Dose-response relationship of epirubicin-based first-line chemotherapy for advanced breast cancer: a prospective randomized trial.

1993 ◽  
Vol 11 (7) ◽  
pp. 1253-1263 ◽  
Author(s):  
C Focan ◽  
J M Andrien ◽  
M T Closon ◽  
M Dicato ◽  
P Driesschaert ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Dose Response ◽  
Response Rate ◽  
Advanced Breast ◽  
Response Relationship ◽  
Dose Response Relationship ◽  
First Line ◽  
Group A ◽  
Group B

PURPOSE We compared prospectively the antitumor efficacy of two combination chemotherapy regimens with two different dose levels of epirubicin as first-line treatment for advanced breast cancer. PATIENTS AND METHODS One hundred forty-one fully assessable patients were randomized to receive either our intensified schedule (group A, n = 71) of epirubicin 50 mg/m2 on days 1 and 8 (every 3 weeks), or a non-intensified program (group B, n = 70) in which epirubicin was only administered on day 1. Both groups also received fluorouracil (5 FU) and cyclophosphamide 500 mg/m2 on day 1 of each course. RESULTS A statistically significant difference in response rate was observed (69% in group A v 41% in group B, P < .001) for both locally advanced (LA) and recurrent metastatic (RM) disease. Response duration (22 v 14 months, P < .01) and time to progression (TTP; 19 v 8 months, P < .02) were also significantly improved. Overall survival was similar in both groups. However, univariate and/or multivariate analyses showed a meaningful relationship between type of treatment allocated, dose-intensity (DI) of epirubicin, and response rate, as well as between TTP and survival. Ultimately, TTP and survival were also influenced by further treatment modalities, namely, hormonotherapy and chemotherapy. CONCLUSION This study validates prospectively the concept of a dose-response relationship for an anthracycline-based chemotherapy in previously untreated advanced breast cancer.

Sequential versus Alternating Regimens in the Treatment of Advanced Breast Cancer

1989 ◽  
Vol 75 (2) ◽  
pp. 137-140 ◽  
Author(s):  
Omar Fernández Giachella ◽  
Carlos Gálvez ◽  
Carlos Rufino ◽  
Adelina Rufino ◽  
Federico Morera ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Response Rate ◽  
Advanced Breast ◽  
The Other ◽  
Trial Group ◽  
Duration Of Response ◽  
Group A ◽  
Alternate Forms ◽  
Group B

With the object of proving whether seqeuntial or alternate forms of chemotherapy would be advantageous one over the other in treating advanced breast cancer and with the purpose of evaluating two different anthracyclines at equimolecular doses in the above-mentioned alternating regimens, 250 patients who had received no prior chemo- or hormonotherapy were entered in a prospective randomized trial. Group A was administered 4-epiadriamycin and cyclophosphamide for 8 courses, followed by 6 cycles of CMF, and medroxyprogesterone acetate (MPA) from the beginning of therapy until progression. In group B, adriamycin + cyclophosphamide were alternated with CMF every two courses until 14 cycles were completed. Group C received 4'-epiadriamycin + cyclophosphamide alternated with CMF for 14 courses. In groups B and C, MPA was administered as in group A. Two hundred and twenty-four patients were evaluated. CR+PR were observed in 55.8 % of group A, 43.4 % of group B, and 46.4 % of group C. Median duration of responses was 16 months (m) in group A, 13 m in group B and 20 m in group C., and median survival (CR + PR) was 16.5 m in group A, 16 m in group B and 24 m in group C. There were no statsitically significant differences among the three groups in terms of response rate, duration of response and survival; furthermore, toxicity was moderate in all groups. At equimolecular doses there were no differences between adriamycin and epirubicin in the alternating schedules.

Treatment of advanced breast cancer with tamoxifen: Evaluation of the dose-response relationship at two dose levels

1982 ◽  
Vol 2 (4) ◽  
pp. 395-400 ◽  
Author(s):  
Carsten Rose ◽  
Karen Theilade ◽  
Else Boesen ◽  
Marianne Salimtschik ◽  
Per Dombernowsky ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Dose Response ◽  
Advanced Breast ◽  
Response Relationship ◽  
Dose Response Relationship ◽  
Dose Levels

Radioimmunoguided surgery after primary treatment of locally advanced breast cancer.

