Overall Survival Metastatic Breast Cancer

What Is A 5

A relative survival rate compares women with the same type and stage of breast cancer to women in the overall population.For example, if the 5-year relative survival rate for a specific stage of breast cancer is 90%, it means that women who have that cancer are, on average, about 90% as likely as women who dont have that cancer to live for at least 5 years after being diagnosed.

Description Of Study Cohort And Patient Characteristics

Between Jan 1st, 2005 and Dec 31st, 2016, a total of 3124 women were diagnosed with MBC in the StockholmGotland region, of whom 600 women were registered to have an OS of 90 days or less, thus being eligible for inclusion in the study cohort. After reviewing medical records, 102 women were excluded from the study cohort 64 due to discrepancy in registered OS, 15 due to other active synchronous cancers, 12 due to metastasis from another primary cancer, 10 due to ongoing treatment for local recurrence or having untreated primary BC, and one due to diagnosis prior to Jan 1st, 2005. As a result, 498 women were enrolled in the final study cohort. From the control cohort, 7 patients were excluded, leaving 2581 women in the final control cohort . Thus, almost one out of six women died within 90 days of MBC diagnosis.

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New Cdk4/6i Data At Asco Reinforce Novartis Kisqali As Only Drug In Class With Consistently Proven Overall Survival Benefit In Hr+/her2

• Kisqali is the only CDK4/6 inhibitor with consistent overall survival benefit seen across all three Phase III trials, with the longest median OS benefit ever reported for HR+/HER2- mBC1-10

• OS benefit from Kisqali in combination with letrozole was maintained in 1L treatment of postmenopausal women with HR+/HER2- mBC, following Kisqali dose reduction when recommended11

• A matching-adjusted indirect comparison analysis shows Kisqali plus an aromatase inhibitor is associated with better symptom-related quality of life when compared to Verzenio®* plus AI when used in 1L12

Basel, June 3, 2022 Novartis today announced new overall survival and quality of life analyses which evaluated Kisqali® plus endocrine therapy for patients with hormone receptor-positive/human epidermal growth factor receptor-negative advanced or metastatic breast cancer. These data will be presented at the 2022 American Society of Clinical Oncology Annual Meeting.

Kisqali is the only CDK4/6 inhibitor to have consistently demonstrated statistically significant overall survival across its entire Phase III program, said Reshema Kemps-Polanco, Executive Vice President, US Oncology at Novartis. Overall survival is the ultimate goal of oncology clinical trials and what patients hope forto live longer, and to thrive. We are extremely proud of our quality of life data and that Kisqali has the longest median overall survival ever reported in HR+/HER2- metastatic breast cancer.

References

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Survival Rates For Stage Iv Breast Cancer

Stage of breast cancer at diagnosis is one of the most important prognostic factors. Above is a bar chart from the National Cancer Institute statistics for 2012. As we can see, the 5-year survival rate for women diagnosed with Stage IV breast cancer was 22%.

Remember, these figures are still quite dated as it takes 5 years to determine survival rates and treatment is improving all the time.

A recent study found that 37% of women survived for three years after a Stage IV breast cancer diagnosis, although some women do survive longer.

However, although the 5-year survival rates are much higher for earlier stages of breast cancer at diagnosis, there is no predicting which cases will progress to metastatic breast cancer in the future.

Although it is important to be realistic regarding the survival of metastatic breast cancer, each individual situation is unique and ultimately, statistics are meaningless.

There is a small subcategory of people with Stage IV breast cancer who beat the odds and live for years. However, it is difficult to predict who will fall into this group.

All that is known is that people in this group have secondary spread to the bones. Furthermore, cancer is often estrogen positive and responds to hormone treatments.

