A method for the evaluation of dose-toxicity relationships in clinical trials.
This paper considers a proportional hazards model that describes the relationship between time-dependent cumulative dose of drug and development of toxicity. We estimate probabilities of developing toxicity in both the presence and the absence of competing risks and provide variances for the latter case. Mitoxantrone data collected in Southwest Oncology Group studies illustrate the methods.
Mather
F J
FJ
Department of Biostatistics and Epidemiology, Tulane University Medical Center, New Orleans, LA 70112.
Simon
R M
RM
Clark
G M
GM
Von Hoff
D D
DD
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects*; D002986:Clinical Trials as Topic / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D004341:Drug Evaluation / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D008942:Mitoxantrone / Q000009:adverse effects; D015233:Models, Statistical; D009369:Neoplasms / Q000188:drug therapy / Q000401:mortality; D011336:Probability; D012306:Risk
D000970:Antineoplastic Agents; D008942:Mitoxantrone