ADT Before or After Surgery Gives Similar Survival Rates in Prostate Cancer

The gist: Recent research found that prostate cancer patients have similar survival rates whether they have androgen deprivation therapy (ADT) before or after tumor-removal surgery. The study focused on men with intermediate- or high-risk prostate cancer who were treated between 1995 and 2002.

“Patients with intermediate- or high-risk prostate cancer demonstrated similar biochemical relapse-free survival, distant metastasis-free survival and OS regardless of whether they received androgen deprivation in the neoadjuvant or adjuvant settings, according to study results.

“Patients with localized prostate cancer typically undergo androgen deprivation therapy (ADT) in the neoadjuvant setting, concurrent with radiation therapy.

“Michael A. Weller, MD,of Cleveland Clinic, and colleagues assessed whether patients who underwent ADT in the adjuvant setting experienced different outcomes.

“The analysis included 515 patients treated with radiation therapy and ADT from 1995 to 2002. Of these patients, 311 underwent ADT in the neoadjuvant setting, beginning 2 to 3 months before the start of radiation therapy. The other 204 patients underwent ADT in the adjuvant setting, immediately after the completion of radiation therapy.”


The Role of Pertuzumab in Treating HER2+ Breast Cancer


Pertuzumab (Perjeta) is a relatively new drug that targets HER2, a protein found at higher-than-normal levels in about 15% to 20% of all breast cancers. Too much HER2 leads to tumor growth. Currently, all newly diagnosed breast cancer patients have their tumors’ HER2 levels tested. Knowing whether a patient’s HER2 levels are abnormally high (HER2-positive) or normal (HER2-negative) is a major factor in choosing a treatment, thanks to the availability of trastuzumab (Herceptin) and, now, other HER2-targeted drugs such as Perjeta, T-DM1 (Kadcyla), and lapatinib (Tykerb). These drugs are all used to treat HER2-positive patients. Continue reading…


Subcutaneous, IV Trastuzumab Similarly Safe, Effective for HER-2-Positive Early Breast Cancer

The gist: Breast cancer patients being treated with the drug trastuzumab (Herceptin) receive the same benefits whether they take it intravenously (by IV) or as an injection.

“Subcutaneous trastuzumab demonstrated comparable safety and efficacy to IV trastuzumab in patients with HER-2–positive early breast cancer, according to results of an international randomized, open-label phase 3 study.

“Christian Jackisch, MD, PhD, of the Breast Cancer and Gynecology Cancer Center at Sana Klinikum Offenbach GmbH in Germany, and colleagues compared the pharmacokinetics, efficacy and safety of subcutaneous vs. IV trastuzumab (Herceptin, Genentech). The study included 596 women with HER-2–positive, operable, locally advanced or inflammatory breast cancer in the neoadjuvant/adjuvant setting.

“All women underwent treatment with eight cycles of neoadjuvant chemotherapy administered concurrently with trastuzumab. Trastuzumab was administered either via 3-weekly fixed doses of 600 mg or via the standard weight-based method.

“Patients continued treatment with trastuzumab for 1 year after surgery.”


Herceptin May Be of Little Use in Immune Cell-Heavy Breast Ca

The gist: Many women with HER2-positive breast cancer take the drug trastuzumab (aka Herceptin) along with chemotherapy after tumor-removal surgery to keep the cancer from returning. However, new research shows that women who have high levels of certain immune system cells in their tumors might not benefit from Herceptin. For these patients, chemotherapy might be just as effective at preventing the return of cancer as the chemo/Herceptin combo.

“HER2-positive breast cancers with a high level of immune cell infiltration might not benefit from the addition of trastuzumab (Herceptin) to chemotherapy, a trial analysis suggested.

“The 10% of patients with stromal tumor-infiltrating lymphocyte-predominant breast cancer in the Alliance N9831 trial showed similar recurrence-free survival (RFS) whether they received chemotherapy alone or with trastuzumab (10-year rate 90.9% versus 80.0%,P=0.21), Edith A. Perez, MD, of the Mayo Clinic in Jacksonville, Fla., and colleagues found.

