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Radiochemotherapy with short daily infusion of low-dose oxaliplatin, leucovorin, and 5-FU in T3-T4 unresectable rectal cancer: a phase II IATTGI study.
- Source :
-
International journal of radiation oncology, biology, physics [Int J Radiat Oncol Biol Phys] 2002 Oct 01; Vol. 54 (2), pp. 397-402. - Publication Year :
- 2002
-
Abstract
- Purpose: Oxaliplatin (OXA)/5-fluorouracil (5-FU) have confirmed their preclinical synergy in advanced colorectal cancer patients. Chemoradiotherapy with 5-FU + leucovorin (LV) is considered the standard treatment in unresectable rectal cancer patients. The objective was to evaluate OXA with 5-FU + LV and concurrent radiotherapy in unresectable rectal cancer patients.<br />Treatment: OXA 25 mg/m(2)/day in 30-min infusions, followed by bolus LV 20 mg/m(2)/day and bolus 5-FU 375 mg/m(2)/day. All drugs were given on 4 days during Weeks 1 and 5 of a standard radiotherapy cycle (50.4 Gy). A single OXA dose (50 mg/m(2)) was also given on the third week of radiotherapy. A cycle of OXA with 5-FU + LV was administered 4 weeks after chemoradiotherapy, with surgery planned 4 weeks later.<br />Results: Between March 1998 and April 2000, 22 patients with T3-T4 unresectable rectal cancer were accrued. Patient characteristics included the following: 11 females, 11 males, median age 58 (range: 18-76). Performance status ECOG (PS) 0: 2 patients, PS 1: 7 patients, and PS 2: 13 patients. The following RTOG Grade 3-4 toxicities were reported: diarrhea, 6 patients; cutaneous, 3 patients; neutropenia-leukopenia, 2 patients; and thrombocytopenia, 1 patient; 1 treatment-related death resulted (febrile neutropenia-sepsis after chemoradiotherapy). Only 1 patient had neurosensory Grade 2 (OXA-specific Levi's scale) toxicity. Nine patients had PS worsening during treatment. Five patients had chemoradiotherapy delay (median: 6 days). Of 22 patients, 16 underwent surgery (without serious surgical complications); 12/16 had a complete resection (5/12 had sphincter preservation). Pathologic examination revealed 3/12 complete remissions, 2/12 minimal microscopic residual disease, 2/12 T2N0, 1/12 T3N0, and 4/12 positive nodes; 4/16 had unresectable disease. Median follow-up was 15 months (range: 3.0-43.4 months), median time to progression was 15.7 months (CI 95%, 0, 31.7), and median overall survival was 19.5 months (CI 95%, 18.0, 21).<br />Conclusions: Outpatient treatment with low-dose, 30-min daily OXA infusion was feasible and very active, with acceptable toxicity.
- Subjects :
- Adenocarcinoma pathology
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols adverse effects
Combined Modality Therapy
Drug Administration Schedule
Female
Fluorouracil administration & dosage
Fluorouracil adverse effects
Follow-Up Studies
Humans
Leucovorin administration & dosage
Leucovorin adverse effects
Male
Middle Aged
Neoplasm Staging
Organoplatinum Compounds administration & dosage
Organoplatinum Compounds adverse effects
Oxaliplatin
Prognosis
Rectal Neoplasms pathology
Adenocarcinoma drug therapy
Adenocarcinoma radiotherapy
Antineoplastic Combined Chemotherapy Protocols administration & dosage
Rectal Neoplasms drug therapy
Rectal Neoplasms radiotherapy
Subjects
Details
- Language :
- English
- ISSN :
- 0360-3016
- Volume :
- 54
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- International journal of radiation oncology, biology, physics
- Publication Type :
- Academic Journal
- Accession number :
- 12243813
- Full Text :
- https://doi.org/10.1016/s0360-3016(02)02933-4