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issues in oncology

FDA Maintains Ongoing Efforts to Expedite Drug Approvals

The U.S. Food and Drug Administration (FDA) is continuing its efforts to expedite oncology-hematology drug approvals. As of May 15, 2016, FDA has approved the following agents since January of this year. Lenvatinib (Lenvima), in combination with everolimus (Afinitor), for the treatment of advanced ...

breast cancer

Palbociclib Combined With Fulvestrant in Advanced Breast Cancer Progressing After Endocrine Therapy

On February 19, 2016, palbociclib (Ibrance) was approved for use in combination with fulvestrant (Faslodex) for treatment of hormone receptor–positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.1,2 In February 2015, palbociclib in...

breast cancer

Adding Palbociclib to Fulvestrant Prolongs Progression-Free Survival in Hormone Receptor–Positive, HER2-Negative Metastatic Breast Cancer

As reported in The Lancet Oncology by Cristofanilli et al, the final results of the phase III PALOMA-3 trial show that the addition of the CDK4/CDK6 inhibitor palbociclib (Ibrance) to fulvestrant (Faslodex) improved progression-free survival in women with hormone receptor–positive,...

breast cancer

FDA Approves Palbociclib in Combination With Fulvestrant in Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer

On February 19, 2016, the U.S. Food and Drug Administration approved palbociclib (Ibrance) in combination with fulvestrant for the treatment of women with hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative advanced or metastatic breast cancer with...

breast cancer
issues in oncology

PI3K Inhibitor Buparlisib Extends Progression-Free Survival  in Advanced Breast Cancer

Addition of the oral investigational pan-PI3K inhibitor buparlisib to the endocrine agent fulvestrant (Faslodex) improved progression-free survival among postmenopausal women with advanced hormone receptor–positive/HER2-negative advanced breast cancer. “We are happy to announce that the phase III...

breast cancer

Neoadjuvant Palbociclib Enhances Effect of Anastrozole on Complete Cell-Cycle Arrest

The cyclin-dependent kinase (CDK) 4/6  inhibitor palbociclib (Ibrance) enhanced cell-cycle control over that achieved with anastrozole alone in a study that evaluated the drugs’ ability to induce complete cell-cycle arrest in tumor cells and to produce clinical responses, as neoadjuvant therapy for ...

breast cancer

Male Breast Cancer Differs from Breast Cancer in Women, but Little Data Informs Treatment

Although a rare occurrence, men do get breast cancer, and when they do, it has a distinct biology from that of female breast cancer. About 90% of cases most closely resemble postmenopausal female invasive ductal carcinoma, and 10% are ductal carcinoma in situ (DCIS), which accounts for 25% of...

breast cancer

SWOG S0226 Findings Revive Interest in Combination Hormonal Therapy

Two hormonal therapies combined are more efficacious than one when used as first-line treatment for hormone receptor–positive metastatic breast cancer in postmenopausal women, finds Southwest Oncology Group trial S0226. Results of the phase III trial, reported at the 2011 CTRC-AACR San Antonio...

breast cancer

Will mTOR Inhibitors Change the Treatment of Endocrine-sensitive HER2-negative Breast Cancer?

For the treatment of endocrine-sensitive metastatic breast cancer, the combination of an mTOR inhibitor and an endocrine agent represents a promising new option. At the 2012 Breast Cancer Symposium, the 18-month update of BOLERO-2, which tested therapy with everolimus (Afinitor) plus exemestane,...

breast cancer

Research Roundup from San Antonio: New Data on Triple-negative, HER2-positive, Local, and Advanced Breast Cancer 

The 2012 San Antonio Breast Cancer Symposium featured more than 2,500 abstracts and lectures, including timely research in the field and discussions for scientists and clinicians alike. In addition to nearly two dozen in-depth reports from the meeting, The ASCO Post brings readers the following...

breast cancer

Optimizing Anti-HER2 Treatment for Metastatic Breast Cancer in 2013 

The good news about HER2-positive breast cancer is that recurrent disease is plummeting, owing to the impact of adjuvant trastuzumab [Herceptin]. Hopefully, first-line metastatic treatment is becoming a thing of the past,” said Harold Burstein, MD, PhD, of Dana-Farber Cancer Institute, Boston....

