In this study, women with advanced HER2-positive breast cancer who had already been treated with trastuzumab and a taxane drug received either trastuzumab emtansine (an "antibody linked to chemotherapy" drug) or the combination of lapatinib and capecitabine. Patients in the trastuzumab emtansine group stayed longer without their disease progressing and lived longer. Severe side effects were also less common in this group.
HER2-positive, after previous trastuzumab and a taxane (or relapse during or within 6 months of adjuvant treatment)
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Trastuzumab emtansine (Kadcyla) | 3.6 mg/kg (never more) | IV infusion; initial 90 minutes, then 30 minutes if tolerated | Day 1 |
On the page “Trastuzumab emtansine (Kadcyla)” · Dose and schedule (FDA label)
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Trastuzumab emtansine (T-DM1).
Trastuzumab emtansine 3.6 mg/kg IV (30 to 90 minutes) on day 1 of each 21-day cycle until progression or unmanageable toxicity.
Lapatinib with capecitabine.
Lapatinib 1250 mg (five 250 mg tablets) orally once daily continuously + capecitabine 1000 mg/m² orally twice daily, days 1 to 14 of each 21-day cycle, until progression or unmanageable toxicity.
Source of the regimen details: ClinicalTrials.gov NCT00829166 and the FDA label for Kadcyla (DailyMed, section 14.1)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Patients with HER2-positive advanced breast cancer previously treated with trastuzumab and a taxane.
Primary endpoints: progression-free survival (by independent review), overall survival and safety. Secondary endpoints: progression-free survival (by investigator assessment), objective response rate and time to symptom progression. Two interim analyses of overall survival were performed.
Grade 3 or 4 adverse events were more frequent in the lapatinib plus capecitabine group (57% versus 41%). Thrombocytopenia and elevated serum aminotransferase levels were more frequent with T-DM1, whereas diarrhoea, nausea, vomiting and palmar-plantar erythrodysesthesia were more frequent with lapatinib plus capecitabine.
According to the abstract, in patients with HER2-positive advanced breast cancer previously treated with trastuzumab and a taxane, T-DM1 improved progression-free and overall survival and had fewer grade 3 or 4 adverse events than lapatinib plus capecitabine. Drug approval status and its place in current guidelines should be checked separately, as they are not stated in the abstract.
The comparison was only with lapatinib plus capecitabine. Overall survival results come from a second interim analysis. Further details on limitations should be checked in the full text of the paper. The trial was funded by F. Hoffmann-La Roche/Genentech.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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