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Combination chemo helps people with Leiomyosarcoma cancer live longer – Study finds
For years, the chemotherapy drug doxorubicin has been the mainstay of treatment for people with many types of advanced sarcoma i.e. cancers that begin in the bone or the soft tissues of the body.
Previously, it had been established that combinations of doxorubicin with other chemotherapy drugs helped some people live longer.
“But, compared with doxorubicin alone, the side effects of such combinations were severe, leading many doctors to consider them to be too risky to use in everyday patient care,” the National Cancer Institute (NCI) of the U.S says.
But based on the results of a clinical trial conducted in France, this may soon change.
The trial, NCI reports, showed that adding trabectedin (Yondelis) to doxorubicin as an initial treatment for people with a type of sarcoma called leiomyosarcoma helped them live longer than people initially treated with doxorubicin alone. This increased the median survival time from 24 months to 33 months.
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The findings were published September 5, 2024, in the New England Journal of Medicine.
Understanding Leiomyosarcoma
So what is Leiomyosarcoma? The name itself might sound foreign to many people but to those affected, it does ring a bell.
It is a rare and aggressive type of cancer that develops in the smooth muscle cells found throughout the body. Smooth muscle cells can be found in the urinary tract system, digestive system, uterus and blood vessels.
There are three different types of Leiomyosarcoma (LMS): Cutaneous or Subcutaneous LMS, Somatic soft tissue LMS and LMS of Vascular region.
According to Cleveland Clinic, Somatic soft tissue LMS affects your body’s connective tissue. It’s the most common form of LMS. Cutaneous or subcutaneous LMS affects the piloerector muscles in the skin. The piloerector muscles are located in your skin and eyes. They’re responsible for giving you goosebumps and making your pupils dilate. LMS of a vascular origin on the other hand is the rarest type of leiomyosarcoma. It develops in a major blood vessel, such as the pulmonary artery, inferior vena cava or peripheral arteries.
Although Leiomyosarcoma affects both men and women, data shows that it occurs more often in women, and it’s more common in people over the age of 50.
The process in which this cancer develops is through a genetic mutation in the smooth muscle cells which can result to uncontrolled cell growth and multiplication.
There are several risk factors that can increase a person’s likelihood of developing Leiomyosarcoma including; genetic conditions, exposure to chemicals such as, vinyl, asbestos or pesticides.
According to the NCI, Early signs and symptoms of this cancer vary depending on the part of the body affected and the tumor size, and they may include; changes in bladder function, gastrointestinal complaints such as nausea, vomiting, belly discomfort and bloating, pain and swelling on the affected area, unintended weight loss and a lump on the affected area.
Despite there being signs, it’s quite crucial for Leiomyosarcoma to be detected early because the symptoms can tend to mimic those of other conditions.
It is diagnosed through a physical examination in order to assess the patient’s health and look for any signs of the disease, imaging tests like x-rays, CT scans or MRI’s and a biopsy is also done by taking a small sample of tissue of the affected area and analyzed.
After the diagnosis, treatment begins. The treatment options, NCI says, are;
Surgery: The best option for LMS treatment is surgery. If all of the tumor is removed, there is a good chance of LMS being cured. If some cancer cells are left behind, there is a greater chance of the cancer coming back in the same spot, or a different part of the body.
Radiation therapy: Radiation therapy can be used around the time of surgery. The radiation is aimed at the tumor area to prevent it from growing back after it is removed.
Chemotherapy: When the LMS tumors are large, or the cancer cells have spread to other parts of the body, then chemotherapy is used in combination with surgery.
The likely outcome of this disease and the survival rates vary depending on the stage of the cancer, the location of the tumor and the overall health of the patient. In the case of the stage of the disease, there is a 5-year relative survival rate whereby; 60% is for localized disease that is one that is still confined within its original site, 37% for regional disease that shows up in tissue or lymph nodes near the original site and 12% for distant disease that which has been found in tissue away from the original location. Distant disease is most common in places like the lungs, liver, brains and bones.
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Treating people who have advanced leiomyosarcoma with the combo chemotherapy drugs trabectedin (Yondelis) and doxorubicin can help them live longer, a clinical trial has found.
Combination Chemo Helps People with Leiomyosarcoma Live Longer
Leiomyosarcoma is a malignant tumor of smooth muscle cells; it’s most common in the uterus, abdomen or pelvis.
By Sharon Reynolds
For decades, the chemotherapy drug doxorubicin has been the mainstay of treatment for people with many types of advanced sarcoma, cancers that begin in the bone or the soft tissues of the body. Previously tested combinations of doxorubicin with other chemotherapy drugs helped some people live longer. But, compared with doxorubicin alone, the side effects of such combinations were severe, leading many doctors to consider them to be too risky to use in everyday patient care.
But that may soon change, based on the results of a clinical trial conducted in France. The trial showed that adding trabectedin (Yondelis) to doxorubicin as an initial treatment for people with a type of sarcoma called leiomyosarcoma helped them live longer than people initially treated with doxorubicin alone: a median of 33 months versus 24 months.
The findings were published September 5 in the New England Journal of Medicine.
Giving the drugs at the same time also appeared to be more effective than giving one for a period followed by the other (sequentially). Although almost 60% of people in the trial initially treated with doxorubicin alone later received trabectedin, they still didn’t live as long as those who got both drugs together from the beginning of their treatment.
People initially treated with the combination, which was given for about four and a half months, could continue taking trabectedin by itself for up to almost a year, a strategy called maintenance therapy.
This makes it hard to tease out the effects of the combination from the effects of longer treatment overall, explained Dr. Margaret von Mehren, MD., a sarcoma expert from Fox Chase Cancer Center, who was not involved with the study.
