Table 1.
Pivotal Phase III studies of bev in NSCLC: ECOG4599 and AVAiL
| ECOG 459913 | AVAiL28 | |
|---|---|---|
| Eligibility criteria | ||
| Diagnoses | Stage IIIB, IV, or recurrent | Stage IIIB, IV, or recurrent |
| Histology | No predominantly squamous-cell cancer | Only nonsquamous NSCLC |
| Age | ≥18 years | ≥18 years |
| Performance Status | ECOG 0–1 | ECOG 0–1 |
| Main exclusion criteria | – Significant hemoptysis | – Significant hemoptysis |
| – CNS metastases | – CNS metastases | |
| – Hemorrhagic diathesis | – History of thrombotic or hemorrhagic disorders | |
| – Coagulopathy | – Therapeutic anticoagulation | |
| – Therapeutic anticoagulation | – Use of aspirin | |
| – Use of aspirin | – Uncontrolled hypertension | |
| – Uncontrolled hypertension | – Tumors invading or abutting major blood vessels | |
| Treatment arms | Arm 1: bev + carbo + pac | Arm 1: cis + gem + bev 7.5 mg/kg |
| Arm 2: carbo + pac | Arm 2: cis + gem + bev 15 mg/kg Arm 3: cis + gem + placebo |
|
| Primary endpoint | OS | PFS |
| Results | Improvement in OS, PFS, ORR with bev | Improvement in PFS and ORR with both doses of bev No significant difference in OS |
Abbreviations: bev, bevacizumab; carbo, carboplatin; cis, cisplatin; CNS, central nervous system; ECOG, Eastern Cooperative Oncology Group; gem, gemcitabine; NSCLC, non-small-cell lung cancer; ORR, objective response rate; OS, overall survival; pac, paclitaxel; PFS, progression-free survival.