Randomized phase III trial of gemcitabine plus cisplatin compared with gemcitabine alone in advanced pancreatic cancer.

Abstract

PURPOSE:

To compare the effectiveness and tolerability of gemcitabine plus cisplatin with single-agent gemcitabine as first-line chemotherapy for locally advanced or metastatic pancreatic cancer.

PATIENTS AND METHODS:

Patients with advanced adenocarcinoma of the pancreas were randomly assigned to receive either gemcitabine 1,000 mg/m2 and cisplatin 50 mg/m2 given on days 1 and 15 of a 4-week cycle (GemCis arm) or gemcitabine alone at a dose of 1,000 mg/m2 on days 1, 8, and 15 of a 4-week regimen (Gem arm). The primary end point was overall survival; secondary end points were progression-free survival, response rate, safety, and quality of life.

RESULTS:

One hundred ninety-five patients were enrolled and showed baseline characteristics well balanced between treatment arms. Combination treatment in the GemCis arm was associated with a prolonged median progression-free survival (5.3 months v 3.1 months; hazard ratio [HR] = 0.75; P = .053). Also, median overall survival was superior for patients treated in the GemCis arm as compared with the Gem arm (7.5 v 6.0 months), an advantage which did not, however, reach statistical significance (HR = 0.80; P = .15). Tumor response rates were comparable between treatment arms (10.2% v 8.2%). The rate of stable disease was, however, greater in the combination arm (60.2% v 40.2%; P < .001). Grade 3 to 4 hematologic toxicity did not exceed 15% in both treatment arms.

CONCLUSION:

These results support the efficacy and safety of an every-2-weeks treatment with gemcitabine plus cisplatin. Median overall survival and progression-free survival were more favorable in the combination arm as compared with gemcitabine alone, although the difference did not attain statistical significance.

• Authors: Volker Heinemann, Detlef Quietzsch, Frank Gieseler, Michael Gonnermann, Herbert Schönekäs, Andreas Rost, Horst Neuhaus, Caroline Haag, Michael Clemens, Bernard Heinrich, Ursula Vehling-Kaiser, Martin Fuchs, Doris Fleckenstein, Wolfgang Gesierich, Dirk Uthgenannt, Hermann Einsele, Axel Holstege, Axel Hinke, Andreas Schalhorn, Ralf Wilkowski
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 24 Issue 24 Pg. 3946-52 (Aug 20 2006) ISSN: 1527-7755 [Electronic] United States
• PMID: 16921047 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)

Chemical References

• Antimetabolites, Antineoplastic
• Deoxycytidine
• Cisplatin
• Gemcitabine

Topics

• Adult
• Aged
• Aged, 80 and over
• Antimetabolites, Antineoplastic (administration & dosage, adverse effects, therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Cisplatin (administration & dosage)
• Deoxycytidine (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Disease-Free Survival
• Drug Administration Schedule
• Female
• Humans
• Male
• Middle Aged
• Multivariate Analysis
• Pancreatic Neoplasms (drug therapy, pathology)
• Prognosis
• Quality of Life
• Risk Factors
• Survival Analysis
• Treatment Outcome
• Gemcitabine