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Stage 4 Cancer

Stage 4, Stage IV metastatic cancer

“Metastases cancer” or stage 4 cancer, is the medical term for describing a condition where a tumor originating in a certain organ, “primary tumor”, is identified in another organ or in a distant location from the original organ, e.g., metastases of breast cancer can be found in the lungs, brain, bones and liver.

It is important to note, metastases are the same type of the original primary tumor, even if its location is in distant organs and so are the treatments regarded as such, for example, a treatment for a metastatic lung cancer that has spread to the liver, is determined by the treatment for metastatic lung cancer and not by the treatment for liver cancer.

Metastases formation

Cancer cells of the primary tumor can be released into the bloodstream and lymphatic system and circulate to distant organs or adjacent organs and tissues to the primary tumor and “settle” in them and grow.

There are different types of cancer which is known where metastases can be formed, for example,

  • Breast cancer can spread to the bones, brain, liver and lungs
  • Lung cancer can spread to the brain, bones, liver and kidney
  • Prostate cancer can spread to the bones
  • Colon cancer, rectal cancer, colorectal cancer can spread to the liver and lungs
Breast cancer can spread to the bones, brain, liver and lungs
Breast cancer can spread to the bones, brain, liver and lungs

Stage IV metastatic cancer and recovery

In the vast majority of the metastatic cases, the treatments do not cure. Treatment goals are slowing tumor growth rate, prolonging life and reducing the symptoms of the disease, improving the quality of life of the patient.

The efficacy of the treatments is affected by many factors, among them are the type of cancer, number of metastases (also called “lesions”) and their location, how much cancer the patient has in his or her body, growth rate of the tumor lesions, medical history of the patient, background diseases, microenvironment between the tumor cells themselves, resistance the tumor has developed to previous treatments and other.

Advanced treatments and clinical trials for stage 4

The National Cancer Institute (NCI) highlights the fact that for a certain group of metastatic cancer patients, the best treatment option is to join one of the many clinical trials existing worldwide aiming to increase their chances of therapeutic success.

This is also recommended by the USA national comprehensive cancer network, NCCN,  (USA national comprehensive cancer network)

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

Currently, every patient will be offered the standard protocols described above. Sometimes the oncologist may suggest integrating these therapies with trials carried out in the Institute.

Advances in cancer therapies may be found in clinical trials prescribing cutting edge, interesting drugs, some of which have already been recognized by the FDA (US Food & Drug Administration) as “breakthrough treatments” and require further information input before being finally and fully approved.

An entire world of clinical trials and compassionate drugs and treatments are open and available worldwide. It is important to know which cutting edge treatments exist which patients can gain far more from them than the standard care offered.

For most patients with stage 4 metastatic cancer, current treatments are insufficiently effective. This gives rise to the need for innovative strategies with greater efficacy in fighting the disease.

Read our publications on innovative treatments for stage 4 metastatic cancer:

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Breast Cancer – Benefits of Trodelvy in HR+/HER2-


The antibody-drug conjugate Trodelvy offers statistically and clinically significant benefits for patients with heavily pretreated HR+/HER2- breast cancer, according to results of the TROPiCS-02 study, recently presented.

HR+/HER2- is defined as hormone receptors positive – ER and PR positive – and HER2 status negative breast cancer.

Heavily pretreated patients are patients who have failed at least two prior chemotherapy regimens in this study.

Breast cancer is a leading cause of cancer death, and HR+/HER2- disease is the most common subset, representing approximately 70% of this disease. For metastatic, HR+ breast cancer, international guidelines recommend sequential endocrine therapy, starting with first-line endocrine drug, like Tamoxifen, Letrozole and others given in combination with CDK4/6 inhibitor drugs, like Verzenio, Ibrance and Kisqali.

When resistance to endocrine therapy develops, single-agent chemotherapy is recommended but is associated with declining efficacy and increased toxicity.

So, in later lines of treatment there are limited options to offer patients.

What is Trodelvy?

Trodelvy is directed to Trop-2. Trop-2 is a biological entity is overexpressed in many cancers, including breast cancer, and is associated with poor survival. About 80% of breast cancer tumors highly express Trop-2.

It is currently approved for use in metastatic Triple-Negative Breast Cancer patients who have received at least 2 prior therapies, with at least 1 given in the metastatic setting.

About the TROPiCS-02 Study in Breast Cancer

The goal of this phase III study was to determine whether Trodelvy can help fulfill the clinical need in HR+/HER2-, in which patients were randomized to receive Trodelvy or treatment of physician’s choice (Xeloda, Halaven, Navelbine, or Gemzar) until disease progression or unacceptable toxicity.

All patients had received 2 to 4 prior chemotherapy protocols.

Study Results

Trodelvy was associated with better median PFS (Progression Free Survival, which is the length of time until progression of the disease or unacceptable toxicity) vs physician’s choice: 5.5 versus 4.0 months.

The percentage of patients with no disease progression or unacceptable toxicity at 6-month was 46% versus 30% and at 12-month was 21% versus 7%, in favor of Trodelvy.

In the first of three planned OS analyses, the median Survival was 13.9 months with Trodelvy versus 12.3 months with physician’s choice therapy.

The percentage of patients who experienced decrease in the volume of their tumors was 21% versus 14% in favor of Trodelvy.

The percentage of patients who experienced decrease in the volume of their tumors plus stable disease (no change) was 34% versus 22% in favor of Trodelvy.

Overall, 74% in the Trodelvy arm versus 60% of patients in the physician’s choice arm experienced harsh side effects.

Unfortunately, there was 1 treatment-related death in the Trodelvy arm and none in the treatment of physician’s choice arm.

Key Messages for Breast Cancer patients

  • Trodelvy demonstrated PFS benefit over chemotherapy in
  • A higher proportion of patients were alive and progression-free
  • Trodelvy also demonstrated an overall health-related quality of life benefit over chemotherapy, with delayed deterioration in fatigue.


Trodelvy demonstrated significant and clinically meaningful benefit and should be considered a potential treatment option in this heavily pretreated population of HR+/HER2- breast cancer.

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Breast Cancer - Benefits of Trodelvy in HR+/HER2-
Breast Cancer – Benefits of Trodelvy in HR+/HER2-

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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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