PMID- 32097505
OWN - NLM
STAT- MEDLINE
DCOM- 20210114
LR  - 20231205
IS  - 1097-0142 (Electronic)
IS  - 0008-543X (Print)
IS  - 0008-543X (Linking)
VI  - 126
IP  - 10
DP  - 2020 May 15
TI  - Evaluation of toxicities related to novel therapy in clinical trials for women 
      with gynecologic cancer.
PG  - 2139-2145
LID - 10.1002/cncr.32783 [doi]
AB  - 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.
CI  - (c) 2020 American Cancer Society.
FAU - Lee, Yeh Chen
AU  - Lee YC
AUID- ORCID: 0000-0003-2009-8263
AD  - Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, 
      Canada.
FAU - Wang, Lisa
AU  - Wang L
AD  - Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, 
      Canada.
FAU - Kohn, Elise C
AU  - Kohn EC
AD  - Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, Maryland.
FAU - Rubinstein, Lawrence
AU  - Rubinstein L
AD  - Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, Maryland.
FAU - Ivy, S Percy
AU  - Ivy SP
AD  - Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, Maryland.
FAU - Harris, Pamela J
AU  - Harris PJ
AD  - Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, Maryland.
FAU - Lheureux, Stephanie
AU  - Lheureux S
AUID- ORCID: 0000-0003-4405-5890
AD  - Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, 
      Canada.
LA  - eng
GR  - UM1 CA186644/CA/NCI NIH HHS/United States
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20200225
PL  - United States
TA  - Cancer
JT  - Cancer
JID - 0374236
RN  - 0 (Antineoplastic Agents)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents/*adverse effects/therapeutic use
MH  - Clinical Trials, Phase I as Topic
MH  - Databases, Factual
MH  - Drug-Related Side Effects and Adverse Reactions/classification/*epidemiology
MH  - Female
MH  - Genital Neoplasms, Female/*drug therapy
MH  - Humans
MH  - Middle Aged
MH  - National Cancer Institute (U.S.)
MH  - Retrospective Studies
MH  - United States
MH  - Young Adult
PMC - PMC10693932
MID - NIHMS1946319
OTO - NOTNLM
OT  - clinical protocols
OT  - drug therapy
OT  - ovarian neoplasms
OT  - toxicity
COIS- CONFLICT OF INTEREST DISCLOSURES Stephanie Lheureux reports consulting for 
      AstraZeneca, Merck, Roche, and GSK. The other authors made no disclosures.
EDAT- 2020/02/26 06:00
MHDA- 2021/01/15 06:00
PMCR- 2023/12/03
CRDT- 2020/02/26 06:00
PHST- 2019/10/26 00:00 [received]
PHST- 2019/12/30 00:00 [revised]
PHST- 2020/01/26 00:00 [accepted]
PHST- 2020/02/26 06:00 [pubmed]
PHST- 2021/01/15 06:00 [medline]
PHST- 2020/02/26 06:00 [entrez]
PHST- 2023/12/03 00:00 [pmc-release]
AID - 10.1002/cncr.32783 [doi]
PST - ppublish
SO  - Cancer. 2020 May 15;126(10):2139-2145. doi: 10.1002/cncr.32783. Epub 2020 Feb 25.