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Study Showed Lilly's GEMZAR(R) (gemcitabine HCl for injection) Improved Progression-Free Survival in Cervical Cancer Patients
Date:5/31/2009

ORLANDO, Fla., May 31 /PRNewswire-FirstCall/ -- Eli Lilly and Company announced today that Phase III trial data showed the addition of Lilly's GEMZAR(R) (gemcitabine HCl for injection) to the current standard of care provided a statistically significant increase in progression-free survival at three years for women with locally advanced cervical cancer.

Cervical cancer is the world's second most commonly diagnosed women's cancer, and the second most common cause of cancer death in women.(1)

The current standard of care for women with locally advanced cervical cancer consists of the chemotherapy cisplatin and radiation (chemoradiation). This has been the recommended course of treatment since 1999.

Results from this global, multicenter, open-label, randomized Phase III trial were presented at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO) during an ASCO-sponsored press conference on May 31 at 8:30 a.m. EDT, and as an oral presentation at the meeting at 10:30 a.m. EDT (ASCO Abstract #CRA5507).(2)

With 515 patients evaluated, the data showed a statistically significant (p=0.029) increase in progression-free survival at three years for patients treated with the gemcitabine chemoradiation combination versus those treated only with chemoradiation (74% vs. 65%, respectively). Patients on the gemcitabine arm experienced significantly more grade 3/4 toxicities. Additionally, two patients on the gemcitabine arm died due to causes possibly attributed to treatment-related toxicities. Most side effects were hematologic, including anemia (low red blood cell count), neutropenia (low white blood cell count) and thrombocytopenia (low blood platelet count).

"While there have been tremendous advances in cervical cancer prevention in the form of early screening and vaccination, oncologists have essentially been using the same treatment standard for the last
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SOURCE Eli Lilly and Company
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