Gemcitabine and Paclitaxel Versus Gemcitabine Alone After 5-Fluorouracil, Oxaliplatin, and Irinotecan in Metastatic Pancreatic Adenocarcinoma: A Randomized Phase III PRODIGE 65-UCGI 36-GEMPAX UNICANCER Study

Author:

De La Fouchardière Christelle1ORCID,Malka David2ORCID,Cropet Claire3,Chabaud Sylvie3,Raimbourg Judith4,Botsen Damien5ORCID,Launay Simon6,Evesque Ludovic7,Vienot Angélique8,Perrier Hervé9,Jary Marine10ORCID,Rinaldi Yves11,Coutzac Clélia1,Bachet Jean Baptiste12,Neuzillet Cindy13ORCID,Williet Nicolas14ORCID,Desgrippes Romain15,Grainville Thomas16,Aparicio Thomas17,Peytier Annie18,Lecomte Thierry1920ORCID,Roth Gaël S.21,Thirot-Bidault Anne22,Lachaux Nicolas23,Bouché Olivier24ORCID,Ghiringhelli François25

Affiliation:

1. Medical Oncology Department, Centre Leon Bérard, University Lyon I, Lyon, France

2. Department of Cancer Medicine, Gustave Roussy, University of Paris-Saclay, Villejuif, France

3. Department of Clinical Research and Innovation, Léon Bérard Centre, Lyon, France

4. Medical Oncology Department, ICO René Gauducheau, Nantes, France

5. Medical Oncology Department, Godinot Institute, Unicancer Champagne, Reims, France

6. Medical Oncology Department, Paoli Calmettes Institute, Marseille, France

7. Pole of Medicine/Gastro-enterology, Antoine Lacassagne Centre, Nice, France

8. Medical Oncology Department, Jean Minjoz Hospital, Besançon, France

9. Oncology Department, Saint Joseph Hospital, Marseille, France

10. Oncology Department, Nord Franche Comté Hospital, Montbéliard, France

11. Hepato-gastroenterology and Digestive Oncology Department, European Hospital of Marseille, Marseille, France

12. Hepato-gastroenterology and Digestive Oncology Department, Pitié-Salpêtrière Hospital, Paris, France

13. Medical Oncology Department, Curie Institute, Saint Cloud, France

14. Hepato-gastroenterology Department, University Institute of Cancerology and Hematology of Saint-Etienne (ICHUSE), Targeting Research Unit in Oncology at the University Hospital of Saint-Etienne (URCAS), Saint-Priest-en-Jarez, France

15. Hepato-Gastroenterology and Digestive Oncology Department, Broussais Hospital, Saint-Malo, France

16. Medical Oncology Department, Eugène Marquis Centre, Rennes, France

17. Gastroenterology and Digestive Cancerology Department, Saint Louis Hospital, Paris, France

18. Hepato-Gastroenterology Department, Hospital Centre of Bayeux, Bayeux, France

19. Hepato-gastroenterology and Digestive Oncology Department, CHU Tours, Tours, France

20. Department of Nutrition, Growth and Cancer, INSERM UMR1069, University of Tours, Tours, France

21. Hepato-Gastroenterology and Digestive Oncology Department, CHU Grenoble Alpes, Institute for Advanced Biosciences, CNRS UMR 5309-INSERM U1209, Université Grenoble Alpes, Grenoble, France

22. Institute of Cancerology Paris Sud—Private Hospital of Antony, Antony, France

23. UCGI, PRODIGE Intergroup, Unicancer, Paris, France

24. Hepatogastroenterology and Digestive Cancerology Department, CHU Robert Debré, Reims, France

25. Medical Oncology Department, Georges François Leclerc Centre, Dijon, France

Abstract

PURPOSE GEMPAX was an open-label, randomized phase III clinical trial designed to assess the efficacy and tolerability of gemcitabine plus paclitaxel versus gemcitabine alone as second-line treatment for patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) who previously received 5-fluorouracil, oxaliplatin, and irinotecan. METHODS Patients with histologically or cytologically confirmed mPDAC were randomly assigned (2:1) to receive GEMPAX (paclitaxel 80 mg/m2 + gemcitabine 1,000 mg/m2; IV; once at day (D) 1, D8, and D15/arm A) or gemcitabine (arm B) alone once at D1, D8, and D15 every 28 days until progression, toxicity, or patient's decision. The primary end point was overall survival (OS). Secondary end points included progression-free survival (PFS), objective response rate (ORR), quality of life, and safety. RESULTS Overall, 211 patients (median age, 64 [30-86] years; 62% male) were included. After a median study follow-up for alive patients of 13.4 versus 13.8 months in arm A versus arm B, the median OS (95% CI) was 6.4 (5.2 to 7.4) versus 5.9 months (4.6 to 6.9; hazard ratio [HR], 0.87 [0.63 to 1.20]; P = 0.4095), the median PFS was 3.1 (2.2 to 4.3) versus 2.0 months (1.9 to 2.3; HR, 0.64 [0.47 to 0.89]; P = 0.0067), and the ORR was 17.1% (11.3 to 24.4) versus 4.2% (0.9 to 11.9; P = 0.008) in arm A versus arm B, respectively. Overall, 16.7% of patients in arm A and 2.9% in arm B discontinued their treatment because of adverse events (AEs). One grade 5 AE associated with both gemcitabine and paclitaxel was reported in arm A (acute respiratory distress), and 58.0% versus 27.1% of patients experienced grade ≥3 treatment-related AEs in arm A versus arm B, among which 15.2% versus 4.3% had anemia, 15.9% versus 15.7% had neutropenia, 19.6% versus 4.3% had thrombocytopenia, 10.1% versus 2.9% had asthenia and 12.3% versus 0.0% had neuropathy. CONCLUSION While GEMPAX did not meet the primary end point of OS versus gemcitabine alone in patients with mPDAC in the second-line setting, both PFS and ORR were significantly improved.

Publisher

American Society of Clinical Oncology (ASCO)

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