Online Exclusive - December 11, 2009
ASCO first published a guideline on Non-Small Cell Lung Cancer (NSCLC) in
1997 and updated it in
2003. It is one of the most frequently downloaded ASCO guidelines from the
National Guidelines Clearinghouse. Since the publication of ASCO’s previous guideline on NSCLC, there has been an explosion in research on NSCLC. In its
2009 update, the Update Committee of the Expert Panel on NSCLC considered the many topics covered in the 2003 guideline update, especially those topics where there were phase III randomized controlled trials (RCTs) published since then. The Update Committee found that there were some areas in which there were not completed prospective clinical trials and others in which completed trials have had low impact, such as diagnosis and radiation therapy.
In contrast, completed trials in the treatment of stage IV NSCLC have had “major impact” on practice, according to Christopher G. Azzoli, MD, co-chair of the Update Committee and oncologist at the Memorial Sloan-Kettering Cancer Center in New York City. The other Update Committee co-chair is Giuseppe Giaccone, MD, of the National Cancer Institute. The 2009 update, therefore, covers the treatment of stage IV NSCLC in-depth.
The present edition of the guideline includes a new section on biomarkers, a focus on age and performance status, and recommendations regarding several new agents approved by the FDA since 2003.
The average person with stage IV NSCLC is older than 70 years. Therefore, there is a large interest in the treatment of older people, with the attendant concerns of comorbid illnesses, the number of medications taken, and the potential greater susceptibility to the side effects of chemotherapy relative to younger people. Clinical trials have not been able to demonstrate that older people receive fewer benefits from chemotherapy than younger people, nor have they demonstrated the best chemotherapy regime for this population. In addition, chronological age does not incorporate the difference between the various levels of physical fitness and daily functioning of a person. Therefore, the guideline concludes that chronological age is not a reason to choose a particular regimen. In a recommendation intended to guide clinical practice, the guideline supports obtaining larger biopsy samples to allow analyses of tissue by histology or, when they are better able to predict chemotherapy outcomes, molecular characteristics.
There were insufficient data in several areas, including third-line therapy and beyond and biomarkers, optimal treatment for people with stage IV NSCLC PS2. The guideline looks forward to more research undertaken and completed in these areas. The full version of the guideline includes a section on health disparities, which are very prominent in NSCLC in the United States. Published data show poor quality of care and lack of access to care and, among other factors, this has resulted in disproportionate suffering among people of color in the United States. However, ”…just like age alone, ethnicity alone isn’t as important as other prognostic factors,” according to Dr. Azzoli.
Finally, the full guideline includes a section on Clinician-Patient Communication, which reviews some of the literature on this topic and makes suggestions intended to promote successful communication and shared decision-making.
This is the first time the JCO has published an abridged version of an ASCO guideline in print. The full version of the guideline is published online only. This change primarily occurred to address concerns about guideline length and will help conserve paper. The abridged guideline summarizes the volume and breadth of the evidence supporting each recommendation, while the full guideline discusses the literature and pertinent clinical trials informing each recommendation in more depth, as well as the methodology of the development of the guideline.
An executive summary, slide set, decision aids, patient guide and the abridged and full versions of the guideline are available at
www.asco.org/guidelines/nsclc.
