1340P - FACT- B and ESAS in metastatic breast cancer (MBC) patients (pts) treated with eribulin: Results of a multicenter prospective observational study

Date 28 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Breast Cancer, Metastatic
Palliative Care
Presenter Lucia Mentuccia
Citation Annals of Oncology (2014) 25 (suppl_4): iv471-iv477. 10.1093/annonc/mdu350
Authors L. Mentuccia1, P. Vici2, I. Sperduti3, L. Pizzuti4, L. Moscetti5, A. Vaccaro6, S. Quadrini6, E. Magnolfi6, M.A. Fabbri5, G. Zampa7, M.A. Giampaolo6, D. Sergi4, F. Narducci6, M. Maugeri Sacca2, T. Gamucci6
  • 1Department Of Oncology, “S.S. Trinita′” Hospital, 03039 - Sora/IT
  • 2Division Of Medical Oncology B, Regina Elena National Cancer Institute, 00144 - Rome/IT
  • 3Biostatistics, Regina Elena National Cancer Institute, 00144 - Rome/IT
  • 4Division Of Medical Oncology B, Regina Elena National Cancer Institute, Rome/IT
  • 5Division Of Medical Oncology, Belcolle Hospital, ASL di Viterbo Oncology Unit, Viterbo/IT
  • 6Department Of Oncology, “S.S. Trinita′” Hospital, Sora/IT
  • 7Medical Oncology Unit, ASL RMA, Rome/IT

Abstract

Aim

Eribulin (E) is a non taxane microtubule inhibitor indicated for treatment of MBC. To evaluate its tolerability, impact on Quality of Life (QoL) and symptoms improvement in MBC pts, from April 2012, we conducted a prospective observational study.

Methods

Pts pretreated with anthracyclines (A) and taxanes (T) who have received 2 CHT lines for MBC, scheduled to be treated with E, were considered eligible. Pts completed ESAS at each cycle and FACT-B every 2 cycles. Outcome of QoL included the FACT-B total score, FACT-General (FACT-G) score and the Trial Outcome Index (TOI) score. Paired data were analyzed with non parametric Wilcoxon, McNemar and Friedman tests. Kaplan-Meier method was used for survival calculation.

Results

50 consecutive MBC pts entered the study. Median age 64 (range 31-85), 83% of pts had PS (ECOG) 0-1, 23% had triple-negative MBC, 75% ER/PgR positive and 63% HER2 positive. All pts were pretreated with A and T, 19 (76%) also with capecitabine. Median E cycles administered was 5 (range 1-17), 31% of pts received more than 6 cycles. Main side effects G2-G3 were: 42% alopecia, 38% asthenia, 15% peripheral neuropathy,16% neutropenia. At a median follow-up of 7 months (mo) (range 2-21), 17% (CI 95% 6-28) of pts achieved partial response (PR), 39% stable disease (SD) and 44% progressive disease; disease control rate (PR + SD ≥ 6 mo) occurred in 40% of pts. Median PFS is 4 mo (95% CI, 3-5); median OS is 9 mo (CI 95% 2-16); 1-yr overall survival is 49%. Items in ESAS which at baseline had score more than >5 in at least 25% of pts were anorexia, drowsy, anxiety, loss of activity and wellbeing; all these symptoms not worsened in subsequent evaluations. Data of ESAS and QoL are reported in table. ESAS and QoL assessments were adjusted for response, PS and age.

Conclusions

Our results shows that treatment with E is associated with a good maintenance of QoL and ESAS scores with expected and manageable toxicities.

Basal median score(range) Final median score (range) P value
ESAS 30 (3-63) 28 (3-60) 0.91
FACT- B 79 (55-117) 81(45-119) 0.36
FACT-G 59 (40-88) 60 (30-93) 0.98
TOI 53 (33-78) 52 (29-78) 0.23

Disclosure

All authors have declared no conflicts of interest.