Chemotherapy For Early Breast Cancer Research Articles

Pretreatment Serum Anti-Müllerian Hormone Predicts Long-Term Ovarian Function and Bone Mass after Chemotherapy for Early Breast Cancer

Administration of chemotherapy to premenopausal women shortens their reproductive lifespan by depleting nonrenewable oocytes. Preservation of fertility is a priority for many such women, and identification of women at risk of infertility is therefore important. However, age is the only patient characteristic currently recognized to be predictive of long-term ovarian function after chemotherapy. Our objective was to assess markers of ovarian reserve and age as long-term predictors of ovarian function after chemotherapy. We conducted a prospective, longitudinal study at a university hospital and research institute. Patients included women who were premenopausal at the time of diagnosis of early breast cancer. Ovarian function was assessed at 5 yr follow-up in relation to pretreatment hormonal and ultrasound markers of ovarian reserve. Forty-two women received (neo-)adjuvant chemotherapy. Continuing menses 4-5 yr after diagnosis closely reflected ovarian activity as assessed by a range of serum markers, including estradiol, inhibin B, FSH, and anti-müllerian hormone (AMH). Pretreatment serum AMH, FSH, antral follicle count, and age predicted late ovarian activity by univariate analysis. However, only AMH was predictive in a multivariate logistic regression (odds ratio = 13.0; 95% confidence interval = 2.5-66.7); 0.71 ng/ml gave peak likelihood ratio of 7.0 with 54% sensitivity and 92% specificity. Bone mineral density fell over the 4-5 yr after diagnosis with greater loss in women with lower ovarian activity. Higher pretreatment AMH was associated with lower bone mineral density at both lumbar spine and hip at 5 yr (P < 0.02). Measurement of AMH at cancer diagnosis predicts long-term ovarian function after chemotherapy. Use of this in clinical practice may allow better prediction of chemotherapy-related risk to future fertility.

Abstract P5-10-25: Docetaxel/Cyclophosphamide (TC) Chemotherapy for Early Breast Cancer: Is Primary g-csf Prophylaxis Necessary?

Abstract Introduction Febrile neutropenia (FN) is a recognised complication of adjuvant systemic chemotherapy which leads to hospitalisation, treatment delays and dose reductions which ultimately may compromises treatment efficacy and patient (pt) outcomes. The use of granulocyte-colony stimulating factor (G-CSF) is recommended within clinical guidelines as routine prophylaxis if the chemotherapy regimen is likely to cause FN rates of &amp;gt;20%.For regimens associated with FN rates of 10-20%, pt may increase the risk.(Aapro et al, 2006). Following the publication of Jones et al (2006), the Beatson West of Scotland Cancer Centre (BWOSCC) adopted TC chemotherapy as an option for patients with intermediate/high risk breast cancer as an alternative to anthracyline based regimens. This was primarily for patients who had major co-morbidities precluding anthracycline use, had prior exposure to anthracylines or who were deemed unable to tolerate a protracted course of treatment for clinical reasons. The study by Jones et al (2006) described an overall FN rate of 5% with an increased rate of FN (8%) in patients &amp;gt; 65 yrs, with a 4% rate in those &amp;lt;65yrs. Recently Soong et al (2009) reported a higher rate of FN of 50% within the first cohort of patients (6/12 pts) treated within their centre, which resulted in subsequent prophylactic G-CSF usage. A recent paper by Chan et al (2010) concluded that Asian patients who have a recognised higher incidence of Docetaxel induced myelosuppresion warranted G-CSF propylaxis. Their experience of using TC resulted in FN rates of 25% in those patients who didn't receive G-CSF, 6.3% FN rates in those who did with an absolute risk reduction of FN events by 18.7%. With this in mind, an audit of our local practice and usage of TC chemotherapy was conducted. Methods A retrospective/prospective case note review of patients treated using (neo) adjuvant TC within the BWOSCC and satellite units between October 2007 and October 2010 is being undertaken. Data in respect to the first 51 consecutive pts identified from pharmacy records, treated between October 2007 and October 2009 is available. The median age was 58 (range 27 — 81): female 50, male 1: adjuvant 50, neo-adjuvant 1. All patients received Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 at first cycle. Results 5/51 pts (9.8%) had an episode of FN, 2 pts at cycle 1, with 1 pt at cycles 2, 3 and 4. No pt had more than 1 episode of FN.22 pts (43%) received primary G-CSF prophylaxis whilst 29pts (57%) did not. The rate of FN in the primary prophylactic group was 9% (2/22 pts) and 10% (3/29pts) in those who didn't receive G-CSF. In the G-CSF group, 1 patient required a dose reduction and 5 patients had dose delays whilst 5 patients had a dose reduction and 3 required dose delays in the non G-CSF group. Conclusion The overall rate of FN observed was approximately 10% and for a substantial proportion of patients, primary prophylaxis with G-CSF is not required. Results of ongoing data collection will be presented with regard to patient characteristics, outcomes, and indications for G-CSF primary prophylaxis in this group of patients. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P5-10-25.

