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Willem Oosterlinck - One of the best experts on this subject based on the ideXlab platform.
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the effect of age on the efficacy of maintenance bacillus calmette guerin relative to maintenance Epirubicin in patients with stage ta t1 urothelial bladder cancer results from eortc genito urinary group study 30911
European Urology, 2014Co-Authors: Jorg R Oddens, Richard J Sylvester, Maurizio Brausi, Wim J Kirkels, Cees Van De Beek, George Van Andel, Theo M De Reijke, Stephen Prescott, Alfred J Witjes, Willem OosterlinckAbstract:Abstract Background Although maintenance bacillus Calmette-Guerin (BCG) is the recommended treatment in high-risk non–muscle-invasive bladder cancer (NMIBC), its efficacy in older patients is controversial. Objective To determine the effect of age on prognosis and treatment outcome in patients with stage Ta T1 NMIBC treated with maintenance BCG. Design, setting, and participants A total of 957 patients with intermediate- or high-risk Ta T1 (without carcinoma in situ) NMIBC were randomized in European Organization for Research and Treatment of Cancer (EORTC) trial 30911 comparing six weekly instillations of Epirubicin, BCG, and BCG plus isoniazid followed by three weekly maintenance instillations over 3 yr. Outcome measurements and statistical analysis Cox multivariate proportional hazards regression models were used to assess the relative importance of age for recurrence, progression, overall survival, and NMIBC-specific survival with adjustment for EORTC risk scores. Results and limitations Overall, 822 eligible patients were included: 546 patients in the BCG with or without INH arms and 276 in the Epirubicin arm. In patients treated with BCG with or without INH, 34.1% were >70 yr of age and 3.7% were >80 yr. With a median follow-up of 9.2 yr, patients >70 yr had a shorter time to progression ( p =0.028), overall survival ( p p =0.049) after adjustment for EORTC risk scores in the multivariate analysis. The time to recurrence was similar compared with the younger patients. BCG was more effective than Epirubicin for all four end points considered, and there was no evidence that BCG was any less effective compared with Epirubicin in patients >70 yr. Conclusions In intermediate- and high-risk Ta T1 urothelial bladder cancer patients treated with BCG, patients >70 yr of age have a worse long-term prognosis; however, BCG is more effective than Epirubicin independent of patient age. Patient summary Intravesical bacillus Calmette-Guerin for non–muscle-invasive bladder cancer is less effective in patients >70 yr of age, but it is still more effective than Epirubicin. Trial registration This study was registered with the US National Cancer Institute clinical trials database (protocol ID: EORTC 30911; http://www.cancer.gov/clinicaltrials/search/view?cdrid=77075&version=HealthProfessional&protocolsearchid=12442243#StudyIdInfo_CDR0000077075).
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a prospective european organization for research and treatment of cancer genitourinary group randomized trial comparing transurethral resection followed by a single intravesical instillation of Epirubicin or water in single stage ta t1 papillary carc
The Journal of Urology, 1993Co-Authors: Willem Oosterlinck, K H Kurth, Fritz H Schroder, Jozef Bultinck, Bernadette Hammond, Richard SylvesterAbstract:AbstractA total of 431 eligible patients with solitary, primary or recurrent stages Ta and Tl transitional cell carcinoma of the bladder was included in a randomized multicenter trial to compare a single intravesical instillation of 80mg. Epirubicin with water given immediately after resection, with respect to the disease-free interval and recurrence rate. The interval to initial recurrence was significantly better in favor of the Epirubicin group. After a mean followup of 2 years it became evident that the recurrence rate after a single Epirubicin instillation was decreased by nearly half with the same trend being found in all subgroups examined. Toxicity was mainly restricted to bladder irritation in plus or minus 10% of the cases. Pathology review brought considerable changes in T category from stages Tl to Ta (53%). Changes in grade were less pronounced but nevertheless important.
Richard J Sylvester - One of the best experts on this subject based on the ideXlab platform.