breast cancer

Final Overall Survival Data Show Better Results With Higher Dose of Fulvestrant

Among patients with locally advanced or metastatic estrogen receptor–positive breast cancer, fulvestrant (Faslodex) given at 500 mg “is associated with a 19% reduction in risk of death and a 4.1-month difference in median overall survival compared with fulvestrant 250 mg,” according to final...

breast cancer

Drugging PI3K in Breast Cancer: Findings From SABCS 2013

Components of the phosphatidylinositide 3-kinase/mammalian target of rapamycin (PI3K/mTOR) pathway are deregulated in many human cancers, with about 30% of breast cancers harboring PIK3CA gene mutations. Emerging research shows that these mutations may render estrogen receptor alpha-positive tumors ...

breast cancer

A New Era in the Management of Advanced HER2-Positive Breast Cancer

Approximately 20% of all breast cancers are human epidermal growth factor receptor 2 (HER2)-positive. Prior to the era of HER2-targeted therapy, HER2-positive breast cancer was characterized by a poor prognosis.1,2 The development of the first HER2-targeted therapy, trastuzumab (Herceptin), led to...

breast cancer

Novel Agents May Address Endocrine Therapy Resistance

Progress has recently been swift in the development of new drugs to improve the response to hormone therapy in breast cancer, according to Hope S. Rugo, MD, Professor of Medicine and Director of Breast Oncology and Clinical Trials Education at the University of California, San Francisco, Helen...

breast cancer

Complexities of Targeting HER2 in Estrogen Receptor–Positive Breast Cancers

The interactions between the estrogen receptor (ER) and HER2 pathways in breast cancers are clearly complex and remain incompletely understood. Historically, cancers that express both ER and HER2 were thought to be intrinsically resistant to endocrine therapy, likely due to HER2 being the dominant...

breast cancer

No Benefit of Adding Lapatinib to Fulvestrant in Hormone Receptor–Positive Advanced Breast Cancer

In a phase III trial (Cancer and Leukemia Group B [CALGB] 40302/Alliance) reported in the Journal of Clinical Oncology, Harold J. Burstein, MD, PhD, of Dana-Farber Cancer Institute, Boston, and colleagues found that the addition of the dual EGFR-HER2 inhibitor lapatinib (Tykerb) to endocrine...

breast cancer

Fulvestrant Surpasses Anastrozole in First-Line Treatment of Metastatic Breast Cancer

Fulvestrant (Faslodex) at a 500-mg dose was superior to anastrozole as first-line therapy for advanced hormone receptor–positive breast cancer in the phase II FIRST study.1 Overall survival and time to disease progression were significantly better with fulvestrant than with the current standard of...

breast cancer

News Roundup From the 2014 San Antonio Breast Cancer Symposium

Highlighted here are summaries of four abstracts presented at the 2014 San Antonio Breast Cancer Symposium: They focus on the EPO-ANE-3010 clinical trial of epoetin alfa (Epogen, Procrit) in anemic patients with metastatic breast cancer, a New York Cancer Consortium trial of fulvestrant (Faslodex)...

breast cancer

PI3K Inhibition in Hormone Receptor–Positive Breast Cancer ‘Not Ready for Prime Time’

Interest is high in studying the PI3K pathway in hormone receptor–positive breast cancer, but it is not clear which of the PI3K inhibitors under development—if any—will be a “home run.” The phase II FERGI study, reported at the 2014 San Antonio Breast Cancer Symposium, failed to meet its primary...

breast cancer
survivorship

Breast Cancer Management in Review

With the field of breast oncology as complex as ever, a brief update of the latest findings impacting breast cancer treatment seems timely. To that end, I have assembled highlights from a collection of newsworthy studies featured over the past year and into early 2015. Part 1 of this review, which...

breast cancer

Partnering Therapies for Estrogen Receptor–Positive Breast Cancer Requires Close Monitoring and Patient Communication

