Abstract A56: Clinical benefit of early phase clinical trial participation for Hispanic patients with advanced hematological malignancies
Authors: Mazo-Canola Marcela , Karnad Anand B. , Weitman Steven , Malik Laeeq , Garcia Alex V. Mejia 
Published: October 2015

Background: Standard systemic treatment options for patients with advanced hematological malignancies are limited. Although disparities in solid tumors such as lung, breast, and colorectal cancers have been well studied, racial and ethnically based outcomes in hematologic malignancies, clinical trial participation and clinical benefit from this have received much less attention in this population. Comprehensive information is lacking on early phase cancer clinical trials in this rapidly growing demographic group.

Aim: To describe, evaluate and compare the clinical benefit and characteristics of a cohort of consecutive Hispanic and Non-Hispanics patients with advanced hematologic malignancies enrolled on clinical trials at CTRC, a National Cancer Institute-designated Cancer Center from 2000 to 2013.

Methods: We retrospectively reviewed and report baseline demographic characteristics, response, toxicity and outcomes based on ethnicity of patients with hematological malignancies treated within Phase I/II clinical trials at the Cancer Therapy and Research Center. This constitutes the preliminary findings of the first 106 patients out of a larger cohort of patients currently under study.

Results: One hundred and six patients were treated. The median number of prior systemic therapies was 3 for both Hispanics (range 0-5) and Non-Hispanics (range 0-12). The median age of Hispanic patients was 52 years and for non-Hispanics was 64 years, with a male/female ratio of 29/22 for Hispanics and of 27/24 for non-Hispanics respectively. (table 1)

Among 53 Hispanic patients, the mean progression free (PFS) and overall survival (OS) were 3.6 and 5.3 months respectively [95% CI for PFS 2.45-4.6 months and for OS 3.5–7.1 months]. Among 53 Non-Hispanic patients, the mean progression free (PFS) and overall survival (OS) were 3.9 and 5.2 months respectively [95% CI for PFS 2.4-5.2 months and for OS 2.7–7.7 months]. There were no statistically significant differences in outcome between ethnicities. (p=0.73 for PFS and p=0.97 for OS). The clinical benefit rate (CBR=SD+CR+PR) was 26% for Hispanics and 22% for Non-Hispanic patients. No significant differences occurred in hematological or non-hematological toxicities between the Hispanic and non-Hispanic group and most of these were grade 1 and 2.

Conclusion: Our preliminary clinical outcome and safety data suggests that early phase clinical trials may offer potential clinical benefit and are a reasonable option for Hispanic patients with advanced hematological malignancies. There are no significant differences in outcomes and reported toxicities when compared with patients of non-Hispanic origin. Further analysis is needed to determine other prognostic indicators in this population.

Citation Format: Marcela Mazo-Canola, Anand B. Karnad, Steven Weitman, Laeeq Malik, Alex V. Mejia Garcia. Clinical benefit of early phase clinical trial participation for Hispanic patients with advanced hematological malignancies. [abstract]. In: Proceedings of the Seventh AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Nov 9-12, 2014; San Antonio, TX. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2015;24(10 Suppl):Abstract nr A56.