Gemcitabine as palliative treatment in patients with unresectable pancreatic cancer previously treated with placement of a covered metal stent. A randomized controlled trial.

Abstract

PURPOSE:

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).

PATIENTS AND 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).

CONCLUSION:

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.

• Authors: D Xinopoulos, D Dimitroulopoulos, I Karanikas, A Fotopoulou, N Oikonomou, D Korkolis, E Kouroumalis, G Antsaklis, P Vassilopoulos, E Paraskevas
• Journal: Journal of B.U.ON. : official journal of the Balkan Union of Oncology (J BUON) 2008 Jul-Sep Vol. 13 Issue 3 Pg. 341-7 ISSN: 1107-0625 [Print] Cyprus
• PMID: 18979547 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Antimetabolites, Antineoplastic
• Deoxycytidine
• Ribonucleotide Reductases
• Gemcitabine

Topics

• Adenocarcinoma (drug therapy, surgery)
• Adult
• Aged
• Antimetabolites, Antineoplastic (therapeutic use)
• Deoxycytidine (analogs & derivatives, therapeutic use)
• Female
• Humans
• Male
• Middle Aged
• Palliative Care
• Pancreatic Neoplasms (drug therapy, surgery)
• Prospective Studies
• Quality of Life
• Ribonucleotide Reductases (antagonists & inhibitors)
• Salvage Therapy
• Stents
• Surveys and Questionnaires
• Survival Rate
• Gemcitabine