ dokumentu časopisecké články, randomizované kontrolované studie
- MeSH
- cyklofosfamid škodlivé účinky MeSH
- difúzní velkobuněčný B-lymfom * terapie MeSH
- dospělí MeSH
- doxorubicin škodlivé účinky MeSH
- imunokonjugáty * škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- lokální recidiva nádoru farmakoterapie MeSH
- mladý dospělý MeSH
- monoklonální protilátky MeSH
- prednison škodlivé účinky MeSH
- protokoly protinádorové kombinované chemoterapie škodlivé účinky MeSH
- rituximab terapeutické užití MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- vinkristin škodlivé účinky MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH
CONTEXT: R-CHOP is the standard of care for newly diagnosed DLBCL patients; however, 40% remain uncured. Polatuzumab vedotin (Pola), a CD79b-targeting antibody-drug conjugate, has shown promising activity/safety in a Phase Ib/II study (Tilly, et al. Lancet Oncol 2019). We report the Phase III double-blind, placebo-controlled, international POLARIX study (NCT03274492), which compared Pola-R-CHP with R-CHOP in treatment-naïve DLBCL patients with an International Prognostic Index score of 2-5. DESIGN: Patients were randomized (1:1) to six cycles of Pola-R-CHP or R-CHOP and on Day 1 of each cycle received Pola 1.8mg/kg or vincristine 1.4mg/m2, plus intravenous rituximab 375mg/m2, cyclophosphamide 750mg/m2, and doxorubicin 50mg/m2. Patients also received oral prednisone 100mg once daily (Days 1-5) and two further cycles of rituximab. The primary endpoint was investigator-assessed progression-free survival (PFS). RESULTS: Overall, 879 patients (median age 65 [range 19-80] years) were randomized (Pola-R-CHP: n=440; R-CHOP: n=439). At primary data cut-off (28 June 2021), median follow-up was 28.2 months. PFS was superior with Pola-R-CHP vs R-CHOP (hazard ratio [HR] 0.73; 95% confidence interval [CI]: 0.57-0.95; P=0.02) and 2-year PFS rate was improved (76.7% [95% CI: 72.7-80.8] vs 70.2% [95% CI: 65.8-74.6], respectively). Investigator-assessed event-free survival favored Pola-R-CHP vs R-CHOP (HR 0.75; 95% CI: 0.58-0.96; P=0.02) and overall survival was comparable (HR 0.94; 95% CI: 0.65-1.37; P=0.75). While independent review committee-assessed end-of-treatment complete response rate by positron emission tomography-computed tomography was not significantly different with Pola-R-CHP (78.0%) vs R-CHOP (74.0%; P=0.16), disease-free survival suggested more durable responses with Pola-R-CHP vs R-CHOP (HR 0.70; 95% CI: 0.50-0.98). Safety profiles were similar for Pola-R-CHP vs R-CHOP: grade 3-4 adverse event (AE) rates, 57.7% vs 57.5%, respectively; serious AEs, 34.0% vs 30.6%; grade 5 AEs, 3.0% vs 2.3%; AEs leading to dose reduction, 9.2% vs 13.0%; and peripheral neuropathy, any grade, 52.9% vs 53.9%. At data cut-off, fewer patients treated with Pola-R-CHP (23%) vs R-CHOP (30%) had received ≥1 subsequent anti-lymphoma therapy. CONCLUSIONS: As the first-line treatment of DLBCL, Pola-R-CHP demonstrated a 27% reduction in the relative risk of disease progression, relapse, or death, and a similar safety profile, compared with R-CHOP.
