Cisplatin and etoposide as first-line chemotherapy for metastatic breast carcinoma: a prospective randomized trial of the Italian Oncology Group for Clinical Research.

1991 ◽  
Vol 9 (4) ◽  
pp. 664-669 ◽  
Author(s):  
G Cocconi ◽  
G Bisagni ◽  
M Bacchi ◽  
C Boni ◽  
R Bartolucci ◽  
...  
Keyword(s):  
Randomized Study ◽  
Metastatic Breast ◽  
Hematologic Toxicity ◽  
First Line ◽  
Metastatic Breast Carcinoma ◽  
Level Of Activity ◽  
Duration Of Response ◽  
Gastrointestinal Side Effects ◽  
High Level ◽  
Line Chemotherapy

In this prospective randomized study, first-line treatment with the combination of cisplatin (P) and etoposide (E) was compared with the standard cyclophosphamide, methotrexate, and fluorouracil (CMF) combination in 140 patients. Complete remissions were obtained in 11% of 65 assessable patients on CMF and in 12% of 65 assessable patients on PE. Complete plus partial remission rates were 48% on CMF and 63% on PE (P = .08). Time to progression (median, 32 v 31 weeks), duration of response (48 v 39 weeks), and survival (75 v 76 weeks) were not different. Hematologic toxicity was significantly higher with PE, and gastrointestinal side effects were frequent with this treatment. This study demonstrated that the PE combination is effective as front-line chemotherapy. As far as response rate is concerned, a trend of superiority over CMF was observed, which was of borderline significance. Due to the lack of survival advantage and to toxicity, this combination is not recommended for routine clinical use. However, its high level of activity should be taken into account for further research.

Ifosfamide and mitoxantrone as first-line chemotherapy for metastatic breast cancer.

1993 ◽  
Vol 11 (3) ◽  
pp. 461-466 ◽  
Author(s):  
J E Perez ◽  
M Machiavelli ◽  
B A Leone ◽  
A Romero ◽  
M G Rabinovich ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Metastatic Breast ◽  
Complete Response ◽  
Severe Toxicity ◽  
First Line ◽  
Metastatic Breast Carcinoma ◽  
Time To Treatment Failure ◽  
Grade 3 ◽  
Line Chemotherapy

PURPOSE A phase II trial was performed to evaluate the efficacy and toxicity of a combination of ifosfamide (IFX) and mitoxantrone (MXN) as first-line chemotherapy for metastatic breast carcinoma. PATIENTS AND METHODS Between January 1990 and August 1991, 48 patients with metastatic breast cancer were entered onto the study. Therapy consisted of IFX 2 g/m2 given as a 1-hour intravenous (IV) infusion on days 1 to 3; mesna 400 mg/m2 as an IV bolus immediately before and 4 hours after IFX administration and 2,000 mg orally 8 hours after IFX administration on days 1 to 3; and MXN 12 mg/m2 as an i.v. bolus on day 3. Cycles were repeated every 21 days until progressive disease (PD) or severe toxicity developed. RESULTS One patient was considered not assessable for response. Objective regression (OR) was observed in 28 of 47 patients (60%; 95% confidence interval, 46% to 74%). Six patients (13%) had a complete response (CR) and 22 (47%) had a partial response (PR). The median time to treatment failure for the whole group was 9 months (range, 1 to 28); median survival was 19 months (range, 2 to 28). There were no treatment-related deaths. The limiting toxicity was myelosuppression. Leukopenia occurred in 37 patients (77%) and was grade 3 or 4 in 19 patients (40%). Nausea and vomiting were observed in 38 patients (80%), mucositis in 16 patients (33%), and grade 2 hematuria in two patients (4%). Eight patients (16%) developed mild neurotoxicity. CONCLUSION The combination of IFX plus MXN is an active regimen against metastatic breast cancer with moderate toxicity that deserves further evaluation.

Vinorelbine as first-line chemotherapy for metastatic breast carcinoma.

1994 ◽  
Vol 12 (2) ◽  
pp. 336-341 ◽  
Author(s):  
A Romero ◽  
M G Rabinovich ◽  
C T Vallejo ◽  
J E Perez ◽  
R Rodriguez ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Breast Carcinoma ◽  
Objective Response ◽  
Metastatic Breast ◽  
Survival Duration ◽  
Severe Toxicity ◽  
First Line ◽  
Metastatic Breast Carcinoma ◽  
Line Chemotherapy

PURPOSE A phase II trial was performed to evaluate the efficacy and toxicity of vinorelbine (VNB) as first-line chemotherapy for metastatic breast carcinoma. PATIENTS AND METHODS Between August 1991 and February 1993, 45 patients with metastatic breast cancer were entered onto the study. Therapy consisted of VNB 30 mg/m2 diluted in 500 mL of normal saline administered as a 1-hour intravenous infusion. Injections were repeated weekly until evidence of progressive disease (PD) or severe toxicity developed. RESULTS One patient was considered not assessable for response. An objective response (OR) was observed in 18 of 44 patients (41%; 95% confidence interval, 26% to 56%). Three patients (7%) had a complete response (CR) and 15 (34%) had a partial response (PR). The median time to treatment failure for the entire group was 6 months (range, 1 to 15), and the median duration of response was 9 months (range, 1 to 15). The median survival duration has not been reached yet. There were no treatment-related deaths. The dose-limiting toxicity was myelosuppression. Leukopenia occurred in 35 patients (78%) and was grade 3 or 4 in 16 (36%). Phlebitis was observed in 19 of 29 patients (66%) who did not have central implantable venous systems. Fifteen patients (33%) developed peripheral neurotoxicity. Myalgia occurred in 20 patients (44%). CONCLUSION VNB is an active drug against metastatic breast cancer with moderate toxicity, which justifies further evaluation in association with other agents.

