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See detailCPT-11 and concomitant hyperfractionated accelerated radiotherapy induce efficient local control in rectal cancer patients: results from a phase II
Voelter, V; Zouhair, A; Vuilleumier, H et al

in British Journal of Cancer (2006), 95

Patients with rectal cancer are at high risk of disease recurrence despite neoadjuvant radiochemotherapy with 5-Fluorouracil (5FU), a <br />regimen that is now widely applied. In order to develop a ... [more ▼]

Patients with rectal cancer are at high risk of disease recurrence despite neoadjuvant radiochemotherapy with 5-Fluorouracil (5FU), a <br />regimen that is now widely applied. In order to develop a regimen with increased antitumour activity, we previously established the <br />recommended dose of neoadjuvant CPT-11 (three times weekly 90 mgm 2) concomitant to hyperfractionated accelerated <br />radiotherapy (HART) followed by surgery within 1 week. Thirty-three patients (20 men) with a locally advanced adenocarcinoma of <br />the rectum were enrolled in this prospective phase II trial (1 cT2, 29 cT3, 3 cT4 and 21 cNþ). Median age was 60 years (range 43– <br />75 years). All patients received all three injections of CPT-11 and all but two patients completed radiotherapy as planned. Surgery <br />with total mesorectal excision (TME) was performed within 1 week (range 2–15 days). The preoperative chemoradiotherapy was <br />overall well tolerated, 24% of the patients experienced grade 3 diarrhoea that was easily manageable. At a median follow-up of 2 <br />years no local recurrence occurred, however, nine patients developed distant metastases. The 2-year disease-free survival was 66% <br />(95% confidence interval 0.48–0.83). Neoadjuvant CPT-11 and HART allow for excellent local control; however, distant relapse <br />remains a concern in this patient population. [less ▲]

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See detailPreoperative hyperfractionated accelerated radiotherapy (HART) in locally advanced rectal cancer (LARC) immediately followed by surgery. A prospective phase II trial
Coucke, Philippe ULg; Notter; Stamm et al

in Radiotherapy & Oncology (2005)

Background and purpose We aim to report on local control in a phase II trial on preoperative hyperfractionated and accelerated radiotherapy schedule (HART) in locally advanced resectable rectal cancer ... [more ▼]

Background and purpose We aim to report on local control in a phase II trial on preoperative hyperfractionated and accelerated radiotherapy schedule (HART) in locally advanced resectable rectal cancer (LARC). This fractionation schedule was designed to keep the overall treatment time (OTT) as short as possible. Patients and methods This is a prospective trial on patients with UICC stages II and III rectal cancer. The patients were submitted to a total dose of 41.6 Gy, delivered in 2.5 weeks at 1.6 Gy per fraction twice a day with a 6-h interfraction interval. Surgery was performed within 1 week after the end of irradiation. Adjuvant chemotherapy was delivered in a subset of patients. Results Two hundred and seventy nine patients were entered and 250 are fully assessable, with a median follow-up of 39 months. The 5-years actuarial local control (LC) rate is 91.7%. The overall survival (OS) is 59.6%. The freedom from disease relapse (FDR) is 71.5%. Downstaging was observed in 38% of the tumors. Conclusion The actuarial LC at 5 years is 91.7%, although we are dealing with stages II–III LARC, mainly located in the lower rectum (median distance=5 cm). The pattern of failure is dominated by distant metastases and treatment intensification will obviously require a systemic approach. [less ▲]

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See detailRepeated beta irradiation for recurrent coronary in-stent restenosis.
Eeckhout, E; Roguelov, C; Berger, A et al

in Heart (2005), 91

Vascular brachytherapy (VBT) is the only proven treatment option for patients with in-stent restenosis. In seven randomised trials with almost 1500 patients that evaluated {gamma} (five studies) and ß ... [more ▼]

