Gemcitabine, oxaliplatin, and capecitabine (GEMOXEL) compared with gemcitabine alone in metastatic pancreatic cancer: a randomized phase II study.

Abstract

BACKGROUND:

Single-agent gemcitabine (GEM) has been considered for many years as the standard first-line treatment for advanced pancreatic cancer. However, recently, several studies reported encouraging activity and good tolerability for some combination regimens. Considering the apparently non-overlapping toxicity and the proved individual efficacy of GEM, oxaliplatin (L-OHP), and capecitabine (CAP), this randomized phase II study compared the activity and safety of the combination GEM, L-OHP, and CAP (GEMOXEL) versus GEM alone, in patients with metastatic pancreatic cancer.

MATERIALS AND METHODS:

The treatment in GEMOXEL arm consisted of GEM 1,000 mg/m(2) as a 30-min intravenous infusion on days 1, 8, 15, 22, L-OHP 100 mg/m(2) i.v. on day 2, and CAP 1,500 mg/m(2)/day in two divided doses on days 1-14, every 21 days (one cycle). In both treatment groups, GEM was administered weekly for seven consecutive weeks followed by 1-week rest for the first 8 weeks, and thereafter, GEM was continued on days 1, 8, 15, every 28 days. Chemotherapy was administered until disease progression or unacceptable toxicity.

RESULTS:

Sixty-seven patients were enrolled in the study. Thirty-four were randomly assigned to GEMOXEL and 33 to GEM. At 4 months, disease control rate was 79.4% with GEMOXEL versus 45.4 % with GEM (p = 0.004). The median progression-free survival was 6.8 months (95% CI 5.3-7.3 months) in GEMOXEL arm and 3.7 months (95% CI 2.9-4.7 months) in GEM arm (p < 0.001). The median OS was 11.9 months (95% CI 10.6-12.9 months) in GEMOXEL arm and 7.1 months (95% CI 5.5-9.1 months) in GEM arm (p < 0.001). Hematologic and non-hematologic toxicity was more severe with combination chemotherapy, yet still tolerable. No grade 4 adverse events were observed with either regimen.

CONCLUSION:

GEMOXEL regimen seemed to be safe and more efficient than the standard therapy with GEM alone in the treatment of metastatic pancreatic cancer.

• Authors: Roberto Petrioli, Giandomenico Roviello, Anna Ida Fiaschi, Letizia Laera, Daniele Marrelli, Franco Roviello, Edoardo Francini
• Journal: Cancer chemotherapy and pharmacology (Cancer Chemother Pharmacol) Vol. 75 Issue 4 Pg. 683-90 (Apr 2015) ISSN: 1432-0843 [Electronic] Germany
• PMID: 25618415 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial)

Chemical References

• Organoplatinum Compounds
• Oxaliplatin
• Deoxycytidine
• Capecitabine
• Fluorouracil
• Gemcitabine

Topics

• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects, therapeutic use)
• Capecitabine
• Deoxycytidine (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Disease-Free Survival
• Drug Administration Schedule
• Female
• Fluorouracil (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Humans
• Infusions, Intravenous
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Neoplasm Metastasis
• Organoplatinum Compounds (administration & dosage, adverse effects, therapeutic use)
• Oxaliplatin
• Pancreatic Neoplasms (drug therapy, pathology)
• Gemcitabine