-
Je něco špatně v tomto záznamu ?
Five-year survival in patients with extensive-stage small cell lung cancer treated with atezolizumab in the Phase III IMpower133 study and the Phase III IMbrella A extension study
M. Reck, R. Dziadziuszko, S. Sugawara, S. Kao, M. Hochmair, F. Huemer, G. de Castro, L. Havel, R. Bernabé Caro, G. Losonczy, JS. Lee, DM. Kowalski, Z. Andric, R. Califano, A. Veatch, G. Gerstner, M. Batus, S. Morris, M. Kaul, V. Cuchelkar, H. Li,...
Jazyk angličtina Země Irsko
Typ dokumentu časopisecké články, klinické zkoušky, fáze III, randomizované kontrolované studie, multicentrická studie
- MeSH
- dospělí MeSH
- etoposid aplikace a dávkování terapeutické užití MeSH
- humanizované monoklonální protilátky * terapeutické užití aplikace a dávkování škodlivé účinky MeSH
- karboplatina * aplikace a dávkování terapeutické užití MeSH
- lidé středního věku MeSH
- lidé MeSH
- malobuněčný karcinom plic * farmakoterapie mortalita patologie MeSH
- míra přežití MeSH
- nádory plic * farmakoterapie mortalita patologie MeSH
- následné studie MeSH
- protokoly protinádorové kombinované chemoterapie * terapeutické užití škodlivé účinky MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- staging nádorů MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
OBJECTIVES: IMbrella A is a Phase III extension study that allowed rollover from Roche/Genentech-sponsored atezolizumab trials, including IMpower133, a Phase I/III trial of first-line atezolizumab or placebo plus carboplatin/etoposide in extensive-stage small cell lung cancer. We report outcomes from an exploratory analysis of IMpower133 with extended time-to-event data for patients who rolled over to IMbrella A. MATERIALS AND METHODS: IMpower133 patients could roll over to IMbrella A to receive atezolizumab 1200 mg intravenously every three weeks if they continued to receive atezolizumab at IMpower133 closure or were in survival follow-up after atezolizumab discontinuation. Overall survival and safety were assessed; only serious adverse events and AEs of special interest were collected in IMbrella A. RESULTS: Eighteen of 26 eligible patients rolled over to IMbrella A. At clinical cutoff (March 16, 2023), median follow-up in the atezolizumab plus carboplatin/etoposide arm (IMpower133 and IMbrella A) was 59.4 months. The three-, four-, and five-year overall survival (95 % CI) estimates were 16 % (11 %-21 %), 13 % (8 %-18 %), and 12 % (7 %-17 %), respectively. In IMbrella A, serious adverse events occurred in three patients (16.7 %), and one adverse event of special interest was reported (grade two hypothyroidism). CONCLUSION: This long-term analysis of patients from IMbrella A previously enrolled in IMpower133 provides the first report of five-year overall survival outcomes in patients with extensive-stage small cell lung cancer treated with first-line cancer immunotherapy and chemotherapy. While limited by small patient numbers and lack of long-term data for the IMpower133 control arm, exploratory overall survival analyses in patients treated with atezolizumab plus carboplatin/etoposide compared favorably with historical data with chemotherapy alone. NCT03148418.
