Gemcitabine and vinorelbine in pretreated advanced breast cancer: A pilot study

Valenza, Roberto; Leonardi, V.; Gebbia, Vittorio; Agostara, Biagio

doi:10.1023/a:1008348704373

Cited by 38 publications

(27 citation statements)

References 5 publications

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“…For the use of gemcitabine-vinorelbine, an RR of 22∼55.5% and a TTP of 6.8∼9.5 months for first-line and second line treatments have been reported (17)(18)(19). For the use of capecitabine, an RR of 28% and a TTP of 4.9 months for second-line to fifth-line treatment have been reported (20).…”

Section: Discussionmentioning

confidence: 99%

Phase II Study of Gemcitabine plus Cisplatin in Patients with Anthracycline- and Taxane- Pretreated Metastatic Breast Cancer

Kim

Kwon

et al. 2008

Cancer Res Treat

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Purpose: Metastatic breast cancer patients are usually exposed to taxane and anthracycline as neoadjuvant, adjuvant and palliative chemotherapeutic agents. This study was designed to determine the efficacy and safety of the use of a gemcitabine and cisplatin (GP) combination treatment in patients with metastatic breast cancer that were pretreated with anthracycline and taxane. Materials and Methods:We evaluated the use of a GP regimen (1,000 mg/m 2 gemcitabine administered on days 1 and 8 plus 60 mg/m 2 cisplatin administered on day 1 every 3 weeks) in 38 breast cancer patients who had received prior chemotherapy with anthracycline and taxane as an adjuvant or neoadjuvant therapy, or as a palliative therapy.Results

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Section: Discussionmentioning

confidence: 99%

Phase II Study of Gemcitabine plus Cisplatin in Patients with Anthracycline- and Taxane- Pretreated Metastatic Breast Cancer

Kim

Kwon

et al. 2008

Cancer Res Treat

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“…The T-gem-vin combination was chosen on the basis of experimental data demonstrating additive or synergistic activity among these drugs (15), and clinical trials confirming the clinical activity and safety of gemcitabine and vinorelbine in previously treated MBC (18)(19)(20)(21). In particular, the results of our previously published phase I-II study suggested that the gemcitabine-vinorelbine combination, using the same schedule and dose tested in this study, is an active and well-tolerated second-line therapy in patients pretreated with both anthracyclines and taxanes (22).…”

Section: Discussionmentioning

confidence: 99%

“…Preclinical data suggest that the combination of trastuzumab with the antimetabolite gemcitabine or the semisynthetic vinca alkaloid vinorelbine has additive or synergistic activity (15). Gemcitabine and vinorelbine have demonstrated satisfactory antitumoral activity as single agents in metastatic breast cancer (16) and, due to the substantial antitumoral activity of the two drugs, different mechanisms of action and favorable toxicological profile, their combined use has been successfully tested for the palliative treatment of advanced (17)(18)(19)(20) and also active in patients with progressive disease after anthracyclines and taxanes (21). Taken together, these pre-clinical and clinical data suggest that the combination of trastuzumab, gemcitabine and vinorelbine is a potentially active and safe treatment for previously treated patients with HER-2/neu-positive MBC.…”

Section: Introductionmentioning

confidence: 99%

Trastuzumab in combination with gemcitabine and vinorelbine as second-line therapy for HER-2/neu overexpressing metastatic breast cancer

