SAFETY PROFILE IN METASTATIC BREAST CANCER


Most common adverse reactions (ARs) in the CLEOPATRA trial

Most common ARs all grades (>30%) or serious ARs Grades 3-4 (>2%)1

  • Anemia also occurred in >2% of patients treated with PERJETA + Herceptin + docetaxel (Grades 3-4)1
  • Asthenia also occurred in >2% of patients treated with PERJETA + Herceptin + docetaxel (Grades 3-4)1

*Denotes an adverse reaction that has been reported in association with a fatal outcome.

1% difference in discontinuation rate due to ARs in all study therapy was observed between treatment arms1:

  • 6% for PERJETA + Herceptin + docetaxel
  • 5% for placebo + Herceptin + docetaxel

Select adverse reaction information1,2

Febrile neutropenia

An increased incidence of febrile neutropenia was observed for Asian patients in both treatment arms compared with patients of other races and from other geographic regions.

  • Among Asian patients, the incidence of febrile neutropenia was higher in the PERJETA-treated group (26%) compared with the control group (12%)
  • In patients from other geographic regions, the incidence of febrile neutropenia was 8.5% in the PERJETA-based arm and 5.6% in the Herceptin + docetaxel arm
  • After docetaxel treatment was stopped, no instances of febrile neutropenia were reported in either treatment arm
  • Use of granulocyte colony–stimulating factor (GCSF) was allowed for the treatment of febrile neutropenia and as prophylaxis; however, docetaxel dose reductions were the preferred measure for prevention of febrile neutropenia in subsequent cycles

Diarrhea

The majority of diarrhea episodes occurred during the first 3 cycles of treatment.

  • The incidence of diarrhea was higher in the PERJETA-containing arm, a trend that persisted for Grade 1-2 severity following docetaxel discontinuation
  • For patients experiencing diarrhea, intervention with loperamide was allowed

ARs following discontinuation of docetaxel

Adverse reaction incidence decreased after docetaxel was discontinued1

  • Incidence rate of all other adverse reactions was <10% with PERJETA + Herceptin after docetaxel was discontinued with the exception of diarrhea (19%), upper respiratory tract infection (13%), rash (12%), headache (11%), and fatigue (11%) 1

Docetaxel should be administered for a minimum of 6 cycles.

Cardiac safety profile in patients with metastatic disease

PERJETA + Herceptin + docetaxel did not increase the rate of cardiac events1

Median follow-up was 30.1 months.1

  • Assess LVEF prior to initiation of PERJETA and at regular intervals (eg, every 3 months) during treatment to ensure that LVEF is within the institution's normal limits1

References