Abstract P5-13-07: Hormone Levels in the OPTION Trial Show No Ovarian Protection by Goserelin in Adjuvant Chemotherapy for Early Breast Cancer — An Anglo-Celtic Collaborative Group and NCRN Trial

Abstract Non-randomised data suggest a protective benefit on ovarian function for using GnRH analogues to suppress menses during chemotherapy. However there have been no published randomised clinical trials to date that confirm this protection indicated by recovery of menstrual function. Observational data suggest that patient age and cumulative dose of alkylating agent or selection and intensity of dose other agents such as anthracyclines or taxanes are also important variables that determine the risk of chemotherapy-induced premature ovarian failure (POF). This trial in premenopausal women has tested the effect of goserelin (G) given randomly before and during adjuvant chemotherapy in premenopausal women with breast cancer. Any standard regimen was allowed but women were randomised in 2 strata, under 40 yrs and over 40 yrs at diagnosis. 227 patients were recruited by end December 2009, and 173 met the criteria for 1 year follow-up for this analysis; 140 patients of these 173 patients had provided adequate data on menstrual bleeding; 87 patients were aged under 40 and 53 patients were aged over 40 at the time of chemotherapy. Cessation of menstruation during chemotherapy was defined as at least two consecutive cycles with no menstrual bleeding since the previous cycle. Additionally, prior to the final cycle of chemotherapy, there had to be no return of menstrual bleeding. Of those patients who had ceased periods during chemotherapy, those with no further menstrual bleeding at 12 months follow up were deemed to have reached menopause. Patients were randomised to receive G or no G at start of chemotherapy. Primary endpoint was recovery of menses at 12 months from start of chemotherapy. Secondary endpoints included quality of life, oestrogen/LH/FSH levels at start and completion and at 12 months along with anti-mullerian hormone (AMH, as an indicator of impending ovarian failure). Endocrine data over time showed a close correlation with menses in that both measures indicated no protective effect in the treatment group. There was no significant difference with respect to POF when all patients were considered. However there was a trend to poorer recovery of menstrual function at 12 months in the under-40 yrs group who had G with 34.7% having POF in the G treated group and 15.8% in the chemotherapy only treated group (P ≥0.05). This is mirrored by the oestrogen data which show an incomplete recovery at 12 months of oestrogen in the G group compared with controls although a complete recovery at 24 months. LH and FSH levels showed appropriate suppression by G and thereafter similar levels to controls. Early follow up data on the hormone levels shows no difference between the treatment groups. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P5-13-07.

Cancers du sein de stade II-IIIA : la radiothérapie exclusive est-elle une option en cas de réponse clinique complète à la chimiothérapie néoadjuvante ?