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the effect of age on the efficacy of maintenance bacillus calmette guerin relative to maintenance Epirubicin in patients with stage ta t1 urothelial bladder cancer results from eortc genito urinary group study 30911
European Urology, 2014Co-Authors: Jorg R Oddens, Richard J Sylvester, Maurizio Brausi, Wim J Kirkels, Cees Van De Beek, George Van Andel, Theo M De Reijke, Stephen Prescott, Alfred J Witjes, Willem OosterlinckAbstract:Abstract Background Although maintenance bacillus Calmette-Guerin (BCG) is the recommended treatment in high-risk non–muscle-invasive bladder cancer (NMIBC), its efficacy in older patients is controversial. Objective To determine the effect of age on prognosis and treatment outcome in patients with stage Ta T1 NMIBC treated with maintenance BCG. Design, setting, and participants A total of 957 patients with intermediate- or high-risk Ta T1 (without carcinoma in situ) NMIBC were randomized in European Organization for Research and Treatment of Cancer (EORTC) trial 30911 comparing six weekly instillations of Epirubicin, BCG, and BCG plus isoniazid followed by three weekly maintenance instillations over 3 yr. Outcome measurements and statistical analysis Cox multivariate proportional hazards regression models were used to assess the relative importance of age for recurrence, progression, overall survival, and NMIBC-specific survival with adjustment for EORTC risk scores. Results and limitations Overall, 822 eligible patients were included: 546 patients in the BCG with or without INH arms and 276 in the Epirubicin arm. In patients treated with BCG with or without INH, 34.1% were >70 yr of age and 3.7% were >80 yr. With a median follow-up of 9.2 yr, patients >70 yr had a shorter time to progression ( p =0.028), overall survival ( p p =0.049) after adjustment for EORTC risk scores in the multivariate analysis. The time to recurrence was similar compared with the younger patients. BCG was more effective than Epirubicin for all four end points considered, and there was no evidence that BCG was any less effective compared with Epirubicin in patients >70 yr. Conclusions In intermediate- and high-risk Ta T1 urothelial bladder cancer patients treated with BCG, patients >70 yr of age have a worse long-term prognosis; however, BCG is more effective than Epirubicin independent of patient age. Patient summary Intravesical bacillus Calmette-Guerin for non–muscle-invasive bladder cancer is less effective in patients >70 yr of age, but it is still more effective than Epirubicin. Trial registration This study was registered with the US National Cancer Institute clinical trials database (protocol ID: EORTC 30911; http://www.cancer.gov/clinicaltrials/search/view?cdrid=77075&version=HealthProfessional&protocolsearchid=12442243#StudyIdInfo_CDR0000077075).
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intravesical instillation of Epirubicin bacillus calmette guerin and bacillus calmette guerin plus isoniazid for intermediate and high risk ta t1 papillary carcinoma of the bladder a european organization for research and treatment of cancer genito u
The Journal of Urology, 2001Co-Authors: Adrian P M Van Der Meijden, Maurizio Brausi, Wim J Kirkels, Victor Zambon, Christine De Balincourt, Richard J SylvesterAbstract:Purpose: After transurethral resection, we compared the efficacy and side effects of weekly intravesical instillations of Epirubicin, bacillus Calmette-Guerin (BCG), and BCG plus isoniazid during a 6-week interval followed by 3 weekly maintenance instillations at months 3, 6, 12, 18, 24, 30 and 36 in patients with intermediate and high risk Ta, T1 bladder cancer.Materials and Methods: A total of 957 patients were randomized at 44 institutions in a phase III multicenter trial.Results: The time to first recurrence was significantly longer in patients treated with BCG and BCG plus isoniazid compared to Epirubicin (p = 0.0001) but there was no difference between the 2 BCG regimens (p = 0.27). Progression to muscle invasive cancer was rare (5%) and did not differ significantly among the 3 arms (p = 0.12). Drug induced cystitis was observed in 31% of the patients treated with Epirubicin, 42% BCG and 45% BCG plus isoniazid. Systemic side effects, such as fever and malaise, were not observed in patients treated w...
