dc.contributor | Vall d'Hebron Barcelona Hospital Campus |
dc.contributor.author | McDermott, David F. |
dc.contributor.author | Lee, Jae-Lyun |
dc.contributor.author | Ziobro, Marek |
dc.contributor.author | Suárez Rodríguez, Cristina |
dc.contributor.author | Langiewicz, Przemyslaw |
dc.contributor.author | Matveev, Vsevolod Borisovich |
dc.date.accessioned | 2021-07-21T10:30:49Z |
dc.date.available | 2021-07-21T10:30:49Z |
dc.date.issued | 2021-03-20 |
dc.identifier.citation | McDermott DF, Lee JL, Ziobro M, Suarez C, Langiewicz P, Matveev VB, et al. Open-Label, Single-Arm, Phase II Study of Pembrolizumab Monotherapy as First-Line Therapy in Patients With Advanced Non-Clear Cell Renal Cell Carcinoma. J Clin Oncol. 2021 Mar 20;39(9):1029-1039. |
dc.identifier.issn | 1527-7755 |
dc.identifier.uri | https://hdl.handle.net/11351/6191 |
dc.description | Renal Cell Carcinoma; Pembrolizumab |
dc.description.abstract | PURPOSE
Programmed death 1 (PD-1) pathway inhibitors have not been prospectively evaluated in patients with non–clear cell renal cell carcinoma (nccRCC). The phase II KEYNOTE-427 study (cohort B) was conducted to assess the efficacy and safety of single-agent pembrolizumab, a PD-1 inhibitor, in advanced nccRCC.
METHODS
Patients with histologically confirmed, measurable (Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) nccRCC and no prior systemic therapy received pembrolizumab 200 mg intravenously once every 3 weeks for ≤ 24 months. The primary end point was objective response rate (ORR) per RECIST v1.1.
RESULTS
Among enrolled patients (N = 165), 71.5% had confirmed papillary, 12.7% had chromophobe, and 15.8% had unclassified RCC histology. Most patients (67.9%) had intermediate or poor International Metastatic RCC Database Consortium risk status and tumors with programmed death ligand 1 (PD-L1) combined positive score (CPS) ≥ 1 (61.8%). The median time from enrollment to database cutoff was 31.5 months (range, 22.7-38.8). In all patients, the ORR was 26.7%. The median duration of response was 29.0 months; 59.7% of responses lasted ≥ 12 months. The ORR by CPS ≥ 1 and CPS < 1 status was 35.3% and 12.1%, respectively. The ORR by histology was 28.8% for papillary, 9.5% for chromophobe, and 30.8% for unclassified. Overall, the median progression-free survival was 4.2 months (95% CI, 2.9 to 5.6); the 24-month rate was 18.6%. The median overall survival was 28.9 months (95% CI, 24.3 months to not reached); the 24-month rate was 58.4%. Overall, 69.7% of patients reported treatment-related adverse events, most commonly pruritus (20.0%) and hypothyroidism (14.5%). Two deaths were treatment related (pneumonitis and cardiac arrest).
CONCLUSION
First-line pembrolizumab monotherapy showed promising antitumor activity in nccRCC. The safety profile was similar to that observed in other tumor types. |
dc.language.iso | eng |
dc.publisher | American Society of Clinical Oncology |
dc.relation.ispartofseries | Journal of Clinical Oncology;39(9) |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 International |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ |
dc.source | Scientia |
dc.subject | Adenocarcinoma |
dc.subject | Ronyons - Càncer |
dc.subject | Medicaments antineoplàstics - Ús terapèutic |
dc.subject.mesh | Carcinoma, Renal Cell |
dc.subject.mesh | Antineoplastic Agents |
dc.subject.mesh | /therapeutic use |
dc.title | Open-Label, Single-Arm, Phase II Study of Pembrolizumab Monotherapy as First-Line Therapy in Patients With Advanced Non–Clear Cell Renal Cell Carcinoma |
dc.type | info:eu-repo/semantics/article |
dc.identifier.doi | 10.1200/JCO.20.02365 |
dc.subject.decs | carcinoma de células renales |
dc.subject.decs | antineoplásicos |
dc.subject.decs | /uso terapéutico |
dc.relation.publishversion | https://ascopubs.org/doi/full/10.1200/JCO.20.02365 |
dc.type.version | info:eu-repo/semantics/publishedVersion |
dc.audience | Professionals |
dc.contributor.organismes | Institut Català de la Salut |
dc.contributor.authoraffiliation | [McDermott DF] Beth Israel Deaconess Medical Center, Boston, MA. [Lee JL] Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea. [Ziobro M] Centrum Onkologii-Instytut im. Marii Sklodowskiej, Cracow, Poland. [Suarez C] Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Langiewicz P] Wojskowy Instytut Medyczny Centralny Szpital Medyczny MON, Warszawa, Poland. [Matveev VB] N.N. Blokhin Russian Cancer Research Center, Moscow, Russia |
dc.identifier.pmid | 33529058 |
dc.identifier.wos | 000655499200010 |
dc.rights.accessrights | info:eu-repo/semantics/openAccess |