Combination of gemcitabine and cetuximab in patients with advanced cholangiocarcinoma: a phase II study of the Belgian Group of Digestive Oncology.

BACKGROUND: Cholangiocarcinomas are uncommon tumours with a poor prognosis, that frequently present epidermal growth factor receptor overexpression. METHODS: In a multi-centre phase II trial, patients with unresectable cholangiocarcinoma, naïve to chemotherapy, received Cetuximab (400 mg/m(2) at week 1, then 250 mg/m(2)/week) and Gemcitabine (1 g/m(2) on day 1, 8 and 15 every 4 weeks). Primary end point was progression-free survival (PFS) rate at 6 months, using a Simon 2-stage design. Moreover, we assessed the impact of KRAS status and skin toxic effect on efficacy. RESULTS: Forty-four patients (41% locally advanced/59% metastatic) were enrolled. Median age was 61.5 years; ECOG PS was 0 (68%) or 1. Six months PFS reached 47%. Median OS was 13.5 months [95% confidence interval (CI) 9.8-31.8 months]. Nine patients (20.4%) had PR and disease-control rate was 79.5%. Grade 3/4-related toxic effects were haematological (52.2%), skin rash (13.6%) and fatigue (11.4%). KRAS mutations were found in 7 of 27 patients and had no influence on PFS. Skin toxic effect ≥grade 2 was associated with increased PFS (P = 0.05). CONCLUSION(S): Our study met its primary end point, suggesting that Gemcitabine-Cetuximab has activity in cholangiocarcinoma. KRAS status was not associated with PFS, unlike skin toxic effect, which could be used as a surrogate marker for efficacy. ClinicalTrials.gov Identifier: NCT00747097.

Health data quality improvement by comparing administrative medical data and billing data.

OBJECTIVE: The increasing use of medical administrative databases in hospital financing means more attention is being paid to their quality. The object of this study is to compare diagnoses found in the medical database to treatments mentioned in the billing database and to identify hospital stays with discrepancies. METHOD: The analysis is performed for the diagnoses of heart failure, hypertension, and pneumonia. Data were extracted from the 2000 National Medical Minimum Basic Data Set (MBDS) database and from the 2000 National bill summary database. The in-hospital stays were split into four analysis groups: patients with the selected disease and a corresponding treatment, patients with the selected disease but without a corresponding treatment, patients with a treatment, without the selected disease, but with another pathology requiring the same treatment, and patients with a treatment, without the selected disease and without any other pathology requiring the same treatment. RESULTS: The proportion of in-hospital stays with the disease in the medical database but without a corresponding treatment mentioned in the billing database was 1.1% for heart failure, 12.0% for hypertension, and 5.1% for pneumonia. Under-reporting (patient with a treatment but without any corresponding disease) concerned a high proportion of stays for heart failure and for hypertension (29.6% and 26.8%, respectively). CONCLUSIONS: This database comparison identified hospital stays with discrepancies between the medical database and the billing database. This method allows a better focus on the medical MBDS to be reviewed but must be completed by a thorough analysis of the medical chart. An extension of this methodology to other pathology would be useful to assess the quality of administrative data.

Weekly vinorelbine and docetaxel as second-line chemotherapy for pretreated non-small cell lung cancer patients: a phase I-II trial.

Docetaxel was proven to be effective as second-line therapy for patients with advanced NSCLC after failure of platinum-based front-line chemotherapy. We designed this phase I/II study to define the Maximum Tolerated Dose of weekly docetaxel combined with weekly vinorelbine, and subsequently evaluate tolerability and activity of this schedule in NSCLC patients who were progressive after treatment with either cisplatin and gemcitabine or carboplatin and paclitaxel regimens. To be eligible for the study, patients were required to have a WHO performance status < or =2, failure after at least two cycles of first platinum-based chemotherapy, and no prior treatment with docetaxel and vinorelbine. A total of 27 patients were enrolled in this phase I/II study. A weekly docetaxel dose of 25 mg/m2 was recommended in combination with fixed vinorelbine dose of 20 mg/m2, and 24 patients were treated at this dose level. Severe neutropenia (62%) and febrile neutropenia (29%) were the most frequent toxicities, with 83% of patients requiring dose modification or delay. In the phase II study, 5 (21%) patients obtained a partial response, 8 (33%) patients had stable disease, whereas 10 (42%) patients progressed. After a median follow-up of 18.7 months, median survival was 8 months, with 30% surviving at 1 year. Regardless of the use of weekly docetaxel schedule, this regimen was highly myelosuppressive, and did not seem to improve response rate and survival compared to single-agent docetaxel. No further developments of this schedule are warranted.