Miguel Gonzalez Velez

Representation of minorities and women in oncology clinical trials: Review of the past 14 years

PURPOSE Many cancer clinical trials lack appropriate representation of specific patient populations, limiting their generalizability. Therefore, we determined the representation of ethnic minorities and women in cancer clinical trials. METHODS Enrollment data from all therapeutic trials reported as completed in ClinicalTrials.gov from 2003 to 2016 were analyzed. We calculated enrollment fractions (EFs) for each group, defined as the number of enrollees divided by the 2013 Surveillance, Epidemiology, and End Results (SEER) database cancer prevalence. RESULTS Of 1,012 clinical trials, 310 (31%) reported ethnicity with a total of 55,689 enrollees. Participation varied significantly across ethnic groups. Non-Hispanic whites were more likely to be enrolled in clinical trials (EF, 1.2%) than African Americans (EF, 0.7%; P < .001) and Hispanics (EF, 0.4%; P < .001). A decrease in African American (6% v 9.2%) and Hispanic (2.6% v 3.1%) enrollment was observed when compared with historical data from 1996 to 2002. Younger patients (age younger than 65 years) were more likely to be enrolled in clinical trials than the elderly (64% v 36%; P < .001). Low recruitment of female patients was observed in clinical trials for melanoma (35%), lung cancer (39%), and pancreatic cancer (40%). CONCLUSION We observed a decrease in recruitment of minorities over the past 14 years compared with historical data. African Americans, Hispanics, and women were less likely to be enrolled in cancer clinical trials. Future trials should take extra measures to recruit participants that adequately represent the US cancer population.

Abstract A27: Diversity in multiple myeloma clinical trials

Background: Multiple myeloma (MM) accounts for approximately 1% of all cancers and 10% of hematologic malignancies in the United States (U.S.). MM occurs in all races, but the incidence in African Americans is two to three times higher than in non-Hispanic whites. MM is also slightly more frequent in men than women (1.4:1). Many clinical trials lack appropriate representation of specific patient populations, limiting the generalizability of the evidence obtained. Therefore, we determined the representation of ethnic minorities, the elderly, and women in MM clinical trials. Methods: Enrollment data from all therapeutic trials reported as completed in clinicaltrial.gov from 2000 to 2016 were analyzed. Clinical trials including other hematologic malignancies and with recruitment outside of the U.S. were excluded. Enrollment fraction (EF) was defined as the number of enrollees divided by the 2013 SEER database MM complete prevalence. Chi-square test was used to estimate differences in categorical data. Results: Out of 177 MM clinical trials (CT), 78 (44%) reported ethnicity with a total of 12,055 enrollees. Regarding enrollees9 ethnic composition, 84% were non-Hispanic White (NHW), 8.6% African American (AA), 2.8% Asian, 1.8% Hispanic, and 0.1% Native American/Alaskan Indian. Out of those 78 CT, 52 (66%) were phase II, 15 (19%) phase III, and 11 (14%) phase I. Most of the results were published from 2012 to 2016 (74%). Forty-six (59%) trials were sponsored by industry, 7 (9%) by NCI, and 25 (32%) were investigator initiated. Participation in CT varied significantly across ethnic groups, NHW were more likely to be enrolled in CT (EF of 0.23) than AA (EF of 0.08, p Conclusions: Despite the higher incidence of MM in African Americans and the elderly, the former only represented 8.6% of the study participants and 66% of these were less than 65 years of age; therefore, we are lacking data in the tolerability of these new agents in our aging MM population. We also observed that industry studies were less likely to recruit AA patients. Collaborations between investigators, sponsors, and the community are necessary to increase our minority and elderly patients9 access to clinical trials. Citation Format: Narjust Duma, Miguel Gonzalez Velez, Jesus Vera-Aguilera, Richardo Parrondo, Veronica Mariotti, Jonas Paludo, Yucai Wang, Ronald Go, Alex Adjei. Diversity in multiple myeloma clinical trials [abstract]. In: Proceedings of the Tenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2017 Sep 25-28; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2018;27(7 Suppl):Abstract nr A27.

Predictors of recurrence in stage I/II colorectal cancer: Analysis of a single institution’s experience for over 24 years.

