Patients with recently diagnosed MBC have high informational needs and decreased overall QOL. Additional research and supportive services meeting the informational and psychosocial needs of patients living with MBC are warranted.

Background: Psychosocial distress is common after a diagnosis of breast cancer. Little is known about the informational needs and the psychosocial adjustment of patients diagnosed with metastatic breast cancer (MBC) within the first year of their diagnosis. Methods: Patients with MBC from a single academic institution completed a cross-sectional self-administered paper survey. The survey included demographics, the Medical Outcomes Study Short Form-36 (SF-36), the Hospital Anxiety and Depression Scale (HADS), and Toronto Informational Needs Questionnaire-Breast Cancer (TINQ). Medical history was obtained by chart review. The Spearman correlation coefficient assessed the relationship between TINQ and the following: age at MBC diagnosis, disease free interval (DFI), time between survey completion and MBC diagnosis, number of lines of therapy, and HADS. Results: Fifty-two (90%, 50F 2M) patients completed the survey. Median age at MBC diagnosis was 52 yrs (range 22–81). Thirty-nine (75%) patients had completed college, 92% were Caucasian. Median time between MBC diagnosis and survey completion was 6 months (range 1–12). Sixteen (31%) patients had de novo stage 4 disease. At time of survey completion, 36 (69%) patients were on 1st line therapy with some patients were receiving their 4th line of therapy. SF-36 scores were lower in all 8 subscales compared to the general population. In particular, role limitations due to physical health (Norm-based transformation mean score 39.3, SD=12.1), social functioning (Mean 41.8, SD=12.7), role limitations due to emotional problems (Mean 43.3, SD=13.3), vitality (Mean 44.1, SD=10.8) and general health (Mean 44.3, SD=12.1) were diminished. The Physical and Mental Component Summary norm-based transformation scores were 43.2 (SD = 11.7) and 45.4 (SD = 11.3) respectively.9/48 (19%) patients met criteria for anxiety, and 4/48 (8%) patients met criteria for depression by HADS criteria (scores > 11). TINQ scores range from 51 to 255, with 35/52 (69%) having a total score > 200, suggesting high informational need. Of the 5 subscales, treatment information was most important, followed by information about disease, physical care, psychosocial needs and investigative tests. The most important informational issues for patients were: if there was cancer anywhere else in their body (Mean score 4.78), how to deal with side effects (Score 4.78), and if there were ways to prevent treatment side effects (Score 4.77), with a score of 5=extremely important, and 1= not important. Only DFI correlated with TINQ (Spearman coefficient −0.413, p = 0.011), with patients who had a shorter DFI having greater informational needs. Age at MBC diagnosis, time of completion of survey, number of lines and HADS were not significant. Conclusion: Based on this study, patients with recently diagnosed MBC have high informational needs and poor psychosocial adjustment. The overall quality of life appears to be worse in this population of patients compared to the general population. There is also a subset of patients who are dealing with significant anxiety and depression. Additional research, education, and supportive care services aimed at meeting the informational and psychosocial needs of women living with MBC are warranted. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P6-08-03.

Background: Circulating tumor cells (CTCs) with evidence of HER2 amplification can occur in patients (pts) with clinically HER2 negative metastatic breast cancer. While these findings potentially have profound implications for CTCs as a biomarker for treatment, prospective validation and characterization of this subgroup is necessary. Methods: We created a prospective cohort of pts with metastatic breast cancer that were HER2 negative by IHC and/or FISH on all available primary and metastatic biopsies. Blood samples were collected at study entry and then again at ≥ 3 weeks if available. CTCs were enumerated by a modification of the Veridex CellSearch Profile kit. FISH was performed on each CTC sample and reported as positive if the HER2/CEP17 ratio was ≥ 2.0. Analyses are descriptive. Results: 66 pts were consented for study and this report includes the 65 pts with detectable CTCs. Median number of CTCs was 226 (range 112 to > 3000). At initial testing, 23 pts (35%) had HER2 positive CTCs, median HER2:CEP17 ratio of 3.4. 50% (11 of 22) of the pts with lobular or ductal/lobular histology had HER2 amplified CTCs, compared to only 27% (10 of 36) of patients with ductal histology. Women with ER positive disease had HER2 positive CTCs in 40% of cases (20 of 49) compared to 19% of ER negative pts (3 of 16). To assess concordance of HER2 amplification of CTCs over time, 34 pts consented to be retested at a median 5.9 weeks after initial screening (range 3.3 - 17 weeks) and all but 1 had detectable CTCs. Baseline characteristics of these 34 pts were similar to the original population, with HER2 amplified CTCs detected in 35% (12 of 34) pts at initial screening. HER2 positive CTCs were concordant at time of retesting in 83% (10 of 12) pts; the 2 women with discordant CTCs were receiving HER2 directed therapy. Of the pts with HER2 negative CTCs at initial screening, 81% (17 of 21) continued to have HER2 negative CTCs at time of retesting. Conclusion: We observed a higher prevalence of HER2 positive CTCs among pts with ER positive disease and evidence of lobular histology. The presence of HER2 positive CTCs is concordant over time in the majority of pts. The functional significance of HER2 positive CTCs in patients with clinically HER2 negative breast cancer will be tested in a prospective study with HER2−directed therapy. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr PD05-07.