P Fargeot - One of the best experts on this subject based on the ideXlab platform.
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long term cardiac toxicity after adjuvant Epirubicin based chemotherapy in early breast cancer french adjuvant study group results
Annals of Oncology, 2006Co-Authors: P Fumoleau, P Fargeot, H Roche, P Kerbrat, J Bonneterre, P Romestaing, M Namer, A Monnier, Philippe Montcuquet, M J GoudierAbstract:Abstract Background: The aim of the study was to evaluate and compare incidence and risk factors of left ventricular dysfunction (LVD) in early breast cancer patients receiving (E+) or not (E−) Epirubicin-based adjuvant chemotherapy. Patients and methods: Among eight FASG trials, 3577 assessable patients were analyzed retrospectively: 2553 received Epirubicin, 662 received hormonotherapy alone and 362 had no systemic treatment. Chemotherapy was FEC regimen in 86% of cases (fluorouracil, Epirubicin, cyclophosphamide). Epirubicin cumulative dose was Results: Twenty delayed LVD occurred: two in E− patients and 18 in E+ patients. In E+ patients, 14 patients normalized their cardiac function or did not require further investigations, one patient was stabilized with specific treatment, two patients worsened their functions and one died of congestive heart failure. The 7-year risk of LVD was 1.36% (95% CI 0.85–1.87) in E+ patients and 0.21% (95%CI: 0.00–0.52) in E− patients (P = 0.004). Two significant risk factors were identified: age ≥65 years and body mass index >27 kg/m2. Conclusion: After a long-term follow-up, Epirubicin-related LVD risk was acceptable (1.36%) with one toxic death (0.04%). In 78% of cases, LVD were transient or well controlled.
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risk of acute myeloid leukemia and myelodysplastic syndrome in trials of adjuvant Epirubicin for early breast cancer correlation with doses of Epirubicin and cyclophosphamide
Journal of Clinical Oncology, 2005Co-Authors: Claudio Praga, Jonas Bergh, J M Bliss, Jacques Bonneterre, Bruno Mario Cesana, Charles R Coombes, P Fargeot, Annika Folin, Pierre Fumoleau, Rosa GiulianiAbstract:Purpose We reviewed follow-up of patients treated in 19 randomized trials of adjuvant Epirubicin in early breast cancer to determine incidence, risk, and risk factors for subsequent acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Patients and Methods The patients (N = 9,796) were observed from the start of adjuvant treatment (53,080 patient-years). Cases of AML or MDS (AML/MDS) were reported, with disease characteristics. Incidence and cumulative risk were compared for possible risk factors, for assigned regimens, and for administered cumulative doses of Epirubicin and cyclophosphamide. Results In 7,110 patients treated with Epirubicin-containing regimens (92% of whom also received cyclophosphamide), 8-year cumulative probability of AML/MDS was 0.55% (95% CI, 0.33% to 0.78%). The risk of developing AML/MDS increased in relation to planned Epirubicin dose per cycle, planned Epirubicin dose-intensity, and administered cumulative doses of Epirubicin and cyclophosphamide. Patients with admini...
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randomized trial comparing six versus three cycles of Epirubicin based adjuvant chemotherapy in premenopausal node positive breast cancer patients 10 year follow up results of the french adjuvant study group 01 trial
Journal of Clinical Oncology, 2003Co-Authors: Pierre Fumoleau, P Fargeot, P Romestaing, M Namer, Pierre Kerbrat, Alain Bremond, Simon Schraub, Mariejo Goudier, Jeanne Mihura, A MonnierAbstract:Purpose: To evaluate the duration and dose intensity of Epirubicin-based regimens in premenopausal patients with lymph node-positive breast cancer. Patients and Methods: Between 1986 and 1990, 621 patients with operable breast cancer were randomly assigned to receive fluorouracil (Roche SA, Basel, Switzerland) 500 mg/m2, Epirubicin (Pharmacia SA, Milan, Italy) 50 mg/m2, and cyclophosphamide (Asta Medica AG, Frankfurt, Germany) 500 mg/m2 every 21 days (FEC 50) for six cycles (6 FEC 50); FEC 50 for three cycles (3 FEC 50); or the same regimen with Epirubicin 75 mg/m2 (FEC 75) for three cycles (3 FEC 75). All patients in the three arms received chest wall irradiation at the end of the third cycle. Results: After a 131-month median follow-up, the 10-year disease-free survival (DFS) was 53.4%, 42.5%, and 43.6% (P = .05) in the three arms, respectively. Pairwise comparisons demonstrate that 6 FEC 50 was superior both to 3 FEC 50 (P = .02) and to 3 FEC 75 (P = .05). The 10-year overall survival (OS) for the 6 FE...
