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Ovarian Cancer: Avastin Efficacy Data

Stage III or IV ovarian cancer (OC) after primary surgery
Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection.

Recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (rOC)
Avastin, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens.

Avastin, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. 

1L: GOG-0218 study results 2L: OCEANS study results 2L: GOG-0213 study results  2L/3L: AURELIA study results 
1L: GOG-0218 study results

Patients achieved a median PFS benefit of >6 months in stage III or IV ovarian cancer after primary surgery[1]

In the GOG-0218 study, median PFS with Avastin plus chemotherapy followed by single-agent Avastin was 18.2 months vs 12.0 months with chemotherapy alone[1] 

Avastin® (bevacizumab) GOG-0218 study median PFS KM curve

PFS=progression-free survival; GOG=Gynecologic Oncology Group; HR=hazard ratio; CI=confidence interval; CP=carboplatin + paclitaxel; PBO=placebo; AUC=area under the curve; q3w=every 3 weeks; KM=Kaplan-Meier; OS=overall survival.
CP+Avastin→Avastin=carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles, with concurrent Avastin started at cycle 2, followed by single-agent Avastin q3w for a total of up to 22 cycles of therapy.
CP+Avastin→PBO=carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles, with concurrent Avastin started at cycle 2, followed by placebo alone q3w for a total of up to 22 cycles of therapy.
CP+PBO→PBO=carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles, with concurrent placebo started at cycle 2, followed by placebo alone q3w for a total of up to 22 cycles of therapy.
*Survivor function at the far right of a KM survival curve should be interpreted cautiously since there are fewer patients remaining in the study group and the survival estimates are not as accurate.[18]

  • Median PFS: 18.2 months in the CP+Avastin→Avastin arm vs 12.0 months in the CP+PBO→PBO arm[1]
    • 38% reduction in the risk of progression in the CP+Avastin→Avastin arm as compared with the CP+PBO→PBO arm (HR=0.62 [95% CI, 0.52–0.75], P<0.0001)
    • The median PFS in the CP+Avastin→PBO arm was 12.8 months vs 12.0 months in the CP+PBO→PBO arm and was not statistically significant (HR=0.83 [95% CI, 0.70–0.98])
  • Median OS: 43.8 months in the CP+Avastin→Avastin arm vs 40.6 months in the CP+PBO→PBO arm (HR=0.89 [95% CI, 0.76–1.05]), and 38.8 months in the CP+Avastin→PBO arm vs 40.6 months in the CP+PBO→PBO arm (HR=1.06 [95% CI, 0.90–1.24])[1]

Select Important Safety Information

The Warnings and Precautions for Avastin include gastrointestinal perforation and fistulae, surgery and wound healing complications, hemorrhage, arterial thromboembolic events, venous thromboembolic events, hypertension, posterior reversible encephalopathy syndrome, renal injury and proteinuria, infusion-related reactions, embryo-fetal toxicity, ovarian failure, and congestive heart failure.

The GOG-0218 study: Study design and patient population[1,19]

GOG-0218 study design in stage III/IV ovarian cancer

PS=performance status; FIGO=International Federation of Gynecology and Obstetrics; IV=intravenous.
†Patients continued treatment for 22 cycles unless there was disease progression, unacceptable toxicity, or withdrawal.

  • GOG-0218 was a Phase III, multicenter, randomized, double-blind, placebo-controlled trial[1,19]
  • Overall, approximately 34% of patients had resected FIGO stage III with residual disease <1 cm, 40% had resected stage III with residual disease >1 cm, and 26% had resected stage IV disease[1]
  • At baseline, approximately 50% of patients had a GOG PS of 0 and 43% had a GOG PS score of 1. Patients had either epithelial ovarian cancer (83%), primary peritoneal cancer (15%), or fallopian tube cancer (2%)[1] 

Bevacizumab plus carboplatin and paclitaxel is a category 2A option for stage III−IV ovarian cancer per the National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology (NCCN Guidelines®)[20]‡ 

‡NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 

2L: OCEANS study results

Avastin plus chemotherapy (carboplatin and gemcitabine) resulted in significant improvement in PFS vs placebo plus chemotherapy in the OCEANS study (median 12.4 vs 8.4 months)[1]

OCEANS study: PFS results in patients with psOC who have not received prior chemotherapy in the recurrent setting or prior Avastin treatment[1]

  • Median PFS: 12.4 months with Avastin plus chemotherapy vs 8.4 months with placebo plus chemotherapy
    • Hazard ratio (HR)=0.46 (95% confidence interval [CI], 0.37–0.58), P<0.0001

Avastin® (bevacizumab) OCEANS Study KM Curve

PFS=progression-free survival; psOC=platinum-sensitive ovarian cancer.
PFS data are based on investigator assessment.

