Randomized phase III study of docetaxel plus bavituximab in previously treated advanced non-squamous non-small-cell lung cancer.

Background: Bavituximab is a monoclonal antibody that targets phosphatidylserine in the presence of ß2 glycoprotein 1 (ß2GP1) to exert an antitumor immune response. This phase III trial determined the efficacy of bavituximab combined with docetaxel in patients with previously treated advanced non-small-cell lung cancer (NSCLC). Patients and methods: Key eligibility criteria included advanced non-squamous NSCLC with disease progression after treatment with platinum-based doublet chemotherapy, evidence of disease control after at least two cycles of first-line therapy, presence of measurable disease, ECOG performance status 0 or 1, adequate bone marrow and organ function, and no recent history of clinically significant bleeding. Eligible patients were randomized 1 : 1 to receive up to six 21-day cycles of docetaxel plus either weekly bavituximab 3 mg/kg or placebo until progression or toxicity. The primary end point was overall survival (OS). Results: A total of 597 patients were enrolled. Median OS was 10.5 months in the docetaxel + bavituximab arm and was 10.9 months in the docetaxel + placebo arm (HR 1.06; 95% CI 0.88-1.29; P = 0.533). There was no difference in progression-free survival (HR 1.00; 95% CI 0.82-1.22; P = 0.990). Toxicities were manageable and similar between arms. In subset analysis, among patients with high baseline serum ß2GP1 levels ≥200 µg/ml, a nonsignificant OS trend favored the bavituximab arm (HR 0.82; 95% CI 0.63-1.06; P = 0.134). Among patients who received post-study immune checkpoint inhibitor therapy, OS favored the bavituximab arm (HR 0.46; 95% CI 0.26-0.81; P = 0.006). Conclusions: The combination of bavituximab plus docetaxel is not superior to docetaxel in patients with previously treated advanced NSCLC. The addition of bavituximab to docetaxel does not meaningfully increase toxicity. The potential benefit of bavituximab observed in patients with high ß2GP1 levels and in patients subsequently treated with immune checkpoint inhibitors requires further investigation. Clinical trial number: NCT01999673.

Baseline tumour measurements predict survival in advanced non-small cell lung cancer.

BACKGROUND: The association between tumour measurements and survival has been studied extensively in early-stage and locally advanced non-small cell lung cancer (NSCLC). We analysed these factors in patients with advanced NSCLC. METHODS: Data were derived from the E4599 trial of paclitaxel-carboplatin±bevacizumab. Associations between the Response Evaluation Criteria in Solid Tumors (RECIST) baseline sum longest diameter (BSLD), response rate, progression-free survival (PFS) and overall survival (OS) were evaluated using univariate and multivariable Cox regression models. RESULTS: A total of 759 of the 850 patients (89%) in the E4599 trial had measurable diseases and were included in this analysis. The median BSLD was 7.5 cm. BSLD predicted OS (hazard ratio (HR) 1.41; P<0.001) and had a trend towards association with PFS (HR 1.14; P=0.08). The median OS was 12.6 months for patients with BSLD <7.5 cm compared with 9.5 months for BSLD ≥ 7.5 cm. This association persisted in a multivariable model controlling multiple prognostic factors, including the presence and sites of extrathoracic disease (HR 1.24; P=0.01). There was no association between BSLD and response rate. CONCLUSION: Tumour measurements are associated with survival in the E4599 trial. If validated in other populations, this parameter may provide important prognostic information to patients and clinicians.

ALCHEMIST: Bringing genomic discovery and targeted therapies to early-stage lung cancer.

The identification of druggable molecular alterations represents one of the greatest advances in cancer treatment. Such progress is particularly evident for lung cancer, which now has numerous molecularly defined subsets such as epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) rearrangements. However, understanding of the significance of these genomic alterations is largely limited to incurable, metastatic lung cancer. ALCHEMIST (Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial) is a National Cancer Institute-sponsored initiative to address these questions in earlier-stage disease.

Community resources for clients with mobility problems.

Clients are leaving the hospital "quicker and sicker," and they frequently have acute care needs that must be met by resources outside the hospital setting. Community resources are diverse, vary widely from place to place, and have no central administration. Thus, using them can be challenging for both the nurse, client, and family. Reimbursement mechanisms underlie a person's ability to use resources and receive health care. By presenting two actual case scenarios where clients have mobility problems commonly seen by orthopaedic nurses, the authors discuss the community resources available, avenues of access to them, and their reimbursement mechanisms.

Death in the operating room and postanesthesia care unit: helping nurses to cope.

The death of patients in the OR and PACU is an unexpected event that can cause grief, burnout, and turnover among the caregivers who work there. In this era of emphasis on quality, customer satisfaction, and cost containment, prevention of these negative outcomes is important. Although there is scant literature devoted to how nurses cope with patient death in this setting, many of the principles described in the literature for other settings can be applied to assist caregivers to view death as a growth-producing experience, both personally and professionally.

Teaching students about nursing and the environment: Part 1--Nursing role and basic curricula.

Since the time of Nightingale, the phenomena of health, person, nursing, and environment have been considered central to nursing. However, of all the concepts, environment appears to have been the least explored, practiced, and researched. Nursing education does not adequately prepare nurses to understand the impact of the environment on health or to implement environmental interventions. This 2-part series is designed to assist faculty in teaching this content. Part 1 provides historical background, the role of nursing, a basic curriculum, and student learning activities.

Teaching students about nursing and the environment: Part 2--Legislation and resources.

This 2-part series is designed to assist faculty in teaching students about the impact of the environment on health. Part 1 (Gerber & McGuire, 1999/this issue) provides historical background, the role of nursing, a basic curriculum, and student learning activities. Part 2 presents national environmental health objectives, pertinent legislation, organization of environmental health services, global environmental health, and student learning activities. We designed the material to be practical, so that this critical area becomes a routine part of assessment data for nurses as they care for clients.

Perceived etiology of foodborne illness among public health personnel.

Few data exist about perceptions regarding the etiology of foodborne illness. Among public health staff throughout Tennessee, the three pathogens most commonly believed to cause foodborne illness in the United States actually account for only 12% of disease. Fewer than 3% of respondents correctly identified the leading cause of foodborne illness.

Meeting the diverse needs of clients in the community: effective use of the referral process.

Because clients today generally move quickly from one care setting to another, it is essential to identify their need for follow-up care in the community. A wide array of helping resources are available to enhance continuous, comprehensive care for these clients. When nurses have an understanding of the referral process, they can help clients gain access to appropriate community resources. Establishing an effective referral system facilitates use of the referral process and identification of clients who need ongoing care.