The evolution of lung cancer surgery contributes to the sharpest drop in overall cancer mortality in the U.S.
Woman, 23, Had A 'burning Sensation' In Her Stomach. It Was The First Sign Of A Rare Cancer
In 2023, Sydney Towle, then 23, developed a bump on her abdomen that she could feel. When she exercised, she experienced a stinging in her stomach. Worried that she developed a hernia, Towle visited an urgent care clinic.
"The doctor thought I had a hernia, but he was like, 'I'll send you in for an ultrasound, just in case,'" Towle, now 25, of New York City, tells TODAY.Com. "I got an ultrasound, and it showed a solid mass."
Follow-up tests revealed Towle had bile duct cancer, also called cholangiocarcinoma, a rare cancer that forms on the network of tubes that link the liver, gallbladder and small intestine, according to the National Cancer Institute. According to the American Cancer Society, bile duct cancers are most often diagnosed in people in their 70s. Towle felt stunned by the news.
"I've never heard of bile duct cancer," she says. "I only knew the major forms of cancer like breast cancer, lymphoma."
Unexpected bump and painWhile she noticed the bump for a few months, Towle didn't visit the doctor immediately because she was "young and healthy," she recalls. But when she started experiencing pain, she realized she needed to seek medical care.
"When I was going on walks, I started feeling a burning sensation in my stomach," she says.
After the ultrasound showed a mass, Towle underwent an MRI.
"(It) showed that it was cancerous," she says. "I had to go to the hospital to get a biopsy, which determines the type of cancer that I had."
The biopsy revealed she had bile duct cancer, and doctors considered how to proceed with her care. At the time, it had not spread to other locations in her body.
"There's not one set treatment plan because it's such a rare cancer," she says.
Still, doctors believed that chemotherapy to reduce the size of the tumor paired with surgery that would effectively treat her cancer. For five months, Towle did chemotherapy and immunotherapy. At times, she felt overwhelmed with its side effects.
"The first few days after I got chemo, I was pretty much in bed the whole time because it makes you extremely tired," she says. "Then I would try to go about my life as normally as possible."
By sharing her experience with bile duct cancer on TikTok, Sydney Towle has connected with other young people grappling with cancer diagnoses.Courtesy Sydney Towle She experienced extreme bloating and swelling, as well as exhaustion, but nothing more serious.
"I feel like I got pretty lucky with the symptoms because I am pretty young and healthy," she says. "I wasn't getting extremely sick."
The chemotherapy worked, too.
"I responded very well, my oncologist said," Towle recalls. "They reduced it to good margins to the point where I could get surgery."
Towle underwent surgery in January of this year to remove the remaining mass.
"It went really well. I came out of it, and the surgeon said that she got all of it pretty much," Towle says. "There was some cancer like left on the margin where they resected my liver. But overall the tumors were gone."
That meant she didn't need to restart chemotherapy, though she still had some cancer lingering in her body.
"My oncologist was like, 'You're not cancer free. You still have cancer on the margins of where they took out the tumor. ... You should be fine for now and we'll just keep an eye on it,'" Towle explains.
For several months, she underwent regular scans to make sure the remaining cancer didn't grow. Everything was clear until an MRI in in August detected a small lesion. Doctors initially thought it could've been scar tissue from her previous surgery and scheduled another MRI for a month later to see if the spot had changed at all.
Doctors told Towle that if the follow-up MRI showed the spot had grown, then it was likely cancer, but if it stayed the same, it was just scar tissue.
"It had doubled in that time so that proved it was cancerous," Towle says.
Bile duct cancerBile duct cancer is rare and comes with few symptoms, which means many people are diagnosed at later stages.
"Sadly, we do often find these in stages where they're not surgically manageable," Dr. Antony Ruggeri, a medical oncologist at Aurora St. Luke's Medical Center, who did not treat Towle, previously told TODAY.Com.
According to the American Cancer Society, symptoms can include:
People at higher risk include:
Towle cannot receive chemotherapy again because her white blood cell count is too low from her previous treatment and the cancer growing back. She currently has cancer on her liver, and it has spread to one abdominal lymph node. She was told her options were surgery or joining a clinical trial.
"I don't think I've processed it," she says. "I've kind of disassociated from it."
After recently moving to New York City for work, Towle is seeing a new medical team, who will conduct their own scans and take a biopsy of her cancer growth to understand it and come up with a new treatment plan.
Sydney Towle hopes her story encourages others to be kind to people because it's hard to know what struggles people are facing in their lives.Courtesy Sydney Towle While Towle appreciates that her new doctors are being thorough, it also feels "very frustrating" because all the retesting feels like a step back, she shared on her TikTok account.
