A new option for metastatic breast cancer

Gemzar (gemcitabine hydrochloride) is proven to be active in a number of tumour types, including non-small cell lung cancer, adenocarcinoma of the pancreas and bladder cancer.3 Now, Gemzar is approved for use, in combination with paclitaxel,for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant or neoadjuvant chemotherapy (prior chemotherapy should have included an anthracycline unless clinically contraindicated).3 Gemzar + paclitaxel versus paclitaxel monotherapy: greater efficacy and manageable toxicity4

A multicentre, international phase III study found that Gemzar in combination with paclitaxel produced significant efficacy advantages over paclitaxel alone.4 The Gemzar combination regimen (Gemzar 1250 mg/m 2 d1, 8 + paclitaxel 175 mg/m 2 d1 q21d) significantly improved time to progression (5.4 months vs 3.5 months, p = 0.0013)and overall response rate (39.3% vs 25.6%, p = 0.0007) compared with paclitaxel monotherapy (175 mg/md1 q21d). Haematological toxicities were more frequent in the combination arm but investigators reported that toxicities were manageable in both arms, and there were no significant differences between arms in pain scores or quality of life. The primary endpoint of median survival has not yet been reached and final data are expected in late 2004. The low incidence of symptomatic toxicities such as alopecia, nausea and vomiting with Gemzar monotherapy make it a rational addition to taxane-based regimens.5-8References: 1. Sandler AB et al. J Clin Oncol 2000; 18: 122-30 2. Thatcher N et al. Eur J Cancer 1997; 33 (Suppl. 1): S8-13. 3. Gemzar Approved Product Information.4. O’Shaughnessy J et al. Proc Am Soc Clin Oncol 2003; 22: Abstract 25. 5. Eli Lilly. Overview of Gemzar (gemcitabine HCl) plus taxanes in the treatment of metastatic breast cancer. Indianapolis: Eli Lilly, 2003. 6. Schmid P et al. Anticancer Drugs 1999; 10: 625-31. 7. Murad AM et al. Oncology (Huntingt) 2001; 15 (2 Suppl. 3): 25-7. 8. Georgoulias VA. Oncology (Huntingt) 2001; 15 (2 Suppl. 3): 18-24. Eli Lilly Australia Pty Ltd, ACN 000 233 992, 112 Wharf Road, West Ryde NSW 2114, Australia. Gemzar is a registered trademark of Eli Lilly. PL52419 ELI1070/01/04