Dec 10

Afatinib (BIBW 2992*) Triples Progression Free Survival in Lung Cancer Patients


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Boehringer Ingelheim announced promising results from two clinical trials of its investigational cancer compound afatinib (BIBW 2992) presented at the 35th European Society for Medical Oncology (ESMO) Congress in Milan, Italy. Results from the LUX-Lung 1 trial suggest that afatinib (BIBW 2992) is highly active in late-stage patients with NSCLC1, while in the LUX-Lung 2 phase II trial afatinib demonstrated encouraging activity in advanced NSCLC patients that have a mutated EGF Receptor.

Afatinib, which is taken as a tablet, is a next generation inhibitor of the epidermal growth factor receptor (EGFR) and human epidermal receptor 2 (HER2) tyrosine kinase (TK) and unlike first generation TKIs irreversibly binds to EGFR/HER2. The compound is under development in several solid tumour types.

The LUX-Lung 1 trial (phase II b/III) compared afatinib to placebo in over 580 patients with advanced NSCLC whose disease has progressed after receiving chemotherapy and a first-generation EGFR Tyrosine Kinase Inhibitor (gefitinib or erlotinib)  results showed1:

* Even though the LUX-Lung 1 trial did not meet the primary endpoint of prolonging overall survival (OS), afatinib significantly extended the time before the tumour progressed; specifically it led to a three-fold extension of progression-free survival (PFS, key secondary endpoint) from 1.1 months to 3.3 months over placebo.
* The PFS benefit was apparent as a robust effect across all patient subgroups and has been confirmed by independent review.
* There was a significantly higher rate of tumour control or shrinkage in those patients who took afatinib (disease control rate: 58%) versus those taking placebo (disease control rate: 19%); also independently verified.
* Afatinib significantly improved the lung-cancer related symptoms cough, dyspnea (shortness of breath) and pain, and delayed the time to deterioration of cough, individual dyspnea items and chest pain significantly.
* There were no new or unexpected safety findings; the main side effects were diarrhea and rash.

The results of LUX-Lung 1 in a special patient population whose cancers probably have a high incidence of EGFR mutations have substantially contributed to better understanding of the biology of these tumours.

Conclusions from the trial will be relevant for the design of further clinical studies, which will evaluate further patient populations and their mutation status.

Lung cancer is the most common and most deadly form of cancer in the world, accounting for 1.6 million new cancer cases annually and 1.4 million deaths2 from lung cancer. Lung cancer remains an area of high unmet need, especially in its advanced stages where it is particularly aggressive and patients have limited treatment options. No approved therapy is currently available for patients with advanced lung cancer who have failed chemotherapy and progressed after treatments with EGFR TKI.

In clinical practice, it is of high relevance to patients to have improvement in key lung cancer related symptoms such as cough, shortness of breath and pain? commented Dr Vera Hirsh, investigator of the trial, and Chair of the Lung Cancer Committee, McGill University, Canada. Furthermore, the time to deterioration, meaning the time before the symptoms get worse, was significantly extended for some of these symptoms in the LUX Lung 1 study.

This is the first time that a compound has demonstrated in a controlled study, a clinically meaningful improvement in PFS in patients with NSCLC who have progressed on first generation EGFR TKIs.

Encouraging results were also presented for LUX-Lung 2, a phase II trial studying patients with advanced NSCLC who harbour EGFR mutations. This result shows that the use of afatinib led to a high rate of tumour size reduction (overall response rate of 61%) and a long delay in the progression of cancer by over 1 year (PFS of 14 months)3. These results help to underline afatinib?s potential benefit as a first or second line treatment in patients with EGFR mutations. Two phase III trials, LUX-Lung 3 and LUX-Lung 6 are currently underway to further evaluate afatinib as a first-line treatment in this patient group.

Afatinibs clinical trial programme: LUX Trial Programme

The LUX-trial programme is a comprehensive and robust programme that comprises more than ten trials conducted across the globe, investigating afatinib in a variety of different solid tumour types, including NSCLC, breast and head and neck cancer.

LUX-Lung 1 is a phase III trial investigating afatinib plus best supportive care (BSC) versus placebo plus BSC in NSCLC patients who were previously treated with chemotherapy and first generation EGFR-TKIs, erlotinib or gefitinib.

LUX-Lung 2 is a phase II trial evaluating afatinib in NSCLC patients with EGFR mutations, either chemotherapy naïve or after one line of chemotherapy.