Vascular brachytherapy (VBT) is the only proven treatment option for patients with in-stent restenosis. In seven randomised trials with almost 1500 patients that evaluated {gamma} (five studies) and ß (two trials) irradiation, target vessel failure reduction ranged from 73% to 34% by VBT compared with conventional angioplasty.1 However, the reported restenosis rates with the active treatment still varied between 17% and 32%.1 We therefore postulated that repeat VBT is safe and efficacious for preventing refractory in-stent restenosis in high risk patients with failed VBT. METHODS Beginning in January 1999, VBT was applied for all patients with in-stent restenosis. VBT was systematically performed with intravascular ultrasound (IVUS) guidance. The repeat procedure was performed with a strontium/yttrium-90 source train (BetaCath, Novoste, Norcross, Georgia, USA). The design and application of this catheter have been described previously.2 The dosimetry was based on the manufacturer’s recommendations but taking into account not the angiographic vessel reference diameter but the external elastic membrane diameter (as determined by IVUS). The mean dose delivered at 2 mm from the source centre was 23.3 (2.2) Gy during the index procedure and 25.3 (2.2) Gy during the repeat intervention. Percutaneous coronary intervention (PCI) was performed according to standard clinical practice. Failed VBT was defined as angina recurrence combined with target vessel failure (as documented by any repeat angiography: premature depending on early symptom recurrence or at the planned six month control). Repeat VBT was considered for patients estimated to be at high risk for refractory in-stent restenosis or if they had a prognostic risk—that is, diffuse or ostial in-stent restenosis or total occlusion, or proximal left anterior descending artery stenosis. Focal edge effect stenoses and non-prognostic lesion locations in symptomatic patients were treated by conventional PCI. Written informed consent was obtained from all patients before intervention. The study was approved by the hospital ethics committee. All VBT patients were prospectively entered in a dedicated database by a person not taking part in the interventions. A combined antiplatelet treatment (aspirin 100 mg and clopidogrel 75 mg daily) was prescribed for at least six months after the index procedure and for one year after the second VBT. Control angiography was mandatory at six months in all VBT patients and systematic long term clinical follow up was carried out. RESULTS Between July 1998 and March 2003, 251 VBT interventions were performed at our institution: 22 patients were treated for primary restenosis prevention and 229 patients for in-stent restenosis. VBT failed in 34 patients (14.8%): 23 underwent conventional PCI and 11 underwent repeat VBT. The baseline clinical and angiographic demographics were comparable for both groups. Concerning the repeat VBT group, mean (SD) age was 60 (7) years, nine patients were men, and two had diabetes. All patients who underwent a repeat procedure had incapacitating angina pectoris. Angina recurred at 7 (2) months (range 4–10) after the first, failed VBT. The restenosis pattern (table 1Go) was diffuse in the majority of patients at the first presentation and remained diffuse with exacerbation to total occlusion in two patients. In the focal restenosis group, two patients had ostial in-stent restenosis. The cause of recurrent in-stent restenosis was an evident geographical miss in two patients (a focal and a diffuse pattern case). IVUS and angioplasty were successful before irradiation therapy in all patients. During repeat VBT, a 40 mm source train was used in seven patients and a pullback technique was required in two because of the length of the restenotic segment. No additional stents were implanted and no evidence of geographical miss was seen at repeat intervention. Table 1Go shows quantitative coronary angiography and IVUS data. During the index procedure, the minimum in-stent luminal area increased from mean (SD) 5.8 (1.8) to 7.5 (1.4) mm2. This area was maintained at the repeat intervention at 7.8 (2.1) mm2 and further expanded to 8.9 (1.8) mm2. All repeat interventions were technically successful and there were no adverse clinical events during the in-hospital phase. [less ▲]

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See detailA pilot study of silicone tissue expander prosthesis to protect the small bowel during radiation therapy for uterine malignancies
Zouhair, Abderrahim; Delaloye, J-F; Oszahin, Mahmut et al

in Turkish Journal of Cancer (2004), 34(1), 11-18

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See detailDecreased local control following radiation therapy alone in early stage glottic carcinoma with anterior commissure extention.
Azria, D; COUCKE, Philippe ULg; Matzinger, O et al

in Sonderbande zur Strahlentherapie und Onkologie (2004), 2

Purpose: To assess the patterns of failure in the treatment of early-stage squamous cell carcinoma of the glottic larynx. Patients and Methods: Between 1983–2000, 122 consecutive patients treated for ... [more ▼]

