Response to reintroduction of cetuximab in 5 patients with advanced, chemotherapy-resistant, colorectal cancer without progressive disease following first-line therapy with a cetuximab-containing regimen.

OBJECTIVE: We aimed to determine the response to cetuximab in advanced, chemotherapy-resistant, colorectal cancer following successful first-line therapy with the antibody. METHODS: Five patients with metastatic colorectal cancer were treated with a cetuximab-containing regimen after failure of several conventional chemotherapies. RESULTS: These patients had been successfully treated with cetuximab as first-line therapy, and the antibody was then discontinued without disease progression. No severe toxicities were observed upon reexposure to cetuximab. Partial response was noted in 1 patient and tumor stabilization in 2 patients. CONCLUSION: Reintroduction of cetuximab in combination with chemotherapy is safe and efficacious in patients with colorectal cancer whose tumors were not refractory to a prior cetuximab-containing therapy.

Ultrasonographically detected gallbladder polyps: a reason for concern? A seven-year follow-up study.

BACKGROUND: The management of coincidental detected gallbladder polyps (GP) is still nebulous. There are few published data regarding their long-term growth. Objective of the present study was to investigate the prevalence and growth of gallbladder polyps in a survey of unselected subjects from the general population of a complete rural community. METHODS: A total of 2,415 subjects (1,261 women; 1,154 men) underwent ultrasound examination of the gallbladder, in November 1996 as part of a prospective study. Subjects in whom GP were detected at the initial survey underwent follow-up ultrasound examinations after 30 and 84 months. RESULTS: At the initial survey gallbladder polyps were detected in 34 subjects (1.4%; females: 1.1%, range 14 to 74 years; males: 1.7%, range 19 to 63 years). Median diameter was 5 +/- 2.1 mm (range 2 to 10 mm) at the initial survey, 5 mm +/- 2.8 mm (range 2 to 12 mm) at 30 months and 4 +/- 2.3 mm (range 2 to 9 mm) at 84 months. At the time of first follow-up no change in diameter was found in 81.0% (n = 17), reduction in diameter in 4.8% (n = 1) and increase in diameter in 14.3% (n = 3). At the time of second follow-up no increase in polyp diameter was found in 76.9% (n = 10) and reduction in diameter in 7.7% (n = 1). No evidence of malignant disease of the gallbladder was found. CONCLUSION: Over a period of seven years little change was measured in the diameter of gallbladder polyps. There was no evidence of malignant disease of the gallbladder in any subject.

Beneficial Treatment Management with Trifluridine/Tipiracil in a Patient with Metastatic Colorectal Cancer and Pronounced Hematological Event History during Previous Treatments.

Trifluridine/tipiracil (FTD/TPI) significantly improves overall survival in patients with metastatic colorectal cancer (mCRC). The most common treatment-related event (grade ≥3) was hematological toxicity. We here report long-term disease-stabilizing FTD/TPI treatment of an mCRC patient (KRAS wild-type, ECOG performance status 1 at baseline and at the end of FTD/TPI therapy) with multifocal synchronous metastases and a longstanding history of extensive hematological events during previous treatments. Finally, this 62-year-old male patient was treated for 10 months with FTD/TPI by consecutive alteration of treatment parameters: (i) initial daily dose reduction to 80 mg (72% of the recommended dose), (ii) 20 days dose delay, (iii) a second and later third dose reduction to 70 mg and 60 mg (about 64% and 55%, respectively, of the recommended dose), and (iv) 30 µg per day of granulocyte colony-stimulating factor administration first for 3 days, and later for 5 days, for each treatment cycle.

Prevalence of cholelithiasis in patients with chronic inflammatory bowel disease.

AIM: To investigate the effect of chronic inflammatory bowel disease (CIBD) specific risk factors for cholecystolithiasis, as duration and involvement pattern of the disease and prior surgery in patients with Crohn's disease (CD) and ulcerative colitis (UC). METHODS: A total of 222 patients with CD (135 females, 87 males; average age, 35.8+/-11.8 years; range 17-81 years) and 88 patients with UC (39 females, 49 males; average age, 37.2+/-13.6 years; range 16-81 years) underwent clinical and ultrasound examinations. Besides age, sex and degree of obesity, patients' CIBD specific parameters, including duration and extent of disease and prior operations were documented and evaluated statistically using logistic regression. RESULTS: The overall prevalence of gallbladder stone disease in patients with CD was 13% (n = 30). Only age could be shown to be an independent risk factor (P = 0.014). Compared to a collective representative for the general population in the same geographic region, the prevalence of cholecystolithiasis was higher in all corresponding age groups. Patients with UC showed an overall prevalence of gallbladder stone disease of only 4.6%. CONCLUSION: Disease-specific factors such as duration and extent of disease, and prior surgery are independent risk factors for the development of cholecystolithiasis in patients with CIBD.

HLA polymorphisms influence the development of skin rash arising from treatment with EGF receptor inhibitors.

