Prospective Phase I Study of Capecitabine and Oxaliplatin Concurrent with Radiation Therapy for the Treatment of Locally Advanced Pancreatic Adenocarcinoma, and Retrospective Comparison to Concurrent 5-Fluorouracil/Radiation and Gemcitabine/Radiation.
Summary of "Prospective Phase I Study of Capecitabine and Oxaliplatin Concurrent with Radiation Therapy for the Treatment of Locally Advanced Pancreatic Adenocarcinoma, and Retrospective Comparison to Concurrent 5-Fluorouracil/Radiation and Gemcitabine/Radiation."
PURPOSE:
The aims of this study is to determine the maximum tolerated dose of capecitabine and oxaliplatin (CAPOX) delivered concurrent with radiation therapy (RT) in the treatment of locally advanced pancreatic adenocarcinoma and to retrospectively compare outcomes with this regimen to concurrent 5-fluorouracil or capecitabine with RT (5FU-RT) or concurrent gemcitabine-based chemotherapy with RT (GEM-RT). MATERIALS AND
METHODS:
Twelve patients were enrolled in a phase I study using 50.4 Gy RT concurrent with capecitabine chemotherapy (twice daily, 7 days per week) and oxaliplatin (once weekly during weeks 1, 2, 4, and 5). Capecitabine and oxaliplatin doses were 400 mg/m(2) and 50 mg/m(2), respectively, at dose level 1; 600 mg/m(2) and 50 mg/m(2) at level 2; and 600 mg/m(2) and 60 mg/m(2) at level 3. A standard dose of gemcitabine was recommended following RT or following surgery (if done). The outcomes of patients treated with this regimen were retrospectively compared to 20 patients treated with 5FU-RT and 30 patients treated with GEM-RT.
RESULTS:
Dose level 3 was tolerated with acceptable toxicity. Survival in patients receiving CAPOX-RT did not differ from GEM-RT or 5FU-RT. Response of the primary tumor was observed in 38% of patients treated with CAPOX-RT, 31% of patients treated with 5FU-RT, and 66% of patients treated with GEM-RT (p = 0.03 GEM-RT versus 5FU-RT).
CONCLUSIONS:
CAPOX-RT has acceptable toxicity. A retrospective comparison shows higher response rate with GEM-RT versus 5FU-RT, but this difference did not translate into improvement in overall survival.
Affiliation
Department of Radiation Oncology, University of Arizona, 1501 N Campbell Ave., P.O. Box 245081, Tucson, AZ, 85724-5081, USA, lhazard@email.arizona.edu.
Journal Details
This article was published in the following journal.
Name: Journal of gastrointestinal cancer
ISSN: 1941-6636
Pages:
Links
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/21243531
- DOI: http://dx.doi.org/10.1007/s12029-011-9251-7
Medical and Biotech [MESH] Definitions
Prospective Payment Assessment Commission
The commission charged with evaluating issues and factors which affect the implementation of the PROSPECTIVE PAYMENT SYSTEM.
Interphase
The interval between two successive CELL DIVISIONS during which the CHROMOSOMES are not individually distinguishable. It is composed of the G phases (G1 PHASE; G0 PHASE; G2 PHASE) and S PHASE (when DNA replication occurs).
Prospective Studies
Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group.
Metabolic Detoxication, Phase I
Functionalization of exogenous substances to prepare them for conjugation in PHASE II DETOXIFICATION. Phase I enzymes include CYTOCHROME P450 enzymes and some OXIDOREDUCTASES. Excess induction of phase I over phase II detoxification leads to higher levels of FREE RADICALS that can induce CANCER and other cell damage. Induction or antagonism of phase I detoxication is the basis of a number of DRUG INTERACTIONS.
G2 Phase
The period of the CELL CYCLE following DNA synthesis (S PHASE) and preceding M PHASE (cell division phase). The CHROMOSOMES are tetraploid in this point.
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