D Bloomfield - One of the best experts on this subject based on the ideXlab platform.
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accelerated versus standard Epirubicin followed by cyclophosphamide methotrexate and fluorouracil or capecitabine as adjuvant therapy for breast cancer in the randomised uk tact2 trial cruk 05 19 a multicentre phase 3 open label randomised controlled
Lancet Oncology, 2017Co-Authors: David Cameron, R E Coleman, R K Agrawal, Jp Morden, P Canney, Galina Velikova, John M S Bartlett, J Banerji, G Bertelli, D BloomfieldAbstract:Summary Background Adjuvant chemotherapy for early breast cancer has improved outcomes but causes toxicity. The UK TACT2 trial used a 2×2 factorial design to test two hypotheses: whether use of accelerated Epirubicin would improve time to tumour recurrence (TTR); and whether use of oral capecitabine instead of cyclophosphamide would be non-inferior in terms of patients' outcomes and would improve toxicity, quality of life, or both. Methods In this multicentre, phase 3, randomised, controlled trial, we enrolled patients aged 18 years or older from 129 UK centres who had histologically confirmed node-positive or high-risk node-negative operable breast cancer, had undergone complete excision, and were due to receive adjuvant chemotherapy. Patients were randomly assigned to receive four cycles of 100 mg/m 2 Epirubicin either every 3 weeks (standard Epirubicin) or every 2 weeks with 6 mg pegfilgrastim on day 2 of each cycle (accelerated Epirubicin), followed by four 4-week cycles of either classic cyclophosphamide, methotrexate, and fluorouracil (CMF; 600 mg/m 2 cyclophosphamide intravenously on days 1 and 8 or 100 mg/m 2 orally on days 1–14; 40 mg/m 2 methotrexate intravenously on days 1 and 8; and 600 mg/m 2 fluorouracil intravenously on days 1 and 8 of each cycle) or four 3-week cycles of 2500 mg/m 2 capecitabine (1250 mg/m 2 given twice daily on days 1–14 of each cycle). The randomisation schedule was computer generated in random permuted blocks, stratified by centre, number of nodes involved (none vs one to three vs four or more), age (≤50 years vs >50 years), and planned endocrine treatment (yes vs no). The primary endpoint was TTR, defined as time from randomisation to first invasive relapse or breast cancer death, with intention-to-treat analysis of standard versus accelerated Epirubicin and per-protocol analysis of CMF versus capecitabine. This trial is registered with ISRCTN, number 68068041, and with ClinicalTrials.gov, number NCT00301925. Findings From Dec 16, 2005, to Dec 5, 2008, 4391 patients (4371 women and 20 men) were recruited. At a median follow-up of 85·6 months (IQR 80·6–95·9) no significant difference was seen in the proportions of patients free from TTR events between the accelerated and standard Epirubicin groups (overall hazard ratio [HR] 0·94, 95% CI 0·81–1·09; stratified p=0·42). At 5 years, 85·9% (95% CI 84·3–87·3) of patients receiving standard Epirubicin and 87·1% (85·6–88·4) of those receiving accelerated Epirubicin were free from TTR events. 4358 patients were included in the per-protocol analysis, and no difference was seen in the proportions of patients free from TTR events between the CMF and capecitabine groups (HR 0·98, 95% CI 0·85–1.14; stratified p=0·00092 for non-inferiority). Compared with baseline, significantly more patients taking CMF than those taking capecitabine had clinically relevant worsening of quality of life at end of treatment (255 [58%] of 441 vs 235 [50%] of 475; p=0·011) and at 12 months (114 [34%] of 334 vs 89 [22%] of 401; p Interpretation We found no benefit from increasing the dose density of the anthracycline component of chemotherapy. However, capecitabine could be used in place of CMF without significant loss of efficacy and with improved quality of life. Funding Cancer Research UK, Amgen, Pfizer, and Roche.
