Gemcitabine Based Regimens Improve Quality of Life in Non-Small Cell Lung Cancer
May 18, 2005 - 9:49:00 AM, Reviewed by: Dr.
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"Traditionally, treatment of Stage I or II non-small cell lung cancer has only involved surgery. The goal of administering these regimens prior to surgery is to treat any microscopic spread of disease and shrink the tumor to enhance the likelihood of surgical removal of the tumor."
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By Eli Lilly ,
Data presented today(1,2,3) from ongoing clinical trials show that therapies based on Eli Lilly and Company's (LLY) Gemzar(R) (gemcitabine, HCl) administered prior to surgery have a positive impact on survival, tumor shrinkage and quality of life among patients with early-stage non-small cell lung cancer (NSCLC).
Gemzar, which is approved in various countries for the treatment of lung, breast, pancreatic, bladder, ovarian and cervical cancers, is one of the most highly studied anti-cancer agents in the world and these findings add to the body of evidence of Gemzar's efficacy in another stage of lung cancer.
The study results, presented at the 41st annual meeting of the American Society of Clinical Oncology (ASCO), are part of the ongoing GINEST Project, which is a dual-clinical trial project evaluating the effectiveness of Gemzar in combination with other leading chemotherapy agents in the treatment of Stage I or II non-small cell lung cancer.
"Unfortunately, the risk of recurrence of lung cancer is a major problem even in early stages of the disease," said Richard Gralla, M.D., president of the New York Lung Cancer Alliance and a GINEST investigator. "Traditionally, treatment of Stage I or II non-small cell lung cancer has only involved surgery. The goal of administering these regimens prior to surgery is to treat any microscopic spread of disease and shrink the tumor to enhance the likelihood of surgical removal of the tumor. As we continue this project, we hope to learn which chemotherapy regimens produce the best results, and do so safely while maintaining or improving patients' quality of life."
Study Highlights
* Pre-operative therapy with Gemzar plus platinum or non-platinum agents was highly tolerable, allowing 77 percent of patients to proceed to surgical removal of the tumor; of these patients, 90 percent have had complete removal of their lung cancer. Treatment with Gemzar-based therapy also demonstrated a one-year survival rate of 74 percent in clinical study.(4)
* Pulmonary function testing (assessment of how well the lungs are working) and dyspnea scores (assessment of breathing difficulties) obtained pre- and post-chemotherapy to assess drug-induced injury to the lungs and effect on the ability to undergo surgery confirmed the safety of these regimens. Of the 62 patients evaluated, only two were unable to undergo surgery because of reduced lung function, and no patients experienced severe respiratory problems.(5)
* At six months after surgery, 78 percent of patients rated their quality of life as improved or stable.(6)
* Seven patients reported worsening of quality of life due to undergoing more than one operation and/or advancing to Stage III lung cancer. The decreased quality of life did not seem to be a result of the chemotherapy regimen.(7)
* The most common side effects were blood-related:
-- Twenty-four patients (30 percent) experienced Grade 3/4 leukopenia (an abnormal decrease in the number of white blood cells); and 8 patients (10 percent) experienced Grade 3/4 thrombocytopenia (a decrease in the number of platelets in the blood, resulting in the potential for increased bleeding and decreased ability for clotting).(8)
According to the World Health Organization, approximately 1.2 million people globally will be diagnosed with lung cancer this year.(9) It is the most lethal of all cancers. About 80 percent of all lung cancer diagnoses are of the non-small cell variety. As with any cancer, early detection and treatment of lung cancer provides the best hope for managing the disease effectively.
"Gemzar has a strong heritage in the treatment of advanced non-small cell lung cancer," said Coleman Obasaju, MD, U.S. oncology medical director at Lilly. "Gemzar's ability to demonstrate efficacy with a wide array of chemotherapeutic regimens makes it a cornerstone of lung cancer therapy."