“The rest showed, as expected, significantly better recurrence-free survival with addition of trastuzumab (10-year rate 79.6% versus 64.3%, hazard ratio 0.49, P=0.0003), they reported here at the San Antonio Breast Cancer Symposium.”


Plexxikon and QuantumLeap Healthcare Collaborative Announce Selection of PLX3397 for I-SPY 2 TRIAL in Breast Cancer

The gist: A new drug called PLX3397 will now be available through the innovative I-SPY 2 clinical trial, which uses molecular testing to match breast cancer patients to the pre-surgery treatments most likely to work for them. The trial is open for participation by women with newly diagnosed, locally advanced breast cancer.

“Plexxikon Inc., a member of Daiichi Sankyo Group, and QuantumLeap Healthcare Collaborative today announced that Plexxikon’s drug candidate, PLX3397, has been selected for study in the I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2). I-SPY 2 is a standing phase 2 randomized, controlled, multicenter trial for women with newly diagnosed, locally advanced breast cancer (minimum of Stage 2) that is designed to test whether adding investigational drugs to standard chemotherapy is better than standard chemotherapy alone in the neoadjuvant setting (prior to surgery).

“I-SPY 2 is conducted by a consortium that brings together the Food and Drug Administration (FDA), National Cancer Institute (NCI), pharmaceutical companies, leading academic medical centers, and patient advocacy groups under its umbrella. The trial is sponsored by QuantumLeap Healthcare Collaborative (QLHC), a 501(c)(3) non-profit organization dedicated to accelerating healthcare solutions.

“The I-SPY 2 TRIAL employs a unique adaptive trial design to match experimental therapies with patients. Genetic or biological markers (‘biomarkers’) from individual patients’ tumors are used to screen promising new treatments, identifying which therapies are most effective in specific patient subgroups. Regimens that have a high Bayesian predictive probability of showing superiority in a 300 patient phase 3 confirmatory trial in at least one of 10 predefined signatures may ‘graduate’ from I-SPY. This high efficacy bar and rapid turnaround time allows the trial to identify the right drug for the right patient in the most expeditious fashion.”


Greater Suppression of Intraprostatic Androgens by Adding Abiraterone to LHRH Agonist in Patients With Prostate Cancer

The gist: Patients with intermediate- or high-risk prostate cancer who are prescribed treatment with leuprolide acetate before prostatectomy may benefit more if they also take abiraterone acetate (aka Zytiga).

“In a phase II study reported in the Journal of Clinical Oncology, Taplin et al found that the addition of neoadjuvant abiraterone acetate (Zytiga) to the luteinizing hormone–releasing hormone (LHRH) agonist leuprolide acetate resulted in greater suppression of intraprostatic androgens in patients with intermediate- or high-risk localized prostate cancer.

“In the study, 58 patients were randomly assigned to receive abiraterone plus leuprolide (n = 30) or leuprolide alone (n = 28) for 12 weeks followed by prostate biopsy. All patients then received 12 weeks of abiraterone plus leuprolide and underwent radical prostatectomy…

“The investigators concluded: ‘LHRH [agonist] plus [abiraterone acetate] treatment suppresses tissue androgens more effectively than LHRH [agonist] alone. Intensive intratumoral androgen suppression with LHRH [agonist] plus [abiraterone acetate] before prostatectomy for localized high-risk [prostate cancer] may reduce tumor burden.’ “


PET Scan Could Predict Response to Pre-Surgery Treatment with Chemo + Herceptin

The gist: A recent clinical trial found that positron emission tomography (PET) scans could be used to predict how well a patient will respond to neoadjuvant (pre-surgery) treatment with chemotherapy and trastuzumab (Herceptin). Doctors might recommend a change in treatment to a patient whose PET scans show that current treatment isn’t working. In the study, researchers treated women with early-stage, HER2-positive breast cancer. Based on PET scans, the researchers were able to predict which patients would still have signs of an invasive tumor after treatment. They also found that adding the drug bevacizumab (Avastin) to the treatment plan could improve responses for some of these patients.