TY - JOUR
T1 - Carboplatin dosing in the treatment of ovarian cancer
T2 - An NRG oncology group study
AU - Praiss, Aaron M.
AU - Miller, Austin
AU - Smith, Judith
AU - Lichtman, Stuart M.
AU - Bookman, Michael
AU - Aghajanian, Carol
AU - Sabbatini, Paul
AU - Backes, Floor
AU - Cohn, David E.
AU - Argenta, Peter
AU - Friedlander, Michael
AU - Goodheart, Michael J.
AU - Mutch, David G.
AU - Gershenson, David M.
AU - Tewari, Krishnansu S.
AU - Wenham, Robert M.
AU - Wahner Hendrickson, Andrea E.
AU - Lee, Roger B.
AU - Gray, Heidi
AU - Secord, Angeles Alvarez
AU - Van Le, Linda
AU - O'Cearbhaill, Roisin E.
N1 - Publisher Copyright:
© 2023 Elsevier Inc.
PY - 2023/7
Y1 - 2023/7
N2 - 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(CrClJelliffe) 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.
AB - 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(CrClJelliffe) 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.
KW - Carboplatin dosing
KW - Cockcroft-Gault formula
KW - Creatinine clearance
KW - Jelliffe formula
KW - Modification of diet in renal disease formula
KW - Wright formula
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U2 - 10.1016/j.ygyno.2023.05.013
DO - 10.1016/j.ygyno.2023.05.013
M3 - Article
C2 - 37229879
AN - SCOPUS:85162227678
SN - 0090-8258
VL - 174
SP - 213
EP - 223
JO - Gynecologic oncology
JF - Gynecologic oncology
ER -