  • Objective response rate (ORR): 78% with Avastin plus chemotherapy vs 57% with placebo plus chemotherapy (P<0.0001)
  • Overall survival (OS): OS was not significantly improved with the addition of Avastin to chemotherapy (HR=0.95 [95% CI, 0.77–1.17])

Select Important Safety Information

The Warnings and Precautions for Avastin include gastrointestinal perforation and fistulae, surgery and wound healing complications, hemorrhage, arterial thromboembolic events, venous thromboembolic events, hypertension, posterior reversible encephalopathy syndrome, renal injury and proteinuria, infusion-related reactions, embryo-fetal toxicity, ovarian failure, and congestive heart failure.

OCEANS study: Efficacy data overview[1] 

Endpoint Avastin + chemotherapy (n=242) Placebo + chemotherapy (n=242) HR (95% CI) P value
PFS (main efficacy outcome measure) 12.4 months 8.4 months 0.46 (0.37–0.58) <0.0001
ORR (secondary outcome measure) 78% 57%   <0.0001

PFS data are based on investigator assessment.

Stage III or IV ovarian cancer (OC) after primary surgery
Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection.

Recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (rOC)
Avastin, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens.

Avastin, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

The OCEANS study evaluated Avastin plus chemotherapy vs placebo plus chemotherapy in psOC[1,21] 

Avastin® (bevacizumab) OCEANS Study Trial Design

ECOG=Eastern Cooperative Oncology Group; PS=performance status; IV=intravenous; q3w=every 3 weeks; AUC=area under the curve.

  • OCEANS was a Phase III, randomized, double-blind, placebo-controlled study
  • Eligibility criteria included: measurable disease at baseline
  • Ineligibility criteria included: prior chemotherapy in the recurrent setting or prior Avastin treatment
  • Stratification factors included: platinum-free interval of 6–12 months, >12 months

The OCEANS study included a diverse population of women[1,21] 

Baseline patient characteristics
Age Median age
Range
≥65 years
<65 years		 61 years
28–87 years
37%
63%
ECOG PS 0
1
2		 75%
24%
<1%
Measurable disease Measurable disease at baseline
Baseline CA-125 levels above ULN (>35 U/mL)		 100%
74%
Platinum-free interval 6–12 months
>12 months		 42%
58%

CA=cancer antigen; ULN=upper limit of normal. 

2L: GOG-0213 study results 

Avastin plus chemotherapy (carboplatin and paclitaxel) demonstrated a 5.3-month increase in median OS compared with chemotherapy alone in the GOG-0213 study (42.6 vs 37.3 months)[1]

GOG-0213 study: OS results in patients with psOC who have not received more than 1 prior chemotherapy regimen[1]

  • Median overall survival (OS): 42.6 months with Avastin plus chemotherapy vs 37.3 months with chemotherapy alone
    • Hazard ratio (HR)=0.84 (95% confidence interval [CI], 0.69–1.01 [IVRS]); HR=0.82 (95% CI, 0.68–0.996 [eCRF])

Avastin® (bevacizumab) GOG-0213 Study KM Curve

GOG=Gynecologic Oncology Group; psOC=platinum-sensitive ovarian cancer; IVRS=interactive voice response system; eCRF=electronic case report form.

  • Median progression-free survival (PFS): 13.8 months with Avastin plus chemotherapy vs 10.4 months with chemotherapy alone (HR=0.61 [95% CI, 0.51–0.72] [IVRS])
  • Objective response rate (ORR): 78% with Avastin plus chemotherapy vs 56% with chemotherapy alone

Select Important Safety Information

The Warnings and Precautions for Avastin include gastrointestinal perforation and fistulae, surgery and wound healing complications, hemorrhage, arterial thromboembolic events, venous thromboembolic events, hypertension, posterior reversible encephalopathy syndrome, renal injury and proteinuria, infusion-related reactions, embryo-fetal toxicity, ovarian failure, and congestive heart failure.

