Adjuvant Treatment of Esophageal or Gastroesophageal Junction Cancer Clinical Trial Results | OPDIVO® (nivolumab) (2023)

OPDIVO can cause problems that can sometimes become serious or life-threatening and can lead to death. Serious side effects may include lung problems; intestinal problems; liver problems; hormone gland problems; kidney problems; skin problems; problems in other organs and tissues; severe infusion reactions; and complications of stem cell transplant that uses donor stem cells (allogeneic). Call or see your healthcare provider right away for any new or worsening signs orsymptoms.

Important Facts About OPDIVO® (nivolumab)

This is a summary of important information that you need to know about OPDIVO. Your healthcare team can work with you to help answer any questions you may have about OPDIVO. Keep this information in a safe place so you can refer to it before and during your treatment.

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What is OPDIVO?

OPDIVO is a prescription medicine that may be used to help prevent cancer of the tube that connects the throat to the stomach (esophageal cancer) or cancer where the esophagus joins the stomach (gastroesophageal junction cancer) from coming back in adults who:

(Video) Nivolumab for perioperative esophageal and gastroesophageal cancer: CheckMate 577

Have been treated with chemoradiation AND THEN

Had surgery to completely remove the cancer, but some cancer cells were still present in the removed tumor or lymph nodes.

It is not known if OPDIVO is safe and effective in children younger than 18 years of age.

OPDIVO (10 mg/mL) is an injection for intravenous (IV) use.

What is the most important information I should know about OPDIVO?

OPDIVO is a medicine that may treat certain cancers by working with your immune system. OPDIVO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work.

Get medical help immediately if you develop any of these signs or symptoms or they get worse. It may keep these problems from becoming more serious. Your healthcare team will check you for these problems during treatment and may treat you with corticosteroid or hormone replacement medicines. If you have severe side effects, your healthcare team may also need to delay or completely stop your treatment.

What are the serious side effects of OPDIVO?

(Video) Adjuvant Nivolumab in Patients with Resected Esophageal or GEJ Cancer (CheckMate 577)

A serious side effect is a side effect that can sometimes become severe or life-threatening and can lead to death. They may happen anytime during treatment or even after your treatment has ended. You may have more than one of these problems at the same time.

Call or see your healthcare provider right away if you develop any new or worse signs or symptoms, including:

Lung problems — Things to look out for may include:

  • new or worsening cough
  • shortness of breath
  • chest pain

Intestinal problems — Things to look out for may include:

  • diarrhea (loose stools) or more frequent bowel movements than usual
  • stools that are black, tarry, sticky, or have blood or mucus
  • severe stomach-area (abdominal) pain or tenderness

Liver problems — Things to look out for may include:

  • yellowing of your skin or
    the whites of your eyes
  • severe nausea or vomiting
  • pain on the right side of your
    stomach area (abdomen)
  • dark urine (tea colored)
  • bleeding or bruising more easily
    than normal

Hormone gland problems — Things to look out for may include:

  • headaches that will not go away or unusual headaches
  • eye sensitivity to light
  • eye problems
  • rapid heartbeat
  • increased sweating
  • extreme tiredness
  • weight gain or weight loss
  • feeling more hungry or thirsty than usual
  • urinating more often than usual
  • hair loss
  • feeling cold
  • constipation
  • your voice gets deeper
  • dizziness or fainting
  • changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems — Things to look out for may include:

  • decrease in your amount of urine
  • blood in your urine
  • swelling of your ankles
  • loss of appetite

Skin problems — Things to look out for may include:

(Video) Drs. Kelly & Molena discuss new Esophageal Cancer updates:

  • rash
  • itching
  • skin blistering or peeling
  • painful sores or ulcers in the mouth or nose, throat, or genital area

Problems can also happen in other organs and tissues. These are not all the signs and symptoms of immune system problems that can happen with OPDIVO. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include:

  • Chest pain, irregular heartbeat, shortness of breath, swelling of ankles
  • Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
  • Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
  • Persistent or severe muscle pain or weakness, muscle cramps
  • Low red blood cells, bruising

What are the possible side effects of OPDIVO?

OPDIVO can cause serious side effects, including:

See the previous section, “What is the most important information I should know about OPDIVO?”

