Résumé
The standard combination chemotherapy of SCLC is an etoposide based regimen. After failure of this regimen the prognosis is very poor although the use of a rescue regimen still displays clinical activity.
It has been already suggested that investigational new drugs should to be assessed in second line therapy in SCLC and that a RR
≥
10% among 29 patients would be relevant for the screening of active new compounds.
CPT11 is a new DNA topoisomerase I inhibitor active in colorectal cancer and other solid adult tumors.
22 patients with progressive extensive SCLC after a prior response on a VP16-based chemotherapy have been so far entered onto the study. Sex ratio M/F
=
19/3; median age
=
57.2 (43–72). Performance Status 0
=
14%; 1
=
45%; 2
=
41%. Median number of involved organ 4 (1–6) with liver (27%), lung (22%), lymph nodes (16%) and brain (11% of patients).
57 cycles at the planned dose of 350
mg/m
2 every 3 weeks have been delivered with a median Relative Dose Intensity of 0.95 (0.78–1. 03).
Efficacy: One CR and three PR have been observed among the 15 evaluable patients.
Safety: The incidence of grade 3 and 4 toxicity per cycle has been: neutropenia: 49% (with febrile neutropenia sepsis in 14%), delayed diarrhea: 18%, nausea vomiting: 14%.
The activity of CPT 11 in SCLC is likely to be attractive on the basis of these preliminary data. Neutropenia is clearly the dose limiting toxicity in this population of pretreated patients with frequent occult bone marrow involvement.