6028 Background: Eftilagimod alpha (efti) is a soluble LAG-3 protein that binds to a subset of MHC class II molecules to mediate antigen presenting cell (APC) activation and CD8 T-cell activation. The stimulation of the dendritic cell network and subsequent T cell recruitment with efti may lead to stronger anti-tumor responses in combination than observed with pembrolizumab alone. We hereby report results of the 2nd line metastatic squamous head and neck carcinoma (HNSCC) cohort (part C) of phase II trial (NCT03625323). Methods: Patients (pts) with HNSCC progressed on or after 1st line platinum-based therapy and unselected for PD-L1 expression were recruited into part C. The study used a Simon's 2-stage design (18 pts planned for stage 1 and 19 for stage 2), with objective response rate (ORR) by iRECIST as the primary endpoint (EP). Secondary EPs include tolerability, disease control rate (DCR), progression free survival (PFS), overall survival (OS), pharmacokinetics, pharmacodynamics and immunogenicity. Efti was administered as 30 mg subcutaneous injection every 2 wks for 8 cycles and then every 3 wks for 9 cycles with pembrolizumab (200 mg intravenous infusion every 3 wks for up to 2 yrs). Imaging was performed every 8 weeks. PD-L1 was assessed centrally (22C3 clone). The study was approved by ethics committees and institutional review boards. Results: In total 38 pts were enrolled. The median age was 62 yrs (range 37-84) and 89 % were male. The ECOG PS was 0 and 1 in 34% and 66%, respectively. Primary location at diagnosis was the oral cavity (29%), oropharynx (37%), hypopharynx (18%) and the larynx (16%). All PD-L1 subgroups (CPS < 1 %, ≥ 1 to ≤19; ≥20) were included. All pts were pre-treated with platinum-based chemotherapy. Pts received a median of 3.0 (range 1 – 21) pembrolizumab and 5.0 (range 1-31) efti administrations. Thirty-five (35) pts were evaluated for response (cut-off Jan 2021) with 4 (11 %) pts showing CR, 7 (20 %) pts PR, 3 (9 %) pts SD, 16 (46 %) pts PD with 5 (14 %) pts being not evaluable as per iRECIST. ORR was reported with 31.4 % (95 % CI 16.9 % - 49.3 %) and DCR 40 %Median PFS was 2.1 months and 35 % were progression free at 6 months. Median OS (46 % events) was 12.6 months. There were no adverse reactions leading to treatment discontinuation. The most common ( > 10 %) treatment emergent adverse events were cough (18 %), asthenia (16 %), dyspnea (11 %), fatigue (13 %), diarrhea (11 %), hypothyroidism (11%), upper respiratory tract infection (11%) and back pain (11%). Conclusions: Efti in combination with pembrolizumab is safe and shows encouraging antitumor activity in platinum pre-treated 2nd line HNSCC patients. Clinical trial information: NCT03625323.
Introduction: Clinical trial accrual and enrollment are essential to break disparities seen in minority populations affected by cancer. Despite Hispanics (HI) being 18.9% of the US population and the fastest-growing minority in the US, they only represent 4% of the patients enrolled in clinical trials. These disparities are often explained by different social determinants of health, but could also be due to decreased perceived interest by oncologists in their participation simply due to lack of English proficiency. Effective doctor-patient communication is vital in establishing a healthy doctor-patient relationship, and is vital in delivering high-quality health care. In this study, we explore whether physician-patient language concordance affects clinical trial enrollment. Methods: We evaluated 233 patients diagnosed with breast cancer who consented to experimental clinical trials in a private Oncology practice in Houston, Texas, from 2008-2022. All trials had approved consent in English and Spanish. We used logistic regression to model the probability of treatment, while adjusting for the effects of cancer type, gender, race, ethnicity, and language concordance. Results: Of the 233 patients with breast cancer, 191(82%) were enrolled in a clinical trial, and 96% of these patients spoke the same language as their providers. 42 patients were not enrolled, with 95% of patients speaking the same language as their provider. There were 209 (90%) patients who spoke English, 22 (9%) were Spanish speakers and 2 (1%) were Arabic speakers. Of the Spanish speakers, 18 were enrolled, with 13 (72%) having language concordance with their provider. The ethnicity was evaluated, resulting in 72 (31%) patients being Hispanics, 55 (24%) African American, 94 (40%) Caucasian, 7 (3%) Asian, 4 (2%) Middle Eastern and 1 (0.4%) American Indian. It also evaluated the rate of consent withdrawal, showing only 6 (3%) patients. After evaluating the results, it was noted that there was no statistically significant association of physician-patient language concordance with enrollment rate (p=0.776). There was also no significant difference in consent withdrawal (p=0.626), and no change associated with gender (p=0.344) or ethnicity when evaluated (p=0.13). Conclusion: In conclusion, our analysis confirms no significant difference in breast cancer patients’ enrollment in clinical trials if there is language concordance between physician and patient. The efforts of the medical workforce to use translators and translated versions of informed consents, surveys or outcome assessments, when available, seem enough for our patients to agree to continue enrollment. Citation Format: Daniela Urueta Portillo, Ana M. Mendoza Sanchez, Nitzia E. Quilantan, Lisa Maria Mendoza Sanchez, Marcela Mazo Canola, Jonathan Gelfond, Julio A. Peguero. Does physician-patient language concordance increase clinical trial enrollment in breast cancer patients?: A real-life study in a majority-minority population. [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 5522.
