Erlotinib improves progression-free survival as first-line therapy in advanced lung cancer

For patients with advanced lung cancer whose tumors carry EGFR activating mutations, first-line treatment with erlotinib nearly tripled progression-free survival compared to a standard chemotherapy combination, show results from the first prospective Phase-III study to report findings in this setting.
The new results from the OPTIMAL trial were reported at the 35th Congress of the European Society for Medical Oncology (ESMO) in Milan, Italy.
"Erlotinib is very effective and well tolerated in advanced NSCLC patients who harbor EGFR activating mutations. It is 2 to 3 times more effective than doublet chemotherapy," said study leader Professor Caicun Zhou of Shanghai Pulmonary Hospital, Tongji University, China.
The OPTIMAL study included 165 patients whose lung cancer carried mutations activating the Epithelial Growth Factor Receptor (EGFR). Participants had not received systemic treatment for their cancer.
Of these patients, 83 were randomly assigned to receive erlotinib 150 mg/day, and 82 patients were assigned to receive a 'doublet' combination chemotherapy of gemcitabine and carboplatin. The primary endpoint of the study was progression-free survival.
In his presentation at the ESMO Congress, Prof Zhou reported that the median progression-free survival in the erlotinib arm was 13.1 months, compared to 4.6 months for the chemotherapy arm of the study. The objective response rate with erlotinib was 83%, compared to 36% for gemcitabine plus carboplatin. 31 patients in the erlotinib arm are still under study and progression free compared to only 1 in the chemotherapy arm.
"OPTIMAL is the first reported prospective Phase-III study to confirm the role of erlotinib in advanced NSCLC patients with EGFR activating mutations," Prof Zhou said. "It does much better than the standard doublet chemotherapy and so we should start erlotinib treatment as soon as possible after the diagnosis of advanced NSCLC with EGFR activating mutations," he added.
Safety analyses showed lower rates of adverse events with erlotinib than with chemotherapy, the researchers report.
Also at the ESMO Congress, Professor Yi-long Wu from Guangdong General Hospital (GGH) & Guangdong Academy of Medical Sciences in China reported the first biomarker results from the study. This analysis aimed to evaluate the impact on various biomarkers with survival among the patient population.
"Detailed biomarker analysis did not identify additional markers that could be used to further optimize treatment decisions. It was found that patients who had exon 19 deletions in EGFR had longer progression-free survival with erlotinib than those with L858R mutations and only one patient had an EGFR T790M mutation, and remained progression-free for only 0.62 months," Prof Wu said.
The results of the OPTIMAL trial have implications for clinical practice, commented Dr Federico Cappuzzo, Director of Medical Oncology at Ospedale Civile in Livorno, Italy.
"These data, combined with data coming from another four large Phase-III studies comparing chemotherapy versus gefitinib, another orally available EGFR tyrosine kinase inhibitor (EGFR-TKI), confirmed that erlotinib or gefitinib represent the best therapeutical option we can offer today as front-line therapy in metastatic NSCLC with activating EGFR mutations."
Dr Cappuzzo noted that all studies so far in this setting have been conducted in Asian populations. A confirmatory study in Caucasian patients is currently ongoing.

**In ESMO 2010 Congress

Surgical technique relieves painful spine fractures in patients with metastatic cancer

A surgical technique appears to offer quick and effective relief for debilitating spinal fractures often suffered by patients with metastatic cancer, researchers reported at the 35th Congress of the European Society for Medical Oncology (ESMO) in Milan.
Many patients with multiple myeloma, or those whose cancer has spread beyond the initial tumor site, suffer compression fractures in their spine. This is partly because the spine is one of the most common sites for metastatic spread of the disease, making the vertebrae brittle and at risk for fractures. Widely-used cancer treatments such as corticoid treatment, hormone therapy, radiation therapy can also have a weakening effect on bone and increase the risk for fractures in these patients.
Professor Leonard Bastian from Klinikum Leverkusen in German led an international trial testing a new technique to treat these compression fractures, called balloon kyphoplasty.
"Balloon Kyphoplasty is a minimally invasive surgical procedure to treat patients with painful vertebral compression fractures," Prof Bastian explained.
To perform the procedure, a surgeon inserts a small orthopedic balloon through a 1 cm incision into the fractured vertebra. Inflation of the balloon can restore the shape and height of the vertebrae. The balloon is then deflated and removed and a precise amount of quick-setting bone cement is injected in the vertebral body restoring the shape and strength of the vertebrae.
At the congress, Prof Bastian reported the results of a trial including 134 patients randomly assigned to either balloon kyphoplasty (70 patients) or non-surgical management (64).
Those who had the surgery showed improvements in a questionnaire designed to measure their level of disability at one month after surgery. They also experienced a significant improvement in back pain one week after surgery, while those who received non-surgical management saw no improvement.
After one month, patients in the non-surgical arm of the study were allowed to receive balloon kyphoplasty. Thirty-eight chose to do so. All patients who underwent balloon kyphoplasty reported sustained improvements in quality of life for a year after treatment.
"Balloon kyphoplasty offers quick pain relief; restores patient activity and mobility and it gives an important improvement of quality of life," Prof Bastian said. "It may be the right treatment option for vertebral compression fractures if conventional pain medication has not been effective or has too many side-effects."
"This study demonstrates balloon kyphoplasty should be considered when painful vertebral compression fractures occur in cancer patients. It is an additional therapy which can really add to the patient's quality of life."
"The role of balloon kyphoplasty for the control of pain and disability in cancer patients is a hot topic," commented Dr Fausto Roila from Ospedale Santa Maria, Terni, Italy. "Managing the side-effects of therapies and the symptoms of cancer is an important aspect of cancer care."
The study by Prof Bastian's group adds to a growing literature on the role of kyphoplasty, Dr Roila noted. "As research into this technique continues it will be important to conduct double-blind, placebo-controlled studies to identify the place of balloon kyphoplasty in cancer care."

