Magazin
2005-07-05
Barcelona (ots/PRNewswire) -
- New data may provide important treatment advances inmesothelioma and lung cancer
Patients with a cancer of the lining of the lung, known asmalignant pleural mesothelioma (MPM), lived longer than previouslyreported(1), when treated with Eli Lilly and Company's Alimta(R)(pemetrexed) in combination with cisplatin, according to updateddata presented today at the 11th annual Conference on Lung Cancer(WCLC).
Alimta is the first and only approved therapy to show astatistically significant survival advantage in patients sufferingfrom this difficult-to-treat cancer(2). Alimta is also approved inthe United States, the European Union and several other countries asa monotherapy for second-line non-small cell lung cancer (NSCLC).
"Before Alimta was available, patients suffering from mesotheliomahad no hope -- rarely living a year after diagnosis," said NicholasJ. Vogelzang, MD, director of the Nevada Cancer Institute in LasVegas. "At 18 months, there is still a statistically significantdifference in survival, which demonstrates patients are living longerwhen treated with this Alimta combination. If you look out further to24 months, 22 percent of patients treated with Alimta are stillalive."
Mature data presented at WCLC represent an update from trialresults from the largest randomized, Phase III mesothelioma trialever reported involving 448 patients published in the Journal ofClinical Oncology (JCO) in July 2003(2). Today's data showed mediansurvival of patients treated with Alimta plus cisplatin was almostthirteen (12.8) months after diagnosis and 42 percent (3.8 months)longer than patients who received cisplatin alone (p = 0.003).
In addition, 33 percent of mesothelioma patients treated withAlimta plus cisplatin survived 18 months compared with 23 percenttreated with cisplatin alone. This difference was statisticallysignificant (p = 0.030). When treated with Alimta plus cisplatin, 22percent of patients survived 24 months compared with 17 percentreceiving single-agent cisplatin (p = 0.209).
When Alimta is given as a single agent, the most common sideeffects include disorders of the blood and lymphatic system,gastrointestinal disorders, fatigue, and rash. The risk and severityof side effects associated with Alimta can be controlled when usedwith folic acid and vitamin B12 -- a supplement unique to Alimtatherapy.
Alimta Data in NSCLC Presented at WCLC
"Elderly Patients Benefit From Alimta in Second-line Treatment forAdvanced NSCLC"
Non-small cell lung cancer is a disease that strikes olderpatients, with an estimated 63 percent of Europeans and 66 percent ofU.S. lung cancer patients aged 65 or older being diagnosed(3).
"This is the first set of data for second-line use that suggestselderly patients, like younger patients, tolerate and receive benefitfrom a salvage chemotherapy regimen," said Karen Kelly, M.D., medicaldirector for lung and chest cancer at the University of Colorado atDenver Health Services Center. "This exploratory subset analysis ofelderly patients measuring time to progression favored the Alimta armwith a trend toward improved survival as compared to docetaxel."
Alimta showed similar median overall survival benefit whencompared to Taxotere(R) (docetaxel) (9.5 months versus 7.7 months) ina retrospective, subset analysis of 86 patients (greater than orequal to 70 years old) in a randomized Phase III trial, in previouslytreated, recurrent NSCLC(4). Patients treated with Alimta experiencedconsiderably lower incidence of neutropenia (a drop in the number ofwhite blood cells) at 12.5 percent and febrile neutropenia(neutropenia accompanied with fever) at 2.5 percent when comparedwith docetaxel at 29.7 percent and 18.9 percent, respectively. Whilethe differences between Alimta and docetaxel in time to progression(4.6 months compared to 2.9 months respectively) and median overallsurvival were not statistically significant, it highlights the trendtoward improved survival with fewer side effects.(5)
"Does Reporting Expected Duration And Severity Of Adverse EventsProvide Clinically Relevant Information When Selecting A ChemotherapyRegimen? An Example Using Pemetrexed And Docetaxel"
To better understand the full burden of toxicity on a patient,researchers analyzed the randomised Phase III trial of Alimta versusdocetaxel in patients with NSCLC previously treated withchemotherapy(4).
