Impact of FDG PET Imaging for Expanding Patient Eligibility and Measuring Treatment Response in a Genome-Driven Basket Trial of the Pan-HER Kinase Inhibitor, Neratinib.

Purpose: To determine whether FDG PET can expand eligibility in biomarker-selected clinical trials by providing a means to quantitate response in patients with non-assessable disease by RECIST.

Experimental Design: SUMMIT (NCT01953926) is a multicenter phase II "basket" trial of the Pan-HER kinase inhibitor, neratinib. Patients had advanced ERBB2 (HER2)-mutant solid tumors, ≥1 measurable lesion, preferably defined unidimensionally by RECIST v1.

Choosing Appropriate Metrics to Evaluate Adverse Events in Safety Evaluation.

Safety assessment and monitoring are critical throughout the life cycle of drug development. The evaluation of safety information, specifically adverse events, from clinical trials has always been challenging for a number of reasons, such as the unexpectedness and rarity of some important adverse events, the fact that some events can recur, and the events' variability in duration and severity. To accurately characterize and communicate the risk profile of a drug, the choice of metrics is critical.

Pegfilgrastim on the Same Day Versus Next Day of Chemotherapy in Patients With Breast Cancer, Non-Small-Cell Lung Cancer, Ovarian Cancer, and Non-Hodgkin's Lymphoma: Results of Four Multicenter, Double-Blind, Randomized Phase II Studies.

Purpose: To compare data on severe (grade 4) neutropenia duration and febrile neutropenia incidence in patients receiving chemotherapy with pegfilgrastim administered the same day or 24 hours after chemotherapy.

Patients And Methods: These were similar, randomized, double-blind phase II noninferiority studies of patients with lymphoma or non-small-cell lung (NSCLC), breast, or ovarian cancer. Each study was analyzed separately.

A randomized phase IIIB trial of chemotherapy, bevacizumab, and panitumumab compared with chemotherapy and bevacizumab alone for metastatic colorectal cancer.

Purpose: Panitumumab, a fully human antibody targeting the epidermal growth factor receptor, is active in patients with metastatic colorectal cancer (mCRC). This trial evaluated panitumumab added to bevacizumab and chemotherapy (oxaliplatin- and irinotecan-based) as first-line treatment for mCRC.

Patients And Methods: Patients were randomly assigned within each chemotherapy cohort to bevacizumab and chemotherapy with or without panitumumab 6 mg/kg every 2 weeks.

A combined analysis of average relative dose intensity in the chemotherapy of solid tumors with pegfilgrastim or filgrastim support.

A metaanalysis of 4 clinical studies that treated adult solid tumors with standard combination chemotherapy and growth factor support was conducted to study average relative dose intensity. All studies compared pegfilgrastim with filgrastim in a randomized, doubleblinded design. A total of 564 patients were included in the analyses: 291 who received pegfilgrastim and 273 who received filgrastim.

Elderly cancer patients receiving chemotherapy benefit from first-cycle pegfilgrastim.

Background: There is a misconception that elderly cancer patients cannot tolerate standard doses of chemotherapy because of the frequency and severity of myelosuppressive complications. The reactive use of colony-stimulating factors (i.e.

Biochemical efficacy and safety of a new pooled human plasma alpha(1)-antitrypsin, Respitin.

Background: Augmentation therapy with pooled human plasma-derived alpha(1)-antitrypsin (AAT) has been shown to have biochemical efficacy in restoring serum AAT levels above the protective threshold. Also, clinical efficacy has been suggested.

Objective: To evaluate the bioequivalence of a new solvent detergent-treated preparation of pooled human plasma-derived AAT (proposed name Respitin; Alpha Therapeutic Corporation; Los Angeles, CA) to the commercially available preparation (Prolastin; Bayer Corporation; West Haven, CT), we conducted a randomized controlled trial.