Efficacy of late line pertuzumab with trastuzumab and chemotherapy in HER2-positive metastatic breast cancer: An Australian case series.

BACKGROUND: Pertuzumab, when combined with trastuzumab and chemotherapy, is a highly active human epidermal growth factor receptor 2 (HER2), targeting agent in the neoadjuvant, adjuvant and first-line metastatic HER2-positive breast cancer setting. The efficacy of late-line (after first/second-line) pertuzumab in combination with trastuzumab and chemotherapy is unknown. AIMS: To establish pertuzumab efficacy by performing an audit of patients who received pertuzumab after first-line HER2 directed therapy. We sought to establish whether efficacy differed by clinicopathological factors. METHODS: The primary endpoint was progression-free survival (PFS) and the secondary endpoint, overall survival (OS). Clinicopathological factors, PFS and OS data were collated and clinicopathological factors associated with PFS were evaluated using Cox regression models. RESULTS: Fourteen women were identified. Six (43%) had hormone receptor (HR) negative and eight (57%) had HR-positive, metastatic HER2-positive breast cancer. Median follow up was 22.8 months, median prior lines of therapy were 5 (range: 1-9). Median time from diagnosis of metastatic disease to receiving pertuzumab was 4.5 years (range: 4.2-5.8). All patients received initial chemotherapy with pertuzumab and trastuzumab (taxane-based 71%). Median PFS was 9 months (95% confidence interval [CI]: 7-not estimable [NE]) and median OS was not reached (95% CI, 16 months-NE). Univariable analysis demonstrated that HR-negative patients had a significantly longer PFS than HR-positive patients (hazard ratio = 0.11; 95% CI, 0.01-0.88; P = 0.04). CONCLUSION: This small cases series reports a favorable PFS and OS for pertuzumab with trastuzumab and chemotherapy in the later line metastatic setting. This finding warrants further study.

Mortality within 30 days of receiving systemic anti-cancer therapy at a regional oncology unit: what have we learned?

AIMS: Benefits to patients from systemic anti-cancer therapies (SACT) occur at a cost of significant toxicities that can be life threatening. Published data of SACT mortality outside clinical trials is limited with no published Australia data. We aim to establish local outcomes at a regional Victorian oncology center to allow comparison with limited international data. METHODS: An audit was undertaken at Ballarat Health Services to analyze all deaths occurring within 30 and 60 days of receiving SACT (cytotoxic chemotherapy and targeted therapy) for epithelial malignancies and hematological malignancies (excluding acute leukemia), over a 12-month period. Hormonal therapy was excluded. RESULTS: Between 1 January and 31 December 2008, 378 patients received SACT. In total 13 deaths (3.4%) occurred within 30 days following SACT. Three deaths (23%) were definitely treatment-related - neutropenic sepsis, pneumocystis pneumonia and bowel perforation, respectively. Eight deaths (62%) were definitely unrelated to treatment. Most deaths were due to disease progression (six patients) For two patients (15%), the cause of death was unknown. Most patients were treated with palliative intent. Most patients were receiving first-line treatment (seven patients, 50%). A further five deaths (1.3%) occurred 31-60 days after SACT, four of which were due to disease progression. CONCLUSION: Our local outcome data are comparable to limited current international data. This type of audit reviews local outcomes and identifies factors contributing to mortality in order to improve standards of care. We encourage similar audits to establish national benchmarks of 30-day mortality rate.