1996 ◽  
Vol 14 (5) ◽  
pp. 1599-1603 ◽  
Author(s):  
P Percivale ◽  
S Bertoglio ◽  
P Meszaros ◽  
G Canavese ◽  
F Cafiero ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Primary Tumor ◽  
Locally Advanced Breast Cancer ◽  
Locally Advanced ◽  
Advanced Breast ◽  
Primary Chemotherapy ◽  
Radioimmunoguided Surgery ◽  
Group A ◽  
Group B

PURPOSE To assess the role of radioimmunoguided surgery (RIGS) using a handheld intraoperative gamma-detecting probe (GDP) to identify neoplastic disease after primary chemotherapy in locally advanced breast cancer (LABC) patients injected with iodine 125-labeled monoclonal antibodies (MAbs). PATIENTS AND METHODS Twenty-one patients with histologically documented LABC were treated with a combined modality approach. After three courses of primary chemotherapy and before modified radical mastectomy, the 125I-radiolabeled MAbs B72.3 (anti-TAG72) and FO23C5 (anti-carcinoembryonic antigen [CEA]) were administered to 11 patients (group A) and 10 patients (group B), respectively. At surgery, a GDP was used to locate the primary tumor and to assess possible tumor multicentricity and the presence of ipsilateral axillary metastases. Routine pathologic examination was performed in neoplastic and normal tissue specimens of all 21 patients. In addition, immunohistochemical assay for TAG72 and CEA expression was performed. RESULTS In group A patients, RIGS identified primary tumor in seven of 11 patients (63.3%) and unpalpable multicentric tumor lesions were located in two of four (50%). Positive axillary lymph nodes were histologically documented in eight of 11 patients (72.7%) and RIGS identified three of eight (37.5%). In group B, RIGS located the primary tumor lesion in four of 10 patients (40%); in two cases, the tumor was not clinically evident. Multicentricity was observed in one of two patients and lymph node involvement in three of nine (33.3%). No false-positive results were observed in either group A or B. CONCLUSION RIGS appears to be a safe and reliable technique. However, the MAbs used in this study are not sufficiently specific. RIGS represents a technique for which the full potential for intraoperative assessment of breast cancer lesions can be reached when more specific antibodies become readily available.

CEA as a prognostic factor in locally advanced breast cancer patients undergoing neoadjuvant chemotherapy

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10705-10705
Author(s):  
N. Valeri ◽  
N. Battelli ◽  
C. Mariotti ◽  
A. Santinelli ◽  
W. Siquini ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Advanced Breast Cancer ◽  
Locally Advanced Breast Cancer ◽  
Locally Advanced ◽  
Advanced Breast ◽  
Breast Cancer Patients ◽  
Ca 15.3 ◽  
Group A ◽  
Group B

10705 Background: CEA and CA 15.3 are most commonly used to evaluate disease progression in metastatic and recurrent breast cancer. Only few significant studies showed a potential predictive role of CEA and CA 15.3 in adjuvant or neoadjuvant setting. We evaluated the correlation between tumour markers level at diagnosis and outcome in locally advanced breast cancer patients treated with neoadjuvant chemotherapy. Methods: Patients with locally advanced breast cancer (T > 3.5 cm and T4) at diagnosis entered the study. All patients had to have initial negative staging (chest X-ray, abdominal ultrasonography, bone scintigraphy and CT scan), whereas all patients who developed metastatic disease in sites which were uncertain during initial staging were excluded. Tumour markers at diagnosis were considered negative if CEA was inferior to 5 ng/ml and CA 15.3 inferior to 35 U/ml. All patients received neoadjuvant chemotherapy (4–6 cycles with regimens containing Anthracyclines and Taxanes or FEC). Most of patients underwent radical mastectomy followed by sequential radiation therapy and adjuvant chemotherapy and/or hormonotherapy in hormonal responsive patients. Results: Fifty-three patients entered the study. At a median follow up of 73 months, 35 patients were disease free after adjuvant treatment (group A), whereas 18 patients developed metastatic disease during follow-up (group B). At diagnosis 14 patients had CA 15.3 greater than 34 U/ml (7 in group A and 7 in group B), 6 patients had CEA greater than 5 ng/ml (1 in group A and 5 in group B) and 18 patients had CEA or CA 15.3 greater than normal values (7 in group A and 11 in group B).We analyzed DFS and OS in patients with normal (CEA < 5 ng/ml, CA15.3 < 35 U/ml) and elevated (CEA ≥ 5 ng/ml, CA 15.3 ≥ 35 U/ml) tumour markers at diagnosis; DFS (p = 0.001) and OS (p = 0.03) were significantly reduced in patients with elevated CEA at diagnosis; differences were not statistically significant for CA 15.3 (p > 0.05). Conclusions: CEA levels before neoadjuvant treatment could represent an important prognostic factor and may influence the choice of treatment in locally advanced breast cancer patients . No significant financial relationships to disclose.