Morabito,

Longo,

Gattuso

et al. 2006

Oncol Rep

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Abstract. The aim of this study was to evaluate the safety and efficacy of combined treatment with trastuzumab (T), gemcitabine (gem) and vinorelbine (vin) as second-line therapy for HER-2 overexpressing metastatic breast cancer, pretreated with anthracyclines and/or taxanes and/or trastuzumab. Eligible patients had HER-2/neu-positive disease (IHC 2+ or 3+), performance status (PS) ≤2 and normal L-VEF. Patients were treated with weekly T (4 mg/kg on day 0, then 2 mg/kg), in combination with gem (800 mg/m 2 ) and vin (25 mg/m 2 ) on days 1 and 8, every 21 days. Patients were restaged every 3 cycles. A total of 30 patients (median age, 58 years; range, 41-74) were enrolled in the study. Fifteen patients were HER-2 3+ and 26 (86.7%) presented ≥2 metastatic sites. Of the patients, 7 (23.3%) had received trastuzumab as first-line therapy. Treatment was welltolerated with grade 4 neutropenia in 6 patients, grade 3 thrombocytopenia and grade 3 anemia in 1 patient, and grade 3 asthenia in 4 patients. Fifteen patients obtained an objective response (response rate, 50%; C.I. 95%, range, 31.3-68.7%). Among the patients with HER-2/neu 3+, the response rate was 73.3%. Noteworthy were 4 objective responses observed in patients with brain metastasis. Also, 7 patients had stable disease (23.3%). Median progression-free survival was 7 months (range 5-10), and median overall survival was 15 months (range 5-33). T-gem-vin is a safe and active regimen in this subgroup of patients with poor prognosis, and the efficacy of such a schedule was particularly satisfactory in patients with HercepTest 3+.

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“…Two additional studies that applied 4-week regimens of gemcitabine plus vinorelbine, but solely as second-line therapy (after anthracyclines B taxanes), achieved response rates of 48 and 54%, respectively [59,60]. Threeweek regimens using identical schedules but slightly different doses of gemcitabine or vinorelbine as second-or third-line therapy produced lower response rates of 22% [61,62] or 39% [63].…”

Section: Gemcitabine Plus Vinorelbinementioning

confidence: 99%

Role of Gemcitabine in the Treatment of Advanced and Metastatic Breast Cancer

Heinemann¹

2003

Oncology

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Gemcitabine is an antimetabolite drug with proven antitumor activity and tolerability in metastatic breast cancer. In a total of nine studies, gemcitabine monotherapy has reached response rates of up to 37% in the first-line setting, 26% in the second-line setting, and 18% or better in the third-line setting. Gemcitabine is an excellent choice for combination therapy by its unique mechanism of action and favorable toxicity profile, thus limiting the risk of pretreatment-related drug resistance and overlapping toxicity, and by its potential for synergistic interaction with some combination partners as indicated in preclinical studies. Numerous phase II clinical studies have combined gemcitabine with other active agents such as the taxanes, vinorelbine, vindesine, cisplatin, 5-fluorouracil, as well as anthracyclines across various regimens and conditions of pretreatment. Most of these two-drug combinations have consistently demonstrated higher efficacy than either single agent, particularly in pretreated patients. Even higher efficacy has been obtained with triple-drug regimens including gemcitabine, anthracyclines (epirubicin or doxorubicin), and paclitaxel; these regimens have yielded overall response rates of 58-92% as first-line treatment. In view of these results, gemcitabine may be regarded as a valuable alternative to the palliative treatment of metastatic breast cancer, and an excellent option for the development of effective combination treatment not only in first-line therapy, but also for intensively pretreated patients previously exposed to anthracyclines and/or the taxanes.

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Gemcitabine and vinorelbine in pretreated advanced breast cancer: A pilot study

Abstract: The GEM-VNR combination seems to be active in pretreated ABC with an acceptable toxicity pattern, and may well reppresent an interesting therapeutic choice after anthracycline/taxane regimens.

Cited by 38 publications

References 5 publications

Phase II Study of Gemcitabine plus Cisplatin in Patients with Anthracycline- and Taxane- Pretreated Metastatic Breast Cancer

Phase II Study of Gemcitabine plus Cisplatin in Patients with Anthracycline- and Taxane- Pretreated Metastatic Breast Cancer

Trastuzumab in combination with gemcitabine and vinorelbine as second-line therapy for HER-2/neu overexpressing metastatic breast cancer

Role of Gemcitabine in the Treatment of Advanced and Metastatic Breast Cancer

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