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Phase 1 trial evaluating cisplatin, gemcitabine, and veliparib in 2 patient cohorts: Germline BRCA mutation carriers and wild‐type BRCA pancreatic ductal adenocarcinoma
Cancer, 2018-04, Vol.124 (7), p.1374-1382
O'Reilly, Eileen M.
Lee, Jonathan W.
Lowery, Maeve A.
Capanu, Marinela
Stadler, Zsofia K.
Moore, Malcolm J.
Dhani, Neesha
Kindler, Hedy L.
Estrella, Hayley
Maynard, Hannah
Golan, Talia
Segal, Amiel
Salo‐Mullen, Erin E.
Yu, Kenneth H.
Epstein, Andrew S.
Segal, Michal
Brenner, Robin
Do, Richard K.
Chen, Alice P.
Tang, Laura H.
Kelsen, David P.
2018
Volltextzugriff (PDF)
Details
Autor(en) / Beteiligte
O'Reilly, Eileen M.
Lee, Jonathan W.
Lowery, Maeve A.
Capanu, Marinela
Stadler, Zsofia K.
Moore, Malcolm J.
Dhani, Neesha
Kindler, Hedy L.
Estrella, Hayley
Maynard, Hannah
Golan, Talia
Segal, Amiel
Salo‐Mullen, Erin E.
Yu, Kenneth H.
Epstein, Andrew S.
Segal, Michal
Brenner, Robin
Do, Richard K.
Chen, Alice P.
Tang, Laura H.
Kelsen, David P.
Titel
Phase 1 trial evaluating cisplatin, gemcitabine, and veliparib in 2 patient cohorts: Germline BRCA mutation carriers and wild‐type BRCA pancreatic ductal adenocarcinoma
Ist Teil von
Cancer, 2018-04, Vol.124 (7), p.1374-1382
Ort / Verlag
United States: Wiley Subscription Services, Inc
Erscheinungsjahr
2018
Quelle
Free E-Journal (出版社公開部分のみ)
Beschreibungen/Notizen
BACKGROUND A phase 1 trial was used to evaluate a combination of cisplatin, gemcitabine, and escalating doses of veliparib in patients with untreated advanced pancreatic ductal adenocarcinoma (PDAC) in 2 cohorts: a germline BRCA1/2‐mutated (BRCA+) cohort and a wild‐type BRCA (BRCA–) cohort. The aims were to determine the safety, dose‐limiting toxicities (DLTs), maximum tolerated dose, and recommended phase 2 dose (RP2D) of veliparib combined with cisplatin and gemcitabine and to assess the antitumor efficacy (Response Evaluation Criteria in Solid Tumors, version 1.1) and overall survival. METHODS Gemcitabine and cisplatin were dosed at 600 and 25 mg/m2, respectively, over 30 minutes on days 3 and 10 of a 21‐day cycle. Four dose levels of veliparib were evaluated: 20 (dose level 0), 40 (dose level 1), and 80 mg (dose level 2) given orally twice daily on days 1 to 12 and 80 mg given twice daily on days 1 to 21 (dose level 2A [DL2A]). RESULTS Seventeen patients were enrolled: 9 BRCA+ patients, 7 BRCA– patients, and 1 patient with an unknown status. DLTs were reached at DL2A (80 mg twice daily on days 1 to 21). Two of the 5 patients in this cohort (40%) experienced grade 4 neutropenia and thrombocytopenia. Two grade 5 events occurred on protocol. The objective response rate in the BRCA+ cohort was 7 of 9 (77.8%). The median overall survival for BRCA+ patients was 23.3 months (95% confidence interval [CI], 3.8‐30.2 months). The median overall survival for BRCA– patients was 11 months (95% CI, 1.5‐12.1 months). CONCLUSIONS The RP2D of veliparib was 80 mg by mouth twice daily on days 1 to 12 in combination with cisplatin and gemcitabine; the DLT was myelosuppression. Substantial antitumor activity was seen in BRCA+ PDAC. A randomized phase 2 trial is currently evaluating cisplatin and gemcitabine with and without veliparib for BRCA+ PDAC (NCT01585805). Cancer 2018;124:1374‐82. © 2018 American Cancer Society. The recommended phase 2 dose of veliparib, combined with fixed‐dose cisplatin and gemcitabine, is 80 mg by mouth twice daily on days 1 to 12 of a 3‐week cycle. Substantial antitumor activity has been identified in a germline BRCA‐mutated patient population with untreated advanced pancreatic adenocarcinoma.
Sprache
Englisch
Identifikatoren
ISSN: 0008-543X
eISSN: 1097-0142
DOI: 10.1002/cncr.31218
Titel-ID: cdi_proquest_journals_2017674615
Format
–
Schlagworte
Adenocarcinoma
,
Adenocarcinoma - drug therapy
,
Adenocarcinoma - genetics
,
Adenocarcinoma - pathology
,
Adult
,
Aged
,
Anticancer properties
,
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
,
Antitumor activity
,
Benzimidazoles - administration & dosage
,
BRCA
,
BRCA1 protein
,
BRCA1 Protein - genetics
,
BRCA2 Protein - genetics
,
Breast cancer
,
Cancer
,
Carcinoma, Pancreatic Ductal - drug therapy
,
Carcinoma, Pancreatic Ductal - genetics
,
Carcinoma, Pancreatic Ductal - pathology
,
Cisplatin
,
Cisplatin - administration & dosage
,
Cohort Studies
,
Confidence intervals
,
Deoxycytidine - administration & dosage
,
Deoxycytidine - analogs & derivatives
,
Female
,
Follow-Up Studies
,
Gemcitabine
,
Germ-Line Mutation
,
germline
,
Heterozygote
,
Humans
,
Male
,
Middle Aged
,
Myelosuppression
,
Neutropenia
,
Oncology
,
Pancreas
,
Pancreatic cancer
,
Pancreatic Neoplasms
,
Pancreatic Neoplasms - drug therapy
,
Pancreatic Neoplasms - genetics
,
Pancreatic Neoplasms - pathology
,
Patients
,
Prognosis
,
Solid tumors
,
Survival
,
Survival Rate
,
Thrombocytopenia
,
Toxicity
,
Tumors
,
veliparib
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