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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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Endometrial Cancer – Vistusertib Plus Arimidex in Patients With HR+

Importance

Endometrial cancer is often hormone-dependent and treated with aromatase inhibitors, (AIs).

The uncontrolled PI3K-AKT-mTOR pathway observed in this type of cancer drives hormonal resistance. Therefore, there is rationale of combining mTOR inhibitor with endocrine therapy.

This is what the investigators evaluated in the VICTORIA clinical trial.

This phase I/II clinical trial evaluated the efficacy and safety of Vistusertib, an mTOR inhibitor, combined with Arimidex in patients with hormone receptor–positive, HR+, recurrent or metastatic endometrial cancer.

After 8 weeks the percentage of women who had no progression almost doubled with Vistusertib plus Arimidex compared with Arimidex alone.

Vistusertib plus Arimidex demonstrated clinically meaningful benefit, with manageable side effects, in patients with recurrent or metastatic HR+ endometrial cancer.

Objective

To evaluate the safety and efficacy of Vistusertib in combination with Arimidex in the treatment of women with hormone receptor-positive (HR+) recurrent or metastatic endometrial cancer.

About the VICTORIA Study in Endometrial Cancer Patients

The VICTORIA study was a multicenter, randomized clinical trial that enrolled 75 patients with hormone receptor-positive recurrent or metastatic endometrial cancer.

Patients were recruited to the study from 12 cancer centers in France in April 2016 to October 2019.

Study Treatment

Patients were randomized to two arms: Oral Vistusertib (125 mg twice daily 2 days per week) and oral Arimidex (1 mg daily) in the combination Vistusertib with Arimidex arm (V+A arm) or oral Arimidex alone (A arm).

Results of the Study

Of the 75 patients, 73 were treated:

V+A arm: 49 patients

A arm: 24 patients

In the V+A arm, 67.3% of patients were did not progress after 8 weeks and in the A arm, 39.1% did not progress.

No significant serious side effects were reported.

The overall Response Rate was 24.5% in the V+A arm vs 17.4% in the A arm.

Median Progression Free Survival, PFS, was 5.2 months in the V+A arm and 1.9 months in the A arm.

Fatigue, lymphopenia, hyperglycemia, and diarrhea were the most common side effects associated with Vistusertib.

Conclusions for Endometrial Cancer Patients

This multicenter, phase 1/2 clinical trial demonstrated that adding Vistusertib to Arimidex improved treatment outcomes for patients with endometrial cancer.

Vistusertib plus Arimidex had manageable side effects.

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