1st Faculty of Medicine Charles University Thomayer Hospital Prague Czech Republic
Computational Sciences Genentech South San Francisco CA USA
Department of Internal Medicine Seoul National University Bundang Hospital Seongnam South Korea
Department of Medical Oncology Chris O'Brien Lifehouse Camperdown NSW Australia
Department of Medical Oncology Clinical Hospital Centre Bezanijska Kosa Belgrade Serbia
Department of Medical Oncology Hospital Universitario Virgen del Rocío Seville Spain
Department of Pulmonary Medicine Sendai Kousei Hospital Sendai Japan
F Hoffmann La Roche Ltd Basel Switzerland
Faculty of Medicine Semmelweis University Budapest Hungary
Genentech South San Francisco CA USA
Illinois Cancer Care Peoria IL USA
Medical Oncology Rush University Medical Center Chicago IL USA
Northwest Medical Specialties Puyallup WA USA
Oncology Product Development Safety Genentech Inc South San Francisco CA USA
Product Development Oncology Hematology Genentech South San Francisco CA USA
Citace poskytuje Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc25003996
- 003
- CZ-PrNML
- 005
- 20250206105026.0
- 007
- ta
- 008
- 250121e20240810ie f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1016/j.lungcan.2024.107924 $2 doi
- 035 __
- $a (PubMed)39306923
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a ie
- 100 1_
- $a Reck, Martin $u Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany. Electronic address: m.reck@lungenclinic.de
- 245 10
- $a Five-year survival in patients with extensive-stage small cell lung cancer treated with atezolizumab in the Phase III IMpower133 study and the Phase III IMbrella A extension study / $c M. Reck, R. Dziadziuszko, S. Sugawara, S. Kao, M. Hochmair, F. Huemer, G. de Castro, L. Havel, R. Bernabé Caro, G. Losonczy, JS. Lee, DM. Kowalski, Z. Andric, R. Califano, A. Veatch, G. Gerstner, M. Batus, S. Morris, M. Kaul, V. Cuchelkar, H. Li, BJ. Danner, BY. Nabet, SV. Liu
- 520 9_
- $a OBJECTIVES: IMbrella A is a Phase III extension study that allowed rollover from Roche/Genentech-sponsored atezolizumab trials, including IMpower133, a Phase I/III trial of first-line atezolizumab or placebo plus carboplatin/etoposide in extensive-stage small cell lung cancer. We report outcomes from an exploratory analysis of IMpower133 with extended time-to-event data for patients who rolled over to IMbrella A. MATERIALS AND METHODS: IMpower133 patients could roll over to IMbrella A to receive atezolizumab 1200 mg intravenously every three weeks if they continued to receive atezolizumab at IMpower133 closure or were in survival follow-up after atezolizumab discontinuation. Overall survival and safety were assessed; only serious adverse events and AEs of special interest were collected in IMbrella A. RESULTS: Eighteen of 26 eligible patients rolled over to IMbrella A. At clinical cutoff (March 16, 2023), median follow-up in the atezolizumab plus carboplatin/etoposide arm (IMpower133 and IMbrella A) was 59.4 months. The three-, four-, and five-year overall survival (95 % CI) estimates were 16 % (11 %-21 %), 13 % (8 %-18 %), and 12 % (7 %-17 %), respectively. In IMbrella A, serious adverse events occurred in three patients (16.7 %), and one adverse event of special interest was reported (grade two hypothyroidism). CONCLUSION: This long-term analysis of patients from IMbrella A previously enrolled in IMpower133 provides the first report of five-year overall survival outcomes in patients with extensive-stage small cell lung cancer treated with first-line cancer immunotherapy and chemotherapy. While limited by small patient numbers and lack of long-term data for the IMpower133 control arm, exploratory overall survival analyses in patients treated with atezolizumab plus carboplatin/etoposide compared favorably with historical data with chemotherapy alone. NCT03148418.
