New Data Show Gemzar(R)-Based Combination Therapies May Provide Significant Clinical Value in Early-Stage Non-Small Cell Lung Ca
17 May 2005 - 11:02PM
PR Newswire (US)
New Data Show Gemzar(R)-Based Combination Therapies May Provide
Significant Clinical Value in Early-Stage Non-Small Cell Lung
Cancer INDIANAPOLIS, May 17 /PRNewswire-FirstCall/ -- 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. 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) (Logo:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO DATASOURCE:
Eli Lilly and Company 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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