GOG-0213 study: Efficacy data overview[1] 

Endpoint Avastin + chemotherapy Chemotherapy alone HR (95% CI)
OS (main efficacy outcome measure) 42.6 months (n=337) 37.3 months (n=336) 0.84
(0.69–1.01 [IVRS])
0.82
(0.68–0.996 [eCRF])
PFS (additional efficacy outcome measure) 13.8 months (n=337) 10.4 months (n=336) 0.61
(0.51–0.72 [IVRS])
ORR (exploratory efficacy outcome measure) 78% (n=274)* 56% (n=286)*  

*Number of patients with measurable disease at baseline.

The GOG-0213 study evaluated Avastin plus chemotherapy vs chemotherapy alone in psOC[1,3] 

Avastin® (bevacizumab) GOG-0213 Study Trial Design

PS=performance status; IV=intravenous; q3w=every 3 weeks; AUC=area under the curve.

  • GOG-0213 was a Phase III, randomized, controlled, open-label study[1,3]
  • Eligibility criteria included: prior Avastin allowed
  • Ineligibility criteria included: symptoms or diagnosis of bowel obstruction
  • Stratification factors included: participation in surgical randomization (yes or no), and treatment-free interval prior to study enrollment (6–12 or >12 months)[1,3]
  • 10.3% of platinum-sensitive patients enrolled in GOG-0213 received prior bevacizumab

Patients who progress after 6 months with platinum therapy are considered platinum sensitive[1] 

GOG-0213 Clinical Study Patient Disease Progression Timeline
  • Upon completion of indicated cycles of combination therapy, Avastin is indicated for continued use as a single agent until disease progression in patients with platinum-sensitive recurrent ovarian cancer

GOG-0213 did not exclude patients who received prior treatment with bevacizumab. Avastin is not approved in the refractory setting.

The GOG-0213 study included a diverse population of women[1,3] 

Baseline patient characteristics
Age Median age
Range
≥65 years
<65 years		 60 years
23–85 years
33%
67%
GOG PS 0
1
2		 82%
17%
1%
Measurable disease Measurable disease at baseline
Baseline CA-125 levels above ULN (>35 U/mL)		 83%
74%
Platinum-free interval 6–12 months
>12 months		 26%
74%

CA=cancer antigen; ULN=upper limit of normal. 

2L/3L: AURELIA study results 

Avastin plus chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan) significantly increased PFS over chemotherapy alone in the AURELIA study (HR=0.38 [95% CI, 0.30–0.49], P<0.0001)[1]

AURELIA study: PFS results in patients with prOC who received no more than 2 prior chemotherapy regimens[1]

  • Median PFS: 6.8 months (95% CI, 5.6–7.8) with Avastin plus chemotherapy vs 3.4 months (95% CI, 2.1–3.8) with chemotherapy alone
    • HR=0.38 (95% CI, 0.30–0.49), P<0.0001 

Avastin® (bevacizumab) AURELIA Study KM Curve

PFS data are based on investigator assessment.

  • Objective response rate (ORR): 28% (n=142 [95% CI, 21%–36%]) with Avastin plus chemotherapy vs 13% (n=144 [95% CI, 7%–18%]) with chemotherapy alone. The number of patients with measurable disease at baseline was 142 in the Avastin plus chemotherapy arm and 144 in the chemotherapy alone arm
  • Avastin plus chemotherapy demonstrated
    • A 62% reduction in the risk of disease progression vs chemotherapy alone
    • Doubled median PFS vs chemotherapy alone (6.8 vs 3.4 months)

Select Important Safety Information

The Warnings and Precautions for Avastin include gastrointestinal perforation and fistulae, surgery and wound healing complications, hemorrhage, arterial thromboembolic events, venous thromboembolic events, hypertension, posterior reversible encephalopathy syndrome, renal injury and proteinuria, infusion-related reactions, embryo-fetal toxicity, ovarian failure, and congestive heart failure.

AURELIA study: Efficacy data overview in ITT population[1]

Endpoint Avastin + chemotherapy Chemotherapy alone HR (95% CI) P value
PFS (main outcome measure) 6.8 months (n=179) 3.4 months (n=182) 0.38
(0.30–0.49)		 <0.0001
OS (secondary outcome measure) 16.6 months (n=179)
(95% CI, 13.7–19.0)		 13.3 months (n=182)
(95% CI, 11.9–16.4)		 0.89
(0.69–1.14)		  
ORR (secondary outcome measure) 28% (n=142)
(95% CI, 21%–36%)		 13% (n=144)
(95% CI, 7%–18%)		    

PFS=progression-free survival; HR=hazard ratio; CI=confidence interval; prOC=platinum-resistant ovarian cancer; ITT=intent-to-treat; OS=overall survival.