In two further ongoing global phase III trials, LUX-Lung 3 and LUX-Lung 6, the efficacy and safety profile of afatinib is compared to standard chemotherapy for first-line treatment of NSCLC patients with EGFR mutations in different geographical regions.

Another trial, LUX-Lung 5, is a global phase III trial in patients previously treated with erlotinib or gefitinib. This is the first randomised phase III trial investigating whether patients who initially benefit from treatment with afatinib alone may further benefit from afatinib beyond progression when given in combination with chemotherapy.

Further indications

Additionally, Boehringer Ingelheim has recently commenced a phase III clinical trial evaluating afatinib in advanced breast cancer (LUX-Breast 1).

Afatinib is also being investigated in head and neck cancer, glioblastoma and colorectal cancer.

Afatinib & BIBF 1120*: the two front-runner molecules within Boehringer Ingelheim?s investigational oncology portfolio

Apart from afatinib, Boehringer Ingelheim?s late stage oncology portfolio includes BIBF 1120, also in phase III development for the treatment of patients in two different indications, advanced NSCLC and ovarian cancer.

BIBF 1120 is a triple angiokinase inhibitor that acts on three growth factors simultaneously: vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor (PDGFR) and fibroblast growth factor receptor (FGFR) all crucially involved in the formation of blood vessels, which supply tumours with nutrients and oxygen needed for the cancer to grow.

About lung cancer

Lung cancer is the world’s most common cancer and kills more people than any other cancer.In 2008, approximately 1.6 million new cases of lung cancer were diagnosed worldwide, with 1.4 million people dying from the disease.2

About breast cancer

There are more than one and a half million cases of breast cancer diagnosed each year4. It is the leading cause of cancer deaths in women worldwide, resulting in more than 500,000 deaths per year. Breast cancer accounts for around a third of all cancers diagnosed in women, making it the most commonly diagnosed tumour type in females5.

About head and neck cancer

Head and neck cancer can occur in over 30 different places in any of the tissues or organs in the head and neck6 and is the sixth most frequently occurring cancer worldwide7. Most head and neck cancers are squamous cell carcinomas8 over 90% of which express EGFR9 which is critical for tumour growth.10

About ovarian cancer

Each year approximately 204,000 new cases of ovarian cancer are diagnosed in women worldwide, with an estimated 125,000 dying of the disease each year11. One of the greatest challenges in the management of ovarian cancer is that the majority of cases are not found at an early stage11 (when definitive cure is possible by surgery) since the tumour usually causes only non-specific symptoms, commonly attributed to non-serious causes.

Boehringer Ingelheim announced promising results from two clinical trials of its investigational cancer compound

afatinib (BIBW 2992) presented at the 35th European Society for Medical Oncology (ESMO) Congress in Milan, Italy.

Results from the LUX-Lung 1 trial suggest that afatinib (BIBW 2992) is highly active in late-stage patients with

NSCLC1, while in the LUX-Lung 2 phase II trial afatinib demonstrated encouraging activity in advanced NSCLC patients

that have a mutated EGF Receptor.

Afatinib, which is taken as a tablet, is a next generation inhibitor of the epidermal growth factor receptor (EGFR)

and human epidermal receptor 2 (HER2) tyrosine kinase (TK) and unlike first generation TKIs irreversibly binds to

EGFR/HER2. The compound is under development in several solid tumour types.

The LUX-Lung 1 trial (phase II b/III) compared afatinib to placebo in over 580 patients with advanced NSCLC whose

disease has progressed after receiving chemotherapy and a first-generation EGFR Tyrosine Kinase Inhibitor (gefitinib

or erlotinib)  results showed1:

* Even though the LUX-Lung 1 trial did not meet the primary endpoint of prolonging overall survival (OS),

afatinib significantly extended the time before the tumour progressed; specifically it led to a three-fold extension

of progression-free survival (PFS, key secondary endpoint) from 1.1 months to 3.3 months over placebo.
* The PFS benefit was apparent as a robust effect across all patient subgroups and has been confirmed by

independent review.
* There was a significantly higher rate of tumour control or shrinkage in those patients who took afatinib

(disease control rate: 58%) versus those taking placebo (disease control rate: 19%); also independently verified.
* Afatinib significantly improved the lung-cancer related symptoms cough, dyspnea (shortness of breath) and pain,

and delayed the time to deterioration of cough, individual dyspnea items and chest pain significantly.
* There were no new or unexpected safety findings; the main side effects were diarrhea and rash.

