دورية أكاديمية
أعرض في EDS

Carboplatin dosing in the treatment of ovarian cancer: An NRG oncology group study.

التفاصيل البيبلوغرافية
العنوان: Carboplatin dosing in the treatment of ovarian cancer: An NRG oncology group study.
المؤلفون: Praiss AM; Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, United States of America. Electronic address: PraissA@mskcc.org., Miller A; NRG Oncology Statistics and Data Center, Roswell Park Cancer Institute, Buffalo, NY, United States of America. Electronic address: MillerA@NRGOncology.org., Smith J; McGovern Medical School, The University of Texas Health Science Center, Houston, TX, United States of America. Electronic address: judith.ann.smith@uth.tmc.edu., Lichtman SM; Gynecologic Medical Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, United States of America; Department of Medicine, Weill Cornell Medical College, New York, NY, United States of America. Electronic address: LichtmaS@mskcc.org., Bookman M; Department of Medical Oncology, Kaiser-Permanente Northern California, San Francisco, CA, United States of America. Electronic address: Michael.A.Bookman@kp.org., Aghajanian C; Gynecologic Medical Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, United States of America; Department of Medicine, Weill Cornell Medical College, New York, NY, United States of America. Electronic address: aghajanc@MSKCC.org., Sabbatini P; Gynecologic Medical Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, United States of America; Department of Medicine, Weill Cornell Medical College, New York, NY, United States of America. Electronic address: sabbatip@mskcc.org., Backes F; Department of Oncology, James Cancer Center, Ohio State University Comprehensive Cancer Center, Columbus, OH, United States of America. Electronic address: Floor.Backes@osumc.edu., Cohn DE; Department of Oncology, James Cancer Center, Ohio State University Comprehensive Cancer Center, Columbus, OH, United States of America. Electronic address: David.Cohn@osumc.edu., Argenta P; Department of Obstetrics, Gynecology and Women's Health, Division of Gynecologic Oncology, University of Minnesota, Minneapolis, MN, United States of America. Electronic address: argenta@umn.edu., Friedlander M; Department of Medical Oncology, Prince of Wales Hospital and Prince of Wales Clinical School, UNSW, Sydney, New South Wales, Australia. Electronic address: Michael.Friedlander@health.nsw.gov.au., Goodheart MJ; Gynecologic Oncology, University of Iowa Hospitals, Iowa City, IA, United States of America. Electronic address: Michael-goodheart@uiowa.edu., Mutch DG; Gynecologic Oncology, Washington University, St. Louis, MO, United States of America. Electronic address: mutchd@wustl.edu., Gershenson DM; Gynecologic Oncology, University of Texas, MD Anderson Cancer Center, Houston, TX, United States of America. Electronic address: dgershen@mdanderson.org., Tewari KS; Gynecologic Oncology, University of California, Irvine Medical Center, Orange, CA, USA. Electronic address: ktewari@uci.edu., Wenham RM; Gynecologic Oncology, Moffitt Cancer Center and Research Institute, Tampa, FL, United States of America. Electronic address: Robert.wenham@moffitt.org., Wahner Hendrickson AE; Division of Medical Oncology, Mayo Clinic, Rochester, MN, United States of America. Electronic address: WahnerHendrickson.Andrea@mayo.edu., Lee RB; Gynecologic Oncology, Tacoma General Hospital, Tacoma, WA, United States of America., Gray H; Gynecologic Oncology, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America. Electronic address: hgray@uw.edu., Secord AA; Gynecologic Oncology, Duke Cancer Institute, Duke University Medical Center, Durham, NC, United States of America. Electronic address: angeles.secord@duke.edu., Van Le L; Gynecologic Oncology, University of North Carolina, United States of America. Electronic address: linda_van_le@med.unc.edu., O'Cearbhaill RE; Gynecologic Medical Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, United States of America; Department of Medicine, Weill Cornell Medical College, New York, NY, United States of America. Electronic address: ocearbhr@mskcc.org.