Background: Intravascular large b-cell lymphoma (IVLBCL) is a rare but highly aggressive subtype of non-Hodgkin lymphoma (NHL). IVLBCL is a clonal proliferation with selective growth within the blood vessel. It has been primarily described in Asian and European populations, and a median age presentation is in the sixth to seventh decades without a sex predilection. The US incidence is 0.95 in 1 million, but is thought to be higher, as the diagnosis is mainly done postmortem. Meanwhile, the incidence rate of IVBCL in Hispanics (HI) remained unknown. This study looks at demographics, treatment patterns, and outcomes of patients with IVLBCL in the US, examining disparities by HI vs Non-Hispanic (NH). Methods: Data were analyzed on IVLBCL patients reported to the SEER 18 database between 2000 and 2018. SEER 18 contains the most comprehensive population-based cancer information in the US, covering approximately 27% of the US population and 36% of HI alone. The racial groups analyzed were NH whites, HI whites, blacks, and Asians/PIs (Pacific Islanders). Patient characteristics, age-adjusted incidence rate, and survival rate were compared across ethnic groups. Kaplan-Meier and Cox regression analyses compared overall survival (OS) between HI and NH. Multivariate analysis and propensity score matching were performed, with adjustment for age, stage and B-symptoms. Results: We identified 164 patients with IVLBCL, of which 10% were HI. 41% of HI were male vs 44% of NH. HI were diagnosed at an older age, 72. vs 69 y.o., compared to NHI (p=0.907). Most of NH and HI were diagnosed between 60-80 y.o. (p=0.322), 53.1% and 47.1%, respectively. Regarding race, HI and NH were mainly identified as whites (88% vs 78%), followed by Asians (6% vs 17%) (p=0.013). For HI, 53% presented B symptoms compared to 16% of NH (p=<0.001). On survival analysis, the survival probability at 2, 5 and 10 years of HI vs NH was (0.540 vs 0.505), (0.432 vs 0.425), and (0.443 vs 0.237), respectively. The median survival time was 0.8 years for HI and 1.9 years for NH. The 10 year OS probability was not significantly different for HI vs NH (p=0.66).On multivariate analysis, when adjusted for age, those patients who were 60 to 80 y.o. had worse OS compared to those younger than 60 y.o., with HR 1.4 (95% CI: 0.7 - 2.1). Conclusion: In our study, despite a lower percentage of patients identified as Asian in our HI population, there is a significant difference in the presence of B-symptoms between HI and NH, going against the traditional description of an Asian variant with increased systemic symptoms. Despite this finding, it demonstrated similar outcomes in the 10 years survival analysis for HI and NH. Standardized treatment may explain why no variation was reported in OS. Our analysis shows that ethnic variations do not seem to affect oncological outcomes in IVLBCL for HI in the US. Citation Format: Daniela Urueta Portillo, Daniel Rosas, Joel E. Michalek, Qianqian Liu, Adolfo E. Diaz Duque. Racial and ethnic disparities for intravascular large B-cell lymphoma: A Surveillance, Epidemiology, and End Results (SEER) database analysis with emphasis on Hispanics. [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 5521.
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