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Bevacizumab taxan Första linjens behandling vid metastaserande Her2- bröstcancer.

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Presentation on theme: "Bevacizumab taxan Första linjens behandling vid metastaserande Her2- bröstcancer."— Presentation transcript:

1 Bevacizumab taxan Första linjens behandling vid metastaserande Her2- bröstcancer

2 3 randomiserade studier E2100 E2100 AVADO AVADO RIBBON 1 RIBBON 1 2 METAANALYSER 2 METAANALYSER

3 E patienter 722 patienter 90 mg paklitaxel/m2 dag 1, 8, 15 +/- bevacizumab 10 mg/kg dag 1, mg paklitaxel/m2 dag 1, 8, 15 +/- bevacizumab 10 mg/kg dag 1, 15 Primär endpoint: PFS Primär endpoint: PFS

4 Progressionsfri överlevnad

5 AVADO 736 patienter 736 patienter Docetaxel 100mg/m2 + placebo Docetaxel 100mg/m2 + placebo Docetaxel 100mg/m2 + bevacizumab 7,5 mg eller 15 mg qW 3 Docetaxel 100mg/m2 + bevacizumab 7,5 mg eller 15 mg qW 3

6 Bevacizumab 7.5mg/kg q3w + docetaxel (n=248) 9.0 AVADO: updated PFS 7.5mg dose PFS estimate Time (months) Placebo + docetaxel (n=241) Unstratified HR=0.86 (0.72–1.04), p=0.1163* 8.2 Intent-to-treat analysis; *p values are of exploratory nature ‡ censored for non-protocol therapy prior to progressive disease Stratified HR ‡ =0.80 (0.65–1.00), p=0.0450* 8.1

7 Bevacizumab 15mg/kg q3w + docetaxel (n=247) AVADO: updated PFS 15mg dose PFS estimate Time (months) Placebo + docetaxel (n=241) 10.1 Unstratified HR=0.77 (0.64–0.93), p=0.0061* 8.2 Intent-to-treat analysis; *p values are of exploratory nature ‡ censored for non-protocol therapy prior to progressive disease Stratified HR ‡ =0.67 (0.54–0.83), p=0.0002*

8 AVADO: updated efficacy ORR and 1-year survival Placebo + docetaxel Bev 7.5* + docetaxel Bev 15* + docetaxel Patients with measurable disease at baseline n=207n=201n=206 ORR, % Difference vs placebo p value vs placebo ‡ ‡ *mg/kg q3w ‡ p values are of exploratory nature ITT populationn=241n=248n=247 1-year survival rate, % Difference vs placebo p value vs placebo0.198 ‡ 0.02 ‡ Patients still at risk, n

9 RIBBON patienter 1237 patienter Bevacizumab 15 mg qW 3 gavs som tilläggsbehandling till capecitabin, taxan- eller anthracyklingbehandling Bevacizumab 15 mg qW 3 gavs som tilläggsbehandling till capecitabin, taxan- eller anthracyklingbehandling

10 Study Design Capecitabine (1000 mg/m 2 BID x 14d) Taxane (docetaxel q3w or protein-bound paclitaxel q3w) Anthracycline-based chemotherapy (AC, EC, FAC, FEC) Placebo or bevacizumab (15 mg/kg q3w) CHOICE OF CHEMO BY INVESTIGATOR Capecitabine or Taxane or Anthracyclin e Previously untreated MBC (n=1237) Stratification Factors: Disease-free interval Previous adjuvant chemotherapy Number of metastatic sites Cape, T or Anthra Chemo + bevacizumab q3w Chemo + placebo q3w Optional 2 nd -line Chemo + bevacizumab Treat until PD RANDOMIZE 2:1

11 Capecitabine: PFS by Investigator Median, mo HR (95% CI)0.69 (0.56–0.84) p-valuep= Median, mo HR (95% CI)0.68 (0.54–0.86) p-valuep= PL (n=206) BV (n=409) IRC INV

12 Taxane/Anthra: PFS by Investigator Median, mo HR (95% CI)0.64 (0.52–0.80) p-valuep< Median, mo HR (95% CI)0.77 (0.60–0.99) p-valuep=0.040 PL (n=207) BV (n=415) IRC INV

13 Analysis of PFS by stratification factors: Cape and T/Anthra Cohorts Analysis of PFS by stratification factors: Cape and T/Anthra Cohorts + BV better + PL better Baseline Factor Total n Hazard Ratio All Patients Disease-free interval (mo) ≤ > Number of metastatic sites < ≥ Prior adjuvant chemotherapy Yes No BV better + PL better Total n Hazard Ratio CapeT/Anthra

14 Objective Response Rate Measurable disease (n) Includes only patients with measurable disease at baseline Cape p= T/Anthra p= % BVPLBVPL

15 Metaanalys Lee et al

16 Metaanalys


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