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Treating Lung Cancer Patients Earlier May Improve Outcomes

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http://www.medicalnewstoday.com/medical ... wsid=27215

Treating Lung Cancer Patients Earlier May Improve Outcomes

11 Jul 2005

Combination therapy with Lilly's Gemzar® May Provide Clinical Benefit in Early-Stage, Non-Small Cell Lung Cancer -

Building on the accepted practice of treating resected early-stage lung cancer with adjuvant chemotherapy, newer studies are evaluating chemotherapy in the neoadjuvant or preoperative setting. This approach may offer an increased benefit in achieving desired therapeutic outcomes for patients(1). By shrinking the tumor before surgery with three cycles of chemotherapy, patients may be able to undergo surgery to improve their chances of complete tumor removal and cure.

According to new data presented today by Eli Lilly and Company at the World Conference on Lung Cancer (WCLC), Gemzar®-based chemotherapy showed promise in the neoadjuvant setting for patients with early-stage, non-small cell lung cancer (NSCLC)(2). Gemzar (gemcitabine) is currently a standard of care for the treatment of advanced non-small cell lung cancer. In addition to its use in NSCLC, Gemzar is also approved in various countries around the world for the treatment of breast, pancreatic, bladder, ovarian and cervical cancers.

"This is promising data suggesting that gemcitabine-based therapy is well tolerated, appears active in this disease setting and warrants further investigation via a randomized phase III trial," said Mark A. Socinski, M.D., a member of the Multidisciplinary Thoracic Oncology Program of the Lineberger Comprehensive Cancer Center at the University of North Carolina at Chapel Hill. "The data derived from this phase II experience is encouraging. The ability to deliver chemotherapy known to be active in advanced NSCLC prior to surgical resection seems to improve the outcome of surgery in this disease."

The GINEST (Gemzar in Neoadjuvant Early Stage Trials) Project consisted of two similar phase II trials involving 83 patients with clinical Stage 1 (24 percent) and Stage II (76 percent) NSCLC. Patients in the first trial were randomized to receive Gemzar plus carboplatin or Gemzar plus Taxol® (paclitaxel) before surgery. In the second trial, patients were randomized to receive the same regimen of Gemzar/carboplatin or Gemzar/cisplatin. Of the patients treated with Gemzar plus platinum or non-platinum agents before surgery, 77 percent were able to proceed with surgery; of those patients, 91 percent experienced complete resection of their tumor.

Interim results showed that the use of Gemzar-based therapy prior to a lung resection is well tolerated and the majority of patients (76 percent) reported quality of life as improved or stable when evaluated six months after neoadjuvant treatment. The safety of Gemzar-based chemotherapy was assessed through the use of pulmonary function testing (evaluation of how well the lungs are working) and dyspnea scores (assessment of breathing difficulties) obtained pre- and post-chemotherapy. In addition, patients completed the Lung Cancer Symptom Scale (LCSS) before each chemotherapy cycle, pre-op and every three months post-op as a surrogate for quality of life.

Of the 83 patients, no patients experienced severe respiratory problems and only two were unable to undergo surgery due to reduced lung function. The most common side effects were blood-related with 24 patients (30 percent) experiencing Grade 3/4 leukopenia (an abnormal decrease in the number of white blood cells); and 8 patients (10 percent) experiencing Grade 3/4 thrombocytopenia (a decrease in the number of platelets in the blood).

Additional Gemzar Data Presented at WCLC

"Phase II trial of gemcitabine-carboplatin-paclitaxel (GCP) as neoadjuvant chemotherapy for operable non-small cell lung cancer (NSCLC)"

In an open-label, single-arm phase II trial, 33 patients (out off 44) being treated with GCP in the neoadjuvant setting prior to surgery showed partial response to chemotherapy for a response rate of 75 percent with 36 patients (81 percent) having undergone complete resection of their tumor. Most common side effects were Grade 3/4 leukopenia and Grade 3/4 thrombocytopenia, 77 percent and 25 percent respectively.

"The results of these studies support Gemzar's potential as a foundation of neoadjuvant chemotherapy for patients," said Edmundo Muniz, M.D., vice president of Lilly Research Laboratories and Oncology platform team leader. "Gemzar continues to be an innovative drug that improves patient outcomes with a manageable side-effect profile."


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 of care for pancreatic cancer and in many parts of the world for non-small cell lung and bladder 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® (paclitaxel), in more than 30 countries for the treatment of metastatic breast 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 appears to slow or stop tumor growth.

About Lung Cancer

According to the most recent World Health Organization Cancer Report, lung cancer is the world's most common cancer and the leading cause of cancer death for both men and women. There will be 1.2 million cases diagnosed this year around the world(3).

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.

Lilly Oncology

A pioneer and industry partner, Lilly Oncology is committed to delivering innovative treatment strategies and essential support programs that advance physician care and respond to patient needs. From chemotherapies that have become standards of care to novel targeted therapies currently being investigated, Lilly has been at the forefront of cancer research for more than 40 years. Lilly Oncology continues in its spirit of innovation with a broad product pipeline representing a vibrant and cutting edge research platform, built upon extensive medical expertise and human insight.

This press release contains forward-looking statements about the potential of Gemzar chemotherapy, particularly in the neoadjuvant setting, and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that the product will continue to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

Gemzar® (gemcitabine, Eli Lilly and Company) Taxol® (paclitaxel, Bristol Myers Squibb)

(1) Scagliotti, GV et al. Preliminary results of Ch.E.S.T.: A randomized phase III trial of surgery alone or surgery plus preoperative gemcitabine- cisplatin in clinical early stage non-small cell lung cancer (NSCLC). ASCO 2005 Abstract Book.

(2) Socinski MA, Detterbeck FC, Gralla RJ, Edelman MJ, Jahan TM, Loesch D, Limentani SA, Govindan R, Bloss LP and Obasaju CK. Induction Chemotherapy with Gemzar-containing Regimens in Stage I-II Non-small Cell Lung Cancer (NSCLC): Initial Results of the GINEST Project. Presented at WCLC 2005.

(3) World Health Organization Cancer Report, WHO. Globocan 2002: Cancer Incidence, Mortality, and Prevalence Worldwide, International Association of Cancer Registries. http://www-dep.iarc.fr/


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