المصدر: Gynecologic oncology [Gynecol Oncol] 2023 Jul; Vol. 174, pp. 213-223. Date of Electronic Publication: 2023 May 23.
نوع المنشور: Clinical Trial, Phase III; Journal Article; Research Support, N.I.H., Extramural
اللغة: English
بيانات الدورية: Publisher: Academic Press Country of Publication: United States NLM ID: 0365304 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1095-6859 (Electronic) Linking ISSN: 00908258 NLM ISO Abbreviation: Gynecol Oncol Subsets: MEDLINE
أسماء مطبوعة: Original Publication: New York, Academic Press.
مواضيع طبية MeSH: Ovarian Neoplasms*/drug therapy, Female ; Humans ; Carboplatin ; Creatinine ; Glomerular Filtration Rate ; Kidney Function Tests ; Retrospective Studies
مستخلص: Objective: To determine the effects of using National Comprehensive Cancer Network (NCCN) guidelines to estimate renal function on carboplatin dosing and explore adverse effects associated with a more accurate estimation of lower creatinine clearance (CrCl).
Methods: Retrospective data were obtained for 3830 of 4312 patients treated on GOG182 (NCT00011986)-a phase III trial of platinum-based chemotherapy for advanced-stage ovarian cancer. Carboplatin dose per patient on GOG182 was determined using the Jelliffe formula. We recalculated CrCl to determine dosing using Modification of Diet in Renal Disease (MDRD) and Cockcroft-Gault (with/without NCCN recommended modifications) formulas. Associations between baseline CrCl and toxicity were described using the area under the receiver operating characteristic curve (AUC). Sensitivity and positive predictive values described the model's ability to discriminate between subjects with/without the adverse event.
Results: AUC statistics (range, 0.52-0.64) showed log(CrCl Jelliffe ) was not a good predictor of grade ≥3 adverse events (anemia, thrombocytopenia, febrile neutropenia, auditory, renal, metabolic, neurologic). Of 3830 patients, 628 (16%) had CrCl <60 mL/min. Positive predictive values for adverse events ranged from 1.8%-15%. Using the Cockcroft-Gault, Cockcroft-Gault with NCCN modifications, and MDRD (instead of Jelliffe) formulas to estimate renal function resulted in a >10% decrease in carboplatin dosing in 16%, 32%, and 5.2% of patients, respectively, and a >10% increase in carboplatin dosing in 41%, 9.6% and 12% of patients, respectively.
Conclusion: The formula used to estimate CrCl affects carboplatin dosing. Estimated CrCl <60 mL/min (by Jelliffe) did not accurately predict adverse events. Efforts continue to better predict renal function. Endorsing National Cancer Institute initiatives to broaden study eligibility, our data do not support a minimum threshold CrCl <60 mL/min as an exclusion criterion from clinical trials.
