Radical Prostatectomy or Radiotherapy in High-Risk Prostate Cancer: A Systematic Review and Metaanalysis

BackgroundRadical prostatectomy (RP) is one of the treatment options for localized, high-risk prostate cancer (PC), but it has never been compared with external beam radiotherapy (RT), which is an alternative approach, in a large randomized trial. To compare the outcomes of patients treated with surgery versus RT, we performed a metaanalysis of available studies on this topic.Materials and MethodsWe performed a search of MEDLINE, EMBASE, Web of Science, SCOPUS, and The Cochrane Central Register of Controlled Trials (CENTRAL) for randomized or observational studies that investigated overall survival (OS) and PC-specific mortality (PCSM) risks in relation to use of surgery or RT in patients with high-risk PC. Fixed- and random-effect models were fitted to estimate the summary odds ratio (OR). Between-study heterogeneity was tested using χ² statistics and measured using the I² statistic. Publication bias was evaluated using a funnel plot and Egger regression asymmetry test.ResultsSeventeen studies were included (1 randomized and 16 retrospective). RP was associated with improved OS (OR, 0.51; 95% confidence interval [CI], 0.38-0.68; P < .00001), PCSM (OR, 0.56; 95% CI, 0.37-0.85; P = .007), and non-PCSM (OR, 0.53; 95% CI, 0.35-0.8; P = .002) compared with RT. Biochemical relapse-free survival rates were similar to those of RT.ConclusionOverall and cancer-specific mortality rates appear to be better with RP compared with RT in localized, high-risk PC. Surgery is also associated with a 50% decreased risk of non-PCSM compared with RT.     

Outcomes for Young Men With Localized Intermediate-Risk Prostate Cancer: An Analysis of the NCDB

BackgroundPrimary management of localized, intermediate-risk prostate cancer consists of radical prostatectomy (RP), radiotherapy (RT) with short-course androgen deprivation therapy (ADT), or RT alone. The purpose of this study was to determine if these treatment strategies have equivalent overall survival (OS) in patients < 55 years old with intermediate-risk prostate cancer.Patients and MethodsWe identified 35,134 patients in the National Cancer Data Base with localized intermediate-risk prostate cancer treated with RP, RT + ADT, or RT from 2004 to 2013. Ten-year OS rates were estimated by the Kaplan-Meier method. Adjusted hazard ratios (HR) with 95% confidence intervals (CI) were computed by multivariate Cox regression.ResultsA total of 29,920 patients (85.2%) underwent RP, 1393 (4.0%) RT + ADT, and 3821 (10.9%) RT. Median patient age was 51 years old, and median follow-up was 59.9 months. Ten-year OS was estimated to be 94.2% for RP, 80.7% for RT + ADT, and 85.2% for RT (P < .0001). On multivariate analysis, treatment with RT + ADT or RT was associated with significantly worse OS compared to treatment with RP (RT + ADT HR = 2.06, 95% CI 1.67-2.54, P < .0001; RT HR = 2.0, 95% CI 1.71-2.33, P < .0001). Patients who met all 3 of the intermediate-risk criteria showed worse OS compared to patients who met only one criterion (HR = 1.80; 95% CI, 1.32-2.44; P = .0002).ConclusionRP is significantly more likely than RT + ADT or RT to be used as a primary treatment for young men with localized intermediate prostate cancer. RP was also associated with improved OS compared to RT + ADT and RT.     

Survival Outcomes for Metastatic Prostate Cancer Patients Treated With Radical Prostatectomy or Radiation Therapy: A SEER-based Study

