Fruquintinib prolongs survival in clinical trial

T​his study expands research into the treatment of refractory metastatic colorectal cancer, which is colorectal cancer that has spread and is difficult to control or treat.

T​he study was an international, randomized, double-blind, placebo-controlled, phase 3 study. This type of study allows for valuable data collection with a low risk of bias. The study included data from participants in 14 countries, a total of 691 participants. All participants had already received previous treatment for colorectal cancer.

The researchers divided participants into two groups. One group received a placebo, and the other received fruquintinib, a medication that influences cell growth.

Dr. Wael Harb, a hematologist and medical oncologist at MemorialCare Cancer Institute at Orange Coast Medical Center in Fountain Valley, California, and vice president of Medical Affairs at Syneos Health, who was not involved in the study, explained that fruquintinib is “a selective inhibitor of vascular endothelial growth factor (VEGF) receptors, works by essentially depriving the tumor of its blood supply, thus impeding its growth and spread.”

Participants also received supportive care. Researchers looked at survival rates among the two groups. Overall, researchers found that fruquintinib was superior to the placebo.

I​n the fruquintinib group, researchers found that participants had a 34% reduced risk of death, and 24% of participants in the treatment group also had progression-free survival after six months. In contrast, only 1% of the placebo group had progression-free survival after six months.

The treatment group also had a longer overall survival than the placebo group.

Dr. Harb highlighted these key findings to Medical News Today:

“The study highlighted a meaningful enhancement in overall and progression-free survival rates among patients who have undergone multiple lines of treatment, exhibiting median survival times of 7.4 months versus 4.8 months in the placebo group. This substantial improvement, especially considering fruquintinib’s acceptable safety profile, is particularly noteworthy. Adverse events were generally manageable with a minimal treatment discontinuation rate due to treatment-related toxicity.”

Research like the current study offers hope for improving treatment for severe colorectal cancer. Dr. Misagh Karimi, a medical oncologist specializing in gastrointestinal cancers at City of Hope Orange County Lennar Foundation Cancer Center in Irvine, California, and director of clinical operations at City of Hope Newport Beach Fashion Island, who was not involved in the study, told MNT:

“These findings could be very beneficial for patients facing an advanced stage of colorectal cancer and indicate the importance of clinical trials in developing the next generation of treatment.”

“While we can see from the study that more research is needed on fruquintinib to assess the quality of life and safety of the drug, this phase 3 study showed significant improvements in overall survival for pretreated patients with refractory metastatic colorectal cancer.”
— Dr. Misagh Karimi

Colorectal cancer is an umbrella category for cancers affecting the rectum or large intestine. While anyone can get colorectal cancer, certain risk factors will increase someone’s chances of colorectal cancer. For example, people with a family history of colorectal cancer, people who smoke, or those who have obesity may be at an increased risk of developing colorectal cancer.

The progression of colorectal cancer will impact survival rates and potential approaches to treatment. Early screening for colorectal cancer can help improve options for treatment.

When colorectal cancer has spread to other organs like the liver, the five-year survival rate dramatically declines. The five-year survival rate for colorectal cancer that has spread to distant organs is about 13%. In contrast, cancer that is still only in the colon or rectum has a 91% 5-year survival rate.

Dr. Harb told MNT that “[n]early 50% of [colorectal cancer] patients will develop distant metastases at some point, and unfortunately, the overall 5-year survival rate for these patients hovers around 15%.”

“Colorectal cancer (CRC) is a globally significant health issue, and its severity largely hinges on factors such as its stage at diagnosis and the patient’s overall health. Successful treatment and recovery are quite feasible when the disease remains localized. However, when it metastasizes or spreads to other body parts, the prognosis becomes far graver.”
— Dr. Wael Harb

A​ significant limitation of this study is how the COVID-19 pandemic limited researchers’ ability to complete certain analyses. This allowed for less research into who might benefit most from fruquintinib. The local clinical practices determined the best supportive care measures for participants, which could have some variation.

T​his study builds on previous research, and the results of this study likely mean that fruquintinib may be useful in treating metastatic colorectal cancer. The study authors note, “Additional research will be needed to determine the optimal sequencing strategy for patients who have failed at least two lines of therapy.”

Doctors would need to weigh the risk of fruquintinib use, as there is the potential for adverse events with use.

D​r. Harb said there were many areas for further study to see if fruquintinib is a viable treatment for colorectal cancer.

“Continued research is paramount to corroborate our understanding of fruquintinib’s efficacy. Future research should investigate synergistic approaches, such as combining fruquintinib with other treatment modalities, including chemotherapy, targeted therapy, and immunotherapy. These combinations might bolster therapeutic effectiveness and better patient outcomes,” he said.

“One intriguing area of exploration is the potential benefits of employing fruquintinib earlier in the treatment plan,” he added.

Because of the severity of colorectal cancer after metastasis, it is also critical for people to undergo appropriate screening and follow-up for early detection and treatment.

Dr. Karimi noted the importance of early detection.

“It is important to note that the best way to stop cancer is to prevent it in the first place. Research has indicated an overall shift to more diagnoses of advanced stages of cancer and the latest findings show that over 50 percent of all new colorectal cancer cases among all ages were advanced,” he said.

“Once severe [colorectal cancer] symptoms arise, the cancer has usually progressed to a more advanced stage and has metastasized. This is one of many reasons why people should know their family medical history and tell their physician if something feels wrong. If the symptoms might be caused by colorectal cancer, there are screening tests that can be done to find the cause.”
— Dr. Misagh Karimi