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• W4386404310 abstract "LEE011; letrozole; breast cancer: LEE011; letrozole; breast cancerAdditional analyses from the phase III MONALEESA-2 study found LEE011 (ribociclib) plus letrozole significantly prolonged progression-free survival (PFS) across pre-planned patient subgroups with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. The analyses were presented at the 2016 San Antonio Breast Cancer Symposium (Abstracts P4-22-05 and P4-22-16). The MONALEESA-2 trial evaluated the safety and efficacy of LEE011 in combination with letrozole compared to letrozole alone in postmenopausal women with HR+/HER2- advanced breast cancer who received no prior therapy for their advanced breast cancer, according to Howard A. Burris, MD, President, Clinical Operations and Chief Medical Officer, Sarah Cannon, Nashville, Tenn. “The trial included pre-planned patient subgroups, including post-menopausal women diagnosed de novo, those with visceral liver and lung metastases, and those with bone-only disease,” he explained. “The analyses help us to better understand the type of patient who may benefit from a particular treatment.” Patients in the phase III, double-blind, international study were randomized 1:1 to receive LEE011 (600 mg/day; 3-weeks-on/1-week-off in 28-day treatment cycles) plus letrozole (2.5 mg/day; continuous) or placebo plus letrozole. Randomization was stratified according to presence of liver and/or lung metastases. Researchers performed supportive analyses in prespecified subgroups, including among patients with de novo advanced breast cancer as well as those with the presence of liver and/or lung or bone-only metastases. The primary endpoint was locally assessed PFS survival, which was analyzed in all patients, including the predefined patient subgroups. “Because de novo disease has not been previously treated with systemic therapy for early-stage breast cancer, tumors may exhibit a different disease biology, which could result in varied responses compared to patients who experienced recurrence,” reported Burris. “We evaluated women with de novo HR+/HER2- advanced breast cancer to better understand the response of LEE011 plus letrozole in this patient population. “Similarly, those with visceral metastases have metastatic growth at the site of the lung or liver, and typically have a poorer prognosis than patients with non-visceral disease, and women with bone-only metastases tend to have a better prognosis,” he continued. “Since these women have unique experiences, we also evaluated the patient subgroups to understand how treatment with LEE011 plus letrozole may benefit these distinct populations.” Results of Subgroup Analyses Findings from the subgroup analyses have demonstrated the treatment benefits of LEE011 plus letrozole in the first-line setting, across patient subgroups no matter the disease burden or tumor location, including patients with aggressive disease. Patients with de novo disease The subgroup analysis of the MONALEESA-2 trial evaluated the safety and efficacy of LEE011 plus letrozole versus letrozole alone in 227 patients with de novo advanced breast cancer. Results showed PFS was significantly prolonged in this patient population. Burris reported that LEE011 plus letrozole reduced the risk of disease progression or death in 55 percent over letrozole alone (HR=0.448 [95% CI: 0.267-0.750]). The 12-month PFS rate was 82 percent in the LEE011 plus letrozole arm compared to 66 percent with letrozole alone. Most adverse events, which were mild to moderate in severity, were identified early through routine monitoring, and generally managed through dose interruption and reduction, according to Burris. The most common all-grade adverse events (≥30% of patients with de novo advanced breast cancer) in the LEE011 plus letrozole arm were neutropenia (70.2%), nausea (48.2%), fatigue (42.1%), alopecia (39.5%), and leukopenia (31.6%). “Results from the de novo subgroup of women in the MONALEESA-2 trial establish ribociclib in combination with letrozole as a meaningful treatment option in the first-line setting for this patient population,” noted Joyce O'Shaughnessy, MD, Co-Chair, Breast Cancer Research, Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas. “These de novo patients are often diagnosed initially with advanced breast cancer that has already metastasized, so it is critical to start them with treatments that extend time until disease progression.” Patients with visceral or bone-only disease MONALEESA-2 trial investigators evaluated 393 patients with advanced breast cancer with visceral metastases and 147 patients with bone-only disease in separate subgroups. The analyses determined that first-line LEE011 plus letrozole reduced the risk of disease progression or death by 46.5 percent (patients with visceral disease: HR=0.535 [95% CI: 0.385-0.742]) and 31 percent (patients with bone-only disease: HR=0.690 [95% CI: 0.381-1.249]), respectively. Treatment benefit with LEE011 in combination with letrozole was observed regardless of the number of metastatic sites (HR=0.607 (95% CI: 0.437-0.845) among patients with fewer than three metastases; HR=0.456 (95% CI: 0.298-0.700) among patients with three or more metastases), researchers reported. The most frequent all-grade adverse events observed among patients with visceral metastases in the LEE011 plus letrozole arm (≥30% of patients; regardless of study treatment relationship) were neutropenia (79.2%), nausea (56.3%), fatigue (36.0%), leukopenia (35.5%), diarrhea (33.5%), and alopecia (31.5%). Researchers noted that nausea, fatigue, and diarrhea were predominately low-grade. The most frequent all-grade adverse events reported in patients with bone-only disease (≥30% of patients; regardless of study treatment relationship) were neutropenia (63.8%), nausea (46.4%), alopecia (44.9%), diarrhea (40.6%), fatigue (39.1%), and leukopenia (30.4%). Diarrhea and fatigue were for the most part low-grade, according to study authors. “Breast cancer that has metastasized to areas such as the liver or lungs can often be more challenging to effectively treat with current standards of care,” Burris explained. “We have been encouraged by the MONALEESA-2 results because treatment benefit was observed regardless of the number of metastatic sites and was maintained across all subgroups taking ribociclib plus letrozole. Our observations indicate that this novel therapy may be a promising treatment option for many patients living with advanced forms of breast cancer,” he emphasized. Catlin Nalley is associate editor." @default.
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• W4386404310 date "2017-02-10" @default.
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• W4386404310 title "LEE011 Plus Letrozole Analyses Show Prolonged PFS" @default.
• W4386404310 doi "https://doi.org/10.1097/01.cot.0000513006.02913.99" @default.
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