Prognostic value of immunohistochemical phenotypes (IP) of 141 operable breast cancer patients (pts) included in phase III trials of adjuvant therapy

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 21040-21040
Author(s):  
R. Trujillo ◽  
E. Gallego ◽  
A. Márquez ◽  
N. Ribelles ◽  
J. Trigo ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cox Regression ◽  
Phase Iii ◽  
Rank Test ◽  
Prognostic Effect ◽  
Log Rank Test ◽  
Kaplan Meier ◽  
Phase Iii Trials ◽  
Her 2

21040 Background: Gene expression arrays and IP studies classified breast cancer in three distinct subtypes: basal, HER2/neu and luminal that are associated with different clinical outcomes. Methods: In 141 pts with operable breast cancer, included in phase III trials of adjuvant therapy in our center, immunohistochemical staining was performed on 3μm sections of paraffin blocks, containing tissue-arrays of tumour tissue.A basal phenotype (BP) was defined by negative estrogen receptor (ER) and progesterone receptor (PR) and positive cytokeratin (CK) 5/6 or EGFR immunoreactivity. HER2/neu phenotype as positive c-erb B2 by HercepTest™ and luminal phenotype (LP) by positive ER, PR and CK 7/8 and negative HER-2. Survival curves were calculated by the Kaplan-Meier method. The differences between survivals were estimated using the log rank test. Multivariate Cox regression analysis was used to evaluate any independent prognostic effect of the variables on disease-free survival (DFS). Results: Complete clinical follow-up information was available for 141 pts. The median follow-up period was 52 months (range 1–103 months). During this period, 13.8% pts died from breast cancer and 27.7% pts relapsed. At the time of the primary diagnosis 10.4% of the pts had lymph node negative disease and 89.6% had positive lymph nodes. 50.8% pts received taxane chemotherapy, 7.7% Trastuzumab, 62.3% radiotherapy and 61% pts received hormonotherapy. Positivity for LP was 65.2%, BP 9.9% and Her-2 phenotype 8.5%. 16.3% didn't fit for any of the three subtypes. Median DFS for BP: 24 moths, for LP and Her-2 phenotypes median DFS was not reached. 5 years DFS were; BP: 19%, LP: 63% and Her-2: 56%. Kaplan-Meier survival analyses demonstrated that the presence of a detectable BP was highly significantly associated with a worse DFS compared with the presence of a LP, log rank test (p= 0.0001). Multivariate Cox regression analyses estimated that the prognostic effect of BP in relation to DFS was independent of lymph node, stage and tumor size, HR: 0.12 95% CI (0.05–0.2). Conclusions: We found that expression of BP was associated with poor prognostic in the context of randomized phase III trials. No significant financial relationships to disclose.

scholarly journals 308 Association of Diabetes and Frailty with Mortality in Middle-Aged and Older Europeans

2019 ◽  
Vol 48 (Supplement_3) ◽  
pp. iii17-iii65
Author(s):  
Mark O'Donovan ◽  
Duygu Sezgin ◽  
Aaron Liew ◽  
Rónán O'Caoimh
Keyword(s):  
Sex Education ◽  
Cox Regression ◽  
Metastatic Cancer ◽  
Frailty Index ◽  
Rank Test ◽  
Middle Aged ◽  
Log Rank Test ◽  
Kaplan Meier ◽  
Age Related

Abstract Background Frailty is a common, multi-factorial, age-related syndrome commonly observed in people with diabetes. Although older diabetics are prone to adverse healthcare outcomes and diabetes increases the risk of developing frailty, little is known about the effects of frailty on diabetes. This paper examines the association between diabetes, frailty, and mortality in Europeans aged ≥50 years. Methods Data were included from The Survey of Health, Ageing and Retirement in Europe (SHARE) waves one and six. A participant’s first interview was taken as the baseline and subsequent waves were used for mortality follow-up (time and cause). Frailty and pre-frailty were measured using established cut-offs using the Physical Phenotype (SHARE-FI) and a 55-item Frailty Index (FI-55). Kaplan-Meier survival analysis was used to assess the relationship between frailty and mortality in people with diabetes and significance tested using log-rank test. Cox regression was used to adjust for potential confounders (age, sex, education, income, employment, alcohol use, smoking, hypertension, hypercholesterolaemia, myocardial infarction, stroke, metastatic cancer, chronic lung disease, polypharmacy, self-perceived health and depression). Results Data from 8,954 diabetics aged 50-99 years were included with 1,598 deaths (17.8%). According to the SHARE-FI, 1,971 (22.0%) were frail, 4,183 (46.7%) pre-frail and 2,800 (31.3%) robust. According to the Kaplan-Meier log-rank test survival varied significantly across frailty strata according to both indexes (p<0.001). At 10-year follow-up, adjusting for confounders SHARE-FI frailty and pre-frailty were significantly associated with mortality, adjusted Hazard Ratio (HR) 2.19, (95% CI:1.66-2.89), and 1.38 (95% CI:1.09-1.74), respectively. Results were similar using the FI-55, HR for frailty 1.66 (95% CI:1.09-2.54). Causes of mortality were significantly different according to frailty status (p<0.05). Conclusion Frailty and pre-frailty are independent risk factors for mortality in diabetics. The identification of frailty is important for the risk-stratification and management of middle aged and older patients with diabetes and should be included in the routine assessment of these high-risk individuals.

