RESUMO
Exploratory analyses of high-dose alkylating chemotherapy trials have suggested that BRCA1 or BRCA2-pathway altered (BRCA-altered) breast cancer might be particularly sensitive to this type of treatment. In this study, patients with BRCA-altered tumors who had received three initial courses of dose-dense doxorubicin and cyclophosphamide (ddAC), were randomized between a fourth ddAC course followed by high-dose carboplatin-thiotepa-cyclophosphamide or conventional chemotherapy (initially ddAC only or ddAC-capecitabine/decetaxel [CD] depending on MRI response, after amendment ddAC-carboplatin/paclitaxel [CP] for everyone). The primary endpoint was the neoadjuvant response index (NRI). Secondary endpoints included recurrence-free survival (RFS) and overall survival (OS). In total, 122 patients were randomized. No difference in NRI-score distribution (p = 0.41) was found. A statistically non-significant RFS difference was found (HR 0.54; 95% CI 0.23-1.25; p = 0.15). Exploratory RFS analyses showed benefit in stage III (n = 35; HR 0.16; 95% CI 0.03-0.75), but not stage II (n = 86; HR 1.00; 95% CI 0.30-3.30) patients. For stage III, 4-year RFS was 46% (95% CI 24-87%), 71% (95% CI 48-100%) and 88% (95% CI 74-100%), for ddAC/ddAC-CD, ddAC-CP and high-dose chemotherapy, respectively. No significant differences were found between high-dose and conventional chemotherapy in stage II-III, triple-negative, BRCA-altered breast cancer patients. Further research is needed to establish if there are patients with stage III, triple negative BRCA-altered breast cancer for whom outcomes can be improved with high-dose alkylating chemotherapy or whether the current standard neoadjuvant therapy including carboplatin and an immune checkpoint inhibitor is sufficient. Trial Registration: NCT01057069.
RESUMO
BACKGROUND: The decision to discharge a patient from a hospital is a complex process governed by many medical and non-medical factors, while the actual reasons for discharge frequently remain ill-defined. AIM: To define relevant discharge criteria as perceived by doctors, nurses and patients for the development of a standard hospital discharge policy, we collected actual reasons and most pivotal medical and organisational criteria for discharge among all stakeholders. SETTING: A tertiary referral university teaching hospital. METHODS: We conducted a mixed methods analysis, using patient questionnaires, interviews and a focus group with caregivers, and observations during the daily rounds of doctors, nurses and patients during their hospital stay. Fourteen wards of the Surgery, Paediatrics and Neurology departments contributed. RESULTS: We observed 426 patients during their hospital stay. Forty doctors and nurses were interviewed, and 7 senior nurses attended a focus group. The most commonly used discharge criteria were clinical factors, organisational discharge issues and patient-related factors. A total of 269 patients returned their questionnaires. About one third of the adult patients and nearly half of the children (or their parents) felt their personal situation and assistance needed at home was insufficiently taken into account before discharge. Patients were least satisfied with the information given about what they were allowed to do or should avoid after discharge and their involvement in the planning of their discharge. Thus, besides obvious medical reasons for discharge, several non-medical reasons were signalled by all stakeholders as important issues to be improved. CONCLUSIONS: A set of discharge criteria could be defined that is useful for a more uniform hospital discharge policy that may help reduce unnecessary length of stay and improve patient satisfaction.