The first biologic regimen to show a benefit in PFS, OS, and ORR in prOC[1]

  • Median PFS: 6.8 months (95% CI, 5.6–7.8) with Avastin plus chemotherapy vs 3.4 months (95% CI, 2.1–3.8) with chemotherapy alone (HR=0.38 [95% CI, 0.30–0.49], P<0.0001)
  • ORR: 28% (n=142 [95% CI, 21%–36%]) with Avastin plus chemotherapy vs 13% (n=144 [95% CI, 7%–18%]) with chemotherapy alone. The number of patients with measurable disease at baseline was 142 in the Avastin plus chemotherapy arm and 144 in the chemotherapy alone arm
  • Median OS: 16.6 months (95% CI, 13.7–19.0) with Avastin plus chemotherapy vs 13.3 months (95% CI, 11.9–16.4) with chemotherapy alone (HR=0.89 [95% CI, 0.69–1.14])
  • Median duration of response: 9.4 months with Avastin plus chemotherapy vs 5.4 months with chemotherapy alone

PFS benefit was achieved in all 3 chemotherapy cohorts[1]

Median PFS by chemotherapy cohort 

Progression-free survival by chemotherapy cohort

PLD=pegylated liposomal doxorubicin.

Cohort analysis was exploratory. Analysis not designed to evaluate statistical significance between treatment arms or compare among the 3 chemotherapy cohorts.

Median OS by chemotherapy cohort 

Chemotherapy cohort Avastin + chemotherapy Chemotherapy alone HR (95% CI)
Avastin + paclitaxel 22.4 months (n=60) 13.2 months (n=55) 0.64 (0.41–1.01)
Avastin + topotecan 13.8 months (n=57) 13.3 months (n=63) 1.12 (0.73–1.73)
Avastin + PLD 13.7 months (n=62) 14.1 months (n=64) 0.94 (0.63–1.42)

Cohort analysis was exploratory. Analysis not designed to evaluate statistical significance between treatment arms or compare among the 3 chemotherapy cohorts.

ORR by chemotherapy cohort 

Chemotherapy cohort Avastin + chemotherapy Chemotherapy alone
Avastin + paclitaxel 53% (95% CI, 39%–68%) (n=45) 30% (95% CI, 17%–44%) (n=43)
Avastin + topotecan 17% (95% CI, 6%–28%) (n=46) 2% (95% CI, 0%–6%) (n=50)
Avastin + PLD 16% (95% CI, 6%–26%) (n=51) 8% (95% CI, 0%–15%) (n=51)

Cohort analysis was exploratory. Analysis not designed to evaluate statistical significance between treatment arm or compare among the 3 chemotherapy cohorts.

Serious adverse reactions (Warnings and Precautions)

  • Serious and sometimes fatal adverse reactions with increased incidence in the Avastin-treated arm vs chemotherapy arm included:
    • Gastrointestinal (GI) perforation ranged from 0.3% to 3% of patients across clinical studies
    • Non-GI fistulae (<1% to 1.8%, highest in patients with cervical cancer)
    • Arterial thromboembolic events (Grade ≥3, 5%, highest in patients with GBM)
    • The incidence of wound healing and surgical complications, including serious and fatal complications, is increased in Avastin-treated patients
    • Hemorrhage (Grade 3–5) ranged from 0.4% to 7% of patients across clinical studies
    • Renal injury and proteinuria
      • Grade 3–4 proteinuria ranged from 0.7% to 7% in clinical studies
      • Nephrotic syndrome
  • Additional serious adverse reactions with increased incidence in the Avastin-treated arm vs chemotherapy arm included:
    • Venous thromboembolism (Grade ≥3, 11% seen in GOG-0240)
    • Hypertension (Grade 3–4, 5%–18%)
    • Posterior reversible encephalopathy syndrome (PRES) (<0.5%)
    • Congestive heart failure (CHF): Grade ≥3 left ventricular dysfunction (1%)
  • Infusion-related reactions with the first dose of Avastin occurred in <3% of patients, and severe reactions occurred in 0.4% of patients
  • Avoid use in patients with ovarian cancer who have evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction
  • Inform females of reproductive potential of the risk of ovarian failure prior to initiating treatment with Avastin
  • An evaluation for the presence of varices is recommended within 6 months of initiation of Avastin in patients with HCC

The AURELIA study evaluated Avastin plus chemotherapy vs chemotherapy alone in prOC[1]

Avastin® (bevacizumab) AURELIA study design

ECOG PS=Eastern Cooperative Oncology Group performance status; CT=computerized tomography; IV=intravenous; q2w=every 2 weeks; q3w=every 3 weeks; PD=progressive disease; q4w=every 4 weeks.
*Avastin used in combination with paclitaxel, PLD, or weekly topotecan was dosed at 10 mg/kg q2w. Avastin used in combination with topotecan q3w was dosed at 15 mg/kg q3w.