Efficacy of palbociclib after everolimus in hormone receptor-positive, HER2-negative advanced breast cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e13030-e13030
Author(s):  
Anja Kovac ◽  
Cvetka Grasic Kuhar ◽  
Tanja Ovcaricek ◽  
Erika Matos ◽  
Marina Mencinger ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Hormone Receptor ◽  
Previous Treatment ◽  
Advanced Breast ◽  
Primary Study ◽  
Naive Group ◽  
Hormone Receptor Positive ◽  
Group A ◽  
Group B

e13030 Background: Palbociclib and other selective cyclin-dependent kinases 4 and 6 inhibitors in combination with endocrine therapy (ET) have become the standard of care in the treatment of patients with hormone receptor-positive (HR+), HER2-negative advanced breast cancer (ABC). Their role in the first and second line of therapy is well established, whereas their use in subsequent lines and after treatment with everolimus remains unclear. Methods: We performed retrospective observational study of all patients who initiated treatment with palbociclib at the Institute of Oncology Ljubljana between March 8, 2018 and March 8, 2019 and received at least two prior lines of treatment for ABC. We collected individual patient data from electronic medical records. Patients were divided in two groups – everolimus-pretreated (group A) and everolimus-naïve (group B). The primary study outcomes were clinical benefit rate (CBR), time to treatment failure (TTF) and overall survival (OS). Results: Overall, 65 patients´ data was evaluated. The majority of patients (n = 50, 76.9%) received palbociclib in combination with fulvestrant, others (n = 15, 23.1%) with aromatase inhibitors. There were 25 (38.5%) patients in group A and 40 (61.5%) in group B. Patients´ and previous treatment characteristics are shown in table. CBR was the same, 40%, in both groups. The median follow-up time was 14.9 months. The median TTF was 5.28 months for the whole group, 5.0 months for everolimus-pretreated and 5.5 months for everolimus-naïve group (p = 0.7). The median OS was 18.1 months for the whole group, 14 months for everolimus-pretreated and 18.1 months for everolimus- naïve group (p = 0.7). Conclusions: Patients with HR+, HER-2-negative ABC benefit from addition of palbociclib to ET after two lines of prior systemic therapy. The benefit remained unchanged if the patients were previously treated with everolimus. [Table: see text]

Efficacy and tolerance of vinorelbine and fluorouracil combination as first-line chemotherapy of advanced breast cancer: results of a phase II study using a sequential group method.

1996 ◽  
Vol 14 (12) ◽  
pp. 3097-3104 ◽  
Author(s):  
V Dieras ◽  
J M Extra ◽  
E Bellissant ◽  
M Espie ◽  
F Morvan ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Phase Ii ◽  
Response Rate ◽  
Phase Ii Study ◽  
Sequential Design ◽  
Advanced Breast ◽  
Group Sequential Design ◽  
First Line ◽  
Group Sequential

PURPOSE To assess the antitumor efficacy and safety profile of the combination of Fluorouracil (5FU) and vinorelbine given as first-line therapy to patients with advanced breast cancer. PATIENTS AND METHODS As defined in the seven consecutive steps of a phase II group sequential design, 63 patients received 5FU 750 mg/m2/d for 5 consecutive days as a continuous infusion and vinorelbine 30 mg/ m2 on days 1 and 5 as a short intravenous (I/V) infusion every 3 weeks. RESULTS Forty-one of 63 patients achieved an objective response, which allowed us to discontinue the study and reject a response rate less than 50% with a statistical power of 90%. The unbiased estimate of the response rate was 61.6%. Response rate did not differ significantly according to the following: (1) type of prior adjuvant therapy (none, n = 23; without anthracycline, n = 6; with anthracyline, n = 34); (2) site of metastatic disease; and (3) number of metastatic sites. The median time to progression was 8.4 months. The median response duration was 12.3 months, and the median duration of complete response (CR), from the first assessment of CR, was 7.3 months. The median overall survival time was 23 months (28.1 months for patients with a CR). The main toxicities (grades 3 and 4) were neutropenia (90% of patients), infection (12.7%), mucositis (37%), and constipation (9.5%). Nevertheless, treatment could be given on an outpatient basis to the majority of patients, and the median relative dose-intensity was 86%. CONCLUSION This phase II study, which used a group-sequential design, shows that the combination of 5FU and vinorelbine is an active and tolerable regimen for the treatment of first metastatic progression of breast cancer. It provides an alternative regimen for patients who have previously received anthracycline-based adjuvant chemotherapy or in whom anthracyclines cannot be used.