Preliminary results of a multicenter phase II trial of vinflunine (with trastuzumab in HER2+ pts) as first-line treatment in metastatic breast cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 1043-1043 ◽  
Author(s):  
N. W. Peacock ◽  
D. R. Spigel ◽  
M. G. Mainwaring ◽  
D. S. Thompson ◽  
L. Simons ◽  
...  
Keyword(s):  
De Novo ◽  
Vinca Alkaloid ◽  
Metastatic Breast ◽  
Stage Iv ◽  
First Line ◽  
Microtubule Inhibitor ◽  
Level Of Activity ◽  
Significant Efficacy ◽  
High Level ◽  
Ecog Ps

1043 Background: Vinflunine (VFL) is a new and innovative microtubule inhibitor of the vinca alkaloid class that achieves high intracellular concentrations. By inhibition of tubulin polymerization, cell proliferation is arrested leading to apoptotic death. Demonstrating anti- angiogenic and vascular disrupting activities, VFL has demonstrated significant efficacy as 2nd line chemotherapy in MBC (M. Campone, BJC 2006). This trial was designed to evaluate the response rate and safety of VFL as 1st line therapy in MBC as well as its activity in combination with trastuzumab in HER2+ MBC pts. Methods: Eligibility: 0 prior regimens for MBC, > 6 mo from adjuvant therapy, RECIST measurable disease, ECOG PS 0–2, adequate organ function, < G2 neuropathy. Treatment: 320 mg/m2 IV over 20 minutes q3 weeks; 280 mg/m2 with trastuzumab 6 mg/kg q3 weeks in HER2+ pts. Response evaluations q9 weeks; treatment continued until progression or toxicity. A total of 96 pts will be enrolled, 48 pts per each of 2 cohorts, HER2- and HER2+. Results: 18 pts are enrolled, 13 pts evaluable for toxicity and 12 pts for response. 3 pts received VFL monotherapy and 10 pts were treated with VFL + trastuzumab. Median age: 59 years (43–78). ECOG PS 0: 9 pts, 1: 3 pts, 2: 1 pt. Prior adjuvant chemo: 7 pts (54%), with 5 prior anthracyclines and 6 prior taxanes. 2 pts received adjuvant hormonal therapy only. 4 pts presented with de novo stage IV HER2+ MBC. Metastatic disease sites: liver: 6 pts, lung: 7 pts, bone: 5 pts, lymph nodes: 6 pts. 46% had 3 or more sites of organ involvement. Median of 3 cycles (range:1 - 11) was delivered. 7 pts (58%, all HER2+) had a PR and 4 pts (33%) achieved SD. Only 1 pt progressed. Heme toxicity: G3/4 neutropenia: 2 pts (16%); no febrile neutropenia was noted. G3 non-heme toxicity consisted of N/V: 2 pts and myalgia, 2 pts. There were no G4 events. 4 pts were hospitalized (vomiting: 2, cerebro-vascular accident: 1, back pain: 1 pt). 92% of pts remain free of progression at 6 months. Median TTP has not been reached. Conclusions: Vinflunine is a promising new drug with a high level of activity as first line MBC therapy, especially in combination with trastuzumab. VFL is well tolerated in this patient population with a manageable toxicity profile. Accrual to this trial continues. [Table: see text]

scholarly journals A phase II study of paclitaxel plus carboplatin as first-line chemotherapy for women with metastatic breast carcinoma

Cancer ◽  
2000 ◽  
Vol 88 (1) ◽  
pp. 124-131 ◽  
Author(s):  
Edith A. Perez ◽  
David W. Hillman ◽  
Philip J. Stella ◽  
James E. Krook ◽  
Lynn C. Hartmann ◽  
...  
Keyword(s):  
Breast Carcinoma ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Metastatic Breast ◽  
First Line ◽  
Metastatic Breast Carcinoma ◽  
Line Chemotherapy

scholarly journals Taxanes with anthracyclines as first-line chemotherapy for metastatic breast carcinoma

Cancer ◽  
2005 ◽  
Vol 103 (4) ◽  
pp. 672-679 ◽  
Author(s):  
Emilio Bria ◽  
Diana Giannarelli ◽  
Alessandra Felici ◽  
William P. Peters ◽  
Cecilia Nisticò ◽  
...  
Keyword(s):  
Breast Carcinoma ◽  
Metastatic Breast ◽  
First Line ◽  
Metastatic Breast Carcinoma ◽  
Line Chemotherapy

