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  3. New Treatment For Esophageal Cancer 2022 - FDA Approved
  • Cancer

New Treatment For Esophageal Cancer 2022 - FDA Approved

By Aranya Doloi| Last Updated at: 27th Mar '24| 16 Min Read

Esophageal cancer is a form of common gastrointestinal malignancy that originates in the esophagus. There are two most common types of esophageal cancer:

  • Adenocarcinoma
  • Squamous cell carcinoma 

Adenocarcinoma occurs closer to the stomach. On the other hand, squamous cell carcinoma occurs mainly in the upper part of the esophagus. 


Esophageal cancer is the 8th most commonly diagnosed form of cancer worldwide. As per reports, it is the 13th most common cancer among women and the 7th most common type of cancer in men. 2020 reported more than 6 lakh cases of esophageal cancer around the world. According to WHO, GLOBOCAN 2018, it is the 6th most common cancer in India, with an incidence rate of 5.04%. In India, it is the 6th common cancer in females and 5th in males.


However, the advancement of medical science has opened new avenues of treatment for esophageal cancer. In the past few years, we saw several techniques and drugs for esophageal cancer cures getting FDA approval. 2022 is no different. Revolutionary immunotherapy for esophageal cancer has created a buzz in oncology. Nivolumab, sold under the brand name Opdivo, Bristol-Myers Squibb Company, got FDA approval on May 27, 2022, as a first-line treatment

Read on to learn more about this new treatment for esophageal cancer


FDA Approves Nivolumab/Chemo and Nivolumab/Ipilimumab

FDA approved nivolumab (Opdivo, Bristol-Myers Squibb Company) plus chemotherapy and nivolumab plus ipilimumab (Yervoy, Bristol-Myers Squibb Company) as a treatment for patients with advanced or metastatic esophageal cancer. These new cancer cure therapies are especially beneficial for those who cannot undergo esophageal cancer surgery. 


 

The approval by the FDA was based on the phase 3 CheckMate 648 trial (NCT03143153). In the trial, researchers used nivolumab in combination with ipilimumab or chemotherapy for esophageal cancer. The results showed that patients given nivolumab had better overall survival (OS) than those who only received chemotherapy. 

To give you more clarity, we have mentioned how the study of this new esophageal cancer treatment worked.

More detail about CheckMate 648

Researchers performed CheckMate 648 with 970 randomized patients. All the patients had advanced or metastatic squamous cell carcinoma untreatable through esophagus surgery. There were three categories in the trial. 

  • The first was administered a combination of nivolumab and chemotherapy. 
  • The second group in the trial underwent immunotherapy only and took a combination of nivolumab-ipilimumab. 
  • The third group took only chemotherapy for esophageal cancer


Researchers presented their analysis at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. The trial results showed that the nivolumab-chemotherapy combination conferred longer overall survival (OS) vs. chemotherapy alone among all patients.

Key Findings of the New Treatment & Possible Benefits

  • The two immunotherapy-based combinations are the new hope for many with advanced esophageal cancer
  • It is the world's first treatment regimen without chemotherapy to benefit patients with previously untreated esophageal cancer. Even the combination of nivolumab and ipilimumab significantly prolonged OS against those who took only chemotherapy. 
  • The trial results also showed positive effects in patients with tumor cell PD-L1 expression of 1% or greater. PD-1 is a protein in T cells and plays a significant role in our bodies immune system. When PD-1 binds to another protein called PD-L1, it decreases the ability of T cells to kill cancer cells. Immunotherapy is beneficial in cases where cancer cells have a high amount of PDL1.
  • In the trial CheckMate 648, 48% of the patients in the chemotherapy group and 49% in the combination therapy groups had PD-L1 positive tumors. A follow-up of 13 months showed overall survival was better amongst patients in both combination groups whose tumors were PD-L1 positive. The combination groups also had a percentage of patients whose tumors shrank. 
Treatment GroupAll ParticipantsParticipants with PD-L1+ tumours
Nivolumab + Chemotherapy13.2 months15.4 months
Nivolumab + Ipilimumab12.8 months13.7 months
Chemotherapy alone10.7 months9.1 months


These new therapies can potentially improve the outlook for patients and families affected by esophageal cancer. Such innovation brings us closer to effective, lasting cures for esophageal cancer.

