ASCO Annual Meeting 2019: Laparoscopic Surgery for Metastatic Colorectal Cancer, Expanding Eligibility Criteria for Advanced Non-Small Cell Lung Cancer, and a New Targeted Therapy for Advanced Bladder Cancer

2019 ASCO ® Annual Meeting; #ASCO19
June 3, 2019
Greg Guthrie, ASCO staff

The theme of the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting is Caring for Every Patient, Learning from Every Patient. For the past year, ASCO President Monica M. Bertagnolli, MD, FACS, FASCO, has visited local groups across the United States to learn what patients and doctors truly experience when receiving and providing cancer care. As she writes in this year’s Clinical Cancer Advances report, “Cancer treatment advances are only as good as patients’ ability to access them.” This year’s ASCO Annual Meeting strikes the balance in Dr. Bertagnolli’s theme, bringing late-breaking research news to the public and exploring the ways that access to cancer care can be improved for patients. 

More than 32,000 oncology professionals from around the world are at the ASCO Annual Meeting in Chicago, presenting and discussing the latest research in cancer treatment and patient care.share on twitter Learn about the research released today:

  • For colorectal cancer, laparoscopic surgery is as effective as open surgery in treating liver metastases

  • Expanding eligibility criteria would double the number of people with advanced lung cancer who could join clinical trials

  • Advanced bladder cancer and other urothelial cancers respond to enfortumab vedotin in nearly half of patients

Watch a patient education video with Dr. Bertagnolli explaining how the ASCO Annual Meeting changes patients’ lives.

For colorectal cancer, laparoscopic surgery is as effective as open surgery in treating liver metastases

A phase III clinical trial from Norway called OSLO-COMET found that laparoscopic surgery was as effective as open surgery to remove colorectal cancer that had spread, or metastasized, to the liver.

Laparoscopic surgery, also called keyhole surgery, uses several small cuts that are one-quarter inch or less in length. During this type of surgery, the surgeon directs robotic instruments to do the surgery through the several small cuts in the skin. In open surgery, a single, large cut, sometimes several inches long or more, is made on the abdomen. For this reason, laparoscopic surgery is often referred to as minimally invasive surgery.

From February 2012 to January 2016, the researchers randomly assigned 280 people with colorectal cancer that had spread to the liver to receive either laparoscopic surgery or open surgery. Of those, 133 people had laparoscopic surgery and 147 had open surgery. About half of the study participants also received chemotherapy before or after the surgery based on the country’s standard guidelines for treatment.

The researchers found similarities between the 2 types of surgery:

  • People in both groups lived the same amount of time. Those who were treated with laparoscopic surgery lived a median of 80 months after the surgery. The median is the midpoint, meaning that half of the people lived less than 80 months and the other half lived more than 80 months. Those treated with open surgery lived a median of 81 months.

  • For people who had all of their liver tumors removed, the median period without the disease recurring or spreading was 19 months for laparoscopic surgery and 16 months for open surgery.

Open surgery caused problems and side effects in 31% of study participants, compared with 19% of those who had laparoscopic surgery. This means that people treated with laparoscopic surgery had a better health-related quality of life after the treatment.

What does this mean? This study provides evidence that laparoscopic surgery is just as effective as open surgery in extending the lives of people with colorectal cancer that has spread to the liver, while causing less side effects for patients.share on twitter

“Laparoscopic liver surgery not only had a lower rate of post-operative complications, an improved quality of life, and was cost-effective, compared to open liver surgery, it also had life expectancies that are similar to open surgery.”

—   lead study author Åsmund Avdem Fretland, MD
Oslo University Hospital
Oslo, Norway

Expanding eligibility criteria would double the number of people with advanced lung cancer who could join clinical trials

An analysis of 10,500 health records for people with advanced non-small cell lung cancer (NSCLC) from the CancerLinQ database found that broadening the eligibility criteria for clinical trials would allow almost all of these patients to enroll in clinical trials, nearly doubling the percentage from about 52% to more than 98%.

CancerLinQ is a database initiative of ASCO that collects and analyzes electronic health record information from patients at practices across the United States. Information that could identify individual patients is removed from the database. This data is made available to academic researchers, nonprofit organizations, government agencies, and others in the oncology community to improve the quality of cancer care through CancerLinQ Discovery.

Clinical trials are research studies involving volunteers and are the main way that doctors find better treatments for cancer. Doctors decide who can be in a clinical trial by looking for people with certain things in common. This is often called the “eligibility criteria.” This allows researchers to define their study, give it structure, and accurately compare the clinical trial results with previous studies. However, one of the problems with eligibility criteria is that it sometimes leads to participants in a clinical trial not fully representing the characteristics of the wider population of people who are diagnosed with that disease. For example, many people diagnosed with lung cancer are older, but often people are excluded from clinical trials based on their age. This means that less is known about how to effectively treat older people with lung cancer.