Purpose: To assess the patterns of failure in the treatment of early-stage squamous cell carcinoma of the glottic larynx. Patients and Methods: Between 1983–2000, 122 consecutive patients treated for early laryngeal cancer (UICC T1N0 and T2N0) by radical radiation therapy (RT) were retrospectively studied. Male-to-female ratio was 106 : 16, and median age 62 years (35–92 years). There were 68 patients with T1a, 18 with T1b, and 36 with T2 tumors. Diagnosis was made by biopsy in 104 patients, and by laser vaporization or stripping in 18. Treatment planning consisted of three-dimensional (3-D) conformal RT in 49 (40%) patients including nine patients irradiated using arytenoid protection. A median dose of 70 Gy (60–74 Gy) was given (2 Gy/fraction) over a median period of 46 days (21–79 days). Median follow-up period was 85 months. Results: The 5-year overall, cancer-specific, and disease-free survival amounted to 80%, 94%, and 70%, respectively. 5-year local control was 83%. Median time to local recurrence in 19 patients was 13 months (5–58 months). Salvage treatment consisted of surgery in 17 patients (one patient refused salvage and one was inoperable; total laryngectomy in eleven, and partial laryngectomy or cordectomy in six patients). Six patients died because of laryngeal cancer. Univariate analyses revealed that prognostic factors negatively influencing local control were anterior commissure extension, arytenoid protection, and total RT dose < 66 Gy. Among the factors analyzed, multivariate analysis (Cox model) demonstrated that anterior commissure extension, arytenoid protection, and male gender were the worst independent prognostic factors in terms of local control. Conclusion: For early-stage laryngeal cancer, outcome after RT is excellent. In case of anterior commissure extension, surgery or higher RT doses are warranted. Because of a high relapse risk, arytenoid protection should not be attempted. [less ▲]

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See detailPositive interactive radiosensitization observed in vitro with the combination of two nucleoside analogs (E)-2'-deoxy-2'-(fluoromethylene) cytidine (FMdC) and iododeoxyuridine (IdUrd).
Coucke, Philippe ULg; Cottin, E; Azria, D et al

in European Journal of Cancer (2004)

(E)-20-Deoxy-20-(fluoromethylene) cytidine (FMdC), an inhibitor of ribonucleotide diphosphate reductase (RR), is a potent radiation-sensitiser acting through alterations in the deoxyribonucleoside ... [more ▼]

(E)-20-Deoxy-20-(fluoromethylene) cytidine (FMdC), an inhibitor of ribonucleotide diphosphate reductase (RR), is a potent radiation-sensitiser acting through alterations in the deoxyribonucleoside triphosphate (dNTP) pool in the de novo pathway to DNA synthesis. The activity of thymidine kinase (TK), a key enzyme in the ‘salvage pathway’, is known to increase in response to a lowering of dATP induced by FMdC. Nucleoside analogues such as iododeoxyuridine (IdUrd) are incorporated into DNA after phosphorylation by TK. Radiation sensitisation by IdUrd depends on IdUrd incorporation. Therefore, we have investigated the radiosensitising effect of the combination of FMdC and IdUrd on WiDr (a human colon cancer cell-line) and compared it to the effect of either drug alone. We analysed the effects of FMdC and IdUrd on the dNTP pools by high-performance liquid chromatography, and measured whether the incorporation of IdUrd was increased by FMdC using a [125I]-IdUrd incorporation assay. The combination in vitro yielded radiation-sensitiser enhancement ratios of >2, significantly higher than those observed with FMdC or IdUrd alone. Isobologram analysis of the combination indicated a supra-additive effect. This significant increase in radiation sensitivity with the combination of FMdC and IdUrd could not be explained by changes in the dNTP pattern since the addition of IdUrd to FMdC did not further reduce the dATP. However, the increase in the radiation sensitivity of WiDr cells might be due to increased incorporation of IdUrd after FMdC treatment. Indeed, a specific and significant incorporation of IdUrd into DNA could be observed with the [125I]-IdUrd incorporation assay in the presence of 1 lM unlabelled IdUrd when combined with FMdC treatment. 2004 Elsevier Ltd. All rights reserved. [less ▲]

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See detailLa gynécomastie sous antiandrogènes : un mal inéluctable? la radiothérapie : une solution simple et efficace!
Coucke, Philippe ULg; JICHLISKI; MATZINGER et al

in Revue Médicale de la Suisse Romande (2004), 124(1), 51-54

La gynécomastie secondaire au traitement par anti-androgènes, est une complication fréquente des traitements hormonaux utilisés pour les patients souffrant de cancer prostatique. Cette gynécomastie est le ... [more ▼]

