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    <recommendedItem id="20100101_19_345"
                     title="FDA Okays Drug Combo for Advanced Breast Cancer"
                     score="0.009"
                     href="http://www.medpagetoday.com/ProductAlert/Prescriptions/tb/18224?impressionId=1265749349489"
                     
      &lt;p&gt;The FDA has approved a combination of lapatinib (Tykerb) and letrozole (Femara) to treat hormone-positive and HER2-positive advanced breast cancer in postmenopausal women.&lt;/p&gt;
&lt;p&gt;The approval follows a company-sponsored study that found that women with HER2-positive disease who were taking the combination had survival rates more than double that of women on letrozole alone (35 weeks versus 13 weeks).&lt;/p&gt;
&lt;p&gt;Lapatinib is an oral kinase inhibitor that blocks the function of the HER2-positive protein. In 2007, it was approved in combination with capecitabine (Xeloda) to treat advanced HER2-positive breast cancer tumors in refractory disease. (See &lt;a href=&quot;http://www.medpagetoday.com/HematologyOncology/Chemotherapy/5247&quot; mce_href=&quot;http://www.medpagetoday.com/HematologyOncology/Chemotherapy/5247&quot; target=&quot;_blank&quot;&gt;FDA Okays Lapatinib (Tykerb) for Treatment-Resistant Breast Cancer&lt;/a&gt;).&lt;/p&gt;
&lt;p&gt;The FDA said the most commonly reported side effects of the lapatinib/letrozole combination were diarrhea, rash, nausea, and fatigue.&lt;/p&gt;
&lt;p&gt;Treatment with lapatinib has also been associated with decreased heart function, liver damage, and inflammation of lung tissue, the agency cautioned. It may also cause harm to the fetus if used in pregnant women.&lt;/p&gt;
&lt;p&gt;Richard Pazdur, MD, director of the FDA&apos;s office of oncology drug products, said in a prepared statement that the combination &quot;provides women being treated for advanced breast cancer with an important treatment option.&quot;&lt;/p&gt;
&lt;p&gt;Lapatinib is marketed by GlaxoSmithKline and letrozole by Novartis AG.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_298"
                     title="FDA Updates Myeloma Drug Label for New Risks"
                     score="0.004"
                     href="http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/18158?impressionId=1265749349489"
                     
      &lt;p&gt;WASHINGTON  --  The FDA has revised dosage and safety information for bortezomib (Velcade), the myeloma and mantle cell lymphoma drug, to reflect an increased toxicity risk.&lt;/p&gt;
&lt;p&gt;The new labeling includes a warning for patients with moderate-to-severe hepatic impairment and now recommends at-risk patients start at a lower dosage of 0.7 mg for the first cycle of treatment and escalate to 1.0 mg, or reduce further to 0.5 mg, in subsequent cycles.&lt;/p&gt;
&lt;p&gt;The label has also been updated to include clinical study data showing a higher median survival rate in patients using a combination of bortezomib, melphalan, and prednisone versus a regiment of just melphalan and prednisone (&lt;em&gt;P&lt;/em&gt;=0.00084).&lt;/p&gt;
&lt;p&gt;The drug is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol. The FDA also warns that women should avoid becoming pregnant while undergoing treatment with bortezomib.&lt;/p&gt;
&lt;p&gt;The drug is manufactured by Millennium: The Takeda Oncology Company of Cambridge, Mass.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_250"
                     title="Cancer Research &quot;Giant&quot; Lawrence Garfinkel Dies at 88"
                     score="-0"
                     href="http://www.medpagetoday.com/Pulmonology/Smoking/tb/18108?impressionId=1265749349489"
                     
      &lt;p&gt;Epidemiologist Lawrence Garfinkel, MA, a legendary researcher for the American Cancer Society whose work helped establish a link between cancer and smoking and other activities, died of cardiovascular disease Thursday in Seattle, Washington at 88.&lt;/p&gt;
&lt;p&gt;&quot;The American Cancer Society today mourns the loss of one of its most important historical figures,&quot; said John R. Seffrin, PhD, the society&apos;s chief executive officer.&lt;/p&gt;
&lt;p&gt;&quot;Larry Garfinkel joined the American Cancer Society as a young scientist in 1947, and for more than four decades played an instrumental role in expanding knowledge of and reducing death from smoking.&quot;&lt;/p&gt;