Severe infusion reactions — Things to look out for may include:

  • chills or shaking
  • itching or rash
  • flushing
  • shortness of breath or wheezing
  • dizziness
  • feel like passing out
  • fever
  • back or neck pain

Tell your healthcare team right away if you get these symptoms during an infusion of OPDIVO.

Complications of bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be severe and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with OPDIVO. Your healthcare provider will monitor you for these complications.

What are the most common side effects of OPDIVO?

(Video) Gastroesophageal Cancer: Current Positioning of Immunotherapy

The most common side effects of OPDIVO when used alone include:

  • feeling tired
  • rash
  • pain in muscles, bones, and
  • itchy skin
  • diarrhea
  • nausea
  • weakness
  • cough
  • vomiting
  • shortness of breath
  • constipation
  • decreased appetite
  • back pain
  • upper respiratory tract infection
  • fever
  • headache
  • stomach-area (abdominal) pain
  • urinary tract infection

These are not all the possible side effects. Talk to your healthcare team or pharmacist for more information. You are encouraged to report side effects of prescription drugs to the FDA. Call 1-800-FDA-10881-800-FDA-1088.

What should I discuss with my healthcare team before receiving OPDIVO?

Tell your healthcare provider about all your medical conditions, including if you:

  • have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
  • have received an organ transplant
  • have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
  • have received radiation treatment to your chest area in the past and have received other medicines that are like OPDIVO
  • have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
  • are pregnant or plan to become pregnant. OPDIVO can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if OPDIVO passes into your breast milk. Do not breastfeed during treatment and for 5 months after your last dose of OPDIVO.

Females who are able to become pregnant:
Your healthcare provider should do a pregnancy test before you start receiving OPDIVO.

  • You should use an effective method of birth control during your treatment and for at least 5 months after your last dose of OPDIVO. Talk to your healthcare provider about birth control methods that you can use during this time.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with OPDIVO. You or your healthcare provider should contact Bristol Myers Squibb at 1-844-593-7869 as soon as you become aware of a pregnancy.

Tell your healthcare provider about all the medicines you take, including:

  • prescription medicines
  • over-the-counter medicines
  • vitamins
  • herbal supplements

For more information, please see U.S. Full Prescribing Information and Medication Guide for OPDIVO, or talk to your healthcare team.

(Video) Nivolumab for oesophageal cancer following chemoradiation therapy


Is Nivolumab approved for esophageal cancer? ›

The FDA approved nivolumab on May 20, 2021, for the adjuvant treatment of completely resected (negative margins) esophageal or gastroesophageal junction cancer (EC/GEJC) in patients who had residual pathologic disease following chemoradiotherapy.

How effective is Opdivo for esophageal cancer? ›

At 1 year half of the patients on OPDIVO + chemotherapy* went 7.7 months without their cancer spreading, growing or getting worse, whereas half of the patients on chemotherapy* alone went 6.0 months.

Is immunotherapy successful for esophageal cancer? ›

Immunotherapy has been proven effective for head and neck and lung cancers, leading to interest across various neoplasias, including esophageal/ GEJ cancer. The 2 key immunotherapies to have achieved success in esophageal/GEJ cancer are the PD-1 monoclonal antibodies, pembrolizumab (Keytruda) and nivolumab (Opdivo).

What is the best Immunotherapy for esophageal cancer? ›

Pembrolizumab can be used to treat some advanced cancers of the esophagus or gastroesophageal junction (GEJ), typically when treatments such as surgery and chemoradiation (chemotherapy plus radiation therapy) can't be done. Pembrolizumab might be given by itself or along with chemotherapy, depending on the situation.

What is the new cancer treatment for esophageal? ›

Trastuzumab, a medication that targets a gene called HER2, has been approved by the U.S. Food and Drug Administration (FDA) as a first-line treatment of esophageal cancer that has an abnormal alteration in the HER2 gene (“HER2-positive” esophageal cancer).

What is the 10 year survival rate for esophageal cancer? ›

Overall, more than 1 in 10 people diagnosed with oesophageal cancer today are predicted to survive their disease for at least ten years.

Does esophageal cancer ever go into remission? ›

Currently available combination chemotherapy treatment for stage IV cancer results in complete remission in up to 20% of patients, with average survival of 8-12 months.