Testosterone levels in metastatic castration-resistant prostate cancer (mCRPC).

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 191-191 ◽  
Author(s):  
Christoph A. J. von Klot ◽  
Alena Boeker ◽  
Thomas R. W. Herrmann ◽  
Mario W. Kramer ◽  
Markus A. Kuczyk ◽  
...  
Keyword(s):  
Median Survival ◽  
Second Generation ◽  
Cox Regression ◽  
Abiraterone Acetate ◽  
Rank Test ◽  
Testosterone Levels ◽  
Risk Of Death ◽  
Log Rank Test ◽  
Kaplan Meier

191 Background: It is common practice to continue anti-androgen therapy in terms of androgendeprivation when performing chemotherapy or androgendeprivation with new second generation therapeutic agents such as enzalutamide or abiraterone acetate. Clinical Studies aiming at the question whether continuation of conventional ADT is necessary in this setting are currently recruiting. In this study we analyzed androgen deprivation in patients with mCRPC under chemotherapy and second generation androgen suppression. Methods: Out of 620 screened patients a total of 36 patients with continuous testosterone monitoring and mCRPC underwent therapy with docetaxel, abiraterone acetate, enzalutamide, carboplatin, carbozantinib or cabazitaxel and were evaluated. Data were gathered from our center over a median follow up period of 27.8 (0.6 - 65.1) month. A cutoff of 0.5 ng/dL was used to discriminate patients according to testosterone castration levels. Statistical evaluation was performed applying Kaplan Meier survival estimates, Cox regression and log rank test. Results: Median follow up was 26.2 month (range 1.4 - 64.8 month). Mean patient age was 70.9 years (range 51 - 86 years). The mean testosterone concentration in our cohort was 0.5 ng/dL. Serum testosterone levels varied greatly: ranging from 0 to 16 ng/dL. A total of 18 patients died during follow up. Median survival over all patients according to Kaplan-Meier survival estimation was 38.7 month (95% CI: 31 - NA month). Median survival for patients with testosterone levels below and above 0.5 ng/dL were 48.67 and 18.13 month respectively (log rank test: p = 0.0029). In Cox regression analysis, the hazard ratio for risk of death for patients with testosterone concentrations > 0.5ng/dL was 6.03 (95% CI: 1.5 - 25, p - 0.0132). For the covariates PSA velocity, patient age and primary Gleason score there was no significant effect on risk of death (p = 0.0597, 0.5006, 0.7354). Conclusions: In patients with mCRPC i.e rising PSA or progression under androgen deprivation, conventional suppression of testosterone levels still represents a vital factor for overall survival even at the mCRPC stage and under therapy with second line anti hormonal therapeutic medication and chemotherapy.

