Trastuzumab and paclitaxel or vinorelbine for HER2+ metastatic breast cancer: A retrospective study and analysis of economic cost

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 11517-11517
Author(s):  
A. Scola ◽  
H. Koussis ◽  
A. Jirillo ◽  
C. Ghiotto ◽  
S. Lonardi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Metastatic Breast Cancer ◽  
Lymph Nodes ◽  
Metastatic Breast ◽  
Cost Benefit ◽  
Economic Cost ◽  
Response Duration ◽  
Grade 3 ◽  
Metastatic Sites

11517 Background: We analyses a mono institutional series of patients treated with metastatic breast cancer (MBC). Methods: From 2000 to 2006 forty consecutive patients affected by MBC were evaluated. The average age was 50 years (range: 30–79). All patients had HER2+ tumors (IHC 3+ or FISH+) and LVEF > 50%. Metastatic sites were: liver 18, lymph nodes 10, bone 9, skin 7, lung 5 pts. In 11 cases the sites of metastases were multiple (1–3). All patients were treated with Trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly thereafter with weekly Paclitaxel 80 mg/m2 or weekly Vinorelbine 25 mg/m2; specifically, Paclitaxel was used in 26 patients and Vinorelbine in 14 patients. The endpoints were time to progression (TTP), duration of response, toxicity (including cardiologic) and overall survival. Results: A total of 1271 courses of weekly Trastuzumab were administered (average 28 courses per patient: range 8–72). There were 22 complete and partial responses (CR+PR=55%). In the association of Trastuzumab and Paclitaxel were seen :11 CR, 6 PR, 3 SD and 6 PD, (RR 65.3%). In the combination of Trastuzumab and Vinorelbine: 2 CR, 3 PR, 4 SD and 5 PD (RR 35.7%) . The most responsive sites were: liver 15 CR+PR (37.5%), lung 11 CR+PR (27.5%), lymph nodes 8 CR+PR (20%), and skin 6 CR+PR (15%). TTP was 7 months (2–27 months) and response duration 6.7 months (2–26 months). Overall survival at 5 years was estimated at 26.4 months. Toxicity rates were: hematological grade 4 in 2 pts, grade 3 in 3 pts, neurological grade 3 in 19 pts. No important cardiologic toxicity was observed: LVEF was reduced to 40% in 4 pts. Seven patients developed brain metastasis during therapy. The patients in PD continued Trastuzumab with other chemotherapy, no responses were observed. The median cost of treatment with Trastuzumab for patient was 16.147 € (range 3.987–39.959 €. Conclusions: Treatment with Trastuzumab plus chemotherapy has been shown to be effective and well-tolerated providing a good quality of life. The economic impact is important and is to define. The cost/benefit in this cohort of the patients is ongoing. No significant financial relationships to disclose.

Phase III Trial of Epirubicin Plus Paclitaxel Compared With Epirubicin Plus Cyclophosphamide As First-Line Chemotherapy for Metastatic Breast Cancer: United Kingdom National Cancer Research Institute Trial AB01

2005 ◽  
Vol 23 (33) ◽  
pp. 8322-8330 ◽  
Author(s):  
Ruth E. Langley ◽  
James Carmichael ◽  
Alison L. Jones ◽  
David A. Cameron ◽  
Wendi Qian ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Metastatic Breast Cancer ◽  
Survival Time ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
First Line ◽  
Free Survival ◽  
Grade 3 ◽  
Line Chemotherapy

