ABSTRACT
BACKGROUND: Metastatic colorectal cancer (mCRC) frequently occurs in elderly patients. However, data from a geriatric tailored randomized trial about tolerance to and the efficacy of doublet chemotherapy (CT) with irinotecan in the elderly are lacking. The benefit of first-line CT intensification remains an issue in elderly patients. PATIENTS AND METHODS: Elderly patients (75+) with previously untreated mCRC were randomly assigned in a 2 × 2 factorial design (four arms) to receive 5-FU (5-fluorouracil)-based CT, either alone (FU: LV5FU2 or simplified LV5FU2) or in combination with irinotecan [IRI: LV5FU2-irinotecan or simplified LV5FU2-irinotecan (FOLFIRI)]. The CLASSIC arm was defined as LV5FU2 or LV5FU2-irinotecan and the SIMPLIFIED arm as simplified LV5FU2 or FOLFIRI. The primary end point was progression-free survival (PFS). Secondary end points were overall survival (OS), safety and objective response rate (ORR). RESULTS: From June 2003 to May 2010, 71 patients were randomly assigned to LV5FU2, 71 to simplified LV5FU2, 70 to LV5FU2-irinotecan and 70 to FOLFIRI. The median age was 80 years (range 75-92 years). No significant difference was observed for the median PFS: FU 5.2 months versus IRI 7.3 months, hazard ratio (HR) = 0.84 (0.66-1.07), P = 0.15 and CLASSIC 6.5 months versus SIMPLIFIED 6.0 months, HR = 0.85 (0.67-1.09), P = 0.19. The ORR was superior in IRI (P = 0.0003): FU 21.1% versus IRI 41.7% and in CLASSIC (P = 0.04): CLASSIC 37.1% versus SIMPLIFIED 25.6%. Median OS was 14.2 months in FU versus 13.3 months in IRI, HR = 0.96 (0.75-1.24) and 15.2 months in CLASSIC versus 11.4 months in SIMPLIFIED, HR = 0.71 (0.55-0.92). More patients presented grade 3-4 toxicities in IRI (52.2% versus 76.3%). CONCLUSION: In this elderly population, adding irinotecan to an infusional 5-FU-based CT did not significantly increase either PFS or OS. Classic LV5FU2 was associated with an improved OS compared with simplified LV5FU2. CLINICALTRIALSGOV: NCT00303771.
Subject(s)
Adenocarcinoma/drug therapy , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Colorectal Neoplasms/drug therapy , Adenocarcinoma/mortality , Adenocarcinoma/secondary , Aged , Aged, 80 and over , Camptothecin/administration & dosage , Camptothecin/analogs & derivatives , Colorectal Neoplasms/mortality , Colorectal Neoplasms/pathology , Female , Fluorouracil/administration & dosage , Humans , Irinotecan , Leucovorin/administration & dosage , Male , Multivariate Analysis , Proportional Hazards Models , Treatment OutcomeSubject(s)
Alendronate/adverse effects , Esophagitis/chemically induced , Aged , Aged, 80 and over , Esophagitis/diagnosis , Esophagoscopy , Female , HumansSubject(s)
Anaphylaxis/chemically induced , Antineoplastic Agents/adverse effects , Organoplatinum Compounds/adverse effects , Adenocarcinoma/drug therapy , Adenocarcinoma/secondary , Antimetabolites, Antineoplastic/administration & dosage , Antineoplastic Agents/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Fluorouracil/administration & dosage , Humans , Leucovorin/administration & dosage , Liver Neoplasms/drug therapy , Liver Neoplasms/secondary , Male , Middle Aged , Organoplatinum Compounds/administration & dosage , Oxaliplatin , Sigmoid Neoplasms/drug therapyABSTRACT
We report two patients with large bowel submucosal diaphragm disease associated with nonsteroidal anti-inflammatory drugs (slow release form of diclofenac and phenylbutazone) who were admitted in 1990 and 1991 because of iron deficiency. At colonoscopy, the lumen of the ascending colon was divided into compartments by multiple thin circumferential mucosal membranes. Barium enema showed two short strictures in one patient. Right hemicolectomy was carried out on one patient. The other patient was simply advised to discontinue taking diclofenac and remains well. Such lesions are rare (10 cases have been reported) and resemble those previously described in the small bowel.
Subject(s)
Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Colonic Diseases/chemically induced , Diclofenac/adverse effects , Phenylbutazone/adverse effects , Aged , Aged, 80 and over , Anti-Inflammatory Agents, Non-Steroidal/administration & dosage , Colonic Diseases/epidemiology , Colonic Diseases/pathology , Colonoscopy , Constriction, Pathologic/chemically induced , Constriction, Pathologic/epidemiology , Constriction, Pathologic/pathology , Delayed-Action Preparations , Diclofenac/administration & dosage , Drug Administration Schedule , Female , Humans , Male , Osteoarthritis/drug therapy , Phenylbutazone/administration & dosage , Spondylitis, Ankylosing/drug therapySubject(s)
Fatty Liver/physiopathology , Adolescent , Adult , Chemical and Drug Induced Liver Injury/etiology , Child , Fatty Liver/chemically induced , Fatty Liver/etiology , Fatty Liver/pathology , Fatty Liver, Alcoholic/etiology , Female , Hepatitis C/complications , Hepatitis D/complications , Humans , Male , Pregnancy , Pregnancy Complications , Reye Syndrome/complicationsABSTRACT
BACKGROUND: A correlation between acute intermittent porphyria or porphyria cutanea tarda and hepatocellular carcinoma (HCC) has been noted in several studies, but only one case of association between HCC and porphyria variegata has been reported. We therefore report another case of association between HCC and porphyria variegata. METHODS: A 54-year-old nurse with familial porphyria variegata who developed an HCC was studied. The diagnosis of porphyria variegata was made in the course of a familial survey by means of measuring lymphocyte protoporphyrinogen oxidase activity, at a time when the patient had no symptoms. Eighteen years later the patient presented with a firm enlargement of the liver. RESULTS: Histologic examination showed a well-differentiated HCC. The diagnosis was confirmed by positive immunostaining for alpha-foetoprotein antibodies. DISCUSSION: Sixteen months after surgical resection of the HCC the patient was still alive.
