Laura Holmes Haddad was diagnosed with Stage IV inflammatory breast cancer at 37—the mom of two children ages 1 and 4. A rare and aggressive form of cancer attacking the lymphatic system near the breast, it is a deadly form of the disease—typically far distributed across the body by the time it is diagnosed. She ended up participating in a clinical trial at City of Hope—several years later, the cancer was gone. The City of Hope study saved her life. But tens of thousands of Americas with cancer could use this kind of help as well. Unfortunately, only 1 in 20 adult cancer patients in America enroll in a clinical trial based on a 2019 study in the Journal of the National Cancer Institute—or only 8% of eligible cancer patients are participating in what can be a life-saving study. The need for access is severe and imminent. Why? 1.7 million new cases of cancer are diagnosed annually.
Laura’s Dead End
First misdiagnosed then understood to be a cancer that had spread to the lymph nodes and rib, Ms. Holmes Haddad underwent chemotherapy. After two rounds the breast tumor persisted and grew—two more rounds of AC chemotherapy and yet no progress. Her oncologist conceded there was nothing else to do.
Introduction to Experimental Therapy
Stunned and feeling hopeless something thereafter she connected with an oncologist as a comprehensive care center who suggested clinical trials may be tried. Although the prospect of taking an experimental drug was terrifying the prospect of dying was even more so—survival kicked in and she opted in to the study.
But entry into a clinical trial isn’t necessarily easy—there are inclusion and exclusion criteria that must be applied to the situation. Laura was ready however as there was no other place to turn. She had hear that clinical trials can save lives. There are obstacles as she highlights in her editorial in Call Matters: items such as travel costs are rarely covered by the drug company or insurance. Hence, a patient can be accepted but can’t even afford to participate due to limited income and travel costs.
The Clinical Trial at City of Hope
Laura was suited for a trial but it was closed. However, 30 days later she was accepted under a compassionate use waiver, or what the FDA tags “expanded access.” The patient such as Laura whose life is in immediate danger has access opened up—they can receive the “investigational medical product.”
Laura reported that every week for six months she traveled from her home in the San Francisco Bay Area to the City of Hope campus in Southern California. She received a chemotherapy treatment, blood draw and scan at clinical research site City of Hope—as part of the expanded access exception Laura because City of Hope trial patient $985.
A Toll—Financially, Emotionally & Physically
The clinical trial pushed Laura to the edges—financially, physically and emotionally. She often received donations for airline miles and hotel points not to mention babysitting support. It was exhausting.
It Starts to Work
After six months into the study, Laura started to notice a miraculous change: the tumor began to shrink to the point that she became a surgical candidate. She receive a bilateral mastectomy with 19 lymph nodes removed; a salpingo-oophorectomy—42 days of radiation therapy and follow up reconstructive surgery. Laura remained on 800mg of the study drug daily for nearly another two days. By May 2015, she was declared, “no evidence of disease” or “NED.” She remains so to this day at the age of 44!
A Crisis in the Making
With 1.7 million new cancer diagnoses per year, only 8% of all eligible cancer patients in the U.S. will enroll in a clinical trial today according to Laura’s piece. This isn’t acceptable. Too many lives will be lost that don’t need to be. Too many children will lose a parent and a spouse loses a loved one.
What can be Done?
Ms. Holmes Haddad suggests the following two0fold remedy: 1) improved patient and provider education about clinical trials; how to find them; access them and how participation can be financed; 2) a stronger connection must be developed between regional treatment sites (community practices typically cannot offer trials due to the complexity although this is starting to change with clinical research as a care option); and larger comprehensive cancer centers, involving coordinated and seamless access to the larger centers given the greater availability of clinical trials conducted in those facilities.
Ultimately patients need better, faster and higher quality information and the collaboration between community provider and comprehensive center can offer patients more research options.
Comment on Author: Ms. Laura Holmes Haddad, the survivor, is a cancer-patient advocate speaker residing in Marin County, California. She is the author of “This is Cancer: Everything you need to know, from waiting room to the bedroom.”
Call to Action: Contact Ms. Holmes Haddad to learn more.