La gynécomastie secondaire au traitement par anti-androgènes, est une complication fréquente des traitements hormonaux utilisés pour les patients souffrant de cancer prostatique. Cette gynécomastie est le résultat d'un déséquilibre hormonal entre les oestrogènes et les androgènes. On peut raisonnablement estimer que l'incidence de cette gynécomastie va augmenter compte tenu de l'effet bénéfique de la manipulation hormonale sur le devenir des patients atteints d'un cancer de la prostate. La gynécomastie, souvent associée à la mastodynie, a un effet délétère sur la qualité de vie. Si la chirurgie est une option thérapeutique pour les formes installées et irréversible, caractérisée par une composante de hyalinisation et fibrose dominant le tableau histologique, la radiothérapie reste le traitement de choix pour les formes précoces, voire même à titre prophylactique dans les groupes de patients à haut risque. C'est un traitement simple et efficace, peu toxique et bénéfique en qualité de vie et ceci a été confirmé par des essais randomisés. L'approche médicamenteuse n'a pas encore démontré son efficacité ni son innocuité et de toute façon aucune substance médicamenteuse n'a été enregistrée pour cette indication. [less ▲]

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See detailClinical outcome following combination of cutting balloon angioplasty and coronary β-radiation for in-stent restenosis: A report from the RENO registry
Coucke, Philippe ULg; Roguelov; Eeckhout

in Journal of Invasive Cardiology (The) (2003, December), 15(12), 706-709

At present, vascular brachytherapy is the only efficient therapy for in-stent restenosis. Nevertheless, edge restenosis often related to geographical miss has been identified as a major limitation of the ... [more ▼]

At present, vascular brachytherapy is the only efficient therapy for in-stent restenosis. Nevertheless, edge restenosis often related to geographical miss has been identified as a major limitation of the technique. The non-slippery cutting balloon has the potential to limit vascular barotraumas, which, together with low-dose irradiation at both ends of the radioactive source, are the prerequisite for geographical miss. This prospective study aimed to examine the efficacy of combining cutting balloon angioplasty and brachytherapy for in-stent restenosis. The Radiation in Europe NOvoste (RENO) registry prospectively tracked all patients who had been treated by coronary β-radiation with the Beta-Cath System (Novoste Corporation, Brussels, Belgium) but were not included in a randomized radiation trial. A subgroup of patients with in-stent restenosis treated by cutting balloon angioplasty and coronary β-radiation (group 1, n = 166) was prospectively defined, and clinical outcomes of patients at 6 months were compared with those of patients treated by conventional angioplasty and coronary β-radiation (group 2, n = 712). At 6-month follow-up, there was a significant difference between groups 1 and 2 in target vessel revascularization (10.2% versus 16.6% respectively; p = 0.04) and in the incidence of major adverse clinical events (MACE) including death, myocardial infarction, and revascularization (10.8% versus 19.2%; p = 0.01). This observation was confirmed by a multivariate analysis indicating a lower risk for MACE at 6 months (odds ratio: 0.49; confidence intervals: 0.27-0.88; p = 0.02). Compared to conventional angioplasty, cutting balloon angioplasty prior to coronary beta-radiation with the Beta-Cath System seems to improve the 6-month clinical outcome in patients with in-stent restenosis. [less ▲]

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See detailChanger l’organisation du « système » TRM* en radio-oncologie par l’introduction d’un apprentissage organisationnel pour faciliter la mise en place des progrès technologiques.
COUCKE, Philippe ULg

Master of advanced studies dissertation (2003)

Le service de radio-oncologie est caractérisé par la technicité et la complexité toujours en évolution de la prise en charge thérapeutique. Le développement dans ce domaine est tel que le service de radio ... [more ▼]