The results of LUX-Lung 1 in a special patient population whose cancers probably have a high incidence of EGFR

mutations have substantially contributed to better understanding of the biology of these tumours. Conclusions from

the trial will be relevant for the design of further clinical studies, which will evaluate further patient

populations and their mutation status.

Lung cancer is the most common and most deadly form of cancer in the world, accounting for 1.6 million new cancer

cases annually and 1.4 million deaths2 from lung cancer. Lung cancer remains an area of high unmet need, especially

in its advanced stages where it is particularly aggressive and patients have limited treatment options. No approved

therapy is currently available for patients with advanced lung cancer who have failed chemotherapy and progressed

after treatments with EGFR TKI.

In clinical practice, it is of high relevance to patients to have improvement in key lung cancer related symptoms

such as cough, shortness of breath and pain? commented Dr Vera Hirsh, investigator of the trial, and Chair of the

Lung Cancer Committee, McGill University, Canada. Furthermore, the time to deterioration, meaning the time before the

symptoms get worse, was significantly extended for some of these symptoms in the LUX Lung 1 study.

This is the first time that a compound has demonstrated in a controlled study, a clinically meaningful improvement in

PFS in patients with NSCLC who have progressed on first generation EGFR TKIs.

Encouraging results were also presented for LUX-Lung 2, a phase II trial studying patients with advanced NSCLC who

harbour EGFR mutations. This result shows that the use of afatinib led to a high rate of tumour size reduction

(overall response rate of 61%) and a long delay in the progression of cancer by over 1 year (PFS of 14 months)3.

These results help to underline afatinib?s potential benefit as a first or second line treatment in patients with

EGFR mutations. Two phase III trials, LUX-Lung 3 and LUX-Lung 6 are currently underway to further evaluate afatinib

as a first-line treatment in this patient group.

Afatinibs clinical trial programme: LUX Trial Programme

The LUX-trial programme is a comprehensive and robust programme that comprises more than ten trials conducted across

the globe, investigating afatinib in a variety of different solid tumour types, including NSCLC, breast and head and

neck cancer.

LUX-Lung 1 is a phase III trial investigating afatinib plus best supportive care (BSC) versus placebo plus BSC in

NSCLC patients who were previously treated with chemotherapy and first generation EGFR-TKIs, erlotinib or gefitinib.

LUX-Lung 2 is a phase II trial evaluating afatinib in NSCLC patients with EGFR mutations, either chemotherapy naïve

or after one line of chemotherapy.

In two further ongoing global phase III trials, LUX-Lung 3 and LUX-Lung 6, the efficacy and safety profile of

afatinib is compared to standard chemotherapy for first-line treatment of NSCLC patients with EGFR mutations in

different geographical regions.

Another trial, LUX-Lung 5, is a global phase III trial in patients previously treated with erlotinib or gefitinib.

This is the first randomised phase III trial investigating whether patients who initially benefit from treatment with

afatinib alone may further benefit from afatinib beyond progression when given in combination with chemotherapy.

Further indications

Additionally, Boehringer Ingelheim has recently commenced a phase III clinical trial evaluating afatinib in advanced

breast cancer (LUX-Breast 1).

Afatinib is also being investigated in head and neck cancer, glioblastoma and colorectal cancer.

Afatinib & BIBF 1120*: the two front-runner molecules within Boehringer Ingelheim?s investigational oncology

portfolio

Apart from afatinib, Boehringer Ingelheim?s late stage oncology portfolio includes BIBF 1120, also in phase III

development for the treatment of patients in two different indications, advanced NSCLC and ovarian cancer.

BIBF 1120 is a triple angiokinase inhibitor that acts on three growth factors simultaneously: vascular endothelial

growth factor receptor (VEGFR), platelet-derived growth factor receptor (PDGFR) and fibroblast growth factor receptor

(FGFR) all crucially involved in the formation of blood vessels, which supply tumours with nutrients and oxygen

needed for the cancer to grow.

About lung cancer

Lung cancer is the world’s most common cancer and kills more people than any other cancer.In 2008, approximately 1.6

million new cases of lung cancer were diagnosed worldwide, with 1.4 million people dying from the disease.2

About breast cancer

There are more than one and a half million cases of breast cancer diagnosed each year4. It is the leading cause of

cancer deaths in women worldwide, resulting in more than 500,000 deaths per year. Breast cancer accounts for around a

third of all cancers diagnosed in women, making it the most commonly diagnosed tumour type in females5.