How much longer does Opdivo prolong life? ›

Researchers conducted follow-up for a median of 8.4 months in the Opdivo plus Yervoy group, 9.9 months in the Opdivo alone group and 9.1 months in the placebo group. During follow-up, overall survival was a median of 9.2 months with Opdivo plus Yervoy, 10.4 months with Opdivo and 9.6 months with placebo.

What is the success rate of immunotherapy for throat cancer? ›

The drug has been developed as a treatment for multiple cancers, and Wise-Draper said it has shown early success as a treatment for head and neck cancers that have spread or returned after initial treatment, with early studies reporting effectiveness for about 20% of patients treated.

What are the chances of beating esophageal cancer? ›

The overall five-year survival rate for esophageal cancer is about 20%, but survival rates can range from 5% to 47%. When esophageal cancer is found early and when it is small, the five-year survival rate is higher.

Can you survive advanced esophageal cancer? ›

The 5-year survival rate of people with cancer located only in the esophagus is 46%. The 5-year survival rate for those with disease that has spread to surrounding tissues or organs and/or the regional lymph nodes is 26%. If it has spread to distant parts of the body, the survival rate is 5%.

Can you survive cancer with immunotherapy? ›

Immunotherapy drugs work better in some cancers than others and while they can be a miracle for some, they fail to work for all patients. Overall response rates are about 15 to 20%.

How long can a cancer patient live with immunotherapy? ›

In her study, 70% of the patients who were able to complete 2 years on the chemo-immunotherapy combination were still alive at five years. They get infusions every three weeks for those two years, but most can work during treatment. "The quality of life of these patients is quite high," Garassino said.

How do you beat esophageal cancer? ›

Studies have shown that patients experience better results when they receive radiation therapy in esophageal cancer treatment.
  1. In early-stage cancer, radiation therapy may be the only treatment approach necessary.
  2. You may also receive radiation therapy before or after surgery, or in combination with chemotherapy.

How do you slow down esophageal cancer? ›

A diet rich in fruits and vegetables may help lower esophageal cancer risk. Obesity has been linked with esophageal cancer, particularly the adenocarcinoma type, so staying at a healthy weight may also help limit the risk of this disease. Being physically active may also reduce your risk of esophageal cancer.

What are the side effects of immunotherapy for esophageal cancer? ›

Common Side Effects of Esophageal Cancer Immunotherapies Can Include:
  • Feeling weak or tired.
  • Muscle or joint pain.
  • Loss of appetite.
  • Constipation or diarrhea.
  • Shortness of breath.
  • Skin rash.
  • Itching.
  • Nausea.
Jan 19, 2022

Where is the best place to treat esophageal cancer? ›

Mayo Clinic doctors have experience treating this disease. Each year, Mayo Clinic doctors care for more than 1,100 people with esophageal cancer. The latest techniques and technologies. Mayo Clinic is dedicated to developing cutting-edge diagnostic tests and innovative treatments for patients with esophageal cancer.

Can you survive esophageal cancer without surgery? ›

If the cancer is in the upper part of the esophagus (in the neck), chemoradiation may be recommended as the main treatment instead of surgery. For some patients, this may cure the cancer. Close follow-up with endoscopy is very important in looking for possible signs of cancer returning.

Can you live 10 years with esophageal cancer? ›

Survival for all stages of oesophageal cancer

more than 15 out of every 100 (more than 15%) will survive their cancer for 5 years or more. more than 10 out of 100 (more than 10%) will survive their cancer for 10 years or more.

Can you live longer than 5 years with esophageal cancer? ›

Although many people with esophageal cancer will go on to die from this disease, treatment has improved and survival rates are getting better. During the 1960s and 1970s, only about 5% of patients survived at least 5 years after being diagnosed. Now, about 20% of patients survive at least 5 years after diagnosis.

Does esophageal cancer always come back? ›

It has been reported that more than half of esophageal cancer patients have recurrence or metastases within 2-3 years after resection (3,4). Mariette et al. (5) have reported 90% of recurrence occurred within 38 months after surgery. 88.9% of our patients had recurrence or metastasis within 3 years after surgery.

Can Stage 4 cancer be cured with immunotherapy? ›

Can immunotherapy cure stage 4 cancer? While immunotherapy doesn't cure stage 4 cancer, it can improve the quality and longevity of your life.

