Medical researchers and specialists are continually searching for ways to diagnose and treat diseases more effectively. Clinical trials help those experts explore new technologies to zero in on a diagnosis quickly, new therapies to achieve better outcomes, and new strategies to improve patients’ quality of life.
This is especially true in cancer, where the pace of research and innovation has been unprecedentedly brisk. Investigators have been hard at work exploring experimental treatments, new uses for existing agents, and new combinations of approved therapies. And each year, new regimens are approved by the U.S. Food and Drug Administration (FDA) and introduced into clinical practice.
These advances have contributed to an overall 33% decline in cancer deaths since 1991, translating to 3.8 million lives saved during that time, the American Cancer Society reports.
Colorectal cancer (CRC), however, remains an area of particular concern. While death rates from the disease fell steadily for many decades, they have been increasing by about 1% annually since the mid-2000s, the American Cancer Society says.
Reversing that uptick in death rates will require progress on many fronts. This includes broad adoption of lifestyle changes to address risk factors for CRC, such as obesity, a sedentary lifestyle, and consumption of large amounts of red meat and processed meats. It also will entail expanded screening for colorectal cancer and precancerous conditions, such as colon polyps. Findings published in the journal Nature estimate that for every 1,000 colonoscopies performed, 28 lives are saved. additionally, it will require continued progress in developing effective therapies, particularly for people whose cancer has progressed or returned following initial treatment.
In many cases, achieving further progress against these advanced-stage colorectal cancers will require using combinations of recently approved and/or long-approved therapies, as illustrated by the results of a 2023 study that led to FDA approval of a new combination-treatment regimen for metastatic colorectal cancer.
Before reviewing that trial’s design and findings, let’s set the stage by quickly discussing what CRC is. Not including skin cancers, colorectal cancer is the third most common cancer diagnosed in both men and women in the United States, the American Cancer Society reports. Colon and rectal cancers often are grouped together because they share many similarities.
Colorectal cancer starts when abnormal growths, called polyps, form in the colon or rectum. Over time, these growths can turn cancerous without warning signs or symptoms. That is why patients should receive regular colon cancer screenings.
The clinical trial, called SUNLIGHT, was headed by Josep Tabernero, MD, PhD, of the Vall d’Hebron University Hospital in Barcelona, Spain. The study included nearly 500 participants with advanced colorectal cancers whose condition worsened after undergoing at least two treatment regimens. Prior treatments included:
The study evaluated the efficacy and safety of trifluridine and tipiracil (Lonsurf®) in combination with bevacizumab. The FDA previously had approved these agents separately for treating colorectal cancer.
The open-label, controlled, two-arm, phase 3 study assigned participants at random to receive trifluridine and tipiracil alone or combined with bevacizumab.
The study found that using the two therapies together benefitted patients with previously treated metastatic colorectal cancer. After a median follow-up of 14 months, participants who received the combination therapy survived for a median of 10.8 months, compared with a median of 7.5 months among patients who received trifluridine–tipiracil alone.
The two-therapy regimen also lengthened progression-free survival by several months (a median of 5.6 months versus 2.4 months with the single therapy).
Participants in both groups reported side effects. The most common side effects included:
The combination-therapy group reported more cases of neutropenia and hypertension (high blood pressure) than the single-therapy group. The study’s investigators noted that the combination group experienced additional side effects compared with the single-treatment group, but that most patients tolerated those side effects reasonably well.
On the strength of these findings, in August 2023 the FDA approved use of trifluridine-tipiracil in combination with bevacizumab for the treatment of metastatic colorectal cancer after the above-mentioned chemotherapies or certain biologic agents have failed.
Though the survival gains in SUNLIGHT were modest, they represent further progress toward the goal of making later-stage cancers more treatable. In many, many types of cancer, patients with advanced disease are living far longer than they would have just 5 or 10 years ago, and often are doing so with a very good quality of life. Studies such as SUNLIGHT are key to continued progress in preserving both life and quality of life.
Drug therapies such as the combination regimen evaluated in the SUNLIGHT study and then approved by the FDA represent just one facet of physicians’ comprehensive approach to treating colorectal cancer. Other interventions, such as surgery and radiation therapy, also play a key role, and a person with colorectal cancer may well be treated with, for example, surgery followed by chemotherapy, or other sequences or combinations of treatment modalities. Options for treating CRC include:
Surgery is often the first and main form of treatment for early-stage colorectal cancers. The location, type, and stage of cancer determines the type of surgery performed.
Radiation therapy uses high-energy rays to kill cancer cells and prevent their spread. Radiation therapy often is combined with other types of treatment.
Chemotherapy uses powerful medications to attack and kill cancer cells or prevent them from spreading. By reducing the size of tumors, these drugs may also alleviate pain and other symptoms. Chemotherapy may be administered orally or intravenously.
Like chemotherapy, targeted therapy uses drugs to attack cancer cells or disrupt their function and reproduction. However, these medications specifically affect malignant cells – typically by binding to receptors on their surface — while leaving healthy cells intact.
Immunotherapy enhances the body’s immune system, empowering it to recognize and destroy cancer cells.
If you’ve been diagnosed with colorectal cancer or need a second opinion, the dedicated treatment team at RCCA is here to help. Our experienced medical oncologists and hematologists offer compassionate, comprehensive care and cutting-edge, evidence-based treatment.
RCCA has 22 community-based, conveniently located treatment centers throughout New Jersey, Connecticut, Maryland, and the Washington, DC area. To learn more or to arrange an appointment, contact RCCA today.
For more information or to schedule an appointment,
call 844-346-7222. You can also schedule an appointment by calling the RCCA location nearest you.
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