Detail
Článek
Článek online
FT
Medvik - BMČ
  • Je něco špatně v tomto záznamu ?

Open-Label, Single-Arm Phase II Study of Pembrolizumab Monotherapy as First-Line Therapy in Patients With Advanced Clear Cell Renal Cell Carcinoma

DF. McDermott, JL. Lee, GA. Bjarnason, JMG. Larkin, RA. Gafanov, MD. Kochenderfer, NV. Jensen, F. Donskov, J. Malik, A. Poprach, SS. Tykodi, T. Alonso-Gordoa, DC. Cho, PF. Geertsen, MA. Climent Duran, C. DiSimone, RK. Silverman, RF. Perini, C....

. 2021 ; 39 (9) : 1020-1028. [pub] 20210202

Jazyk angličtina Země Spojené státy americké

Typ dokumentu klinické zkoušky, fáze II, časopisecké články, multicentrická studie, Research Support, N.I.H., Extramural, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc21025953

Grantová podpora
P50 CA101942 NCI NIH HHS - United States

PURPOSE: Pembrolizumab, a programmed death 1 inhibitor, demonstrated promising single-agent activity in untreated patients with various cancer types. The phase II KEYNOTE-427 study evaluated efficacy and safety of single-agent pembrolizumab in treatment-naive patients with advanced clear cell renal cell carcinoma (ccRCC; cohort A) and advanced non-ccRCC (cohort B). Results of cohort A are reported. METHODS: In this open-label, single-arm phase II study, patients with advanced ccRCC received pembrolizumab 200 mg every 3 weeks for ≤ 24 months. The primary end point was objective response rate by RECIST, version 1.1. RESULTS: In the total population (N = 110), median time from enrollment to data cutoff was 35.9 (range, 29.5-40.3) months. Objective response rate was 36.4% with four (3.6%) complete responses and 36 (32.7%) partial responses; disease control rate was 58.2% (95% CI, 48.4 to 67.5). Most patients (68.2%) had a decrease in target lesions, including 30.9% with a reduction ≥ 60%. Median duration of response was 18.9 (range, 2.3-37.6+) months; 64.1% of responders had a response ≥ 12 months (Kaplan-Meier). Median progression-free survival was 7.1 months (95% CI, 5.6 to 11.0). Median overall survival was not reached; 12-month and 24-month overall survival rates were 88.2% and 70.8%, respectively. Durable responses were observed across all International Metastatic RCC Database Consortium categories. Grade 3-5 treatment-related adverse events were reported in 30.0% of patients, of which colitis and diarrhea were most frequent. CONCLUSION: Single-agent pembrolizumab showed promising antitumor activity as a first-line treatment in patients with advanced ccRCC, with durable responses across International Metastatic RCC Database Consortium categories. Safety and tolerability profile of pembrolizumab monotherapy was comparable to what has been previously described in other tumor types.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc21025953
003      
CZ-PrNML
005      
20211026133339.0
007      
ta
008      
211013s2021 xxu f 000 0|eng||
009      
AR
024    7_
$a 10.1200/JCO.20.02363 $2 doi
035    __
$a (PubMed)33529051
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxu
100    1_
$a McDermott, David F $u Dana-Farber/Harvard Cancer Center, Boston, MA
245    10
$a Open-Label, Single-Arm Phase II Study of Pembrolizumab Monotherapy as First-Line Therapy in Patients With Advanced Clear Cell Renal Cell Carcinoma / $c DF. McDermott, JL. Lee, GA. Bjarnason, JMG. Larkin, RA. Gafanov, MD. Kochenderfer, NV. Jensen, F. Donskov, J. Malik, A. Poprach, SS. Tykodi, T. Alonso-Gordoa, DC. Cho, PF. Geertsen, MA. Climent Duran, C. DiSimone, RK. Silverman, RF. Perini, C. Schloss, MB. Atkins
520    9_
$a PURPOSE: Pembrolizumab, a programmed death 1 inhibitor, demonstrated promising single-agent activity in untreated patients with various cancer types. The phase II KEYNOTE-427 study evaluated efficacy and safety of single-agent pembrolizumab in treatment-naive patients with advanced clear cell renal cell carcinoma (ccRCC; cohort A) and advanced non-ccRCC (cohort B). Results of cohort A are reported. METHODS: In this open-label, single-arm phase II study, patients with advanced ccRCC received pembrolizumab 200 mg every 3 weeks for ≤ 24 months. The primary end point was objective response rate by RECIST, version 1.1. RESULTS: In the total population (N = 110), median time from enrollment to data cutoff was 35.9 (range, 29.5-40.3) months. Objective response rate was 36.4% with four (3.6%) complete responses and 36 (32.7%) partial responses; disease control rate was 