Competing Interests: Declaration of Competing Interest Dr. O'Cearbhaill reports support for this study from NCI/NIH P30 CA008748 and grants to Institution from Bayer/Celgene/Juno, Tesaro/GSK, Merck, Ludwig Cancer Institute, AbbVie/Stemkens, Regeneron, TCR2 Therapeutics, Atara Biotherapeutics, Marker Therapeutics, Syndax Pharmaceuticals, Genmab/Seagen Therapeutics, Genentech, Kite Pharma, Acrivon and Gynecologic Oncology Foundation. Outside of the submitted work, Dr. O'Cearbhaill reports honoraria from GSK, Bayer, Regeneron, SeaGen, Fresenius Kabi, Immunogen, MJH Life Sciences and Curio. Dr. O'Cearbhaill reports receiving support to attend meetings and/or travel from Hitech Health, Gathering Around Cancer, Ireland, GOG Foundation and SGO. Dr. O'Cearbhaill participated on Data Safety Monitoring Board or Advisory Board for each of the following: AstraZeneca (DUO-0), GSK (moonstone, Prima), Acrivon, Carina Biotech, Link therapeutics, Tesaro/GSK, Regeneron, Seattle Genetics/Seagen, Immunogen, Bayer, R-Pharm, 2seventybio, Miltenyi and Fresenius Kabi. Dr. O'Cearbhaill also served as Vice-chair for the CPC, SGO as well a Chair, Developmental Therapeutics Committee for NRG Oncology. Dr. Aghajanian received research grants from AbbVie, Clovis, Genentech and Astra Zeneca and served on advisory boards for AbbVie, AstraZeneca/Merck, Eisai/Merck, Mersana Therapeutics, Repare Therapeutics and Roche/Genentech and received consulting fees for serving. Dr. Aghajanian served on the Blueprint Medicine Advisory Board (uncompensated). Dr. Aghajanian also serves on the GOG Foundation, Board of Directors (travel cost reimbursement for attending meetings) as well as the NRG Oncology Board of Directors (unpaid). Dr. Floor Backes wishes to report research grants from Immunogen, Clovis, Merck, Eisai, Natera and Beigene. Dr. Backes reports receiving consulting fees received from Eisai, Merck, Agenus, AstraZeneca, GlaxoSmithKline; Myriad, Clovis Oncology and Immunogen. Dr. Backes received honoraria for serving on advisory boards from Medlearning Group, CEC Oncology, OncLive, i3Health, and Medscape. Dr. Backes serves as Co-Chair of the NRG Oncology Developmental Therapeutics. Dr. Backes is a member of the Uterine Corpus Committee as well as a NCCN Ovary member and serves as an SGO Board Member. Dr. Michael Bookman reports payment to his Institution from Immunogen Data Monitoring Committee (unrelated to this project). Dr. David Cohn reports receiving honoraria from UpToDate as an Author as well as receiving payment for his role with Elsevier, Gynecologic Oncology as an Editor-in-Chief. Dr. Michael Friedlander reports that personally receiving consulting fees from AstraZeneca, Novartis, GSK and Incyclix (Nil). Dr. Friedlander also reports receiving honoraria from AstraZeneca and GSK and also received travel funding from AstraZeneca. Dr. Friedlander reports participating on Data Safety Monitoring Board/Advisory Board for AGITG IDSMB and ENDO-3. Dr. Friedlander reports that his Institution received grants from AstraZeneca, Beigene and Novartis. Dr. David Gershenson reports support from NRG Oncology with regard to this Study. Dr. Gershenson also acknowledges grants to his Institution from Novartis, GOG Foundation, and the NCI. Dr. Gershenson personally received royalties from Elsevier and UpToDate and consulting fees from Genentech (uncompensated) and Verastem. Dr. Gershenson received honoraria from University of Washington OB/GYN Grand Rounds and Yale University OB/GYN Grand Rounds and participating in a data safety monitoring/advisory board for Onconova, Aadi and Springworks. Dr. Gershenson also served on the International Consortium for Low-Grade Serous Ovarian Cancer and NCCN Ovarian Cancer Panel (uncompensated). Dr. Gershenson also wishes to disclose having stock in managed accounts for Bristol Myers Squibb, Johnson & Johnson and Procter & Gamble. Dr. Michael Goodheart reports