GINEST Methods
Eighty-two patients with clinical Stage I (24 percent) and Stage II (76 percent) NSCLC were randomized and treated with chemotherapy prior to surgery. In the first trial, 54 patients were treated with either Gemzar 1000 mg plus carboplatin, or Gemzar 1000 mg plus paclitaxel 200 mg. In the second trial, 28 patients received the same regimen of Gemzar/carboplatin, or Gemzar 1000 mg plus cisplatin 75 mg. Each combination was given for three cycles every 21 days. In the quality of life evaluation, the analysis compares patient- determined quality of life ratings from baseline to 6 months after surgery (total 9-month evaluation period). This ongoing portion of the study includes 33 patients (48 percent male, 52 percent female) at an average age of 63, 94 percent of whom underwent surgery. Patients completed the Lung Cancer Symptom Scale (LCSS) (an instrument used to assess health-related quality of life in patients with lung cancer) at baseline and every three months after surgery.
Gemzar
Gemzar is one of the most widely studied treatments in the history of chemotherapy agents, and has been approved for use in more than 90 countries worldwide. It is the worldwide standard for care of pancreatic cancer and in many parts of the world for non-small cell lung, bladder and breast cancers.
Gemzar is approved in more than 60 countries as a single agent for the treatment of locally advanced or metastatic pancreatic cancer. It is also approved, in combination with Taxol(R) (paclitaxel), in more than 30 countries for the treatment of metastatic breast cancer. In most European countries, Gemzar is approved as a single agent or in combination with cisplatin for the treatment of advanced non-small cell lung cancer.
Gemzar, in combination with carboplatin, is approved in several European markets for the treatment of recurrent epithelial ovarian cancer. Most recently, Gemzar was approved in Mexico for cervical cancer, making it the first approval for this disease. Gemzar is a nucleoside analogue that interferes with the process of DNA production; thereby preventing cancer cells from replicating and thus slows or stops tumor growth. 
- The study results were presented at the 41st annual meeting of the American Society of Clinical Oncology (ASCO)
www.lilly.com
Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available at http://www.lilly.com/ . P-LLY
This press release contains forward-looking statements about Gemzar in combination with Taxotere and reflects Lilly's current beliefs. However, as with any pharmaceutical product under development, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that the product will receive additional regulatory approvals and there is also no guarantee that the product will continue to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filing with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
(1) Evaluating the Impact of Neoadjuvant Chemotherapy and Surgery on Quality of Life (QL) in Patients with Early Stage NSCLC: A Prospective Analysis as part of the GINEST Project; RJ Gralla, MJ Edelman, FC Detterbeck, TM Jahan, D Loesch, S Limentani, R Govindan, CK Obasaju, MA Socinski (Abstract # 8092)
(2) Neoadjuvant Chemotherapy with Gemcitabine-containing Regimens in Patients with Early Stage Non-small Cell Lung Cancer (NSCLC): Initial Results of the GINEST Project; F. Detterbeck, MA Socinski, RJ Gralla, MJ Edelman, TM Jahan, D Loesch, S Limentani, R Govindan, LP Bloss, CK Obasaju (Abstract # 7215)
(3) Neoadjuvant chemotherapy with gemcitabine-containing regimens in stage I-II Non-Small Cell Lung Cancer (NSCLC): Initial Results of pre- operative pulmonary function testing (PFTs) in the GINEST Project; MP Rivera, FC Detterbeck, MA Socinski, D Moore, MJ Edelman, TM Jahan, R Ansari, J Luketich, CK Obasaju, RJ Gralla (Abstract # 7227)
(4) F. Detterbeck (Abstract # 7215)
(5) MP Rivera (Abstract # 7227)
(6) RJ Gralla (Abstract # 8092)
(7) Ibid.
(8) F. Detterbeck (Abstract # 7215)
(9) "Global cancer rates could increase by 50% to 15 million by 2020." World Health Organization 3 April 2003; Accessed 26 April 2005 http://www.who.int/mediacentre/news/releases/2003/pr27/en/
Gemzar(R) (gemcitabine HCl, Lilly)
Taxol(R) (paclitaxel, Bristol-Myers Squibb)
CONTACT: Gregory L. Clarke (U.S. Media), +1-317-276-5222,pager: +1-877-892-7864, or Carla L. Cox (non-U.S. Media), +1-317-651-1473,pager: +1-888-446-5740, both of Eli Lilly and Company
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