A phase-II clinical trial of 4?-epi-doxorubicin in advanced solid tumors

Martoni, Andrea; Giovannini, M; Tomasi, Luciana; Camaggi, C. M.; Bellanova, B; Monetti, Nino; Rossini, Giovanni; Tarquinii, M; Martini, A.; Pannuti, F

doi:10.1007/bf00256541

Cited by 22 publications

(4 citation statements)

References 2 publications

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“…The objective response rate of the present study is comparable to the results obtained in the seventies in phase II trials of ADR as single agent in the standard therapeutic regimen of 60 mg/m2 intravenously every 3 weeks in pretreated breast cancer patients [22], Similar rates of objective responses were obtained in phase II trials of EPI used at dosages of 60 95 mg/m2 every 3 weeks in more recent trials [6,8,10,13,23], Doxorubicin used in a weekly schedule, preceded or not by a loading course, was demonstrated having an activity comparable to that of the usual regimen first by Weiss et al [14] and Weiss and Manthei [15], and also by Bonadonna et al [24] in initial phase II studies, subsequently by Creech et al [16] and Chlebowski et al [17]. In all these series of patients, the response rate of breast cancer patients was about 30%.…”

Section: Comment and Discussionsupporting

confidence: 75%

Epirubicin Treatment of Advanced Breast Carcinoma with the Weekly Low-Dose Regimen

Beretta¹,

Locatelli²,

Tabiadon³

et al. 1987

Oncology

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Authors describe the results obtained with weekly low-dose (20 or 30 mg/total) of intravenous bolus epirubicin, used as second line chemotherapy, after CMF, in 29 advanced breast carcinoma patients. 29% objective response rate (1 complete + 6 partial responses) has been observed in 24 evaluable patients, with median response duration of 4 months (range 1–7⁺). The discrete response rate and the minimal incidence of side effects call for further studies and more extensive evaluation of epirubicin given alone or in combination through this new treatment schedule.

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Section: Comment and Discussionsupporting

confidence: 75%

Epirubicin Treatment of Advanced Breast Carcinoma with the Weekly Low-Dose Regimen

Beretta¹,

Locatelli²,

Tabiadon³

et al. 1987

Oncology

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“…Epirubicin has been extensively evaluated as single agent in NSCLC (Table 11) (150)(151)(152)(153)(154)(155)(156)(157)(158). Overall, the response rate among 296 patients in 9 studies was only 6%.…”

Section: Nsclc Phase II Trials Single Agentsmentioning

confidence: 99%

“…Seven early phase I1 trials all used the 3-weekly schedule (154,(219)(220)(221)(222)(223)(224). The average response rate in 147 patients is 25%, but these trials were all very small, recruiting from 13-36 patients with response rates ranging from 6% to 43%.…”

Section: Advanced Breast Cancer Phase II Trialsmentioning

confidence: 99%

Current Status of Epirubicin (Farmorubicin) in the Treatment of Solid Tumours

et al. 1990

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“…4″-epidoxorubicin (epirubicin) is a less cardiotoxic synthetic analogue of doxorubicin. When administered at doses up to 90 mg m -2 , single-agent epirubicin is not active in NSCLC (Kalman et al, 1983;Joss et al, 1984;Martoni et al, 1984;Meyers et al, 1986). In contrast, high-dose epirubicin (120-150 mg m -2 every 4 weeks) resulted in response rates ranging from 19-36% in chemotherapynaive patients with advanced NSCLC (Wils et al, 1990;Feld et al, 1992;Smit et al, 1992).…”

mentioning

confidence: 99%

True

2001

Br J Cancer

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The purpose of this study is to determine whether it is feasible to administer high-dose epirubicin (135 mg m-2) combined with a fixed dose of cisplatin every 2 weeks with G-CSF support in patients with metastatic non-small-cell lung cancer (NSCLC). Subsequently, the efficacy of the recommended dose of this regimen was tested in a phase II study in patients with relapsed NSCLC. In the initial feasibility study at least 6 patients were entered at each of the 4 dose levels tested. A fixed dose of cisplatin 60 mg m-2 was given. Epirubicin was administered at 120 mg m-2 on dose level 1, 135 mg m-2 on dose level 2 and 3 and 135 mg m-2 on dose level 4. Patients treated at dose level 3 and 4 received G-CSF support on days 3-12. Cycles were repeated every 3 weeks on the first 3 dose levels and every 2 weeks on the fourth dose level. A total of 27 patients were then treated on dose level 4, which appeared to be feasible in the initial study. In the initial study, a total of 86 courses were administered. Haematological toxicity was the principal side effect. None of the patients encountered dose-limiting toxicity in the first course, which confirmed that epirubicin 135 mg m-2 could be combined with cisplatin 60 mg m-2 and accelerated by G-CSF support to a 14-day-schedule. In the subsequent phase II study with this schedule, 89 courses were administered. The relative dose intensity of cisplatin and epirubicin was 0.90 and 0.91, respectively. Myelosuppression was frequent with 70% and 63% of patients experiencing WHO grade III or IV leukocytopenia and thrombocytopenia, respectively. 6 cases of febrile neutropenia were observed, with 2 treatment-related deaths. Non-haematological toxicity consisted mainly of nausea and vomiting, which was grade III in 22% of patients. Renal toxicity grade I and II occurred in 37% and 4% of patients, respectively. 55% of these patients had received prior cisplatin-containing chemotherapy. On an intention-to-treat basis 9 partial responses were recorded in 27 patients (33%; 95% confidence interval, 15%-51%). Accelerated cisplatin and high-dose epirubicin with G-CSF support is a feasible and promising regimen in relapsed NSCLC. Myelosuppression limits the use of this regimen in the second-line setting to a selected group of patients with a good performance status. Since the activity of this regimen is encouraging, it is probably best studied in untreated patients.

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A phase-II clinical trial of 4?-epi-doxorubicin in advanced solid tumors

Cited by 22 publications

References 2 publications

Epirubicin Treatment of Advanced Breast Carcinoma with the Weekly Low-Dose Regimen

Epirubicin Treatment of Advanced Breast Carcinoma with the Weekly Low-Dose Regimen

Current Status of Epirubicin (Farmorubicin) in the Treatment of Solid Tumours

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