Publication outcomes of phase II oncology clinical trials.

OBJECTIVES: Translation of evidence-based medicine into oncology practice depends on timely and full publication of clinical trials. We investigated publication outcomes of Phase II trial abstracts from the annual meetings of the American Society of Clinical Oncology (ASCO). METHODS: We searched the 1997, 1999, and 2001 ASCO annual meeting proceedings and identified all Phase II trials, excluding those that reported preliminary results. Literature search was performed using PubMed, EMBASE, and Google for corresponding publications in peer-reviewed journals. We attempted to contact authors of all unpublished trials. RESULTS: Only 60.8% of t he 559 trials identified were published, with a median time to publication of 41 months. At 5 years, 65.9%, 62.7%, and 57.0% of studies from 1997, 1999, and 2001, respectively, were published. Studies with larger samples were associated with a shorter time to publication, as were oral and poster presentations versus print only (P < 0.001). Common reasons for not publishing were uninteresting results, lack of time, and relocation of authors. Among abstracts reporting response rates, 37.7% showed different results in subsequent publications. Though not statistically significant, over the 5-year period, abstracts presented at later years had a lower rate of publication, longer time to publication, and a higher likelihood of showing a better tumor response. CONCLUSIONS: Almost half of Phase II trials presented at ASCO annual meetings within the last 10 years remain unpublished. Over one-third of published trials reported results different from those presented in abstracts. Like Phase I and III trials, Phase II trials often are unpublished.

Macrocytosis associated with monoclonal gammopathy.

OBJECTIVE: To report the potential association between unexplained macrocytosis and monoclonal gammopathy. METHODS: We retrospectively reviewed the medical records of patients who had monoclonal protein detected by serum electrophoresis and immunofixation from October 1999 until September 2003 at our institution. Patients with concomitant macrocytosis were included in this study. We collected data on patient demographics, evaluations performed for macrocytosis, pertinent laboratory tests relevant to the diagnosis of monoclonal gammopathy and presence of associated hematologic disorders. RESULTS: We identified 258 patients with monoclonal gammopathy. Thirty-one (12%) of them had concomitant macrocytosis. Of the latter group, 14 (5%) patients had no identifiable cause of macrocytosis after thorough evaluation and were considered to have macrocytosis associated with monoclonal gammopathy. The median values for mean cell volume and serum monoclonal protein were 103.9 fL (range 100.8-109.8) and 1.95 gm/dL (range 0.8-4.3), respectively. Most patients had IgG (71%) and kappa light chain (79%). All of the 11 (of 14) patients who underwent a bone marrow biopsy as part of the initial evaluation had megaloblastoid maturation of the erythroid precursors. No correlation was found between the level of serum monoclonal protein and the degree of macrocytosis (r = +0.48, P = 0.08). After a median follow-up of 22.5 month (range 3-60+), all but one patient had persistent but stable macrocytosis. CONCLUSION: Macrocytosis can be a manifestation of monoclonal gammopathy. Disorders associated with monoclonal gammopathy should be considered in the differential diagnoses during evaluation of macrocytosis.