Paclitaxel, Epirubicin and Capecitabine (TEX) as First-Line Treatment for Metastatic Breast Cancer: A Pilot Phase I/II Feasibility Study

Thirteen patients with untreated metastatic breast cancer received epirubicin 60 mg/m2, paclitaxel 155 mg/m2 (both day 1) and capecitabine 665 mg/m2 twice daily (days 1-14) every 21 days, with intra-patient dose escalation/reduction. Grade 3/4 events were infrequent. Nine patients (69%) achieved an objective response. Median time to progression and overall survival were 6.6 and 23.5 months, respectively.

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Gemcitabine in metastatic breast cancer

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.10735 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 10735-10735 ◽

Cited By ~ 1

Author(s):

A. Bensalem ◽

K. Bouzid

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Clinical Benefit ◽

Objective Response ◽

Metastatic Breast ◽

Complete Response ◽

Hematologic Toxicity ◽

Line Treatment ◽

First Line ◽

First Line Treatment

10735 Background: Gemcitabine (GEM) has shown efficacy in metastatic breast cancer (MBC). We conducted studies with GEM-based regimens to assess the efficacy and toxicity of GEM combined with other drugs in MBC. GEM was combined with docetaxel (DXL) in pre-treated MBC with an anthracycline-based regimen and GEM was combined with doxorubicin (DXR) in chemonaive patients (pts) with MBC. The studies’ objectives were to show clinically relevant hematologic toxicity and response rates among pts treated with GEM-DXL either in combination in pre-treated pts with anthracycline regimen or GEM-DXR in chemonaive pts with MBC to assess the efficacy of GEM in MBC either in neoadjuvant or first-line treatment. Methods: For GEM-DXL: 42 pts were enrolled; GEM: 1250 mg /m2 D1 & D8, DXL: 75 mg /m2 D1, every 21 days with classical premedication for DXL. For GEM-DXR: 51 pts were enrolled; GEM: 1250 mg /m2 D1 & D 8, DXR: 25 mg/m2 D1 & D8, every 21 days. Results: See table below. In the GEM-DXR group, surgery was performed in 30 pts, and 13 (43.2%) had histologically complete response. The median TTP in this group was 13.3 months (range, 2–53). Conclusions: GEM in MBC is very efficient and produced an interesting objective response and clinical benefit. This activity is consistent in either chemonaive pts or in pts with relapsing breast cancer. [Table: see text] No significant financial relationships to disclose.

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Vinorelbine with or without Trastuzumab in Metastatic Breast Cancer: A Retrospective Single Institution Series

ISRN Oncology ◽

10.1155/2014/289836 ◽

2014 ◽

Vol 2014 ◽

pp. 1-7 ◽

Cited By ~ 2

Author(s):

Athina Stravodimou ◽

Khalil Zaman ◽

Ioannis A. Voutsadakis

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Median Overall Survival ◽

Objective Response ◽

Metastatic Breast ◽

Line Treatment ◽

Breast Cancer Patients ◽

Single Institution ◽

First Line ◽

First Line Treatment

Background. We report our experience with vinorelbine, a widely used chemotherapeutic, in unselected metastatic breast cancer patients treated in clinical routine. Patients and Methods. The data of all patients with metastatic breast cancer receiving vinorelbine with or without trastuzumab during a six year period were reviewed. Patients received vinorelbine intravenous 25–30 mg/m2 or 60–80 mg/m2 orally in days 1 and 8 of a 21 day cycle. Results. Eighty-seven women were included. Sixty-two patients received vinorelbine alone and 25 patients received vinorelbine in combination with trastuzumab. In 67 patients this was the first line treatment for metastatic disease and in 20 patients it was 2nd or later line of treatment. The median TTP was six months (range: 1–45). The median overall survival was 11.5 months (range: 1–83). Seventy patients were evaluable for response. In patients receiving first line treatment 44.4% had a response while in the second and subsequent lines setting 12.5% of patients responded (P=0.001). Objective response was obtained in 63.6% of patients receiving concomitant trastuzumab and in 25% of patients receiving vinorelbine alone (P=0.0002). Conclusion. This study confirms a high disease control rate. Response rate and TTP were superior in first line treatment compared to subsequent lines.

