Cervical Cancer: Avastin Efficacy Data

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.

Avastin plus chemotherapy demonstrated statistically significant overall survival (OS) vs chemotherapy alone in CC in the GOG-0240 study[1]

GOG-0240 study: OS results in CC patients

  • 3.9-month increase in median OS: 16.8 months with Avastin plus chemotherapy vs 12.9 months with chemotherapy alone[1]
    • Hazard ratio (HR)=0.74 (95% confidence interval [CI], 0.58–0.94); P=0.0132

Chemotherapy included either cisplatin/paclitaxel or topotecan/paclitaxel.
GOG=Gynecologic Oncology Group.

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

GOG-0240 study: Efficacy data overview[1]

Endpoint   Avastin + chemotherapy Chemotherapy alone HR (95% CI) P value
  Number of patients 227 225    
Primary OS (median) 16.8 months 12.9 months 0.74 (0.58–0.94) 0.0132
Secondary ORR 45% (95% CI, 39%–52%) 34% (95% CI, 28%–40%)    

Chemotherapy included either cisplatin/paclitaxel or topotecan/paclitaxel.
ORR=overall response rate.

Avastin plus chemotherapy demonstrated increases in OS and ORR[1]

  • A 30% increase in median OS vs chemotherapy alone (16.8 vs 12.9 months)
  • A 26% reduction in the risk of death vs chemotherapy alone
     

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

OS results by chemotherapy regimen (platinum doublet vs nonplatinum doublet) were also evaluated in the GOG-0240 study, regardless of combination with Avastin[1]

Chemotherapy analysis of the GOG-0240 study: platinum doublet vs nonplatinum doublet

  Topotecan/paclitaxel ± Avastin
(n=223)
Cisplatin/paclitaxel ± Avastin
(n=229)
Median OS (months) 13.3 15.5
HR 1.15 (95% CI, 0.91–1.46)
P=0.23
 
  • HR for OS with Avastin plus cisplatin/paclitaxel vs cisplatin/paclitaxel alone was 0.72 (95% CI, 0.51–1.02)
  • HR for OS with Avastin plus topotecan/paclitaxel vs topotecan/paclitaxel alone was 0.76 (95% CI, 0.55–1.06)

The GOG-0240 study evaluated Avastin plus chemotherapy vs chemotherapy alone for CC[1,16]

  • The GOG-0240 study was a randomized, active-controlled, multicenter study conducted in the US and Spain through GOG and the Spanish Research Group for Ovarian Cancer, and was sponsored by the National Cancer Institute
  • The primary endpoint of the GOG-0240 study was OS, and the secondary endpoint was ORR

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

The GOG-0240 study included a diverse population of women with CC[1]

Patient characteristics All patients randomized at baseline
(N=452)
Median age (range) 48 years (20–85)
Race
Caucasian
Non-Caucasian

78%
22%
Prior radiation 80%
Prior chemotherapy concurrent with radiation 74%
Platinum-free interval <6 months 32%
GOG PS
0
1

58%
42%
Demographic and disease characteristics were balanced across arms

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