receiving consulting fees from GlasoSmithKlein GSK/Tesaro, Merck, AstraZeneca, Clovis Oncology, SeaGen and Eisai. Dr. Angeles Alvarez Secord reports clinical trial grants received from the following: AbbVie, Aravive, AstraZeneca, BoehringerIngelheim, Clovis, Eisai, Ellipses, I-MAB Biopharma, Immunogen, Merck, Oncoquest/Canaria Bio, Seagen Inc., TapImmune, Tesaro/GSK, VBL Therapeutics. Dr. Secord also wishes to report receiving clinical trial grant/translational research grant from Roche/Genentech as well as Consulting fee from Myriad. Dr. Secord also received support for attending meetings/travel from GSK, GOG Foundation and NRG. Dr. Secord also served on the Clinical Trial Steering Committees for Aravive, Genentech/Roche, VBL Therapeutics and Oncoquest/Canaria Bio without compensation. Dr. Secord personally received compensation from GOG Foundation and NRG Oncology paid compensation to Institution. Dr. Secord also served in Leadership roles for Society of Gynecologic Oncology and American Association of Obstetrics and Gynecology Foundation (uncompensated). Dr. Judith Smith received honoraria for Speaking at the HOPA Annual Meeting 2016 – Harmonization of Carboplatin Dosing, Dr. Smith serves as Chair on the NRG Oncology Pharmacy Subcommittee. Dr. Tewari also reports receiving honoraria from Eisai, AstraZeneca, Clovis, GSK/Tesaro, Merck and Seagen/Genmab. Dr. Krishnansu Tewari reports receiving consulting fees from Regeneron, Eisai, AstraZeneca, Clovis, GSK/Tesaro, Merck, Seagen/Genmab. Dr. Andrea Wahner Hendrickson reports receiving Clinical Trial support from Prolynx and Site PI Clinical Trial Support from both Amgen and TORL Biotherapeutics. Dr. Wahner Hendrickson reports serving on Oxcia Advisory Board (uncompensated). Dr. Wahner Hendrickson reports serving on an Advisory Board for the Mayo Clinic Data Safety Monitoring Board (uncompensated). Dr. Wahner Hendrickson also served on the NCCN Ovarian Cancer Committee (uncompensated). Dr. Robert Wenham reports personal and institutional grants received from Merck and Ovation Diagnostics. Dr. Wenham reports receiving consulting fees from Merck, Legend Biotech, Genentech, Ovation Diagnostics, GSK/Tesaro, Clovis, AstraZeneca, AbbVie, Legend Biotech, Regeneron, Seagen, Sonic Biotherapeutics, Shattuck Labs, Novacure, Eisai and Immunogen. Dr. Wenham also reports receiving Institutional Clinical Trial Fees from AbbVie, AstraZeneca, Regeneron and Eisai. Dr. Wenham reports serving on Advisory Board for Seagen and GSK/Tesaro. Dr. Wenham would like to disclose personally owning stock in Ovation Diagnostics. Dr. Peter Argenta, Dr. Heidi Gray, Dr. Roger Lee, Dr. Stuart Lichtman, Dr. Austin Miller, Dr. David Mutch, Dr. Aaron Praiss, Dr. Paul Sabbatini and Dr. Linda Van Le have no potential conflicts of interest to disclose.
(Copyright © 2023 Elsevier Inc. All rights reserved.)
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معلومات مُعتمدة: U10 CA180868 United States CA NCI NIH HHS; UL1 TR001412 United States TR NCATS NIH HHS; P30 CA086862 United States CA NCI NIH HHS; P30 CA008748 United States CA NCI NIH HHS; UG1 CA233191 United States CA NCI NIH HHS; U10 CA180888 United States CA NCI NIH HHS; U10 CA180822 United States CA NCI NIH HHS; UG1 CA233339 United States CA NCI NIH HHS; UG1 CA233290 United States CA NCI NIH HHS; UG1 CA233331 United States CA NCI NIH HHS
فهرسة مساهمة: Keywords: Carboplatin dosing; Cockcroft-Gault formula; Creatinine clearance; Jelliffe formula; Modification of diet in renal disease formula; Wright formula
سلسلة جزيئية: ClinicalTrials.gov NCT00011986
المشرفين على المادة: BG3F62OND5 (Carboplatin)
AYI8EX34EU (Creatinine)
تواريخ الأحداث: Date Created: 20230525 Date Completed: 20230627 Latest Revision: 20240702
رمز التحديث: 20240702
مُعرف محوري في PubMed: PMC10330633
DOI: 10.1016/j.ygyno.2023.05.013
PMID: 37229879
قاعدة البيانات: MEDLINE
الوصف
تدمد:1095-6859
DOI:10.1016/j.ygyno.2023.05.013