Purpose To compare the effectiveness and tolerability of epirubicin and paclitaxel (EP) with epirubicin and cyclophosphamide (EC) as first-line chemotherapy for metastatic breast cancer (MBC). Patients and Methods Patients previously untreated with chemotherapy (except for adjuvant therapy) were randomly assigned to receive either EP (epirubicin 75 mg/m2 and paclitaxel 200 mg/m2) or EC (epirubicin 75 mg/m2 and cyclophosphamide 600 mg/m2) administered intravenously every 3 weeks for a maximum of six cycles. The primary outcome was progression-free survival; secondary outcome measures were overall survival, response rates, and toxicity. Results Between 1996 and 1999, 705 patients (353 EP patients and 352 EC patients) underwent random assignment. Patient characteristics were well matched between the two groups, and 71% of patients received six cycles of treatment. Objective response rates were 65% for the EP group and 55% for the EC group (P = .015). At the time of analysis, 641 patients (91%) had died. Median progression-free survival time was 7.0 months for the EP group and 7.1 months for the EC group (hazard ratio = 1.07; 95% CI, 0.92 to 1.24; P = .41), and median overall survival time was 13 months for the EP group and 14 months for the EC group (hazard ratio = 1.02; 95% CI, 0.87 to 1.19; P = .8). EP patients, compared with EC patients, had more grade 3 and 4 mucositis (6% v 2%, respectively; P = .0006) and grade 3 and 4 neurotoxicity (5% v 1%, respectively; P < .0001). Conclusion In terms of progression-free survival and overall survival, there was no evidence of a difference between EP and EC. The data demonstrate no additional advantage to using EP instead of EC as first-line chemotherapy for MBC in taxane-naïve patients.

Doxorubicin and Paclitaxel Versus Fluorouracil, Doxorubicin, and Cyclophosphamide as First-Line Therapy for Women With Metastatic Breast Cancer: Final Results of a Randomized Phase III Multicenter Trial

2001 ◽  
Vol 19 (6) ◽  
pp. 1707-1715 ◽  
Author(s):  
Jacek Jassem ◽  
Tadeusz Pieńkowski ◽  
Anna Płuzańska ◽  
Svetislav Jelic ◽  
Vera Gorbunova ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Metastatic Breast Cancer ◽  
Metastatic Breast ◽  
Phase Iii ◽  
Time To Progression ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Grade 3

PURPOSE: This phase III trial compared the efficacy and safety of doxorubicin and paclitaxel (AT) to 5-fluorouracil, doxorubicin, and cyclophosphamide (FAC) as first-line therapy for women with metastatic breast cancer. PATIENTS AND METHODS: A total of 267 women with metastatic breast cancer were randomized to receive either AT (doxorubicin 50 mg/m2 followed 24 hours later by paclitaxel 220 mg/m2) or FAC (5-fluorouracil 500 mg/m2, doxorubicin 50 mg/m2, cyclophosphamide 500 mg/m2), each administered every 3 weeks for up to eight cycles. Patients had to have measurable disease and an Eastern Cooperative Oncology Group performance status of 0 to 2. Only one prior non–anthracycline, nontaxane-containing adjuvant chemotherapy regimen was allowed. RESULTS: Overall response rates for patients randomized to AT and FAC were 68% and 55%, respectively (P = .032). Median time to progression and overall survival were significantly longer for AT compared with FAC (time to progression 8.3 months v 6.2 months [P = .034]; overall survival 23.3 months v 18.3 months [P = .013]). Therapy was generally well-tolerated (median of eight cycles delivered in each arm). Grade 3 or 4 neutropenia was more common with AT than with FAC (89% v 65%; P < .001); however, the incidence of fever and infection was low. Grade 3 or 4 arthralgia and myalgia, peripheral neuropathy, and diarrhea were more common with AT, whereas nausea and vomiting were more common with FAC. The incidence of cardiotoxicity was low in both arms. CONCLUSION: AT conferred a significant advantage in response rate, time to progression, and overall survival compared with FAC. Treatment was well-tolerated with no unexpected toxicities.

Combination of paclitaxel and two schedules of gefitinib in patients with metastatic breast cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10599-10599 ◽  
Author(s):  
S. Cresta ◽  
A. Perotti ◽  
L. Merlini ◽  
M. Mansutti ◽  
A. Marchianã ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Antitumor Activity ◽  
Metastatic Breast ◽  
Sensory Neuropathy ◽  
Response Duration ◽  
Skin Toxicity ◽  
Median Response ◽  
Grade 3