Who are some famous esophageal cancer survivors? ›

For decades, esophageal cancer has defied scientific attempts to discover a therapy that extends patients' survival, year after year claiming the lives of such illustrious people as Humphrey Bogart, Christopher Hitchens and Ann Richards, the former governor of Texas.

What causes death from esophageal cancer? ›

During the 1-year follow-up period, patients with EC had statistically highest risk of death from septicemia (SMR: 7.61; 95% CI: 6.38-9.00). Within more than 10 years after EC diagnosis, more and more patients died from chronic obstructive pulmonary disease (SMR: 2.38; 95% CI: 1.79-3.10).

Can you stay on immunotherapy indefinitely? ›

Currently, there's no designated end to immunotherapy treatment. You may continue on the regimen as long as you continue to have a good response. Patients sometimes ask to take a break from treatment.

What are the reviews for nivolumab? ›

Nivolumab has an average rating of 4.6 out of 10 from a total of 98 reviews on 38% of reviewers reported a positive experience, while 58% reported a negative experience.

What is the survival rate after immunotherapy? ›

Immunotherapy is helping improve outcomes for people with several types of cancer that typically have a poor diagnosis including advanced bladder, kidney, and lung cancers. The average response rate of cancer patients to immunotherapy drugs is between 20 to 50%.

Can immunotherapy cure stage 3 cancer? ›

Immunotherapy is a newer form of treatment for stage 3 lung cancer, but it's showing promise as an effective solution for dealing with this disease. While it isn't right for everyone, immunotherapy may allow you to use your own body to help fight your cancer.

Can immunotherapy put cancer into remission? ›

Cancer immunotherapy can work on many different types of cancer. Cancer immunotherapy offers the possibility for long-term cancer remission. Cancer immunotherapy may not cause the same side effects as chemotherapy and radiation.

Which cancers are most successfully treated with immunotherapy? ›

There are so many different immune therapies available right now. Some are drugs. Some are cells. And the most successful arena, at least for the cell-directed therapy, tends to be the blood cancers, such as lymphoma, leukemia, to some extent multiple myeloma.

How old are most people with esophageal cancer? ›

People between the ages of 45 and 70 have the highest risk of esophageal cancer. Gender. Men are 3 to 4 times more likely than women to develop esophageal cancer.

How long does it take for esophageal cancer to metastasize? ›

Distant metastases mostly develop within 6 months of radical treatment, and median survival after diagnosis of distant metastasis is only 5 months (4–6). Therefore, distant metastasis remains the major cause of treatment failure and death in esophageal cancer.

Where does esophageal cancer spread first? ›

The most common place for oesophageal cancer to spread to is the liver. It can also spread to the lungs or lymph nodes.

Why is esophageal cancer so hard to treat? ›

Because esophageal cancer is usually diagnosed in the later stages, it has often spread, making it difficult to treat.

Can esophageal cancer be slow growing? ›

Stomach and oesophageal cancers present as malignant tumours found in the tissues of the stomach or oesophagus. It is a slow growing cancer that may grow for many years before symptoms are felt.

What is the downside of immunotherapy? ›

For patients receiving immunotherapy drugs that are given intravenously, the most common side effects include skin reactions at the site of the injection, such as pain, swelling, and soreness. Some immunotherapy drugs may cause severe or even fatal allergic reactions, though this is rare.

What are the disadvantages of immunotherapy for cancer? ›

Immunotherapy may cause lowered blood counts, which may lead to bleeding, anemia, and other problems. Lungs. Immune checkpoint inhibitors may cause pneumonitis, which is inflammation of the lungs that can cause a cough or trouble breathing. Pneumonitis is uncommon but may be serious.

How long does it take for tumor to shrink with immunotherapy? ›

For all these reasons, it can take about 2 months after initiating treatment to see a measurable response to immunotherapy.

At what stage is esophageal cancer usually found? ›

The earliest stage esophageal cancers are called stage 0 (high grade dysplasia). It then ranges from stage I (1) through IV (4). As a rule, the lower the number, the less the cancer has spread. A higher number, such as stage IV, means cancer has spread more.

How long can you live with Stage 1 esophageal cancer? ›

In one clinical study from Japan, the 5-year survival rate for patients with stage I esophageal cancer was 86% following endoscopic surgical resection. In another study from Japan, the average survival for 6 patients treated with surgery alone was 15 years.

