A randomised Phase III trial of glufosfamide compared with best supportive care in metastatic pancreatic adenocarcinoma previously treated with gemcitabine.
OBJECTIVE
There are currently no approved therapies for patients with metastatic pancreatic adenocarcinoma previously treated with gemcitabine. This Phase III trial evaluated the efficacy and safety of glufosfamide as compared with best supportive care (BSC) in this patient population.


METHODS
Patients were randomised to glufosfamide plus BSC or to BSC alone with baseline performance status as a stratification factor. The primary end-point was overall survival.


RESULTS
Three hundred and three patients were randomised: 148 to glufosfamide plus BSC and 155 to BSC alone. There was an 18% increase in overall survival for glufosfamide that was not statistically significant: hazard ratio (HR) 0.85 (95% confidence interval (CI) 0.66-1.08, p=0.19). Median survival was 105 (range 5-875) days for glufosfamide and 84 (range 2+ to 761) days for BSC. Grade 3/4 creatinine increase occurred in 6 patients on glufosfamide, including 4 with dosing errors.


CONCLUSIONS
These results suggest low activity of glufosfamide in this very refractory patient population.
Ciuleanu
Tudor E
TE
Ion Chiricuta Cancer Institute, 34-36 Gh. Bilascu St., Cluj-Napoca, Cluj 400015, Romania. tudor@iocn.ro
Pavlovsky
Alexander V
AV
Bodoky
Gyorgy
G
Garin
Avgust M
AM
Langmuir
Virginia K
VK
Kroll
Stewart
S
Tidmarsh
George T
GT
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018906:Antineoplastic Agents, Alkylating / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D005260:Female; D005947:Glucose / Q000031:analogs & derivatives; D006801:Humans; D007069:Ifosfamide / Q000031:analogs & derivatives; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy*; D010752:Phosphoramide Mustards / Q000009:adverse effects / Q000627:therapeutic use*; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
D018906:Antineoplastic Agents, Alkylating; D010752:Phosphoramide Mustards; C092028:beta-D-glucosylisophosphoramide mustard; D003841:Deoxycytidine; D005947:Glucose; D007069:Ifosfamide; D000093542:Gemcitabine