10599 Background: The epidermal growth factor receptor (EGFR) may be overexpressed in breast cancer. Inhibition of EGFR signaling by gefitinib (Iressa) enhances the in vitro antitumor activity of many cytotoxic drugs including paclitaxel. Methods: In this phase II study patients (pts) with measurable metastatic breast cancer and maximum prior exposure to two chemotherapies were randomized to paclitaxel (100 mg/m2 on days 1, 8 q21) and continuous gefitinib, 250 mg daily for 21 days (arm A); or paclitaxel (100 mg/m2 on days 8, 15 q21) with gefitinib 250 mg daily from day 1 to 15 (arm B). Therapy continued for at least 4 cycles after best response. After 6 cycles, responding pts continued with gefitinib monotherapy until progression or unacceptable toxicity. Results: 16 pts in arm A and 17 in arm B were enrolled; 25 had visceral disease (12 in arm A and 13 in arm B). Median age was 53 years (range 29–70). All but one pt received prior anthracyclines and 9 also prior taxanes. Overall 17 pts responded to therapy (intent to treat analysis; arm A: 62.5%, 95% CI: 35.4–84.8%; arm B: 41.2%, 95% CI: 18.4–67.1%). Disease control (CR+PR+SD) was achieved in 81.3% of pts in arm A and 76.5% in arm B, with 10 and 6 pts who continued with gefitinib monotherapy after completing the combination schedule. Median time to progression was 250 (arm A) and 204 days (arm B), while median response duration was 212 (arm A) and 285 days (arm B). Tolerability was good with either schedule of gefitinib. Diarrhea was frequent (68.8% and 64.7%) and of grade 3–4 severity in 6% of pts in arm A and in arm B. Grade 3–4 neutropenia affected 6% and 12% of pts respectively, and 6% of pts in both arms had a grade 3–4 increase of AST and ALT. Other grade 1–2 adverse events included acneiform rash (100% in arm A and 58.8% in arm B), sensory neuropathy (68.8% and 58.8%), anemia (50.0% and 52.9%), neutropenia (25.0% and 17.6%) and myalgia (37.5% and 41.2%). Conclusions: The combination of paclitaxel with gefitinib given continuously or for 2 out of every 3 weeks is feasible and well tolerated. The discontinuous schedule caused less skin toxicity. The good antitumor activity deserves further studies to identify sensitive subgroups and mechanisms of sensitivity. IRESSA is a trademark of the AstraZeneca group of companies. [Table: see text]

Tesetaxel: Activity of an oral taxane as first-line treatment in metastatic breast cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 1016-1016 ◽  
Author(s):  
Andrew David Seidman ◽  
Lee Steven Schwartzberg ◽  
Joyce O'Shaughnessy ◽  
Gabriella D'Andrea ◽  
Peter Rubin ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Estrogen Therapy ◽  
Metastatic Breast ◽  
Hypersensitivity Reactions ◽  
Highly Active ◽  
Line Therapy ◽  
Grade 3 ◽  
Metastatic Sites

1016 Background: Tesetaxel, unlike standard taxanes (docetaxel, paclitaxel), is not a substrate for Pgp, a major cause of taxane resistance in tumor models. In a DU4475 breast cancer xenograft that overexpresses Pgp, tesetaxel induced a 94% reduction in tumor size, markedly exceeding the activity of docetaxel (46%) and paclitaxel (26%). Tesetaxel is associated with substantially less neuropathy preclinically than equi-myelotoxic doses of docetaxel. In clinical studies to date, tesetaxel is not associated with hypersensitivity reactions (0% incidence in > 450 patients [pts]), thus eliminating the need for premedication and extended observation. In a prior study, tesetaxel (27-35 mg/m2 Q3 wks) achieved a 38% partial response (PR) rate as 2nd-line therapy in pts with metastatic breast cancer (MBC) who had progressed after multidrug anthracycline-containing regimens. To extend these data, we initiated a phase 2 study of tesetaxel as 1st-line therapy in women with MBC. Methods: Eligibility included MBC; HER2-; ECOG PS 0-1; and adequate organ function. Adjuvant chemotherapy (including taxanes) was allowed. Tesetaxel was administered orally without anti-allergic premedication at a starting dose of 27 mg/m2 once every 3 wks. Overall response rate (ORR; RECIST) was the primary endpoint. Results: All 45 pts have been accrued. Median age is 58 y (range 36-80); median time from diagnosis, 4.0 y (range 0-21); triple negative status, 8 pts at diagnosis, 14 at time of metastasis. Metastatic sites are lung (22 pts), lymph nodes (22), liver (24), and bone (21). Prior treatment includes anti-estrogen therapy (32 pts), adjuvant chemotherapy (31), prior taxane (25), and radiotherapy (28). ORR in 24 pts evaluable for response is 50% (1 CR [4%], 11 PR [46%]); 5 responding pts had prior taxane therapy. Neutropenia is the most common ≥ Grade 3 adverse event with 50% of cases observed after dose escalation to 35 mg/m2; febrile neutropenia and Grade 3 peripheral neuropathy occurred in 2 pts each. There were no hypersensitivity reactions. Conclusions: Tesetaxel is highly active in 1st-line MBC and overcomes multiple limitations of standard taxanes. Updated ORR and PFS for all pts will be presented. Weekly dosing will be evaluated in a new cohort of pts.

