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
Read Related Topics on Breast Cancer and Cancer Care News .
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Filed under Quit Smoking by on Oct 12th, 2011. Comment. 
There are endless good reasons to quit smoking, including reducing your risk of cancer, heart disease and early death. Despite these well-known risk factors, however, many smokers find themselves needing a more personal reason to want to kick the habit; possibly because the threat of “maybe” contracting a deadly disease just doesn’t seem likely (the old, “it will never happen to me” syndrome).
This article is going to share some easy steps to help you come up with your own powerful, compelling reason(s) to quit smoking once and for all.
1) First, take a few moments to jot down on a sheet of paper the negative aspects of how smoking makes you feel. You can include actual physical problems like shortness of breath and fatigue; as well as feelings like embarrassment that your clothing and hair may stink; feeling like an outcast stepping outside to smoke while everyone else stays inside socializing and having a good time; or even your fears, like dying young and leaving your children before your time.
Write down as many reasons as you can, and try to make them reasons that really matter to YOU – not just what other people have said to you or you’ve heard others say before.
2) When you’re done with your list, look it over carefully. Read each item on the list, and really think about how it feels to experience that situation in your daily life. Now choose the top three reasons that are most repulsive to you and circle them.
Take another sheet of paper and write a longer description of each of those three items. For example, if one of your top reasons was “to not die young and abandon my children”, write a paragraph or two about why that is important to you. How would it affect your children if you died before your time? How will your smoking impact them, now and in the future? Will your smoking addiction encourage them to smoke later in life? Continue writing until you feel you have identified your core reason for wanting to quit smoking. This may seem like a morbid exercise, but it can be incredibly powerful. Being a smoker for a long time desensitizes you to the true long-term effects of smoking. This exercise jars you out of the haze of denial.
Now go through this same process for the other two important reasons on your list.
3) When you’ve got your three descriptions written, read them over again. Now take a final sheet of paper and write a description of the opposite outcome. When you do quit smoking, what will happen instead of those other experiences? For example, you might write that you will be around to love your children and grandchildren for many years to come, your kids will be really proud of you for quitting, they’ll be blessed with a healthy, strong parent that has the energy and stamina to play with them, and so on.
Do this for all three reasons you described earlier.
Carry these lists with you and read them slowly each day, really paying attention to how they make you feel. With enough repetition, you will actually begin training your brain to view smoking as an unpleasant, dangerous activity – which will make quitting easier when you decide it’s time.
While this may not remove the discomfort that comes along with nicotine withdrawal, it will certainly help you to stop seeing smoking as a harmless activity and instead see it for what it is: a true threat to your health, happiness and longevity.
If that isn’t enough reason to quit, what is?
Filed under Quit Smoking by on Feb 15th, 2010. Comment.
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Hi, my name is Karen and I am a non-smoker. Having kicked my addiction to nicotine and cigarettes I am living a healthier no smoking lifestyle. If you would like to be a non-smoker, too, join me on your quest to find the best solution to help you stop smoking.
