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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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Not only for MSI-H! A combination of two approved drugs is in Phase III trial for MSS colorectal cancer

Background –

The combination of regorafenib (Stivarga) and nivolumab (Opdivo) will be compared with regorafenib alone in a phase III trial of patients with microsatellite stable (MSS) colorectal (CRC), cancer, following encouraging phase Ib findings of the REGONIVO study.

In this early-phase study of 50 evaluable patients, results of which were presented at the 2019 ASCO Annual Meeting. The combination led to an overall response rate (ORR) of 40% in patients with CRC or gastric cancer, the majority of which were MSS tumors. The disease control rate (DCR) was 88%.

Approval status –

Regorafenib is currently approved by the FDA as a second-line treatment for patients with advanced CRC who progressed on prior therapy.

The FDA approved nivolumab in August 2017 for the treatment of adult and pediatric patients with microsatellite instability-high or mismatch repair deficient metastatic CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

REGONIVO (EPOC1603) trial –

Fifty patients with advanced or metastatic gastric cancer (25 patients) or CRC (25 patients) were evaluated. The median number of prior therapies was 3.

98% of patients had MSS tumors and 41% of patients had PD-L1–positive disease.
When stratified by tumor type, patients with CRC had an ORR of 36%, including 33% in those with MSS disease.

The ORR was 44% in patients with gastric cancer, all of whom had MSS tumors.
The median time to disease progression under the treatment (PFS), for those with CRC and gastric cancer were 6.3 months and 5.8 months, respectively.

Safety –

Regarding safety, all-grade adverse events (AEs) occurred in 100% of patients. Severe AEs included hand-foot syndrome (10%), hypertension (4%), rash (12%), proteinuria (12%), liver dysfunction (6%), diarrhea (2%), and decrease in platelet count (2%).

Is this new trial attractive?

With such positive early results, it seems that the study is not attractive to patients who can get the drugs outside the study, through health insurances for example, making sure they will receive the combination rather than a single drug, regorafenib.

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