SUMMARY: Cognitive impairment in patients with breast cancer has been frequently attributed to chemotherapy (Chemo Brain) without any data supporting this hypothesis. Utilizing functional magnetic resonance imaging, brain function was tested while the patients were performing a working memory task in the scanner, before adjuvant treatment and then one month after adjuvant treatment. Sixty six breast cancer patients with Stages 0-IIIA were studied and their cognitive function was compared with 32 healthy controls. Patients on treatment were receiving either an anthracyline-based adjuvant chemotherapy regimen (n = 29) or radiotherapy (n = 37). Patients self-reported on levels of cognitive functioning and fatigue after each imaging study. Pretreatment brain imaging revealed decreased functioning in the frontal lobe of the brain (responsible for memory and cognition), compared to the controls and this cognitive impairment was most severe in patients awaiting chemotherapy, whereas the radiotherapy group fell between the pre-chemotherapy and control group. Of Interest, the decreased functioning in the frontal lobe area before treatment predicted the severity of fatigue. Further, those with greater fatigue experienced greater cognitive impairment over time. The authors concluded that the cognitive problems are probably related to worry and fatigue prior to treatment intervention rather than the treatment itself. They recommend identifying patients at risk and early intervention. Cimprich B, Hayes DF, Askren MK, et al. CTRC-AACR San Antonio Breast Cancer Symposium, 2012; Abstract S6-3.
Author: RR
ATLAS 10 v 5 years of adjuvant tamoxifen (TAM) in ER+ disease effects on outcome in the first and in the second decade after diagnosis
SUMMARY: Historically, adjuvant treatment with tamoxifen beyond five years has not been recommended, as the benefit of tamoxifen beyond five years was unknown but there was an increased risk of endometrial cancer. (Tamoxifen Treatment for Breast Cancer and Risk of Endometrial Cancer: A Case-Control Study, J Natl Cancer Inst 2005; 97: 375-384). The ATLAS trial has now shed some light on the duration of tamoxifen treatment. In this study, 6846 women with ER positive breast cancer were enrolled between 1996 and 2005 and following five years of adjuvant tamoxifen were randomized to five additional years of tamoxifen or observation. Women who continued on tamoxifen had a 25% lower recurrence rate and 29% lower breast cancer mortality rate compared with women who stopped tamoxifen after five years. This significant benefit was seen in the second decade after diagnosis with little benefit seen in the 5-9 year period after diagnosis. There was a higher cumulative risk of death from endometrial cancer for those who continued tamoxifen beyond 5 years compared to those who did not (0.4% vs 0.2%). It appears that the reduction in breast cancer deaths outweigh the risk of endometrial cancer and other adverse events associated with longer duration of tamoxifen use. This new information will help physicians make appropriate treatment recommendations for those patients on adjuvant tamoxifen. Davis C, Hongchao P, Godwin J, et al. CTRC-AACR San Antonio Breast Cancer Symposium, 2012; Abstract S1-2.
Chemotherapy prolongs survival for isolated local or regional recurrence of breast cancer the CALOR trial (Chemotherapy as Adjuvant for Locally Recurrent breast cancer; IBCSG 27-02, NSABP B-37, BIG 1-02)
SUMMARY: Approximately 5% to 15% of all breast cancer patients present with local and/or regional recurrences. The role of adjuvant chemotherapy after resection of an isolated recurrence of breast cancer is unknown. To address this, in the CALOR trial, 162 patients with recurrent tumors underwent surgery and were then randomized to receive either four cycles of a multidrug chemotherapy regimen of investigator’s choice (n=85) or observation (n=77). The median age was 56 years. The treatment groups were well balanced and 68% and 58% of patients in the observation and treatment arms respectively received prior adjuvant chemotherapy. The median time to recurrence was 5 years in the treatment group and 6 years in the observation group. The primary end point was disease free survival (DFS). The 5-year DFS rate for the chemotherapy group and observation group was 69% vs 57% respectively. This translated into a relative risk reduction of 41% (hazard ratio [HR], 0.59; P = 0.045). The 5-year overall survival rate between the chemotherapy group and observation group was 88% vs 76% with a 59% reduction in the relative risk for death for patients treated with chemotherapy (HR, 0.41; P = 0.02). In patients with ER-negative tumors, the 5-year DFS was 67% in the treatment arm versus 35% in the control group (HR = 0.32; P = 0.007). This data supports the role of chemotherapy for patients with completely resected isolated locoregional recurrences of breast cancer. Aebi S, Gelber S, Láng I, et al. Presented at: CTRC-AACR San Antonio Breast Cancer Symposium, 2012. Abstract S3-2.
VORAXAZE® (Glucarpidase)
The FDA on January 17, 2012 approved VORAXAZE® for the treatment of toxic plasma methotrexate concentrations (> 1 μmol/L) in patients with delayed methotrexate clearance due to impaired renal function. VORAXAZE® is a product of BTG International Inc.
INLYTA® (Axitinib)
The FDA on January 27, 2012 approved INLYTA® for the treatment of advanced renal cell carcinoma after failure of one prior systemic therapy. INLYTA® is a product of Pfizer, Inc.
ERIVEDGE® (Vismodegib)
The FDA on January 30, 2012 approved ERIVEDGE® for the treatment of adults with metastatic basal cell carcinoma or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation. ERIVEDGE® is a product of Genentech, Inc.
GLEEVEC® (Imatinib)
The FDA on January 31, 2012 granted regular approval for GLEEVEC® (Imatinib mesylate) for the adjuvant treatment of adult patients for a period of 36 months following complete gross resection of Kit (CD117) positive Gastrointestinal Stromal Tumors (GIST). GLEEVEC® is a product of Novartis Pharmaceuticals.
AFINITOR® (Everolimus tablets)
The FDA on April 26, 2012 granted accelerated approval to AFINITOR® for the treatment of adults with renal angiomyolipoma, associated with tuberous sclerosis complex (TSC), who do not require immediate surgery. AFINITOR® is a product of Novartis Pharmaceuticals.
VOTRIENT® (Pazopanib tablets)
The FDA on April 26, 2012 approved VOTRIENT® for the treatment of patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy. The efficacy of pazopanib for the treatment of patients with adipocytic STS or gastrointestinal stromal tumors (GIST) has not been demonstrated. VOTRIENT® is a product of GlaxoSmithKline.
PERJETA® (Pertuzumab)
The FDA on June 8, 2012 approved PERJETA® injection for use in combination with HERCEPTIN® (Trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. PERJETA® is a product of Genentech, Inc.
