American College Of Surgeons - Inspiring Quality: Highest Standards, Better Outcomes

Clinical Updates

ACS Review and Recommendations on the SARS-CoV-2 Vaccine

The Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Pfizer/BioNTech's mRNA vaccine against the SARS-CoV-2 virus. The FDA's Vaccines and Related Biological Products Advisory Committee voted on Thursday, December 10, to recommend the FDA issue an EUA, following extensive review of safety and efficacy data on the Pfizer/BioNTech vaccine. The clinical trials of the vaccine included more than 40,000 participants—all over the age of 16—and found high vaccine efficacy in all age groups, genders, races, ethnicity and participants with the presence of comorbidities. Access the FDA briefing materials that provide a comprehensive overview of the safety and efficacy data.

The ACS has reviewed the safety and efficacy data submitted by Pfizer/BioNTech and strongly encourages surgeons to take the vaccine when available to them. Mild systemic side effects are very common with this two-dose vaccine (fatigue, injection site reactions, and fever) but serious adverse side effects were very rare. Doses will be dispensed to individual states, which will control local distribution.

Prepared by Kenneth W. Sharp, MD, FACS, on behalf of the American College of Surgeons Board of Regents

A Renewed Focus on Early Onset Colorectal Cancer and Screening

Submitted by the ACS Advisory Council for Colon and Rectal Surgery

Screening for colorectal cancer is performed through stool-based tests, imaging (such as CT colonography) or endoscopy. The latter, colonoscopy, is considered the "gold standard," offering the ability to both diagnose lesions at an early stage, as well as treat premalignant lesions endoscopically and thereby prevent cancer. Recent changes in the American Cancer Society Guideline for Colorectal Cancer Screening have recommended starting routine screening for average-risk patients at age 45, down from the previously recommended age of 50 (read the updated American Cancer Society guidelines). The U.S. Preventive Services Task Force, which in 2016 had recommended to begin screening at age 50 for average-risk individuals, also more recently released draft guidelines recommending lowering the age to 45 for this same group (read the USPSTF update).

These changes were in direct response to the increase in incidence of early age onset colorectal cancer. Yet, colorectal cancer remains the second or third leading cause of cancer-related death each year in the U.S. While colorectal cancer incidence and death rates have seen a decrease over the last few decades—in part due to awareness and screening strategies—the recent death of actor Chadwick Boseman, of Marvel Comic's Black Panther, has drawn further public attention to the rising incidence of colorectal cancer in adults under the age of 50. According to the National Cancer Institute, since 1994, cases of early-onset colorectal cancer have increased by 51 percent.

While a cancer diagnosis at any age calls for expert treatment, young patients with colorectal cancer often have diagnostic and treatment considerations that are specific to their early age of onset. David Liska, MD, director of Cleveland Clinic's Sanford R. Weiss, MD Center for Hereditary Colorectal Neoplasia, has established an Early Onset Colorectal Cancer Center with the aim of providing young colorectal cancer patients with personalized, comprehensive and coordinated world-class care. "Along with other institutions in the United States, we recognize the need for a multidisciplinary team that understands that young adults with colorectal cancer face unique issues that require expert support at the time of diagnosis, during treatment, and during the survivorship and surveillance phase," Dr. Liska said.

Composed of providers with renowned expertise in surgery, oncology, radiation therapy, genetics, gastroenterology, oncofertility, psychology and lifestyle medicine, the center aims to design a personalized care plan with a focus on curing cancer and maximizing survival, while also assuring optimal quality-of-life for patients whose cancer diagnosis can interrupt their most productive years. By bringing together a team of experts, the hope is to also stimulate groundbreaking molecular and clinical research to better understand the etiology underlying the alarming rise in early onset colorectal cancer, with the goal of developing novel treatments and risk-based screening recommendations.

The renewed focus on expanding screening for colorectal cancer also is a reminder that even in the setting of a pandemic such as COVID-19, with its associated challenges, there is a tremendous need to continue with important baseline health maintenance screening examinations like colonoscopy.