Anticancer drugs off label used in Tenon hospital were analysed by a panel of 12 experts not working at Tenon hospital. They distinguished 3 groups of off-label prescribing according to scientific ...evidence, labelling anticancer drugs alternative in presence and patient's characteristics: justified off label used (62%), unjustified off label used (26%) and prescriptions for which no consensus had been reached between the experts (12%). Nineteen per cent of unjustified off label used had labelling alternative and 7% did not have anticancer drugs labelling alternative. Questions who experts had to answer to analyse drugs prescribing could be systematically asked when a chemotherapy is prescribed. It could allowed to take into account scientific, economic and ethical requirements. This method proposed by the local drug committee could be used to regulate economic resources and to justify financing of some expensive anticancer drugs.
Cancer and the law Moulin, Anne Sophie; Lotz, Jean-Pierre
Bulletin du cancer
90, Številka:
1
Journal Article
Recenzirano
Health professionals are being impacted by a major reform in 2002. Indeed, after 4 years of dialogues the French parliament has adopted a particularly innovative law of which title "Law in relation ...to patients rights and to the quality of the Health System" leads us to predict the dimension of the disruptions to come affecting the relation between physicians and patients in its legislative way. This law is directly descended from the "Huriet Law"--voted on December the 20th, 1988--outlining the every day process of clinical research. This constitutes a significant challenge to rethink the medical informations we communicate to patients. The low number of oncologists in France is more than ever affected by this law, despite the will of the health professionals. More time spent with patients could only occur should there be increased human resources.
As part of the National Science Foundation funded "Gemini in the Era of MultiMessenger Astronomy" (GEMMA) program, Gemini Observatory is developing GNAO, a widefield adaptive optics (AO) facility for ...Gemini-North on Maunakea, the only 8m-class open-access telescope available to the US astronomers in the northern hemisphere. GNAO will provide the user community with a queue-operated Multi-Conjugate AO (MCAO) system, enabling a wide range of innovative solar system, Galactic, and extragalactic science with a particular focus on synergies with JWST in the area of time-domain astronomy. The GNAO effort builds on institutional investment and experience with the more limited block-scheduled Gemini Multi-Conjugate System (GeMS), commissioned at Gemini South in 2013. The project involves close partnerships with the community through the recently established Gemini AO Working Group and the GNAO Science Team, as well as external instrument teams. The modular design of GNAO will enable a planned upgrade to a Ground Layer AO (GLAO) mode when combined with an Adaptive Secondary Mirror (ASM). By enhancing the natural seeing by an expected factor of two, GLAO will vastly improve Gemini North's observing efficiency for seeing-limited instruments and strengthen its survey capabilities for multi-messenger astronomy.
We describe a phase I-II study of two consecutive 5-day courses of a three-drug regimen of ifosfamide (IFM), carboplatin (CBDCA), and either etoposide (VP-16) (regimen 1) or teniposide (VM-26) ...(regimen 2) in high doses together with autologous bone marrow transplantation (ABMT), for previously treated patients with ovarian carcinoma (OC), germ cell tumors (GCT), gestational trophoblastic disease (GTD), or oat cell carcinoma (OCC). Forty-four patients entered the study. Two patients with OC received regimen 1, and 22 were given regimen 2. Sixteen patients with GCT, two with GTD, and two with OCC were treated with regimen 1. Six patients (13%) died of toxicity. Nephropathy and esophagitis were the dose-limiting toxic effects. The maximum-tolerated doses (MTDs) were 1,500 and 200 mg/m2/d for 5 days for IFM and CBDCA, respectively, in combination with VP-16 250 mg/m2/d for 5 days (regimen 1), and 150, 1,500, and 200 mg/m2/d for 5 days for VM-26, IFM, and CBDCA, respectively (regimen 2). The response rate of patients with OC was 78% (complete response CR, 14%). For patients previously resistant to chemotherapy, the response rate was 70%. There were no long-term disease-free survivors among patients with OC. The response rate of patients with GCT was 60% (CR, 33%). All responders with GCT were resistant to previous chemotherapy. Unmaintained CRs lasted 2, 6, 8+, 27+, and 37+ months. Of the two patients with GTD, one with previous resistance to chemotherapy attained a CR of 18+ months. One patient with OCC attained a CR lasting 6 months. The regimen possesses great antitumor activity. It produced CRs of long duration in a number of patients with GCT and GTD who were previously resistant to chemotherapy.
For patients with Hodgkin's disease (HD) who do not achieve complete response (CR), who experience a relapse within the first year of CR, and for those who have two or more relapses, the outcome is ...poor. Salvage chemotherapy regimens at conventional doses produce a CR rate that ranges from 10% to 50% and a 5-year disease-free survival (DFS) between 10% and 25%. On the other hand, high-dose chemotherapy regimens given in combination with bone marrow transplantation (BMT) produce a CR rate that ranges from 40% to 80% and a 3-year DFS of approximately 40%. We report the 5-year results of a prospective study in patients with refractory HD who were treated with three courses of intensive chemotherapy without BMT.
Thirty-nine adult patients with refractory HD were treated with three courses of intensive chemotherapy. Each cycle of chemotherapy comprised vindesine 1 mg/m2/d in continuous intravenous (IV) infusion from day 1 to day 5; Adriamycin (doxorubicin; Roger Bellon Laboratories, Neuilly, France) 40 mg/m2/d in continuous IV infusion from day 1 to day 3; carmustine 140 mg/m2/d at day 3; etoposide 200 mg/m2/d from day 3 to day 5; and methylprednisolone 120 mg/m2/d from day 1 to day 5. After the third cycle of chemotherapy, irradiation (20 Gy) was performed whenever possible and depended on previous irradiation.
At the end of the treatment, 31 patients (79%) were in CR. Among these patients, 10 relapsed after a median time of 3 months. The overall 5-year survival rate was 46%. The freedom from progression (FFP) and the freedom from treatment failure (FFTF) rates were 48% and 43%, respectively. The main toxicities were hematologic (neutropenia and thrombocytopenia) and digestive. Four patients died due to treatment-related complications (two from septic shocks, one from respiratory insufficiency, and one from posttransfusional AIDS).
The results of this study seem to be comparable to those results obtained with high-dose chemotherapies with autologous BMT.
A practice survey was performed in Tenon hospital on 396 consecutive patients treated for solid tumors during 4 weeks in november 2002. 33% of anticancer drugs were off label used. The wording ...heterogeneity of the different anticancer drugs approved labeling and the lack of anticancer drugs in a number of cancers can explain those results. On one hand, randomised comparative clinical trial, considered as the best level of evidence to obtain a label used, is not always possible in cancerology, especially for rare tumors. One the other hand, pharmaceutical firm are not obliged to asked a label used for an anticancer drugs in spite of high level of evidence. So, label used can not be the own references for anticancer drugs prescribing, therapeutic advanced can be realised and disseminated before their taking into account in the label used.
A patient with long-standing Waldenström's disease and cryoglobulinemia, treated with chlorambucil, developed hepatocellular carcinoma. Although HBs antigen, anti-HBs, and anti-HBc antibodies were ...not detected in his serum by conventional polyclonal radioimmunoassays, immunofluorescence techniques showed HBs antigen to be present in hepatocytes.
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