Which U.S. state is the most diverse? You've probably guessed the answer, based on the title of this post. Per the 2020 census, Hawaii has the highest Diversity Index (DI), at 0.76 (a state's DI is the probability that two residents chosen at random will be from different race and ethnicity groups).

Importantly, for the past decade, the Hawaii Minority/Underserved NCI Community Oncology Research Program (MU-NCORP) community site, based at the University of Hawaii Cancer Center, has been working to ensure all groups within the state’s uniquely diverse population have access to NCI-sponsored clinical trials. This NCORP supports more than two-thirds of all patients with cancer in the state.

This continues a long tradition: for two decades before the birth of the NCI’s NCORP program in 2014, a Minority-Based Community Clinical Oncology Program (remember MB-CCOPs?) at the University of Hawaii Cancer Center pursued a similar mission.

Principal investigator (PI) for the Hawaii MU-NCORP grant is Jeffrey L. Berenberg, MD, while Jared D. Acoba, MD (one of my former and all-time best fellows!), serves as SWOG site PI for the organization. Erin Fukaya, MS, is lead administrator for the NCORP overall and is its SWOG lead oncology research professional (lead ORP). The Hawaii MU-NCORP represents 24 affiliated sites, home to more than 70 SWOG investigators and well over 100 associates.

The Hawaii MU-NCORP also counts the Family Health Plan Health Center in Guam as a member site, under the leadership of Sami Ambrale, MD, making NCI-sponsored clinical trials also available to patients in this U.S. territory.

The Hawaii MU-NCORP’s enrollment to SWOG trials is in many ways reflective of its particular patient population:

  • Hawaii has one of the highest rates of cholangiocarcinoma in the U.S., and the Hawaii MU-NCORP was among the top-accruing institutions to SWOG’s S1815 trial, which tested adding nab-paclitaxel to the standard cisplatin plus gemcitabine chemotherapy combination for patients with advanced biliary tract cancers (initial S1815 results were presented at last year’s ASCO’s Gastrointestinal Cancers Symposium).
  • Not unusually, colon cancer is the second leading cause of cancer death in Hawaii. The Hawaii MU-NCORP was one of the top-accruing sites to the S0820 PACES trial, which is testing a chemoprevention combination to prevent the recurrence of high-risk adenomas and second primary colorectal cancers (enrollment to the study closed last year, and some patients are still in follow-up).
  • This NCORP has also been a leader in accruing to cancer care delivery trials, and is among the top enrollers to SWOG’s S2108CD, which is testing whether using an educationally enhanced genomic tumor board to evaluate patients’ genomic test results leads to more patients being treated with evidence-based, genome-informed therapy.

In a recently published paper, Drs. Acoba and Berenberg, joined by Hawaii MU-NCORP colleague Kenneth Sumida, MD, outline some of the success their institutions have had in increasing clinical trial enrollment of Asian and Native Hawaiian patients, with details about strategies that have worked for them, including strategies for hiring minority healthcare providers and staff, approaches to ensuring all patients are offered the same opportunities to participate in clinical trials, and efforts to bring in funding specifically to enhance accrual of patients from historically underrepresented groups.

Speaking of which, one of the first Hope Foundation for Cancer Research NCORP Pilot Grants, which fund demonstration projects to improve clinical trial access for underrepresented populations, was awarded to support outreach initiatives by the Hawaii MU-NCORP. Jami Fukui, MD, PI on that grant, reported on some of the impact of those initiatives at a recent meeting of SWOG’s recruitment and retention committee.

The funded project’s specific goal was to increase participation of rural Native Hawaiians and Pacific Islanders to the Tomosynthesis Mammographic Imaging Screening Trial (TMIST), but more broadly the project was also intended to expand outreach and trial awareness and to increase breast cancer screening among underserved and rural populations on Oahu. The NCORP team reported some clear measures of success. Their efforts in community building and patient engagement increased the numbers of community members getting mammograms and resulted in numerous direct enrollments to the TMIST trial.

SWOG and Hope are proud to support such efforts and we’re even prouder to have members like the Hawaii MU-NCORP, which so clearly exemplify the NCI’s NCORP’s mission of bringing cancer clinical trials and care delivery studies to people – all people – in their own communities. 

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Trial of the Week

S2303: Randomized Phase II/III Trial of 2nd-Line Nivolumab + Paclitaxel + Ramucirumab versus Paclitaxel + Ramucirumab in Patients with PD-L1 CPS ≥ 1 Advanced Gastric and Esophageal Adenocarcinoma (PARAMUNE)

The S2303 PARAMUNE trial is one of SWOG’s newest, having activated just last month. Word has it the first patient was enrolled this week!

The trial accrues patients with unresectable or metastatic gastric, esophageal, or gastroesophageal junction adenocarcinoma who have a PD-L1 combined positive score (CPS) of 1 or higher. Their disease must be microsatellite stable and HER2 negative, and it must have progressed on or following front-line chemotherapy plus a PD-1 or PD-L1 inhibitor.

S2303 PARAMUNE tests whether an anti-VEGFR2 plus anti-PD-1/PD-L1 combination as second-line therapy can improve survival outcomes for these patients. Progression-free survival (PFS) is the primary endpoint of the trial’s phase 2 portion. If a sufficient PFS benefit is seen, the trial will move to a phase 3 portion with a primary endpoint of overall survival. The enrollment goal is 224 patients.

The study team will also compare health-related quality of life between treatment arms based on patient-reported outcomes recorded using the Functional Assessment of Cancer Therapy – Gastric (FACT-Ga) tool.

The S2303 PARAMUNE study is led by Drs. Anwaar Saeed, of University of Pittsburgh Medical Center’s Hillman Cancer Center, and Paul E. Oberstein, of New York University’s Perlmutter Cancer Center. 

The trial has been opened at 42 sites thus far, and almost 200 others are in the process of activating it. If your site is not yet among them, please take a closer look at the trial. Learn more on the SWOG S2303 page or the CTSU S2303 page. 

An S2303 patient-friendly summary is being submitted to the NCI’s Central Institutional Review Board and should soon be available for you to use in presenting this study to your patients.