What foods fight esophageal cancer? ›

Fruit and vegetable content in diet has been suggested to be inversely associated with risk of esophageal cancer. The protective effects are thought to be mediated by fiber, lutein and folate. The association appears to be stronger for adenocarcinomas than for squamous cell carcinomas.

What are the best vitamins for esophageal cancer? ›

Core tip: Vitamin D has emerged as a promising anti-cancer agent due to its diverse biological effects on tumor differentiation, apoptosis and suppression of cellular proliferation. Ecological studies evaluating exposure to ultraviolet B radiation yielded an inverse correlation with esophageal cancer.

What vitamins are good for esophageal cancer? ›

Among esophageal cancer cases, increasing meat consumption and vitamin C use were associated with a significantly reduced cancer risk.

Is Opdivo approved for esophageal cancer? ›

FDA approves Opdivo in combination with chemotherapy and Opdivo in combination with Yervoy for first-line esophageal squamous cell carcinoma indications | FDA.

Is Opdivo FDA approved for esophageal cancer? ›

The FDA has approved nivolumab (Opdivo) in combination with fluoropyrimidine- and platinum-containing chemotherapy and nivolumab plus ipilimumab (Yervoy) as a first-line treatment for adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC), irrespective of PD-L1 status.

Is Opdivo used for esophageal cancer? ›

OPDIVO® (nivolumab) is a prescription medicine used to treat adults with cancer of the tube that connects your throat to your stomach (esophageal cancer) if your esophageal cancer is a type called squamous cell carcinoma, and cannot be removed with surgery, and has come back or spread to other parts of the body after ...

What type of cancer is nivolumab used for? ›

Nivolumab is used alone or with other drugs to treat certain types of esophageal cancer, gastroesophageal junction cancer, stomach cancer, colorectal cancer, non-small cell lung cancer, renal cell carcinoma (a type of kidney cancer), melanoma, hepatocellular carcinoma (a type of liver cancer), squamous cell carcinoma ...

Can esophagus cancer go into remission? ›

ASCO recommends chemoradiotherapy before surgery for all people with locally advanced esophageal squamous cell cancer. In some patients, this treatment may send the cancer into remission, and surgery may not be needed immediately.

Who is the ideal patient for immunotherapy? ›

Who is a good candidate for immunotherapy? The best candidates are patients with non–small cell lung cancer, which is diagnosed about 80 to 85% of the time. This type of lung cancer usually occurs in former or current smokers, although it can be found in nonsmokers. It is also more common in women and younger patients.

Can Stage 4 esophageal cancer go into remission? ›

Currently available combination chemotherapy treatment for stage IV cancer results in complete remission in up to 20% of patients, with average survival of 8-12 months.

What is the new indication for nivolumab? ›

The FDA granted a new indication for nivolumab (Opdivo, Bristol Myers Squibb) for the treatment of patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy.

How long do you have nivolumab for? ›

You have nivolumab every 2 to 4 weeks, over 30 or 60 minutes depending on your cancer type.

What is the cost of nivolumab? ›

Opdivo (nivolumab) is a member of the anti-PD-1 monoclonal antibodies drug class and is commonly used for Colorectal Cancer, Esophageal Carcinoma, Head and Neck Cancer, and others.
Intravenous Solution.
QuantityPer unitPrice
24 milliliters$316.05$7,585.09
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How long is nivolumab effective? ›

Bristol Myers Squibb, the maker of nivolumab, sponsored the trial. In the ATTRACTION-4 trial, with a median follow-up period of 11.6 months, median progression-free survival was 10.5 months in the combination-therapy group versus 8.3 months in the chemotherapy-alone group.


1. Checkmate577: nivolumab in EC/GEJC
2. Management of Esophageal/GEJ Cancers: An Interdisciplinary Tumor Board on Adjuvant Immunotherapy
(PeerView Oncology)
3. New evolutions for the neo-adjuvant and adjuvant treatment of esophageal cancer
(HMP Education)
4. Immunotherapy Management of Early and Advanced Gastric, Esophageal, GEJ, and Colorectal Cancers
(PeerView Oncology)
5. Navigating Multidisciplinary Care With Immunotherapy in Esophageal/GEJ Cancer
(PeerView Oncology)
6. Checkmate 577 - Is Nivolumab adjuvant the standard of care in esophagus and GEJ?
(Vinay Prasad MD MPH)
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