Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster display session

1394 - A Phase I/II study everolimus in combination with paclitaxel-carboplatin in patients with advanced adenocarcinoma of the stomach


11 Sep 2017


Poster display session


Cytotoxic Therapy;  Gastric Cancer


Herbert Loong


Annals of Oncology (2017) 28 (suppl_5): v122-v141. 10.1093/annonc/mdx367


H.H. Loong1, F. Mo1, L. Li2, C. Lee3, K. Lam2, J. Koh1, P. Chiu4, A. Teoh4, A.T..C. Chan1, E. Ng4, W. Yeo1

Author affiliations

  • 1 Department Of Clinical Oncology, The Chinese University of Hong Kong, 00000 - Hong Kong/HK
  • 2 Department Of Clinical Oncology, Prince of Wales Hospital, 00000 - Hong Kong/HK
  • 3 Department Of Oncology, United Christian Hospital, Hong Kong/HK
  • 4 Department Of Surgery, The Chinese University of Hong Kong, 00000 - Hong Kong/HK


Abstract 1394


Significant proportion of patients (pts) with adenocarcinoma of stomach (ADCS) present with advanced disease. Paclitaxel (P), either alone, or in combination with carboplatin (C) is well-tolerated, but has modest activity in ADCS. The PI3K-Akt pathway played an important role in cell proliferation and apoptosis in pre-clinical ADCS models. Everolimus (E) is a potent inhibitor of mTOR, a downstream mediator of the PI3K-Akt pathway. Combining chemotherapies with mTOR inhibition may improve outcome


A single-arm, dose-escalation study of E, in combination with P and C (E+PC) was conducted in pts with metastatic and/or loco-regionally advanced ADCS [NCT01514110]. In the phase 1 portion (P1P), the maximum-tolerated dose (MTD), recommended phase 2 dose (RP2D) and safety of E+PC, were determined using a standard 3 + 3 design. Starting dose (dose level I) was E 5mg/d, P 175mg/m2 and C AUC5 every 3 weeks. Dose-limiting toxicities (DLT) were defined as grade 4 haematological or grade 3 or 4 non-haematological toxicities. Preliminary efficacy of E+PC in pts with ADCS, defined by clinical benefit rate (CBR) (CR+PR+SD for 6wks or more as per RECIST), and survival were determined in the phase 2 portion


30 pts were enrolled (P1P = 12) from Jan 2008 to Nov 2014. In the P1P, 2 DLTs (G5 GI bleeding and G3 joint pain) were experienced at dose level II, thus establishing dose level I as the MTD and RP2D. 21 pts were treated at RP2D. Baseline demographics of phase 2 portion: M/F: 9/12, Median age 54 (range 40-69), ECOG PS 0/1/2: 10/10/1. Prior lines of chemotherapy 0/1/≥2: 7/12/2. Median cycles: 6 (range 1-19). Common related ≥G3 adverse events (AEs) include (%): neutropenia (48%), anaemia (43%), thrombocytopenia (29%), mucositis (10%). Febrile neutropenia occurred in 10% (n = 2) of pts. 18 pts were evaluable for response (5 PR, 9 SD, 4 PD). CBR 77.8% (95% CI 58.6-97.0%). Median PFS and OS was 6.9 and 9.0months (95%CI 3.5 – 7.6; 3.8 – 15.1months) respectively


E+PC administered at RP2D was well-tolerated. Comparing with prior reported series of PC alone, E+PC showed more favorable efficacy and has promising activity in pts with advanced ADCS. Acknowledgement- Supported by Novartis Pharmaceuticals Ltd

Clinical trial identification


Legal entity responsible for the study

The Chinese University of Hong Kong


Novartis Pharmaceuticals Ltd.


H.H. Loong: Research Funding: MSD. Advisory: Novartis, Roche. Travel Support: Abbvie, Bayer, Bristol-Myers-Squibb, Novartis, Roche. Speakers Bureau: Abbvie, Bayer. W. Yeo: Advisor: Novartis, Eli Lilly. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.