Le service de radio-oncologie est caractérisé par la technicité et la complexité toujours en évolution de la prise en charge thérapeutique. Le développement dans ce domaine est tel que le service de radio-oncologie risque très rapidement d’être déphasé par rapport à la qualité de la prise en charge que le patient est en mesure d’attendre dans les limites des ressources disponibles. Si l’organisation n’est pas apte à prendre en compte la nécessité d’une amélioration continue, nous ne serons plus capables d’assurer des soins de haute qualité auquel le patient a droit, et nous perdrons rapidement l’habilité technique dans la pratique des soins. Afin d’assurer la maîtrise et la pérennité d’une prise en charge de haute qualité nous voulons mettre en route une démarche globale d’amélioration continue qui doit finalement aboutir à une démarche de projet de qualité et de certification. Nous faisons le constat, aujourd’hui, que le groupe des techniciens en radiologie médicale* ne répond pas aux critères d’une organisation apprenante qui est une condition sine qua non pour l’amélioration continue. Afin de modifier cette situation, il nous faut définir un facteur suffisamment puissant pour déclencher cet évolution d’état d’esprit. Ce changement sera abordé par la mise en place d’une mesure de satisfaction au sein même du système TRM en collaboration avec la cellule ESOP de l’Institut Universitaire de Médecine sociale et Préventive (IUMSP). Cette démarche basée sur un « brainstorming » dont la trame de réflexion pourrait être l’évaluation du niveau atteint dans la pyramide de satisfaction de Maslow par les TRM (analyse interne du système). Ce genre d’exercice effectué par les TRM pourrait aboutir à une visualisation structurée de la problématique du manque d’amélioration continue et des causes de l’absence d’une telle organisation apprenante en utilisant la technique du diagramme d’Ishikawa. L’avantage de cette démarche, c’est que le groupe TRM en tant que tel va aboutir à l’élaboration active d’un certain nombre d’idées clés censées amener une solution aux problèmes énoncés. En même temps nous voulons déclencher une redéfinition de la vision d’entreprise et des tâches et des compétences requises (une formulation claire des exigences en termes qualitatifs et quantitatifs de l’attente du service vis-à-vis des TRM) ; cette tâche incombe aux mandataires du changement c’est-à-dire les médecins et le groupe des physiciens qui font partie de l’environnement immédiat du système TRM, et qui ont besoin d’une amélioration continue du savoir (savoir, savoir être et savoir faire) des TRM afin de pouvoir implémenter des nouvelles techniques complexes en radio-oncologie. Cette « analyse externe » va permettre de définir des objectifs clairs et une vision commune. Le constat de la différence entre l’analyse externe et interne doit aboutir à un travail de groupe mixte (TRM et mandataires) afin de déboucher sur une concordance des deux visions. Afin de faire participer les TRM à l’élaboration des idées-clés des solutions, la mise en place desdites solutions et l’évaluation de l’efficacité des solutions mises en place, nous prévoyons de créer différents groupes de travail ayant chacun un objectif clair et précis (exemple : mise en place de l’utilisation en routine de l’imagerie portale pour le contrôle de qualité systématique des champs d’irradiation). Cette démarche va provoquer un changement fondamental dans le système TRM, une évolution d’une organisation primaire vers une organisation secondaire travaillant par objectifs, plus apte à s’adapter aux exigences de l’environnement, capable d’anticiper et non pas de subir les mises à jour technologiques. Par la même occasion, cette démarche une fois amorcée va obliger l’intégralité du service de radio-oncologie à établir un référentiel d’auto-évaluation et un guide des procédures qui vont permettre à terme d’aboutir sur une certification ISO 9001-2000. *Le genre masculin du titre professionnel s’entend bien entendu également au féminin. [less ▲]

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See detailRadiothérapie externe accélérée postopératoire des carcinomes épidermoïdes localement évolués de la sphère ORL : étude prospective de phase II
Zouhair, A; COUCKE, Philippe ULg; Azria, D. et al

in Bulletin du Cancer. Radiothérapie : Journal de la Société Française du Cancer : Organe de la Société Française de Radiothérapie Oncologique (2003), 7

Abstract Purpose. – To assess the feasibility and efficacy of accelerated postoperative radiation therapy (RT) in patients with squamous-cell carcinoma of the head and neck (SCCHN). Patients and methods ... [more ▼]

Abstract Purpose. – To assess the feasibility and efficacy of accelerated postoperative radiation therapy (RT) in patients with squamous-cell carcinoma of the head and neck (SCCHN). Patients and methods. – Between December 1997 and July 2001, 68 patients (male to female ratio: 52/16; median age: 60-years (range: 43–81) with pT1-pT4 and/or pN0-pN3 SCCHN (24 oropharynx, 19 oral cavity, 13 hypopharynx, 5 larynx, 3 unknown primary, 2 maxillary sinus, and 2 salivary gland) were included in this prospective study. Postoperative RT was indicated because extracapsular infiltration (ECI) * Auteur correspondant. Adresse e-mail : abderrahim.zouhair@chuv.hospvd.ch (A. Zouhair). Cancer/Radiothérapie 7 (2003) 231–236 www.elsevier.com/locate/canrad © 2003 Éditions scientifiques et médicales Elsevier SAS. Tous droits réservés. doi:10.1016/S1278-3218(03)00041-6 was observed in 20 (29%), positive surgical margins (PSM) in 20 (29%) or both in 23 patients (34%). Treatment consisted of external beam RT 66 Gy in 5 weeks and 3 days. Median follow-up was 15 months. Results. – According to CTC 2.0, acute morbidity was acceptable: grade 3 mucositis was observed in 15 (22%) patients, grade 3 dysphagia in 19 (28%) patients, grade 3 skin erythema in 21 (31%) patients with a median weight loss of 3.1 kg (range: 0–16). No grade 4 toxicity was observed. Median time to relapse was 13 months; we observed only three (4%) local and four (6%) regional relapses, whereas eight (12%) patients developed distant metastases without any evidence of locoregional recurrence. The 2 years overall-, disease-free survival, and actuarial locoregional control rates were 85, 73 and 83% respectively. Conclusion. – The reduction of the overall treatment time using postoperative accelerated RT with weekly concomitant boost (six fractions per week) is feasible with local control rates comparable to that of published data. Acute RT-related morbidity is acceptable. [less ▲]

