Gemcitabine as palliative treatment in patients with unresectable pancreatic cancer previously treated with placement of a covered metal stent. A randomized controlled trial.
OBJECTIVE
To evaluate the efficacy of gemcitabine as palliative treatment in patients with advanced pancreatic cancer (PC) previously treated with placement of a covered metal biliary stent, taking into account survival and quality of life (QoL).


METHODS
Forty-nine patients with unresectable PC and obstructive jaundice, previously treated with the placement of a covered metal biliary endoprosthesis, were randomized to receive gemcitabine (group A: 9 males, 7 females) or to be followed without any anticancer intervention (group B: 18 males, 15 females). Gemcitabine was administered weekly as intravenous (i.v.) 30 min infusion of 1000 mg/m2 for 3 consecutive weeks followed by 1-week rest (28-day cycle). QoL was evaluated with the QLQ-C30 questionnaire.


RESULTS
229 gemcitabine doses were administered (median doses per patient 14.3, range 7-22). No statistically significant differences were observed regarding survival (group A: median 21 weeks, range 13-33; group B: median 22 weeks, range 13-29; p=0.809). According to the average QLQ-C30 score, group B patients showed statistically significant higher values (p=0.0001). Leukopenia, neutropenia, thrombocytopenia and anemia were the most common side effects in group A (81.25, 68.75, 62.50 and 31.25%, respectively).


CONCLUSIONS
Gemcitabine didn't show to improve survival and QoL in patients with advanced PC previously treated with a covered metallic biliary endoprosthesis due to obstructive jaundice.
Xinopoulos
D
D
Gastroenterology Unit, Agios Savvas Cancer Hospital, Athens, Greece.
Dimitroulopoulos
D
D
Karanikas
I
I
Fotopoulou
A
A
Oikonomou
N
N
Korkolis
D
D
Kouroumalis
E
E
Antsaklis
G
G
Vassilopoulos
P
P
Paraskevas
E
E
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000601:surgery; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010166:Palliative Care; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000601:surgery; D011446:Prospective Studies; D011788:Quality of Life; D012264:Ribonucleotide Reductases / Q000037:antagonists & inhibitors; D016879:Salvage Therapy; D015607:Stents; D011795:Surveys and Questionnaires; D015996:Survival Rate; D000093542:Gemcitabine
D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D012264:Ribonucleotide Reductases; D000093542:Gemcitabine