This study included all patients treated at the University Hospital of Geneva for a first episode of uncomplicated diverticulitis. Risks of recurrence and treatment failure were evaluated by comparing the results between short-course and long-course intravenous (IV) antibiotic therapy groups.
Methods
The records of all patients hospitalized at our facility from January 2007 to February 2012 for a first episode of uncomplicated diverticulitis (Hinchey Ia), as confirmed by computed tomography, were prospectively collected. We published an auxiliary analysis from this registered study at Clinicaltrials.gov (identifier number: NCT01015378). Two groups of patients were considered: one received a short-course IV antibiotic arm (ceftriaxone and metronidazole) for up to 5 days (followed by 5 days of oral antibiotics); the other received a long-course IV arm between days 5 and 10. The primary outcome was the recurrence-free survival time.
Results
Follow-up was completed for 256 patients-50% men and 50% women, with a median age of 56 years (range, 24-85 years). The average follow-up was 50 months (range, 19-89 months). Of the 256 patients included in the study, 46 patients received a short-course IV antibiotic treatment and 210 received a long-course treatment. The recurrence-free survivals were very similar between the two groups, which was supported by a log rank test (P = 0.772). Four treatment failures, all in the long-course IV antibiotic treatment group, occurred.
Conclusion
Treatment of diverticulitis with a short IV antibiotic treatment is possible and does not modify the recurrence rate in patients with uncomplicated diverticulitis.
Citations
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PURPOSE Although large clinical trials have been performed attempting to find an optimal 5-fluorouracil (5-FU)-based regimen on the basis of activity and toxicity, there have been few data reporting the toxicity. We experienced a less severe toxicity than previous reports, so we undertook an analysis of the toxicity profiles of 5-FU-based chemotherapy on colorectal cancer patients. METHODS Forty-two patients were consecutively enrolled in this study from Sep. 2002 to Sep. 2003. The primary endpoints were the incidences of anorexia, nausea, vomiting, diarrhea, constipation, headache, stomatitis, alopecia, and leukopenia, as recorded with the standard National Cancer Institute- Common Toxicity Criteria (NCI-CTC). The regimen used in this study was intravenous infusion of 5-FU, 500 mg/m2, plus leucovorin (LV), 20 mg, daily for 5 days every 4 weeks for 6 cycles. Information on toxic profiles was obtained by questionnaire and blood test data during each cycle of treatment. RESULTS Of the patients, 73.8% experienced at least one type of toxicity. There were no clinical grade 3/4 toxicities. Toxicites (grade 1/2) were as follows: anorexia (51.2%), nausea (50.4%), constipation (24.6%), headache (11.5%), vomiting (4.0%), diarrhea (2.4%), alopecia (2.0%), stomatitis (0.4%), and leukopenia (4.0%). The most common adverse event was gastrointestinal toxicity (16.6%). There were no deaths attributed to non-hematologic toxicity. There was no dose reduction during any cycle of treatment. In a comparison of the incidence of toxicity by age (<65 and > or =65), gender, and TNM stage, univariate analysis found no statistical differences. CONCLUSIONS Our data would seem to confirm that Korean patients experienced less incidence and severity of toxicity than Western patients. We believe that the accumulated data provide sufficient evidence that colorectal patients in Korea actually experience a less severe toxicity of 5-FU-based chemotherapy when they are treated on this schedule. Considering this study, a race-specific dose determination for a colorectal cancer adjuvant chemotherapeutic setting is warranted.
PURPOSE Preoperative radiation treatment with concomittant intravenous infusion of 5-fluorouracil has been known to be effective in shrinking and downstaging the tumor. Treatment with Doxifluridine (synthetic 5-deoxynucleoside derivative) medication prolongs drug exposure to tumor tissue, so it can be considered synergistic to concurrent radiotherapy.
Intravenous 5-FU and oral Doxifluridine were compared with respect to tumor response, toxicity, and quality of life of patients. METHODS Twenty eight patients with rectal cancer, staged as over T3N1 or T4 by transrectal ultrasonography between July 1997 and December 1998 were included. Intravenous 5-FU (450 mg/m2/day) and leucovorin (20 mg/m2) was given for five consecutive days during first and fifth weeks of irradiation therapy (50.4 Gy) (N=14). Oral Doxifluridine (700 mg/m2/day) and leucovorin (20 mg/m2) was given daily during radiation treatment (N=14). Quality of life was scored according to twenty two activity items (good: >77, fair: >58, poor: <57).
Surgical resection was performed four weeks after completion of concurrent chemoradiation treatment. Tumor response was classified as CR (Complete Response), PR (Partial Response: 50% diminution of tumor volume or downstaging), or NR (No Response). RESULTS Tumor response was CR: 3/14 (21.4%), PR: 7/14 (50%) and NR: 4/14 (28.6%) in IV arm versus CR: 2/14 (14.2%), PR: 6/14 (42.9%) and NR: 6/14 (42.9%) in oral arm (p=0.16, 0.23, 0.24, respectively). Quality of life was poor (36.4% vs 33.3%), fair and good (63.6% vs 66.7%, respectively) between IV arm and oral arm. Systemic recurrence during follow up periods was 1/14 (7.1%) in IV arm and 2/14 (14.3%) in oral arm, respectively (p=0.307). One local recurrence was observed in oral arm. Hematologic toxicity was 3/14 (21.4%) in IV arm versus 4/14 (28.5%) in oral arm, respectively.
Gastrointestinal toxicity was 2/14 (14.3%) versus 5/14 (35.7%) and stomatitis was observed in IV arm (1/14, 7.1%) CONCLUSION: Oral doxifluridine based chemotherapy shows a comparable tumor response and oncologic results, but there was no benefits as far as quality of life and toxicity were concerned.