At the virtual American Society of Clinical Oncology (ASCO) annual meeting in May/June 2020, promising results from the interim analysis of phase 3 data from the KEYNOTE-177 trial were presented during the plenary session. First-line treatment of a subset of patients with metastatic colorectal cancer (mCRC) with the immunotherapy drug pembrolizumab doubled the median progression-free survival (PFS) compared to patients treated with standard-of-care chemotherapy. This has now led to an FDA approval for the drug.

Trial Results

KEYNOTE-177 was designed as a global, multicenter, open-label, active-controlled, randomized trial that compared treatment of 307 previously untreated patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) mCRC. Mismatch repair is an inherent property of cells that allows them to correct DNA replication errors, and dMMR cell lack this process, resulting in mutations in the DNA. dMMR cells with alterations in short, repetitive DNA sequences are called MSI-H.  Patients were randomized to receive first-line pembrolizumab alone at 200 mg every 3 weeks for up to 2 years or investigator’s choice chemotherapy: FOLFOX (fluorouracil [5-FU], leucovorin, and oxaliplatin) or FOLFIRI (5-FU, leucovorin, and irinotecan) every 2 weeks, with or without bevacizumab or cetuximab.

This was a crossover trial, meaning patients on chemotherapy could cross over to receive pembrolizumab for up to 35 cycles if their disease had progressed. Primary end points were PFS and overall survival (OS); objective response rate (ORR) was the secondary endpoint.

Median PFS was 16.5 months in the pembrolizumab group and 8.2 months in the chemotherapy group. Pembrolizumab showed a 40% reduction in the risk of disease progression (P=0.0002); PFS rates were 55% vs 37% for pembrolizumab vs chemotherapy, respectively, at 12 months, and 48% vs 19%, respectively, at 24 months. ORR were 43.8% and 33.1%, respectively. While the median duration of response was 10.6 months for chemotherapy (2.8-37.5 months), it had not been reached with pembrolizumab (2.3-41.4 months). Complete responses were achieved in 11.1% and 3.9% patients receiving pembrolizumab vs chemotherapy, partial responses were achieved in 32.7% vs 29.2%, respectively.

Only 22% of patients in the pembrolizumab arm had treatment-related adverse events (TRAEs) compared to 66% in the chemotherapy arm. One TRAE death was reported in the chemotherapy arm.

The study is ongoing and OS data are expected to be presented at a later time.

FDA Approval

The above results have led to the FDA approval of pembrolizumab in previously untreated patients with MSI-H/dMMR mCRC. Importantly, this is the first immunotherapy to receive FDA-approval as first line of care in this patient population.

The Coronavirus pandemic has many Americans putting life on hold, bracing for the new normal that is social distancing and staying home during these uncertain times. For many the pandemic has also delayed lifesaving screenings as the Centers for Disease Control and Prevention (CDC) has urged patients to delay any elective surgeries or procedures at this time such as your routine colonoscopy. According to the American Cancer Society, Dr. Rich Wender, Chief Cancer Control Officer for the ACS, stated:

“The American Cancer Society recommends that no one should go to a health care facility for routine cancer screening at this time…Remember, these screening tests save lives. When restrictions lift, it’s important to reschedule any screening test that you’re due to receive…Getting back on track with cancer screening should be a high priority.”

These recommendations have affected those seeking routine colonoscopies, which the American Cancer Society recommends that people at average risk* of colorectal cancer start regular screening at age 45, and every 10 years thereafter. Even with a family history of colorectal cancer or previous instances of cancer and/or polyps, colonoscopies in these instances would still be considered elective non-urgent procedures. Upcoming procedures would need to be rescheduled for the future. Some surveillance colonoscopy could be a higher priority and may need to be performed.

*For screening, people are considered to be at average risk if they do not have:
A personal history of colorectal cancer or certain types of polyps
A family history of colorectal cancer
A personal history of inflammatory bowel disease (ulcerative colitis or Crohn’s disease)
A confirmed or suspected hereditary colorectal cancer syndrome, such as familial adenomatous polyposis (FAP) or Lynch syndrome (hereditary non-polyposis colon cancer or HNPCC)
A personal history of getting radiation to the abdomen (belly) or pelvic area to treat a prior cancer

 

For the latest information related to the Coronavirus pandemic please visit the CDC website.

In the cancer community usually, immune cells in a tumor can improve one’s chances of survival. However, a new study recently found that colorectal cancer patients with too many immune cells may be at risk for disease recurrence and increased risk of death.

New research from City of Hope, an independent research center, published a study in the Journal of Clinical Investigation that offered insight that the standard view of immunology as a positive may adversely affect colorectal cancer patients. 71 patients with colorectal cancer at the City of Hope had immune cells and all of the patients relapsed – all even earlier than those who did not have the immune cells are still relapsed. The researchers hypothesized that the patients’ immune systems were on overdrive.

The study offered new insight into immunotherapy and Immunoscore, which is a recent benchmark that may predict the risk of colon cancer recurring in survivors. City of Hope has identified new recurrence insight based on their studies and hope to apply the same techniques to breast cancer patients and eventually melanoma and lung cancer.

Read more about the study and ask your physician about any questions you may have. 

 

Since the American Cancer Society reduced its screening guidelines for colorectal cancer, it’s no surprise that more young adults are affected by early age onset colon cancer. What is surprising, and just as alarming, is that more young adults are dying from colorectal cancer.

According to the American Cancer Society, the United States has seen a 51% increase in colorectal cancer in those under 50-years-old since 1994. The American Cancer Society reduced its screening guidelines for those at standard risk to 45-years-old because of the rise in early age onset colorectal cancer.

Despite the change in screening standards, mortality rates are increasing for those with early age onset colorectal cancer. According to Colorectal Cancer Alliance research, 67% of young early age onset colorectal cancer patients saw anywhere from two to four doctors before being diagnosed. This means that many patients were slow to recognize their symptoms, which can aid in early detection. 

Early symptoms may include: 

  • A change your bowel habits
  • Diarrhea and constipation
  • Frequent gas, bloating or cramps

 

Learn more about the common symptoms of colorectal cancer and educate your loved ones on how to get screened on our blog. If you have any questions, please reach out to us in the comments.

 

With the recent announcement of lowering the standard screening age to 45-years-old, it’s no surprise that colon cancer is on the rise among young adults in developed countries. Despite rates decreasing in older adults  due to increased screening, early-age onset colorectal cancer continues to affect Americans nationwide.

According to the study, colon cancer rates remained the same in 14 countries, fell in three countries and rose in 19 countries. Italy, Austria and Lithuania were the only countries to see a decrease in colon cancer rates among those under 50-years-old.

In America, and most of the other 19 countries were colon cancer rates increased, researchers indicated that the increase in diagnoses occurred in the mid 1990s. While there is no specific reason indicated in the study for the increase, many scientists agree that lifestyle choices often play a role in developing colon cancer. Increasing your exercise and reducing processed meat may decrease your chance of developing cancer.

However, the best thing that you can do is make sure that you get screened and encourage your loved ones too. If you are concerned about you or a loved one developing colon cancer, learn more about early-onset colon cancer. You should get screened at 45-years-old if you have an average risk and earlier if you have a family history of colorectal cancer.

For more information on early-age onset colorectal cancer, please reach out to us at info@coloncancerchallenge.org or (914) 305-6674.