scholarly journals Metastatic Breast Cancer to the Urinary Bladder in the Caribbean

2021 ◽  
pp. 1586-1590
Author(s):  
Saara Mohammed ◽  
Atiba Akii Bua
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Urinary Bladder ◽  
Lymph Nodes ◽  
Cancer Treatment ◽  
Metastatic Disease ◽  
Bladder Wall ◽  
Metastatic Breast ◽  
The Caribbean ◽  
Metastatic Sites

One of the most common cancers amongst women is breast cancer. The most common metastatic sites are the lymph nodes, lungs, liver, and bone. Metastatic spread to the urinary bladder is rare, and this case, as far as we are aware, is the first reported in the Caribbean. This patient developed urinary symptoms 4 years after her diagnosis of breast cancer. CT imaging showed thickening of the bladder wall, and histology confirmed metastatic breast cancer. As imaging modalities and cancer treatment improve, patients live longer with metastatic disease, and we will potentially see more unusual presentations of metastatic disease.

Capecitabine maintenance therapy after docetaxel/capecitabine combination chemotherapy in patients with metastatic breast cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e12018-e12018
Author(s):  
Pinar Gursoy ◽  
Zeki Gokhan Surmeli ◽  
Burcu Cakar ◽  
Cagatay Arslan ◽  
Baha Zengel ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Maintenance Therapy ◽  
Single Agent ◽  
Objective Response ◽  
Metastatic Breast ◽  
Complete Response ◽  
Response To Treatment ◽  
Grade 3 ◽  
Metastatic Sites

e12018 Background: Addition of capecitabine to docetaxel improves survival outcomes compared with single agent docetaxel in metastatic breast cancer (MBC). In this study we analyzed efficacy of maintenance therapy with single agent capecitabine after six cycles of docetaxel/capecitabine chemotherapy in MBC patients. Methods: Patients with metastatic HER2 negative breast cancer were included. Six cycles of docetaxel (75mg/m2 q3wk) / capecitabine (1650mg/m2/day on days 1 to 14) followed by capecitabine (2000 mg/m2/day on days 1 to 14) were administered. Demographic features, progression free (PFS) and overall survival (OS) and response to treatment were recorded. Results: Fifty-four patients were included. Thirty-five patients (65%) were postmenopausal, and 40 (74%) were ER/PR positive. Median age was 53 (range 28 – 70). Number of metastatic sites was one in 23 patients, two in 21, three or more in 10 patients. Most common metastatic sites were bone (67%), lymph nodes (33%), lungs (30%), liver (13%); 13 patients (24%) had bone only disease. Forty-four (81.5%) patients received treatment in first-line, 10 (18.5%) received in second line setting. Median number of cycles applied (including docetaxel/capecitabine combination) was 9 (range 2 – 31, total 576). Median PFS was 9 months (10.4 for hormone receptor positive, 7.3 for negative patients) and median OS was 28 months. Objective response was assessable in 38 patients. Overall response rate (partial + complete response) was 42.6% (95% CI 29.6 – 55.6) with 1 complete response. Toxicities were evaluated in 41 patients; grade 3/4 neutropenia was observed in 10% and grade 3/4 hand-foot syndrome was observed in 24% of patients. Dose reduction was performed in capecitabine in 37%, and in docetaxel in 20% of patients. Conclusions: Maintenance with single agent capecitabine therapy after six cycles of docetaxel/capecitabine chemotherapy is an effective and tolerable treatment option for HER2 negative MBC patients.