But people in the trabectedin plus doxorubicin group lived almost a year longer, she continued, “which argues that the initial response to combination treatment and maintenance was helpful in a way that sequential therapy is not” she said.
The combination treatment did come with a spike in side effects, including serious issues that can substantially impact quality of life. But many patients may accept that risk if it can potentially help them live longer, said Dr. Robert Benjamin, MD, – Search Videos of the University of Texas MD Anderson Cancer Center, another sarcoma expert who was not involved with the study.
Rare tumors, difficult studies
Sarcomas are rare, making up less than 2% of all cancer diagnoses. This already small number includes around 70 different subtypes. Because of their rarity, clinical trials of new treatments have often included people with many different types of sarcomas in order to have enough participants to produce meaningful results.
But research has indicated that different subtypes of sarcoma may be sensitive to different drugs, suggesting that treatment strategies need to be tailored to each subtype.
The combination of doxorubicin and trabectedin had shown promise in small studies of leiomyosarcoma, a tumor that develops in smooth muscle cells. Although it can arise almost anywhere in the body, it’s most common in the uterus, abdomen, and pelvis.
It took the French Sarcoma Group several years to enroll 150 people into their trial. Participants had been diagnosed with leiomyosarcoma that couldn’t be removed surgically or had spread (metastasized) and hadn’t yet received any treatment.
The researchers randomly assigned about half of the participants to receive up to six cycles of doxorubicin given once every 3 weeks, and the other half to six cycles of doxorubicin plus trabectedin given over the same time frame. Participants in both groups received medications to prevent the number of blood cells in the body from dropping dangerously low.
People in the combination chemotherapy group could continue to receive trabectedin as maintenance therapy for almost a year, as long as the drug appeared to be keeping their cancer in check.
More treatment, longer survival
After a median of more than 4.5 years of follow-up, people who received the combination therapy lived twice as long without their cancer getting worse as those who only got doxorubicin at the start of treatment: 12 months versus 6 months. Two years after starting treatment, 30% of people in the combination chemotherapy group were alive without their cancer getting worse, compared with only 3% who received doxorubicin alone.
Of the people who initially got doxorubicin alone, about 38% eventually received trabectedin after their cancer had come back, or relapsed, and 23% received it after a third or later relapse.
The six cycles of planned chemotherapy shrank the original or metastatic tumors enough to allow for complete surgical removal in 20% of people who received both doxorubicin and trabectedin, compared with only 8% of those who initially received only doxorubicin.
Historically, patients who are able to have their cancer completely removed with surgery “have the same potential for long-term survival” as those whose cancer is completely eradicated by chemotherapy alone, Dr. Benjamin explained.
With more side effects come decisions about best treatment choice
The addition of trabectedin to doxorubicin did substantially increase the number of serious side effects among participants in the combination chemotherapy group.
Almost everyone (97%) in this group had at least one major treatment side effect, including drops in the number of red or white blood cells and temporary liver damage. By comparison, just under 60% of people in the doxorubicin-alone group had serious side effects during treatment.
Despite the higher rate of side effects, 81% of people in the combination chemotherapy group finished all six initial cycles of chemotherapy, compared with 71% of people in the doxorubicin group. One death related to treatment—from heart failure—occurred in the doxorubicin group.
Some people with other health conditions, such as heart problems, liver disease, or problems with their bone marrow, may not be able to receive both drugs together, explained Dr. Benjamin.
“But I think for most patients with leiomyosarcomas, if you need to use chemotherapy, this [combination] is what you would want to use,” he said.
There are other strategies that could be explored to let more patients try combination chemotherapy up front, including the use of drugs that protect the heart, such as dexrazoxane, Dr. Benjamin added.
But some people with advanced sarcomas may still prioritize fewer side effects over a chance at living longer, said von Mehren, MD, “You have to take into account the patient’s preference on the impact of treatment on their ability to [live] their life day to day,” she said.
Others may want to join a clinical trial testing newer treatments, such as immunotherapies, she added. And people shouldn’t be discouraged from joining studies that include people with different sarcoma subtypes if that gives them the opportunity to try other treatment options, she said.
Words of Wisdom From Leiomyosarcoma Survivors | LMSDR Foundation
Brandie always had painful menstrual periods and a family history of fibroids and endometriosis, but her symptoms eventually got much worse! She then underwent ovary removal surgery and an elective hysterectomy. She then learned she had leiomyosarcoma, a rare cancer of the smooth muscle. Leiomyosarcoma is a rare, aggressive cancer that grows in the smooth muscles, like those found in your stomach, bladder, uterus, intestines and blood vessels.
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Leiomyosarcoma: Severe Uterine Symptoms Led to Stage 4 Full story & transcript → Leiomyosarcoma: Severe Uterine Symptoms Led to Stage 4
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My sarcoma was treated at Northwestern Medicine in Chicago. I was first told the tumor was too large to remove. Dr. Akhil Chawla Oncology Northwestern – Search
My surgeon, Dr. Chawla was a sarcoma specialist. I was treated with proton radiation in order to shrink the tumor for surgical removal and it was successful. It made a hash of my bladder too. In fact, in many ways the radiation damage has lasted almost a year. I’m thankful that you made it through your journey. I just celebrated my one year after surgery and tests showed no more cancer so far.
Scott Hamilton’s Chemocare provides chemotherapy drug and side effect information, cancer wellness information, and links to additional reliable resources and organizations. The website is created and reviewed by a multidisciplinary team at Cleveland …
This post was originally published October 2, 2024, by the National Cancer Institute.
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