Postmastectomy Reconstruction is Associated with Improved Survival in Patients with Invasive Breast Cancer: A Single-institution Study

2013 ◽  
Vol 79 (10) ◽  
pp. 977-981 ◽  
Author(s):  
Jennifer L. Baker ◽  
Brian Mailey ◽  
Christopher A. Tokin ◽  
Sarah L. Blair ◽  
Anne M. Wallace
Keyword(s):  
Breast Cancer ◽  
Breast Reconstruction ◽  
Invasive Breast Cancer ◽  
Cox Regression ◽  
Well Being ◽  
Rank Test ◽  
Single Institution ◽  
Cox Regression Analysis ◽  
Kaplan Meier

Breast reconstruction after mastectomy positively affects psychosocial well-being; however, the influence of reconstruction on cancer outcomes is unknown. The objective of our study was to compare survival in reconstructed versus nonreconstructed patients after mastectomy. All consecutive female patients diagnosed with invasive breast cancer and treated with mastectomy between 2002 and 2011 were identified from our single-institution database. All cancer operations were performed by two surgeons. Survival was calculated using the Kaplan-Meier method and compared using the log-rank test. To identify the effect of reconstruction on survival, a multivariate Cox regression analysis was performed. Of 474 patients treated, 340 (71.7%) underwent breast reconstruction. At a mean follow-up 3.3 years, reconstructed patients had a longer 5-year survival (91 vs 74%, P < 0.001). After controlling for age, race, payer source, cancer stage, triple negative status, and receipt of radiation or chemotherapy, reconstructed patients maintained a survival advantage over nonreconstructed patients (hazard ratio, 0.47; 95% confidence interval, 0.25 to 0.88; P = 0.02). Patients with breast cancer who undergo reconstruction have longer survival than nonreconstructed patients. The explanation for this finding may be related to improved psychosocial qualities of life versus possible antitumorigenic effects of implants.

scholarly journals The Poor Survival among Pulmonary Tuberculosis Patients in Chiapas, Mexico: The Case of Los Altos Region

2012 ◽  
Vol 2012 ◽  
pp. 1-6 ◽  
Author(s):  
J. C. Nájera-Ortiz ◽  
H. J. Sánchez-Pérez ◽  
H. Ochoa-Díaz-López ◽  
G. Leal-Fernández ◽  
A. Navarro-Giné
Keyword(s):  
Pulmonary Tuberculosis ◽  
Treatment Duration ◽  
Cox Regression ◽  
Rank Test ◽  
Poor Survival ◽  
Tuberculosis Patients ◽  
Log Rank Test ◽  
Kaplan Meier ◽  
Complete Treatment

Objective. To analyse survival in patients with pulmonary tuberculosis (PTB) and factors associated with such survival.Design. Study of a cohort of patients aged over 14 years diagnosed with PTB from January 1, 1998 to July 31, 2005. During 2004–2006 a home visit was made to each patient and, during 2008-2009, they were visited again. During these visits a follow-up interview was administered; when the patient had died, a verbal autopsy was conducted with family members. Statistical analysis consisted of survival tests, Kaplan-Meier log-rank test and Cox regression.Results. Of 305 studied patients, 68 had died due to PTB by the time of the first evaluation, 237 were followed-up for a second evaluation, and 10 of them had died of PTB. According to the Cox regression, age (over 45 years) and treatment duration (under six months) were associated with a poorer survival. When treatment duration was excluded, the association between poorer survival with age persisted, whereas with having been treated via DOTS strategy, was barely significant.Conclusions. In the studied area it is necessary that patients receive a complete treatment scheme, and to give priority to patients aged over 45 years.

Colorectal Liver Metastases - Does the Number of Lesions Determine the Sensibility of Resection?

Swiss Surgery ◽  
2000 ◽  
Vol 6 (1) ◽  
pp. 6-10
Author(s):  
Knoefel ◽  
Brunken ◽  
Neumann ◽  
Gundlach ◽  
Rogiers ◽  
...  
Keyword(s):  
Liver Metastases ◽  
Colorectal Liver Metastases ◽  
Rank Test ◽  
Log Rank Test ◽  
Kaplan Meier ◽  
Chirurgische Entfernung