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First-line treatment of metastatic breast cancer with weekly abraxane (nab-paclitaxel: a 130 nm albumin-bound paclitaxel particle): A preliminary analysis of the phase II international oncology network ION-04–012 study

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.10707 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 10707-10707 ◽

Cited By ~ 1

Author(s):

B. Mirtsching ◽

T. Chidiac ◽

T. Cosgriff

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Phase Ii ◽

Preliminary Analysis ◽

Metastatic Breast ◽

Line Treatment ◽

First Line ◽

Grade 3 ◽

First Line Treatment ◽

Patient Accrual

10707 Background: Abraxane (paclitaxel protein-bound particles) by intravenous weekly administration schedule has been demonstrated to be active and well tolerated in patients with metastatic breast cancer (MBC) refractory to prior taxane therapy. The purpose of this Phase II, open-label, non-randomized study is to evaluate the efficacy and safety of Abraxane administered weekly to patients with locally-advanced unresectable breast cancer (LABC) or MBC as first-line treatment. Methods: Patients ≥ 18 years with histologically confirmed LABC or MBC received Abraxane (125 mg/m2) by 30 minute IV infusion on days 1, 8, and 15 for the first 3 weeks of each 4-week cycle. HER2-positive patients received concurrent Herceptin given weekly throughout therapy, 4 mg/kg on week 1, and 2 mg/kg on subsequent weeks. Results: From March 11, 2005 to January 4, 2006, 28 patients were enrolled and 27 received study medication (included in this preliminary analysis). Patient accrual continues. Patient characteristics included: gender (M/F) 0/27, median age 60.5 years (range 36–83), ECOG performance status (0–1) 13/14, and HER2 status (±/missing) 6/18/3. A total of 285 cycles have been administered (median 3 [range 1–8]) with a median dose of 125 mg/m2 (range 0–130 mg/m2) and 6 dose modifications have occurred due to toxicity. Eighteen patients are still on study. CTC hematologic toxicities were grade 3 leukopenia (3.7% of patients) and grade 3 neutropenia (7.4%). Grade 3 nonhematologic toxicities were gastritis (3.7%), peripheral sensory neuropathy (7.4%), arthralgia (3.7%), and bone pain (3.7%). No grade 4 nonhematologic toxicities occurred. Conclusions: Preliminary data show that Abraxane given weekly at 125 mg/m2 (with or without Herceptin) for first-line treatment of MBC is well tolerated. Patient accrual continues in this study. Updated analysis of this study will be provided at the meeting. No significant financial relationships to disclose.

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RIBBON-1: Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of Chemotherapy With or Without Bevacizumab for First-Line Treatment of Human Epidermal Growth Factor Receptor 2–Negative, Locally Recurrent or Metastatic Breast Cancer

Journal of Clinical Oncology ◽

10.1200/jco.2010.28.0982 ◽

2011 ◽

Vol 29 (10) ◽

pp. 1252-1260 ◽

Cited By ~ 604

Author(s):

Nicholas J. Robert ◽

Véronique Diéras ◽

John Glaspy ◽

Adam M. Brufsky ◽

Igor Bondarenko ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Objective Response ◽