About head and neck cancer

Head and neck cancer can occur in over 30 different places in any of the tissues or organs in the head and neck6 and

is the sixth most frequently occurring cancer worldwide7. Most head and neck cancers are squamous cell carcinomas8

over 90% of which express EGFR9 which is critical for tumour growth.10

About ovarian cancer

Each year approximately 204,000 new cases of ovarian cancer are diagnosed in women worldwide, with an estimated

125,000 dying of the disease each year11. One of the greatest challenges in the management of ovarian cancer is that

the majority of cases are not found at an early stage11 (when definitive cure is possible by surgery) since the

tumour usually causes only non-specific symptoms, commonly attributed to non-serious causes.

Read Related Topics on Breast Cancer and Cancer Care News .

More Lung Cancer Articles

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Dec 07

Be More Attractive Now : How To Look Good – Feel Great


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A few Lung Cancer products I can recommend:

Be More Attractive Now : How To Look Good – Feel Great
Discover The Essential Process To Looking More Attractive, Younger, And More Seductive. Get Noticed More At Work – And Promoted Faster. Learn To Master Charisma, Body Language And Social Finese And Get That Job. Learn To Dress To Flatter Your Shape.
Be More Attractive Now : How To Look Good – Feel Great

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Dec 05

The Diagnosis of Lung Cancer


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Article by Elizabeth L Perkins

Many patients find that they have lung cancer either because they present symptoms such as persistent coughing and wheezing, sometimes coughing up blood or pain the chest and stomach. This usually prompts further investigation of the chest, typically calling for an x-ray (which may also occur as part of a routine health check) and the testing of sputum samples.

At this point more investigations will be called for dependent upon the results.

Detailed Diagnosis

The purpose of a chest radiograph or x-ray, is to detect enlarged lymph nodes in the chest or the existence of a mass in the lungs. More advanced techniques can be used to provide much more detailed information and include the following:

CAT Scan or CT Scan – a CT Scan is a computer assisted examination which provides a cross-sectional image of the body under examination;

MRI Scan – a Magnetic Resonance Imaging (MRI) scan uses hydrogen ions within the patient’s body which respond to magnetic fields when they are applied to the body or in this case, the chest. A computer then uses the results to create a chest image which allows for precise location of any mass which has been detected and whether it involves the lungs;

Bronchoscopy – this involves an examination of the airways (the windpipe and lung branches) and is usually conducted by a pulmonologist ( a physician who specializes in respiratory diseases). The examination may involve the taking of a swab from these areas or a biopsy (the removal of a tissue sample);

Needle Biopsy – a physician inserts a needle using the results of a CT Scan to guide where the needle, so a sample of tissue may be removed from the mass which has been detected; the tissue samples obtained are then “smeared” on a microscope slide and examined by a histopathologist to detect whether the cells are cancerous; and

Bone Scan – this test may be undertaken to check whether any cancer cells have spread (known as “metastasized”) to the bones from the original tumor.

A technological advancement is the CT/PET fusion imaging scan – this diagnostic tool uses an injected sugar solution which contains a radioactive element to highlight any cancerous mass. Cancer tumors are very fast growing and use a lot of energy so they rapidly absorb the sugar solution which is accumulates around and within the tumor. When a scan is then performed, the concentration of the radioactive sugar is detected and provides the location and detail of the cancer tumor. It should be borne in mind that there are other tissues which will cause the sugar solution to accumulate such as a bacterial infection, so even this test is not conclusive.

Once lung cancer has been diagnosed, the team of oncology physicians treating the patient will review the results to assess the treatment options for the lung cancer and to check whether any spread of the disease has occurred to other parts of the body. Where it is found the disease has not spread to other parts of the body, then a surgical inspection may take place to assess the disease in detail around the lungs, heart, windpipe and tissues of the chest. In addition, extensive blood tests will take place to look for cancer “markers” which are usually proteins that are associated with the development of lung cancer.

Find the rightlung cancer surgeon or mitral valve repair specialist. Early diagnosis can lead to successful results.