BackgroundPatients with metastatic prostate cancer (mPCa) have a very low 5-year survival rate. How to choose proper treatment of mPCa remains controversial.MethodWithin the Surveillance, Epidemiology, and End Results (SEER) database (2004-2015), we performed analyses of cancer-specific mortality (CSM) and overall mortality (OM) in the comparisons of local treatment (LT) versus no local treatment (NLT) and radical prostatectomy (RP) versus radiation therapy (RT). To balance the characteristics between 2 treatment groups, propensity score matching was performed. Considering the selection bias, we additionally used an instrument variate (IVA) to calculate the unmeasured confounders.ResultMultivariate regression showed that patients receiving LT had the lower risks of OM and CSM after adjustment of covariates (hazard ratio [HR] 0.39, 95% confidence interval [CI] 0.35-0.44 and HR 0.39, 95% CI 0.34-0.45). In the IVA-adjusted model, LT showed more survival benefits compared with NLT, with HR of 0.57 (95% CI 0.50-0.65) and cancer-specific HR of 0.59 (95% CI 0.51-0.68), respectively. For those receiving LT, adjusted multivariate regression indicated that RP is superior to RT (HR 0.60; 95% CI 0.43-0.83 for OM and HR 0.61; 95% CI 0.42-0.91 for CSM). The IVA-adjusted model also showed that RP presented with potentially better survival outcome compared with RT, although the effect was not statistically significant (HR 0.63; 95% CI 0.26-1.54 for OM and HR 0.47; 95% CI 0.16-1.35 for CSM).ConclusionAmong patients with metastatic prostate cancer, LT might bring better survival benefits in decreasing CSM and all-cause mortality compared with NLT. For those receiving LT, RP showed better survival outcomes than RT.     

Focal Laser Ablation Versus Radical Prostatectomy for Localized Prostate Cancer: Survival Outcomes From a Matched Cohort

BackgroundFocal therapy for localized prostate cancer (PCa) remains investigational. We aimed to investigate the oncologic outcomes of focal laser ablation (FLA) and compare them with those of radical prostatectomy (RP).Patients and MethodsPatients treated with FLA or RP for localized PCa between 2004 and 2015 were identified from the Surveillance, Epidemiology, and End Results database. Kaplan-Meier curves and multivariate Cox proportional hazard models were utilized to calculate the survival benefits. Propensity score (PS) matching and adjusted standardized mortality ratio weighting (SMRW) models were used to balance the 2 groups. Subgroup analyses according to tumor stage, prostate-specific antigen level, and Gleason score were also conducted.ResultsA total of 12,875 patients were included, of whom 12,433 were treated with RP, whereas 442 were treated with FLA; 321 pairs of patients were eventually matched. Baseline characteristics were well-balanced by PS matching. The mean follow-up was 59.62 months for the RP group and 62.26 months for the FLA group. Before matching, the FLA group had lower but statistically insignificant cancer-specific mortality (CSM) (hazard ratio [HR], 0.61; 95% confidence interval [CI], 0.15-2.45; P = .4879) and higher any-cause mortality (ACM) (HR, 2.35; 95% CI, 1.38-3.98; P = .0016) compared with the RP group, which was supported by the outcomes in the PS-matched cohort (CSM: HR, 0.82; 95% CI, 0.18-3.67; P = .7936; ACM: HR, 2.35; 95% CI, 1.38-3.98; P = .0016) and the SMRW model (CSM: HR, 0.61; 95% CI, 0.15-2.44; P = .4877; ACM: HR, 2.01; 95% CI, 1.18-3.42; P = .0103).ConclusionOur study suggests that FLA had a higher risk of ACM but an insignificantly lower risk of CSM compared with RP. More high-quality trials are needed to confirm and expand our findings.     

Active Surveillance Versus Radical Prostatectomy in Favorable-risk Localized Prostate Cancer

BackgroundActive surveillance (AS) and radical prostatectomy (RP) are both accepted treatments for men with favorable-risk localized prostate cancer (PCa) (ie, clinical tumor category 1-2b, Gleason Grade Group 1-2, and prostate-specific antigen < 20 ng/mL). However, head-to-head studies comparing oncologic outcomes and survival between these 2 treatment strategies are warranted. The objective of this study was to compare the use of prostate cancer treatments and PCa death in men managed on AS and men who underwent immediate RP.Patients and MethodsThis was an observational study including 647 men on AS and 647 men treated with RP propensity score matched. We examined the 10-year cumulative incidence of salvage radiotherapy, hormonal therapy, castration-resistant PCa, and PCa death.ResultsThe 10-year curative treatment-free survival for men on AS was 61% (95% confidence interval [CI], 57%-65%). No differences in use of salvage radiotherapy (AS, 2.7%; 95% CI, 1.4%-4.1% vs. RP 5.4%; 95% CI, 3.4%-7.3%), hormonal therapy (AS, 6.9%; 95% CI, 4.4%-9.4% vs. RP, 4.1%; 95% CI, 2.5%-5.6%), developing castration-resistant PCa (AS, 1.7%; 95% CI, 0.5%-2.9% vs. RP, 2.0%; 95% CI, 0.7%-3.4%), or cumulative PCa mortality (AS, 0.4%; 95% CI, 0%-1.0% vs. RP, 0.5%; 95% CI, 0%-1.5%) were observed between the treatment strategies. The main limitation was the non-random allocation to treatment strategy.ConclusionIn this observational study on men with favorable-risk localized PCa, we found similar PCa mortality at 10 years between men on AS and men who underwent immediate RP. Moreover, there were no differences in the use of PCa therapies between the groups. Our study supports active surveillance as a treatment strategy for men with favorable-risk localized PCa.     

