Loretta and Ken Schatz say they complained all the way up to the president and members of the board of Thomas Jefferson University Hospital to make sure that what happened to them in 2007 would never happen to another patient.
Before Loretta Schatz had surgery for her third recurrence of ovarian cancer, she and her husband of 43 years asked her surgeon to freeze some of the tumor so that she could use it later in a clinical trial of a cancer vaccine. When the trial opened at Hospital of the University of Pennsylvania six months later, they asked for the frozen tissue. After weeks of requests, they learned it hadn't been saved.
They weren't happy to read in The Inquirer recently that Niki Perry, a brain tumor patient from South Philadelphia, had a remarkably similar experience at Jefferson more than two years later. She said she also had asked her surgeon to save frozen tissue when he removed part of her brain tumor. She, too, asked for the tissue for weeks before being told that the hospital had not kept it.
When she learned that another patient had encountered the same problem, Loretta Schatz said, her "heart broke."
Schatz, a Cherry Hill woman who was diagnosed in 2000, knew how important clinical trials can be in hard-to-treat cancers. She was "devastated" when she found out she couldn't enter the vaccine trial because there was no frozen tissue. "Once you're diagnosed and have had it four times, you look for every chance, and I was so looking forward to going on this trial because I thought this could be one thing that may keep it from coming back. . . . There's not a whole lot out there for ovarian cancer."
Schatz had radiation treatment instead and has not had another recurrence. She considered suing, but decided against it. "I didn't want anything out of this, other than, 'Please don't do it again.'"
Storage of cancer tissue is becoming more of an issue as treatment is being tailored to an individual's cancer. Tumor tissue is the key to personalized treatment. Hospitals have always kept wax-embedded tumor tissue for diagnoses. Academic medical centers increasingly are storing frozen tissue for their own research. But the issue of patients wanting pieces of their tumor for use in clinical trials or genetic tests at other hospitals is a relatively new one.
The Schatzes argued that Jefferson should give patients a "tissue directive" before surgery that would allow them to say how they wanted tumor tissue stored. Patients are barraged with forms before surgery that "protect the hospital," Ken Schatz said. "There's not a form there to protect the patients."
When Jefferson officials told him storing frozen tissue is expensive, Ken Schatz said he'd pay. "I was willing to pay and other people may be willing to pay," he said. "Their position was that's not fair. There's a lot of things that aren't fair."
In a written statement, Jefferson said that it has procedures for storing tissue for research. And it will store tissue according to specific rules for a trial in which a patient is already enrolled.
Neither Loretta Schatz nor Niki Perry was enrolled in a specific trial at the time of their surgeries. The written statement does not explain why they were not told that this would be a problem or why they did not learn until later that no frozen tissue had been saved for future use in a clinical trial.
In its statement, Jefferson said it researched whether similar hospitals were offering patients the option of keeping frozen tissue. The hospital said it found none and was also unable to find companies that would store tissue. Jefferson decided to "affirm" its 2007 procedures. It has added sections to the "Surgical Case Scheduling Form and the Operating Room Scheduling Office Communications Form" that allow doctors and their staff to convey special needs to the operating room staff, spokeswoman Jacqueline Kozloski said.
It is possible now to pay for private storage of tumor tissue, although doctors disagree about how useful that might be. Freezing procedures can vary considerably in trials.
Schatz, who says his wife might have had her surgery at Penn if she'd understood Jefferson's tissue rules, is angry that Jefferson led him and his wife to believe that the failure to keep tissue was a mistake.
"It wasn't a mistake," he said. "They didn't have any method for doing it."
Go to http://go.philly.com/tissue for coverage on freezing tumor tissue for cancer patients to submit for later use in clinical trials and tests.
Contact staff writer Stacey Burling at 215-854-4944 or firstname.lastname@example.org.