Oncologic Disorders: Pertuzumab and Trastuzumab Clinical Trial

A large clinical trial with ______ in combination with trastuzumab and chemotherapy in the adjuvant setting for HER2-positive breast cancer recently showed about a 1% absolute benefit in invasive disease-free survival at 3 years. The FDA added an indication for ______ in combination with trastuzumab in the adjuvant setting for high-risk HER2-positive breast cancer based on this trial.

The incidence of adverse cardiac effects associated with the addition of ______ appears to increase when an anthracycline is included in the regimen before administration of ______. The risk of symptomatic heart failure with adjuvant ______ ranges from 0.5% to 4% in highly selected patients who participated in the clinical trials.

The higher risk of cardiac complications may be acceptable in many patients, given the significant reductions in breast cancer recurrence and death. Sequential administration of trastuzumab after ______ (as in the HERA trial) appears to produce a lower incidence of cardiac toxicity.

Also, the use of a non-anthracycline–based regimen in the ______ trial was associated with a low incidence of symptomatic heart failure as compared with other regimens.

However, cross-trial comparisons are difficult because the definition of ______ in each trial was different.

The risk of symptomatic ______ with adjuvant trastuzumab ranges from 0.5% to 4% in highly selected patients who participated in the clinical trials.

Concurrent administration of trastuzumab with an anthracycline is very controversial because of potentially higher rates of cardiac dysfunction and not generally recommended outside of a clinical trial. Similar to many MoABs, trastuzumab is associated with infusion-related reactions such as fever, chills, and ______.

Postmarketing surveillance data have identified pulmonary toxicity and anaphylaxis as rare but potentially life-threatening reactions associated with ______.

Chemotherapy-related adverse effects, including neutropenia, infection, and diarrhea, are slightly more frequent with the addition of concurrent trastuzumab and pertuzumab therapy, but these toxicities are easily managed and do not preclude the use of trastuzumab in patients with ______.

Most of these trials continued trastuzumab administration during adjuvant radiation therapy and endocrine therapy. The administration of trastuzumab during radiation therapy was evaluated in patients that participated in the N9831 clinical trial. Patients who received concurrent radiation therapy with adjuvant trastuzumab did not experience a significant increase in cardiac events or acute radiation-related adverse events with the exception of transient ______.

Therefore, if radiation therapy is clinically indicated, trastuzumab is typically administered concomitantly with ______.

Many questions remain regarding the optimal use of trastuzumab in the adjuvant or neoadjuvant therapy of ______.

The use of trastuzumab with chemotherapy in the adjuvant or neoadjuvant setting is now considered to be the standard of care for patients with node-positive and high-risk node-negative HER2-positive breast ______.

The use of anti-HER2 therapy in patients with small, HER2-positive, node-negative tumors is ______.

Neratinib, an oral tyrosine kinase inhibitor, is indicated for extended adjuvant therapy after completion of trastuzumab in the adjuvant ______.

Its approval was based on ______.

What was the absolute benefit in invasive disease-free survival at 3 years in the large clinical trial with pertuzumab in combination with trastuzumab and chemotherapy for HER2-positive breast cancer?

In which setting did the FDA add an indication for pertuzumab in combination with trastuzumab for high-risk HER2-positive breast cancer?

What was the range of risk of symptomatic heart failure with adjuvant trastuzumab in highly selected patients who participated in the clinical trials?

Which type of regimen in the BCIRG 006 trial was associated with a low incidence of symptomatic heart failure compared with other regimens?

What did sequential administration of trastuzumab after chemotherapy in the HERA trial appear to produce a lower incidence of?

What did postmarketing surveillance data identify as rare but potentially life-threatening reactions associated with a certain treatment?

What is the main reason for the controversy regarding the concurrent administration of trastuzumab with an anthracycline?

What is a rare but potentially life-threatening reaction associated with trastuzumab based on postmarketing surveillance data?

What is the most significant reason for the slightly more frequent chemotherapy-related adverse effects with concurrent trastuzumab and pertuzumab therapy?

In which setting is the use of trastuzumab with chemotherapy considered to be the standard of care for patients with HER2-positive breast cancer?

What is the indication for extended adjuvant therapy after completion of trastuzumab in the adjuvant setting?

What was the basis for the FDA adding an indication for neratinib in combination with trastuzumab in the adjuvant setting for high-risk HER2-positive breast cancer?

What is a significant concern regarding the use of anti-HER2 therapy in patients with small, HER2-positive, node-negative tumors?

What was the outcome of a single arm, nonrandomized clinical trial that evaluated the use of weekly paclitaxel and trastuzumab for 12 weeks followed by trastuzumab every 3 weeks for a total of one year in patients with lymph-node negative, HER2-positive, breast cancers smaller than 3 cm?

What was the impact of concurrent radiation therapy with adjuvant trastuzumab on cardiac events and acute radiation-related adverse events based on the N9831 clinical trial?

What does the text suggest about the administration of trastuzumab during adjuvant radiation therapy?