Randomized Phase II Study of Two Irinotecan Schedules for Patients With Metastatic Breast Cancer Refractory to an Anthracycline, a Taxane, or Both

2004 ◽  
Vol 22 (14) ◽  
pp. 2849-2855 ◽  
Author(s):  
Edith A. Perez ◽  
David W. Hillman ◽  
James A. Mailliard ◽  
James N. Ingle ◽  
J. Michael Ryan ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Metastatic Breast Cancer ◽  
Phase Ii ◽  
Median Overall Survival ◽  
Phase Ii Study ◽  
Objective Response ◽  
Metastatic Breast ◽  
Response Duration ◽  
Median Response

Purpose A pressing need exists for agents active against anthracycline- or taxane-refractory metastatic breast cancer (MBC), or both. Previous clinical trials suggested that irinotecan might have such activity. We conducted this multicenter phase II study to assess efficacy and tolerability of two irinotecan schedules. Patients and Methods MBC patients who experienced disease progression after one to three chemotherapy regimens, including at least one anthracycline- or taxane-based regimen, were randomly assigned to irinotecan in 6-week cycles comprising 100 mg/m2 weekly for 4 weeks, then a 2-week rest (weekly) or 240 mg/m2 every 3 weeks. Results The weekly arm had 52 assessable patients; the every-3-weeks arm had 51 assessable patients. In the weekly arm, the objective response (complete regression [CR] + partial regression [PR]) rate was 23% (one CR, 11 PR; 95% CI, 13% to 37%). Median response duration was 4.9 months (range, 1.9 to 15.9 months), and median overall survival was 9.7 months (95% CI, 8.0 to 14.2 months). In the every-3-weeks arm, the objective response rate was 14% (nine PR; 95% CI, 6% to 26%), median response duration was 4.2 months (range, 3.1 to 13.9 months), and median overall survival was 8.6 months (95% CI, 7.0 to 12.3 months). Treatment generally was well tolerated, especially in the weekly arm. Grade 3 to 4 adverse events with ≥ 10% incidence included neutropenia (29%) and diarrhea (17%) in the weekly arm and neutropenia (36%), vomiting (20%), dyspnea (18%), nausea (16%), and diarrhea (12%) in the every-3-weeks arm. Conclusion Irinotecan is active with good tolerability in refractory MBC. Irinotecan (especially weekly) warrants additional study as monotherapy and in combination regimens in this setting.

scholarly journals Role of Metastatic Lymph Nodes to Totally Removed Lymph Nodes Ratio in Breast Cancer?

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Yasemin Benderli Cihan
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Metastatic Breast Cancer ◽  
Lymph Node ◽  
Lymph Nodes ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Breast Cancer Patients ◽  
Free Survival ◽  
Metastatic Lymph

AbstractAimTo determine prognostic ratio of metastatic lymph nodes to totally removed lymph nodes (MLN/TRLN) on overall and progression-free survival with diagnosis of breast cancer.Material and methodRadiation Oncology department of Kayseri Training and Research Hospital, relationship of MLN/TRLN between prognosis and other prognostic factors was evaluated in T1-3 and N1-3 non-metastatic breast cancer patients.ResultsTwo hundred female patients and 5 male patients with an average age of 56 years were enrolled in this study. Of all patients, 63.4% of the patients were postmenopausal and modified radical mastectomy was performed in 96.6% of them. While 93.2% of the patients were diagnosed with invasive ductal carcinoma, 52.7% of them had clinical N1 disease, 62% of them were staged as T2, 94% of them received chemotherapy and 57.1% of them received hormonal therapy. Metastatic lymph node ratio below 0.2 was 48.8%, between 0.21–0.65 it was 35.1% and above 0.65% it was 16.1%. Five-year Overall survival and progression-free survival rates were 76% and 58% respectively. Statistically significant difference was found between MLN/TRLN and age (p = 0.044), chemotherapy (p = 0.039), pathological lymph nodes (p <0.001) according to Pearson's Chi-Squared test. Factor affecting overall survival was Progesterone receptor status (p = 0.021) and for progression-free survival they were gender (p = 0.003) and human epidermal growth factor receptor 2 (p = 0.018). Univariate and multivariate analysis found that gender (p = 0.04, OR 5.9, CI: 1.7–19.6) and lymph node (p = 0.05, OR: 1.4, CI: 0.9–2.1) were significant factors affecting progression-free survival.ConclusionMLN/TRLN was shown to have no effect on prognosis in non-metastatic breast cancer patients due to small number of patients and short follow-up period.

