ABSTRACT
PARTNER is a prospective, phase II-III, randomized controlled clinical trial that recruited patients with triple-negative breast cancer1,2, who were germline BRCA1 and BRCA2 wild type3. Here we report the results of the trial. Patients (n = 559) were randomized on a 1:1 basis to receive neoadjuvant carboplatin-paclitaxel with or without 150 mg olaparib twice daily, on days 3 to 14, of each of four cycles (gap schedule olaparib, research arm) followed by three cycles of anthracycline-based chemotherapy before surgery. The primary end point was pathologic complete response (pCR)4, and secondary end points included event-free survival (EFS) and overall survival (OS)5. pCR was achieved in 51% of patients in the research arm and 52% in the control arm (P = 0.753). Estimated EFS at 36 months in the research and control arms was 80% and 79% (log-rank P > 0.9), respectively; OS was 90% and 87.2% (log-rank P = 0.8), respectively. In patients with pCR, estimated EFS at 36 months was 90%, and in those with non-pCR it was 70% (log-rank P < 0.001), and OS was 96% and 83% (log-rank P < 0.001), respectively. Neoadjuvant olaparib did not improve pCR rates, EFS or OS when added to carboplatin-paclitaxel and anthracycline-based chemotherapy in patients with triple-negative breast cancer who were germline BRCA1 and BRCA2 wild type. ClinicalTrials.gov ID: NCT03150576 .
ABSTRACT
Burn trauma ranges from the minor burn to the devastating injury, which can impact on all aspects of a person's life including aesthetic appearance, relationships with others and psychological, social and physical functioning. Measurement of outcome in burns patients is therefore complex and multi-faceted. The increasing numbers of major burn survivors implies that understanding health outcomes in these patients has assumed high priority. This paper sets out a conceptual framework for unifying outcome measurement, which may be useful to all members of the multidisciplinary team who are contemplating outcome assessment in their burn patients. It outlines seven core domains of assessment which are (i) skin; (ii) neuromuscular function; (iii) sensory and pain; (iv) psychological function; (v) physical role function; (vi) community participation; and (vii) perceived quality of life. Within each domain, we present a brief clinical review of the most commonly administered measurement tools that have been, or potentially could be, used to assess aspects of these core domains. Where possible, the psychometric properties and clinical utility of these tools are presented. A concise discussion of key methodological issues which should be addressed in this assessment process is then provided, together with suggestions for future research.