Growth Factor Receptor ◽

Metastatic Breast ◽

Phase Iii ◽

Line Treatment ◽

First Line ◽

Epidermal Growth ◽

First Line Treatment

Purpose This phase III study compared the efficacy and safety of bevacizumab (BV) when combined with several standard chemotherapy regimens versus those regimens alone for first-line treatment of patients with human epidermal growth factor receptor 2–negative metastatic breast cancer. Patients and Methods Patients were randomly assigned in 2:1 ratio to chemotherapy plus BV or chemotherapy plus placebo. Before random assignment, investigators chose capecitabine (Cape; 2,000 mg/m2 for 14 days), taxane (Tax) -based (nab-paclitaxel 260 mg/m2, docetaxel 75 or 100 mg/m2), or anthracycline (Anthra) -based (doxorubicin or epirubicin combinations [doxorubicin/cyclophosphamide, epirubicin/cyclophosphamide, fluorouracil/epirubicin/cyclophosphamide, or fluorouracil/doxorubicin/cyclophosphamide]) chemotherapy administered every 3 weeks. BV or placebo was administered at 15 mg/kg every 3 weeks. The primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS), 1-year survival rate, objective response rate, duration of objective response, and safety. Two independently powered cohorts defined by the choice of chemotherapy (Cape patients or pooled Tax/Anthra patients) were analyzed in parallel. Results RIBBON-1 (Regimens in Bevacizumab for Breast Oncology) enrolled 1,237 patients (Cape cohort, n = 615; Tax/Anthra cohort, n = 622). Median PFS was longer for each BV combination (Cape cohort: increased from 5.7 months to 8.6 months; hazard ratio [HR], 0.69; 95% CI, 0.56 to 0.84; log-rank P < .001; and Tax/Anthra cohort: increased from 8.0 months to 9.2 months; HR, 0.64; 95% CI, 0.52 to 0.80; log-rank P < .001). No statistically significant differences in OS between the placebo- and BV-containing arms were observed. Safety was consistent with results of prior BV trials. Conclusion The combination of BV with Cape, Tax, or Anthra improves clinical benefit in terms of increased PFS in first-line treatment of metastatic breast cancer, with a safety profile comparable to prior phase III studies.

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Oral vinorelbine versus intravenous vinorelbine, in combination with epirubicin as first-line chemotherapy in Chinese patients with metastatic breast cancer

Cancer Chemotherapy and Pharmacology ◽

10.1007/s00280-019-04000-3 ◽

2019 ◽

Vol 85 (1) ◽

pp. 205-215

Author(s):

Liang Huang ◽

Xiaojia Wang ◽

Liheng Zhou ◽

Lijun Di ◽

Hongyu Zheng ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Karnofsky Performance Status ◽

Performance Status ◽

Objective Response ◽

Metastatic Breast ◽

Chinese Patients ◽

Line Treatment ◽

First Line ◽

First Line Treatment

AbstractOral VRL offers easier administration, better quality of life, and cost saving. This study aimed to evaluate the treatment efficacy in terms of tumor response of the two formulations of vinorelbine (VRL, oral and IV) in combination with epirubicin (EPI); and the effect of EPI co-administration on VRL pharmacokinetics (PK) in Chinese patients with metastatic breast cancer (MBC) using a phase 2, open label, randomized trial. Patients were aged 18–70 years, had histologically confirmed MBC, Karnofsky Performance Status ≥ 70%, and life expectancy ≥ 12 weeks. The treatment consisted of 6 cycles of 3 weeks each. VRL dose was: (Oral-VRL) 60 mg/m2 for cycle 1, 80 mg/m2 for cycles 2–6, and (IV-VRL) 25 mg/m2 for cycle 1 and 30 mg/m2 for cycles 2–6. EPI dose of 75 mg/m2 was given on day 1 in both arms for all cycles. 133 patients were enrolled: 66 in Oral-VRL and 67 in IV-VRL arms. The median age for Oral-VRL and IV-VRL arms was 48.4 and 50.0 years, respectively. Objective response rates were 50.0% (95% CI 37.4–62.6%) for Oral-VRL and 53.7% (95% CI 41.1–66.0%) for IV-VRL. Both treatment arms met the efficacy objective target of at least 31 responses, demonstrating efficacy as first-line treatment for MBC. Similar blood PK profiles, exposures, and VRL clearance were observed between VRL + EPI vs VRL-only modalities for both arms. Oral VRL is comparable to IV VRL and an effective first-line treatment for Chinese patients with MBC. The activity of VRL + EPI combination is unaltered when VRL is given orally at recommended doses.

