PD4-2-4: Outcome of patients with WHO performance status 2 in a randomized trial comparing vinorelbine/carboplatin with gemcitabine/carboplatin in advanced NSCLC

Abstract

Outcome of patients with WHO performance status 2 in a randomized trial comparing vinorelbine/carboplatin with gemcitabine/carboplatin in advanced NSCLC Helbekkmo, Nina1,6 Aaseboe, Ulf2,6 Sundstrom, Stein H.3 Plessen, Christian v.4,6 Brunsvig, Paal F.5 Bremnes, Roy M.6,7 1 Dept. of Oncology, Universital Hospital of Northern Norway and Institute of Clinical Medicine, University of Tromsoe, Tromsoe, Norway 2 Dept of Pulmonology, University Hospital of Northern Norway, Tromsoe, Norway 3 Dept of Oncology, St. Olavs University Hospital, Trondheim, Norway 4 Dept of Thoracic Medicine, Haukeland University Hospital and Institute of Medicine, University of Bergen, Bergen, Norway 5 Dept of Oncology, Rikshospitalet-Radiumhospitalet, Oslo, Norway 6 Institute of Clinical Medicine, University of Tromso, Tromsoe, Norway 7 Dept of Oncology, University Hospital of Northern Norway, Tromsoe, Norway Background: In a national multicenter phase III study in stage IIIB and IV NSCLC patients, comparison of three cycles of vinorelbine/carboplatin (VC) to three cycles of gemcitabine/carboplatin (GC) concluded with equal survival in the two treatment arms. Hematological toxicity requiring interventions was more frequent in the GC arm but significant differences in quality of life (QOL) were not revealed. PS2 is the most powerful predictor of survival in patients with advanced NSCLC. Since single drug or combination chemotherapy to PS2 patients with advanced NSCLC still is controversial, outcomes following 2-drug combination treatment in this subpopulation were explored. Methods: In the main study of 432 randomized patients, median age was 67 years, 20% were ≥ 75 years old, 71% had stage IV disease and 28% PS 2. The PS2 subpopulation consisted of 123 patients, 62 in the VC and 61 in the GC arm. The total PS2 group and subgroups according to treatment were analyzed with respect to survival, QOL, and toxicity including required interventions. The PS2 group was then compared to PS0/1 with respect to the same variables. Results: Follow-up time was minimum two years. Baseline characteristics were well balanced between PS2 and PS0/1. Planned treatment (three cycles) was completed in 68 % of PS2 versus 85% of PS0/1 patients (p<0.01), and reasons for drop-out were similar in the two subgroups. Median, 1-year and 2-year survival was lower in the PS2 group, 4.5 vs. 8.9 months, 10 % vs. 37 % and 2 % vs. 8.5 %, respectively (p<0.01). Patients with PS2 received significantly less palliative radiotherapy and second-line chemotherapy than the PS0/1 patients. Compared to PS0/1, PS2 patients had lower mean hemoglobin (p<0.01), more need of blood transfusions (p<.01), and more registered hospital admissions due to side effects (p=0.02). Regarding QOL, PS2 patients had significantly lower compliance regarding questionnaire completion and they had more cancer related symptoms at baseline. But global QOL improved and they achieved clinically meaningful pain relief during and after treatment. Conclusions: As expected, patients with PS2 had shorter survival, more anemia and more admissions due to side-effects. More important is that chemotherapy led to improved QOL also in PS2 patients. PD4-2-5 Cytotoxic Chemotherapy I, Tue, 16:00 17:30