&lt;p&gt;Garfinkel&apos;s 1982 Cancer Prevention Study-II (CPS-II) is the largest contemporary study of tobacco and mortality, with 1.2 million participants and 77,000 data-compiling volunteers across 50 states, the District of Columbia, and Puerto Rico.&lt;/p&gt;
&lt;p&gt;CPS-II uncovered the effects of lifestyle factors, such as obesity, alcohol consumption, medications, genetic elements, that affect cancer and other chronic diseases, the analysis of which still reveals important clues about cancer today.&lt;/p&gt;
&lt;p&gt;The study also found lung cancer mortality rates in women increased five-fold from data collected in the original Cancer Prevention Study, while cancer rates among non-smoking women remained the same. This information provided strong evidence that lung cancer was almost exclusively a disease found in smokers.&lt;/p&gt;
&lt;p&gt;Garfinkel was born on January 11, 1922 in Manhattan&apos;s Lower East Side and was raised in the South Bronx.&lt;/p&gt;
&lt;p&gt;He served in the army during World War II, where he was seriously injured in northern France in August, 1944.&lt;/p&gt;
&lt;p&gt;Ultimately, Garfinkel graduated from the City College of New York and received a Masters Degree from Columbia University. He also received several honorary doctorates.&lt;/p&gt;
&lt;p&gt;Garfinkel began work for the ACS in 1947.&lt;/p&gt;
&lt;p&gt;He assisted E. Cuyler Hammond, MD, and Daniel Horn, MD, in the first ACS prospective mortality study of 187,783 males in the late 1940&apos;s by coordinating much of the field work, including training thousands of ACS volunteers in data collection techniques.&lt;/p&gt;
&lt;p&gt;Garfinkel acted as the co-principal investigator of the larger Cancer Prevention Study I (CPS-I) in 1959. The study enrolled 1 million participants across 25 states and required over 68,000 volunteers to collect data.&lt;/p&gt;
&lt;p&gt;In the 1960s, he contributed to more than two dozen major papers on the relation between smoking and health. He was co-author of one of the first reports combining epidemiology with pathology and provided some of the first direct evidence of lung damage related to smoking.&lt;/p&gt;
&lt;p&gt;Garfinkel also contributed to issuance of the landmark 1964 Surgeon General&apos;s report on smoking and health.&lt;/p&gt;
&lt;p&gt;He was appointed director of ACS research in 1979 after Hammond&apos;s retirement.&lt;/p&gt;
&lt;p&gt;Garfinkel retired from the ACS in 1989. Over the course of his career, he had contributed to more than 100 journal articles.&lt;/p&gt;
&lt;p&gt;Richard D. Klausner, MD, then-director of the National Cancer Institute, said at the time: &quot;Few individuals have contributed as much to our present-day knowledge about the disease consequences of smoking.&lt;/p&gt;
&lt;p&gt;&quot;His remarkable achievement is an important reminder what a tremendous impact an individual can make, and inspires all of us to continue the fight against cancer.&quot;&lt;/p&gt;
&lt;p&gt;Garfinkel continued to volunteer with the ACS after his retirement and taught biostatistics at the New York University Dental School.&lt;/p&gt;
&lt;p&gt;He is survived by his brothers, Harold and Melvin; his sons, Martin and Herb; a daughter-in-law, Margaret Cary, and two grandchildren.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_248"
                     title="Continued Smoking Worsens Lung Cancer Prognosis (CME/CE)"
                     score="-0"
                     href="http://www.medpagetoday.com/HematologyOncology/LungCancer/tb/18105?impressionId=1265749349489"
                     
      &lt;p&gt;It&apos;s never too late to stop smoking, even for smokers already diagnosed with lung cancer, a new analysis shows.&lt;/p&gt;
&lt;p&gt;A systematic review of published trials of smokers diagnosed with early stage lung cancer disclosed that patients who stopped smoking when diagnosed were about twice as likely to survive for five years as those who continued to smoke after diagnosis, wrote Amanda Parsons, PhD, a research fellow at the University of Birmingham in England, and colleagues in a paper published online Jan. 22 by &lt;em&gt;BMJ.&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;Continuing smoking was associated with a significantly increased risk of all cause mortality (hazard ratio 2.94, 95% CI, 1.15 to 7.54) as well as increased risk of cancer recurrence (HR 1.86, 95% CI 1.01 to 3.41), they wrote.&lt;/p&gt;