Die komplette chirurgische Entfernung von Lebermetastasen bietet Patienten nach kolorektalem Karzinom die einzige kurative Chance. Es gibt jedoch eine, anscheinend unbegrenzte, Anzahl an Parametern, die die Prognose dieser Patienten bestimmen und damit den Sinn dieser Therapie vorhersagen können. Zu den am häufigsten diskutierten und am einfachsten zu bestimmenden Parametern gehört die Anzahl der Metastasen. Ziel dieser Studie war es daher die Wertigkeit dieses Parameters in der Literatur zu reflektieren und unsere eigenen Patientendaten zu evaluieren. Insgesamt konnte von 302 Patienten ein komplettes Follow-up erhoben werden. Die gebildeten Patientengruppen wurden mit Hilfe einer Kaplan Meier Analyse und konsekutivem log rank Test untersucht. Die Literatur wurde bis Dezember 1998 revidiert. Die Anzahl der Metastasen bestätigte sich als ein prognostisches Kriterium. Lagen drei oder mehr Metastasen vor, so war nicht nur die Wahrscheinlichkeit einer R0 Resektion deutlich geringer (17.8% versus 67.2%) sondern auch das Überleben der Patienten nach einer R0 Resektion tendenziell unwahrscheinlicher. Das 5-Jahres Überleben betrug bei > 2 Metastasen 9% bei > 2 Metastasen 36%. Das 10-Jahres Überleben beträgt bislang bei > 2 Metastasen 0% bei > 2 Metastasen 18% (p < 0.07). Die Anzahl der Metastasen spielt in der Prognose der Patienten mit kolorektalen Lebermetastasen eine Rolle. Selbst bei mehr als vier Metastasen ist jedoch gelegentlich eine R0 Resektion möglich. In diesen Fällen kann der Patient auch langfristig von einer Operation profitieren. Das wichtigere Kriterium einer onkologisch sinnvollen Resektabilität ist die Frage ob technisch und funktionell eine R0 Resektion durchführbar ist. Ist das der Fall, so sollte auch einem Patienten mit mehreren Metastasen die einzige kurative Chance einer Resektion nicht vorenthalten bleiben.

Survival Outcomes for Induction vs Adjuvant Chemotherapy in Squamous Cell Carcinoma of the Maxillary Sinus

2018 ◽  
Vol 160 (4) ◽  
pp. 658-663 ◽  
Author(s):  
Phoebe Kuo ◽  
Sina J. Torabi ◽  
Dennis Kraus ◽  
Benjamin L. Judson
Keyword(s):  
Overall Survival ◽  
Adjuvant Chemotherapy ◽  
Maxillary Sinus ◽  
Induction Chemotherapy ◽  
Squamous Cell ◽  
Cox Regression ◽  
Rank Test ◽  
Controlled Clinical Trial ◽  
Log Rank Test ◽  
Kaplan Meier

Objective In advanced maxillary sinus cancers treated with surgery and radiotherapy, poor local control rates and the potential for organ preservation have prompted interest in the use of systemic therapy. Our objective was to present outcomes for induction compared to adjuvant chemotherapy in the maxillary sinus. Study Design Secondary database analysis. Setting National Cancer Database (NCDB). Subjects and Methods In total, 218 cases of squamous cell maxillary sinus cancer treated with surgery, radiation, and chemotherapy between 2004 and 2012 were identified from the NCDB and stratified into induction chemotherapy and adjuvant chemotherapy cohorts. Univariate Kaplan-Meier analyses were compared by log-rank test, and multivariate Cox regression was performed to evaluate overall survival when adjusting for other prognostic factors. Propensity score matching was also used for further comparison. Results Twenty-three patients received induction chemotherapy (10.6%) and 195 adjuvant chemotherapy (89.4%). The log-rank test comparing induction to adjuvant chemotherapy was not significant ( P = .076). In multivariate Cox regression when adjusting for age, sex, race, comorbidity, grade, insurance, and T/N stage, there was a significant mortality hazard ratio of 2.305 for adjuvant relative to induction chemotherapy (confidence interval, 1.076-4.937; P = .032). Conclusion Induction chemotherapy was associated with improved overall survival in comparison to adjuvant chemotherapy in a relatively small cohort of patients (in whom treatment choice cannot be characterized), suggesting that this question warrants further investigation in a controlled clinical trial before any recommendations are made.

scholarly journals Lymphopenia Is Associated with Gross Target Volumes and Fractions in Hepatocellular Carcinoma Patients Treated with External Beam Radiation Therapy and Also Indicates Worse Overall Survival

2019 ◽  
Vol 2019 ◽  
pp. 1-12 ◽  
Author(s):  
Hai-Ge Zhang ◽  
Ping Yang ◽  
Tao Jiang ◽  
Jian-Ying Zhang ◽  
Xue-Juan Jin ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Overall Survival ◽  
Cox Regression ◽  
External Beam Radiation ◽  
Rank Test ◽  
Beam Radiation ◽  
Kaplan Meier ◽  
Target Volumes ◽  
The Relationship

