Vinorelbine as first-line chemotherapy for metastatic breast carcinoma.

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.

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

Journal of Clinical Oncology ◽

10.1200/jco.1993.11.3.461 ◽

1993 ◽

Vol 11 (3) ◽

pp. 461-466 ◽

Cited By ~ 1

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.

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

Journal of Clinical Oncology ◽

10.1200/jco.1996.14.11.2993 ◽

1996 ◽

Vol 14 (11) ◽

pp. 2993-2999 ◽

Cited By ~ 12

Author(s):

B A Leone ◽

C T Vallejo ◽

A O Romero ◽

J E Perez ◽

M A Cuevas ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Peripheral Neuropathy ◽

Progressive Disease ◽

Metastatic Breast ◽

Survival Duration ◽

First Line ◽

Half Dose ◽

Time To Treatment Failure ◽

Line Chemotherapy

PURPOSE To evaluate the efficacy and toxicity of the combination of ifosfamide (IFX) and vinorelbine (VNB) as first-line chemotherapy in metastatic breast cancer (MBC). PATIENTS AND METHODS Between August 1993 and August 1995, 45 patients with untreated MBC received a regimen that consisted of IFX 2 g/m2 by 1-hour intravenous (i.v.) infusion on days 1 to 3, mesna 400 mg/m2 by i.v. bolus at hours 0 and 4 and 800 mg/m2 orally at hour 8 on days 1 to 3, and VNB 35 mg/m2 by 20-minute i.v. infusion on days 1 and 15. Courses were repeated every 28 days. During the first course only, half-dose VNB (17.5 mg/m2) was administered on days 8 and 22. The median age was 53 years and 30 patients (67%) were postmenopausal. Dominant sites of disease were soft tissue in nine patients, bone in seven, and visceral in 29. RESULTS Objective responses (ORs) were recorded in 25 of 43 assessable patients (58%; 95% confidence interval, 43% to 73%). Complete remissions (CRs) occurred in six patients (14%) and partial remissions (PRs) in 19 (44%). No change (NC) was recorded in 10 patients (23%) and progressive disease (PD) in eight patients (19%). The median time to treatment failure was 12 months and the median survival duration 19 months. Myelosuppression was the limiting toxicity, mainly leukopenia in 32 patients (74%). In contrast, anemia and thrombocytopenia were mild. Other significant toxicities included peripheral neuropathy in nine patients (21%), constipation in 15 (35%), and myalgias in 11 (26%). CONCLUSION IFX/VNB is an active combination against MBC with moderate toxicity and deserves further evaluation.

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Phase II Study of Docetaxel, Doxorubicin, and Cyclophosphamide as First-Line Chemotherapy for Metastatic Breast Cancer

Journal of Clinical Oncology ◽

10.1200/jco.2001.19.2.314 ◽

2001 ◽

Vol 19 (2) ◽

pp. 314-321 ◽

Cited By ~ 79

Author(s):

J. M. Nabholtz ◽

J. R. Mackey ◽

M. Smylie ◽

A. Paterson ◽

D. R. Noël ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Phase Ii ◽

Phase Ii Study ◽

Objective Response ◽

Metastatic Breast ◽

Fluid Retention ◽

First Line ◽

Grade 3 ◽

Line Chemotherapy

PURPOSE: This pilot phase II study investigated the efficacy and toxicity of docetaxel with doxorubicin and cyclophosphamide (TAC) as first-line chemotherapy for anthracycline-naive patients with metastatic breast cancer. PATIENTS AND METHODS: Fifty-four patients received a total of 359 courses consisting of docetaxel 75 mg/m2 given intravenously (IV) over 1 hour, preceded by IV doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 for a maximum of eight 3-week cycles. RESULTS: After an independent panel review, the overall objective response rate was 77% (complete response, 6%). Overall objective response rates in patients with visceral, bone, and liver involvement were 82%, 82%, and 80%, respectively. Median duration of response was 52 weeks, and median time to progression was 42 weeks. With a median follow-up of 32 months, the median survival had not yet been reached, whereas the 2-year survival was 57%. The main toxicities were hematologic (neutropenia grade 3/4 in 100% of patients and 95% of cycles; febrile neutropenia in 34% of patients and 9% of cycles). Documented grade 3 infection was seen in one patient (2%) in one cycle, and no toxic death was reported. Severe acute or chronic nonhematologic adverse events were infrequent, and docetaxel-specific toxicities (such as fluid retention and nail changes) were mild, with only one patient being discontinued for fluid retention. Congestive heart failure was seen in two patients (4%). CONCLUSION: TAC is an active and manageable regimen that has been chosen as the basis of five randomized phase III trials, including two pivotal studies comparing TAC to fluorouracil plus doxorubicin and cyclophosphamide in the metastatic and adjuvant treatment of breast cancer.

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CYCLIN-EPENDENT KINASES 4/6 INHIBITORS IN COMBINATION WITH AROMATASE INHIBITORS IN TREATMENT OF METASTATIC BREAST CANCER (clinical observation)

International Medical Journal ◽

10.37436/2308-5274-2020-1-8 ◽

2020 ◽

pp. 39-41

Author(s):

M. V. Sadchikova ◽

L. V. Syniavina ◽

N. M. Otchenash

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Hormone Therapy ◽

Aromatase Inhibitors ◽

Objective Response ◽

Metastatic Breast ◽

Complete Recovery ◽

Severe Toxicity ◽

First Line ◽

First Line Therapy

It is known that a complete recovery in patients with generalized tumor is impossible, but the use of effective treatment regimens can significantly inhibit the development of the disease. The main goal of treatment of metastatic breast cancer is to increase overall survival, time to disease progression, improvethe quality of life, to prevent serious complications. In recent years, the standard of first−line hormone therapy in postmenopausal patients has been the use of aromatase inhibitors. Recently, a new class of drugs has emerged that can increase the effectiveness of hormone therapy, which significantly strengthens the position of this method in metastatic breast cancer. A clinical trial of PALOMA−2 and its findings are presented: the palbociclib + letrozole protocol as first−line therapy in postmenopausal patients with estrogen−positive Her2 new negative advanced breast cancer improves the objective response rate and clinical efficacy compared to letrozole monotherapy. The overall incidence of adverse responses was higher in patients treated with palbociclib + letrozole compared with placebo + letrozole. This clinical case demonstrates the possibility of long−term effective disease control in metastatic breast cancer. Literature data and personal experience show high efficacy of the combined protocol of hormone therapy and inhibitors of cyclin−dependent kinases 4/6. The use of such protocols is advisable in patients with multiple bone metastases, while achieving an effective reduction of pain. The use of such regimens is possible in patients with a low ECOG score who cannot tolerate chemotherapy with more severe toxicity. Key words: metastatic breast cancer, aromatase inhibitors, palbociclib.

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