  • AURELIA was a multicenter, randomized, open-label clinical trial in patients with prOC that recurred within <6 months from the most recent platinum-based therapy
  • Patients were treated until disease progression or unacceptable toxicity or withdrawal
  • 40% of patients in the chemotherapy alone arm received Avastin monotherapy upon progression

Patients who progress within <6 months after platinum therapy cessation are considered platinum resistant 

Aurelia Clinical Study Patient Disease Progression Timeline

GOG=Gynecologic Oncology Group.

Patients in the AURELIA study received no more than 2 prior chemotherapy regimens across all lines of therapy[1] 

AURELIA patient eligibility graphic

†Chemotherapy included paclitaxel, PLD, or topotecan.

The AURELIA study included a diverse population of women[1] 

Baseline patient characteristics
Age Median age
Range
≥65 years
<65 years		 61 years
25–84 years
37%
63%
ECOG PS 0
1
2		 59%
34%
7%
Baseline characteristics Measurable disease at baseline
Baseline CA-125 levels ≥2 x ULN
Ascites at baseline		 79%
87%
31%
Platinum-free interval 3–6 months
<3 months		 73%
27%

CA=cancer antigen; ULN=upper limit of normal. 

View the AURELIA study publication by Pujade-Lauraine et al

Important Safety Information & Indication

Indication

Ovarian Cancer (OC)

Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection.

Avastin, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens.

Avastin, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Serious adverse reactions (Warnings and Precautions)

  • Serious and sometimes fatal adverse reactions with increased incidence in the Avastin-treated arm vs chemotherapy arm included:
    • Gastrointestinal (GI) perforation ranged from 0.3% to 3% of patients across clinical studies
    • Non-GI fistulae (<1% to 1.8%, highest in patients with cervical cancer)
    • Arterial thromboembolic events (Grade ≥3, 5%, highest in patients with GBM)
    • The incidence of wound healing and surgical complications, including serious and fatal complications, is increased in Avastin-treated patients
    • Hemorrhage (Grade 3–5) ranged from 0.4% to 7% of patients across clinical studies
    • Renal injury and proteinuria
      • Grade 3–4 proteinuria ranged from 0.7% to 7% in clinical studies
      • Nephrotic syndrome (<1%)
  • Additional serious adverse reactions with increased incidence in the Avastin-treated arm vs chemotherapy arm included:
    • Venous thromboembolism (Grade ≥3, 11% seen in GOG-0240)
    • Hypertension (Grade 3–4, 5%–18%)
    • Posterior reversible encephalopathy syndrome (PRES) (<0.5%)
    • Congestive heart failure (CHF): Grade ≥3 left ventricular dysfunction (1%)
  • Infusion-related reactions with the first dose of Avastin occurred in <3% of patients, and severe reactions occurred in 0.4% of patients
  • Avoid use in patients with ovarian cancer who have evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction
  • Inform females of reproductive potential of the risk of ovarian failure prior to initiating treatment with Avastin
  • An evaluation for the presence of varices is recommended within 6 months of initiation of Avastin in patients with HCC

Pregnancy warning

  • Based on the mechanism of action and animal studies, Avastin may cause fetal harm
  • Advise female patients that Avastin may cause fetal harm, and to inform their healthcare provider of a known or suspected pregnancy
  • Advise females of reproductive potential to use effective contraception during treatment with Avastin and for 6 months after the last dose of Avastin
  • Advise nursing women not to breastfeed during treatment with Avastin and for 6 months following their last dose of treatment
  • Avastin may impair fertility

Most common adverse reactions

  • Across studies, the most common adverse reactions observed in Avastin patients at a rate >10% were:
    • Epistaxis
    • Headache
    • Hypertension
    • Rhinitis
    • Proteinuria
    • Taste alteration
    • Dry skin
    • Hemorrhage
    • Lacrimation disorder
    • Back pain
    • Exfoliative dermatitis

