PMID- 38232341
OWN - NLM
STAT- MEDLINE
DCOM- 20240318
LR  - 20240318
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 42
IP  - 9
DP  - 2024 Mar 20
TI  - 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.
PG  - 1055-1066
LID - 10.1200/JCO.23.00795 [doi]
AB  - 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/m(2) + gemcitabine 1,000 mg/m(2); 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.
FAU - De La Fouchardiere, Christelle
AU  - De La Fouchardiere C
AUID- ORCID: 0000-0003-2291-5693
AD  - Medical Oncology Department, Centre Leon Berard, University Lyon I, Lyon, France.
FAU - Malka, David
AU  - Malka D
AUID- ORCID: 0000-0002-7664-0130
AD  - Department of Cancer Medicine, Gustave Roussy, University of Paris-Saclay, 
      Villejuif, France.
FAU - Cropet, Claire
AU  - Cropet C
AD  - Department of Clinical Research and Innovation, Leon Berard Centre, Lyon, France.
FAU - Chabaud, Sylvie
AU  - Chabaud S
AD  - Department of Clinical Research and Innovation, Leon Berard Centre, Lyon, France.
FAU - Raimbourg, Judith
AU  - Raimbourg J
AD  - Medical Oncology Department, ICO Rene Gauducheau, Nantes, France.
FAU - Botsen, Damien
AU  - Botsen D
AUID- ORCID: 0000-0002-2117-4750
AD  - Medical Oncology Department, Godinot Institute, Unicancer Champagne, Reims, 
      France.
FAU - Launay, Simon
AU  - Launay S
AD  - Medical Oncology Department, Paoli Calmettes Institute, Marseille, France.
FAU - Evesque, Ludovic
AU  - Evesque L
AD  - Pole of Medicine/Gastro-enterology, Antoine Lacassagne Centre, Nice, France.
FAU - Vienot, Angelique
AU  - Vienot A
AD  - Medical Oncology Department, Jean Minjoz Hospital, Besancon, France.
FAU - Perrier, Herve
AU  - Perrier H
AD  - Oncology Department, Saint Joseph Hospital, Marseille, France.
FAU - Jary, Marine
AU  - Jary M
AUID- ORCID: 0000-0001-7502-7708
AD  - Oncology Department, Nord Franche Comte Hospital, Montbeliard, France.
FAU - Rinaldi, Yves
AU  - Rinaldi Y
AD  - Hepato-gastroenterology and Digestive Oncology Department, European Hospital of 
      Marseille, Marseille, France.
FAU - Coutzac, Clelia
AU  - Coutzac C
AD  - Medical Oncology Department, Centre Leon Berard, University Lyon I, Lyon, France.
FAU - Bachet, Jean Baptiste
AU  - Bachet JB
AD  - Hepato-gastroenterology and Digestive Oncology Department, Pitie-Salpetriere 
      Hospital, Paris, France.
FAU - Neuzillet, Cindy
AU  - Neuzillet C
AUID- ORCID: 0000-0001-7037-7477
AD  - Medical Oncology Department, Curie Institute, Saint Cloud, France.
FAU - Williet, Nicolas
AU  - Williet N
AUID- ORCID: 0000-0002-7296-5464
AD  - 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.
FAU - Desgrippes, Romain
AU  - Desgrippes R
AD  - Hepato-Gastroenterology and Digestive Oncology Department, Broussais Hospital, 
      Saint-Malo, France.
FAU - Grainville, Thomas
AU  - Grainville T
AD  - Medical Oncology Department, Eugene Marquis Centre, Rennes, France.
FAU - Aparicio, Thomas
AU  - Aparicio T
AD  - Gastroenterology and Digestive Cancerology Department, Saint Louis Hospital, 
      Paris, France.
FAU - Peytier, Annie
AU  - Peytier A
AD  - Hepato-Gastroenterology Department, Hospital Centre of Bayeux, Bayeux, France.
FAU - Lecomte, Thierry
AU  - Lecomte T
AUID- ORCID: 0000-0001-5093-0212
AD  - Hepato-gastroenterology and Digestive Oncology Department, CHU Tours, Tours, 
      France.
AD  - Department of Nutrition, Growth and Cancer, INSERM UMR1069, University of Tours, 
      Tours, France.
FAU - Roth, Gael S
AU  - Roth GS
AD  - Hepato-Gastroenterology and Digestive Oncology Department, CHU Grenoble Alpes, 
      Institute for Advanced Biosciences, CNRS UMR 5309-INSERM U1209, Universite 
      Grenoble Alpes, Grenoble, France.
FAU - Thirot-Bidault, Anne
AU  - Thirot-Bidault A
AD  - Institute of Cancerology Paris Sud-Private Hospital of Antony, Antony, France.
FAU - Lachaux, Nicolas
AU  - Lachaux N
AD  - UCGI, PRODIGE Intergroup, Unicancer, Paris, France.
FAU - Bouche, Olivier
AU  - Bouche O
AUID- ORCID: 0000-0002-8284-3743
AD  - Hepatogastroenterology and Digestive Cancerology Department, CHU Robert Debre, 
      Reims, France.
FAU - Ghiringhelli, Francois
AU  - Ghiringhelli F
AD  - Medical Oncology Department, Georges Francois Leclerc Centre, Dijon, France.
LA  - eng
SI  - ClinicalTrials.gov/NCT03943667
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20240117
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Gemcitabine)
RN  - 7673326042 (Irinotecan)
RN  - U3P01618RT (Fluorouracil)
RN  - 04ZR38536J (Oxaliplatin)
RN  - P88XT4IS4D (Paclitaxel)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 0 (Albumins)
SB  - IM
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Female
MH  - Gemcitabine
MH  - *Pancreatic Neoplasms/pathology
MH  - Irinotecan/adverse effects
MH  - Fluorouracil/adverse effects
MH  - Oxaliplatin/adverse effects
MH  - Paclitaxel/adverse effects
MH  - *Adenocarcinoma/drug therapy/pathology
MH  - Quality of Life
MH  - Deoxycytidine/adverse effects
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - Albumins/adverse effects
EDAT- 2024/01/17 18:42
MHDA- 2024/03/18 06:42
CRDT- 2024/01/17 16:03
PHST- 2024/03/18 06:42 [medline]
PHST- 2024/01/17 18:42 [pubmed]
PHST- 2024/01/17 16:03 [entrez]
AID - 10.1200/JCO.23.00795 [doi]
PST - ppublish
SO  - J Clin Oncol. 2024 Mar 20;42(9):1055-1066. doi: 10.1200/JCO.23.00795. Epub 2024 
      Jan 17.