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FDA Approves Keytruda to Treat Esophageal Cancer, Squamous Cell Carcinoma

July 31, 2019

The FDA approved pembrolizumab as monotherapy for certain patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus.

The approval applies to use of pembrolizumab (Keytruda, Merck) for patients whose tumors express PD-L1 — with a combined positive score of 10 or higher — as determined by an FDA-approved test, and who experienced disease progression after one or more previous lines of systemic therapy.

“Historically, patients with advanced esophageal cancer have had limited treatment options, particularly after their disease has progressed,” Jonathan Cheng, MD vice president for oncology clinical research at Merck Research Laboratories, said in a press release. “With this approval, Keytruda is now the first anti-PD-1 therapy approved for the treatment [for this patient population], providing an important new monotherapy option for physicians and patients in the United States.”

Squamous cell carcinoma is cancer that begins in squamous cells of the esophagus. Squamous cells are thin, flat cells that look like fish scales, and are found in the tissue that forms the surface of the skin, the lining of the hollow organs of the body, and the lining of the respiratory and digestive tracts.  Esophageal squamous cell carcinoma is most often found in the upper and middle part of the esophagus, but can occur anywhere along the esophagus.

Esophageal squamous cell carcinoma

The FDA based the approval on results from the randomized controlled KEYNOTE-181 trial, which included 628 patients with recurrent locally advanced or metastatic esophageal cancer who progressed on or after one prior line of systemic treatment for advanced disease.

Researchers randomly assigned patients 1:1 to pembrolizumab 200 mg every 3 weeks or investigator’s choice of IV chemotherapy with paclitaxel, docetaxel or irinotecan. Treatment continued for up to 24 months, or until disease progression or unacceptable toxicity.

OS among three groups — patients with esophageal squamous cell carcinoma, those whose tumors express PD-L1 with a combined positive score of 10 or higher, and all randomly assigned patients — served as the key efficacy outcome.

Secondary outcomes included PFS, objective response rate and duration of response.

Researchers reported HRs for OS of 0.77 (95% CI, 0.63-0.96) among patients with esophageal squamous cell carcinoma; 0.7 (95% CI, 0.52-0.94) among patients whose tumors met the defined PD-L1 expression threshold; and 0.89 (95% CI, 0.75-1.05) among all randomly assigned patients.

Among patients with esophageal squamous cell carcinoma who met the defined PD-L1 expression threshold, those assigned pembrolizumab achieved longer median OS (10.3 months vs. 6.7 months; HR = 0.64; 95% CI, 0.46-0.9) and median PFS (3.2 months vs. 2.3 months; HR = 0.66; 95% CI, 0.48-0.92).

A higher percentage of pembrolizumab-treated patients achieved response (22% vs. 7%), complete response (5% vs. 1%) and partial response (18% vs. 6%). Median duration of response was 9.3 months in the pembrolizumab group and 7.7 months in the chemotherapy group.

Adverse reactions that occurred among pembrolizumab-treated patients with esophageal cancer appeared similar to those that have been observed among patients with melanoma or non-small cell lung cancer who received pembrolizumab monotherapy.

The FDA also considered data from the KEYNOTE-180 trial, a nonrandomized, open-label study that included 121 patients with locally advanced or metastatic esophageal cancer who progressed on or after at least two prior systemic treatments for advanced disease.

Thirty-five patients with esophageal squamous cell carcinoma expressed PD-L1 with a combined positive score of 10 or higher. Seven patients achieved response, equating to an ORR of 20%. The duration of response ranged from 4.2 months to more than 25.1 months. Five patients achieved responses that lasted 6 months or longer, and three patients achieved responses that lasted 12 months or longer.

In patients with esophageal cancer, the recommended dose of KEYTRUDA is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

Editor Note: Content may be edited.

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Researchers identify cancer-killing capability of lesser known immune cells

July 11, 2019
This article was posted on  to view the original article, please click here.

Researchers at Trinity College Dublin have identified, for the first time in esophageal cancer, the cancer killing capability of a lesser-known type of immune cell, presenting a new potential therapeutic target. Their research has been published today in the international journal Frontiers in Immunology here.

Esophageal cancer is a very aggressive type of cancer with poor prognosis, and the 5-year survival rate is typically less than 15%. Linked with obesity, esophageal cancer is one of the fastest growing cancers in the Western world and incidence is due to double in Ireland within the next few decades. Current treatment strategies work well but only for a minority (approx. 25%) of patients so new treatment options are urgently needed.

New treatment strategies targeting the immune system have had revolutionary effects in other cancer types, but the latest clinical trials show that, disappointingly, immunotherapy offers no real benefit for the majority of patients with esophageal cancer.

To read the full article, please click here.

