Clinical Outcomes of Patients With Gastrointestinal Malignancies Participating in Phase I Clinical Trials

Autor: Barbara Bertels, Tzu Hua Juan, Aaron Cleveland Denson, Gregory M. Springett, Jae K Lee, Georgine Wapinsky, Nancy J. Burke, Richard D. Kim, Amit Mahipal, Daniel M. Sullivan, Jonathan R. Strosberg
Rok vydání: 2018
Předmět:
Male
Cancer Research
medicine.medical_specialty
Kaplan-Meier Estimate
Cancer Care Facilities
Risk Assessment
Disease-Free Survival
Article
Cohort Studies
03 medical and health sciences
Sex Factors
0302 clinical medicine
Cause of Death
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
Confidence Intervals
medicine
Humans
Neoplasm Invasiveness
030212 general & internal medicine
Survival analysis
Aged
Gastrointestinal Neoplasms
Neoplasm Staging
Proportional Hazards Models
Retrospective Studies
Aged
80 and over
Proportional hazards model
business.industry
Patient Selection
Hazard ratio
Age Factors
Cancer
Retrospective cohort study
Middle Aged
Prognosis
medicine.disease
Survival Analysis
Clinical trial
Treatment Outcome
Oncology
030220 oncology & carcinogenesis
Multivariate Analysis
Florida
Female
business
Progressive disease
Cohort study
Zdroj: American Journal of Clinical Oncology. 41:133-139
ISSN: 0277-3732
DOI: 10.1097/coc.0000000000000242
Popis: Objectives Early-phase clinical trials play a pivotal role in drug development. However, limited data are available on outcomes of gastrointestinal (GI) cancer patients enrolled in phase I clinical trials. Here, we evaluated the characteristics associated with survival in GI cancer patients participating in phase I clinical trials and attempted to validate previously established prognostic models. Materials and methods All consecutive patients with advanced GI tumors who participated in phase I clinical trials at our institution from January 2007 to December 2013 and received at least 1 dose of the study drug were included. Cox regression models were used to estimate multivariable-adjusted hazard ratio (HR) and 95% confidence interval. Results In 243 study patients (median age, 62 y [range, 26 to 82 y]; 55% male), treatment included chemotherapy only (14%), targeted therapy (41%), chemotherapy+targeted therapy (42%), and others (2%) for the following disease types: pancreatic (42%), colorectal (34%), gastroesophageal (10%), hepatobiliary (13%), and others (2%). Response rate was 4%, with 38% achieving stable disease and 42% having progressive disease. Median survival was 5.8 months (range, 0.2 to 52.4 mo). Our multivariable Cox regression analyses included the following as predictors of survival: Eastern Cooperative Oncology Group performance score ≥1 (HR=1.76), prior systemic therapies ≥2 (HR=1.63), lactate dehydrogenase >618 IU/L (HR=1.85), sodium >135 mmol/L (HR=0.46), and white blood count >6×10/L (HR=1.5). Our data set was consistent with previous prognostic scores. Conclusions This is the largest study to assess clinical outcomes in this patient population. Phase I trials provide clinical benefit to patients with advanced GI malignancies and should be recommended as a treatment option in appropriate patients.
Databáze: OpenAIRE
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