Pathologic Outcomes of Gleason 6 Favorable Intermediate-Risk Prostate Cancer Treated With Radical Prostatectomy: Implications for Active Surveillance

Background

The safety of active surveillance (AS) for Gleason 6 favorable intermediate-risk (FIR) prostate cancer is unknown. To provide guidance, we examined the incidence and predictors of upgrading or upstaging for Gleason 6 FIR patients treated with radical prostatectomy.

Comparison of Open Versus Robotically Assisted Cytoreductive Radical Prostatectomy for Metastatic Prostate Cancer

IntroductionCytoreductive radical prostatectomy (CRP) may offer a survival advantage, according to several retrospective analyses. However, no direct comparisons are available regarding the type of surgical approach (open vs. robotic) in the metastatic setting. To address intraoperative and postoperative complications of robotically assisted CRP relative to open CRP in patients with metastatic prostate cancer.Patients and MethodsWithin the National Inpatient Sample database (2008-2013), we identified patients with metastatic prostate cancer who underwent robotically assisted versus open CRP. Multivariable logistic regression, multivariable Poisson regression models, and linear regression models were used.ResultsOf 874 patients who underwent CRP, 412 (47.1%) versus 462 (52.9%) underwent open versus robotically assisted CRP, respectively. Between 2008 and 2013, robotically assisted CRP rates increased from 7.6% to 50.0% (P = .5). In multivariable logistic regression models, robotically assisted CRP resulted in lower rates of overall (odds ratio [OR], 0.42; P < .001), miscellaneous medical (OR, 0.47; P = .02), and miscellaneous surgical complications (OR, 0.40; P = .04), as well as in lower rates of blood transfusions (OR, 0.19; P < .001). In multivariable Poisson regression models, robotically assisted CRP was associated with shorter stay (OR, 0.72; P < .001) and higher total hospital charges ($2483 more for each robotic surgery; P < .001). Similar results were recorded after adjustment for clustering.ConclusionThe intraoperative and postoperative complications associated with robotically assisted CRP are lower than those of open CRP. Similarly, robotically assisted CRP is associated with shorter stay. Conversely, an increase in total hospital charges is associated with robotically assisted CRP. Nonetheless, the complication profile of robotically assisted CRP validates its safety and feasibility.     

根治性外放射治疗与根治性前列腺切除术治疗局限性高危前列腺癌的疗效比较

目的 比较根治性外放射治疗（ExRT）与根治性前列腺切除术（RP）治疗局限性高危前列腺癌患者的疗效。方法 回顾性分析诊断为高危前列腺癌（T2b-T4N0M0）并接受ExRT或RP的150例患者。高危前列腺癌的入选标准为PSA≥20 ng/ml或cT3以上或GS≥8。主要研究终点为无生化复发生存期,次要研究终点为无远处转移生存期、癌症特异性生存期及总生存期。结果 88例患者接受了ExRT及雄激素剥夺治疗（ADT）,其余62例患者接受了RP及盆腔淋巴结清扫术（PLND）。两组患者的中位年龄（68.9±5.2 vs. 64.3±6.5岁, P=0.012）及中位随访时间（60.2±32.3 vs. 45.8±25.5月,P=0.005）差异有统计学意义。ExRT组患者生化复发率显著低于RP组患者（23.9% vs. 58.1%, P<0.001）,而无生化复发患者生存期显著延长（96.2±7.4 vs. 38.7±4.6月, P<0.001）。两组无远处转移生存期、癌症特异性生存期及总生存期差异均无统计学意义。结论 与RP相比,接受ExRT治疗的局限性高危前列腺癌患者生化复发率低,无生化复发生存期显著延长。     