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See detailPreoperative hyperfractionated acclerated radiotherapy (HART) and concomittant CPT-11 in advanced rectal carcinoma. A phase I study.
Voelter, V; Stupp, R; Matter, M et al

in International Journal of Radiation, Oncology, Biology, Physics (2003), 56(5), 1288-1294

Purpose: Patients with locally advanced rectal carcinoma are at risk for both local recurrence and distant metastases. We demonstrated the efficacy of preoperative hyperfractionated accelerated ... [more ▼]

Purpose: Patients with locally advanced rectal carcinoma are at risk for both local recurrence and distant metastases. We demonstrated the efficacy of preoperative hyperfractionated accelerated radiotherapy (HART). In this Phase I trial, we aimed at introducing chemotherapy early in the treatment course with both intrinsic antitumor activity and a radiosensitizer effect. Methods and Materials: Twenty-eight patients (19 males; median age 63, range 28–75) with advanced rectal carcinoma (cT3: 24; cT4: 4; cN : 12; M1: 5) were enrolled, including 8 patients treated at the maximally tolerated dose. Escalating doses of CPT-11 (30–105 mg/m2/week) were given on Days 1, 8, and 15, and concomitant HART (41.6 Gy, 1.6 Gy bid 13 days) started on Day 8. Surgery was to be performed within 1 week after the end of radiochemotherapy. Results: Twenty-six patients completed all preoperative radiochemotherapy as scheduled; all patients underwent surgery. Dose-limiting toxicity was diarrhea Grade 3 occurring at dose level 6 (105 mg/m2). Hematotoxicity was mild, with only 1 patient experiencing Grade 3 neutropenia. Postoperative complications (30 days) occurred in 7 patients, with an anastomotic leak rate of 22%. Conclusions: The recommended Phase II dose of CPT-11 in this setting is 90 mg/m2/week. Further Phase II exploration at this dose is warranted. © 2003 Elsevier Inc. [less ▲]

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See detailRENO, a European Postmarket Surveillance Registry, confirms effectiveness of coronary brachytheraypy in routine clinical practice.
Coen, V; Serruys, P; Sauerwein, W et al

in International Journal of Radiation, Oncology, Biology, Physics (2003), 55(4), 1019-1026

Purpose: To assess, by a European registry trial, the clinical event rate in patients with discrete stenotic lesions of coronary arteries (de novo or restenotic) in single or multiple vessels (native or ... [more ▼]

Purpose: To assess, by a European registry trial, the clinical event rate in patients with discrete stenotic lesions of coronary arteries (de novo or restenotic) in single or multiple vessels (native or bypass grafts) treated with -radiation. Methods and Materials: Between April 1999 and September 2000, 1098 consecutive patients treated in 46 centers in Europe and the Middle East with the Novoste Beta-Cath System were included in Registry Novoste (RENO). Results: Six-month follow-up data were obtained for 1085 patients. Of 1174 target lesions, 94.1% were located in native vessels and 5.9% in a bypass graft; 17.7% were de novo lesions, 4.1% were restenotic, and 77.7% were in-stent restenotic lesions. Intravascular brachytherapy was technically successful in 95.9% of lesions. Multisegmental irradiation, using a manual pullback stepping maneuver to treat longer lesions, was used in 16.3% of the procedures. The in-hospital rate of major adverse cardiac events was 1.8%. At 6 months, the rate was 18.7%. Angiographic follow-up was available for 70.4% of the patients. Nonocclusive restenosis was seen in 18.8% and total occlusion in 5.7% of patients. A combined end point for late (30–180 days) definitive or suspected target vessel closure was reached in 5.4%, but with only 2% of clinical events. Multivariate analysis was performed for major adverse cardiac events and late thrombosis. Conclusion: Data obtained from the multicenter RENO registry study, derived from a large cohort of unselected consecutive patients, suggest that the good results of recent randomized controlled clinical trials can be replicated in routine clinical practice. © 2003 Elsevier Science Inc. [less ▲]