"In clinical trials, the focus remains primarily on efficacy andgrade 3/4 side effects, but rarely focuses on how long patients canexpect to be without toxicity," said Shkun Bhalla, health economistat Lilly. "Combining incidence, severity and persistence of adverseevents can produce information of clinical relevance for bothphysicians and patients when selecting a treatment."
Patients who received Alimta spent a statistically significantlonger period of time without toxicity (both haematological andnon-haematological) when compared to docetaxel. This analysis alsoshowed that patients who received Alimta spent a statisticallysignificant shorter period of time experiencing grade 3 and 4toxicities compared to docetaxel.
About Malignant Pleural Mesothelioma
Malignant pleural mesothelioma is a cancer of the lining of thelungs. The disease is often associated with asbestos exposure and hasa long latency period -- usually between 20 and 40 years. Most peopleare not diagnosed until the cancer is in advanced stages andtreatment with surgery or radiation is not an option. It is estimatedthat between 10,000 and 15,000 people around the world are diagnosedannually with malignant pleural mesothelioma, though incidencenumbers are expected to increase within the next few years.
About Lung Cancer
According to the most recent World Health Organization CancerReport, lung cancer is the world's most common cancer and the leadingcause of cancer death for both men and women. There will be 1.2million cases diagnosed this year around the world.(6)
Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing agrowing portfolio of first-in-class and best-in-class pharmaceuticalproducts by applying the latest research from its own worldwidelaboratories and from collaborations with eminent scientificorganizations. Headquartered in Indianapolis, Indiana, Lilly providesanswers -- through medicines and information -- for some of theworld's most urgent medical needs.
Lilly Oncology
A pioneer and industry partner, Lilly Oncology is committed todelivering innovative treatment strategies and essential supportprograms that advance physician care and respond to patient needs.From chemotherapies that have become standards of care to noveltargeted therapies currently being investigated, Lilly has been atthe forefront of cancer research for more than 40 years. LillyOncology continues in its spirit of innovation with a broad productpipeline representing a vibrant and cutting edge research platform,built upon extensive medical expertise and human insight.
Alimta(R) (pemetrexed, Lilly) Taxotere(R) (docetaxel, Aventis)
(1) Vogelzang NJ, Rusthoven JJ, Symanowski J, et al. Long-TermSurvival Update from the Randomized Phase III Study of PemetrexedPlus Cisplatin vs Cisplatin in Patients with Malignant PleuralMesothelioma. Presented at WCLC 2005.
(2) Vogelzang NJ, Rusthoven JJ, Symanowski J, et al. RandomizedPhase III Study of Pemetrexed Plus Cisplatin vs Cisplatin in Patientswith Malignant Pleural Mesothelioma. J Clin Oncol 21:2636-2644, July15 2003.
(3) WHO. Globocan 2000: Cancer Incidence, Mortality, andPrevalence Worldwide, International Association of Cancer Registries.http://www-dep.iarc.fr/
(4) Hanna N, Shepherd F, Fossella F, Pereira J et al. RandomizedPhase III Trial of Pemetrexed Versus Docetaxel in Patients WithNon-Small-Cell Lung Cancer Previously Treated With Chemotherapy JClin Oncol 22:1589-1597, May 1 2004.
(5) Kelly K, Langer C, Rosell R, et al. Elderly Patients BenefitFrom Second-line Cytotoxic Chemotherapy for Advanced NSCLC. Presentedat WCLC 2005.
(6) World Health Organization Cancer Report, WHO. Globocan 2002:Cancer Incidence, Mortality, and Prevalence Worldwide, InternationalAssociation of Cancer Registries. http://www-dep.iarc.fr/
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
ots Originaltext: Eli Lilly and CompanyIm Internet recherchierbar: http://www.presseportal.de
Contact:Carla Cox of Eli Lilly and Company, +1-317-651-1473, mobile: +1-317-332-5557; or Paul George of CPR Worldwide, +1-917-251-1038, Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO,PRN Photo Desk, photodesk@prnewswire.com
Thoracic Cancer Patients Find New Reasons for Hope with Alimta(R)
- New data may provide important treatment advances inmesothelioma and lung cancer
Patients with a cancer of the lining of the lung, known asmalignant pleural mesothelioma (MPM), lived longer than previouslyreported(1), when treated with Eli Lilly and Company's Alimta(R)(pemetrexed) in combination with cisplatin, according to updateddata presented today at the 11th annual Conference on Lung Cancer(WCLC).
