Liposomal doxorubicin and weekly paclitaxel in the treatment of metastatic breast cancer

Schwonzen, Martin; Kurbacher, Christian M.; Mallmann, Peter

doi:10.1097/00001813-200010000-00002

Cited by 61 publications

(30 citation statements)

References 12 publications

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“…A series of phase I studies have evaluated the combination of Caelyx TM with the novel agents gemcitabine, vinorelbine and paclitaxel with encouraging response rates and acceptable toxicity profiles (Burstein et al, 1999;Schwonzen et al, 2000;Rivera et al, 2001). In a recent phase I study, DaunoXome was substituted for doxorubicin in the conventional CHOP regimen to treat patients with low or intermediate non-Hodgkin's lymphomas.…”

Section: Discussionmentioning

confidence: 99%

A phase I dose-escalating study of DaunoXome, liposomal daunorubicin, in metastatic breast cancer

et al. 2002

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The aims of this phase I study were to establish the maximum tolerated dose, safety profile and activity of liposomal daunorubicin, DaunoXome (NeXstar Pharmaceuticals), in the treatment of metastatic breast cancer. DaunoXome was administered intravenously over 2 h in 21 day cycles and doses were increased from 80 to 100, 120 and 150 mg m 2 . Sixteen patients were enrolled. A total of 70 cycles of DaunoXome were administered. The maximum tolerated dose was 120 mg m 2 , the dose-limiting toxicity being prolonged grade 4 neutropenia or neutropenic pyrexia necessitating dose reductions at 120 and 150 mg m 2 . Asymptomatic cardiotoxicity was observed in three patients: grade 1 in one treated with a cumulative dose of 800 mg m 2 and grade 2 in two, one who received a cumulative dose of 960 mg m 2 and the other a cumulative dose of 600 mg m 2 with a previous neoadjuvant doxorubicin chemotherapy of 300 mg m 2 . Tumour response was evaluable in 15 patients, of whom two had objective responses, six had stable disease and seven had progressive disease. In conclusion, DaunoXome is associated with mild, manageable toxicities and has anti-tumour activity in metastatic breast cancer. The findings support further phase II evaluation of DaunoXome alone and in combination with other standard nonanthracycline cytotoxic or novel targeted agents. Although the dose-limiting toxicity for DaunoXome was febrile neutropenia at 120 mg m 2 , we would recommend this dose for further evaluation, as the febrile neutropenia occurred after four or more cycles in three of the four episodes seen, was short lived and uncomplicated.

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Section: Discussionmentioning

confidence: 99%

A phase I dose-escalating study of DaunoXome, liposomal daunorubicin, in metastatic breast cancer

et al. 2002

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“…In fact, according to the favorable toxicity profile and good activity against MBC, PDOX has also been tested in combination with other agents such as taxanes, 5-fluorouracil and cyclophosphamide. PDOX 20 mg/m 2 every 2 weeks has been employed in combination with paclitaxel 100 mg/m 2 on days 1 and 8 in a series of 22 MBC patients, achieving a 48% ORR and 2 CRs [44]. The main toxicities were leukopenia, alopecia, and neuropathy [44].…”

Section: Discussionmentioning

confidence: 99%

Pegylated Liposomal Doxorubicin with Vinorelbine in Metastatic Breast Carcinoma

Gebbia

Mauceri²,

Fallica³

et al. 2002

Oncology

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A multicenter phase I-II trial was carried out with the aim of identifying the dose-limiting toxicity and the maximum tolerated dose of vinorelbine (VNR) in combination with pegylated liposomal doxorubicin at a dose of 20 mg/m² every 15 days in patients with metastatic breast carcinoma. In the phase I part of the trial, VNR was given at a dose of 20 mg/m² every 15 days to a group of 3 patients. In absence of unacceptable toxicity, VNR was escalated to 25, 30, and 35 mg/m² for subsequent groups of 3 patients, until the dose-limiting toxicity was reached. No case of palmar-plantar erythrodysesthesia was recorded in these patients. Grade 4 neutropenia, grade 3 thrombocytopenia, and grade 3 mucositis were the dose-limiting toxicities recorded in patients treated with VNR 35 mg/m². These side effects caused a substantial decrease in programmed dose intensity. Therefore 30 mg/m² was considered the maximum tolerated dose of VNR in combination with pegylated liposomal doxorubicin 20 mg/m², both given every 15 days. These dosages were employed for the treatment of further 18 patients included in phase II of the study. The overall response rate, calculated according to an intention to treat analysis, was 63% (95% CI: 44–80%), with 2 patients achieving a complete response. The median time to progression was 7.0 months or more (range 2–14 months). Median duration of objective responses was 8.4 months or more. The duration of the 2 complete responses was 9 and 14 months, respectively. Median duration of survival was 16.0 months or more (range from 4.0 to ≧24.0). Toxicity was generally mild and easily manageable. Neutropenia and mucositis were the most frequently recorded side effects. A case of palmar-plantar erythrodysesthesia was recorded in phase II of the study. In conclusion, the maximum tolerated dose of VNR in association with pegylated liposomal doxorubicin is 30 mg/m² on a bimonthly schedule. Moreover, the combination of VNR and pegylated liposomal doxorubicin is active against metastatic breast carcinoma and is associated with a good toxicity profile. Further studies with this combination regimen are warranted.

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“…Weekly paclitaxel has been studied in combination with anthracyclines, platinum agents, and trastuzumab (Table 4) [74][75][76][77][78].…”

Section: Weekly Paclitaxel-based Combination Regimens In Mbcmentioning

confidence: 99%

Weekly Administration of Docetaxel and Paclitaxel in Metastatic or Advanced Breast Cancer

2005

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Liposomal doxorubicin and weekly paclitaxel in the treatment of metastatic breast cancer

Cited by 61 publications

References 12 publications

A phase I dose-escalating study of DaunoXome, liposomal daunorubicin, in metastatic breast cancer

A phase I dose-escalating study of DaunoXome, liposomal daunorubicin, in metastatic breast cancer

Pegylated Liposomal Doxorubicin with Vinorelbine in Metastatic Breast Carcinoma

Weekly Administration of Docetaxel and Paclitaxel in Metastatic or Advanced Breast Cancer

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