Guidelines for time-to-event end-point definitions in trials for pancreatic cancer. Results of the DATECAN initiative (Definition for the Assessment of Time-to-event End-points in CANcer trials)

Bonnetain, Franck; Bonsing, Bert A.; Conroy, Thierry; Dousseau, A.; Glimelius, Bengt; Haustermans, Karin; Lacaine, F; Laethem, Jean‐Luc Van; Aparicio, Thomas; Aust, D.; Bassi, Claudio; Berger, Virginie; Chamorey, Emmanuel; Chibaudel, Benoist; Dahan, L.; Gramont, Aimery de; Delpero, Jean‐Robert; Dervenis, Christos; Ducreux, Michel; Gal, Jocelyn; Gerber, Erich; Ghaneh, Paula; Hammel, Pascal; Hendlisz, Alain; Jooste, Valérie; Labianca, Roberto; Latouche, Aurélien; Lutz, Manfred P.; Macarulla, Teresa; Malka, David; Mauer, Murielle; Mitry, Emmanuel; Neoptolemos, John P.; Pessaux, Patrick; Sauvanet, Alain; Tabernero, Josep; Taı̈eb, Julien; Tienhoven, Geertjan van; Gourgou-Bourgade, Sophie; Bellera, Carine; Mathoulin‐Pélissier, Simone; Collette, Laurence

doi:10.1016/j.ejca.2014.07.011

Cited by 59 publications

(33 citation statements)

References 15 publications

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“…The cutoff date for the analysis was October 2015. Survival rates were calculated using the Kaplan-Meier method (26). Overall survival (OS) was calculated from the date of diagnosis until death from…”

Section: Discussionmentioning

confidence: 99%

Plasma Circulating Tumor DNA in Pancreatic Cancer Patients Is a Prognostic Marker

Pietrasz

Pécuchet

Garlan

et al. 2017

Clinical Cancer Research

212

177

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Section: Discussionmentioning

confidence: 99%

Plasma Circulating Tumor DNA in Pancreatic Cancer Patients Is a Prognostic Marker

Pietrasz

Pécuchet

Garlan

et al. 2017

Clinical Cancer Research

212

177

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“…The incidence increases with age and the majority of cases occur in patients over the age of 60 years. It was found, from research in the UK, that <0.4% of cases have been reported to occur in ages <34 years 4. Highest incidences have occurred in Europe and North America, and the lowest in Asia and Africa, with African-Americans and women having an increased risk 5…”

Section: Discussionmentioning

confidence: 99%

Metastatic pancreatic cancer: abdominal pain in a 22-year-old woman

Roy¹,

Roy

2015

BMJ Case Reports

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Pancreatic cancer remains fourth among cancer-related deaths. Its diagnosis is often missed, owing to its vague abdominal symptoms, leading to a diagnosis of stage IV pancreatic cancer. FOLFIRINOX chemotherapy was administered to the patient in this report, resulting in significant improvement based on tests of biological markers as well as radiographic resolution of the metastatic disease. A keen awareness of this condition along with appropriate diagnostic tests can allow for an earlier diagnosis and may impact its high mortality.

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“…The primary objective is to assess PFS at 4 months in both treatment arms: nab-paclitaxel plus gemcitabine (arm A) and nab-paclitaxel plus simplified LV5FU2 (arm B). Survival is defined as the time interval between the randomization date and the date of either first documented disease progression (RECIST v1.1) or death of any cause, whatever occurs first [ 41 ]. Patients alive without progression will be censored at the last tumor assessment, either during study treatment period or during follow-up period.…”

Section: Methodsmentioning

confidence: 99%

“…The secondary objectives are to evaluate RR (RECIST v1.1), duration of RR, duration of disease control (DDC), OS, safety, health-related quality of life (HRQoL), and the prognostic and predictive value of SPARC, hENT1, dCK, and TS expression level in both treatment arms [ 41 ]. Survival is defined as the interval between the randomization date and the date of death from any cause.…”

Section: Methodsmentioning

confidence: 99%

A randomized phase II study of weekly nab-paclitaxel plus gemcitabine or simplified LV5FU2 as first-line therapy in patients with metastatic pancreatic cancer: the AFUGEM GERCOR trial

et al. 2015

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BackgroundMetastatic pancreatic adenocarcinoma (PAC) prognosis remains dismal and gemcitabine monotherapy has been the standard treatment over the last decade. Currently, two first-line regimens are used in this setting: FOLFIRINOX and nab-paclitaxel plus gemcitabine. Increasing translational data on the predictive value of hENT1 for determining gemcitabine efficacy suggest that a non-gemcitabine-based regimen is favored in about 60 % of patients with PAC due to high resistance of PAC to this cytotoxic drug. This study aims to evaluate the efficacy of weekly nab-paclitaxel combined with gemcitabine or a simplified (s) LV5FU2 regimen in patients with previously untreated metastatic PAC.Methods/designAFUGEM is a two-stage, open-label, randomized, multicenter, phase II trial. Patients with PAC who meet the inclusion criteria and provide written informed consent will be randomized in a 1:2 ratio to either nab-paclitaxel (125 mg/m2) plus gemcitabine (1000 mg/m2) given on days 1, 8, and 15 every 28 days or nab-paclitaxel (125 mg/m2) plus sLV5FU2 (leucovorin 400 mg/m2 followed by bolus 400 mg/m2 5-fluorouracil and by 5-fluorouracil 2400 mg/m2 as an 46-h intravenous infusion) given on days 1 and 15 every 28 days. A total of 114 patients will be randomized to one of the treatment arms. The primary endpoint is progression-free survival at 4 months. Secondary outcomes are rate and duration of response, disease control, overall survival, safety, and quality of life. Potential biomarkers of gemcitabine (hENT1, dCK) and 5-fluorouracil (TS) efficacy will be assessed.DiscussionThe AFUGEM trial is designed to provide valuable information regarding efficacy and tolerability of nab-paclitaxel plus gemcitabine and nab-paclitaxel plus sLV5FU2 regimens. Identification of potential predictive biomarkers of gemcitabine and 5-fluorouracil is likely to drive therapeutic decisions in patients with metastatic PAC.Trial registrationAFUGEM is registered at Clinicaltrials.gov: NCT01964534, October 15, 2013.

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Guidelines for time-to-event end-point definitions in trials for pancreatic cancer. Results of the DATECAN initiative (Definition for the Assessment of Time-to-event End-points in CANcer trials)

Cited by 59 publications

References 15 publications

Plasma Circulating Tumor DNA in Pancreatic Cancer Patients Is a Prognostic Marker

Plasma Circulating Tumor DNA in Pancreatic Cancer Patients Is a Prognostic Marker

Metastatic pancreatic cancer: abdominal pain in a 22-year-old woman

A randomized phase II study of weekly nab-paclitaxel plus gemcitabine or simplified LV5FU2 as first-line therapy in patients with metastatic pancreatic cancer: the AFUGEM GERCOR trial

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