One-Two Punch of Palbociclib, Paclitaxel Shows Promise against Advanced Breast Cancer

“Combining the new breast cancer drug palbociclib with paclitaxel (Taxol) shrank tumors in nearly half of patient with estrogen-receptor (ER) positive breast cancer, according to new research from the Perelman School of Medicine at the University of Pennsylvania. The results will be presented Saturday at the 2015 San Antonio Breast Cancer Symposium. A second study provides new clues to how breast cancer develops resistance to the palbociclib, a common occurrence among many patients who take the drug.

” ‘Results of the first study found that palbociclib and paclitaxel can be safely combined on an alternating dosing schedule,’ said Angela DeMichele, MD, MSCE, the Alan and Jill Miller Associate Professor in Breast Cancer Excellence in Penn’s Abramson Cancer Center, and senior author on the study. ‘The high response rate we saw suggests this combination may hold benefits for patients over paclitaxel alone. Based on these results, a larger clinical trial to determine the benefits is warranted.’ “


Denosumab Benefits Postmenopausal Breast Cancer Patients

“The addition of the bone-targeting drug denosumab to adjuvant hormonal therapy in postmenopausal breast cancer patients improves disease-free survival (DFS), reducing the risk of disease recurrence by 18% compared with placebo, according to the results of the Austrian Breast and Colorectal Cancer Study Group (ABCSG)-18 trial.

“The results (abstract S2-02) were presented at the 2015 San Antonio Breast Cancer Symposium (SABCS), held December 8–12 in San Antonio, Texas.

“ ‘This is a very safe treatment and my clinical conclusion is that denosumab reduces the risk of disease recurrence or death, and this benefit is similar to what bisphosphonates can do and comes in addition to highly significantly reducing clinical fractures,’ said study author and presenter Michael Gnant, MD, professor of surgery at the Medical University of Vienna in Austria, during a press conference. ‘I believe that we should offer this treatment to postmenopausal breast cancer patients on adjuvant aromatase inhibitors.’ “


Capecitabine Improved Outcomes for Breast Cancer Patients with Disease after Presurgery Chemo

“Treatment with the chemotherapy agent capecitabine increased disease-free survival for women with HER2-negative breast cancer that was not eliminated by presurgery chemotherapy, according to results from the phase III CREATE-X clinical trial presented at the 2015 San Antonio Breast Cancer Symposium, held Dec. 8-12.

“Treatment given to shrink or eliminate a tumor before surgery is called neoadjuvant therapy. In some patients with breast cancer treated with neoadjuvant chemotherapy, residual invasive cancer can be detected in breast tissue samples and lymph nodes removed during surgery. These patients tend to have worse long-term outcomes compared with women who respond completely to neoadjuvant therapy.

” ‘It has been suggested that patients with residual invasive disease after neoadjuvant chemotherapy have chemoresistant breast cancer, but there have been no large-scale clinical trials to test whether adjuvant systemic chemotherapy is beneficial for these patients,’ said Masakazu Toi, MD, PhD, a professor at Kyoto University Hospital in Japan, and founder and senior director of the Japan Breast Cancer Research Group (JBCRG). ‘CREATE-X was designed to evaluate this clinical question by testing whether capecitabine could improve disease-free survival for patients with residual invasive disease after neoadjuvant chemotherapy.’ “


SABCS 2015: Mastectomy Plus Reconstruction Has Higher Complication Rates and Costs Than Lumpectomy Plus Radiation

“Among the various guideline-concordant local therapy options available for women with early-stage breast cancer in the United States, mastectomy plus reconstruction had the highest complication rates and complication-related costs for both younger women with private insurance and older women on Medicare and was the most expensive option for younger women, according to data presented at the 2015 San Antonio Breast Cancer Symposium, held December 8–12 in San Antonio, Texas (Abstract S3-07).

“ ‘Women with early-stage breast cancer have several local therapy options. Although there’s nuance as far as what treatment is best for which patient, there is a large group of patients for whom most, if not all, of these treatment options are considered guideline-appropriate,’ said Benjamin D. Smith, MD, Associate Professor and Research Director of the Breast Radiation Oncology Section in the Department of Radiation Oncology at The University of Texas MD Anderson Cancer Center.”


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, according to data from the phase III BELLE-2 trial presented at the 2015 San Antonio Breast Cancer Symposium, held Dec. 8–12.

“ ‘BELLE-2 is a randomized, phase III clinical trial designed to assess the efficacy of the investigational PI3K inhibitor buparlisib in combination with fulvestrant in breast cancer patients whose tumors no longer respond to aromatase inhibitors,’ said José Baselga, MD, PhD, physician-in-chief and chief medical officer at Memorial Sloan Kettering Cancer Center in New York.”


T-DM1 Improved Overall Survival for Heavily Pretreated Patients With HER2-positive Breast Cancer

“Among patients with HER2-positive, metastatic breast cancer that had progressed despite treatment with two or more forms of HER2-targeted therapy (trastuzumab [Herceptin] and lapatinib [Tykerb]), median overall survival was increased for those treated with trastuzumab emtansine (T-DM1 [Kadcyla]) compared with those who received treatment of physician’s choice, according to results from the phase III TH3RESA clinical trial presented at the 2015 San Antonio Breast Cancer Symposium, held Dec. 8–12.

“The HER2-targeted antibody-drug conjugate T-DM1 was approved by the U.S. Food and Drug Administration in February 2013 for treating patients with HER2-positive, metastatic breast cancer that had progressed after treatment with trastuzumab and a taxane.”


Partial Breast Irradiation Sufficient in Early Disease

“Accelerated partial breast irradiation (APBI) was shown to be just as effective and safe as whole breast irradiation (WBI), according to the results of a randomized phase III clinical trial conducted in Italy. There was no difference between APBI, delivered as intensity-modulated radiation therapy (IMRT), and WBI after a 5-year median follow-up. APBI also resulted in significantly better safety and cosmetic outcomes for patients. The results were presented by the study’s principal investigator, Lorenzo Livi, MD, of the radiotherapy-oncology unit at Florence University Hospital in Florence, Italy, at the 2014 San Antonio Breast Cancer Symposium (SABCS), held December 9–13 in San Antonio, Texas.

“The mean time to ipsilateral breast tumor recurrence (IBTR) was 2.9 years. There was no statistically significant difference in the 5-year IBTR rate (1.4% and 1.5% in the WBI and APBI arms, respectively; P = .86) or the 5-year overall survival rate (96.6% and 99.4% in the WBI and APBI arms, respectively; P = .057). Because of the low IBTR rate, a longer follow-up is still needed.

“ ‘Our results showed a very low recurrence rate [for APBI] and no differences in terms of distant metastases and overall survival rate. Partial breast [irradiation] certainly will be an effective option for treatment in selected breast cancer patients,’ Livi told Cancer Network via e-mail.”