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Paclitaxel and Doxorubicin Combination in the First-line Treatment of Metastatic Breast Cancer

Tumori Journal ◽

10.1177/030089160208800304 ◽

2002 ◽

Vol 88 (3) ◽

pp. 200-203 ◽

Cited By ~ 2

Author(s):

Eşmen Baltalı ◽

M Kadri Altundağ ◽

Nilüfer Güler ◽

Yavuz Özışık ◽

Dinçer Fırat ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Treatment Protocol ◽

Metastatic Breast ◽

Complete Response ◽

Line Treatment ◽

First Line ◽

Metastatic Breast Carcinoma ◽

Grade 3 ◽

First Line Treatment

Anthracyclines and taxanes are currently the most effective drugs in the treatment of metastatic breast carcinoma. The aim of this study was to determine the efficacy and toxicity of paclitaxel and doxorubicin combination in the first-line treatment of metastatic breast cancer. Forty-five women with metastatic breast cancer were recruited in the study. Median age was 49 years (range, 33-70). Treatment protocol: doxorubicin (50 mg/m2/day, 30-min infusion) followed by paclitaxel (200 mg/m2/day, 3-hr infusion) every 3 weeks. Response rates included complete response in 13 (28.9%) patients and partial response in 19 (42.2%) patients, with an overall response rate of 71%. Five (11%) patients had stable disease and 8 (18%) patients had progressive disease. At a median follow-up of 19.7 months, median time to progression for all patients was 19.9 months (95% confidence interval, 12.8 to 27 months). Median overall survival time was 28.4 months. Grade 3-4 nausea/vomiting and hematological toxicities were observed in 12 (26%) and 6 (13.3%) patients, respectively. Cardiac toxicity was observed in 2 (4.4%) patients. In this trial, paclitaxel and doxorubicin combination was demonstrated to be a favorable and active regimen in the first-line treatment of metastatic breast cancer.

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Efficacy and Safety of Trastuzumab as a Single Agent in First-Line Treatment of HER2-Overexpressing Metastatic Breast Cancer

Journal of Clinical Oncology ◽

10.1200/jco.2002.20.3.719 ◽

2002 ◽

Vol 20 (3) ◽

pp. 719-726 ◽

Cited By ~ 1012

Author(s):

Charles L. Vogel ◽

Melody A. Cobleigh ◽

Debu Tripathy ◽

John C. Gutheil ◽

Lyndsay N. Harris ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Single Agent ◽

Objective Response ◽

Metastatic Breast ◽

Her2 Overexpression ◽

Line Treatment ◽

Efficacy And Safety ◽

First Line ◽

First Line Treatment

PURPOSE: To evaluate the efficacy and safety of first-line, single-agent trastuzumab in women with HER2-overexpressing metastatic breast cancer. PATIENTS AND METHODS: One hundred fourteen women with HER2-overexpressing metastatic breast cancer were randomized to receive first-line treatment with trastuzumab 4 mg/kg loading dose, followed by 2 mg/kg weekly, or a higher 8 mg/kg loading dose, followed by 4 mg/kg weekly. RESULTS: The objective response rate was 26% (95% confidence interval [CI], 18.2% to 34.4%), with seven complete and 23 partial responses. Response rates in 111 assessable patients with 3+ and 2+ HER2 overexpression by immunohistochemistry (IHC) were 35% (95% CI, 24.4% to 44.7%) and none (95% CI, 0% to 15.5%), respectively. The clinical benefit rates in assessable patients with 3+ and 2+ HER2 overexpression were 48% and 7%, respectively. The response rates in 108 assessable patients with and without HER2 gene amplification by fluorescence in situ hybridization (FISH) analysis were 34% (95% CI, 23.9% to 45.7%) and 7% (95% CI, 0.8% to 22.8%), respectively. Seventeen (57%) of 30 patients with an objective response and 22 (51%) of 43 patients with clinical benefit had not experienced disease progression at follow-up at 12 months or later. The most common treatment-related adverse events were chills (25% of patients), asthenia (23%), fever (22%), pain (18%), and nausea (14%). Cardiac dysfunction occurred in two patients (2%); both had histories of cardiac disease and did not require additional intervention after discontinuation of trastuzumab. There was no clear evidence of a dose-response relationship for response, survival, or adverse events. CONCLUSION: Single-agent trastuzumab is active and well tolerated as first-line treatment of women with metastatic breast cancer with HER2 3+ overexpression by IHC or gene amplification by FISH.

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