LONDON, UKThe combination of gemcitabine (Gemzar)/carboplatin (Paraplatin)
was found to be better tolerated and associated with longer survival than MIP (mitomycin
[Mutamycin], ifosfamide [Ifex], and 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 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, 6 mg/m², ifosfamide 3 g/m²,
and cisplatin 50 mg/m², all on day 1.
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.