Purpose. To investigate whether lymphocyte nadir induced by radiation is associated with survival and explore its underlying risk factors in patients with hepatocellular carcinoma (HCC). Methods. Total lymphocyte counts were collected from 184 HCC patients treated by radiotherapy (RT) with complete follow-up. Associations between gross tumor volumes (GTVs) and radiation-associated parameters with lymphocyte nadir were evaluated by Pearson/Spearman correlation analysis and multiple linear regression. Kaplan–Meier analysis, log-rank test, as well as univariate and multivariate Cox regression were performed to assess the relationship between lymphocyte nadir and overall survival (OS). Results. GTVs and fractions were negatively related with lymphocyte nadir (p<0.001 and p=0.001, respectively). Lymphocyte nadir and Barcelona Clinic Liver Cancer (BCLC) stage were independent prognostic factors predicting OS of HCC patients (all p<0.001). Patients in the GTV ≤55.0 cc and fractions ≤16 groups were stratified by lymphocyte nadir, and the group with the higher lymphocyte counts (LCs) showed longer survival than the group with lower LCs (p<0.001 and p=0.006, respectively). Patient distribution significantly differed among the RT fraction groups according to BCLC stage (p<0.001). However, stratification of patients in the same BCLC stage by RT fractionation showed that the stereotactic body RT (SBRT) group achieved the best survival. Furthermore, there were significant differences in lymphocyte nadir among patients in the SBRT group. Conclusions. A lower lymphocyte nadir during RT was associated with worse survival among HCC patients. Smaller GTVs and fractions reduced the risk of lymphopenia.

Effects of electrical stimulation in the treatment of osteonecrosis of the femoral head

2017 ◽  
Vol 28 (4) ◽  
pp. 434-441
Author(s):  
Salvador Fornell ◽  
Juan Ribera ◽  
Mario Mella ◽  
Andrés Carranza ◽  
David Serrano-Toledano ◽  
...  
Keyword(s):  
Electrical Stimulation ◽  
Retrospective Study ◽  
Femoral Head ◽  
Core Decompression ◽  
Rank Test ◽  
Time To Recurrence ◽  
Log Rank Test ◽  
Kaplan Meier

Introduction: The aim of this study was to examine whether the use of an internal electrostimulator could improve the results obtained with core decompression alone in the treatment of osteonecrosis of the femoral head. Methods: We performed a retrospective study of 41 patients (55 hips) treated for osteonecrosis of the femoral head between 2005 and 2014. Mean follow-up time was 56 (12-108) months. We recorded 3 parameters: time to recurrence of pain, time to conversion to arthroplasty and time to radiographic failure. Survival was estimated using the Kaplan-Meier method. The equality of the survival distributions was determined by the Log rank test. Results: Implanted electrostimulator was a factor that increased the survival of hips in a pre-op Steinberg stage of II or below, while it remained unchanged if the stage was III or higher. Conclusions: The addition of an internal electrostimulator provides increased survival compared to core decompression alone at stages below III.

Clinical presentation and outcomes of 2,924 early breast cancer patients (br.ca. pts) treated in a single institution in a 10-year period with a long follow up

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10669-10669
Author(s):  
E. Galligioni ◽  
R. Triolo ◽  
A. Lucenti ◽  
A. Ferro ◽  
M. Frisinghelli ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Rank Test ◽  
Consecutive Series ◽  
Breast Cancer Patients ◽  
Log Rank Test ◽  
Product Limit ◽  
Probability Of Death ◽  
Clinical Records ◽  
Hormonal Receptor Status