1st Faculty of Medicine Charles University General Hospital Prague Czech Republic
BC Cancer Centre for Lymphoid Cancer and the University of British Columbia Vancouver Canada
Centre Henri Becquerel and University of Rouen Rouen France
CHU de Montpellier Montpellier France
Clinical Hospital Feofaniya Kyiv Ukraine
Genentech Inc South San Francisco USA
Hoffmann La Roche Ltd Mississauga Canada
Hospital Erasto Gaertner Curitiba Brazil
Hospital San Pedro de Alcántara Cáceres Spain
Hospital Vall d'Hebron Vall d'Hebron Institute of Oncology Barcelona Spain
Institut Universitaire du Cancer Toulouse Oncopole Toulouse France
Kindai University Faculty of Medicine Osaka Sayama City Japan
Maria Sklodowska Curie National Research Institute of Oncology Krakow Poland
Memorial Sloan Kettering Cancer Center New York City Montvale USA
Memorial Sloan Kettering Cancer Center New York City USA
National Cancer Center Hospital Tokyo Japan
Odette Cancer Centre Sunnybrook Health Sciences Centre University of Toronto Toronto Canada
Peking University Cancer Hospital Beijing China
Princess Alexandra Hospital Brisbane Australia
Rocky Mountain Cancer Centers US Oncology Aurora USA
Taipei Veterans General Hospital Taipei Taiwan
The University of Texas MD Anderson Cancer Center Houston USA
Washington University in St Louis St Louis USA
Willamette Valley Cancer Institute US Oncology Eugene USA
Wilmot Cancer Institute University of Rochester Rochester USA
Citace poskytuje Crossref.org
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- $a CONTEXT: R-CHOP is the standard of care for newly diagnosed DLBCL patients; however, 40% remain uncured. Polatuzumab vedotin (Pola), a CD79b-targeting antibody-drug conjugate, has shown promising activity/safety in a Phase Ib/II study (Tilly, et al. Lancet Oncol 2019). We report the Phase III double-blind, placebo-controlled, international POLARIX study (NCT03274492), which compared Pola-R-CHP with R-CHOP in treatment-naïve DLBCL patients with an International Prognostic Index score of 2-5. DESIGN: Patients were randomized (1:1) to six cycles of Pola-R-CHP or R-CHOP and on Day 1 of each cycle received Pola 1.8mg/kg or vincristine 1.4mg/m2, plus intravenous rituximab 375mg/m2, cyclophosphamide 750mg/m2, and doxorubicin 50mg/m2. Patients also received oral prednisone 100mg once daily (Days 1-5) and two further cycles of rituximab. The primary endpoint was investigator-assessed progression-free survival (PFS). RESULTS: Overall, 879 patients (median age 65 [range 19-80] years) were randomized (Pola-R-CHP: n=440; R-CHOP: n=439). At primary data cut-off (28 June 2021), median follow-up was 28.2 months. PFS was superior with Pola-R-CHP vs R-CHOP (hazard ratio [HR] 0.73; 95% confidence interval [CI]: 0.57-0.95; P=0.02) and 2-year PFS rate was improved (76.7% [95% CI: 72.7-80.8] vs 70.2% [95% CI: 65.8-74.6], respectively). Investigator-assessed event-free survival favored Pola-R-CHP vs R-CHOP (HR 0.75; 95% CI: 0.58-0.96; P=0.02) and overall survival was comparable (HR 0.94; 95% CI: 0.65-1.37; P=0.75). While independent review committee-assessed end-of-treatment complete response rate by positron emission tomography-computed tomography was not significantly different with Pola-R-CHP (78.0%) vs R-CHOP (74.0%; P=0.16), disease-free survival suggested more durable responses with Pola-R-CHP vs R-CHOP (HR 0.70; 95% CI: 0.50-0.98). Safety profiles were similar for Pola-R-CHP vs R-CHOP: grade 3-4 adverse event (AE) rates, 57.7% vs 57.5%, respectively; serious AEs, 34.0% vs 30.6%; grade 5 AEs, 3.0% vs 2.3%; AEs leading to dose reduction, 9.2% vs 13.0%; and peripheral neuropathy, any grade, 52.9% vs 53.9%. At data cut-off, fewer patients treated with Pola-R-CHP (23%) vs R-CHOP (30%) had received ≥1 subsequent anti-lymphoma therapy. CONCLUSIONS: As the first-line treatment of DLBCL, Pola-R-CHP demonstrated a 27% reduction in the relative risk of disease progression, relapse, or death, and a similar safety profile, compared with R-CHOP.
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