In the days following the terrorist attack in New York on Sept. 11, 2001, Bart Zagami spent his time at Ground Zero helping with the task of rescue and recovery.
Zagami, 61, a New York State Supreme Court sergeant at the time, was in his office just blocks from the World Trade Center in lower Manhattan when the terrorists struck.
The next few days were something he will never forget.
Bart Zagami at Ground Zero in New York City shortly after the 9/11 terrorist attacks Image source: Courtesy of Bart Zagami
“The whole area was covered in debris," he told Healthline. "Gigantic piles of dust and rebar was what we were on, passing buckets. Please don't make it sound heroic. We did what we did.”
Nine years after the attacks, as he was about to retire, Zagami was diagnosed with stage 4 marginal zone lymphoma, a type of non-Hodgkin lymphoma for which there were few effective treatments.
Zagami didn’t know it at the time, but his cancer was likely caused by his exposure to the enormous amount of toxins that filled the air at Ground Zero for weeks and months after the terrorist attacks.
A rough treatment road
Cancer was a difficult thing to face as he began his retirement. But Zagami, a New York native who still lives around the corner from the Brooklyn house where he was born, was ready for the fight.
But in 2014, he learned that he was allergic to Rituxan, the successful monoclonal antibody drug used to treat lymphoma.
It was his only remaining treatment option approved by the Food and Drug Administration (FDA), other than chemotherapy.
About six months after his last Rituxan treatment, Zagami had an MRI that showed his spleen was getting larger.
It continued to grow, to the point where it took up his entire midsection and weighed more than 8 pounds.
After having his spleen surgically removed, Zagami recovered again, started exercising, and began feeling better. But within a year, his blood levels were unhealthy again.
Taking a chance with a clinical trial
Zagami’s future was uncertain.
But then his doctors at Memorial Sloan Kettering Cancer Center in New York told him about an experimental treatment with a drug called ibrutinib.
They said it held great promise for his type of cancer.
Ibrutinib, the generic name for the drug Imbruvica, is an oral therapy that inhibits the function of Bruton's tyrosine kinase (BTK), a target for therapy of B cell diseases that includes several types of lymphoma.
The drug, which was developed by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech Inc., causes fewer side effects than traditional chemo because fewer healthy cells are damaged.
When Zagami’s doctors told him about the treatment, it had not yet been approved by the FDA for his type of cancer.
Doctors couldn’t offer Zagami any guarantees that the drug would work on him. But they showed him the positive early data. And he embraced the opportunity.
Enrolling in the clinical trial was an easy decision for Zagami to make.
“My doctors were confident that this drug could help me,” he said. “There was no nervousness. It sounded better than the alternative.”
Better results than anticipated
During the trial, which consisted of a daily dose of four pills, Zagami had few side effects.
Just some blistering on his skin and minor bone and body aches, both of which were temporary.
Blood tests showed his body was responding positively to the medication.
Today, more than two years later, Zagami is doing well.
He continues to take the drug every day — three pills now instead of four.
While he may never be in complete remission due to his type of cancer, he has what is referred to as a partial but durable remission.
His blood counts remain normal. He’s back to working out with weights and walking five miles a day.
“I’m not sick anymore. I feel terrific,” Zagami said. “I get up in the morning and work out with weights every day, then I read the newspapers online, go for five-mile walk, and go shopping. My wife still works. Three days a week I watch my two granddaughters.”
More clinic trial options available
While clinical trials like the one Zagami opted for have always been an important part of cancer care in America, they’ve become an option for more people than ever before.
There are so many new treatments now in the pipeline, everything from targeted therapies like ibrutinib to immunotherapies.
And the risk factors that once scared patients away from clinical trials seem to be diminishing.
Patients are becoming increasingly aware that this new generation of cancer treatments is moving away from the traditional chemotherapy model, and they are often more effective than anything patients have seen in the past.
They are generally safer than drugs of the previous generation, although some are still accompanied by serious but typically short-lived side effects.
