Table 5 Comparison of Key Parameters in Trials with Bevacizumab 1 L Chemotherapy for NSCLC
From: AVAiLABLE NIS – AVASTIN® in lung cancer treatment in routine oncology practice in Germany
AVAiLABLE (N = 987) | ARIES (N = 1967) | SAiL (N = 2212) | AVAiL (N = 345) / (N = 351) | E4599 (N = 434) | |
|---|---|---|---|---|---|
Study design | NIS | NIS | Phase IV | RCT | RCT |
Study duration | 09/2007–10/2013 | 11/2006–03/2012 | 08/2006–07/2009 | 02/2005–10/2006 | 07/2001–04/2004 |
Bevacizumab dosage | Investigator’s choice: 65% pts. 7.5 mg/kg, 20% pts. 15 mg/kg, 15% pts. other dosage; median dose: 7.5 mg/kg | Investigator’s choice | Investigator’s choice: 261 (12%) pts. 7.5 mg/kg, 1947 (88%) pts15 mg/kg | 7.5 mg/kg / 15 mg/kg | 15 mg/kg |
Chemotherapy regimen, patients (%) | Investigator’s choice: 90.7% platinum regimens | Investigator’s choice: 89.9% (1768 pts) platinum-doublets | Investigator’s choice: 86% (1916 pts) platinum-doublets | per protocol: cisplatin + gemcitabine | per protocol: carboplatin + paclitaxel |
Adenocarcinoma histology, patients (%) | 859 (90.1%) | 1363 (69.3%) | 1781 (86%) | 293 (85%) / 300 (85%) | 366 (88%) |
ORR (%) | 45.6 (based on 976 pts) | 49.0 | 51.5 | 37.8 /34.6 | 35 |
Overall median PFS/TTP, [months] (95% CI) | PFS 7.4 (7.1–8.4) (based on 423 pts) | PFS 6.6 (6.3–6.9) | TTP 7.8 (7.5–8.1) | PFS 6.7 / PFS 6.5 [8] | PFS 6.2 |
Bevacizumab maintenance | 314 pts. (45%, based on 697 pts), thereof 166 (53%) more than 6 cycles | 530 pts. post induction therapy [18] | 1047 pts. post induction therapy [19] | 145 pts. (42%) / 145 pts. (41%) | 215 pts. (53%), thereof 107 (50%) more than 5 cycles |
Median OS, [months] (95% CI) | not applicable | 13.0 (12.2–13.8) | 14.6 (13.8–15.3) | 13.6 (11.8–15.8)/13.4 (11.1–15.1) [20] | 12.3 |
Median treatment duration with bevacizumab, (range) | 125.5 (approx. 17.9 weeks) (1–1332) days; 6.0 cycles (0–86 cycles) | 3.7 (0.1–49.3) months (approx. 15.9 weeks); 6 doses (1–88 doses) | 21.3 weeks (0.1–132.3; 9.1–36.4) | 4.9 cycles (approx. 14.7 weeks)/4.4 cycles (approx. 13.2 weeks) | 7 cycles (approx. 21 weeks) |
Duration of follow-up (FU) | one month FU after last bevacizumab administration per patient | median 12.5 months (range 0.2–65.5) | mean 380.4 days (±215.8 days; 12.5 months) | 12.5 months/12.9 months | 2-years OS Data [21] |
Safety | bevacizumab-related ADRs: 266 (27.0%); total ADRs: 4991; pts. with ADRs: 874 (88.6%) | grade ≥ 3 bevacizumab-related AE incidence: 19.7% | AEs of special interest for bevacizumab: 3821 | grade ≥ 3 events: 252 (76%)/265 (81%) | only events grade ≥ 3 and hematologic events grade ≥ 4: 263 |