New Kisqali Data Shows Consistent Overall Survival Benefit Across Genomic And Clinical Subtypes Of Interest In Hr+/her2

• Data from the MONALEESA Phase III program provide further evidence of the unique profile of Kisqali, the CDK4/6 inhibitor with the longest reported median overall survival in HR+/HER2- metastatic breast cancer and proven OS benefit across patient subgroups
• Kisqali pooled data at the San Antonio Breast Cancer Symposium confirms OS benefit across most common genomic intrinsic subtypes of HR+/HER2- metastatic breast cancer, including the aggressive, ET-resistant HER2-enriched subtype
• Data supports rationale for HARMONIA, the first prospective, head-to-head Phase III trial seeking to identify the best therapeutic option between Kisqali and Ibrance®* for patients with the HER2-enriched subtype
• Kisqali remains the only CDK4/6i with consistent OS benefit across the entire MONALEESA program, regardless of site and number of metastases, prior treatment, endocrine partner, line of therapy or menopausal status

EAST HANOVER, N.J., Dec. 8, 2021 — Novartis today announced new Kisqali® data demonstrating a consistent overall survival benefit with Kisqali plus endocrine therapy across genomic subtypes of hormone receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer , similarly in the indolent as well as in the aggressive, endocrine therapy -resistant subtypes6. The findings will be presented as a late-breaking oral presentation at the 2021 San Antonio Breast Cancer Symposium .

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When Can Metastatic Breast Cancer Occur

Most often, metastatic breast cancer arises months or years after a person has completed treatment for early or locally advanced breast cancer. This is sometimes called a distant recurrence.

Some people have metastatic breast cancer when they are first diagnosed . This is called de novo metastatic breast cancer.

Komen Perspectives

Objective Response To First

Out of the 950 patients that received at least one line of treatment, 70 had a radiologically complete response and 343 patients had a PR for an ORR to first-line treatment of 43.5% . In contrast, 273 patients had SD as best response and 192 patients had disease progression at first assessment. The remaining patients had either no evidence of disease or no evaluable information . An objective response was achieved by 51.0% of patients treated with first-line chemotherapy compared to 32.2% of those treated with first-line endocrine therapy . However, rates of PD as best response on first-line treatment were similar between the two groups .

Responders at first line had improved PFS at first line compared to nonresponders but not at second line . At the time of data cutoff, 192 patients with an objective response at first line and 255 patients with SD or PD had died. Median OS was significantly longer for patients that had an objective response the corresponding median OS was 61.9 months for responders versus 41.3 months for nonresponders . In multivariable analysis, failure to achieve an objective response to first-line treatment was an independent predictor of poor survival outcome, when adjusted for ER status, HER2 status, age, site of metastasis, type of first-line therapy, and disease-free interval .

Table 3.

Multivariable Cox regression analysis for overall survival in the 651 patients with available data

Fig. 2.

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Breast Cancer Subtypes Hormonal And Her2 Status And Survival Rates

Many research studies over the years have shown that Estrogen-positive breast cancers have better survival rates than all of the Estrogen-negative subtypes.

Progesterone-positive breast cancer also appears to have improved survival rates in comparison to progesterone-negative cases.

A recent research study combines hormone receptivity, HER2 status and stage and found some interesting results:-

For ER+ sub-types survival rates were significantly better than all other subtypes. For example, at stage 1b,

ER+ PR+ HER2- 5-year survival rates were 98.6%ER+ PR- HER2+ 5-year survival rates were 97.3%

The subtype triple negative breast cancer had the worst survival rates over all three stages. At stage I the 5-year survival rate was 92.9% and at stage III 48.9%.

Are New Treatments For Metastatic Cancer Being Developed

Yes. Researchers are now studying new ways to kill or stop the growth of primary cancer cells and metastatic cancer cells. One new area of research includes ways to boost the strength of the immune response against tumors.

Regulatory T-cells and RANKL proteins may play a role in breast cancer metastasisRecent breast cancer research suggests that the bodys regulatory T cells, which are an integral part of the immune response system, may play a key role in metastasis.

It is speculated that the T cells produce a protein which seems to accelerate the spread of breast cancer cells to other areas of the body. The inflammatory protein RANKL seems to influence the T-cells ability to spread cancer cells to distant areas of the body.