&lt;p&gt;The authors extrapolated the benefit of smoking cessation from both the recurrence and mortality data, since none of the studies contained specific information on the &quot;effect of quitting smoking on cancer specific mortality or on development of a second primary tumor in non-small cell lung cancer.&quot;&lt;/p&gt;
&lt;p&gt;They used life table-modeling to come up with the estimate that 33% of smokers diagnosed with early stage NSCLC at age 65 would survive for five years if they continued to smoke, versus an estimated 70% among those who quit smoking after diagnosis.&lt;/p&gt;
&lt;p&gt;&quot;This review has found evidence that after lung cancer has been diagnosed, reductions in risk of developing a second primary or recurrence were associated with quitting within seven years, suggesting that, even at this stage the prognostic outlook can be improved by smoking cessation,&quot; they wrote.&lt;/p&gt;
&lt;p&gt;Whether this observation can be explained by nicotine or by other components of tobacco smoke is unknown, but regardless of the exact mechanism of harm, the authors wrote, the findings &quot;support the hypothesis that continued smoking affects the behavior of a lung tumor.&quot;&lt;/p&gt;
&lt;p&gt;In an accompanying editorial, Tom Treasure, MD, a cardiothoracic surgeon at University College London, and psychiatrist Janet Treasure, PhD, also from University College, wrote that Parsons et al demonstrated that the impact of continued smoking is so large that both patients and &quot;those caring for them should be given this information because the potential benefit is great.&quot;&lt;/p&gt;
&lt;p&gt;There is one significant problem both for patients and doctors, the editorialists noted: &quot;Fewer than one in three patients with lung cancer survive even one year, so the patients likely to benefit are probably healthier to begin with. So, although the information is valuable, it&apos;s application may be limited.&quot;&lt;/p&gt;
&lt;p&gt;Discussing its limitations, the review&apos;s authors noted that it was based on data from 10 observational studies, which raises the &quot;possibility of uncontrolled confounding.&quot;&lt;/p&gt;
&lt;p&gt;Moreover, definitions of smoking &quot;abstinence were generally poor and only five of the 10 studies assigned patients to smoking categories on the basis of smoking status recorded at six months or more after diagnosis.&quot;&lt;/p&gt;
&lt;p&gt;Additionally, they noted, it appears that &quot;smokers with unfavorable prognostic factors were most likely to give up smoking, so that unadjusted estimates underestimated the benefits of quitting.&quot;&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The study was funded by the UK Center for Tobacco Control Studies, the British Heart Foundation, Cancer Research UK, Economic and Social Research Council, Medical Research Council, and the National Institute for Health Research.&lt;/p&gt;&lt;p&gt;Parsons said she has been reimbursed by Pfizer, maker of varenicline (Chantix) and nicotine nasal spray and inhaler products (Nicotrol).&lt;/p&gt;&lt;p&gt;The editorial writers disclosed no competing interests.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_174"
                     title="AACR-IASLC: MicroRNA Linked to SCLC Response (CME/CE)"
                     score="-0.004"
                     href="http://www.medpagetoday.com/MeetingCoverage/AACR-IASLC/tb/18008?impressionId=1265749349489"
                     
      &lt;p&gt;CORONADO, Calif.  --  Tiny genetic segments may give a big tip-off to platinum chemoresistance in patients with small cell lung cancer, researchers said.&lt;/p&gt;
&lt;p&gt;Three microRNAs were linked to de novo chemoresistance in a small study led by Glen J. Weiss, MD, of Scottsdale Healthcare and the Translational Genomics Research Institute (TGen), both in Scottsdale, Ariz.&lt;/p&gt;
&lt;p&gt;He presented the results here at the Joint Conference on Molecular Origins of Lung Cancer sponsored by the American Association for Cancer Research and the International Association for the Study of Lung Cancer.&lt;/p&gt;