Vinorelbine and Paclitaxel as First-Line Chemotherapy in Metastatic Breast Cancer

1999 ◽  
Vol 17 (1) ◽  
pp. 74-74 ◽  
Author(s):  
L. Romero Acuña ◽  
M. Langhi ◽  
J. Pérez ◽  
J. Romero Acuña ◽  
M. Machiavelli ◽  
...  
Keyword(s):  
Performance Status ◽  
Metastatic Breast ◽  
Survival Duration ◽  
Significant Activity ◽  
First Line ◽  
Peripheral Neurotoxicity ◽  
Metastatic Breast Carcinoma ◽  
Time To Treatment Failure ◽  
Grade 3 ◽  
Line Chemotherapy

PURPOSE: To evaluate the efficacy and toxicity of a combination of vinorelbine (VNB) and paclitaxel (PTX) as first-line chemotherapy in metastatic breast carcinoma (MBC). PATIENTS AND METHODS: Between August 1995 and August 1997, 49 patients with untreated MBC received a regimen that consisted of VNB 30 mg/m2 in a 20-minute intravenous (IV) infusion on days 1 and 8 and PTX 135 mg/m2 in a 3-hour IV infusion (starting 1 hour after VNB) on day 1. Cycles were repeated every 28 days. The median age of the patients was 52 years, and 59% of patients were postmenopausal. Median performance status was 1. Dominant sites of disease were soft tissue in 6%, bone in 29%, and viscera in 65%. RESULTS: Objective responses were recorded in 27 of 45 assessable patients (60%; 95% confidence interval, 46% to 74%). Complete remissions occurred in three patients (7%), and partial remissions occurred in 24 patients (53%). No change was recorded in 12 patients (27%), and progressive disease occurred in six patients (13%). The median time to treatment failure was 7 months, and median survival duration was 17 months. The limiting toxicity was myelosuppression, mainly leukopenia in 49 patients (100%) (grade 1 to grade 2, four patients; grade 3, 30 patients; and grade 4, 15 patients). Neutropenia was observed in 100% of patients (grade 1 to grade 2, three patients; grade 3, 11 patients; grade 4, 35 patients). Two treatment-related deaths due to febrile neutropenia were observed in patients with massive liver involvement. Peripheral neurotoxicity developed in 33 patients (67%) (grade 1, 25 patients; grade 2, eight patients); there were no grade 3 or grade 4 episodes. CONCLUSION: The combination of VNB-PTX showed significant activity as first-line chemotherapy for patients with MBC. Myelosuppression was the dose-limiting side effect, whereas neurotoxicity was mild to moderate.

Mitomycin «C» and Vinorelbine as Second Line Chemotherapy for Metastatic Breast Carcinoma

1994 ◽  
Vol 80 (1) ◽  
pp. 33-36 ◽  
Author(s):  
Biagio Agostara ◽  
Vittorio Gebbia ◽  
Antonio Testa ◽  
Maria Pia Cusimano ◽  
Nicolò Gebbia ◽  
...  
Keyword(s):  
Breast Carcinoma ◽  
Mitomycin C ◽  
Median Duration ◽  
Metastatic Breast ◽  
Outpatient Basis ◽  
Second Line ◽  
First Line ◽  
Metastatic Breast Carcinoma ◽  
Second Line Chemotherapy ◽  
Line Chemotherapy

Aims and background Patients with metastatic breast carcinoma resistant to first line chemotherapy may require further treatment. Results o second line chemotherapy are still largerly unsatisfactory. For this reason a phase II study on the combination of mitomycin C and vinorelbine was carried out. Methods Forty patients with anthracycline pretreated metastatic breast cancer were treated with a combination of mitomycin C 10 mg/m2 i.v. on day 1, and vinorelbine 25 mg/m2 i.v. on days 1 and 8. This cycle was repeated every 28 days. Responses were evaluated according to the WHO criteria. Results A major objective response was recorded in 16 cases (40%; 95% confidence limits 32%-48%), with 2 patients (5%) obtaining a complete response with a median duration of 8.0+ months, and 14 (35%) a partial response with a median duration of 7.3+ months. Nine patients (23%) showed no change, and 15 progressed. Patients who did not meet the minimal required criteria to be evaluable were considered as treatment failures. Responses were seen at all sites of disease, but skin, nodal, and soft tissue lesion were more che-mosensitive than liver, lung, and bone ones. The mean survival of patients with complete and partial responses was 8.9+ months, whereas that of patients with no change or progressive disease was 7.8 and 6.0 months respectively. Treatment was very well tolerated by most patients. Gastrointestinal toxicity was mild. Grade 2 leukopenia was recorder in 45% of patients, and grade 3 leukopenia in only 10%. Grade 2 thrombocytopenia was seen in 5%. Reversible mild to moderate constipation occurred in 45%, but no case of severe neurotoxicity was observed. Conclusions Our data suggest that the combination of mitomycin C and vinorelbine is active in metastatic breast carcinoma refractory to first line chemotherapy containing anthracyclines, and may be safely administered on an outpatient basis.

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