Many somatic genetic abnormalities have been identified in T-cell acute lymphoblastic leukemia (T-ALL) but each individual
PurposeData concerning the prevalence of and outcomes related to thromboembolic events (TEs) in patients with advanced gastroesophageal cancer who are undergoing chemotherapy are limited.Patients and MethodsThis was a prospective, exploratory analysis of TEs in a randomized, controlled trial of 964 patients recruited between 2000 and 2005 and treated with epirubicin/platinum/fluoropyrimidine combination chemotherapy for advanced/locally advanced gastroesophageal cancer. Regimens were epirubicin (E), cisplatin (C), fluorouracil (F; ECF); E, C, capecitabine (X; ECX); E, F, oxaliplatin (O; EOF); and EOX. Continuously infused F was administered via a central venous access device (CVAD) with 1 mg of warfarin for thromboprophylaxis. The principal outcome was the incidence of TEs (venous and arterial) in the whole treated patient cohort, according to chemotherapy, associated with CVADs and TE-related prognoses.ResultsThe incidences of any, of venous, and of arterial TEs among 964 treated patients were 12.1% (95% CI, 10.7 to 14.3), 10.1% (95% CI, 8.3 to 12.3), and 2.2% (95% CI, 1.4 to 3.4) respectively. There were fewer TEs in the O compared with the cisplatin groups (EOF/EOX v ECF/ECX: 7.6% v 15.1%; P = .0003). C was identified as a risk factor for TE in multivariate analysis (hazard ratio [HR], 0.51; 95% CI, 0.34 to 0.76; P = .001). There was no difference in the incidence of TEs for the F group compared with the capecitabine groups. The incidence of CVAD-related thrombosis was 7.0% (ECF/EOF arms). Overall survival was worse for patients who experienced TEs versus no TEs (median survival, 7.4 v 10.5 months; HR, 0.8; 95% CI, 0.64 to 0.99; P = .043).ConclusionThis analysis has prospectively quantified the incidence/pattern of TEs among patients with advanced gastroesophageal cancer who were treated with four triplet regimens, has demonstrated a differential thrombogenic effect according to platinum use, and has noted a poorer outcome associated with TE during treatment. Chemotherapy-related TE should contribute to the risk/benefit assessment of treatment.
The purpose of this study was to determine whether epirubicin, cisplatin and infused 5FU (ECF) improves overall survival (OS) compared to 5FU, etoposide and leucovorin (FELV) in patients with previously untreated advanced biliary cancer in a prospective randomised study. Patients were randomly assigned to receive epirubicin, cisplatin and infused 5FU ECF or bolus 5FU etoposide and leucovorin (FELV). The primary end point was OS with secondary end points of objective response rate (ORR), failure-free survival (FFS), quality of life (QOL) and toxicity. In all, 54 patients were recruited with 27 randomly assigned to each arm. The median OS for ECF was 9.02 months (95% confidence interval (CI): 6.46 -11.51) and FELV 12.03 months (95% CI: 9.3 -14.7), P ¼ 0.2059. Objective response rates were similar for both arms: ECF 19.2% (95% CI: 6.55 -39.3); FELV 15% (95% CI: 3.2 -37.9), P ¼ 0.72. There was significantly increased grade 3/4 neutropenia with FELV vs ECF (53.8 vs 29.5%, respectively, P ¼ 0.020). Symptom resolution was impressive for both regimens. This is the largest reported randomised study to date in this setting. ECF did not improve OS compared to FELV, but was associated with less acute toxicity. These data suggest that chemotherapy can prolong OS and achieve good symptomatic relief in advanced biliary cancer.
Summary Pancreatic cancer has a poor response to conventional chemotherapy and radiotherapy. Inhibition of matrix metalloproteinase activity involved in tumour invasion and metastases is a novel biological approach for cancer treatment. This multicentre phase II clinical trial assessed marimastat, an oral matrix metalloproteinase inhibitor, in patients with advanced pancreatic cancer. A total of 113 patients received marimastat for 28 days at 100 mg b.d. (n = 9), 25 mg o.d. (n = 90) or 10 mg b.d. (n = 14). Patients with a response to treatment could continue marimastat beyond 28 days. Of 113 patients, 90 (80%) completed the 28-day study and 83 (73%) continued treatment. The principal side effect was arthralgia in 14 (12%) patients at 28 days and 33 (29%) patients over the whole study. There were 31 patients (27%) who required dose modification. Of 76 patients with evaluable CA19-9 levels, 23 (30%) showed no increase or fall in CA19-9. Of 83 patients with radiologically assessable disease, 41 (49%) had stable disease. The median survival was 245 days for those with a stable or falling CA19-9 level 128 days in those with rising CA19-9. The overall survival was 3.8 months. 1865-1870© 2001 Cancer Research Campaign doi: 10.1054/ bjoc.2001.2168, available online at http://www.idealibrary.com on http://www.bjcancer.com daily dose (Drummond et al, 1995). The aim of this study was to evaluate the effect and define the tolerability of marimastat in patients with advanced pancreatic cancer. MATERIALS AND METHODS Study designThis was a multicentre open phase II pilot clinical trial to assess the effect of 28 days' administration of oral marimastat (British Biotech Pharmaceuticals Ltd, Oxford, UK) in patients with advanced pancreatic cancer with a facility to continue treatment in those patients with a clinical, serological or radiological 'response' to treatment. Marimastat was administered at a dose of 100 mg b.d., 25 mg o.d. or 10 mg b.d. with the option to reduce the dose in the event of toxicity. Patients were recruited from five centres throughout the UK between August 1995 and December 1997. Ethical committee approval was obtained from the research ethics committee at each investigating centre prior to study commencement. Study objectivesThe aims of this study were:1. To evaluate the effect of 28 days' treatment with oral marimastat on tumour size measured by computerize tomography (CT), disease progression was assessed by the level of cancer antigen CA19-9 and pain, mobility and analgesic use scores 2. To define the tolerability of marimastat 3. To assess the tumour response, safety and tolerability in patients treated beyond 28 days. Patient selectionPatients with radiologically and/or histologically/cytologically proven advanced pancreatic cancer were considered for study entry. Inclusion criteria were: (1) patients over 18 years of age; (2) Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; (3) estimated survival of at least 3 months and the ability to take food by mouth. Exclusion criteria inc...
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