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Evaluating Treatment Tolerability in Cancer Clinical Trials Using the Toxicity Index
- Source :
- JNCI Journal of the National Cancer Institute
- Publication Year :
- 2019
-
Abstract
- Background The National Cancer Institute Moonshot research initiative calls for improvements in the analysis and reporting of treatment toxicity to advise key stakeholders on treatment tolerability and inform regulatory and clinical decision making. This study illustrates alternative approaches to toxicity evaluation using the National Surgical Adjuvant Breast and Bowel Project R-04 clinical trial as an example. Methods National Surgical Adjuvant Breast and Bowel Project R-04 was a neoadjuvant chemoradiation trial in stage II–III rectal cancer patients. A 2 x 2 factorial design was used to evaluate whether the addition of oxaliplatin (Oxa) to 5-fluorouracil (5FU) or capecitabine (Cape) with radiation therapy improved local-regional tumor control. The toxicity index (TI), which accounts for the frequency and severity of toxicities, was compared across treatments using multivariable probabilistic index models, where Pr A Results A total of 4560 toxicities from 1558 patients were analyzed. Results from adjusted probabilistic index models indicate that oxaliplatin-containing regimens had statistically significant (P Conclusions This article uses standard data collected in a cancer clinical trial to introduce descriptive and analytic methods that account for the additional burden of multiple toxicities. These methods may provide a more accurate description of a patient’s treatment experience that could lead to individualized dosing for better toxicity control. Future research will evaluate the generalizability of these findings in trials with similar drugs.
- Subjects :
- Oncology
Adult
Male
Cancer Research
medicine.medical_specialty
Drug-Related Side Effects and Adverse Reactions
Maximum Tolerated Dose
Colorectal cancer
Adenocarcinoma
01 natural sciences
Capecitabine
010104 statistics & probability
03 medical and health sciences
0302 clinical medicine
Internal medicine
Neoplasms
Antineoplastic Combined Chemotherapy Protocols
medicine
Health Status Indicators
Humans
0101 mathematics
Aged
Monitoring, Physiologic
Randomized Controlled Trials as Topic
Aged, 80 and over
Performance status
business.industry
Rectal Neoplasms
Cancer
Articles
Middle Aged
medicine.disease
Prognosis
Confidence interval
Oxaliplatin
Clinical trial
Treatment Outcome
Tolerability
Clinical Trials, Phase III as Topic
Research Design
030220 oncology & carcinogenesis
Female
business
AcademicSubjects/MED00010
medicine.drug
Follow-Up Studies
Subjects
Details
- ISSN :
- 14602105
- Volume :
- 112
- Issue :
- 12
- Database :
- OpenAIRE
- Journal :
- Journal of the National Cancer Institute
- Accession number :
- edsair.doi.dedup.....9fdff3d0870eb530e28c487f9e9bec8e