**In ESMO 2010 Congress

FDA delays review on Roche's Avastin for advanced breast cancer

Roche announced that the FDA delayed a decision on whether to allow the company to continue to market Avastin (bevacizumab) as a first-line treatment for patients with advanced HER2-negative breast cancer. The extension was needed as the additional information provided by the company was "deemed a major amendment" by the agency, according to the drugmaker. The regulators are expected to issue a final decision by December 17.
The FDA granted accelerated approval for Avastin in this indication in 2008 based on studies suggesting it halted the progression of the disease for more than five months. However, two additional clinical studies failed to show benefit, and in July, an FDA advisory panel voted 12 to 1 in favour of recommending that the agency withdraw approval for the breast cancer indication.
Avastin had global sales of nearly $6 billion in 2010, and analysts estimate that if approval of the drug in the breast cancer indication were revoked, it could reduce sales by about $1 billion annually.

Reference Articles
Genentech provides update on Avastin for advanced breast cancer - (Genentech)
FDA delays decision on breast cancer drug Avastin - (MSN Money)
FDA delays decision on Avastin - (San Francisco Business Times)
FDA delays ruling on Avastin's use in advanced breast cancer (free preview) - (The Wall Street Journal)

**Published in "First Word"

Survey Reveals Many are Ignoring Basic Measures to Check for no.1 Heart Killer Disorder in Europe

On World Heart Rhythm Week, Arrhythmia Alliance Launches 'Know Your Pulse' Campaign to Raise Awareness of the Importance of Pulse Checking to Keep Cardiac Conditions Under Control
Arrhythmia Alliance, the Heart Rhythm Charity, announced today the results of a survey conducted in Europe that showed a large number of respondents ignore basic measures to check for potential cardiac arrhythmias, or heart rhythm disorders. To raise awareness of the importance of pulse checking and to inform people about how to take their pulse, the Arrhythmia Alliance will open 2010 World Heart Rhythm Week (7-13 June) with the launch of the global awareness campaign 'Know Your Pulse'.
"Taking your pulse rate is a quick and easy way to identify a heart rhythm problem which in some cases could potentially have serious implications" - explained Prof A John Camm, President of Arrhythmia Alliance. "Being aware of your pulse rate is the easiest way for a patient to check for a potential cardiac arrhythmia and may suggest when to contact a healthcare professional for further investigation."
According to the survey results, nearly 40 percent (37.6%) of respondents do not take their pulse regularly, and 70 percent (70.3%) are unaware if they are at risk of a cardiac arrhythmia. In addition, nearly 60 percent (57.4%) of the respondents who have taken their pulse in the past would not know how to take it again.
Arrhythmias are heart rhythm disorders that can cause a range of conditions including Sudden Cardiac Arrest (SCA) - a leading cause of death in Europe, syncope (blackouts or loss of consciousness), and atrial fibrillation (a leading cause of stroke, and the most common of all cardiac arrhythmias). Conditions caused by heart rhythm disorders kill more people in Europe than breast cancer, lung cancer, stroke or AIDS.
"Surprisingly, anyone at any age can be at risk. Sudden Cardiac Arrest can affect the young and even athletes who are physically fit, for example," commented Trudie Lobban, Founder and Trustee of Arrhythmia Alliance. "This is why on World Heart Rhythm Week this year, we are launching a campaign to encourage people to put into place simple measures that can make a real difference, and detect potential heart rhythm disorders for an early diagnosis and treatment."
The 'Know Your Pulse' campaign also seeks to raise awareness amongst healthcare professionals of the importance of conducting regular pulse checks during normal patient check-ups so that cardiac arrhythmias are given as much attention as other conditions. Almost 80 percent (79.62%) of survey respondents felt that it is important that healthcare professionals acknowledge this.

***Website: http://www.knowyourpulse.org/