It is believed that by interfering with RANKLs ability to interact with the T-cells, the early metastasis of breast cancer cells can be significantly inhibited

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Recurrent Breast Cancer: Facts And Figures

Breast cancer can return at any point after the initial diagnosis and treatment. This is one of the most anxiety-provoking factors for many women after breast cancer diagnosis and treatment.

There are 3 types of cancer recurrence:-

It is very difficult to predict how many breast cancers of all stages recur, at local, regional and distant sites.

Indeed, breast cancer incidence and mortality rates are documented over the years. However, data on most cancer registries do not document the incidence of recurrence.

Furthermore, a local or regional recurrence does not have the same prognostic impact as distant metastasis. Even more difficult to handle, is that cancer can recur at any given point in time.

Disease Free Intervals And Prognosis In Metastasis

The time that passes between the primary diagnosis and treatment of breast cancer and a diagnosis of metastasis is also of prognostic significance.

A 2015 medical study from the Netherlands looked at 815 patients with metastatic breast cancer between 2007 and 2009 in eight hospitals.

Of these 815 patients, 154 had metastatic spread at diagnosis. 176 patients had a metastatic free interval of less than 2 years and 485 patients had been metastasis-free for longer than 2 years.

The ladies presenting with metastatic breast cancer at diagnosis had a longer survival rate than those who experienced a recurrence at distant sites in under 2 years from the initial diagnosis of breast cancer.

However, there were no differences in survival rates between those diagnosed at Stage IV and those women who had metastatic spread over 2 years after an original breast cancer diagnosis and treatment.

Furthermore, some medical studies show that survival rates vary for different types and subtypes of breast tumors according to the time intervals of recurrence. So, for example, breast cancer survival rates comparing two cancers may be better at a 5-year interval for some cancers but even out over 15 years.

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Breast Cancer Metastasis: Secondary Sites

Over the years there have been significant improvements and advancements in the diagnosis and treatment of breast cancer. Indeed, breast cancer is now considered to be a manageable disease.

However, there are still over half a million deaths worldwide from breast cancer and over 90% of these women die of metastasis. Consequently, research into metastasis is of vital importance in overcoming deaths from metastatic breast cancers.

Stage IV or metastatic breast cancer, as mentioned earlier, are cancer cells that have spread from the breast to distant sites around the body. Common secondary sites are:-

• Bone: .
• Lungs
• Liver

Can Stage 4 Breast Cancer Go Into Remission

Stage 4 breast cancer can go into remission, meaning that it isnt detected in imaging or other tests. Pathological complete remission indicates a lack of cancer cells in tissues removed after surgery or biopsy.

But its rare to take tissue samples while treating stage 4 breast cancer. This could mean that although treatment has been effective, it hasnt completely destroyed the cancer.

Advances in stage 4 breast cancer treatments are helping to increase the length of remission.

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Understanding Breast Cancer Metastasis

Metastasis is a complex process in which malignantcancer cells from the breast spread into other regions of the body. Once metastasis has occurred, it is much more difficult to effectively treat breast cancer.

If breast cancer has metastasized to other areas of the body, it is termed a Stage IV breast cancer. Sometimes metastasis has occurred at the time the original breast cancer is diagnosed.

However, in other cases, the metastasis of breast cancer is found months or even years after the initial treatment. This would be termed a recurrent breast cancer.

What Are The Symptoms Of Metastatic Cancer

The symptoms produced by metastatic breast cancer vary depending on the location of the metastases.

For example, metastatic disease to the bone causes severe, progressive pain, and less commonly, pathological fracture, erythema over the affected bone and swelling.

Breast cancer cells that have spread to the brain cause persistent, progressively worsening headache, visual changes, seizures, nausea, vomiting, vertigo, behavioral and personality changes and increased intracranial pressure.

Metastatic disease to the liver causes jaundice, elevated liver enzymes, abdominal pain, loss of appetite, nausea, and vomiting.

Metastatic breast cancer to the lung or pleura causes chronic cough, dyspnea, abnormal chest x-ray, and chest pain.

In addition, general, non-specific systemic symptoms of metastatic breast cancer include fatigue, malaise, weight loss and poor appetite.