Partnering endocrine therapy with new targeted agents for women with estrogen receptor–positive breast cancer “changes the nature of endocrine therapy from something easily tolerated, with not a lot that you have to do as physicians to monitor it,” William J. Gradishar, MD, of the Robert H. Lurie...

palliative care
breast cancer
issues in oncology

SABCS 2015: Phase III BELLE-2 Trial Meets Primary Endpoint of Progression-Free Survival

Among women with locally advanced or metastatic hormone receptor–positive breast cancer that was resistant to hormone therapy, those who had mutated PIK3CA detected in their blood benefited from a combination of the investigational PI3K inhibitor buparlisib and fulvestrant (Faslodex),...

breast cancer

Palbociclib Improves Progression-Free Survival in Advanced Hormone Receptor–Positive Breast Cancer

In a phase III PALOMA 3 trial reported at the 2015 ASCO Annual Meeting and published in The New England Journal of Medicine, Turner et al found that the cyclin-dependent kinase 4 and 6 inhibitor palbociclib (Ibrance) significantly improved progression-free survival in women with advanced hormone...

breast cancer

ASCO 2015: Novel Targeted Drug Palbociclib Slows Progression of Hormone Receptor–Positive Breast Cancer

Results from the phase III registration study PALOMA-3 show that adding the investigational targeted agent palbociclib (Ibrance) to the standard hormonal therapy fulvestrant (Faslodex) more than doubled the duration of disease control, delaying disease progression by roughly 5 months in women with...

palliative care
breast cancer

AACR 2015: Dual mTOR Inhibitor-Fulvestrant Combination Feasible, With Clinical Benefit for Advanced Breast Cancer Patients

The dual mTOR inhibitor AZD2014, when combined with the hormonal therapy fulvestrant (Faslodex), was found to be safe in patients with advanced estrogen receptor–positive breast cancer, and some of them experienced clinical benefit from the drug combination, according to phase I clinical...

breast cancer

No Progression-Free Survival Benefit of Adding Bevacizumab to Endocrine Therapy in First-Line Treatment for Advanced Breast Cancer

In a Spanish-German phase III LEA trial reported in the Journal of Clinical Oncology, Martín et al found that adding bevacizumab (Avastin) to endocrine therapy with letrozole or fulvestrant (Faslodex) in the first-line treatment of postmenopausal women with advanced breast cancer did not...

breast cancer

SABCS 2014: PI3K Inhibition With Pictilisib in Hormone Receptor–Positive Breast Cancer Not Ready for Prime Time

Interest is high in studying the PI3K pathway in hormone receptor–positive breast cancer, but it is not clear which of the PI3K inhibitors under development—if any—will be a “home run.” Adding the pan-class I selective PI3K inhibitor pictilisib to fulvestrant...

breast cancer

No Benefit of Adding Lapatinib to Fulvestrant in Hormone Receptor–Positive Advanced Breast Cancer

In the phase III Cancer and Leukemia Group B (CALGB) 40302/Alliance trial reported in the Journal of Clinical Oncology, Burstein et al found that the addition of the dual EGFR-HER2 inhibitor lapatinib (Tykerb) to endocrine therapy with fulvestrant (Faslodex) did not improve progression-free...

breast cancer

Final Overall Survival Analysis of CONFIRM Trial Shows Advantage of Higher Dose of Fulvestrant in Advanced Breast Cancer

As reported in the Journal of the National Cancer Institute by Di Leo et al, the final overall survival analysis of the CONFIRM trial has shown a significant benefit of fulvestrant (Faslodex) at 500 mg vs 250 mg in postmenopausal women with locally advanced or metastatic estrogen...

breast cancer

No Additional Benefit of Double Endocrine Treatment After Progression on Aromatase Inhibitors in Advanced Hormone Receptor–Positive Breast Cancer

In the SoFEA trial, reported in Lancet Oncology by Stephen R.D. Johnston, PhD, FRCP, of Royal Marsden NHS Foundation Trust, and colleagues, postmenopausal women with advanced hormone receptor–positive breast cancer that progressed on nonsteroidal aromatase inhibitors were treated with the...

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