Résumé
Patients with untreated, stage IV, non small cell lung cancers (NSCLC); aged
≤
75; WHO PS
≤
I; normal hematologic renal and hepatic baseline value have been selected for (treatment with the new Topolsomerase I inhibitor CPT 11 delivered as a 30’ IV infusion every 3 weeks at the dose of 350
mg/m
2. Nineteen patients have been so far entered (M/F: 15/4; median age 62 (41–75); PS 0: 26%, 1: 63%,2: 11%); median number of involved organs: 3 (1–6) with lung in 30%, mediastinum in 21%, bone in 8% and liver in 5% of patients.
All patients but one were chemotherapy naive.
Patients have received 74 cycles (96% at the planned dose) and the median Relative Dose Intensity was 0.99.
(Preliminary Results) PR: 4; NC: 5; PD: 6; not evaluable: 4.
The following grade 3 or 4 toxicities have been observed: (% of patients) neutropenia: 28%; delayed diarrhea:. 26%; nausea/vomiting: 26%; anemia: 22%. An early cholinergic-like syndrome, never severe, was frequently observed. The most common symptom was diffuse sweating in 16% of patients. One toxic death occurred due to the combination of diarrhea and infection.
Severe neutropenia combined to severe diarrhea is the limiting toxicity. From these preliminary results, CPT 11 could be an effective drug in NSCLC, as formerly shown in Japanese studies.