Subject(s)
Carcinoma, Hepatocellular/complications , Liver Neoplasms/complications , Porphyrias, Hepatic/complications , Female , Humans , Middle AgedABSTRACT
This study describes three adults with coeliac disease and hepatic vein obstruction, an association which has not been reported so far. Similarities were found with the cases of five children with Budd-Chiari syndrome and intestinal villous atrophy recently reported in the literature. All subjects had North African origin. Coeliac disease and Budd-Chiari syndrome are uncommon conditions, and it is postulated that this is probably not a chance association, although no link between these diseases and the ethnic origin of the subjects could be elucidated.
Subject(s)
Budd-Chiari Syndrome/complications , Celiac Disease/complications , Adolescent , Adult , Africa, Northern , Celiac Disease/diet therapy , Diet , Female , Glutens/administration & dosage , Humans , MaleABSTRACT
In this paper, three cases of grand mal seizures are reported as a complication of pefloxacin at usual doses (400 mg twice a day) in patients with cirrhosis. Grand mal seizures occurred from 12 h to 8 days after the onset of pefloxacin treatment. In 1 case, seizures recurred after inadvertent rechallenge with the drug. Elevated pefloxacin serum levels were demonstrated in 2 cases. Brain computed tomography in all 3 cases and cerebrospinal fluid examination showed normal results. No etiology other than pefloxacin overdose was found. After pefloxacin withdrawal, no recurrence of seizures were observed. Therefore, when pefloxacin treatment is indicated for cirrhotic patients, a reduced dosage and/or careful monitoring of pefloxacin serum levels should be recommended.
Subject(s)
Epilepsy, Tonic-Clonic/chemically induced , Liver Cirrhosis/drug therapy , Pefloxacin/adverse effects , Child , Female , Humans , Liver Cirrhosis/complications , Middle Aged , Pefloxacin/administration & dosageSubject(s)
Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Colonic Diseases/chemically induced , Ileal Diseases/chemically induced , Intestinal Perforation/chemically induced , Jejunal Diseases/chemically induced , Colitis/chemically induced , Collagen Diseases/chemically induced , Humans , Rectal Diseases/chemically induced , Ulcer/chemically inducedSubject(s)
Colitis/complications , Collagen Diseases/complications , Lymphocytes , Lymphoma, T-Cell/etiology , Mycosis Fungoides/complications , Skin Neoplasms/complications , Aged , Aged, 80 and over , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Colitis/pathology , Collagen Diseases/pathology , Colonoscopy , Combined Modality Therapy , Diarrhea/etiology , Fatal Outcome , Humans , Lymphoma, T-Cell/pathology , Male , Mycosis Fungoides/therapy , Skin Neoplasms/therapySubject(s)
Anti-Inflammatory Agents, Non-Steroidal/pharmacology , Gastrointestinal Motility/drug effects , Intestinal Absorption/drug effects , Intestinal Diseases/chemically induced , Ulcer/chemically induced , Animals , Anti-Inflammatory Agents, Non-Steroidal/administration & dosage , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Cell Membrane Permeability/drug effects , Dogs , Humans , Inflammation/chemically induced , Intestines/drug effects , RatsABSTRACT
Dialytic ultrafiltration of ascites through a hemofilter associated with peritoneal reinfusion (DUF) of the concentrate has been proposed for the treatment of refractory ascites. In five cirrhotic patients, 18 ascites evacuation procedures were randomized either to DUF (n = 8) or to large paracenteses (LP) (n = 10). The effects of these two methods on hemodynamic and renal function were assessed. After DUF, the protein concentration in ascites increased transiently from 28 +/- 7 g/l to 64.8 +/- 8 g/l (p less than 0.04); urinary output increased from day 1 to day 4 (1000 +/- 100) VS 1430 +/- 140 ml/24h; p less than 0.02). After LP, ascitic protein concentration and urinary output were unchanged. No side effects were observed with the two methods. The mean amount of albumin infused was 20 +/- 15 g after DUF and 15 +/- 5 after LP (ns).
Subject(s)
Ascites/therapy , Drainage , Liver Cirrhosis/therapy , Ultrafiltration , Ascites/complications , Ascitic Fluid , Dialysis , Humans , Liver Cirrhosis/complications , PuncturesABSTRACT
The clinical efficacy and tolerance of dialytic ultrafiltration of ascites through a hemofilter (DUF) with peritoneal reinfusion of the concentrate was evaluated in 15 cirrhotic patients with intractable ascites. All together, 51 DUF procedures were carried out. An average of 8.6 was ultrafiltered during 12 h with no significant change in blood pressure, hemoglobin, coagulation parameters or plasma creatinine. A significant increase in ascitic protein concentration was observed immediately after the procedure and a slight but significant increase in 24 h urinary output. A controlled evaluation of DUF compared to large paracenteses seems to be justified by these preliminary results.
