Tracks 1-19

Track 1 NCCTG-N9831 adjuvant trial: Analysis of sequential chemotherapy trastuzumab randomization arm Track 2 Pending report of the HERA trial: Two versus one year of adjuvant trastuzumab Track 3 Perspective on the role of adjuvant anthracyclines in breast cancer (BC) Track 4 Ongoing and recently reported trials with liposomal doxorubicin in BC Track 5 FinXX trial interim analysis: Docetaxel (T) CEF versus docetaxel/ capecitabine (TX) CEX adjuvant therapy for high-risk early BC Track 6 Overview of clinical trial data with chemotherapy/bevacizumab for patients with metastatic BC (mBC) Track 7 RIBBON 1: Chemotherapy (physician’s choice) with or without bevacizumab for first-line treatment of mBC Track 8 Emerging evidence base for continuation of trastuzumab after disease progression in mBC Track 9 Relevance of the study of lapatinib/trastuzumab in heavily pretreated patients with HER2- positive mBC progressing on trastuzumab to the ongoing ALTTO trial Track 10 NCCTG-N0735: A Phase II trial of nanoparticle albumin-bound (nab) paclitaxel, gemcitabine and bevacizumab in mBC Track 11 CALGB-40502: Bevacizumab in combination with weekly paclitaxel, nab paclitaxel or ixabepilone as first-line therapy for mBC Track 12 Ixabepilone with capecitabine versus capecitabine for patients with refractory triple-negative mBC: A pooled analysis from two Phase III clinical studies Track 13 Management of ixabepilone-induced peripheral neuropathy Track 14 Evaluation of bevacizumab in combination with novel chemotherapeutic agents Track 15 Rationale for investigation of PARP inhibitors in patients with BRCA mutations and triple-negative BC Track 16 Clinical use of the Oncotype DX® assay for postmenopausal patients with ER/PR-positive, node-negative or node-positive early BC Track 17 Approaches to improve the reliability of HER2 testing and interpretation Track 18 Investigation of novel HER2 assays Track 19 Potential benefit of adjuvant trastuzumab in patients with “HER2-low” (IHC 1+, 2+) BC

Select Excerpts from the Interview

Tracks 6-7

DR LOVE: Would you summarize where we are currently in terms of clinical research data on bevacizumab for metastatic breast cancer?

DR PEREZ: ECOG-E2100 demonstrated a dramatic improvement in progression-free survival with weekly paclitaxel/bevacizumab as first-line therapy, but no statistical difference in overall survival was seen (Miller 2007; [1.1]). The two agents were continued until disease progression or prohibitive toxic effects occurred.

In the AVADO trial, a statistically significant improvement in median progression-free survival was found for docetaxel/bevacizumab in the first-line setting, but the difference was less than one month (Miles 2008; [1.1]). We can say that the AVADO trial corroborated ECOG-E2100, but it didn’t corroborate it to the degree I would have liked.

Potential explanations are related to the differences between the two trials. In the AVADO trial, the patients received up to nine doses of docetaxel. At the beginning, the patients received docetaxel/bevacizumab, and then the physicians had the option of discontinuing docetaxel and continuing bevacizumab as a single agent (Miles 2008).

DR LOVE: Another potential issue is related to the choice and schedule of taxanes — weekly paclitaxel versus every three-week docetaxel — and their effectiveness as anti-angiogenic agents.

DR PEREZ: That’s possible, because both taxanes have anti-angiogenic properties, but a weekly schedule of administration may be more effective. That’s one of the reasons why RIBBON 1 will be so interesting.

Track 5

DR LOVE: Can you comment on the Finnish study that was presented at San Antonio, which added capecitabine to docetaxel followed by an anthracycline in the adjuvant setting (Joensuu 2008)?

DR PEREZ: This was a provocative trial. The follow-up is short, but the study demonstrated that the addition of capecitabine led to an improvement in disease-free survival (Joensuu 2008; [3.3]), which is consistent with the docetaxel/capecitabine data reported in metastatic breast cancer (O’Shaughnessy 2002).

The investigators diminished the dose of docetaxel to 80 mg/m² instead of 100 mg/m², and they also reduced the dose of capecitabine to 900 mg/m² twice per day. This is a good regimen, and it will be interesting to see longer follow-up of that trial.

Track 4

DR LOVE: Joe Sparano presented data at San Antonio from a study of liposomal doxorubicin with docetaxel in patients with advanced breast cancer (Sparano 2008; [1.2]). What are your thoughts about the role of these agents in breast cancer management?

DR PEREZ: Liposomal anthracyclines are important drugs. When the original study was conducted comparing liposomal anthracyclines to standard doxorubicin in a large number of patients, they were able to demonstrate that patients could receive more anthracycline with the pegylated liposomal encapsulation of the drug (O’Brien 2004).

However, it was difficult to demonstrate statistically significant improvements in survival or disease-free survival. Currently, an ongoing randomized trial for patients with HER2-positive breast cancer is evaluating paclitaxel/trastuzumab versus paclitaxel/trastuzumab/liposomal doxorubicin.

This strategy is based on fascinating Phase III data presented by Jose Baselga and colleagues in the neoadjuvant setting, in which a huge response rate to triplet therapy was demonstrated with essentially no cardiac toxicity when the anthracycline was administered concurrently with trastuzumab (Gianni 2008).

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EDITOR
Neil Love, MD

INTERVIEWS

Edith A Perez, MD
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Stephen E Jones, MD
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Sandra M Swain, MD
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Ian E Krop, MD, PhD
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Breast Cancer Update:
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