Courtesy of www.healthstand.net – Patients talk about diagnosis and living with Lung Cancer. Lung cancer is a disease of uncontrolled cell growth in tissues of the lung. This growth may lead to metastasis, which is the invasion of adjacent tissue and infiltration beyond the lungs. The vast majority of primary lung cancers are carcinomas of the lung, derived from epithelial cells. Lung cancer, the most common cause of cancer-related death in men and women, is responsible for 1.3 million deaths worldwide annually, as of 2004. The most common symptoms are shortness of breath, coughing (including coughing up blood), and weight loss. The main types of lung cancer are small cell lung carcinoma and non-small cell lung carcinoma. This distinction is important, because the treatment varies; non-small cell lung carcinoma (NSCLC) is sometimes treated with surgery, while small cell lung carcinoma (SCLC) usually responds better to chemotherapy and radiation. The most common cause of lung cancer is long-term exposure to tobacco smoke. The occurrence of lung cancer in nonsmokers, who account for as many as 15% of cases, is often attributed to a combination of genetic factors, radon gas, asbestos, and air pollution including secondhand smoke. Lung cancer may be seen on chest radiograph and computed tomography (CT scan). The diagnosis is confirmed with a biopsy. This is usually performed by bronchoscopy or CT-guided biopsy. Treatment and prognosis depend upon the histological type of
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Dec 02

Lung Cancer: Better And Faster Diagnosis With Endo-bronchial Ultrasound (e-bus)


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Nowadays, cancer is one of the most recognized diseases. It has grown acknowledgment after news about well-known personalities who were diagnosed and later died of cancer was made public. Many even claim that cancer is a disease of the rich because of the extravagant cost that people need for its diagnosis and treatment. However, statistics have shown that no one is spared from this disease as cases of cancer continue to increase across the globe inflicting people from different race, ethnicity, and socio-economic status.

Cancer is about to take the place of heart disease as the number one killer according to the statement given by the World Health Organization. It is actually a disease caused by cell abnormalities on which the cells function differently from how they are supposed to be. This cell abnormalities form lumps or tumors that can lead to cancer if malignant.

There are several types of cancer. Since the human body is made up of cells, abnormality of cells may occur in any part. If the cell abnormality starts in the lungs, then it is called lung cancer. Basically, a cancer is named after the body part where it originated. So, you can imagine the existence of brain cancer, breast cancer, colon cancer, and any organs or body parts followed by cancer.

Among all those types of cancer, lung cancer has shown great threat as it is considered the number one killer cancer in many countries. But like other cancers, this one is not easy to bear and detect. Its symptoms can be likened to that of other pulmonary ailments. So, in order for it to be discovered, one must be extra watchful of his body and the signs that his body is telling him.

Like any other disease, early detection is necessary for successful treatment and cure.

In the past, discovering whether a person has lung cancer usually takes a long time and requires tedious and invasive procedures. But thanks to the continuous research and study in the medical field, another breakthrough was made possible to enhance the diagnosis of lung cancer to immediately start treatment, improve its success, and avoid invasive procedure. This new procedure is called endo-bronchial ultrasound.

Endo-bronchial ultrasound is a great technology as it combines bronchoscope and ultrasound plus it permits biopsy without surgery. With these three procedures combined, detecting lung cancer and diagnosing its stage or spread is made more accurate, safer, and even faster.

Result of endo-bronchial ultrasound is deemed more accurate because of the real-time display of the trachea, lymph nodes, lungs, and blood vessels in a better view. Also, areas which are usually difficult to access or are not directly visible using the traditional method can now be examined with this new one.

It is safer because it is categorized as a minimally evasive procedure. While the traditional biopsy where incision is necessary poses a risk of having a blood vessel bleeding that could further lead for the lungs to collapse, this new method eliminates that risk with biopsy without incision.

Fast result is necessary for a higher success. Also, it helps lessen the stress and tension among patients. This new technique requires little time and patients are allowed to go home the same day with minimal efforts to recover from the procedure.

Medical doctors who have performed this new procedure have nothing but good remarks. In a one-time procedure, they could actually do their patients assessment with better specificity and sensitivity which was not possible in some cases with the use of traditional methods. And no serious complication has been reported related to the use of endo-bronchial ultrasound.

Lung cancer can be treated best with early and accurate detection. Stop that cancer cells from growing with all the best possible treatments that can be best advised to you by your doctors with the use of this highly innovative endo-bronchial ultrasound.

And now, Samitijev Hospital is embracing this new technology. With its excellent patient delivery and patient care, Samitijev Hospital is adding endo-bronchial ultrasound to better serve the needs of its patients.

Lung Cancer, caused by the abnormalities of cells found in lungs is now considered as the number one killer cancer in the world. With the continuous breakthrough in medicine and technology, early diagnosis and accurate staging for better treatment is now possible with this highly innovative endo-bronchial ultrasound that combines three procedures into one minimally invasive approach. Now you can http://www.samitivejhospitals.com/MedicalService/Center/MedServiceShortDetail.aspx?MedServiceId=138⊂MedServiceId=195&lid=2> stop lung cancer with e-bus or endo-bronchial ultrasound.

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