58.2% (95% CI, 48.4 to 67.5). Most patients (68.2%) had a decrease in target lesions, including 30.9% with a reduction ≥ 60%. Median duration of response was 18.9 (range, 2.3-37.6+) months; 64.1% of responders had a response ≥ 12 months (Kaplan-Meier). Median progression-free survival was 7.1 months (95% CI, 5.6 to 11.0). Median overall survival was not reached; 12-month and 24-month overall survival rates were 88.2% and 70.8%, respectively. Durable responses were observed across all International Metastatic RCC Database Consortium categories. Grade 3-5 treatment-related adverse events were reported in 30.0% of patients, of which colitis and diarrhea were most frequent. CONCLUSION: Single-agent pembrolizumab showed promising antitumor activity as a first-line treatment in patients with advanced ccRCC, with durable responses across International Metastatic RCC Database Consortium categories. Safety and tolerability profile of pembrolizumab monotherapy was comparable to what has been previously described in other tumor types.
650    _2
$a dospělí $7 D000328
650    _2
$a senioři $7 D000368
650    _2
$a senioři nad 80 let $7 D000369
650    _2
$a humanizované monoklonální protilátky $x terapeutické užití $7 D061067
650    _2
$a protinádorové látky imunologicky aktivní $x terapeutické užití $7 D000074322
650    _2
$a karcinom z renálních buněk $x farmakoterapie $x patologie $7 D002292
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a následné studie $7 D005500
650    _2
$a lidé $7 D006801
650    _2
$a nádory ledvin $x farmakoterapie $x patologie $7 D007680
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a lidé středního věku $7 D008875
650    _2
$a nerandomizované kontrolované studie jako téma $7 D065228
650    _2
$a prognóza $7 D011379
650    _2
$a míra přežití $7 D015996
655    _2
$a klinické zkoušky, fáze II $7 D017427
655    _2
$a časopisecké články $7 D016428
655    _2
$a multicentrická studie $7 D016448
655    _2
$a Research Support, N.I.H., Extramural $7 D052061
655    _2
$a práce podpořená grantem $7 D013485
700    1_
$a Lee, Jae-Lyun $u Asan Medical Center and University of Ulsan College of Medicine, Seoul, Republic of Korea
700    1_
$a Bjarnason, Georg A $u Sunnybrook Odette Cancer Centre, Toronto, ON, Canada
700    1_
$a Larkin, James M G $u Institute of Cancer Research, London, UK
700    1_
$a Gafanov, Rustem A $u Russian Scientific Center of Roentgen Radiology, Moscow, Russia
700    1_
$a Kochenderfer, Mark D $u Carilion Clinic, Roanoke, VA
700    1_
$a Jensen, Niels Viggo $u Odense University Hospital, Odense, Denmark
700    1_
$a Donskov, Frede $u Aarhus University Hospital, Aarhus, Denmark
700    1_
$a Malik, Jahangeer $u Edinburgh Cancer Centre, Western General Hospital, Edinburgh, UK
700    1_
$a Poprach, Alexandr $u Masaryk Memorial Cancer Institute and Masaryk University, Brno, Czech Republic
700    1_
$a Tykodi, Scott S $u University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA
700    1_
$a Alonso-Gordoa, Teresa $u Hospital Universitario Ramón y Cajal, Madrid, Spain
700    1_
$a Cho, Daniel C $u Perlmutter Cancer Center at NYU Langone Medical Center, New York, NY
700    1_
$a Geertsen, Poul F $u Herlev Hospital, University of Copenhagen, Herlev, Denmark
700    1_
$a Climent Duran, Miguel Angel $u Instituto Valenciano de Oncología, València, Spain
700    1_
$a DiSimone, Christopher $u Arizona Oncology/US Oncology, Tucson AZ
700    1_
$a Silverman, Rachel Kloss $u Merck & Co, Inc, Kenilworth, NJ
700    1_
$a Perini, Rodolfo F $u Merck & Co, Inc, Kenilworth, NJ
700    1_
$a Schloss, Charles $u Merck & Co, Inc, Kenilworth, NJ
700    1_
$a Atkins, Michael B $u Georgetown Lombardi Comprehensive Cancer Center, Washington, DC
773    0_
$w MED00002596 $t Journal of clinical oncology : official journal of the American Society of Clinical Oncology $x 1527-7755 $g Roč. 39, č. 9 (2021), s. 1020-1028
856    41
$u https://pubmed.ncbi.nlm.nih.gov/33529051 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y p $z 0
990    __
$a 20211013 $b ABA008
991    __
$a 20211026133345 $b ABA008
999    __
$a ok $b bmc $g 1714844 $s 1146460
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2021 $b 39 $c 9 $d 1020-1028 $e 20210202 $i 1527-7755 $m Journal of clinical oncology $n J. clin. Oncol. $x MED00002596
GRA    __
$a P50 CA101942 $p NCI NIH HHS $2 United States
LZP    __
$a Pubmed-20211013

Najít záznam

Citační ukazatele

Možnosti archivace