Purpose To determine whether exclusive radiotherapy could be a therapeutic option after complete clinical response (cCR) to neoadjuvant chemotherapy (NCT) for early breast cancers (EBC). Patients and methods Between 1985 and 1999, 1477 patients received néoadjuvante chemotherapy for early breast cancer considered to be too large for primary conservative surgery. Of 165 patients with complete clinical response, 65 were treated by breast surgery (with radiotherapy) and 100 by exclusive radiotherapy. Results The two groups were comparable in terms of baseline characteristics, except for larger initial tumor sizes in the exclusive radiotherapy group. There were no significant differences in overall, disease-free and metastasis-free survivals. Five-year and 10-year overall survivals were 91 and 77% in the no surgery group and 82 and 79% in the surgery group, respectively ( P = 0.9). However, a non-significant trend towards higher locoregional recurrence rates (LRR) was observed in the no surgery group (31 vs. 17% at 10 years; P = 0.06). In patients with complete responses on mammography and/or ultrasound, LRR were not significantly different ( P = 0.45, 10-year LRR: 21 in surgery vs. 26% in exclusive radiotherapy). No significant differences were observed in terms of the rate of cutaneous, cardiac or pulmonary toxicities. Conclusion Surgery is a key component of locoregional treatment for breast cancers that achieved complete clinical response to neoadjuvant chemotherapy.

Chimiothérapie des cancers du sein non métastatiques : état des lieux en 2010

The management of breast cancer has changed at both surgery levels, with the development of sentinel node, and at the medical level with the use of new therapies. Breast cancer is a heterogeneous disease and each patient should be offered an adapted treatment in an effort to reduce the risk of relapse and death, with the minimal toxicities. The micrometastatic disease appears early in the history of the tumor and chemotherapy aims to eradicate it. In this review, we describe the state of practice regarding adjuvant and neoadjuvant chemotherapy for early breast cancer.

Zoledronic acid prevents bone loss in premenopausal women with early breast cancer undergoing adjuvant chemotherapy: a phase III trial of the Korean Cancer Study Group (KCSG-BR06-01)

To determine whether zoledronic acid (ZA) can prevent bone loss in premenopausal women undergoing adjuvant chemotherapy for breast cancer. In this randomized, open-label, phase III multicenter trial, premenopausal women >40 years were randomly assigned to ZA treatment (4 mg IV, every 6 months) or observation after surgery. All patients were treated with four cycles of AC followed by four cycles of taxane. Between March 2007 and May 2008, we assessed a total of 112 premenopausal women, all of whom developed amenorrhea at 1 year after chemotherapy. The mean percent change of BMD in the lumbar spine (LS) was -1.1% in the ZA group versus -7.5% in observation group at 12 months. Differences in percent change of BMD from baseline between the two groups were 6.4% for the LS, and 3.6% for the femoral neck. The mean levels of bone turnover at 12 months were significantly lower in the ZA group. ZA was generally well tolerated. Infusion of ZA 4 mg every 6 months effectively prevented bone loss within the first year in premenopausal women receiving adjuvant chemotherapy for early breast cancer. Regular BMD measurements and early bisphosphonate therapy should be considered in these patients.

Regional and seasonal influence in patient’s toxicity to adjuvant chemotherapy for early breast cancer

Results from multinational clinical trials are globally adopted into the routine clinical practice in most countries. Changes in the natural history and incidence of certain diseases as well as in drugs toxicities related to yearly seasons have been reported, however, variations related to climate have never been described. In our study, we assessed whether yearly seasons and climate could influence the chemotherapy toxicity profile. We analyzed the toxicities recorded in the phase III GEICAM 9906 study which was run in different geographically and climatically/seasonally regions in Spain. In this trial 1246 patients were randomized and eligible to receive FEC90 ×6 cycles or FEC90 ×4 cycles followed by eight doses of weekly paclitaxel (T). The results showed differences in hematological and non-hematological toxicities in relation to the season of the year and the climate of the area in which the treatment was administered. We found a higher hematological toxicity in warm seasons (spring and summer) and in Oceanic climate regions (Neutropenia G4: 7.8 vs. 1.0 vs. 1.0%, P < 0.0001). Asthenia was greater frequency in the summer period (FEC90: 21.1%, T: 15.3%) as well as in the Mediterranean areas (FEC: 28% T: 27.2%). Also we observed liver transaminase elevations were more frequent in the summer and in the Oceanic areas. Myalgias and secondary sensory neuropathy to paclitaxel were recorded more frequently during autumn. Climate should be considered a significant variable in toxicity to chemotherapy.