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See detailPredictive factors in locally advanced rectal cancer treated with preoperative hyperfractionated and accelerated radiotherapy.
Bouzourene, H; Bosman, F; Matter, M et al

in Human Pathology (2003), 34(6), 541-548

This study examines the prognostic significance of pathologic factors in patients with primary locally advanced rectal cancer treated prospectively with preoperative radiotherapy. From 1992 to 1998, 104 ... [more ▼]

This study examines the prognostic significance of pathologic factors in patients with primary locally advanced rectal cancer treated prospectively with preoperative radiotherapy. From 1992 to 1998, 104 patients with rectal cancer of grades T3 or T4 and any N underwent preoperative radiotherapy followed by surgical resection. Survival curves were estimated according to the Kaplan-Meier method. Correlation of outcome with clinicopathologic variables (pathologic tumor and lymph node staging, histology, radial resection margin [RRM], clearance, vessel involvement, and tumor regression grade [TRG], quantitated in 5 grades) was evaluated using the Cox proportional hazards model. None of the patients achieved a histologically confirmed complete pathologic response, but 79% of the patients showed partial tumor regression (TRG2–4) and 21% did not show any tumor regression (TRG5). Among the tumors, 22% were of a mucinous type. The RRM was free of tumor in 76% of the surgical specimens. The median clearance was 2 mm. Vascular invasion was present in 37 cases (36%). In the univariate analysis, lymph node metastases, absence of tumor regression, positive RRM, and vascular invasion were correlated with adverse overall survival and diseasefree survival; absence of tumor regression, positive RRM, and clearance <2 mm were correlated with local recurrences; and advanced pT stage was correlated only with disease-free survival. However, in the multivariate analysis, only lymph node metastases and RRM were independent prognostic factors for overall survival and disease-free survival, and clearance <2 mm was an independent prognostic factor for local control. Pathologic parameters remain strong determinants of local recurrence and survival in locally advanced rectal cancer, treated preoperatively with hyperfractionated and accelerated radiotherapy. We show that patients with advanced pT, positive lymph nodes, vascular invasion, positive RRM, clearance <2 mm, or absence of tumor regression are known to have poor clinical outcome. HUM PATHOL 34:541-548. © 2003 Elsevier Inc. All rights reserved. Abbreviations: , computed tomography; DFS, disease-free survival; HART, hyperfractionated accelerated radiotherapy; OS, overall survival; RRM, radial resection margin; TRG, tumor regression grade. [less ▲]

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See detailShortened irradiation scheme, continuous infusion of 5-fluorouracil and fractionation of mitomycin C in locally advanced anal carcinomas. Results of a phase II study of the European Organization for Research and Treatment of Cancer. Radiotherapy and Gastrointestinal Cooperative Groups
Bosset, J. F.; Roelofsen, F.; Morgan, D. A. L. et al

in European Journal of Cancer (2003), 39

Abstract The European Organization for Research and Treatment of Cancer (EORTC) 22861 randomised trial established that combined radiochemotherapy is the standard treatment for locally advanced anal ... [more ▼]

Abstract The European Organization for Research and Treatment of Cancer (EORTC) 22861 randomised trial established that combined radiochemotherapy is the standard treatment for locally advanced anal cancer. This EORTC phase II study (#22953) tests the feasibility of reducing the gap between sequences to 2 weeks, to deliver Mitomycin C (MMC) in each radiotherapy sequence and 5-FU continuously during the treatment. The first sequence consisted of 36 Gy over 4 weeks. 5-FU 200 mg/m2/days 1–26, MMC 10 mg/m2/day 1 gap 16 days. Then a second sequence of 23.4 Gy over 17 days, 5-FU 200 mg/m2/days 1–17 and, MMC 10 mg/m2/day 1 was given. 43 patients with a World Health Organization (WHO) status of 0 (n=27) or 1 (n=16) and with T2-T4, N0-3 tumours were included. Compliance with the planned treatment, doses and duration was 93%. The complete response rate was 90.7%. Grade 3 toxicities of 28, 12 and 2% were observed for skin, diarrhoea and haematological toxicities, respectively. The 3-year estimated rates for trials 22861 and 22953 are: 68 and 88% for local control; 72 and 81% for colostomy-free interval, 62 and 84% for severe late toxicity-free interval, and 70 and 81% for survival, respectively. The 22953 scheme is feasible and the results are promising. This is now considered as the new standard scheme by the EORTC. [less ▲]