  • Across all studies, Avastin was discontinued in 8% to 22% of patients because of adverse reactions

Indication-specific adverse reactions

  • In Stage III or IV OC after primary surgery, 608 patients received CP+Avastin→Avastin, 607 patients received CP+Avastin→PBO, and 602 patients received CP+PBO→PBO. Grade 3–4 adverse reactions occurring at a higher incidence (≥2%) in either of the Avastin arms vs the chemotherapy only arm were fatigue (CP+Avastin→Avastin, 9%; CP+Avastin→PBO, 6%; CP+PBO→PBO, 6%), hypertension (CP+Avastin→Avastin, 10%; CP+Avastin→PBO, 6%; CP+PBO→PBO, 2%), platelet count decreased (CP+Avastin→Avastin, 21%; CP+Avastin→PBO, 20%; CP+PBO→PBO, 15%), and white blood cell count decreased (CP+Avastin→Avastin, 51%; CP+Avastin→PBO, 53%; CP+PBO→PBO, 50%)

  • In psOC, Grade 3 or 4 adverse reactions in the OCEANS study occurring at a higher incidence (≥2%) in 247 patients receiving Avastin plus carboplatin and gemcitabine (chemotherapy), compared to 233 patients receiving placebo plus chemotherapy, were thrombocytopenia (40% vs 34%), nausea (4% vs 1.3%), fatigue (6% vs 4%), headache (4% vs 0.9%), proteinuria (10% vs 0.4%), dyspnea (4% vs 1.7%), epistaxis (5% vs 0.4%), and hypertension (17% vs 0.9%)

  • In psOC, Grade 3 or 4 adverse reactions in the GOG-0213 study occurring at a higher incidence (≥2%) in 325 patients receiving Avastin plus carboplatin and paclitaxel (chemotherapy), compared to 332 patients receiving chemotherapy alone, were hypertension (11% vs 0.6%), fatigue (8% vs 3%), febrile neutropenia (6% vs 3%), proteinuria (8% vs 0%), abdominal pain (6% vs 0.9%), hyponatremia (4% vs 0.9%), headache (3% vs 0.9%), and pain in extremity (3.4% vs 0%)

  • In prOC, Grade 3–4 adverse reactions in AURELIA occurring at a higher incidence (≥2%) in 179 patients receiving Avastin plus chemotherapy, compared to 181 patients receiving chemotherapy alone, were hypertension (6.7% vs 1.1%) and palmar-plantar erythrodysaesthesia syndrome (4.5% vs 1.7%)

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Genentech at (888) 835-2555.

Please see full Prescribing Information for additional important safety information.

    • Avastin Prescribing Information. Genentech, Inc. 2022.

      Avastin Prescribing Information. Genentech, Inc. 2022.

    • Hurwitz H, Fehrenbacher L, Novotny W, et al. N Engl J Med. 2004;350:2335-2342. PMID: 15175435  

      Hurwitz H, Fehrenbacher L, Novotny W, et al. N Engl J Med. 2004;350:2335-2342. PMID: 15175435  

    • Data on file. Genentech, Inc.

      Data on file. Genentech, Inc.

    • Bennouna J, Sastre J, Arnold D, et al. Lancet Oncol. 2013;14:29-37.  

      Bennouna J, Sastre J, Arnold D, et al. Lancet Oncol. 2013;14:29-37.  

    • Österlund P, Alonso-Orduña V, Schlichting C, et al. Poster presented at: European Society for Medical Oncology Meeting; September 28-October 2, 2012; Vienna, Austria.

      Österlund P, Alonso-Orduña V, Schlichting C, et al. Poster presented at: European Society for Medical Oncology Meeting; September 28-October 2, 2012; Vienna, Austria.

    • Giantonio BJ, Catalano PJ, Meropol NJ, et al. J Clin Oncol. 2007;25:1539-1544. PMID: 17442997

      Giantonio BJ, Catalano PJ, Meropol NJ, et al. J Clin Oncol. 2007;25:1539-1544. PMID: 17442997

    • Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Colon Cancer V.2.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed July 24, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org.

      Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Colon Cancer V.2.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed July 24, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org.

    • Sandler A, Gray R, Perry MC, et al. N Engl J Med. 2006;355:2542-2550. PMID: 17167137  

      Sandler A, Gray R, Perry MC, et al. N Engl J Med. 2006;355:2542-2550. PMID: 17167137  

    • Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.5.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed July 24, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org.

      Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.5.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed July 24, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org.

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