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Poster display

3749 - Safety and effectiveness of nab-paclitaxel in young and elderly patients with metastatic breast cancer: a prospective, multicenter non-interventional study

Date

10 Oct 2016

Session

Poster display

Presenters

Günther Steger

Citation

Annals of Oncology (2016) 27 (6): 68-99. 10.1093/annonc/mdw365

Authors

G. Steger1, E. Petru2, F. Haslbauer3, D. Egle4, A. Galid5, T. Sliwa5, A. Lang6, T. Kühr7, A. Petzer8, R. Ruckser9, B. Mlineritsch10, R. Greil11, M. Seifert12, C. Singer12, J. Andel13, W. Kwasny14, C. Marth15, P. Pichler16, C. Tinchon17, R. Bartsch18

Author affiliations

  • 1 Internal Medicine I-oncology, Medizinische Universitaet Wien (Medical University of Vienna), A-1090 - Vienna/AT
  • 2 Dept. Of Obstetrics & Gynecology, Medical University Graz, 8036 - Graz/AT
  • 3 Internal Medicine 1 Oncology, Krankenhaus Voecklabruck, 4840 - Voecklabruck/AT
  • 4 Dept. Obstet. Gynecol, Innsbruck Medical University, 6019 - Innsbruck/AT
  • 5 Department Of Hematology And Oncology, Hanusch Hospital, Vienna/AT
  • 6 Internal Medicine, Landeskrankenhaus Feldkirch, 6807 - Feldkirch/AT
  • 7 Internal Medicine, Klinikum der Kreuzschwestern Wels, Wels/AT
  • 8 Interne I: Internistische Onkologie, Hämatologie Und Gastroenterologie, Krankenhaus der Barmherzigen Schwestern Linz (bhslinz), 4040 - Linz/AT
  • 9 Internal Medicine, Donauspital im SMZ-Ost, Vienna/AT
  • 10 Iiird Medical Department, Salzburg Cancer Research Institute With Laboratory Of Immunological And Molecular Cancer Research And Center For Clinical Cancer And Immunology Trials, Cancer Cluster Salzburg, Paracelsus University Hospital Salzburg, 5020 - Salzburg/AT
  • 11 Head Of The Iiird Medical Department, Paracelsus University Hospital Salzburg, 5020 - Salzburg/AT
  • 12 Universitätsklinik Für Frauenheilkunde, Medizinische Universitaet Wien (Medical University of Vienna), 1090 - Vienna/AT
  • 13 2nd Medical Department, County Hospital Steyr, 4400 - Steyr/AT
  • 14 Surgery, Krankenhaus Wiener Neustadt, Wiener Neustadt/AT
  • 15 Gynecology, Medizinische Universität Innsbruck, Innsbruck/AT
  • 16 Internal Medicine, University Clinic St. Pölten, 3100 - St. Poelten/AT
  • 17 Internal Medicine, Landeskrankenhaus LKH Leoben, Leoben/AT
  • 18 Department Of Medicine 1, Clinical Division Of Oncology, Medizinische Universitaet Wien (Medical University of Vienna), 1090 - Vienna/AT
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Resources

Abstract 3749

Background

Nab-paclitaxel (Abraxane®, Celgene), a nanometer-sized albumin-bound paclitaxel, was developed to reduce the toxicities associated with conventional taxanes and is approved for the second-line treatment of metastatic breast cancer (mBC). This prospective, multicenter, non-interventional study was designed to characterize the treatment patterns, safety, and activity of nab-paclitaxel in young and elderly mBC patients (pts) in routine clinical practice.

Methods

Safety and tolerability of nab-paclitaxel was defined as the primary study endpoint. Secondary endpoints were overall response rate (ORR) and assessment of real-life dosages. Pts with confirmed mBC who met the eligibility criteria were enrolled and prospectively observed for at least 6 treatment cycles or until disease progression or unacceptable toxicity.

Results

Between 5/2012 and 1/2016, 203 pts (median age: 58 years, range 33-91; 34 (17%) ≥70) were included at 16 sites. 81 pts (40%) had ≥3 metastatic lesions, 35 (17%) were triple-negative, and 93 (46%) had grade 3 disease. 44 pts (22%) received nab-paclitaxel as first-line, 54 (26%) as second-line, and 103 (50%) as third- to seventh-line therapy. A total of 1036 treatment cycles (median: 5; range: 1-19) were administered. In a preplanned interim outcome analysis conducted in 132 pts, the ORR was 39%, consisting of 4 complete (CR; 3%) and 47 partial responses (PR;36%). In addition, 43 patients (33%) had stable disease for a clinical benefit rate (CBR) of 72%. In the elderly cohort, 10 pts (30%) had PR and 3 pts (10%) had SD for a CBR of 40%.Overall, Nab-paclitaxel was well tolerated, with most adverse drug reactions (ADRs) mild or moderate in severity. The most common ADRs were peripheral neuropathy, neutro- and leukopenia. ADRs leading to the discontinuation of nab-paclitaxel occurred in 18 pts (9%). No new safety signals were identified and no significant differences in the reason for treatment discontinuation between pts

Conclusions

In this real-life study safety and efficacy data are consistent with previous clinical trial data. Of note, nab-paclitaxel was active and also well tolerated in pts aged ≥70 years.

Clinical trial identification

Legal entity responsible for the study

Medical University of Vienna, Austria

Funding

Celgene

Disclosure

G. Steger, E. Petru, F. Haslbauer, D. Egle, A. Galid, T. Sliwa, A. Lang, T. Kühr, A. Petzer, R. Ruckser, B. Mlineritsch, R. Greil, M. Seifert, C. Singer, J. Andel, W. Kwasny, C. Marth, P. Pichler, C. Tinchon, R. Bartsch: Celgene: Honoraria, advisory boards, and travel support

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