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Monica R McLemore

Publications and source records attributed to Monica R McLemore.

4 recordsLinked to original sources

The role of the data safety monitoring board: why was the Avastin phase III clinical trial stopped?

In early February 2006, Genentech Inc. issued a joint press release with Roche Holding Corporation explaining that their phase III early-stage colon cancer trial of Avastin (bevacizumab, Genentech Inc., South San Francisco, CA) would be stopped after the deaths of four patients. This announcement was the result of preliminary review of the data by the Data Safety Monitoring Board (DSMB) that was formed to monitor the study. What is the DSMB? What criteria does it use to determine whether a study should be stopped early? The purpose of this article is to (a) explain the role of the DSMB, (b) give an overview of the Avastin Adjuvant (AVANT) study, and (c) provide information and resources about clinical trials for practicing RNs in oncology.

Antibodies, Monoclonal↗

Workplace aggression: beginning a dialogue.

The June 2005 Clinical Journal of Oncology Nursing editorial titled "Communication: Whose Problem Is It?" (Griffin-Sobel, 2005) was written to begin a dialogue about a phenomenon frequently experienced yet rarely discussed: workplace aggression, also known as disruptive behavior. Prompted by a groundbreaking study published in the American Journal of Nursing by Rosenstein and O'Daniel (2005), the editorial challenged oncology nurses to begin to fix problems of communication. After reflecting on both of the articles and considering my own experience as a nurse manager, clinician, and scholar, I decided to explore the topic as it relates to nurse-to-nurse workplace aggression. The following is a summary of interviews with nurse managers, nurse practitioners, and nurse scientists about root causes and effective strategies to manage these sometimes complicated situations. This article is meant to continue the dialogue about the very sensitive issue. Confidentiality has been maintained, and I welcome your comments.

Aggression↗

Gardasil: Introducing the new human papillomavirus vaccine.

In 2006, the U.S. Food and Drug Administration (FDA) approved the first vaccine for prevention of cervical cancer based on the molecular biology of the disease. Gardasil (quadrivalent human papillomavirus [HPV] [types 6, 11, 16, and 18] recombinant vaccine, Merck & Co., Inc., Whitehouse Station, NJ) combats the common types of HPV responsible for cervical cancer precursor lesions. This article provides a simple overview of the (a) epidemiology of HPV, (b) HPV vaccine, (c) dosing and administration, and (d) nursing implications about this possibly life-saving vaccine.

Adolescent↗

Introducing the MUC16 gene: implications for prevention and early detection in epithelial ovarian cancer.

More than 24,000 women in the United States are diagnosed with ovarian cancer every year, and half of these women die from their disease. Stage 1 ovarian cancer is curable in 95% of cases; however, due to inadequate screening tools and lack of symptoms in early disease, ovarian cancer is generally at Stage 3 or 4 when finally diagnosed. CA125 is a tumor antigen used to monitor the progression and regression of epithelial ovarian cancer. When its levels are elevated postsurgery (hysterectomy/salpingo-oophorectomy with or without peritoneal washings and lymph node biopsy) and postchemotherapy, it is suggestive of recurrent disease. Due to its similarly elevated levels in some nonmalignant conditions, however, it is not specific enough to be used for population screening. The CA125 molecule is considered a very large glycoprotein because of its molecular weight, and it has three domains: the carboxy terminal domain, the extracellular domain, and the amino terminal domain. MUC16 is the gene that encodes the peptide moiety of the CA125 molecule. MUC16 domains provide novel opportunities to develop new assays and refine current tools to improve the sensitivity and specificity of CA125 for population-based screening guidelines.

Amino Acid Sequence↗