Relationship between obesity and survival in advanced breast cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e11044-e11044
Author(s):  
Nicolas Castagneris ◽  
Matias Nicolas Cortes ◽  
Eduardo Richardet ◽  
Martin Eduardo Richardet ◽  
Perelli Laura ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Statistical Significance ◽  
Small Sample ◽  
Advanced Breast ◽  
Significant Difference ◽  
Group A ◽  
Premenopausal Patients ◽  
Group B ◽  
Risk Of Cancer

e11044 Background: Breast cancer is the second cause of cancer-related deaths. Obesity is defined as an excessive accumulation of fat. The body mass index (BMI) indicates relationship between weight and height and is used to identify obesity, which is associated with increased risk of cancer. Studies have shown the worst prognosis of obese patients undergoing adjuvant therapy. This paper aims to assess progression-free survival (PFS) and overall survival (OS) in relation to BMI, in patients with advanced breast cancer. Methods: We retrospectively analyzed medical records of 132 patients treated in the IONC from 2005 to 2010. We divided the patients into two groups: group A, BMI <30 (not obese), Group B, BMI ≥ 30 (obese). Analysis of SG and TLP were estimated by the Kaplan-Meier method and compared using the log-rank test. Results: The PFS for group A was 16.44 months, and for group B it was 13.08 (p = 0.40). OS was 31.93 and 27.12, respectively (p = 0.31). Regarding BMI and menopausal status, we observed a marked increase in survival for non-obese premenopausal patients with statistical significance. See table below. Conclusions: Patients with BMI <30 had higher survival rates, without reaching statistical significance. This could be due to small sample size and heterogeneity. Another relevant finding is the statistically significant difference in survival that favors premenopausal patients with lower BMI, which raises an area to be studied. This work demonstrates the importance of guiding patients towards a healthier life habit. [Table: see text] [Table: see text]

scholarly journals Osteoprotegerin and osteopontin serum values in postmenopausal advanced breast cancer patients treated with anastrozole

2004 ◽  
Vol 11 (4) ◽  
pp. 771-779 ◽  
Author(s):  
A Martinetti ◽  
E Bajetta ◽  
L Ferrari ◽  
N Zilembo ◽  
E Seregni ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Cancer Patients ◽  
Advanced Breast ◽  
Rank Test ◽  
Percentage Increase ◽  
Breast Cancer Patients ◽  
Short Term ◽  
Group A ◽  
Group B

Osteoprotegerin (OPG) is a potent antiresorptive molecule that binds NF-kappaB ligand, the final effector for osteoclastogenesis. OPG production is regulated by a number of cytokines and hormones. Osteopontin (OPN) is a secreted adhesive glycoprotein involved in tumour angiogenesis, and also a non-collagenous protein involved in bone turnover. OPN serum value is associated with tumour burden and survival in advanced breast cancer patients. The short-term effects of anastrozole on OPG and OPN serum values, and the usefulness of these analytes during follow-up were studied in 34 consecutive advanced breast cancer patients receiving anastrozole 1 mg/day. Blood samples were taken before treatment and at 2, 4, 8 and 12 weeks. OPG and OPN values were measured by ELISA. The results were analysed for all patients, and also separately for patients with (group A, 22 patients) and without (group B, 12 patients) bone metastasis. Whether the survival of all patients was related to their OPN serum values was also tested by placing patients into three groups (terciles) according to their baseline OPN values. No significant changes in OPG and OPN values were observed in the complete patient group. There was no difference in baseline OPG and OPN serum values between patients in groups A and B. In group A, a significant percentage increase in both OPG and OPN values from baseline was detected during treatment. No significant changes were reported for group B patients. Furthermore, in group A, a significant increase in both analytes was evident only for patients with progressive disease (PD). The Kaplan–Meier adjusted survival estimates for patients grouped according to tercile OPN values differed significantly (P = 0.001, log rank test). In conclusion, in the short term, anastrozole does not seem to affect OPG and OPN serum values in patients without bone disease. OPG and OPN appear to be useful predictors of the outcome of skeletal disease and elevated OPN values may be associated with short survival in advanced breast cancer patients.

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