Eli Lilly and Company announced that phase-III trial data showed the addition of Lilly's Gemzar (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.

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 am EDT, and as an oral presentation at the meeting at 10:30 a.m. EDT (ASCO Abstract #CRA5507).

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 per cent vs. 65 per cent, 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 anaemia (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 decade," said study lead author Alfonso Duenas-Gonzalez, 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, 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 one. 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).