Alimta is the first and only approved therapy to show astatistically significant survival advantage in patients sufferingfrom this difficult-to-treat cancer(2). Alimta is also approved inthe United States, the European Union and several other countries asa monotherapy for second-line non-small cell lung cancer (NSCLC).
"Before Alimta was available, patients suffering from mesotheliomahad no hope -- rarely living a year after diagnosis," said NicholasJ. Vogelzang, MD, director of the Nevada Cancer Institute in LasVegas. "At 18 months, there is still a statistically significantdifference in survival, which demonstrates patients are living longerwhen treated with this Alimta combination. If you look out further to24 months, 22 percent of patients treated with Alimta are stillalive."
Mature data presented at WCLC represent an update from trialresults from the largest randomized, Phase III mesothelioma trialever reported involving 448 patients published in the Journal ofClinical Oncology (JCO) in July 2003(2). Today's data showed mediansurvival of patients treated with Alimta plus cisplatin was almostthirteen (12.8) months after diagnosis and 42 percent (3.8 months)longer than patients who received cisplatin alone (p = 0.003).
In addition, 33 percent of mesothelioma patients treated withAlimta plus cisplatin survived 18 months compared with 23 percenttreated with cisplatin alone. This difference was statisticallysignificant (p = 0.030). When treated with Alimta plus cisplatin, 22percent of patients survived 24 months compared with 17 percentreceiving single-agent cisplatin (p = 0.209).
When Alimta is given as a single agent, the most common sideeffects include disorders of the blood and lymphatic system,gastrointestinal disorders, fatigue, and rash. The risk and severityof side effects associated with Alimta can be controlled when usedwith folic acid and vitamin B12 -- a supplement unique to Alimtatherapy.
Alimta Data in NSCLC Presented at WCLC
"Elderly Patients Benefit From Alimta in Second-line Treatment forAdvanced NSCLC"
Non-small cell lung cancer is a disease that strikes olderpatients, with an estimated 63 percent of Europeans and 66 percent ofU.S. lung cancer patients aged 65 or older being diagnosed(3).
"This is the first set of data for second-line use that suggestselderly patients, like younger patients, tolerate and receive benefitfrom a salvage chemotherapy regimen," said Karen Kelly, M.D., medicaldirector for lung and chest cancer at the University of Colorado atDenver Health Services Center. "This exploratory subset analysis ofelderly patients measuring time to progression favored the Alimta armwith a trend toward improved survival as compared to docetaxel."
Alimta showed similar median overall survival benefit whencompared to Taxotere(R) (docetaxel) (9.5 months versus 7.7 months) ina retrospective, subset analysis of 86 patients (greater than orequal to 70 years old) in a randomized Phase III trial, in previouslytreated, recurrent NSCLC(4). Patients treated with Alimta experiencedconsiderably lower incidence of neutropenia (a drop in the number ofwhite blood cells) at 12.5 percent and febrile neutropenia(neutropenia accompanied with fever) at 2.5 percent when comparedwith docetaxel at 29.7 percent and 18.9 percent, respectively. Whilethe differences between Alimta and docetaxel in time to progression(4.6 months compared to 2.9 months respectively) and median overallsurvival were not statistically significant, it highlights the trendtoward improved survival with fewer side effects.(5)
"Does Reporting Expected Duration And Severity Of Adverse EventsProvide Clinically Relevant Information When Selecting A ChemotherapyRegimen? An Example Using Pemetrexed And Docetaxel"
To better understand the full burden of toxicity on a patient,researchers analyzed the randomised Phase III trial of Alimta versusdocetaxel in patients with NSCLC previously treated withchemotherapy(4).
