Efficacy and safety of CT-P6 versus reference trastuzumab in HER2-positive early breast cancer: updated results of a randomised phase 3 trial.

PURPOSE: Neoadjuvant CT-P6, a trastuzumab biosimilar, demonstrated equivalent efficacy to reference trastuzumab in a phase 3 trial of HER2-positive early-stage breast cancer (EBC) (NCT02162667). We report post hoc analyses evaluating pathological complete response (pCR) and breast pCR alongside additional efficacy and safety measures. METHODS: Following neoadjuvant treatment and surgery, patients received adjuvant CT-P6 or trastuzumab (6 mg/kg) every 3 weeks for ≤ 1 year. RESULTS: In total, 271 and 278 patients received CT-P6 and trastuzumab, respectively. pCR and breast pCR rates were comparable between treatment groups regardless of age, region, or clinical stage. Overall, 47.6% (CT-P6) and 52.2% (trastuzumab) of patients experienced study drug-related treatment-emergent adverse events (TEAEs), including 17 patients reporting heart failure (CT-P6: 10; trastuzumab: 7). Two CT-P6 and three trastuzumab patients discontinued adjuvant treatment due to TEAEs. CONCLUSION: Adjuvant CT-P6 demonstrated comparable efficacy and safety to trastuzumab at 1 year in patients with HER2-positive EBC, supporting CT-P6 and trastuzumab comparability.

Phase III study (MONET1) of motesanib plus carboplatin/paclitaxel in patients with advanced nonsquamous nonsmall-cell lung cancer (NSCLC): Asian subgroup analysis.

BACKGROUND: This preplanned subset analysis of the phase III MONET1 study aimed to determine whether motesanib combined with carboplatin/paclitaxel (C/P) would result in improved overall survival (OS) versus chemotherapy alone, in a subset of Asian patients with nonsquamous nonsmall-cell lung cancer (NSCLC). PATIENTS AND METHODS: Patients with nonsquamous NSCLC (stage IIIB/IV or recurrent) and no prior systemic therapy for advanced disease were randomized to IV carboplatin (AUC, 6 mg/ml min) and paclitaxel (200 mg/m2) for up to six 3-week cycles, plus either oral motesanib 125 mg q.d. or placebo. Primary end point was OS; secondary end points included progression-free survival (PFS), objective response rate (ORR), and safety. RESULTS: Two hundred twenty-seven Asian patients from MONET1 were included in this descriptive analysis. Median OS was 20.9 months in the motesanib plus C/P arm and 14.5 months in the placebo plus C/P arm (P=0.0223); median PFS was 7.0 and 5.3 months, respectively, (P=0.0004); and ORR was 62% and 27%, respectively, (P<0.0001). Grade≥3 adverse events were more common in the motesanib plus C/P arm versus placebo plus C/P (79% versus 61%). CONCLUSION: In this preplanned subset analysis of Asian patients with nonsquamous NSCLC, motesanib plus C/P significantly improved OS, PFS, and ORR versus placebo plus C/P. CLINICAL TRIAL NUMBER: NCT00460317.

Nutritional status of cancer patients admitted for chemotherapy at the National Kidney and Transplant Institute.

INTRODUCTION: Malnutrition is common among cancer patients. This study aimed to determine the overall prevalence of malnutrition among patients undergoing chemotherapy and to determine the predictors of malnutrition among cancer patients. METHODS: A cross-sectional study was conducted on 88 cancer patients admitted for chemotherapy at the National Kidney and Transplant Institute, Philippines, from October to November 2009. Subjective Global Assessment (SGA), anthropometric data and demographic variables were obtained. Descriptive statistics, ANOVA and logistic regression analysis were performed between the outcome and variables. RESULTS: A total of 88 cancer patients were included in the study. The mean age of the patients was 55.7 +/- 14.8 years. The mean duration of illness was 9.7 +/- 8.7 months and the mean body mass index (BMI) was 22.9 kg/m2. The mean Karnofsky performance status was 79.3. 29.55 percent of the patients had breast cancer as the aetiology of their illness. 38 patients (43.2 percent) had SGA B and four (4.5 percent) had SGA C, giving a total malnutrition prevalence of 47.7 percent. The patients were statistically different with regard to their cancer stage (p is less than 0.001), weight (p is 0.01), BMI (p is 0.004), haemoglobin level (p is 0.001) and performance status by Karnofsky score (p is less than 0.001), as evaluated by ANOVA. Logistic regression analysis showed that cancer stage and Karnofsky performance score were predictors of malnutrition. CONCLUSION: About 47.7 percent of cancer patients suffer from malnutrition, as classified by SGA. Only cancer stage and Karnofsky performance status scoring were predictive of malnutrition in this select group of patients.

Human parvovirus B19: prevalence of viral DNA in volunteer blood donors and clinical outcomes of transfusion recipients.

BACKGROUND AND OBJECTIVES: Blood donor units are not screened for human parvovirus B19 (B19) even though it can be acquired via blood products. We estimated the prevalence of B19 in a US volunteer blood donor population and determined the clinical outcomes of transfusion recipients. MATERIALS AND METHODS: Donor units were screened for B19 DNA by PCR, and positive units analyzed by EIA for B19 Ig. Unit usage was determined and recipient chart review conducted. RESULTS: B19 DNA was detected in 11/9, 568 allogeneic units (0.1%), of which 3 had no measurable B19 Ig. One individual developed anemia consistent with B19 infection after receiving a DNA+ unit lacking B19 Ig. CONCLUSIONS: The apparent low incidence of disease in patients transfused with B19 DNA+ components may be due to coexistence of neutralizing antibodies in donors and/or recipients.