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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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Cervical Cancer – Accelerated Approval to Tivdak

About the FDA decision in Cervical Cancer

The Food and Drug Administration, the FDA, has granted an accelerated approval to Tivdak (Tisotumab Vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer following disease progression on or after chemotherapy.

The decision from the FDA is supported by data from the single-arm phase 2 innovaTV 204 trial (NCT03438396) of Tivdak which resulted in a 24% confirmed overall response rate by independent review committee in previously treated, recurrent or metastatic cervical cancer.

Overall response rate, ORR, is the percentage of patients whose disease stopped growing plus those whose metastases shrunk between 30-50% in dimensions plus those who reached a complete remission of their disease.

What did the study demonstrate?

Results from the trial that were previously presented at the European Society for Medical Oncology, ESMO, 2020 Virtual Congress highlighted:

  • A 7% complete remission rate
  • A 17% partial response rate
  • A median duration of response was 8.3 months

The application for Tivdak in this indication was submitted in February 2021 to the FDA and granted priority review in April 2021.

Continuous approval may be contingent upon verification from additional clinical data. The phase 3 innovaTV 301 trial (NCT04697628) comparing Tivdak vs investigators choice of chemotherapy in patients with recurrent or metastatic cervical cancer is currently ongoing.

Regarding safety

Tivdak showed a manageable and tolerable safety profile, with no new safety signals identified.

The most common treatment-related side effects with a 10% or higher incidence rate included alopecia (38%), epistaxis (30%), nausea (27%), conjunctivitis (26%), fatigue (24%), dry eye (23%), myalgia (15%), anemia (12%), asthenia (12%), arthralgia (12%), decreased appetite (11%), keratitis (11%), and pruritis (10%).

Most of these were very tolerable, but severe cases occurred in 28% of patients. Of the 4 patients who died, 1 was due to septic shock that was treatment related.

Conclusions

Tivdak may now be used to treat patients with recurrent or metastatic cervical cancer after the FDA’s decision to grant the drug an accelerated approval.

Tivdak’s approval as a monotherapy in the U.S. is an important milestone for women with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, as they need a new treatment option

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About Cervical Cancer

Cervical Cancer - Accelerated Approval to Tivdak
Cervical Cancer – Accelerated Approval to Tivdak

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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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