A phase II/III randomized study in advanced non-small cell lung cancer (NSCLC) with first line combination versus sequential gemcitabine (G) and docetaxel (D): Update on quality of life (QoL), toxicity, and costs

Abstract

7057 Background: Single-agent gemcitabine (G) and docetaxel (D) are not cross-resistant and are effective in chemotherapy-naïve and pretreated patients (pts). The study was to evaluate the clinically, relevant hematologic toxicity (CRHT) in two treatment settings. Interim analysis including survival has been previously presented (ASCO 2004 abstract no. 7095). Methods: Pts received G/D in doses of 1000 mg/m2 /75 mg/m2/q3w either concomitantly in arm A: {G days 1,8 + D day 8 for 6 cycles} or sequentially in arm B: {G: days 1,8 for 3 cycles followed by D: day 1 for 3 cycles}. NCI-CTC grade 3–4 thrombocytopenia requiring transfusion, anaemia requiring transfusion or febrile neutropenia requiring IV antibiotics were defined as CRHT. Results: The table shows the characteristics, costs, and the outcome for 292 pts. In arm B pts received 69% of G and 46% of D of mean doses in arm A, respectively. In arm B CRHT appeared less often (anaemia, p=0.038 and febrile neutropenia, p=0.037, respectively). Interventions (transfusion and IV antibiotic treatment days) were more frequently with Arm A. QoL according to EORTC-LC13 measurement also favored Arm B. Overall survival as reported earlier was not different. Conclusion: Treatment costs are significantly lower if both drugs are given sequentially. Coevally there is more CRHT with concomitant drug application by higher transfusion rates and antibiotic treatment days as with sequential application. From the data available there is no indication that efficacy will differ. Arm A: combination G+D (n=152) Arm B: sequential G→D (n=140) Arm A: combination (n=552 cycles) Arm B: sequential (n=563 cycles) Baseline characteristics Toxicities: CRHT grade 3–4 (cycles) Gender (m/f) 115/37 106/24 Anaemia / transf. 14 5 Median age, years [range] 63.2 [36.6–78.7] 64.4 [39.7–81.2] Thrombocytopenia / transf. 1 1 WHO PS (0–1/1) 128/24 121/19 Febrile neutropenia / IV antibiotics 7 1 Histology: adeno/squamous/other 66/48/38 59/39/42 All interventions Stage IIIB/IV 22/130 21/119 RBC transf. (units) 81 43 Total dosage per patient in mg Platelet transf. (units) 1 2 G 12237 8407 IV antibiotics (treatment days) 400 220 D 433 201 Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Eli Lilly Eli Lilly, sanofi-aventis Eli Lilly, sanofi-aventis