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

FAQs

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.

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.

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).

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.

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).

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

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.

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.

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.

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%.

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%.

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.

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.

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.

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.

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.

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

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.

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).

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.

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

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%.

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.

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.

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.

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.

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

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

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.

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.

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.

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

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.

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.

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.

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

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

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.

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 ...

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 ...

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 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.

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.

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

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.