Esophageal cancer is one of the fastest growing and deadliest cancers in the United States.  There are no routine screenings to detect esophageal cancer in earlier stages and symptoms (such as difficulty swallowing, choking sensation, etc…) often occur once the cancer spreads and becomes more difficult (if not impossible) to treat.

Learn the facts about esophageal cancer

-Esophageal cancer has increased over 700% and is considered one of the fastest growing cancer in the US.*

-Risk factors include:

  • Gastroesophageal Reflux Disease (GERD, acid reflux, chronic heartburn),
  • obesity,
  • poor nutrition,
  • tobacco use,
  • excessive alcohol use,
  • Barrett’s esophagus.

-As one of the deadliest cancers, esophageal cancer has an overall 5 year survival rate of only 19.2%.

-There are no routine or standard screenings to improve early detection of esophageal cancer.

-Symptoms often arise late, once the cancer is considered advanced or “distant” (spread to lymph nodes and other organs.)

-Stage IV esophageal cancer has a survival rate of only 4.8%.

-Despite these facts, esophageal cancer research is extremely underfunded.

To make a tax-deductible donation to The Salgi Esophageal Cancer Research Foundation, please visit: salgi.org/donate


“Building a Cancer Breathalyzer” Esophageal Cancer Research Funded by The Salgi Esophageal Cancer Research Foundation

April 15, 2019

From Virginia Mason Foundation:

What if a “cancer breathalyzer” could detect esophageal cancer so early that many patients could be cured without surgery, chemotherapy or radiation? Virginia Mason surgeon Donald Low, MD, FACS, intends to find out, by developing a breath test that could transform diagnosis for the deadly disease. 

“Esophageal cancers don’t typically show symptoms until they’re very advanced, which is why only 20 to 30 percent of patients live for five years after diagnosis,” Dr. Low says. “If a breath test could detect esophageal cancer before it spreads, we could cure many patients with an endoscopic procedure.”

The Salgi Foundation

The research is fueled by the Salgi Esophageal Cancer Research Foundation, which pools donations from individuals to fight esophageal cancer.

To read more, click here or visit: http://www.virginiamasonfoundation.org

 

 

 

From our blog:

The Salgi Esophageal Cancer Research Foundation Issues Esophageal Cancer Research Funding For the Second Time: SALGI.org/blog

 

 

 

 

 

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Survivor Story: Borden “Yes, you can beat this!”

March 8, 2019

Below is a story from a wife of a man who was diagnosed with esophageal cancer.  We are very thankful to this couple for sharing their personal experiences with us in order to bring awareness to this devastating cancer.  As his wife said, “I want to bring hope to people facing this horrible disease. [My husband} is a testament to fighting and winning!”

Survivor Story: Borden. Story by wife, Mary A.

My husband was diagnosed on March 3, 2009 with stage 3 Esophageal cancer. He fought it with chemo and radiation first then after 2 months if intensive treatments had the 9.5 hr surgery to remove the cancer. He had to learn how to swallow again and ate through a feeding tube for 7 months. It was such a scary time for us.

Jump ahead to ten years later, he’s doing great!!! He survived with lots of care and prayer. My prayers were answered and I hope his story will help others know, yes you can beat this awful disease!

 

Awareness, Early Detection and Research

Too often, esophageal cancer is ignored and disregarded. There is a tremendous need to bring not only awareness but tools and resources to encourage early detection and advocacy and actual funding for esophageal cancer research.

The personal stories we share on our website do just that.  They are each equally important and deserve to be published.  Please do not reproduce any of these stories without our permission.  You may contact us with any questions or comments.

Do you have an experience with esophageal cancer that you would like to share either publicly or privately?  To learn more, please visit: Share Your Story.

 

For more ways to help, please visit:  SALGI.org/ways-to-give 

 

 

 

 

 

 

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The Salgi Esophageal Cancer Research Foundation Issues Esophageal Cancer Research Funding For the Second Time

December 14, 2018

The Salgi Esophageal Cancer Research Foundation has issued funding for esophageal cancer research in November, 2018; the second time in just seven years since the charity was founded.

The Foundation awarded principal investigator, Dr. Donald Low and Virginia Mason Medical Center, grant funding.  Dr. George Hanna of St Mary’s Hospital (Imperial College London) is co-investigator.

In 2011, The Salgi Esophageal Cancer Research Foundation was established to raise awareness, encourage early detection and to fund research of esophageal cancer.  Since 2011, the foundation has both raised awareness and encouraged the importance of earliest possible detection throughout New England, across the United States and internationally.  The Salgi Esophageal Cancer Research Foundation first funded esophageal cancer research in July, 2015.

