651P - Nab-paclitaxel as second line treatment in advanced gastric cancer: A HORG multicenter phase II study

Date 08 October 2016
Event ESMO 2016 Congress
Session Poster Display
Topics Cytotoxic agents
Gastric Cancer
Therapy
Biological therapy
Presenter Panagiotis Katsaounis
Citation Annals of Oncology (2016) 27 (6): 207-242. 10.1093/annonc/mdw371
Authors P. Katsaounis, N. Kentepozidis, A. Kotsakis, A. Polyzos, L. Vamvakas, M. Bakogiorgos, I. Boukovinas, E. Hartabilas, E. Prinarakis, T. Skaltsi, V. Georgoulias, J. Souglakos
  • Medical Oncology, Hellenic Oncology Research Group (HORG), 11471 - Athens/GR

Abstract

Background

There are few therapeutic options for the treatment of metastatic gastric and gastroesophageal junction adenocarcinomas which fail front-line chemotherapy. A phase II multicenter study of second line nab-paclitaxel was conducted aiming to evaluate its efficacy and tolerance in patients with advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma.

Methods

Thirty-nine patients (median age 62 years) with locally advanced inoperable and metastatic gastric and GEJ adenocarcinoma were enrolled. All patients had a PS of 0-1, 17 pts (43.6%) had prior surgery, 4 had received prior adjuvant chemotherapy, and 33 (84.6%) had receiver DCF in the first line setting. The median time from the prior treatment was 2.6 months (range, 1.0-13.8). Nab-paclitaxel was given weekly (125mg/m2, d1,d8, and d15 every 28 days).

Results

Partial response (PR) was achieved in nine pts (23.1%), disease stabilization (SD) in 11 (28.2%) and disease progression in 18 (46.2%) for an ORR of 23.1% (95% CI; 9.85-36.3) and a DCR of 51.3%. Responses were observed irrespectively of the prior administration docetxel-based chemotherapy. The median progression free survival was 3.0 months (95% CI 2.1-3.8) and the median overall survival 6.8 months (95% CI 0.7-8.8). Six (15.3%) pts developed grade 3/4 neutropenia, 7 pts (18%) grade 2/3 asthenia and 8 (20.5%) grade 2/3 neurotoxicity. Other AE were mild (grade

Conclusions

Second line nab-paclitaxed is an active and well tolerated treatment for patients with locally advanced inoperable/metastatic gastric and GEJ carcinomas even in pre-treated pts with a docetaxel-based regimen and merits further evaluation in the first-line setting.

Demographic Data/Responses

N %
Response to treatment
CR/PR (ORR) 9 23.1
SD 9 28,2
Disease Control Rate (DCR) 18 51.3
Time from prior treatment**
Median (min-max) 2.6 ( 0.2 – 13.8)

Clinical trial identification

NCT02251951

Legal entity responsible for the study

N/A

Funding

Celgene

Disclosure

All authors have declared no conflicts of interest.