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Although the new coronavirus has led to a delay in some cholangiocarcinoma trials, experts don’t expect the trials to come to an end.
The development of a routine, no matter the circumstance, can help people feel more in control of what’s going on in their lives. However, as the new coronavirus, also known as COVID-19, has spread across the world, many routines have been completely upended, forcing people to adapt to the situation.
For patients with cancer, that kind of unexpected detour to routine can be a challenge. But as Dr. Milind Javle noted recently, oncologists and their patients are working together to find ways to get through these chaotic times.
As an example, Javle, a professor in the department of gastrointestinal medical oncology at The University of Texas MD Anderson Cancer Center in Houston, highlighted a recent experience he had with a patient who has been treated at the facility for the last decade. According to Javle, the patient, who is in her 70s, has gotten used to coming to the cancer center for routine scans every couple of months with her husband.
“Despite trying to dissuade her not to come, she decided to come, which is good because I love seeing her, but we couldn't have (her) husband anymore in the hospital,” Javle said during a recent webinar hosted by the Cholangiocarcinoma Foundation. “It was shown in studies (from) China that the prime source of infection for hospital staff and medical workers was relatives of COVID patients. This was very difficult for her.”
At first, the patient was distressed, Javle said, but after she received her scan and went home, he was able to have her next appointment via video conference from her living room.
“I got to meet the entire family,” he said. “We just have to think outside the box. What we did before is no longer going to apply. I think (we’re) going to work together to get past this.”
Javle, along with Dr. R. Kate Kelley, recently participated in the foundation’s question-and-answer format webinar and addressed topics including how the rise in COVID-19 research may affect cholangiocarcinoma research, as well as how patients with cholangiocarcinoma should approach getting scans during the pandemic.
Kelley, an associate professor of clinical medicine at UCSF Helen Diller Family Comprehensive Cancer Center, said that COVID-19 has affected many of the decisions oncologists must make regarding treatment. For instance, when it comes to the use of chemotherapy for cholangiocarcinoma, if two choices are on the table, they’ll pick the option that is less likely to leave patients open to infection by causing a low white blood count.
Another change Kelley mentioned involves the process surrounding changing stents that are used to open up bile ducts blocked by cholangiocarcinoma. The process for changing stents has always been individualized, owing to the nuances of each patient’s biliary tree, the type of stent needed and other factors. Generally, Kelley said, a plastic stent would be changed every six to 12 weeks, but as endoscopic procedures — which are needed to place stents — are associated with the risk of spreading infection, there may be a change to how stents are replaced.
One suggested approach is to have oncologists keep an eye on the lab work and look for a change in symptoms before preemptively changing a stent, according to Kelley.
“Again, this is a changing target and our plans for this will evolve depending on the state of infection, but I think it's one way that our treatment program has changed,” she said.
One of the things oncologists are struggling with is whether, and when, to scan patients. The goal in reconsidering scan schedules is to minimize non-essential visits, but as Kelley said, it really depends on the situation with respect to the patient’s cholangiocarcinoma.
“In situations where we're planning a surveillance scan a year or two after a surgery, and someone has no evidence of cancer on their last scan, what we're trying to do is instead of doing a three- to four-month scan interval, pushing it back two or three extra months to try to minimize the number of people coming in … and minimize exposures to that person,” she said. “On the other hand, if the cancer is active and symptomatic and we're making a treatment decision, like which chemo to be on, we think we still need those scans and we still need those labs to keep you healthy from the cancer, which is a more immediate threat.”
Kelley said that the hospital has been like a “ghost town” except for those with essential needs.
“Those surveillance scans, the non-emergent tests, we’re postponing by two or three months depending on the individual,” she said. “That way, at least if you are one of those people who needs your scan this week, there are so many fewer people around that it's hopefully mitigating the risk.”
Kelley also noted that scans and visits for new patients have been prioritized, as getting patients a diagnosis and started on treatment is urgent and essential.
Cholangiocarcinoma Clinical Trials
When it comes to clinical trials, “treatments for cholangiocarcinoma research will never stop,” Javle said. “But we will just learn to live with this new reality.”
For instance, Javle said there has been tremendous work and cooperation between the foundation, researchers and pharmaceutical companies during these times.
“They have given us really enormous latitude which they never gave us before to be able to treat patients closer to home, not have to travel to the clinical trial sites and be monitored by their oncologist closer to their residence, (and in the) case of oral therapy have the medicine shipped to their residence,” he said.
Javle added that trials have slowed, mostly because of the flux of research and support staff, but he doesn’t envision them ending.
“I think we have a lot of activities ongoing, and thankfully (there was) a big surge of progress right before this that is still in play,” she said. “These trials are not going to close, (although) they might take a little longer to enroll right now. And I think we've still been seeing a lot of companies even during this time trying to reach out to get new studies into the pipeline.”
As far as how their institutions are handling their cholangiocarcinoma trials, both Javle and Kelley said it’s a learning process.
“Some of the bright-side points are that we’ve really learned how to put mechanisms in place to use some of our technology tools, like for example DocuSign and ways to do HIPAA-compliant consent signatures remotely — things that are good for the future, regardless of what the pandemic status is,” Kelley said.
Additionally, Kelley said, patients are sending their drug diaries to the trial coordinators via electronic scan or photos.
Javle sees a potential “silver lining” associated with what’s going on.
“I think this entire process is actually going to make us more nimble,” he said. “Now, we often remark to ourselves, ‘Why (are) so many clinic visits … necessary for a trial?’ … But I think at the end of it, this may be a silver lining in the sense (that) the trials become more nimble, less expensive (and) more available to the community.”