[5078] Health-related quality of life among patients with metastatic breast cancer receiving paclitaxel versus paclitaxel plus bevacizumab: results from the eastern cooperative oncology group (ECOG) study E2100.
Wagner LI, Wang M, Miller K, Davidson NE, Gralow J, Dickler M, Cobleigh M, Perez E, Shenkier T, Cella D.. Eastern Cooperative Oncology Group, Chicago, IL
Background: The addition of bevacizumab to paclitaxel was associated with a dramatic increase in progression free survival among women with metastatic breast cancer. E2100 participants who received bevacizumab experienced higher rates of Grade 3/4 hypertension (14% vs. 0% for paclitaxel only arm), proteinura (3% vs. 0%), and neuropathy (24% vs. 18%), the latter likely due to undergoing a longer duration of treatment. No other toxicities were significantly increased. Clinicians documented toxicities using the National Cancer Institute
s Common Toxicity Criteria (NCI-CTC) rating system. When compared to patient self-report, clinician ratings may underestimate symptom severity and overestimate patients functional status. Therefore, patient reported health-related quality of life (HRQL) should also be assessed to understand the impact of treatment on symptom burden and functional status from the patients perspective. In addition, HRQL data were examined to evaluate the impact of neuropathy.
Methods: Women with locally recurrent or metastatic breast cancer were randomized to receive paclitaxel plus bevacizumab (Arm A; n = 368) or paclitaxel (Arm B; n = 354). The Functional Assessment of Cancer Therapy 
Breast (FACT-B) was administered to trial participants at baseline and weeks 17 and 33 to assess breast cancer-specific symptoms and concerns and overall HRQL.
Results: The FACT-B was completed by 610 participants at baseline, 481 participants at 17 weeks, and 356 participants at 33 weeks. A pattern mixture model for analyzing longitudinal data was used to account for non-ignorable missing data. There was insufficient statistical evidence to suggest that the mean scores or mean change scores on the FACT-B, FACT-B subscale, and Trial Outcome Index Breast (TOI-B) between Arms A and B were significantly different at any time point. Mean changes scores and standard deviations are presented below. Negative mean change scores reflect decreases in HRQL.
Conclusions: There was insufficient evidence to conclude that trial participants receiving bevacizumab in addition to paclitaxel differed on self-reported symptom burden and HRQL than those receiving paclitaxel alone. Bevacizumab significantly improved clinical outcomes for women with locally recurrent or metastatic breast cancer without significantly increasing symptom burden or compromising HRQL. Obtaining these results from the patients perspective increases our confidence that the increase in progression-free survival is not at the cost of impairments in HRQL.
| FACT-B mean (SD) | FACT-B subscale mean (SD) | TOI-B mean (SD) | |
| Baseline to Week 17 | |||
| Arm A | -0.55 (5.0) | -0.84 (14.8) | -3.10 (11.8) |
| Arm B | -1.13 (5.3) | -3.09 (17.4) | -3.72 (13.0) |
| Baseline to Week 33 | |||
| Arm A | -0.59 (5.5) | -2.04 (16.9) | -3.72 (12.8) |
| Arm B | -0.96 (5.9) | -3.22 (17.6) | -3.98 (13.6) |
Saturday, December 16, 2006 5:00 PM
Poster Session V: Treatment: Psychosocial Aspects (5:00 PM-7:00 PM)