10669 Background: A consecutive series of br.ca. pts, treated between Jan 1st 1990 to Dec 31st 1999 in our Department, is the basis of our retrospective study, aimed to create a data base on routinary clinical management of early br.ca. pts, to which compare similar series and literature data. Methods: All Clinical Records were reviewed and computerized. Disease free and overall survival were estimated using the product-limit method of Kaplan and Meier. The log-rank test was used to compare prognosis between different subgroups. Results: Among 2924 consecutive br.ca. pts, 836 were younger than 50 years (med. age 44) and 2088 older (med. age 63). Regional nodes were negative (N−) in 1754, positive (N+) in 1027 and unknown in the remaining pts. So, 2593 pts were stage I-II and 301 stage IIIA-B. Hormonal Receptor status (available on 2560 pts) was positive for Estrogen (ER+) in 2021 pts and for Progesterone (PgR+) in 1649 pts. Moreover, 1571 pts were ER+Pgr+, 539 ER-PgR−, 78 ER-PgR+ and 461 ER+PgR−. HER2 was overexpressed in 262/1426 (18%) pts. Tumor grading (available on 2176 cases) was G1–2 in 1411 and G3–4 in 765 cases. After surgery, 731 pts received adjuvant Tamoxifen, 507 pts CMF ± Antracyclines chemotherapy, 434 pts both chemotherapy and Tamoxifen and 958 pts none. (no therapy data are available for the remaining 334 pts). At a median f.up of 9.8 years, 993/2924 pts (33.9%) have recurred, (med. DFS 137 mos) with a 5, 10 and 15 y probability of recurrence of 26, 44 and 63% respectively. Corresponding figures of recurrence for N− pts were 14, 30 and 50% (med. DFS 168 mos), while for N+ pts were 41, 61 and 77% (med DFS 81 mos). For younger N+ pts treated with chemotherapy, the 5 years probability of recurrence was 34% while it was 24% for older ER+ pts treated with hormonal therapy. So far, 794/2924 (27.5%) pts have died, with a 5, 10 and 15 y probability of death of 13, 27 and 41%. This was 5, 16 and 28% for N- pts and 22, 41 and 56% for N+ pts. For younger N+ pts treated with chemotherapy, the 5 y probability of death was 14%, as it was for older ER+ pts treated with Tamoxifen. Conclusions: Although this data are not yet conclusive, it appears that large part of the clinical improvements reported in clinical trials may be achieved in the routine management of breast cancer pts. No significant financial relationships to disclose.

Gemcitabine plus docetaxel versus docetaxel in patients (pts) with HER2-negative locally advanced or metastatic breast cancer (MBC): A randomized phase III study

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 1015-1015
Author(s):  
D. L. Nielsen ◽  
S. T. Langkjer ◽  
K. Bjerre ◽  
S. Cold ◽  
L. Stenbygaard ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Single Agent ◽  
Locally Advanced ◽  
Metastatic Breast ◽  
Phase Iii ◽  
Rank Test ◽  
Hematologic Toxicity ◽  
Phase Iii Study ◽  
Her 2 ◽  
Grade 3

1015 Background: Gemcitabine (G), either as a single agent or in combination with taxanes, has demonstrated efficacy in MBC in phase II and III studies. We conducted a phase III study to compare time to progression (TTP) of G plus docetaxel (T) versus (vs.) T alone. The secondary endpoints included overall survival (OS), overall response rate (ORR), and toxicity. Methods: Females with HER-2-negative locally advanced or MBC and a WHO performance status ≤ 2 were randomized to GT (G 1,000mg/m2 day 1 + 8; T 75mg/m2 day 1) or T (100mg/m2 day 1) every 21 days. Pts were previously untreated, had prior anthracycline-based (neo)adjuvant chemotherapy or had received a single prior anthracycline-bsed chemotherapy regimen for MBC. Time-to-event endpoints were estimated using the Kaplan-Meier method, and the log-rank test was applied for comparisons between regimens. The planned sample size was 254 evaluable pts with α I and β of 0.05 and 0.90, respectively. Results: A total of 336 pts were randomized (170 GT; 166 T), data from one centre are yet missing and the present evaluation is based on data from 306 pts (155 GT; 151 T). The pts had a median age of 58 years in both regimens; range 36–73 years and 30–74 years, respectively. The median TTP was 7.5 months for the GT regimen vs. 6.5 months for the T regimen. The GT arm demonstrated an ORR of 44% vs. 38% in the T arm with 4 and 3 % complete responses, respectively. The OS was 13.4 vs. 13.2 months in the GT and T arm, respectively. Hematologic toxicity was common, especially grade 3–4 neutropenia (GT = 69%; T = 61%); infection was reported in 22 and 20% of the pts, respectively (none of the pts received G-CSF). The most commonly reported non-hematologic toxicities of grade 3–4 included mucositis (GT = 2%; T = 5%), diarrhea (GT = 4%; T = 7 %), fatigue (GT = 6%; T = 11%), oedema (GT = 10%; T = 3%), and peripheral neuropathy (GT = 9%; T = 28%). Conclusions: Preliminary data of GT as first- or second-line chemotherapy demonstrates a TTP advantage among HER-2-negative pts with advanced breast cancer. Updated results and proper statistical analyses will be presented. No significant financial relationships to disclose.

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