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 patient benefit. To assess the value of SD (stabilization of measurable disease for at least 8 weeks) as a predictor of survival following chemotherapy in patients with non-small cell lung cancer (NSCLC), we have analyzed data from 198 NSCLC patients receiving topotecan i.v. or orally as first-line therapy either as single agent or in combination. Proportional hazards (Cox) regression models showed that responders [complete response (CR) + partial response (PR), 1.5% and 11.6% respectively] had an estimated risk of death that 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 was 27.7% of the one of patients with PD (95% CI: 17.8% to 43.1%). In conclusion SD may be a useful indicator of patient benefit from chemotherapy for NSCLC.
Amgen Inc., Thousand Oaks, CA 91320, USA.
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D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D002945:Cisplatin / Q000008:administration & dosage; D017322:Clinical Trials, Phase II as Topic; D016208:Databases, Factual; D018450:Disease Progression; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D017567:Karnofsky Performance Status; D015993:Life Tables; D008113:Liver Neoplasms / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009367:Neoplasm Staging; D016016:Proportional Hazards Models; D012074:Remission Induction; D012189:Retrospective Studies; D012306:Risk; D016019:Survival Analysis; D019772:Topotecan / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D019772:Topotecan; D002945:Cisplatin