LONDON, UK—The combination of gemcitabine(Drug information on gemcitabine) (Gemzar)/carboplatin (Paraplatin) was found to be better tolerated and associated with longer survival than MIP (mitomycin [Mutamycin], ifosfamide(Drug information on ifosfamide) [Ifex], and cisplatin(Drug information on cisplatin) [Platinol]) in patients with advanced non-small-cell lung cancer (NSCLC) in a multicenter phase III European trial (ASCO abstract 1164).
"Most patients presenting with non-small-cell lung cancer have received advanced surgery or radiotherapy," said Robin M Rudd, MD, department of medical oncology at St. Bartholomew’s Hospital, London. "There is evidence of a small survival advantage with cisplatin-based chemotherapy. Our aim was to reduce toxicity from the therapy and hospital admissions, while maintaining response rates and survival in these patients with essentially incurable disease and short life expectancy."
Less Toxic Treatment Sought
The MIP regimen is commonly used in Europe to treat NSCLC. The researchers hypothesized that combination therapy with gemcitabine and carboplatin(Drug information on carboplatin) might be less toxic and confer better quality of life while maintaining the survival advantage of cisplatin. Study endpoints were survival, response rates, toxicity, and quality of life.
Between February 1999 and August 2001, 422 patients were randomized into two study arms. Both received 21-day cycles for up to four courses. Patients in the first arm were given infusions of gemcitabine, 1,200 mg/m², on days 1 and 8 and carboplatin, AUC of 5, on day 1. The control arm received the well-established infusion regimen of mitomycin(Drug information on mitomycin), 6 mg/m², ifosfamide 3 g/m², and cisplatin 50 mg/m², all on day 1.
Study Population
Researchers enrolled patients who were fit to receive chemotherapy and had histologic confirmation of stage III or IV disease, and a greater than 8-week life expectancy. There was no upper age limit, and the median age was 62. The patients in both arms were well matched for age, sex, and histologic distribution, although there was a small excess of patients with stage IV disease and performance status 0-1 in the gemcitabine and carboplatin arm.