"In clinical trials, the focus remains primarily on efficacy andgrade 3/4 side effects, but rarely focuses on how long patients canexpect to be without toxicity," said Shkun Bhalla, health economistat Lilly. "Combining incidence, severity and persistence of adverseevents can produce information of clinical relevance for bothphysicians and patients when selecting a treatment."
Patients who received Alimta spent a statistically significantlonger period of time without toxicity (both haematological andnon-haematological) when compared to docetaxel. This analysis alsoshowed that patients who received Alimta spent a statisticallysignificant shorter period of time experiencing grade 3 and 4toxicities compared to docetaxel.
About Malignant Pleural Mesothelioma
Malignant pleural mesothelioma is a cancer of the lining of thelungs. The disease is often associated with asbestos exposure and hasa long latency period -- usually between 20 and 40 years. Most peopleare not diagnosed until the cancer is in advanced stages andtreatment with surgery or radiation is not an option. It is estimatedthat between 10,000 and 15,000 people around the world are diagnosedannually with malignant pleural mesothelioma, though incidencenumbers are expected to increase within the next few years.
About Lung Cancer
According to the most recent World Health Organization CancerReport, lung cancer is the world's most common cancer and the leadingcause of cancer death for both men and women. There will be 1.2million cases diagnosed this year around the world.(6)
Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing agrowing portfolio of first-in-class and best-in-class pharmaceuticalproducts by applying the latest research from its own worldwidelaboratories and from collaborations with eminent scientificorganizations. Headquartered in Indianapolis, Indiana, Lilly providesanswers -- through medicines and information -- for some of theworld's most urgent medical needs.
Lilly Oncology
A pioneer and industry partner, Lilly Oncology is committed todelivering innovative treatment strategies and essential supportprograms that advance physician care and respond to patient needs.From chemotherapies that have become standards of care to noveltargeted therapies currently being investigated, Lilly has been atthe forefront of cancer research for more than 40 years. LillyOncology continues in its spirit of innovation with a broad productpipeline representing a vibrant and cutting edge research platform,built upon extensive medical expertise and human insight.
Alimta(R) (pemetrexed, Lilly) Taxotere(R) (docetaxel, Aventis)
(1) Vogelzang NJ, Rusthoven JJ, Symanowski J, et al. Long-TermSurvival Update from the Randomized Phase III Study of PemetrexedPlus Cisplatin vs Cisplatin in Patients with Malignant PleuralMesothelioma. Presented at WCLC 2005.
(2) Vogelzang NJ, Rusthoven JJ, Symanowski J, et al. RandomizedPhase III Study of Pemetrexed Plus Cisplatin vs Cisplatin in Patientswith Malignant Pleural Mesothelioma. J Clin Oncol 21:2636-2644, July15 2003.
(3) WHO. Globocan 2000: Cancer Incidence, Mortality, andPrevalence Worldwide, International Association of Cancer Registries.http://www-dep.iarc.fr/
(4) Hanna N, Shepherd F, Fossella F, Pereira J et al. RandomizedPhase III Trial of Pemetrexed Versus Docetaxel in Patients WithNon-Small-Cell Lung Cancer Previously Treated With Chemotherapy JClin Oncol 22:1589-1597, May 1 2004.
(5) Kelly K, Langer C, Rosell R, et al. Elderly Patients BenefitFrom Second-line Cytotoxic Chemotherapy for Advanced NSCLC. Presentedat WCLC 2005.
(6) World Health Organization Cancer Report, WHO. Globocan 2002:Cancer Incidence, Mortality, and Prevalence Worldwide, InternationalAssociation of Cancer Registries. http://www-dep.iarc.fr/
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
ots Originaltext: Eli Lilly and CompanyIm Internet recherchierbar: http://www.presseportal.de
Contact:Carla Cox of Eli Lilly and Company, +1-317-651-1473, mobile: +1-317-332-5557; or Paul George of CPR Worldwide, +1-917-251-1038, Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO,PRN Photo Desk, photodesk@prnewswire.com
Eli Lilly and Company
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