A randomised comparative trial of infusional ECisF versus conventional FEC as adjuvant chemotherapy in early breast cancer: the TRAFIC trial

BackgroundThe epirubicin with cisplatin and infusional 5-fluorouracil (5-FU) (ECisF) regimen was found to be highly active in the treatment of metastatic breast cancer and as neoadjuvant therapy. The UK TRAFIC (trial of adjuvant 5-FU infusional chemotherapy) trial (CRUK/95/007) compared this schedule with 5-FU, epirubicin and cyclophosphamide (FEC60) as adjuvant therapy in patients with early breast cancer. MethodsIn this multicentre, open-label, phase III randomised controlled trial, 349 women were randomly assigned to receive i.v. ECisF [epirubicin 60 mg/m2, day 1, cisplatin 60 mg/m2, day 1 and 5-FU 200 mg/m2 by daily 24-h infusion (n = 172)] or FEC [5-FU 600 mg/m2, day 1, epirubicin 60 mg/m2, day 1 and cyclophosphamide 600 mg/m2, day 1 (n = 177)]. Both treatments were delivered every 3 weeks for six cycles. The primary end point was relapse-free interval (RFI). TRAFIC is registered as an International Standard Randomised Controlled Trial (ISRCTN 83324925). ResultsAll randomised patients were included in the intent-to-treat population. With a median follow-up of 112 months, there was no significant difference in RFI between the treatment groups [hazard ratio 0.84 (95% confidence interval 0.60–1.19); P = 0.33]. Toxic effects were more frequent in patients allocated to ECisF. ConclusionsWhile limited by size, TRAFIC has long follow-up. No evidence of a clinically worthwhile benefit for the infusional treatment compared with standard treatment was observed which would justify further investigation or widespread use.

Gene expression profile predicts outcome after anthracycline-based adjuvant chemotherapy in early breast cancer

Prognosis of early beast cancer is heterogeneous. Today, no histoclinical or biological factor predictive for clinical outcome after adjuvant anthracycline-based chemotherapy (CT) has been validated and introduced in routine use. Using DNA microarrays, we searched for a gene expression signature associated with metastatic relapse after adjuvant anthracycline-based CT without taxane. We profiled a multicentric series of 595 breast cancers including 498 treated with such adjuvant CT. The identification of the prognostic signature was done using a metagene-based supervised approach in a learning set of 323 patients. The signature was then tested on an independent validation set comprising 175 similarly treated patients, 128 of them from the PACS01 prospective clinical trial. We identified a 3-metagene predictor of metastatic relapse in the learning set, and confirmed its independent prognostic impact in the validation set. In multivariate analysis, the predictor outperformed the individual current prognostic factors, as well as the Nottingham Prognostic Index-based classifier, both in the learning and the validation sets, and added independent prognostic information. Among the patients treated with adjuvant anthracycline-based CT, with a median follow-up of 68months, the 5-year metastasis-free survival was 82% in the "good-prognosis" group and 56% in the "poor-prognosis" group. Our predictor refines the prediction of metastasis-free survival after adjuvant anthracycline-based CT and might help tailoring adjuvant CT regimens.