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Stem Cell Transplant Improves Progression

Who does this study affect? People who have been recently diagnosed with multiple myeloma.

What did this study find? The phase III DETERMINATION clinical trial found that including an autologous bone marrow/stem cell transplant early in the treatment plan for younger people with newly diagnosed multiple myeloma significantly improved progression-free survival. Progression-free survival is the amount of time during and after treatment that the cancer does not grow or spread further.

Multiple myeloma is a blood cancer that affects the plasma cells in the bone marrow. Bone marrow is the spongy tissue inside bones that creates different types of blood cells, including plasma cells. Plasma cells produce antibodies to help the body fight infection and they are an important part of the immune system. Multiple myeloma is most commonly diagnosed in people older than 60 and the median age at diagnosis is 70 years old.

The 722 participants in this study had newly diagnosed multiple myeloma and ranged in age from 18 to 65 years. They were randomly divided into 2 treatment arms, or groups.

What does this mean for patients? For younger people with multiple myeloma, initial treatment with an autologous stem cell transplant led to a median 21.4-month improvement in progression-free survival when compared with treatment without a stem cell transplant.

• Read a press release about this abstract on ASCO.org.

lead study author Paul G. Richardson, MD Dana-Farber Cancer Institute

Characteristics Of Patients Who Underwent Primary Tumor Surgery

Thirty-five patients were taken to primary tumor surgery 24 of them presented CB with initial systemic treatment 19 had partial or complete response. Of the 24 patients with CB, 21 had mono-metastatic or oligometastatic disease . The univariate analysis did not show that primary tumor surgery offered additional survival gain in those patients who presented CB with first-line systemic treatment : HR 0.32 . Regarding tumor biology, no significant association was found between the biological classification of BC and primary tumor surgery .

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Study Population And Determination Of Line Of Therapy

Patients who met the following inclusion criteria were included in the analysis:

• breast cancer diagnosis as defined by an ICD-9 or ICD-10 code

• confirmed stage 4 disease or recurrent/metastatic disease

• lung or liver site of metastases as confirmed by radiographic records

• treated with eribulin, gemcitabine, or capecitabine as third-line therapy

Analysis Of Survival Benefits From Surgery

It has been recommended by the NCCN guideline that the primary treatment approach for women with metastatic breast cancer is systemic therapy rather than surgical treatment. In order to evaluate the survival benefits of local breast surgery in patients with metastatic breast cancer, the Kaplan-Meier plot was performed to compare the OS and BCSS between patients who had, or had not undergone local breast surgical treatment. The median follow-up duration in the training set was 30 months . Of all the 5173 patients with metastatic breast cancer, a total of 1947 patients were dead at the time of last follow-up and 1643 of which were dead directly from breast cancer. As shown in Figure 2, patients who had undergone surgical treatment had prominently better OS and BCSS than patients who had not .

Figure 2. Overall survival and breast cancer specific survival curves plotted by Kaplan-Meier method for patients received surgical treatment or not.

Table 2. Subgroup analysis of OS and BCSS outcomes.

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Patients With Short Survival Are Usually Nontreated But Do Not Have More Biologically Aggressive Tumors

Sixty-six patients with an OS of 3 months or shorter were identified in the cohort. Compared to the rest of the cohort, these patients were older and more commonly did not receive any treatment for metastatic disease . However, receptor status , de novo metastatic disease , prior adjuvant chemotherapy and endocrine therapy , as well as the number of organs involved , did not significantly differ between the two patient groups.

Mechanisms Of Breast Cancer Metastasis

No one really knows what factors will make a certain patient more or less susceptible to breast cancer metastasis.

There is growing awareness that part of that susceptibility is due to host factors. The host factors are the characteristics of the non-malignant cells and the general biological environment surrounding the malignant breast tumor.

Sometimes the host factors are referred to as the pre-metastatic niche and it is thought that bone-marrow-derived progenitor cells may directly influence the dissemination of malignant cells to distant areas.

Non-neoplastichost cells within the tumor may also play a key role in the regulation of breast cancer metastasis.

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