A Monnier - One of the best experts on this subject based on the ideXlab platform.
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long term cardiac toxicity after adjuvant Epirubicin based chemotherapy in early breast cancer french adjuvant study group results
Annals of Oncology, 2006Co-Authors: P Fumoleau, P Fargeot, H Roche, P Kerbrat, J Bonneterre, P Romestaing, M Namer, A Monnier, Philippe Montcuquet, M J GoudierAbstract:Abstract Background: The aim of the study was to evaluate and compare incidence and risk factors of left ventricular dysfunction (LVD) in early breast cancer patients receiving (E+) or not (E−) Epirubicin-based adjuvant chemotherapy. Patients and methods: Among eight FASG trials, 3577 assessable patients were analyzed retrospectively: 2553 received Epirubicin, 662 received hormonotherapy alone and 362 had no systemic treatment. Chemotherapy was FEC regimen in 86% of cases (fluorouracil, Epirubicin, cyclophosphamide). Epirubicin cumulative dose was Results: Twenty delayed LVD occurred: two in E− patients and 18 in E+ patients. In E+ patients, 14 patients normalized their cardiac function or did not require further investigations, one patient was stabilized with specific treatment, two patients worsened their functions and one died of congestive heart failure. The 7-year risk of LVD was 1.36% (95% CI 0.85–1.87) in E+ patients and 0.21% (95%CI: 0.00–0.52) in E− patients (P = 0.004). Two significant risk factors were identified: age ≥65 years and body mass index >27 kg/m2. Conclusion: After a long-term follow-up, Epirubicin-related LVD risk was acceptable (1.36%) with one toxic death (0.04%). In 78% of cases, LVD were transient or well controlled.
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randomized trial comparing six versus three cycles of Epirubicin based adjuvant chemotherapy in premenopausal node positive breast cancer patients 10 year follow up results of the french adjuvant study group 01 trial
Journal of Clinical Oncology, 2003Co-Authors: Pierre Fumoleau, P Fargeot, P Romestaing, M Namer, Pierre Kerbrat, Alain Bremond, Simon Schraub, Mariejo Goudier, Jeanne Mihura, A MonnierAbstract:Purpose: To evaluate the duration and dose intensity of Epirubicin-based regimens in premenopausal patients with lymph node-positive breast cancer. Patients and Methods: Between 1986 and 1990, 621 patients with operable breast cancer were randomly assigned to receive fluorouracil (Roche SA, Basel, Switzerland) 500 mg/m2, Epirubicin (Pharmacia SA, Milan, Italy) 50 mg/m2, and cyclophosphamide (Asta Medica AG, Frankfurt, Germany) 500 mg/m2 every 21 days (FEC 50) for six cycles (6 FEC 50); FEC 50 for three cycles (3 FEC 50); or the same regimen with Epirubicin 75 mg/m2 (FEC 75) for three cycles (3 FEC 75). All patients in the three arms received chest wall irradiation at the end of the third cycle. Results: After a 131-month median follow-up, the 10-year disease-free survival (DFS) was 53.4%, 42.5%, and 43.6% (P = .05) in the three arms, respectively. Pairwise comparisons demonstrate that 6 FEC 50 was superior both to 3 FEC 50 (P = .02) and to 3 FEC 75 (P = .05). The 10-year overall survival (OS) for the 6 FE...