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Poster display

3955 - Efficacy and safety of nab-paclitaxel in patients with metastatic breast cancer: final results of the non-interventional study NABUCCO

Date

10 Oct 2016

Session

Poster display

Presenters

Karin Potthoff

Citation

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

Authors

K. Potthoff1, A. Nusch2, U. Söling3, R. Hansen4, C. Salat5, S. Grebhardt6, N. Marschner7

Author affiliations

  • 1 Medical Department, iOMEDICO AG, 79108 - Freiburg/DE
  • 2 Hämatologie Und Internistische Onkologie, Krebszentrum Ratingen, Ratingen/DE
  • 3 Innere Medizin, Hämatologie Und Internistische Onkologie, Onkologische Gemeinschaftspraxis, Kassel/DE
  • 4 Hämatologie Und Onkologie, Onkologische Schwerpunktpraxis Dres. Hansen & Reeb, Kaiserslautern/DE
  • 5 Innere Medizin, Hämatologie Und Internistische Onkologie, Hämato-Onkologische Schwerpunktpraxis, München/DE
  • 6 Clinical Operations, iOMEDICO AG, Freiburg/DE
  • 7 Internal Medicine / Hematology, Praxis für Interdisziplinaere Onkologie, 79110 - Freiburg/DE
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Resources

Abstract 3955

Background

One of the most effective chemotherapies for metastatic breast cancer (MBC) is nab-paclitaxel (nab-P) which is approved for the treatment of MBC after failure of 1st-line therapy and when anthracyclines are not indicated.

Randomized clinical trials have shown high efficacy and acceptable toxicity. Real world data of nab-P in MBC, however, are still limited.

Methods

The prospective multicenter non-interventional study NABUCCO was designed to collect data on the routine treatment of 700 patients (pts) with MBC in approximately 100 sites across Germany. Primary objective was the time to tumor progression (TTP), secondary objectives were overall response rate (ORR), overall survival (OS), the dosage scheme of nab-P, time on treatment, safety parameters and quality of life. Descriptive statistics were used to analyze the data. TTP and OS were calculated using the Kaplan-Meier method.

Results

Between 4/2012 and 4/2015 705 pts with MBC at 128 sites had been enrolled. 697 pts were evaluable with a median follow-up of 17.7 months. Baseline characteristics: Median age 62.3 years (range 29.2-89.3), age ≥ 65 years n = 291 (41.8%), ECOG PS ≥ 2 n = 49 (7.0%), prior taxanes 419 pts (60.1%). Pts were treated at the physician's discretion. The application mode of nab-P was as follows: 260 mg/m2 q3w (n = 153, 22.0%), ≥ 15% reduced dose q3w (n = 37, 5.3%), 150 mg/m2 d1, d8, d15 q4w (n = 54, 7.7%), ≥ 15% reduced dose d1, d8, d15 q4w (n = 219, 31.4%), 100-125 mg/m2 d1,8,15 q3w (n = 90, 12.9%) and other (n = 144, 20.7%).

Summary of effectiveness analyses by treatment line

Total 1st line 2nd line 3rd line ≥ 4th line
n (%) 697 (100) 280 (40.2) 169 (24.2) 141 (20.2) 107 (15.4)
Median TTP, months (95% CI) 5.9 (5.6-6.4) 7.1 (6.0-8.6) 6.0 (5.5-7.3) 5.6 (4.6 -6.7) 5.2 (4.2-5.6)
ORR, % 37.2 46.1 32.0 31.9 29.0

34.3% of pts developed adverse events grade 3/4 which included leukopenia (7.9%) and infections (4.2%). Peripheral sensory neuropathy grade 1/2 was reported for 35.0% of pts and grade 3 for 4.3% of pts, respectively. Further subgroup analyses will be presented.

Conclusions

The results of the NABUCCO study confirm the clinical trial outcomes and the favorable benefit-risk profile of nab-P in pts with MBC in a real-life setting.

Clinical trial identification

Projekt-Nr.: IOM-02240

Legal entity responsible for the study

Ethikkommission der Landesärztekammer Baden-Württemberg

Funding

Celgene GmbH

Disclosure

N. Marschner: Employment or Leadership Position: iOMEDICO AG; Sponsored research: Grant by Celgene GmbH; Other Financial Relationships: Remuneration for presentation and compensation for travel expenses. All other authors have declared no conflicts of interest.

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