- 650 _2
- $a lidé $7 D006801
- 650 12
- $a humanizované monoklonální protilátky $x terapeutické užití $x aplikace a dávkování $x škodlivé účinky $7 D061067
- 650 12
- $a malobuněčný karcinom plic $x farmakoterapie $x mortalita $x patologie $7 D055752
- 650 12
- $a nádory plic $x farmakoterapie $x mortalita $x patologie $7 D008175
- 650 _2
- $a mužské pohlaví $7 D008297
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 _2
- $a lidé středního věku $7 D008875
- 650 12
- $a protokoly protinádorové kombinované chemoterapie $x terapeutické užití $x škodlivé účinky $7 D000971
- 650 _2
- $a senioři $7 D000368
- 650 12
- $a karboplatina $x aplikace a dávkování $x terapeutické užití $7 D016190
- 650 _2
- $a staging nádorů $7 D009367
- 650 _2
- $a etoposid $x aplikace a dávkování $x terapeutické užití $7 D005047
- 650 _2
- $a následné studie $7 D005500
- 650 _2
- $a míra přežití $7 D015996
- 650 _2
- $a dospělí $7 D000328
- 650 _2
- $a senioři nad 80 let $7 D000369
- 655 _2
- $a časopisecké články $7 D016428
- 655 _2
- $a klinické zkoušky, fáze III $7 D017428
- 655 _2
- $a randomizované kontrolované studie $7 D016449
- 655 _2
- $a multicentrická studie $7 D016448
- 700 1_
- $a Dziadziuszko, Rafal $u Faculty of Medicine, Department of Oncology and Radiotherapy, Medical University of Gdańsk, Gdańsk, Poland
- 700 1_
- $a Sugawara, Shunichi $u Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan
- 700 1_
- $a Kao, Steven $u Department of Medical Oncology, Chris O'Brien Lifehouse, Camperdown, NSW, Australia
- 700 1_
- $a Hochmair, Maximilian $u Department of Respiratory and Critical Care Medicine, Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Vienna North Hospital Klinik Floridsdorf, Vienna, Austria
- 700 1_
- $a Huemer, Florian $u Department of Respiratory Care, Ludwig Boltzmann Institute for Lung Health, Klinik Penzing, Vienna, Austria
- 700 1_
- $a de Castro, Gilberto $u Clinical Oncology, Instituto de Cancer do Estado de São Paulo, Hospital Das Clínicas Da FMUSP, São Paulo, Brazil
- 700 1_
- $a Havel, Libor $u First Faculty of Medicine, Charles University, Thomayer Hospital, Prague, Czech Republic
- 700 1_
- $a Bernabé Caro, Reyes $u Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain
- 700 1_
- $a Losonczy, György $u Faculty of Medicine, Semmelweis University, Budapest, Hungary
- 700 1_
- $a Lee, Jong-Seok $u Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea
- 700 1_
- $a Kowalski, Dariusz M $u Department of Lung Cancer and Chest Tumours, Maria Skłodowska-Curie National Research Institute of Oncology, Warsaw, Poland
- 700 1_
- $a Andric, Zoran $u Department of Medical Oncology, Clinical Hospital Centre Bezanijska Kosa, Belgrade, Serbia
- 700 1_
- $a Califano, Raffaele $u Department of Medical Oncology, The Christie NHS Foundation Trust and Division of Cancer Sciences, The University of Manchester, Manchester, UK
- 700 1_
- $a Veatch, Andrea $u Northwest Medical Specialties, Puyallup, WA, USA
- 700 1_
- $a Gerstner, Gregory $u Illinois Cancer Care, Peoria, IL, USA
- 700 1_
- $a Batus, Marta $u Medical Oncology, Rush University Medical Center, Chicago, IL, USA
- 700 1_
- $a Morris, Stefanie $u F. Hoffmann-La Roche Ltd, Basel, Switzerland
- 700 1_
- $a Kaul, Monika $u Oncology Product Development Safety, Genentech Inc, South San Francisco, CA, USA
- 700 1_
- $a Cuchelkar, Vaikunth $u Product Development Oncology-Hematology, Genentech, South San Francisco, CA, USA
- 700 1_
- $a Li, Huafei $u Roche, Product Development China, Shanghai, China
- 700 1_
- $a Danner, Bradford J $u Genentech, South San Francisco, CA, USA
- 700 1_
- $a Nabet, Barzin Y $u Computational Sciences, Genentech, South San Francisco, CA, USA
- 700 1_
- $a Liu, Stephen V $u Thoracic Oncology and Developmental Therapeutics, Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA
- 773 0_
- $w MED00003160 $t Lung cancer $x 1872-8332 $g Roč. 196 (20240810), s. 107924
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/39306923 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y - $z 0
- 990 __
- $a 20250121 $b ABA008
- 991 __
- $a 20250206105022 $b ABA008
- 999 __
- $a ok $b bmc $g 2263624 $s 1240003
- BAS __
- $a 3
- BAS __
- $a PreBMC-MEDLINE
- BMC __
- $a 2024 $b 196 $c - $d 107924 $e 20240810 $i 1872-8332 $m Lung cancer $n Lung Cancer $x MED00003160
- LZP __
- $a Pubmed-20250121