In 2017, 2 groups—ASCO and the Friends of Cancer Research—proposed using expanded eligibility criteria to increase the number of people who could participate in clinical trials. In November 2018, the U.S. National Cancer Institute updated its clinical trial eligibility criteria to reflect those recommendations.

This specific study analyzed health records from CancerLinQ to see if using that revised eligibility criteria would increase the number of people who could join clinical trials in advanced NSCLC, which is the most common type of lung cancer.

The researchers looked at 10,500 health records from 2011 to 2018 for people with advanced NSCLC, including data on kidney function, measured by creatinine clearance, previous or current cancer diagnoses, and whether the cancer had spread to the brain, called brain metastases. Traditional eligibility criteria exclude people with a creatinine clearance less than 60 milliliters per minute and exclude people with previous or current cancer diagnoses and/or brain metastases. The proposed criteria allow a creatinine clearance as low as 30 milliliters per minute and allow people with brain metastases.

Using traditional eligibility criteria, the researchers found that 5,005 patients (nearly 48%) in the CancerLinQ database would not be able to enroll in a clinical trial. However, using the proposed expanded criteria, just 154 patients (1.5%) would not be able to enroll. This means that 4,851 more people could join a clinical trial under the expanded criteria.

The study also showed that the expanded criteria would increase the enrollment for many groups of people with NSCLC who are less represented in clinical trials participation due to other eligibility criteria factors, including:

  • Older patients

  • Women

  • People with stage IV lung cancer

  • People with types of lung cancer that are not squamous cell types

  • People who have never smoked

What does this mean? Broadening eligibility criteria would allow researchers to find safe ways to treat more diverse groups of patients.share on twitter This analysis shows that nearly all the patients with advanced NSCLC found in the CancerLinQ database could join a clinical trial if the ASCO and Friends of Cancer Research criteria were used.

“Ongoing use of historic, narrow eligibility criteria based on antiquated safety concerns place potentially unnecessary restrictions on trial participants, thus making it increasingly difficult to conduct the clinical trials necessary to demonstrate safety and efficacy of new therapies. Changes to eligibility criteria are particularly important as we step further into the era of targeted therapies, including immunotherapies, that have different safety profiles than highly toxic systemic chemotherapies.”

—   lead study author R. Donald Harvey, PharmD, BCOP, FCCP, FHOPA
Winship Cancer Institute of Emory University
Atlanta, Georgia

Advanced bladder cancer and other urothelial cancers respond to enfortumab vedotin in nearly half of patients

A phase II clinical trial has shown that enfortumab vedotin produced responses in 44% of cases of locally advanced or metastatic urothelial cancers, 90% of which are bladder cancer. Urothelial cancers also affect the upper urinary tract, including the urethra, ureters, and renal pelvis, as well as other organs next to the bladder. Enfortumab vedotin is a targeted therapy that targets a protein called nectin-4. Nectin-4 is found in 97% of bladder cancers.

Currently, locally advanced or metastatic urothelial cancer is treated with a platinum-based chemotherapy. If the chemotherapy does not stop the disease, then the next treatment is an immune checkpoint inhibitor, which is a type of immunotherapy. However, in 75% to 80% of people with advanced urothelial cancer, the immunotherapy does not stop the disease. There are no standard treatments beyond immunotherapy.

This study enrolled 125 people with locally advanced or metastatic urothelial cancer who had been treated with both chemotherapy and immunotherapy, but the cancer had not been stopped. Most of the participants were men (70%), and the median age was 69 years.

Among the study’s participants, enfortumab vedotin stopped the growth or spread of the disease or shrank tumors in 44% of them. In 12% of the study participants, there was a complete response, meaning that no signs of cancer could be found after treatment. The people in this study lived for a median of nearly 12 months. The median is the midpoint, meaning that half of the people lived less than that and the other half lived more than that. Enfortumab vedotin also worked in 41% of tumors that had not responded to checkpoint inhibitor immunotherapy and in 38% of cancers that had spread to the liver.

The most common side effects of enfortumab vedotin were fatigue, hair loss, and loss of appetite.

What does this mean? This is an early study, but enfortumab vedotin may be an effective option for people with advanced urothelial cancer if chemotherapy and/or checkpoint inhibitors do not work.share on twitter Because nectin-4 is found in many cases of bladder cancer, many people with bladder cancer could benefit from this treatment.   

“The fact that we have a therapy that can help people who don’t benefit from checkpoint inhibitors is very gratifying.”

—   lead study author Daniel P. Petrylak, MD
Yale Cancer Center
New Haven, Connecticut

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