Cervical Cancer: Avastin Safety Profile

Persistent, recurrent, or metastatic cervical cancer (CC)
Avastin, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer.

Boxed WARNINGS

  • Gastrointestinal (GI) perforation
    • Discontinue for gastrointestinal perforation
  • Surgery and wound healing complications
    • Withhold Avastin for at least 28 days prior to elective surgery. Do not administer Avastin for at least 28 days after surgery and until the wound is fully healed
    • Discontinue in patients with wound healing complications requiring medical intervention
  • Hemorrhage
    • Severe or fatal hemorrhage have occurred
    • Do not administer Avastin to patients with serious hemorrhage or recent history of hemoptysis
    • Discontinue for Grade 3-4 hemorrhage

Safety profile of Avastin in CC was evaluated in the GOG-0240 study: Avastin plus chemotherapy vs chemotherapy alone

Grade 1–4 adverse reactions observed in the GOG-0240 study (with incidence difference of ≥5% between treatment arms)[1]  

Adverse reaction Patients (%)
Avastin + chemotherapy
(n=218)
Chemotherapy alone
(n=222)
Metabolism and nutrition disorders    
Decreased appetite 26 19
Hyperglycemia 34 26
Hypomagnesemia 24 15
Weight decreased 21 7
Hyponatremia 19 10
Hypoalbuminemia 16 11
General disorders    
Fatigue 80 75
Edema peripheral 15 22
Infections and infestations    
Urinary tract infection 22 14
Infection 10 5
Vascular disorders    
Hypertension 29 6
Thrombosis 10 3
Nervous system disorders    
Headache 22 13
Dysarthria 8 1
Gastrointestinal disorders    
Stomatitis 15 10
Proctalgia 6 1
Anal fistula 6 0
Blood and lymphatic system disorders    
Neutropenia 12 6
Lymphopenia 12 5
Psychiatric disorders    
Anxiety 17 10
Reproductive system and breast disorders    
Pelvic pain 14 8
Respiratory, thoracic, and mediastinal disorders    
Epistaxis 17 1
Renal and urinary disorders    
Blood creatinine increased 16 10
Proteinuria 10 3

Chemotherapy included either cisplatin/paclitaxel or topotecan/paclitaxel.

Boxed WARNINGS

  • Gastrointestinal (GI) perforation
    • Discontinue for gastrointestinal perforation
  • Surgery and wound healing complications
    • Withhold Avastin for at least 28 days prior to elective surgery. Do not administer Avastin for at least 28 days after surgery and until the wound is fully healed
    • Discontinue in patients with wound healing complications requiring medical intervention
  • Hemorrhage
    • Severe or fatal hemorrhage have occurred
    • Do not administer Avastin to patients with serious hemorrhage or recent history of hemoptysis
    • Discontinue for Grade 3-4 hemorrhage

Indication-specific adverse events

  • In CC, grade 3 or 4 adverse reactions in Study GOG-0240, occurring at a higher incidence (≥2%) in 218 patients receiving Avastin plus chemotherapy compared to 222 patients receiving chemotherapy alone, were abdominal pain (12% vs 10%), diarrhea (6% vs 3%), anal fistula (4% vs 0%), proctalgia (3% vs 0%), urinary tract infection (8% vs 6%), cellulitis (3% vs 0.5%), fatigue (14% vs 10%), hypertension (11% vs 0.5%), thrombosis (8% vs 3%), hypokalemia (7% vs 4%), hyponatremia (4% vs 1%), dehydration (4% vs 0.5%), neutropenia (8% vs 4%), lymphopenia (6% vs 3%), back pain (6% vs 3%), and pelvic pain (6% vs 1%)