People with advanced colorectal cancer that has spread to the liver can undergo laparoscopic surgery instead of open surgery without affecting their chances of survival, according to data presented June 3 at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago.
Traditionally, when colorectal cancer metastasizes to the liver, surgeons perform open surgery, in which a large incision is made to remove the tumors that have spread there. But the new data, from researchers in Norway, found that survival is as good with laparoscopic surgery, a minimally invasive technique that involves a few small incisions in the abdomen, into which surgical tools are inserted to remove the tumors. In the study, patients lived more than 6.5 years after surgery regardless of the type of surgery they had.
The study is important because laparoscopic surgery typically results in shorter hospital stays, shorter recovery time, less pain, and fewer complications.
Only about 22 percent of U.S. patients with colorectal liver metastasis have laparoscopic surgery, and not every hospital has a laparoscopic program, said the lead study author, Åsmund Avdem Fretland, MD, a surgeon in the intervention center and the department of HPB (hepato-pancreato-biliary) surgery at Oslo University Hospital in Norway.
“We hope these results will encourage more hospitals to establish a laparoscopic surgical program,” he said.
Dr. Fretland and his colleagues randomly assigned 280 colorectal cancer patients with liver metastasis to either laparoscopic or open surgery. All the surgeries were considered “liver sparing,” meaning the surgeon removed the tumors but spared as much of the healthy liver as possible. The study showed survival times were similar for both surgeries, as were the median times before the cancer progressed.
Researchers found that patients undergoing laparoscopy had fewer post-operative complications—19 percent compared with 31 percent with open surgery.
Removal of liver metastases in colorectal cancer patients can cure them of the disease, and either type of surgery is effective, said Nancy N. Baxter, MD, PhD, an ASCO member and the head of the division of general surgery at St. Michael’s Hospital in Toronto, who was not involved in the study.
In Other News From ASCO
Many Lung Cancer Patients Would Benefit From Expanded Clinical Trial Inclusion Criteria
ASCO and other cancer researchers have called for expanded criteria in cancer clinical trials to make more people eligible for the trials and thereby possibly benefit from innovative therapies. Now a study on the issue shows that expanded criteria for people with advanced non-small-cell lung cancer (NSCLC) would nearly double the percentage of patients eligible for enrollment.
Researchers looked at health records for adults with NSCLC and estimated the number who would be eligible for clinical trials using both traditional criteria and newer, expanded criteria. They found that the percentage of eligible patients would double from 52.3 percent to 98.5 percent. The study showed broader criteria would allow more older patients to enter clinical trials as well as more people with late-stage disease.
Expanded criteria involve changes from traditional criteria such as allowing enrollment of patients with brain metastases, a previous cancer diagnosis, or low creatinine levels (a marker of kidney dysfunction).
“Broadened criteria is likely to result in participation that is more reflective of the patients we see in clinics,” said the lead study author, R. Donald Harvey, PharmD, the director of the phase 1 clinical trials section of the Winship Cancer Institute at Emory University in Atlanta.
The National Cancer Institute (NCI) revised its clinical trial protocol guidelines in 2018 to broaden eligibility criteria on the basis of recommendations made by ASCO and Friends of Cancer Research. Researchers say it’s too soon to tell if the new, broader criteria are being adopted.
Such effort is likely to pay dividends, said the ASCO member David L. Graham, MD, a medical director at the Levine Cancer Institute in Charlotte, North Carolina, who was not involved in the study. Broader eligibility in clinical trials has dramatically advanced pediatric cancer care, he noted. “Remarkable advances can happen when a large number of patients are enrolled in clinical trials.”
Not every patient will qualify for a clinical trial, even with broader criteria, said a coauthor of the paper, Richard Schilsky, MD, the senior vice president and chief medical officer of ASCO. “There are still many other reasons that a patient could be excluded,” Dr. Schilsky said. “But the study shows the real value of thinking through, very carefully, what the exclusion criteria should be.”
New Drug Appears to Benefit Patients With Advanced Urothelial Cancer
A phase 2 study shows that an investigational drug called enfortumab vedotin (EV) was effective in about half of people with advanced urothelial cancer, which includes cancers of the bladder (about 90 percent of all cases), the urethra, ureters, or renal pelvis.
The trial involved 125 patients who were treated with enfortumab vedotin, a medication that targets nectin-4, a protein found in almost all urothelial cancers. The study participants had all received treatment with chemotherapy or immunotherapy, but the cancer had progressed.
There is an urgent need for additional therapies for these patients, said one study author, Daniel P. Petrylak, MD, a professor of medicine and urology at Yale Cancer Center in New Haven, Connecticut.
The study showed that 44 percent of people responded to enfortumab vedotin, resulting in either shrinkage or no progression of the tumors. Another 12 percent had a complete response to the drug, meaning there was no evidence of the cancer. The median survival time was 11.7 months. The most common side effects were fatigue, hair loss, and decreased appetite. Overall, the therapy was well tolerated, Dr. Petrylak said.
Enfortumab vedotin was granted breakthrough status by the FDA in 2018. A phase 3 trial is underway, and the drug is also being studied in combination with immunotherapy or chemotherapy.
“For decades, front-line chemotherapy was all we had,” for urothelial cancer patients, said the ASCO member Robert Dreicer, MD, the deputy director of the University of Virgina Cancer Center in Charlottesville, who was not involved in the study. Only about one-quarter of patients with urothelial cancer benefit from the newer immunotherapy medications, he added, “so new therapies are badly needed.”