534 Background: Surgical resection remains a mainstay of treatment for localized colorectal cancer (CRC). However, up to 35% of patients (pts) develop recurrence with a significant decrease in overall survival. The aim of this study was to evaluate clinical characteristics and specific predictors of recurrence for stage I/II CRC Methods: We performed a retrospective analysis of 2310 pts diagnosed with stage I/II CRC at our institution between 1990 and 2013, with a minimum follow up of 24 months. Tumor characteristics and recurrence data were studied. Cox regression was used for statistical analysis. Results: Of the 2310 pts, recurrence was identified in 276 (12%) pts, of which 88 (32%) pts had early recurrence ( < 1 year). Median time of recurrence was 625 days. 210 (76%) pts had local recurrence while 66 (24%) pts had distal recurrence, with liver being the main site of distant metastasis. Males had a higher recurrence rate than females (16% vs. 7%, p < 0.0001). When comparing recurrence pts (R) with non...

Abstract C82: Carboplatin replacing BCNU in the BCNU, etoposide, cyclophosphamide (CVP) regimen for autologous stem cell transplant in patients with advanced lymphoma. Very low toxicity and encouraging results

Introduction: Autologous stem cell transplantation (ASCT) is the standard of care for treating patients with advanced lymphomas. The most commonly employed preparative regimens are BCNU (Carmustine), etoposide, cytosine arabinoside, melphalan (BEAM), and BCNU, etoposide, cyclophosphamide (CVP). Both regimens use BCNU, but this medication is associated with pulmonary toxicity, besides, in some underdeveloped countries there is a serious shortage of it. Carboplatin is an agent with good activity in Hodgkin and non-Hodgkin´s lymphomas and has a tolerable toxicity profile. Here we present our experience in a bone marrow transplant service in Colombia (South America) a country with shortage of BCNU. We evaluated the effects of a high-dose chemotherapy regimen with carboplatin replacing BCNU in the CVP regimen. Methods: After peripheral blood progenitor cells were mobilized with filgrastim 10 µg/kg for five days, twenty four patients with advanced lymphomas were conditioned prior to ASCT. The conditioning regimen consisted of carboplatin (450 mg/m2/ days -5,-4), etoposide (330 mgs mg/m2/days -4,-3,-2) and cyclophosphamide (2.000 mg/m2/days -3,-2,-1). After the autograft all patients received filgrastim or pegfilgrastim from day +5. Results: 24 consecutive patients were transplanted, median age 39.2 years (range 5-70), eleven were female. 11 patients (46%) had Hodgkin lymphoma; 7 in CR2 and four in partial remission or with refractory disease. 13 (54%) had non-Hodgkin´s lymphoma classified as: 6 diffuse large B cell, 5 mantle cell, 2 transformed follicular. Patients with mantle cell lymphoma were in CR1 while the rest were in CR2. The median CD 34+ cells infused was 4.09 x 106 cells/kg. The median time to achieve 500/µL absolute granulocyte count and 20.000/µL platelets was 11.7 days (range 8-17), and 16.5 days (range 7-23) respectively. 20 out of 24 had febrile neutropenia, the other toxicities were mild; grade II mucositis in three patients, neutropenic colitis in two and hemorrhagic cystitis in one. There were no pulmonary or renal toxicities and the transplant related mortality was 0%. The four patients with active disease achieved complete remission after transplant but two of them have relapsed. The one year overall survival is 100%, with a median follow-up of 12 months (range 5-18), and the disease-free survival, estimated by Kaplan-Meier is 90%. Conclusions: The use of carboplatin replacing BCNU in the CVP regimen seems to be a safe and effective conditioning protocol followed by ASCT in patients with various types of lymphomas. This treatment option seems an adequate alternative for underdeveloped countries with shortage of BCNU. The regimen shows good anti-tumor activity, with a tolerable toxicity profile. These promising results must be confirmed with the inclusion of more patients and a longer follow-up. Citation Format: Miguel Gonzalez Velez, Amado Jose Karduss-Urueta, Rosendo Perez, Luis Rodolfo Gomez, Juan Alejo Jimenez, Pedro Alejandro Reyes, Ana Cardona, Liliana Hurtado, Hilda Deossa, Clara Fernandez. Carboplatin replacing BCNU in the BCNU, etoposide, cyclophosphamide (CVP) regimen for autologous stem cell transplant in patients with advanced lymphoma. Very low toxicity and encouraging results. [abstract]. In: Proceedings of the Eighth AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Nov 13-16, 2015; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2016;25(3 Suppl):Abstract nr C82.