Journal article
Gemcitabine, oxaliplatin, and capecitabine (GEMOXEL) compared with gemcitabine alone in metastatic pancreatic cancer: a randomized phase II study
Cancer chemotherapy and pharmacology, Vol.75(4), pp.683-690
04/01/2015
DOI: 10.1007/s00280-015-2683-1
PMID: 25618415
Abstract
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.
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.
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.
GEMOXEL regimen seemed to be safe and more efficient than the standard therapy with GEM alone in the treatment of metastatic pancreatic cancer.
Details
- Title: Subtitle
- Gemcitabine, oxaliplatin, and capecitabine (GEMOXEL) compared with gemcitabine alone in metastatic pancreatic cancer: a randomized phase II study
- Creators
- Roberto Petrioli - University of SienaGiandomenico Roviello - University of SienaAnna Ida Fiaschi - University of SienaLetizia Laera - University of SienaDaniele Marrelli - University of SienaFranco Roviello - University of SienaEdoardo Francini - Policlinico Umberto I
- Resource Type
- Journal article
- Publication Details
- Cancer chemotherapy and pharmacology, Vol.75(4), pp.683-690
- DOI
- 10.1007/s00280-015-2683-1
- PMID
- 25618415
- NLM abbreviation
- Cancer Chemother Pharmacol
- ISSN
- 0344-5704
- eISSN
- 1432-0843
- Publisher
- Springer Nature
- Number of pages
- 8
- Language
- English
- Date published
- 04/01/2015
- Academic Unit
- Internal Medicine
- Record Identifier
- 9985221244202771
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