The Effect of Disease Progression on Patient Reported Outcomes in HER-2 Negative Metastatic Breast Cancer Patients.

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Abstract Background: Patients with HER-2 neg metastatic breast cancer (MBC) often experience a wide range of cancer related symptoms, which may impact their quality of life (QoL). We conducted a retrospective analysis to characterize the differences between patient-reported outcomes (PROs) of MBC patients prior to progression of disease (PD) and following PD, and examined the effect of metastases in bone, lung, liver, peritoneum and central nervous system (CNS) on PROs.Methods: 102 HER-2 neg MBC patients were enrolled from 7 community oncology practices within the U.S. The source data comprised data abstracted from medical records and PROs from the 38-item Patient Care Monitor (PCM). The PCM consists of 6 indices including impaired ambulation, impaired performance, general physical symptoms, treatment-related side effects, despair and depression, and acute distress. Linear mixed-effect models were used to analyze change in PCM index scores over time, controlling for individual, disease, and treatment characteristics. Minimum important difference for PCM index scores was estimated to be 1.5 to 3 points (Ringash 2000).Results: The sample (n=102) consists of 72% Caucasian, 25% African American, 3% other race patients, with mean age of 57 years. The ECOG performance status (PS) was unknown in 58% of the cases. Among those with known PS, 79% had a status of 0 or 1. Most patients (87%) had previous surgery, and 62% had received adjuvant chemotherapy. The mean time from metastatic diagnosis to first PD was 14 months. The predominant sites of metastasis were bone (66%), lung (35%), and liver (33%). First line treatment was hormone therapy only for 29%, no treatment recorded for 4%, taxane based for 42%, and non-taxane based for 25%. Linear mixed-effect model results showed modest but statistically significant (p<0.005) worsening for General Physical Symptoms (2.4 points), Acute Distress (2.3 points), and Impaired Performance (1.7 points) scores following PD. The effect of PD was non significant for other index scores. Changes in symptoms severity following PD varied depending on metastasis location, being on chemotherapy, and ECOG status at baseline. There were marked detrimental effects of liver metastasis on Treatment related Side Effects, and of brain metastasis on Acute Distress. The most consistent effect on PROs was associated with PS. Patients with PS of 2 – 4 had worse scores in all areas except Acute Distress and Treatment Side effects.Conclusions: PD was associated with modest but significant worsening of general physical symptoms, acute distress, and impaired performance scores. Patients with poor ECOG PS at baseline were most affected. These findings suggest that delaying disease progression may have a positive impact on patients' QoL.Reference: Ringash J et al. Minimal important difference for quality of life measures is about five to ten percent of the instrument range. Presented at Proc Am Soc Clin Oncol. May 20-23, 2000. New Orleans, LA. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 5050.