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Poster display session

3600 - A randomized, double-blind, multi-center phase III study evaluating paclitaxel with and without RAD001 in patients with gastric or esophagogastric junction carcinoma who have progressed after therapy with a fluoropyrimidine/platinum-containing regimen (RADPAC).

Date

09 Sep 2017

Session

Poster display session

Presenters

Claudia Pauligk

Citation

Annals of Oncology (2017) 28 (suppl_5): v209-v268. 10.1093/annonc/mdx369

Authors

C. Pauligk1, S. Lorenzen2, T. Goetze1, J. Riera Knorrenschild3, S. Hegewisch Becker4, J. Seraphin5, P. Thuss-Patience6, H. Kopp7, T. Dechow8, A. Vogel9, K. Luley10, D. Pink11, M. Stahl12, F. Kullmann13, H. Hebart14, J.T. Siveke15, M. Egger16, N. Homann17, S. Probst18, S. Al-Batran1

Author affiliations

  • 1 Institute Of Clinical Cancer Research (ikf), Uct-university Cancer Center, Krankenhaus Nordwest, 60488 - Frankfurt/DE
  • 2 Iii. Medizinische Klinik Und Polyklinik, Rechts der Isar Hospital,TUM, 81675 - Munich/DE
  • 3 Medical Clinic, University Hospital, Marburg/DE
  • 4 Haematologisch-onkologische Praxis Eppendorf, Facharztzentrum Eppendorf, Hamburg/DE
  • 5 Mvz, Helios MVZ Südniedersachse, Northeim/DE
  • 6 Department Of Hematology, Oncology, And Tumor Immunology, Charité University Medicine Berlin, Campus Virchow-Klinikum, 13353 - Berlin/DE
  • 7 Medical Center Ii, Universitätsklinikum Tübingen Medizinische Universitätsklinik, 72076 - Tübingen/DE
  • 8 Oncology, Onkologie-Ravensburg, 88212 - Ravensburg/DE
  • 9 Department Of Gastroenterology, Hepatology And Endocrinology, Hannover Medical School, Hannover/DE
  • 10 Med. Klinik I, University SH.-Lübeck, 23538 - Lübeck/DE
  • 11 Klinik Für Innere Medizin Iii M.s. Hämatologie, Onkologie Und Palliativmedizin, HELIOS Klinikum Bad Saarow, 15526 - Bad Saarow/DE
  • 12 Klinik Für Internistische Onkologie/hämatologie, Kliniken Essen Mitte, 45136 - Essen/DE
  • 13 Department Of Internal Medicine I, Academic Teaching Hospital Weiden, Weiden/DE
  • 14 Zentrum Für Innere Medizin, Klinikum Schwäbisch Gmünd Stauferklinik, 73557 - Mutlangen/DE
  • 15 Ii. Medizinische Klinik Und Polyklinik, Rechts der Isar Hospital,TUM, 81675 - Munich/DE
  • 16 Medical Clinic, Ortenau Klinikum Lahr, 77933 - Lahr/DE
  • 17 Department Of Internal Medicine Ii, Klinikum Wolfsburg, 38440 - Wolfsburg/DE
  • 18 Klinik Für Hämatologie Und Onkologie, Klinikum Bielefeld, Bielefeld/DE
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Resources

Abstract 3600

Background

There is a need for effective treatments in the second- or further line setting in advanced gastric cancer, especially for new agents. In the current trial we evaluated paclitaxel with RAD001 (everolimus) in patients with gastric carcinoma who have progressed after therapy with a fluoropyrimidine/platinum-containing regimen.

Methods

This is a randomized, double-blind, multi-center phase III study. Patients with gastric carcinoma or adenocarcinoma of the esophagogastric junction (EGJ) who have progressed after treatment with a fluoropyrimidine/platinum-containing regimen were randomly assigned to receive Paclitaxel (80 mg/m2) on day 1, 8 and 15 plus placebo (arm A) or RAD001 (10mg daily, arm B) d1-d28, repeated every 28 days as 2nd, 3rd or 4th line therapy. Primary end point was overall survival (OS), secondary endpoints were best overall response, disease control rate, progression free survival (PFS) and toxicity.

Results

300 patients (median age: 62 years; median lines prior therapy: 2; 47.7% of patients had prior taxane therapy) were randomly assigned (Arm A, 150, Arm B, 150). In the intention to treat population, there was no significant difference in median PFS (placebo, 2.07 vs. RAD001, 2.2 months, HR 0.88, p = 0.3) or median OS (placebo, 5.0 vs. RAD001, 6.1 months, HR 0.93, p = 0.54). For patients with prior taxane use, RAD001 improved PFS (placebo 1.8 vs. RAD001, 2.7 months, HR 0.69, p = 0.03) and OS (placebo 3.9 vs. RAD001, 5.8 months, HR 0.73, p = 0.07). Combination of paclitaxel and RAD001 was tolerable, but the RAD001 arm was associated with significantly more grade 3-5 mucositis (13.3% vs. 0.7%; p 

Conclusions

The addition of RAD001 to paclitaxel/RAD001 did not improve outcomes in pretreated metastatic gastric/EGJ cancer. Of note, activity was seen in the taxane pretreated group. Additional biomarker studies are planned to look for subgroups that may have a benefit.

Clinical trial identification

Protocol Code: CRAD001RDE35T clinicaltrials.gov NCT01248403

Legal entity responsible for the study

Krankenhaus Nordwest GmbH

Funding

Novartis

Disclosure

S. Lorenzen: Advisory: Roche, BMS, Sanofi, Lilly. Honoraria: Merck, Lilly, Roche, Sanofi, BMS, Celgene; Research fund: Lilly. T. Goetze: Honoraria: MSD, Celgene. Consulting or advisory role: BMS, Baxalta-Shire. J. Riera Knorrenschild: Consulting/Advisory: Roche, Pierre Fabre Pharma. Travel: Mologen Berlin. P. Thuss-Patience: Consulting/Advisory Role: Roche, Lilly, BMS, MSD, Nordic, Pfizer. Research funding: Novartis. Travel, accomodations, expenses: Roche, Merck, Teva. A. Vogel: Honoraria: Novartis. K. Luley: Travel, accomodations, expenses: Ipsen, Novartis, Sanofi. D. Pink: Consulting or advisory role: Lilly, Clinigen. Research funding: PharmaMar. F. Kullmann: Honoraria: Roche. Consulting or advisory role: Celgene, Baxter, Lilly, Sanofi. Research Funding: Sanofi, Celgene. Travel, Accomodations, expenses: Celgene. H. Hebart: Stock or other ownership: Astellas, Gilead, Roche. Consulting or Advisory: Gilead, Roche. Travel: Roche, Celgene, BMS. J.T. Siveke: Consulting or Advisory Role: Merrimack, Baxalter, Celgene, Lilly. Research Funding: Celgene, BMS, 4SC, Novartis. Travel, accomodations, expenses: Roche, Celgene. N. Homann: Consulting or Advisory role: Sanofi, Roche, Amgen, Cellgene, Lilly. S-E. Al-Batran: Honoraria: Roche, Celgene, Lilly, Nordic Pharma. Consulting or advisory role: Merck, Roche, Celgene, Lilly, Nordic Pharma. Research funding: Merck, Roche, Celgene, Vifor, Medac, Hospira, Lilly. All other authors have declared no conflicts of interest.

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