"I'm trying to feel positive about it," she said. "But it just kind of feels like I'm restarting everything."
Towle has been telling her story on social media, and connecting with others has helped her navigate having such a rare cancer.
"They reach such a wide audience that I will get messages from people my age or with parents (who have it)," she says. "It's been a really great way to connect with people even if it's not my specific cancer."
When she was first diagnosed, she felt touched by all the messages of support she received, and that has motivated her to continue being "transparent" about her health.
"I'm bringing light to this, and so that has encouraged me to continuing posting and sharing, especially when I am not doing well or when I receive good news," she says. "It always seems to help people feel less alone like they're not the only ones that are going through something that's very challenging."
Towle hopes her experience teaches people the importance of seeking medical care when something seems wrong.
"If you have some sort of warning signs, do not ignore them because I did," she says.
Surgery To Remove Bile Duct Cancer
Bile duct cancer is also called cholangiocarcinoma. Surgery aims to remove the cancer and some healthy tissue around it. It gives the best chance of a cure. Unfortunately, surgery isn't for everyone. Less than 3 out of 10 people (less than 30%) can have surgery to remove bile duct cancer. This is because the cancer has already spread by the time most people are diagnosed. This is called advanced bile duct cancer. How your surgeon decides Your surgeon looks at your tests and scan results to see if they can remove (resect) the cancer. If they think they can, the cancer is called resectable. They also check how well you are overall. This is because surgery to remove bile duct cancer is a major operation. So, you need to be generally fit to have it. Like all operations, there is a risk of problems after this surgery. Your surgeon will talk to you about: what the operation involves what to expect after the operation the chance of the cancer coming back the risks and benefits of having the operation if you are well enough to have the operation Removing bile duct cancer The type of surgery you have depends on where the bile duct cancer is. There are 3 main types: intrahepatic bile duct cancer - starts in the bile ducts in the liver perihilar bile duct cancer - starts in the bile ducts just outside the liver. This is where the right and left hepatic bile ducts meet distal bile duct cancer - starts in the bile duct near the pancreas and small bowel (duodenum)
During the operation, your surgeon removes the cancer and a border of tissue around it. This is called the margin. It can be difficult for your surgeon to remove a margin without cancer cells in it. This is because the bile ducts are very close to main blood vessels and other organs. If there are cancer cells in the margin it increases the chance of the cancer coming back. Before surgery to remove bile duct cancer If there is a collection of bile in your liver, your surgeon may want to drain it before the operation. This is called biliary drainage. It can make your liver work better. It can also help it grow back if your surgeon needs to remove part of it. They drain the bile: You don't normally need biliary drainage for intrahepatic bile duct cancer. But you might need it if the cancer is in the perihilar or distal bile ducts. Your surgeon will talk to you about how they will drain the bile and the risks and benefits. Surgery to remove intrahepatic or perihilar bile duct cancer Your surgeon normally removes the parts of your liver where the cancer is. The operation is called a liver resection or a hepatectomy. They check how well your liver works before the operation. But having some of your liver removed might sound frightening. You might worry that the remaining part may not work well enough. But your surgeon only needs to leave a third of your liver for it to grow back. And if you don't have other liver problems it will usually work normally. If you have a medical condition called cirrhosis
, you might not have enough healthy liver for your body to cope after the operation. Your doctors will talk to you about other treatment options instead of surgery. Increasing the size of your liver Your surgeon might ask you to have a procedure called a portal vein embolisation before the operation. They do this if your liver is too small to work properly after surgery. It sends more blood to the part of the liver that isn't being removed. The extra blood makes it grow. This means it works better. The portal vein brings blood from your tummy (abdomen) to your liver. In the liver the vein branches in 2. One branch goes to the left side and the other goes to the right. They are called the left and right portal veins. 