AIM: Development of a skin rash under treatment with EGF receptor (EGFR) inhibitors (EGFRIs) has been linked to a favorable prognosis in some studies, suggesting a possible immunological role for EGFRIs in addition to direct antagonistic downstream effects. The present study aimed to investigate whether particular HLA polymorphisms found in cancer patients treated with EGFRIs are associated with the development of skin rash and overall survival rates. PATIENTS & METHODS: HLA typing was performed on 105 cancer patients and the development of skin rash was rated during the first 4 weeks of therapy with EGFRIs. RESULTS: A significantly lower incidence of skin rash was found in patients carrying the HLA-A*02:01 or HLA-A*03:01 alleles (hazard ratio: 0.277; 95% CI: 0.121-0.634; p = 0.002 and hazard ratio: 0.292; 95% CI: 0.113-0.752; p = 0.011, respectively); however, no association with worse survival was seen. CONCLUSION: The chances of developing a skin rash in patients treated with EGFRIs may be lower in patients that carry the HLA-A*02:01 or HLA-A*03:01 alleles, while the antitumor efficacy of EGFRIs does not seem to be significantly impaired in these patients.

A phase I/II study of oxaliplatin and paclitaxel in patients with non-resectable cancer of the oesophagus and adenocarcinoma of the gastro-oesophageal junction: a study of the Arbeitsgemeinschaft Internistische Onkologie.

PURPOSE: To assess the efficacy and toxicity of paclitaxel and oxaliplatin in patients with non-resectable cancer of the oesophagus and adenocarcinoma of the gastro-oesophageal junction. METHODS: Treatment consisted of oxaliplatin 85 mg/m(2) and paclitaxel 90 mg/m(2) on days 1, 15 and 29 every 6 weeks. Patients with a non-resectable cancer of the oesophagus and/or adenocarcinoma of the gastro-oesophageal junction were eligible. RESULTS: Twenty-six chemotherapy-naive patients were enrolled who had the following characteristics: median age 59.5 years (range 46-81); ECOG scores of 0/1/2 for 7/16/3 patients, respectively, and 23 (88%) patients had metastatic disease. There were 5 patients (19%) with adenocarcinoma of the gastro-oesophageal junction and 21 patients (81%) with oesophageal cancer; 19 (73%) had a squamous cell cancer and 7 (27%) had an adenocarcinoma. NCI grade 4 toxicity (neutropenia) was observed in one patient. Non-haematological toxicity consisted mainly of grade 1/2 neurosensory toxicity. The overall response rate by the intention-to-treat analysis was 15% with 4 patients having confirmed partial response. Overall tumour control rate was 73%. Median overall survival was 12.3 months (range 1.5-66) and median time to progression was 4.5 months (range 0.8-19.3). CONCLUSION: This regimen is well tolerated and demonstrates a modest response rate with a favourable disease control rate.

Prevalence of gallbladder stone disease in obese children and adolescents: influence of the degree of obesity, sex, and pubertal development.

OBJECTIVES: The objective of the present study was to investigate the prevalence of gallbladder stone disease (GD) in a collective of obese children and adolescents and to assess the role of potential influencing factors such as the degree of obesity, sex, age, and pubertal development. METHODS: Four hundred ninety-three obese children and adolescents (body mass index standard deviation score [BMI-SDS] > 2.0p) aged 8 to 19 years (218 males, 275 females) were included in the study and underwent ultrasound for detection of GD. RESULTS: Gallbladder stones were detected in 10 of 493 (2.0%; 8 girls, 2 boys) subjects studied. None of the 95 prepubertal children examined were found to suffer from GD. Patients with GD were more severely obese (BMI-SDS 3.4 +/- 0.5 vs. 2.7 +/- 0.4; P < 0.001) and older (16.1 +/- 1.5 vs.13.9 +/- 2.0 years; P < 0.008) than children and adolescents without GD. CONCLUSIONS: Compared with published data for unselected children an adolescents, the prevalence of GD (2.0%) in obese children and adolescents, previously treated with diet for obesity, is high. Obesity and female sex appear even in children and adolescents to be risk factors for the development of GD. The occurrence of prepubertal GD is rare.

Factors affecting liver size: a sonographic survey of 2080 subjects.

OBJECTIVE: We sought to determine the size of the liver in a nonselected population sample to establish normal and reference values and to study potential factors influencing liver size. METHODS: A total of 2080 subjects (983 male and 1097 female; age range, 18-88 years) underwent prospective ultrasound examination to determine the size of the liver. Subjects also underwent physical examination and completed a short standardized interview questionnaire covering potential factors influencing liver size. Data were evaluated descriptively. The influence of multiple variables on liver size was studied by means of a covariance analysis. RESULTS: The average measured liver diameter (midclavicular line) +/- SD was 14.0 +/- 1.7 cm (median, 13.9 cm; range, 9.4-21.3 cm; average in male subjects, 14.5 +/- 1.6 cm; and average in female subjects, 13.5 +/- 1.7 cm). Results of the multivariate analysis showed that the factors body mass index, body height, sex, age, and (in male subjects) frequent alcohol consumption exert an influence over liver size measured at the midclavicular line. CONCLUSIONS: The sonographic measurement of liver size at the midclavicular line was shown to be an easy and practical method for routine use. Only in 239 (11.5%) of 2080 subjects did the size of the liver measured at the midclavicular line exceed 16 cm. Body mass index and body height are the most important factors associated with the diameter of the liver measured at the midclavicular line.