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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

decade," said study lead author Alfonso Duenas-Gonzalez, M.D., Ph.D., Investigador de la Unidad de Investigacion Biomedica en Cancer, Instituto Nacional de Cancerologia e Instituto de Investigaciones Biomedicas in Mexico.

"Lilly continues to look for ways to improve the survival of people living with cancer and fill unmet needs in difficult to treat cancers," said Richard Gaynor, M.D., vice president, cancer research and global oncology platform leader for Lilly.

Researchers also found that overall survival (p=.0224) and time-to-progressive disease (p=.0008) improved significantly. However, results for these two secondary endpoints are considered interim.

The 515 patients had a median age of 46 years and had either stage IIB, III, or IVA carcinoma of the cervix. Patients in the trial were randomly assigned to two arms with well-balanced baseline characteristics between both. Patients on arm A were treated with cisplatin (40 mg/m(2)) and gemcitabine (125 mg/m(2)) weekly for six doses along with concurrent external radiation (50.4 Gy: 1.8 Gy/day, 5 days per week), followed by brachytherapy (30-35 Gy) and then two adjuvant 21-day cycles of gemcitabine (1000 mg/m(2)) on days 1 and 8 plus cisplatin (50 mg/m(2)) on day 1. Patients on arm B were treated with cisplatin (40 mg/m(2)) weekly for six doses along with concurrent external radiation (50.4 Gy: 1.8 Gy/day, 5 days per week), followed by brachytherapy (30-35 Gy).

Important Safety Information for GEMZAR (gemcitabine HCl for injection)

GEMZAR is indicated in combination with cisplatin (another type of chemotherapy) for the first-line treatment of patients with locally advanced (Stage IIIA or Stage IIIB) or metastatic (Stage IV or cancer that has spread) non-small cell lung cancer for whom surgery is not possible.

GEMZAR is indicated in combination with carboplatin (another type of chemotherapy) for the p
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SOURCE Eli Lilly and Company
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