Having a portal vein embolisation A radiologist puts a thin tube called a catheter through your skin and into your liver. They inject a dye (contrast medium) down the catheter. This lets them see the portal vein on an x-ray or scan. They can then inject very thin coils, beads or a special liquid into the portal vein on the same side of the liver as the cancer. This stops blood going to that side. More blood then goes to the other side making it grow. This is the part that isn't going to be removed. After 4 to 6 weeks your surgeon will check the size of your liver again. If they are happy it has grown enough to work properly, they will arrange the operation. Liver resection The liver is split into 8 sections. Your surgeon might remove a number of them. Which ones and how many depends on: the size of the cancer whether the cancer is in the intrahepatic or perihilar bile ducts whether intrahepatic bile duct cancer is in the left or right hepatic duct Your surgeon only removes the hepatic bile duct on the same side of your liver as the cancer. This means bile keeps flowing from the hepatic duct on the other side. Sometimes, they may also need to remove: the junction where the left and right hepatic bile ducts meet the bile ducts outside of the liver your gallbladder This means there will be no connection between the remaining bile duct in your liver and your duodenum. So, your surgeon will need to reconnect it. This is called a Roux-en-Y hepaticojejunostomy. If you have intrahepatic bile duct cancer, your surgeon might remove the cancer using keyhole (laparoscopic) surgery. Surgery to remove distal bile duct cancer Your surgeon may do an operation called a pylorus preserving pancreaticoduodenectomy (pank-ree-at-ic-oh dew-oh-den-ek-tom-ee) or PPPD. Or they may do a pancreaticoduodenectomy. This is also called a Whipple's procedure. PPPD Your surgeon normally removes: the bile ducts outside your liver (extra hepatic bile ducts) your gallbladder part of your pancreas and duodenum 
After the operation, your stomach, pancreas and the remaining part of your bile duct are joined to your duodenum. 
Whipple's procedure As well as your extra hepatic bile ducts, gallbladder and parts of your pancreas and duodenum, your surgeon might also need to remove the lower part of your stomach. 
The diagram below shows how your surgeon might join your pancreas and your remaining stomach and bile duct after the operation. 
Your pancreas is important for digestion of food. It makes: The remaining part of your pancreas should continue to make insulin and pancreatic juice after surgery. So, you may not need to take extra insulin or enzymes. Your doctor will monitor your blood sugar and digestion in case this changes. You will need support with your eating and drinking after these types of surgery. It might take time to return to a normal diet. Lymph nodes Cancer can spread to the lymph nodes. These are part of your lymphatic system. They get rid of damaged cells and waste products. And they contain cells that fight infection. Your surgeon normally removes a number of nodes near the bile ducts during the operation. This is to check for cancer cells. Which lymph nodes they remove depends on where the bile duct cancer is. Problems after surgery Complications after bile duct surgery can be serious. Possible problems include bleeding and liver failure. Risk of the cancer coming back after surgery After any cancer surgery there is a risk the cancer may come back. The risk depends on a number of factors including: the size of the cancer and how far it has grown where it is in your body whether your surgeon can remove a clear margin of tissue from around the cancer whether there are cancer cells in the nearby lymph nodes Unfortunately, it is common for bile duct cancer to come back after surgery. Your surgeon will talk to you about the risk of it coming back and answer any of your questions. Treatment to lower the risk of the cancer coming back After surgery, your doctor might suggest you have treatment to lower the chance of the cancer coming back. This is called adjuvant therapy. You usually have a chemotherapy drug called capecitabine for 6 months after surgery. If the cancer comes back after surgery If bile duct cancer comes back after surgery you normally have treatment with chemotherapy, targeted cancer drugs and immunotherapy. Some targeted and immunotherapy drugs are only used to treat bile duct cancer that has certain gene changes (mutations). Your doctor will test you for these changes. This helps them decide on the best treatment for you. FDA Grants Accelerated Approval Of Ziihera For HER2-Positive Biliary Tract Cancer
On November 20, 2024, the Food and Drug Administration granted accelerated approval to zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals, Inc.), a bispecific HER2-directed antibody, for previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.
Today, the FDA also approved Ventana Pathway anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (Ventana Medical Systems, Inc./Roche Diagnostics) as a companion diagnostic device to aid in identifying patients with BTC who may be eligible for treatment with Ziihera.
Full prescribing information for Ziihera will be posted on Drugs@FDA.
Efficacy and Safety
Efficacy was evaluated in HERIZON-BTC-01 (NCT04466891), an open-label multicenter, single-arm trial in 62 patients with unresectable or metastatic HER2-positive (IHC3+) BTC. Patients were required to have received at least one prior gemcitabine-containing regimen in the advanced disease setting.
The major efficacy outcome measures were objective response rate (ORR) and duration of response (DOR) as determined by an independent central review according to RECIST v1.1. ORR was 52% (95% CI: 39, 65) and median DOR was 14.9 months (95% CI: 7.4, not estimable).
The prescribing information contains a boxed warning for embryo-fetal toxicity. The most common adverse reactions reported in at least 20% of patients who received zanidatamab-hrii were diarrhea, infusion-related reactions, abdominal pain, and fatigue.
Expedited ProgramsThis application was granted priority review, breakthrough therapy designation, and orphan drug designation. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA's MedWatch Reporting System or by calling 1-800-FDA-1088.
For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE's Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.Hhs.Gov.
Follow the Oncology Center of Excellence on X: @FDAOncology.
This announcement was published by the Food and Drug Administration on November 20, 2024.
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