References:

https://www.wcrf.org/

https://journalrcr.org/

https://www.healio.com/

https://cancercommons.org/

https://www.cancerresearch.org/

https://www.mskcc.org/

https://www.cancerresearch.org/

https://news.bms.com/news/details/2022/U.S.-Food-and-Drug-Administration-Approves-Two-Opdivo-nivolumab-Based-Regimens-as-First-Line-Treatments-for-Unresectable-Advanced-or-Metastatic-Esophageal-Squamous-Cell-Carcinoma/default.aspx

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Question and Answers

. Heterogeneous Soft Tissue Nodule in the Right Lower Lobe (RLL) Size: 14 x 8 mm This nodule is described as heterogeneously enhancing, which suggests it may have varying levels of blood flow or different tissue densities within it. This could be indicative of a tumor. 2. Air Space Opacification in the Right Upper Lobe (RUL) Finding: There is patchy air space opacification with interlobular septal thickening in the posterior segment of RUL. This could represent infection, inflammation, or more concerningly, metastatic disease or lung cancer causing these changes. 3. Left-sided Pleural Effusion and Subsegmental Atelectasis Pleural Effusion: Mild left-sided pleural effusion is noted. Pleural effusion can occur in the context of metastatic disease or cancer. Atelectasis: This refers to partial lung collapse, which may occur when there is a mass obstructing the airflow or due to pleural fluid. 4. Enlarged Mediastinal and Hilar Lymph Nodes Lymphadenopathy: There are multiple enlarged and necrotic lymph nodes, most notably in the right hilar region, with the largest measuring 35 x 25 mm. Enlargement and necrosis of lymph nodes can be a sign of metastatic spread. The presence of enlarged lymph nodes in the mediastinum and hilum is typical of malignancy spreading beyond the primary lung site. 5. Liver Lesion Size: 14 x 13 mm lesion in the right hepatic lobe, which is well-defined and peripherally enhancing. A hypodense lesion could indicate a metastatic tumor, especially since it shows peripheral enhancement, a characteristic of some types of metastases. 6. Skeletal Lesions Multiple Lesions: There are mixed lytic and sclerotic bony lesions, some with soft tissue components. These lesions involve the vertebrae, ribs, glenoids, sternum, sacral ala, iliac bones, and femur. Soft Tissue Components: Some of the lesions, such as those in the ribs and iliac bones, have a soft tissue component, which suggests more advanced involvement, possibly indicating metastases. 7. Other Findings: No signs of emphysema, bronchiectasis, or pneumothorax were noted, which is reassuring as it reduces the likelihood of certain types of lung diseases. The liver, spleen, pancreas, kidneys, urinary bladder, and prostate all appear normal on imaging, which helps to rule out major issues in these organs. Impression: The findings of a heterogeneously enhancing solitary pulmonary nodule in the right lung, with associated hilar and mediastinal lymphadenopathy, along with a hepatic lesion and extensive skeletal involvement (with mixed lytic and sclerotic lesions), strongly raise concern for metastatic disease, most likely originating from the lung. The primary lung cancer is a potential consideration, though other primary sites are also possible. Next Steps: Histopathological correlation: This means a biopsy or tissue sample should be taken from one of the lesions (pulmonary, hepatic, or bone) to confirm whether the lesions are malignant and, if so, to identify the type of cancer. This will help determine the best course of treatment. The overall picture suggests a metastatic malignancy, likely of pulmonary origin, but further investigations and biopsy are essential to establish a definitive diagnosis and treatment plan.

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