Hypoxic pelvic perfusion with mitomycin C using a simplified balloon-occlusion technique in the treatment of patients with unresectable locally recurrent rectal cancer.
Arch Surg
; 136(1): 105-12, 2001 Jan.
Article
en En
| MEDLINE
| ID: mdl-11146790
ABSTRACT
HYPOTHESIS:
To evaluate the role of hypoxic pelvic perfusion in providing therapeutic options for palliation without relevant complications in a homogeneous group of patients with unresectable locally recurrent rectal cancer who are nonresponders or have disease progression after the standard treatments.DESIGN:
Nonrandomized and noncontrolled phase II experimental study.SETTING:
University hospital, L'Aquila, and the National Cancer Institute, Naples and Milan, Italy. PATIENTS Eleven patients had symptomatic unresectable pelvic recurrent rectal cancer. The mean +/- SD product of the 2 maximum perpendicular diameters of the recurrent cancer was 24.2 +/- 11.0 cm(2) (range, 10-48 cm(2)). Tumor fixation to the pelvic side walls or proximal sacrum were the main criteria for unresectability. All patients were free from extrapelvic disease and had a life expectancy longer than 3 months. INTERVENTION Patients were submitted to one course of pelvic perfusion with mitomycin C (MMC) (25 mg/m(2)) by means of a simplified balloon occlusion technique. A pharmacokinetic evaluation of the procedure was also performed. MAIN OUTCOMEMEASURES:
Response rate and time to disease progression were the primary endpoints; overall survival was the secondary endpoint.RESULTS:
Mean +/- SD value of the ratios of pelvic MMC area under the plasma concentration curve (0 to 20 minutes) (AUC(0-20)) to systemic MMC AUC(0-20) was 13.30 +/- 6.52. During the procedures there were no technical, hemodynamic, or vascular complications, and no deaths occurred during surgery or in the postoperative period. The response rate was 36.3% (95% confidence interval [CI], 6.5%-66.1%). Pain response rate was 45.4% (95% CI, 16.6%-76.2%). Median survival was 12.2 months (range, 5.7-19.5 months). Median time to disease progression was 6 months (range, 3-8 months). Two-year overall survival was 9.1%.CONCLUSIONS:
Hypoxic pelvic perfusion with MMC is a safe and good palliative treatment for patients with unresectable locally recurrent rectal cancer. Further studies are necessary to establish if a different sequence in the multimodular treatment of these patients could be more useful.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Cuidados Paliativos
/
Neoplasias del Recto
/
Mitomicina
/
Antibióticos Antineoplásicos
/
Recurrencia Local de Neoplasia
Límite:
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
Arch Surg
Año:
2001
Tipo del documento:
Article
País de afiliación:
Italia