Evaluation of toxicities related to novel therapy in clinical trials for women with gynecologic cancer.
Adult
Aged
Aged, 80 and over
Antineoplastic Agents
/ adverse effects
Clinical Trials, Phase I as Topic
Databases, Factual
Drug-Related Side Effects and Adverse Reactions
/ classification
Female
Genital Neoplasms, Female
/ drug therapy
Humans
Middle Aged
National Cancer Institute (U.S.)
Retrospective Studies
United States
Young Adult
clinical protocols
drug therapy
ovarian neoplasms
toxicity
Journal
Cancer
ISSN: 1097-0142
Titre abrégé: Cancer
Pays: United States
ID NLM: 0374236
Informations de publication
Date de publication:
15 05 2020
15 05 2020
Historique:
received:
26
10
2019
revised:
30
12
2019
accepted:
26
01
2020
pubmed:
26
2
2020
medline:
15
1
2021
entrez:
26
2
2020
Statut:
ppublish
Résumé
Women with gynecologic cancer may be at increased risk for adverse events (AEs) due to peritoneal disease burden and prior treatment (surgery, chemotherapy, and pelvic radiotherapy). This study compared the toxicity profiles of patients with and without gynecologic cancer enrolled in phase 1 trials. This was a retrospective analysis of the National Cancer Institute phase 1 database for all trials enrolling 1 or more patients with gynecologic cancer over 2 decades (1995-2015). Clinical parameters collected included demographics, cancer history, trial information, AEs, and responses. AEs (according to the Common Terminology Criteria for Adverse Events) were documented for each patient during treatment, and they were counted once and analyzed on the basis of the highest grade and drug attribution. Multiple regression models were used to compare AEs at the baseline and during treatment. A total of 4269 patients enrolled in 150 trials were divided into 3 groups: 1) women with gynecologic cancer (n = 685), 2) women with nongynecologic cancer (n = 1698), and 3) men with cancer (n = 1886). The median age was 58 years. The mean number of total AEs reported during treatment was highest for women with gynecologic cancer (17.1 vs 14.7 vs 13.5; P < .001), even though they were similar at the baseline (7.0 vs 7.4 vs 7.0; P = .09). The mean number of drug-related AEs was also highest for women with gynecologic cancer (8.3 vs 6.9 vs 6.2; P < .001). Grade 3 to 5 AEs were similar (2.3 vs 2.3 vs 2.1); however, grade 2 AEs were more frequent in women with gynecologic cancer (4.6 vs 3.9 vs 3.5). Treatment discontinuations due to AEs were similar (9% vs 9% vs 10%). Women with gynecologic cancer experienced more frequent low-grade AEs during treatment, and this warrants attention to support their symptom burden. Study dose management should be considered for recurrent grade 2 AEs, particularly during continuous therapy.
Sections du résumé
BACKGROUND
Women with gynecologic cancer may be at increased risk for adverse events (AEs) due to peritoneal disease burden and prior treatment (surgery, chemotherapy, and pelvic radiotherapy). This study compared the toxicity profiles of patients with and without gynecologic cancer enrolled in phase 1 trials.
METHODS
This was a retrospective analysis of the National Cancer Institute phase 1 database for all trials enrolling 1 or more patients with gynecologic cancer over 2 decades (1995-2015). Clinical parameters collected included demographics, cancer history, trial information, AEs, and responses. AEs (according to the Common Terminology Criteria for Adverse Events) were documented for each patient during treatment, and they were counted once and analyzed on the basis of the highest grade and drug attribution. Multiple regression models were used to compare AEs at the baseline and during treatment.
RESULTS
A total of 4269 patients enrolled in 150 trials were divided into 3 groups: 1) women with gynecologic cancer (n = 685), 2) women with nongynecologic cancer (n = 1698), and 3) men with cancer (n = 1886). The median age was 58 years. The mean number of total AEs reported during treatment was highest for women with gynecologic cancer (17.1 vs 14.7 vs 13.5; P < .001), even though they were similar at the baseline (7.0 vs 7.4 vs 7.0; P = .09). The mean number of drug-related AEs was also highest for women with gynecologic cancer (8.3 vs 6.9 vs 6.2; P < .001). Grade 3 to 5 AEs were similar (2.3 vs 2.3 vs 2.1); however, grade 2 AEs were more frequent in women with gynecologic cancer (4.6 vs 3.9 vs 3.5). Treatment discontinuations due to AEs were similar (9% vs 9% vs 10%).
CONCLUSIONS
Women with gynecologic cancer experienced more frequent low-grade AEs during treatment, and this warrants attention to support their symptom burden. Study dose management should be considered for recurrent grade 2 AEs, particularly during continuous therapy.
Identifiants
pubmed: 32097505
doi: 10.1002/cncr.32783
pmc: PMC10693932
mid: NIHMS1946319
doi:
Substances chimiques
Antineoplastic Agents
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
2139-2145Subventions
Organisme : NCI NIH HHS
ID : UM1 CA186644
Pays : United States
Informations de copyright
© 2020 American Cancer Society.
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