“The Salgi Esophageal Cancer Research Foundation is excited to be a part of Dr. Low’s, Professor Hanna’s and Virginia Mason’s research efforts in honor of all the brave men and women who have been affected by esophageal cancer and to hopefully reduce incidence and improve outcomes for individuals in the future,” President of the foundation, stated.

The research intends to establish a non-invasive test for the detection of esophageal cancer that is based upon the unique signature of volatile organic compounds (VOCs) within exhaled breath and to analyze exhaled VOCs in response to therapeutic intervention in patients.

Learn the Facts About Esophageal Cancer

One of the primary risk factors associated with esophageal cancer is Gastroesophageal Reflux Disease, also known as GERD or acid reflux disease, of which the most common symptom is chronic heartburn.  Other risk factors include obesity, heavy drinking, poor nutrition and smoking and/or use of tobacco products.

With over a 733% increase in the past four decades, esophageal cancer is among the fastest growing and deadliest cancers in the United States and the western world.1

There are no current standard or routine screenings to detect esophageal cancer in its earlier stages. Current guidelines recommend referral for endoscopy “only in the setting of ‘red flag’ symptoms that are frequently associated with inoperable disease,” Dr. Low stated.

These ‘red flag’ symptoms, such as difficulty swallowing, typically appear once the cancer has become advanced.  This, in addition with other factors mentioned, leads to the current overall five-year survival rate of only 19.2%.2  Despite its rapid increase and poor prognosis, esophageal cancer receives very little awareness and research funding.

The Salgi Esophageal Cancer Research Foundation

The Salgi Foundation: Past Esophageal Cancer Research Funding

In July, 2015, the Salgi Esophageal Cancer Research Foundation issued esophageal cancer research funding to Program Director Dr. Carlos Minacapelli and Rutgers Robert Wood Johnston Medical School.  That research was presented as a poster presentation during Digestive Disease Week in May, 2017.

Thank you!

The Salgi Esophageal Cancer Research Foundation would like to thank all our supporters and donors who believe in this mission and who make these accomplishments possible.  However, this is just the beginning.  The Salgi Esophageal Cancer Research Foundation continuously receives many requests for esophageal cancer research.  We need to continue our efforts to fundraise so that we may continue to fulfill this mission to raise awareness, encourage early detection and fund research.

To make a tax-deductible donation to The Salgi Esophageal Cancer Research Foundation, please visit: SALGI.org/donate.

 

 

 

 

Sources:

1 “Esophageal Cancer Sees Dramatic Spike.” Gastroenterology and Endoscopy News. 18 October 2018. https://www.gastroendonews.com/In-the-News/Article/10-18/Esophageal-Cancer-Sees-Dramatic-Spike-/53083

2 “Cancer Stat Facts: Esophageal Cancer.” National Cancer Institute, Surveillance, Epidemiology, and End Results Program.  11 December 2018. https://seer.cancer.gov/statfacts/html/esoph.html


Foundation Reaches Milestone: Issues Esophageal Cancer Research Funding For the First Time.

July 28, 2015

The Salgi Esophageal Cancer Research Foundation has issued its first round of funding for esophageal cancer research earlier this month.

The foundation awarded program director, Dr. Carlos Minacapelli and Rutgers Robert Wood Johnston Medical School grant funding.

In 2011, The Salgi Esophageal Cancer Research Foundation was established to raise awareness, encourage early detection and to fund research of esophageal cancer.  Since 2011, the foundation has both raised awareness and encouraged the importance of earliest possible detection throughout New England, across the United States and internationally.

“The Salgi Esophageal Cancer Research Foundation is excited to be a part of Dr. Minacapelli’s and Rutger’s research efforts in honor of all the brave men and women who were affected by esophageal cancer and to hopefully reduce incidence and improve outcomes for individuals in the future” President of the foundation stated.

The Salgi Esophageal Cancer Research Foundation would like to thank all of our supporters and donors who believe in this mission and who make these accomplishments possible.  However, this is just the beginning.  We received many other research requests that we were unable to fund at this time.  We need to continue our efforts to fundraise so that we may continue to fund research.

Gastroesophageal Reflux Disease, also known as GERD or acid reflux disease, of which the most common symptom is chronic heartburn, is one of the primary risk factors associated with esophageal cancer.  Other risk factors include obesity, poor nutrition and smoking.  With over a 600% increase in the past decades, esophageal cancer is among the fastest growing and deadliest cancers in the United States and western world.

Currently, there are no standard or routine screenings to detect esophageal cancer in earlier stages. Symptoms, such as difficulty swallowing, typically appear once the cancer has become advanced and the overall five-year survival rate is only 17.5%.  Despite its rapid increase and poor prognosis, esophageal cancer receives very little awareness and research funding.

To make a tax-deductible donation to The Salgi Esophageal Cancer Research Foundation, please visit: SALGI.org/donate.