Is symptom improvement in patients with small cell lung cancer (SCLC) associated with clinical response? An analysis using the Patient Symptom Assessment Lung Cancer (PSALC) scale in a randomized trial comparing oral topotecan (OT) with best supportive care (BSC)

Abstract

7725 Background: SCLC is a highly symptomatic disease with poor survival in prior treated patients. To evaluate the role of chemotherapy, a recent multicenter trial randomized 141 patients with prior treatment to receive either OT + BSC or BSC only. This was the first trial to use a BSC control group in SCLC while evaluating survival, response and symptoms. Survival data were reported (O'Brien et al JCO 2006; median survival of 25.9 weeks on OT + BSC vs 13.9 weeks on BSC, p = 0.01). 51% on OT had “disease control” (partial response [PR] + stable disease [SD]); no patient on BSC was reported to have a major response, although response was not an endpoint for this group. Trials have shown that those with progressive disease have the most symptom worsening, as occurred in this trial. The objective of this analysis is to determine if patients with PR report greater symptom relief than those with SD, in that SD can reflect a more indolent course in some patients while PR is due to treatment effect only. Methods: We used the investigators evaluation of response (PR or SD) and analyzed these groups by the patients’ scoring of their symptoms using the PSALC instrument which evaluates 9 SCLC symptoms, in the 71 patients on the OT + BSC arm. Results: Patients with lower ECOG PS at baseline reported more severe symptoms (higher PSALC score). Mean changes in PSALC score from baseline are shown in the Table and demonstrate an association between tumor response and decrease in symptoms. Conclusions: Patients who achieved a major response on OT treatment reported significantly better symptom control than those whose best response was SD. This indicates that in addition to a survival benefit, treatment with this chemotherapy can aid in symptom control. While the small number of patients limits the strength of the conclusions, this trial represents the largest BSC controlled study in SCLC. No significant financial relationships to disclose. [Table: see text]