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Stage 4 Cancer

Metastatic Cancer or Stage 4 Cancer, Stage IV

Metastatic cancer, or stage 4 cancer, is a medical term describing a condition where the tumor that started in a specific organ is detected in another organ or location distant from that source organ, also called the “primary tumor”. For example, breast cancer metastases can be diagnosed in the lungs, brain, bones, and liver.

It is important to note that a metastasis is the same tumor as the original tumor, even if it has settled in another organ, and the treatment is addressed accordingly. For example, treatment for lung cancer that has metastasized to the liver will be determined according to the treatment for metastatic lung cancer, not according to the treatment for liver cancer.

The Process of Metastasis Formation

Cancer cells from the original, primary tumor can be released into the bloodstream and lymphatic system, flow through them to distant organs or those adjacent to the primary tumor, “settle” there, and grow.

There are types of cancer for which it is known where metastases can form, for example:

  • Breast cancer can send metastases to the bones, brain, liver, and lungs.
  • Lung cancer can send metastases to the brain, bones, liver, and kidney.
  • Prostate cancer can send metastases to the bones.
  • Colon and rectal cancer can send metastases to the liver and lungs.
Breast cancer metastasis formation process

Chances of Recovery from Metastatic Cancer, Stage 4

In the vast majority of metastatic cases, treatments are not curative. The therapeutic goals are slowing the tumor growth rate, extending life, reducing disease symptoms, and improving the patient’s quality of life.

The efficacy of treatments is affected by multiple factors, including: cancer type, number and location of metastases, tumor burden in the patient’s body, growth rate of cancerous lesions, the patient’s treatment history, background diseases, the tumor microenvironment among the cancer cells themselves, resistance the cancer has developed to previous treatments, and more.

Innovative Personalized Treatments and Clinical Trials in Metastatic Stage 4 Cancer

For most cancer patients, existing treatments do not cure the cancer, hence the need for innovative and effective strategies to fight the disease.

The National Cancer Institute in the USA, the NCI, recommends that patients with advanced-stage cancer participate in one of the many clinical trials existing worldwide to increase therapeutic success chances. Joining this recommendation is the umbrella organization of leading US cancer centers, the NCCN, emphasizing that every patient should be encouraged to participate in clinical trials at every stage of the disease:

“Patients with cancer should be encouraged to participate in clinical trials during all aspects of their diagnosis and treatment”

Today, every patient will be treated with the standard protocols mentioned above, and sometimes the oncologist will offer to join trials open at their institute.

Advancement in cancer treatments lies in clinical trials, where the most advanced and interesting drugs are found, some of which have even earned FDA recognition as “Breakthrough Therapies,” with more data required from studies until final official approval.

A whole world of trials and compassionate use treatments is open and available globally, and it is important to know which treatments from the forefront of science exist worldwide that the patient can benefit from much more than any conventional treatment offered.

For most patients with malignant cancer, existing treatments do not cure the cancer, hence the need for innovative and effective strategies to fight the disease.

You are invited to read our publications about innovative and breakthrough treatments from around the world for metastatic stage 4 cancer >>


Common Questions about Stage 4 Cancer (Summary)

Q: What is the difference between metastatic cancer and primary cancer?

Metastatic cancer (Stage 4) is a condition where cells from the original tumor have migrated to other organs. Treatment is always determined by the origin of the primary tumor, not the organ where the metastasis was detected.

Q: Are there treatments beyond the standard protocol?

Yes. Beyond the standard protocol, there are clinical trials worldwide, compassionate use drugs, and advanced biological treatments (Off-label) that may suit the specific characteristics of the tumor.

Q: Why does the NCI recommend clinical trials?

Because that is where progress lies. Clinical trials allow access to breakthrough drugs that have not yet reached final approval and may be more effective than existing standard treatment.

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Lung Cancer – Another new drug for EGFR: Ameile

Background

Epidermal Growth Factor Receptor, EGFR, mutations are one of the most common driver mutations in Non–Small-Cell Lung Cancer, NSCLC.

Tagrisso, a third-generation EGFR tyrosine kinase inhibitor, TKI, is approved for first-line treatment of patients with advanced NSCLC and EGFR exon 19 deletion or L858R mutations.

In the pivotal FLAURA study, treatment with Tagrisso resulted in a 54% reduction in the risk of disease progression or death as compared with treatment with a first-generation EGFR TKI.

However, the toxicities of rash and diarrhea are strongly associated with inhibition of wild-type EGFR.

There is a need for additional third-generation EGFR inhibitors that both offer effective first-line treatment of EGFR-mutant NSCLC and are well-tolerated.

About the AENEAS Trial

This is a phase III trial of Ameile (Aumolertinib) vs Gefitinib as first-line therapy for locally advanced or Metastatic Non–Small-Cell Lung Cancer with EGFR Exon 19 Deletion or L858R Mutations

Purpose

Ameile is a novel third-generation Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor approved in China.

This double-blind phase III trial evaluated the efficacy and safety of Ameile compared with Iressa as a first-line treatment for locally advanced or metastatic EGFR-mutated non–small-cell lung cancer

Methods

Patients were randomly assigned to receive either Ameile (110 mg) or Iressa (250 mg) once daily.

The primary end point was Progression-Free Survival, PFS, per investigator assessment.

Results of the AENEAS Trial

A total of 429 patients who were naïve to treatment for locally advanced or metastatic NSCLC were enrolled.

PFS was significantly longer with Ameile compared with Iressa.

The median PFS with Ameile was 19.3 months versus 9.9 months with Iressa.

Objective Response Rate and Disease Control Rate, which the percentage of patients whose disease had stopped growing or decreased in size of tumor, were similar in the Ameile and Iressa groups.

The median Duration of Response was 18.1 months with Ameile versus 8.3 months with Iressa.

Adverse events of high 3 severity were observed in 36.4% and 35.8% of patients in the Ameile and Iressa groups, respectively.

Rash and diarrhea were observed in 23.4% and 16.4% of patients who received Ameile compared with 41.4% and 35.8% of those who received Iressa, respectively.

Conclusion

Ameile is a well-tolerated third-generation epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor that could serve as a treatment option for EGFR-mutant NSCLC in the first-line setting.

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Lung Cancer - Another new drug for EGFR: Ameile
Lung Cancer – Another new drug for EGFR: Ameile

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Improving therapeutic success, extending life and quality of life are our main business. We extend to metastatic cancer patients and patients with brain tumors, the most advanced treatment options in the world and the best experts in Israel and abroad.

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