Circulating sphingosine-1-phosphate inversely correlates with chemotherapy-induced weight gain during early breast cancer

Weight gain in women receiving chemotherapy for breast cancer is associated with a higher risk of recurrence. Using metabonomic profiling, we recently reported that plasma lactate and alanine were prognostic for weight gain in individuals with breast cancer receiving chemotherapy. The role of lipid second messengers has not been studied. We assessed serum levels of sphingosine-1-phosphate (S1P), a known secreted lipid second messenger with a role in cell growth, in sequential samples from post-menopausal women receiving standard chemotherapy for early breast cancer and correlated these with body mass measurements and metabonomic profiling. While serum S1P levels prior to treatment did not correlate with body weight changes or circulating alanine and lactate, S1P levels measured during therapy were inversely correlated with weight gain (P = 0.04), but not weight loss (P = 0.74) or no change in weight (P = 0.5), suggesting a role of dynamic circulating S1P in adipocyte growth. These data provide evidence for an association between serum S1P and weight gain during chemotherapy cycles in women with breast cancer. Lipid second messengers have a role in chemotherapy-induced weight gain in breast cancer.

Nurse prescribing of chemotherapy: docetaxel in early breast cancer

Capacity issues and streamlining of processes are important to the modernization of chemotherapy services; however, the role of the nurse prescriber is also a key consideration. To undertake an effective prescribing role in chemotherapy, the nurse must understand the evidence base not only for the treatment itself, but also for the management of the associated toxicities. This article explores these issues from the point of view of docetaxel-based chemotherapy for early breast cancer.

Randomized, controlled pilot trial of electro-acupuncture for nausea, vomiting, and myelosuppression in women receiving adjuvant chemotherapy for early breast cancer.

e19630 Background: Nausea, vomiting and myelosuppression are common side effects of chemotherapy. Despite recent advances in anti-emetic therapy, a significant percent of women still experience nausea and vomiting. Nonblinded trials have suggested acupuncture may have some benefit in controlling these side effects. The primary objective of this study was to assess feasibility and safety of electro-acupuncture (EA) used in women receiving adjuvant anthracycline based chemotherapy for early breast cancer. Secondary objectives were to assess any benefit of EA on reducing chemotherapy induced nausea, vomiting and myelosuppression. Methods: Thirty women receiving adjuvant anthracycline based chemotherapy for early breast cancer were randomized to receive sham EA (n=16) or real EA (n=14). Acupuncture was administered immediately prior to chemotherapy and on day 2 for the first 2 cycles. All patients received standard anti-emetic therapy. Nausea and vomiting were assessed in the first 3 cycles of chemotherapy wi...

The OPTION trial of adjuvant ovarian protection by goserelin in adjuvant chemotherapy for early breast cancer.

590 Background: Nonrandomised studies suggest that goserelin may protect the ovaries against chemotherapy induced premature menopause. The primary objective of the open, randomised multicentre OPTION trial was to determine the impact of goserelin on the incidence of premature ovarian failure following chemotherapy for operable breast cancer. Secondary objectives were to record menstruation (diary) and pregnancies, assess quality of life (FACT-ES) and menopausal symptoms, and measure changes in bone mineral density (BMD) and bone turnover markers, hormone levels (including AMH and inhibin B). Methods: All premenopausal ER negative women (or ER positive women for whom ovarian suppression was not considered necessary) planned for adjuvant or neoadjuvant chemotherapy, were considered for inclusion. Women were stratified by age >/ = 40 or < 40 years at randomisation, and by centre. Chemotherapy regimens comprised any 6-8 cycles of chemotherapy containing cyclophosphamide and/or anthracycline. Regimens could include taxanes. Goserelin was randomly allocated to start before or at first chemotherapy cycle and continued 3-4 weekly to final cycle. For the purposes of the sample size calculation, the rates of premature menopause were assumed to be 40% in the under 40 age group and 80% in the over 40 age group (Bines et al, J Clin Oncol 14(5):1718-29 1996). Reported rates of preservation of ovarian function using goserelin with chemotherapy in uncontrolled studies are around 80%, (possibly higher in the under 40's): i.e. rates of premature menopause with goserelin of around 20% or less. Based on a one sided test with 5% false positive rate, the groups required approximately 140 and 70 patients respectively to have a 80% chance of detecting an absolute reduction in premature menopause rate of 20% and 25% respectively, that is from 40% to 20% in the under 40 age group and from 80% to 55% in the over 40 age group. A total of 210 patients were therefore required. Results: At trial closure, 31/12/09, 227 patients had been randomised. Conclusions: The primary accrual endpoint of more than 210 patients has been achieved and so we expect the statistical requirements to be met. Primary and selected secondary endpoints will be presented. No significant financial relationships to disclose.

