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PER® Miami Breast Cancer Conference

The addition of sorafenib to capecitabine as a first-line therapy for patients with advanced breast cancer resulted in a 42% reduction in the risk of disease progression or death among participants in a phase IIB trial, according to research reported at the Miami Breast Cancer Conference. 

In one of the top posters presented at the conference, researchers said that the results warranted a phase III trial for sorafenib, an antiangiogenic and antiproliferative multikinase inhibitor. In fact, a phase 3 trial was launched in February.

Lead investigator Patricia Gómez, MD, an attending physician and senior clinical investigator at the Hospital Vall d’Hebron, Barcelona, Spain, said the research team wanted to examine how the addition of a targeted therapeutic agent would impact conventional therapy. She said they chose sorafenib because of its antiangiogenic qualities and because patients can take it orally.

Until now, sorafenib (Nexavar), which was approved by the FDA in 2005, has been used only for the treatment of unresectable hepatocellular carcinoma and advanced renal cell carcinoma. However, the SOLTI-0701 multinational, double-blind study enrolled 229 patients with advanced HER2-negative breast cancer previously treated with ≤1 prior chemotherapy regimens. Patients were randomized virtually 1:1 to sorafenib with capecitabine or placebo with capecitabine. Progression-free survival (PFS) was the primary endpoint of the study.

As first-line therapy, PFS for patients in the sorafenib arm was 7.6 months, compared with 4.1 months for those in the placebo group. Gómez said that was the most significant finding of the study.

As second-line therapy, sorafenib made a measurable but not statistically significant difference, improving median PFS to 5.7 months compared with 4.1 months for the placebo group.

In overall survival (OS), a secondary endpoint, the median OS for the sorafenib arm was 22.9 months, compared with 20.9 months for the placebo arm.

Gómez said the most significant adverse effect in the sorafenib arm was hand-foot skin reaction, with 44% of patients reporting grade 3 symptoms. She felt those symptoms could be managed.

The study is 1 of 4 phase IIB trials studying the combination of sorafenib with other therapies as part of the TIES (Trials to Investigate the Effects of Sorafenib) breast cancer program.

The addition of sorafenib to capecitabine as a first-line therapy for patients with advanced breast cancer

Phase II Sorafenib Study Yields Positive Results

Daniel A. Osman, MD, Founder and Course Director of the Miami Breast Cancer Conference Discusses Methods for Detecting Malignant Conditions in Breast Cancer

Dr. Osman on Detecting Malignant Breast Cancer

The climate for medical malpractice litigation in breast cancer treatment seems to be worsening, with “designer lawsuits” linked to imaging and genetic tests among the emerging trends, according to Patrick I. Borgen, MD chairman of the Department of Surgery and director of the Brooklyn Breast Cancer Program at Maimonides Medical Center in Brooklyn, New York.

“Failure to diagnose breast cancer accounts for about 40% of all medical malpractice suits filed,” said Borgen, a widely published author and editor.

He said allegations of a delay in diagnosis of breast cancer is the number 1 basis for medical malpractice lawsuits and the second most expensive generator of liability claims against physicians. 

Borgen identified these allegations as emerging areas of litigation:

		Failure to identify genetic risk factors

		Failure to use available technology to determine ideal treatment

		Breast cancer caused by hormone replacement therapy

He also said plaintiffs are showing an increased interest in genomic profiling in cases where complications arose after unnecessary chemotherapy.

“What’s driving this today more than anything else is unrealistically high expectations,” Borgen said.

Often, these expectations are fueled by simplistic media reports that fail to convey the complexities of breast cancer or the limitations of clinical studies, Borgen said. For instance, he cited research showing that 57% of women over 40 years old believe getting a mammogram reduces their risk of breast cancer.

Borgen said oncologists could take steps to prevent malpractice suits, such as controlling their practices, maintaining documentation, and managing a patient’s anger at her condition. He also suggested that physicians could be more selective about the patients they treat.

Above all, he said, oncologists must manage expectations about treatment outcomes—their own expectations and those of their patients.

