Researchers: Mesothelioma Trials Need More Inclusive Criteria

Research & Clinical Trials
Reading Time: 4 mins
Publication Date: 02/02/2021
Fact Checked
Our fact-checking process begins with a thorough review of all sources to ensure they are high quality. Then we cross-check the facts with original medical or scientific reports published by those sources, or we validate the facts with reputable news organizations, medical and scientific experts and other health experts. Each page includes all sources for full transparency.
Reviewed

Asbestos.com is the nation’s most trusted mesothelioma resource

The Mesothelioma Center at Asbestos.com has provided patients and their loved ones the most updated and reliable information on mesothelioma and asbestos exposure since 2006.

Our team of Patient Advocates includes a medical doctor, a registered nurse, health services administrators, veterans, VA-accredited Claims Agents, an oncology patient navigator and hospice care expert. Their combined expertise means we help any mesothelioma patient or loved one through every step of their cancer journey.

More than 30 contributors, including mesothelioma doctors, survivors, health care professionals and other experts, have peer-reviewed our website and written unique research-driven articles to ensure you get the highest-quality medical and health information.

About The Mesothelioma Center at Asbestos.com

  • Assisting mesothelioma patients and their loved ones since 2006.
  • Helps more than 50% of mesothelioma patients diagnosed annually in the U.S.
  • A+ rating from the Better Business Bureau.
  • 5-star reviewed mesothelioma and support organization.
Learn More About Us

Testimonials

"My family has only the highest compliment for the assistance and support that we received from The Mesothelioma Center. This is a staff of compassionate and knowledgeable individuals who respect what your family is experiencing and who go the extra mile to make an unfortunate diagnosis less stressful. Information and assistance were provided by The Mesothelioma Center at no cost to our family."
Lashawn
Mesothelioma patient’s daughter
  • Google Review Rating
  • BBB Review Rating

How to Cite Asbestos.com’s Article

APA

Povtak, T. (2021, February 3). Researchers: Mesothelioma Trials Need More Inclusive Criteria. Asbestos.com. Retrieved January 30, 2023, from https://www.asbestos.com/news/2021/02/02/mesothelioma-trials-inclusive-criteria/

MLA

Povtak, Tim. "Researchers: Mesothelioma Trials Need More Inclusive Criteria." Asbestos.com, 3 Feb 2021, https://www.asbestos.com/news/2021/02/02/mesothelioma-trials-inclusive-criteria/.

Chicago

Povtak, Tim. "Researchers: Mesothelioma Trials Need More Inclusive Criteria." Asbestos.com. Last modified February 3, 2021. https://www.asbestos.com/news/2021/02/02/mesothelioma-trials-inclusive-criteria/.

Clinical trials for mesothelioma need more inclusive criteria to better reflect the patients being seen at major cancer treatment centers, according to a recent study conducted in Sydney, Australia.

The study demonstrated a significant difference between those carefully selected for clinical trials and real-world patients with pleural mesothelioma.

“A broader patient population more resembling real life would be able to access the novel treatment early,” Dr. Steven Kao, medical oncologist at Chris O’Brien Lifehouse hospital and one of the study authors, told The Mesothelioma Center at Asbestos.com. “And when the trial results are published, the efficacy results would be more applicable to the real-world population.”

Clinical Lung Cancer published the study in 2020, accentuating the high rates of ineligibility caused by criteria that is too strict, potentially denying many patients the chance for improved mesothelioma survival.

Authors were from the University of Sydney Medical School and the Chris O’Brien Lifehouse Department of Medical Oncology.

The retrospective study ran from 2012 to 2018 and involved 133 consecutive patients with unresectable malignant pleural mesothelioma. All attended the medical oncology clinic at Royal Prince Alfred or Chris O’Brien Lifehouse hospitals in Sydney.

Qualifying for Mesothelioma Clinical Trials Is Difficult

Data for the study was compared to eligibility criteria for the international MAPS and KEYNOTE-028 studies, involving immunotherapy agents bevacizumab and pembrolizumab in combination with chemotherapy.

Of patients treated at one of the two leading centers in Australia, 50.5% failed to meet the eligibility criteria for the MAPS trial and 37% failed to qualify for the KEYNOTE-028 study.

Age (under 75) and performance status (Eastern Cooperative Oncology Group Scale) were the two most restrictive factors for patients not meeting the eligibility criteria. Others included concomitant medication and comorbidity.

In the MAPS clinical trial, median overall survival for those eligible was 25.1 months, compared to 21.5 months for those not eligible.

With the KEYNOTE-028 clinical trial, the median overall survival was 25.1 months for those eligible and 19.5 months for those ineligible.

“Clinicians should think about whether the particular treatment in question would result in similar efficacy or toxicity if their patients don’t fit in the eligibility criteria,” Kao said. “It is important to recognize that and discuss with patients accordingly.”

Investigational Drugs Benefit Mesothelioma Patients

Although efforts to broaden eligibility criteria for all clinical trials is ongoing – an estimated 10% of cancer patients overall participate in clinical trials, according to the study – limited participation makes advancements more difficult.

In this retrospective study, the majority of those who were eligible for the MAPS and KEYNOTE-028 trials did not participate in either trial. Of the 26.3% who were part of an investigational anticancer therapy study, the median overall survival was 32.4 months, compared to just 20.5 months for those who did not participate.

The issue of restricting eligibility is especially critical in rare cancers such as mesothelioma, presenting a barrier to efficient drug treatment development.

“This work is hypothesis generating,” the authors wrote. “Perhaps these exclusion criteria could be relaxed in future trials of patients with malignant pleural mesothelioma, although future study is warranted.”

The U.S. Food and Drug Administration approved the immunotherapy combination of Opdivo and Yervoy, known generically as nivolumab and ipilimumab, for first-line treatment of unresectable pleural mesothelioma in October 2020. It was the first new drug regimen approved in 16 years.

In July 2020, the FDA approved Keytruda, also known as pembrolizumab, in limited use for metastatic tumors, but only with certain restrictions for pleural mesothelioma.

“We have established that the MAPS and KEYNOTE-028 trials in MPM enrolled a select population that differs greatly from regular patients seen in the clinic,” the authors wrote. “This finding presents a challenge in practicing truly evidence-based medicine for real-world cohorts.”

The overall median survival was 22.7 months when all 133 patients were grouped, considerably better than the average survival for patients diagnosed with mesothelioma today.

“Generalizing results from trial to clinic is challenging, and future trials should aim to have more inclusive criteria,” the study concludes.

Connect with a Mesothelioma Doctor
Find a Top Specialist Near You