Abstract
Integration of a first-in-class drug into clinical practice generates a need for information to support its safe and effective use. In the early days post-FDA approval, the amount of available information can be limited and knowing how to get information is critical. Several paths exist, including queries to the pharmaceutical company and the pertinent literature. Good clinical assessment/judgment based on the medical history and clinical status of a patient further dictates the appropriate actions to be taken. Palbociclib, a novel CDK 4/6 inhibitor, was approved in February 2015 in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease. The most commonly reported adverse reaction is neutropenia. Herein we highlight the clinical information needs of advanced practitioners (APs) and resources for managing neutropenia in metastatic breast cancer patients on palbociclib using a hypothetical case study to illustrate. In the first six months on the market, Pfizer US Medical Information (USMI) received 1943 queries related to palbociclib, 540 (28%) of which were generated by nurses and pharmacists. Of these, the most frequent requests sought information related to the use of palbociclib in alternative disease or clinical settings, product availability, and safety. Neutropenia was the primary focus of these safety queries. USMI responded to practitioners with letters containing a concise summary of relevant information from the FDA label, publications, and applicable Pfizer data. Addressing why neutropenia may be related to the mechanism of action of palbociclib and how this toxicity may be managed through dose modifications are among the important practical information included in these letters. Additionally, opportunities exist to obtain a broader review of the clinical trial data and treatment recommendations by accessing key publications available in the public domain. Furthermore, clinical assessment (including a thorough medical/treatment history) and clinical judgment are central to the safe management of patients on any new therapy. Adherence to recommended monitoring guidelines and comprehensive patient education around signs and symptoms of infection can aid in the early identification of neutropenia, its management, and interventions for potential complications. The emergence of new and innovative therapeutics, such as palbociclib, requires APs to rapidly integrate evidence from multiple sources. Clinical trial data, management guidelines/recommendations, and clinical assessment findings provide clinicians with the critical information and practical details necessary to safely and effectively manage their patients.