scholarly journals Progression-Free Survival and Overall Survival of CDK 4/6 Inhibitors Plus Endocrine Therapy in Metastatic Breast Cancer: A Systematic Review and Meta-Analysis

2020 ◽  
Vol 21 (17) ◽  
pp. 6400 ◽  
Author(s):  
Michela Piezzo ◽  
Paolo Chiodini ◽  
Maria Riemma ◽  
Stefania Cocco ◽  
Roberta Caputo ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Metastatic Breast Cancer ◽  
Endocrine Therapy ◽  
Meta Analysis ◽  
Objective Response ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Free Survival ◽  
Metastatic Sites

The introduction of CDK4/6 inhibitors in combination with endocrine therapy (ET) represents the most relevant advance in the management of hormone receptor (HR) positive, HER2-negative metastatic breast cancer over the last few years. This meta-analysis of randomized controlled trials (RCTs) is aimed to better characterize the efficacy of CDK4/6 inhibitors in some relevant subgroups and to test heterogeneity between different compounds with a particular focus on their ability to improve overall survival (OS). Pooled estimates of hazard ratios (HRs) were computed for progression-free survival (PFS), OS, and objective response rate (ORR) analysis in predefined subgroups to better understand treatment effect concerning specific patients’ characteristics. To estimate the absolute benefit in terms of PFS, pooled survival curves were generated by pooling the data of all trials. A total of eight RCTs were included. Adding a CDK4/6 inhibitor to ET is beneficial in terms of PFS, irrespective of the presence or not of visceral metastases, the number of metastatic sites, and the length of the treatment-free interval (TFI). The addition of CDK4/6 inhibitors produces a significant OS improvement, both in aromatase inhibitor (AI)-sensitive (HR 0.75, 95% CI) and AI-resistant patients (HR 0.77, 95% CI [0.67–0.89]). Pooled data from each single drug show that palbociclib remains the only class member not showing a statistically significant HR for OS (HR 0.83, 95% CI [0.68–1.02]).

Docetaxel plus capecitabine in the treatment of previous anthracycline-treated patients with metastatic breast cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e12014-e12014
Author(s):  
A. Bensalem ◽  
K. Bouzid
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Liver Toxicity ◽  
Objective Response ◽  
Metastatic Breast ◽  
Response Duration ◽  
Complete Response ◽  
Clinical Activity ◽  
Median Response ◽  
Metastatic Sites

e12014 Background: Anthracyclines have been considered the challenge of the treatment of metastatic breast cancer. Docetaxel has changed this belief. We conducted a study in previously anthracyclines treated metastatic breast cancer by the regimen docetaxel 75 mg/m2 Day 1 - capecitabine 2500 mg/m2 day split-up over 2 daily doses from Day 1 to Day 14; every 21 Days. Methods: Patients were eligible if they had metastatic breast cancer after an adjuvant setting by anthracyclines. All patients had measurable disease, PS ≤ 2, adequate organ function. Results: From April 2004 to June 2006, 18 patients were enrolled in the study and were evaluated for the toxicity and preliminary responses to the treatment. 100 % of patients had metastatic breast cancer. The sites of metastases were liver in 14 ( 77.7%), lung in 5 (27.7%) and bone in 9 (50%). 11 patients (61.1%) had 1 or 2 metastatic sites, 7 (38.9%) had 3 metastatic sites. All of 18 patients were assessed for toxicity. The main toxicities were as follows: neutropenia grade 3 in 3 patients (16.6 %), anemia grade 2–3 in 2 patients (11.1%), fatigue in 2 patients (11.1%), hand-foot syndrome in 7 patients (38.9%), vomiting-nausea in 4 patients (22.2%), diarrhea in 2 patients (11.1%), liver toxicity in 3 patients (16.6%). The objective response was obtained in 8 patients (44.4%) (Complete response in 3 patients (16.6%), partial response in 5 patients (27.7%). Median response duration was 9 months (range 4 - 17). 7 Patients (38.9%) had stable disease, progression was observed in 3 (16.6%) of patients. Conclusions: In this preliminary analysis, the combination of docetaxel - capecitabine in the treatment of previously anthracyclines treated metastatic breast cancer appears to be an active schedule. It is safe and active, with a manageable toxicity profile and a good clinical activity. No significant financial relationships to disclose.

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