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See detailProspective studyof CD4 and CD8 T-lynphocyte apoptosis as a marker for radiation induced late effects in 399 individual patients
Ozsahin; Crompton; Shi et al

in International Journal of Radiation, Oncology, Biology, Physics (2003), 55(2), 551-552

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See detailAccelerated postoperative radiation therapy with weekly concomitant boost in high risk patients with squamous-cell carcinoma of the head and neck
Chevalier; Pasche; COUCKE, Philippe ULg et al

in Radiotherapy & Oncology (2002), 64(supp 1), 248

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See detailDecreased local control following radiation therapy alone in early larynx cancer with anterior commisure extension
Ozsahin; Bron; COUCKE, Philippe ULg et al

in Radiotherapy & Oncology (2002), 64(supp 1), 243-244

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See detailImportance of Tumor Regression Assessment in Predicting the Outcome in Patients with Locally Advanced Rectal Carcinoma Who Are Treated with Preoperative Radiotherapy
Bouzourene, Hanifa; Bosman, Fred; Seelentag, Walter et al

in Cancer (2002), 94(4), 1121-1130

BACKGROUND: Locally advanced rectal carcinoma has a poor prognosis. However, <br />since the introduction of preoperative radiotherapy, the outcome of patients with <br />rectal carcinoma has been ... [more ▼]

BACKGROUND: Locally advanced rectal carcinoma has a poor prognosis. However, <br />since the introduction of preoperative radiotherapy, the outcome of patients with <br />rectal carcinoma has been reported to have improved. Nevertheless, to the authors’ <br />knowledge few data are available regarding the histopathologic response to <br />radiotherapy as assessed on surgical specimens as a potential predictive factor for <br />outcome. <br />METHODS: To estimate the effect of radiotherapy on rectal carcinoma, the authors <br />retrospectively reviewed the surgical specimens of 102 patients with T3-4, N0 or <br /> N1 rectal carcinoma and 1 patient with T2 but N1 rectal carcinoma. All patients <br />were treated preoperatively with a hyperfractionated accelerated radiotherapy <br />schedule in a prospective protocol (Trial 93-01). Using a standardized approach, <br />tumor regression was graded using a system that varies from Grade 1 (tumor <br />regression Grade [TRG] 1) when complete tumor regression is observed to Grade 5 <br />(TRG5) when no tumor regression is observed. <br />RESULTS: Radiotherapy resulted in tumor downstaging in 43% of the patients. <br />There were 2 pT1 tumors (2%), 21 pT2 tumors (20%), 66 pT3 tumors (64%), and 14 <br />pT4 tumors (14%) after treatment. Regional lymph nodes were involved in 55 <br />patients (53%). None of the patients demonstrated a complete tumor regression <br />after radiotherapy, but in 79% of the specimens a partial tumor regression was <br />observed (TRG1: 0%; TRG2: 20%; TRG3: 39%; TRG4: 20%; and TRG5: 21%). The <br />median actuarial overall survival (OS) and disease-free survival (DFS) were 52 <br />months. Actuarial local recurrence rates at 2 years and 5 years were 6.4% and 7.6%, <br />respectively. Univariate analysis showed the actuarial DFS to be significantly lower <br />in patients with lymph node metastases (P 0.0004) and advanced pT stages <br />(pT3-4) (P 0.03). A favorable outcome for OS, DFS, and local control was <br />observed in patients with TRG2-4 (i.e., responders) compared with patients with <br />TRG5 (i.e., nonresponders), but also in patients with low residual tumor cell <br />density (TRG2, 3, and 4). On multivariate analysis, TRG remained an independent <br />prognostic indicator for local tumor control. <br />CONCLUSIONS. Tumor regression as well as residual tumor cell density were found <br />to be predictive factors of survival in rectal carcinoma patients after preoperative <br />radiotherapy. Even after preoperative radiotherapy, the pathologic stage of the <br />surgical specimen remained a prognostic factor. The use of a standardized approach <br />for pathologic evaluation must be implemented to allow comparison between <br />the results of various treatment approaches. [less ▲]

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