Substituting doxorubicin with nonpegylated liposomal doxorubicin (NPLD) in adjuvant/primary chemotherapy for early breast cancer, impact in cardiac function: A pilot study.

616 Background: NPLD (Myocet, Cephalon UK Ltd) is effective for the treatment of metastatic breast cancer and is less cardiotoxic than doxorubicin. However, there are currently limited data for NPLD in early breast cancer, where it may be particularly beneficial, as cardiotoxicity may be treatment-limiting and is a key survivorship issue. Methods: Consecutive patients with early breast cancer treated with NPLD substituting for doxorubicin were studied to evaluate change in cardiac function. Echocardiogram results and details of other treatments and disease progression were assessed. Results: 80 patients (median age 54 (33-77) years) were studied, with most receiving NPLD adjuvantly (76%; primary 24%) in sequence with a taxane (AC+T 73%; AC 8%; TAC 19%). 83% had radiotherapy and 16% received trastuzumab. The 48 evaluable patients had mean left ventricular ejection fraction (LVEF) values within the normal range (>50%) at baseline (64%), during chemotherapy (65%), < 4 months (63%) and >12 months (63%) after chemotherapy. There was no significant change in cardiac function whether NPLD was given as primary or adjuvant therapy, at baseline (65% vs. 64%), during (65% vs. 65%) or < 4 months after therapy (60% vs. 64%). No difference in cardiac function was observed when categorised by chemotherapy regimen at baseline (AC: 63%; AC+T: 63%; TAC: 67%), during (AC: 64%; AC+T: 65%; TAC: 67%) or < 4 after therapy (AC: no data; AC+T: 63%; TAC: 63%). There was also no difference in cardiac function between patients who did and did not receive trastuzumab at baseline (65% vs. 64%), during (64% vs. 66%), or < 4 months after therapy (65% vs. 62%). Results for age > 60 vs. < 60 years were also similar (baseline 67% vs. 63%; during 67% vs. 65%; or < 4 months after 64% vs. 63%). 8 (10%) of the 80 patients experienced disease recurrence/progression and 2 (3%) died. Conclusions: NPLD appears to have good cardiac tolerability and be efficacious in early breast cancer. Larger, longer-term studies are required to confirm these promising results to protect cardiac function, particularly when breast cancer patients are living longer with multiple lines of treatment for metastatic cancer. No significant financial relationships to disclose.

Prognostic Significance of Neutropenia on Day One of Anthracycline-Based Neoadjuvant Chemotherapy in Operable Breast Cancer

Objectives: It is currently unknown whether neutropenia during neoadjuvant chemotherapy for early breast cancer is associated with prognosis. Methods: We retrospectively analyzed 103 breast cancer patients who were treated with neoadjuvant chemotherapy including epirubicin-based chemotherapy followed by docetaxel. The association between neutropenia due to epirubicin-based chemotherapy and distant disease-free survival (DDFS) was assessed. Results: Thirty-one patients (30%) demonstrated neutropenia during the epirubicin-based regimen. Patients without neutropenia showed a significantly (p = 0.004) lower 5-year DDFS rate (64%) than those with neutropenia (97%). In addition, multivariate analysis showed that neutropenia is an independent prognostic factor for DDFS (p = 0.02). Conclusion: Neutropenia occurring in early breast cancer patients during the initial neoadjuvant treatment is strongly associated with a better prognosis.

