Stabilization of disease as an indicator of clinical benefit associated with chemotherapy in non-small cell lung cancer patients

In Phase II oncology studies, response rate has traditionally been used to assess activity. However stabilization of disease (SD) may also provide pat ient benefit. To assess the value of SD (stabilization of measurable diseas e for at least 8 weeks) as a predictor of survival following chemotherapy i n patients with non-small cell lung cancer (NSCLC), we have analyzed data f rom 198 NSCLC patients receiving topotecan i.v. or orally as first-line the rapy either as single agent or in combination. Proportional hazards (Cox) r egression models showed that responders [complete response (CR) + partial r esponse (PR), 1.5% and 11.6% respectively] had an estimated risk of death t hat was 9.8% (95% CI: 4.2% to 22.7%) of that for progressive disease (PD) ( 60.1% of the patient population). Similarly, patients with SD (26.8% of the patient population) showed a potential benefit with a risk of death that w as 27.7% of the one of patients with PD (95% CI: 17.8% to 43.1%). In conclu sion SD may be a useful indicator of patient benefit from chemotherapy for NSCLC.