Efficacy of scalp cooling in reducing alopecia in early breast cancer patients receiving contemporary chemotherapy regimens.

INTRODUCTION: Hair loss as a result of chemotherapy for early breast cancer (EBC) is a frequent and distressing side effect. Minimising hair loss may improve mood and body image. Our aim was to determine scalp cooling (SC) efficacy in EBC patients receiving contemporary chemotherapy regimen, to inform future patients choice to use SC or not. METHODS AND RESULTS: Prospective cohort study of 60 stage 1-3 EBC patients recommended to receive taxane or anthracycline-taxane chemotherapy regimens. The primary outcome was incidence of minimal hair-loss (MHL - defined as 60% Dean grade 1 or 2). Patients were categorised by chemotherapy (3 groups) and randomised 1:1 within each group to two scalp cooling temperature settings using the Dignitana Dignicap machine (secondary endpoint). Patients reported degree of hair loss using the Dean score on day 1 of each cycle and following the last chemotherapy. RESULTS: On an intention-to-treat basis, 33% of patients reported MHL, thus our primary endpoint was not achieved. Patients receiving taxane-only chemotherapy had the highest rate of MHL (45%). No other factors (including hair type, age, body weight, temperature setting) predicted for MHL. Patient-reported anxiety reduced significantly in all patients, but no difference was observed for depression or body image irrespective of degree of hair loss. SC-related adverse events were uniformly of low grade and all resolved. We would recommend the use of SC for all patients receiving taxane-based chemotherapy, with its use for those patients recommended for anthracycline-taxane regimens being made on an individual basis. Trial Registration anztr.org.au ACTRN12615001106527.

Phase II, open-label trial of lapatinib and vinorelbine in women with previously treated HER2-positive metastatic breast cancer.

AIM: To evaluate the efficacy and tolerability of lapatinib (L) and intravenous vinorelbine (V) in patients with metastatic HER2-positive breast cancer who have previously received two lines of anti-HER2 therapy (i.e. trastuzumab [T] with chemotherapy and lapatinib with capecitabine [LC]). METHOD: Consenting patients with measurable or evaluable disease and normal cardiac function who had progressed were recruited. Patients received LV (lapatinib 1250 mg orally daily, vinorelbine 20 mg/m(2) intravenously on days 1 and 8 every 3 weeks) until progressive disease, intolerable toxicity or patient request. RESULTS: The trial was closed early following inclusion of 19 patients due to slow accrual. Ten, five and four patients had received two, three and more than four lines of chemotherapy with T and LC, respectively, prior to study entry. Patients received a median of 5 cycles (range 1-18) of LV. Confirmed partial response was seen in 2 of 16 patients with measurable disease (12.5%); stable disease >24 weeks was seen in two patients (10.5%) with a clinical benefit rate of 20%. Fatigue and any grade neutropenia occurred commonly, but grade 4 severity occurred in only 5 and 11%, respectively. There were no episodes of cardiac dysfunction and no treatment-related deaths. The median progression-free survival was 3.9 months and overall survival (OS) was 9.1 months. CONCLUSION: The combination of LV demonstrated modest efficacy but was well tolerated. This combination may be of benefit to those patients who are unable to access the newer anti-HER2 agents and the low rate of treatment-emergent adverse effects will enable patients' symptoms, such as pain, to be minimized.