Characteristics of Patients with Stage I Follicular Lymphoma (FL) Selected for Watchful Waiting (WW) in the US: Report from the National LymphoCare Study (NLCS).

The NLCS is a multi-center, disease-based, longitudinal, observational study designed to collect information on treatment regimens and outcomes for patients (pts) with newly-diagnosed FL in the US. We have previously demonstrated that demographics of enrolled patients are similar to the SEER and FLIPI databases. There remains controversy and lack of consensus regarding the appropriate initial therapy for pts with FL. Historically, randomized trials have indicated no benefit to early therapeutic intervention, and many pts were managed by a “watchful waiting” (WW), or observation, approach. More recently, studies have suggested that initial treatment of FL may influence survival, calling into question the role of WW today. The National Comprehensive Cancer Network (NCCN) guidelines identify locoregional radiotherapy (RT) as the treatment of choice for stage I and II FL pts, whereas WW is reserved for select pts where toxicity of RT outweighs potential clinical benefit. The NLCS has over 2700 pts enrolled, and, of these, 455 were managed with WW as their initial therapy as of 1/31/07. This analysis focuses on the 134 stage I FL pts (29.3% of all stage I pts) in the NLCS database who were initially managed with WW, and examined their baseline characteristics as possible predisposing factors to a WW approach. The cohort of WW pts includes pts meeting both of the following criteria: initially reported to be managed by WW by the investigator, and were not administered treatment within 3 months of diagnosis. Age distribution was 6.0%