ABSTRACT
INTRODUCTION: Exisulind is an apoptotic agent with preclinical activity in non-small cell lung cancer (NSCLC). Vinorelbine is safe and effective in older patients with advanced NSCLC. We assessed these agents together as palliative treatment for older patients with advanced NSCLC. METHODS: Chemotherapy-naive patients >/=70-years-old with stage IIIB-IV NSCLC and a performance status (PS) =2 were eligible. Primary endpoints were the maximum tolerated dose (phase I) and time-to-progression (phase II) of oral exisulind with 25 mg/m/wk of intravenous vinorelbine on a 28-day cycle. Patients with clinical benefit after 6 cycles of this combination received exisulind alone. RESULTS: Fourteen phase I patients (median PS 1; median age 78 years) were enrolled. Dose-limiting toxicities included grade 3 constipation (one patient), grade 3 febrile neutropenia (one patient) and grade 3 diarrhea (one patient). The maximum tolerated dose of oral exisulind with 25 mg/m/wk of intravenous vinorelbine was 125 mg twice daily. Thirty phase II patients (median PS 1; median age 78 years) were enrolled. Grade >/=3 neutropenia occurred in 14/30 patients. Two patients experienced neutropenic fever. There were no complete responses, one partial response and 12 patients with stable disease as their best response. The objective response rate was 4.0% (95% CI: 0.1-20.4%). Phase II median time-to-progression was 4.7 months (95% CI: 3.1-9.3 months) and median OS was 9.6 months (95% CI: 6.6-19.1 months). CONCLUSIONS: This combination is safe, seems to have activity in the elderly with advanced NSCLC and a PS =2, and warrants further investigation.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma, Non-Small-Cell Lung/drug therapy , Lung Neoplasms/drug therapy , Aged , Aged, 80 and over , Carcinoma, Non-Small-Cell Lung/pathology , Female , Humans , Lung Neoplasms/pathology , Male , Maximum Tolerated Dose , Neoplasm Staging , Prognosis , Sulindac/administration & dosage , Sulindac/analogs & derivatives , Survival Rate , Vinblastine/administration & dosage , Vinblastine/analogs & derivatives , VinorelbineABSTRACT
BACKGROUND: Lung cancer is a disease with a stigma of being primarily self-induced. We hypothesize that this negative connotation for patients and physicians could lead to differences in referral patterns, treatment, and, ultimately, poorer outcomes compared with patients with non-self-induced diseases. We conducted a survey of primary care physicians to determine whether treatment and referral patterns of breast cancer patients differed from those of lung cancer patients. METHODS: Case scenarios were mailed to 1132 primary care physicians in Wisconsin. Physicians were randomized to receive one of four scenarios on the basis of cancer type and smoking status. Physicians' referral patterns, length of follow-up, and knowledge about the benefits of chemotherapy were compared. RESULTS: Six hundred seventy-two physicians replied (response rate 59.4%). On the basis of the responses to the clinical scenarios, physicians were less likely to refer patients with advanced lung cancer than patients with advanced breast cancer (p < 0.001). More physicians knew that chemotherapy improved survival in advanced breast cancer than in advanced lung cancer (p = 0.0145). Breast cancer patients were more likely to be referred for further therapy, whereas lung cancer patients were often referred only for symptom control (p = 0.0092). Yet, when asked directly, physicians stated that type of cancer was not a factor in their decisions to refer patients. There were no statistically significant differences between smoking and nonsmoking patients. CONCLUSIONS: There is a difference in referral patterns and a lack of knowledge in the primary care community regarding the benefit of treatment of patients with lung cancer compared with breast cancer patients.