PURPOSE: BioPATH is a non-interventional study evaluating the relationship of molecular biomarkers (PTEN deletion/downregulation, PIK3CA mutation, truncated HER2 receptor [p95HER2], and tumor HER2 mRNA levels) to treatment responses in Asian patients with HER2+ advanced breast cancer treated with lapatinib and other HER2-targeted agents. MATERIALS AND METHODS: Female Asian HER2+ breast cancer patients (n=154) who were candidates for lapatinib-based treatment following metastasis and having an available primary tumor biopsy specimen were included. The primary endpoint was progression-free survival (PFS). Secondary endpoints were response rate, overall survival on lapatinib, correlation between biomarker status and PFS for any previous trastuzumab-based treatment, and conversion/conservation rates of the biomarker status between tissue samples collected at primary diagnosis and at recurrence/metastasis. Potential relationships between tumor mRNA levels of HER2 and response to lapatinib-based therapy were also explored. RESULTS: p95HER2, PTEN deletion/downregulation, and PIK3CA mutation did not demonstrate any significant co-occurrence pattern and were not predictive of clinical outcomes on either lapatinib-based treatment or any previous trastuzumab-based therapy in the metastatic setting. Proportions of tumors positive for p95HER2 expression, PIK3CA mutation, and PTEN deletion/down-regulation at primary diagnosis were 32%, 31.2%, and 56.2%, respectively. Despite limited availability of paired samples, biomarker status patterns were conserved in most samples. HER2 mRNA levels were not predictive of PFS on lapatinib. CONCLUSION: The prevalence of p95HER2 expression, PIK3CA mutation, and PTEN deletion/downregulation at primary diagnosis were similar to previous reports. Importantly, no difference was observed in clinical outcome based on the status of these biomarkers, consistent with reports from other studies.
Asian Continental Ancestry Group ; Biomarkers ; Biopsy ; Breast Neoplasms ; Breast ; Diagnosis ; Disease-Free Survival ; Female ; Humans ; Neoplasm Metastasis ; Prevalence ; RNA, Messenger ; Trastuzumab

Background: Data on the clinical characteristics and outcomes of Filipino cancer patients who acquired the coronavirus disease 2019 (COVID-19) are limited and local information is lacking. Here we characterize the outcomes of patients with cancer and COVID-19. Methods: Medical records of Filipino cancer patients with COVID-19 from the University of the Philippines – Philippine General Hospital (UP-PGH), Southern Philippines Medical Center (SPMC), De La Salle – University Medical Center (DLS- UMC), and St Luke’s Medical Center (SLMC) from March to December 2020 were reviewed. Results: Sixty-nine cancer patients were identified to have COVID-19. The mean age was 53 years (range 19-88) and 45 (65%) patients were female. The most prevalent malignancies were from the gastrointestinal tract (16 [23%]) and the breast (14 [20%]). The majority (34 [49%]) had metastatic disease and had a functional status of Eastern Cooperative Oncology Group (ECOG) 2 or worse (39 [57%]). Forty-two (61%) patients had active oncologic treatment given for the past three months and twenty-four (35%) of these patients were on chemotherapy. The most common symptoms upon presentation were cough (34 [49%]) followed by dyspnea (28 [41%]). COVID-19 severity of this series was as follows: 15 mild (22%), 32 moderate (46%), 7 severe (10%), and 15 critical (22%). The majority received intravenous antibiotics (54 [78%]), investigational treatments (27 [39%]), and steroids (20 [29%]). Common complications were acute respiratory failure (20 [29%]), acute respiratory distress syndrome (17 [25]), and septic shock (15 [22%]). At the end of the collection period, 21 (30%) cancer patients died. The mean length of hospital stay was 22 days. Conclusion Based on the findings of our case series, ECOG 2 and higher, metastatic stage, higher neutrophil to lymphocyte ratio showed a trend to worse outcomes. Cancer-related treatment within the past months did not appear to affect outcomes.
COVID-19 ; SARS-COV2 ; Cancer ; Philippines