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Adjuvant Trial Evaluating Trastuzumab and/or Lapatinib in HER2-Positive Disease

Track 31

DR LOVE: Eric, the ALTTO trial is evaluating adjuvant chemotherapy followed by trastuzumab versus lapatinib versus the combination or the sequence (1.3). What are your thoughts about the combination and about the fact that some patients will not receive trastuzumab on this study?

DR WINER: In terms of the combination, what is known comes mostly from a trial at Indiana University evaluating the combination in a Phase I setting (Storniolo 2005). The combination was tolerable, although there was some suggestion that more responses occurred than had been recorded with single-agent lapatinib, but that’s comparing across trials.

I believe it’s reasonable to have a lapatinib-only arm, but patients should not receive lapatinib alone outside of a trial. I believe that we all felt more comfortable after the results were presented at ASCO this year on administering lapatinib in combination with paclitaxel to patients who were thought to have HER2-negative disease (Di Leo 2007). The addition of lapatinib led to a similar improvement in outcome to that seen with trastuzumab.

DR LOVE: Joyce, how would you feel about putting a patient with multiple positive lymph nodes on the ALTTO trial (1.3)?

DR O’SHAUGHNESSY: I would be comfortable supporting the ALTTO trial. The paclitaxel data that Eric referred to were impressive.

1.3

ALTTO Trial of Trastuzumab, Lapatinib or the Combination

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Adjuvant Chemotherapy for Patients with HER2-Negative Disease

Adjuvant Systemic Therapy for Patients with HER2-Positive Disease

Adjuvant Therapy for Elderly Patients with HER2-Positive Disease

Adjuvant Trial Evaluating Trastuzumab and/or Lapatinib in HER2-Positive Disease
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Role of Bevacizumab for Patients with HER2-Negative Metastatic Disease

Adjuvant Trial Combining Bevacizumab with Trastuzumab

Optimizing First-Line Systemic Therapy for Patients with ER-Positive, HER2-Positive Metastatic Disease
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