Febrile Neutropenia Rates with Adjuvant Docetaxel and Cyclophosphamide Chemotherapy in Early Breast Cancer: Discrepancy between Published Reports and Community Practice—A Retrospective Analysis

Adjuvant therapies, including chemotherapy [...]

The predictive value of the 70-gene signature for adjuvant chemotherapy in early breast cancer

Multigene assays have been developed and validated to determine the prognosis of breast cancer. In this study, we assessed the additional predictive value of the 70-gene MammaPrint signature for chemotherapy (CT) benefit in addition to endocrine therapy (ET) from pooled study series. For 541 patients who received either ET (n = 315) or ET + CT (n = 226), breast cancer-specific survival (BCSS) and distant disease-free survival (DDFS) at 5 years were assessed separately for the 70-gene high and low risk groups. The 70-gene signature classified 252 patients (47%) as low risk and 289 (53%) as high risk. Within the 70-gene low risk group, BCSS was 97% for the ET group and 99% for the ET + CT group at 5 years with a non-significant univariate hazard ratio (HR) of 0.58 (95% CI 0.07-4.98; P = 0.62). In the 70-gene high risk group, BCSS was 81% (ET group) and 94% (ET + CT group) at 5 years with a significant HR of 0.21 (95% CI 0.07-0.59; P < 0.01). DDFS was 93% (ET) versus 99% (ET + CT), respectively, in the 70-gene low risk group, HR 0.26 (95% CI 0.03-2.02; P = 0.20). In the high risk group DDFS was 76 versus 88%, HR of 0.35 (95% CI 0.17-0.71; P < 0.01). Results were similar in multivariate analysis, showing significant survival benefit by adding CT in the 70-gene high risk group. A significant and clinically meaningful benefit was observed by adding chemotherapy to endocrine treatment in 70-gene high risk patients. This benefit was not significant in low risk patients, who were at such low risk for recurrence and cancer-related death, that adding CT does not appear to be clinically meaningful.

48 The addition of capecitabine to neoadjuvant chemotherapy for early breast cancer (EBC): a review of clinical study data

48 The addition of capecitabine to neoadjuvant chemotherapy for early breast cancer (EBC): a review of clinical study data

Molecular Predictors of Locoregional Recurrence in Breast Cancer: Ready for Prime Time?

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Potential economic impact of the 21-gene expression assay on the treatment of breast cancer in brazil

The 21-gene expression assay may support the decision regarding use of chemotherapy in early breast cancer. We sought to investigate the potential impact of incorporating the 21-gene expression assay into private practice in Brazil, from the perspective of third party payers. We conducted a web-based survey with 30 (of a total of approximately 700) Brazilian medical oncologists, who were stratified by State according to the proportion of patients with breast cancer and private health insurance. We evaluated the possible treatment of first choice for patients with lymph-node-negative, estrogen-receptor-positive breast cancer, regardless of menopausal status. Interviewees were not aware of the objective of the study. Responses permitted a quantitative assessment of the care patterns regarding use of different chemotherapy regimens, type of premedication, use of growth factors, and use of intravenous antibiotics for febrile neutropenia. We calculated medication costs using the manufacturer's recommended prices. Other direct medical expenses, indirect medical costs, and non-medical costs were not included. Considering a hypothetical cohort of 100 patients without access to the 21-gene expression assay, the survey showed that 84 patients would receive chemotherapy. Reclassifying patient eligibility for chemotherapy according to the 21-gene expression assay would lower this number to 49. For a hypothetical cohort of 100 patients with access to the test, US$ 79,361.43 would be saved in main direct medical costs. Such results, however, would greatly vary according to tumor size: the 21-gene expression assay could increase direct medical costs in T1 tumors, and decrease costs in cases with T >2 cm. Considering the current price for the 21-gene expression assay in Brazil, our economic analysis suggests that such testing is an overall cost-saving, from the perspective of third party payers. Further, optimal use of resources would entail targeted use of the 21-gene expression assay.