Last week, the FDA announced that because of the positive responses to ibrutinib in people with MZL, like Zagami and others in the Sloan Kettering trial, the agency has granted “accelerated approval” for the drug for this type of cancer.
Dr. Ariela Noy, a hematologic oncologist at Sloan Kettering, and lead investigator of the study, told Healthline that “Imbruvica’s approval helps fill a significant treatment gap for previously treated MZL patients who will benefit from a targeted therapy rather than a traditional chemotherapy.”
Dr. Darrin Beaupre, head of early development and immunotherapy at Pharmacyclics LLC, added, “Imbruvica’s approval for patients with MZL is significant. Now patients have the option of a well-tolerated, effective treatment in a disease that had no prior approved therapies.”
Ground Zero cancer legacy
For Zagami, who’ll be allowed to continue the clinical trial for two more years despite the fact that the drug has now been approved for MZL, his cancer has taken on an even deeper meaning.
The thick dust that covered Zagami and tens of thousands of others who worked at Ground Zero in the days after 9/11 held a mixture of toxins and irritants.
These include asbestos, polychlorinated biphenyls (PCBs), benzene, dioxin, glass fibers, gypsum, cement particles, heavy metals such as lead, and more.
In January 2011, less than a year after Zagami was diagnosed with lymphoma, President Barack Obama signed into law the James Zadroga 9/11 Health and Compensation Act of 2010.
The Zadroga Act created the World Trade Center Health Program, which covers medical expenses for a list of more than 90 conditions linked to exposure at Ground Zero, including multiple types of lymphoma and leukemia.
As of June 2016, the Centers for Disease Control and Prevention (CDC) and the WTC Health Program reported an enrollment of more than 5,400 people who have been diagnosed with cancers linked to the 9/11 attacks.
While his cancer was probably caused by the exposure, Zagami didn’t initially file a claim.
In fact, he’s been private about his cancer diagnosis.
“I didn’t tell anyone anything, I kept it a secret,” said Zagami, who has two children and two grandchildren. “Only my wife and kids knew, but the rest of my family didn’t. Both of my parents are still alive and they’re elderly. I didn’t want them to worry about me. I was doing well. But now they know.”
Zagami said he finally decided recently to file a claim with the WTC Health Program.
“Some people I worked with got sick. I didn’t want to, but people told me to do it, so I filed a claim,” he said.
But Zagami added that if he could go back in time and was given the option of not volunteering at Ground Zero, he would still do it again.
Treating other cancers
Meanwhile, people with a number of different cancers have benefitted from ibrutinib.
Its approval last week for MZL is just the latest breakthrough for this drug.
In addition to MZL, ibrutinib has also been approved to treat people with:
- chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), including people with 17p deletion.
- mantle cell lymphoma (MCL) in people who have received at least one prior therapy
- Waldenstrom macroglobulinemia (WM), another type of non-Hodgkin lymphoma
Janssen, which has the rights to the drug outside the United States, is also expanding its use in Europe.
Janssen announced last May that the European Commission (EC) approved the drug for all patients with CLL, expanding the number of people who may benefit from this treatment.
Janssen also expects to introduce the drug to people with lymphoma sometime later this year in China, where lymphoma is on the rise.
Marginal zone lymphoma is China’s second most common type of non-Hodgkin lymphoma, following diffuse large B cell lymphoma (DLBCL), multiple cancer researchers and industry observers in China told Healthline.
There is currently no standard treatment in China for these people. But sources tell Healthline that physicians in China took notice of the news that ibrutinib was approved by the FDA for people in the United States with MZL.
Janssen has submitted ibrutinib for approval in China and asked that the drug get priority review due to better efficacy than what is currently available.
The company is working with the national cancer community in China and patient advocates to inform people with lymphoma about their treatment options. The national cancer community is waiting until the drug is officially approved by China authorities.
Meanwhile, Zagami said the drug was a lifesaver for him.
“I think with ibrutinib, it just made my cancer a manageable disease,” he said. “The same way people take blood pressure medication to make that manageable.”