The climate for medical malpractice litigation in breast cancer treatment seems to be worsening

Malpractice Claims Target Breast Cancer Specialists

Breast pain is among the most common reasons that women seek medical attention from a breast specialist. According to speakers at the Miami Breast Cancer Conference, an appropriate diagnosis is of utmost concern even though the condition most frequently proves to be benign.

The reasons for breast pain can be attributed to hormonal cycles or to diet and lifestyle patterns. Benign breast conditions were the focus at a mini-symposium Wednesday as 2 speakers presented both an American and European perspective on diagnosis and treatment.

An American Perspective: Watch Out for Bursitis

Women who experience breast pain often fear they have cancer, so alleviating their cause of distress is essential, according to V. Suzanne Klimberg, MD, a professor of surgery and pathology and director of the Breast Cancer Program at the Winthrop P. Rockefeller Cancer Institute in Little Rock, Arkansas.

Klimberg noted that 7% of breast cancer patients present with breast pain only, heightening the importance of diagnosing pain.

“When a patient complains of breast pain, important first steps are determining the relationship between her symptoms and her menstrual cycle, and whether the pain radiates from her arm or bears similarities to bursitis, Klimberg explained.

“There are a variety of factors that could play a role in breast pain,” Klimberg said. These include dietary factors such as caffeine use, consuming high-fat meals, or eating chocolate, cheese, or drinking wine. Stress can also exacerbate the pain, she said.

As a result, reassurance works well for half of the patients with mild breast pain. For dietary issues, nutritional changes often help.

Klimberg finds the most frequent cause of difficult-to-treat breast pain is bursitis. “Breast pain associated with bursitis is important to diagnose because it is the most often missed and the easiest to treat with physical therapy or trigger point injections,” she said.  She uses long- and short-acting pain medication.

A European Perspective: Repetitive Strain Has an Impact

R. Douglas Macmillan, MBChB, MD, FRCS, found that the strain of typing all day at a computer keyboard or toting around a young child frequently causes breast pain, which, in severe cases, is treatable with steroid injections.

Macmillan, an oncoplastic surgeon and clinical lead at the Nottingham Breast Institute, United Kingdom, said that breast pain can be divided into 2 broad categories:

		Hormonal pain usually linked to the patient’s menstrual cycle and to hormone replacement therapy in postmenopausal women

		Chest wall pain that can be diagnosed more precisely into 2 repetitive strain syndromes by determining which ribs are affected

For hormonal pain, “the mainstay of management is reassurance with expectation of spontaneous resolution,” with severe cases requiring low-dose, short-term, intermittent tamoxifen.

When it comes to chest wall pain, the answer often lies in the patient’s daily activities. Macmillan analyzed rib complaints of 138 women and found that pain was localized to 1 rib in 66% of the patients and to 2 ribs in 21%.

In the serratus syndrome, 2 or 3 adjacent ribs of the upper 8 ribs where the serratus arises are most commonly affected; these patients likely work regularly at a computer although other activities that involve using the same arm position for long periods of time (ie, hairdressing or repetitive lifting) might also cause this type of pain.

In the pectoralis syndrome, pain in ribs 3 to 5 at the origin of the pectoralis minor typically is caused when a patient carries a young child on the affected side or regularly performs similar lifting tasks.

To manage the pain, Macmillan first recommends that patients avoid the activity causing the problem. For patients with resistant, more severe pain localized to 2 or 3 ribs, a direct steroid injection such as depomedrone 80 mg was shown to be effective for 85% of patients in 1 small study. Other treatments can include a Botox injection, acupuncture, or local anesthetic patches.

Breast pain is among the most common reasons that women seek medical attention from a breast specialist.

Diet and Lifestyle Are Factors in Breast Pain

Daniel A. Osman, M.D. Founder and Course Director of the Miami Breast Cancer Conference on Breast Cancer Changes in the Past 10 Years

PER® Miami Breast Cancer Conference | Conference

Phase II Sorafenib Study Yields Positive Results

Dr. Osman on Detecting Malignant Breast Cancer

Malpractice Claims Target Breast Cancer Specialists

Diet and Lifestyle Are Factors in Breast Pain

Dr. Osman on Breast Cancer Changes in the Past 10 Years