HOPE Inc. Feeds Cancer Research

There are more than 174 clinical trials devoted to cancer research in Arkansas. Helping Oncology Patients Excel Inc., a nonprofit organization in Springdale, is trying to get even more off the ground locally by offering physicians something precious: time.

Thad Beck, a medical oncologist with Highlands Oncology Group, said the biggest problem in expanding trials outside of his clinic is the logistics of completing the background work.

“Surgeons have a hard time making time to do that,” Beck said. “A lot of the sub-specialty surgeons are overworked, so they don’t have a lot of extra time.”

Beck said Highlands has been performing trials for 10 years, but he wants to see trials expanded into surgeon’s offices like that of Randall Hightower, a gynecological oncologist for Northside Specialty Clinic who is working with HOPE Inc. on three clinical trials.

Since June, HOPE has had eight trials approved and is in the process of getting enrollees. The group was founded in 2001 with a $94,000 grant from The Cancer Challenge organization. Since then, it has assisted more than 500 patients with prescription and emergency financial assistance, helping them get more than $350,000 worth of free drugs last year alone.

In 2003, HOPE expanded its scope to include clinical trials and hired Nancy Roller as director of research.

“We had already built up our patient assistance part of what we do, but to get that research going we really needed someone in there who could focus their efforts on it completely,” said Cyndi Bilyeu, executive director of HOPE

Hightower said that many physicians are interested in trials, but they just don’t have the resources to do it. Enter HOPE as the facilitator.

Hightower said he receives patient referrals from as far as Morrilton, Fort Smith, Conway and Joplin, Mo.

“If you have individuals you know that are active in cancer research, patients are more apt to go to an area where they have those things available,” Hightower said.

HOPE, along with Highlands Oncology Group, are the only organizations now offering clinical cancer trials. Along with HOPE’s nine trial offerings, Highlands Oncology offers 25 to 30 trials at any given time.

“HOPE is really instrumental in making clinical trials possible,” said Chad Brekelbaum, a urologist with Northwest Arkansas Urology Associates. “It takes a lot of time to educate the patient and inform them on what they are getting into.”

It isn’t cost-effective, Brekelbaum said, for an average-size physician’s group to perform trials.

“For smaller groups, it really takes someone else to help offset the cost of the trial because it is expensive,” Brekelbaum said. Highlands employs its own research coordinator, Kim Davison.

Financial Hurdles

The fiscal year for HOPE runs from July through June. Its budget for the 2004-2005 year is more than $230,000, which is more than double its 2001-2002 first-year budget of less than $100,000.

The Cancer Challenge, Bilyeu said, will give HOPE $58,400 this year starting Sept. 1, which will be less than the previous year, because that organization is diversifying its funding.

HOPE will receive $18,000 in grant money from the Susan G. Koman Breast Cancer Foundation for its patient-assistance program as well as $7,000 from the Baum Foundation for its general operating fund. HOPE has an annual spring fund-raiser and has added a new event called The Gentleman of Distinction Fashion Show and Awards, which will be held Oct. 22 and feature prominent business leaders as fashion models, Bilyeu said.

Gary Head, founder of Signature Bank in Fayetteville, is chairing the event.

“If we do not have the expenses covered in a trial, our fund-raising efforts make up the difference,” Bilyeu said.

Logistics

Of the nine trials HOPE has opened, two are physician-initiated and are funded through grant money raised through The Cancer Challenge. The rest are sanctioned by the National Cancer Institute and funded through cooperative groups: Four are related to gynecological cancers, three are related to prostate cancer, one is for breast cancer and one is for small-cell lung cancer.

When trials are sponsored by pharmaceutical companies, costs are covered by that particular company. HOPE sponsors trials that compare one combination of drugs to another. The cost of the trial has to be supplemented by the patient’s insurance or other grant funding.

“There are a lot of different cancers that we don’t know what the best treatment is,” Hightower said. “The trial is a controlled situation that provides the means of evaluating the effectiveness of these different agents with careful scrutiny.”

The nonprofit works with physicians who then select trials that they want to institute. Aside from Cancer Challenge funds, the NCI will give a certain amount of trial-related expense funding to the local nonprofit cooperative group. HOPE works with the Southwest Oncology Group and the Gynecological Oncology Group for its trials. The groups pay the physicians, who will then contract with HOPE to perform all of services for the trials.

“Eventually if we had enough trials and enough patients it might be able to cover our expenses, but it doesn’t,” Bilyeu said.

Participation

Getting qualified patients and willing patients can sometimes be a challenge, Bilyeu said.

The National Cancer Institute estimates that about 2.5 percent of adult cancer patients participate in clinical trials nationwide.

“There are a lot of people that are really skeptical of trials and think they are going to be treated like a guinea pig,” Brekelbaum said. “You’d be surprised, I’ve had a handful of patients that have been candidates for trials and are not interested.”

In fact, Bilyeu said, a trial patient is monitored more closely than a regular patient.

“We are constantly collecting data to make sure it is still safe for them to be on the trial,” Bilyeu said.

“In order to go through some of the fallacies about clinical trials, it takes a long time to educate the patient and that time really isn’t afforded in a clinical setting,” Brekelbaum said.

Roller, a former chemotherapy nurse, said the average informed-consent agreement runs eight to 12 pages long. Although she has a consent template to follow, it still might take several months to get that informed consent approved by the local Institutional Review Board.

“Everything has to be written down so that the patient has a complete picture of the trial,” Roller said. Details, such as how much blood will be drawn at each doctor’s appointment, can’t be left out.

The organization uses the Washington Regional Medical Center review board as its local IRB. The group, Roller said, meets an average of once per month.

“One of the problems with trials is that we are [trying to] write the trials at a level the patient can understand them,” Hightower said.

Hightower, Brekelbaum and Beck all echoed the importance of clinical trials in the advancement of treatments.

“Usually when you see some big headline in the newspaper or on a news report about new medicine for breast cancer, leukemia or whatever, that is usually information that was developed in clinical trials,” Beck said.

Hitting Home
The following are incidence of cancer from 1996 to 2001:ttt

Cancer — Benton County — Washington County — Arkansas

All Types — 3,809 — 3,016 — 70,975
Male — 2,080t — 1,545 — 37,555
Femalet — 1,729 — 1,471 — 33,415
Early Stage — NA — NA — 32,908
Late Stage — NA — NA — 32,022
Prostate — 719 — 390 — 10,456
Breast — 597 — 481 — 10,457
Lung — NA — NA — 13,609
Colorectal — NA — NA — 8,390
Totals — 8,934 — 6,903 — 249,787

Note: NA – not available
Source: The Arkansas Central Cancer Registry-Arkansas Department of Health