&lt;p&gt;Further validation would be needed before denying any patient chemotherapy based on the findings, cautioned Tyler Jacks, PhD, of the Massachusetts Institute of Technology and president of the AACR.&lt;/p&gt;
&lt;p&gt;However, &quot;biomarkers of this sort will be useful in diagnosing patients and applying relevant therapies  --  in this instance perhaps applying novel therapies, given the belief that the conventional therapies will be of no value to these individuals,&quot; he said as discussant on the study at a press conference.&lt;/p&gt;
&lt;p&gt;Weiss agreed.&lt;/p&gt;
&lt;p&gt;&quot;This is early stage,&quot; he said in an interview. &quot;But hopefully down the road it will have implications for treating patients with small cell [lung cancer].&quot;&lt;/p&gt;
&lt;p&gt;Non-small cell lung cancer has been a success story for personalized treatment.&lt;/p&gt;
&lt;p&gt;It was revolutionized by discovery of epidermal growth factor receptor (EGFR) mutations as both a prognostic factor and treatment target for the EGFR tyrosine kinase inhibitors.&lt;/p&gt;
&lt;p&gt;But for small cell lung cancer, the standard treatment is platinum-based chemotherapy with only two real options in first-line treatment, the researchers said.&lt;/p&gt;
&lt;p&gt;Worse, 15% to 30% of small cell tumors are intrinsically resistant to platinum chemotherapy and never respond.&lt;/p&gt;
&lt;p&gt;&quot;[Small cell] lung cancer patients haven&apos;t had a real advance in 15 years or more for chemotherapy,&quot; Weiss told &lt;em&gt;MedPage Today&lt;/em&gt;. &quot;What we&apos;re trying to do is identify the group that doesn&apos;t respond to standard therapy so that we can identify new treatments for them up front instead of treating everyone the same.&quot;&lt;/p&gt;
&lt;p&gt;Among the genetic possibilities for these efforts, microRNA  --  RNA molecules of around 20 nucleotides in length  --  are a good option, Weiss explained.&lt;/p&gt;
&lt;p&gt;They regulate gene expression like messenger RNA but are smaller and more stable across a variety of fluid and tissue types, he said.&lt;/p&gt;
&lt;p&gt;In the study, the researchers analyzed diagnostic tumor samples from 34 patients with small cell lung cancer.&lt;/p&gt;
&lt;p&gt;Among them, 19% had de novo chemoresistance marked by progressive disease. Most had had a partial or complete response to chemotherapy (61.9% and 9.5%, respectively).&lt;/p&gt;
&lt;p&gt;After extraction of total RNA, microRNA profiling revealed 16 top candidates for association with progressive disease.&lt;/p&gt;
&lt;p&gt;The 28 samples with sufficient RNA for further testing showed three microRNAs linked to chemoresistance that were validated by quantitative real-time PCR: &lt;ul&gt; &lt;li&gt;miR-92a-2* with a &lt;em&gt;P&lt;/em&gt;-value of 0.010&lt;/li&gt; &lt;li&gt;miR-147 with a &lt;em&gt;P&lt;/em&gt;-value of 0.018&lt;/li&gt; &lt;li&gt;miR-574-5p with a &lt;em&gt;P&lt;/em&gt;-value of 0.039&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Many of the patients had comorbidities at baseline, including 47.1% with hypertension and 32% with emphysema or chronic obstructive pulmonary disease. But these did not predict chemotherapy response.&lt;/p&gt;
&lt;p&gt;The next step is to validate the biomarkers in an independent cohort of small cell lung cancer patients, the researchers concluded.&lt;/p&gt;
&lt;p&gt;Then studies will need to determine what does work in these chemoresistant patients, Weiss said.&lt;/p&gt;
&lt;p&gt;&quot;We&apos;ve learned that if we&apos;re going to make the next hurdle and if we&apos;re going to better treat this disease, we need more personalized care,&quot; agreed Roy Herbst, MD, PhD, of M.D. Anderson Cancer Center in Houston.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The study was supported by the American Cancer Society-Sylvia Chase Pilot Grant, IBIS Foundation of Arizona, and the TGen Foundation.&lt;/p&gt;&lt;p&gt;Weiss reported recieving lab support from TGen Foundation and Scottsdale Healthcare Foundation as well as being party to provisional patents related to microRNAs in lung cancer.&lt;/p&gt;&lt;p&gt;Jacks provided no information on conflicts of interest.&lt;/p&gt;&lt;p&gt;Herbst has reported financial relationships with Genentech, Lilly, Amgen, and AstraZeneca. &lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
</recommendedContent>