Evaluation of Biochemical Recurrence-free Survival after Radical Prostatectomy by Cancer of the Prostate Risk Assessment Post-Surgical (CAPRA-S) Score

Background: The cancer of the prostate risk assessment (CAPRA) score has been defined to predict prostatecancer recurrence based on the pre-clinical data, then pathological data have also been incorporated. Thus,CAPRA post-surgical (CAPRA-S) score has been developed based on six criteria (prostate specific antigen(PSA) at diagnosis, pathological Gleason score, and information on surgical margin, seminal vesicle invasion,extracapsular extension and lymph node involvement) for the prediction of post-surgical recurrences. In thepresent study, biochemical recurrence (BCR)-free probabilities after open retropubic radical prostatectomy (RP)were evaluated by the CAPRA-S scoring system and its three-risk level model. Materials and Methods: CAPRA-Sscores (0-12) of our 240 radical prostatectomies performed between January 2000-May 2011 were calculated.Patients were distributed into CAPRA-S score groups and also into three-risk groups as low, intermediate andhigh. BCR-free probabilities were assessed and compared using Kaplan-Meier analysis and Cox proportionalhazards regression. Ability of CAPRA-S in BCR detection was evaluated by concordance index (c-index). Results:BCR was present in 41 of total 240 patients (17.1%) and the mean follow-up time was 51.7 ± 33.0 months. MeanBCR-free survival time was 98.3 months (95% CI: 92.3-104.2). Of the patients in low, intermediate and highrisk groups, 5.4%, 22.0% and 58.8% had BCR, respectively and the difference among the three groups wassignificant (P = 0.0001). C-indices of CAPRA-S score and three-risk groups for detecting BCR-free probabilitiesin 5-yr were 0.87 and 0.81, respectively. Conclusions: Both CAPRA-S score and its three-risk level model wellpredicted BCR after RP with high c-index levels in our center. Therefore, it is a clinically reliable post-operativerisk stratifier and disease recurrence predictor for prostate cancer.     

Prostate Cancer: A Hospital-Based Survival Study from Mumbai,India

Background: Prostate cancer is common in elderly men, especially in western countries, and incidencesare rising in low-risk populations as well. In India, the age-standardized rates vary between registries. Underthese circumstances we have estimated the survival of prostate cancer patients based on age, family history,diabetes, hypertension, tobacco habit, clinical extent of disease (risk group) and treatment received. Materialsand Methods: The present retrospective study was carried out at the Tata Memorial Hospital (TMH), Mumbai,India. During years 1999-2002, some 850 prostate cancer cases, including 371 new cases, treated in TMH wereconsidered as eligible entrants for the study. Five-year survival rates using actuarial and loss-adjusted (LAR)method were estimated. Results: The patient population was distributed uniformly over the three age groups. Alarger proportion of the patients were diagnosed at ‘metastatic stage’ and hormone treatment was most common.20% patients had history of diabetes and 40% with hypertension. The 5-year overall survival rate was 64%.Survival was 55%, 74% and 52% for ‘<59 years’,’60-69 years’ and ‘>70 years’ respectively. Non-diabetic (70%),hypertensive (74%), with family history (80%) of cancer, with localized-disease (91%) and treated with surgery,either alone or in combination, (91%) had better survival. Conclusions: The present study showed that prostatecancer patients with localized disease at diagnosis experience a better outcome. Local treatment with eithersurgery or radiation achieves a reasonable outcome in prostate cancer patients. A detailed study will help inunderstanding the prognostic indicators for survival especially with the newer treatment technologies availablenow.     

Validation of the 6th edition AJCC Pancreatic Cancer Staging System: report from the National Cancer Database

BACKGROUND

With the development of stage‐specific treatments for pancreatic cancer, controversies exist concerning optimal clinical and pathologic staging. The most recent edition of the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 6^th Edition included some notable modifications. In anticipation of the 7^th edition's publication, the authors evaluated the predictive ability of the current pancreatic adenocarcinoma staging system.

METHODS

By using the National Cancer Data Base (1992–1998), 121,713 patients were identified with pancreatic adenocarcinoma. All patients were restaged by AJCC 6^th edition guidelines. Stage‐specific overall survival was estimated by using the Kaplan‐Meier method and compared with log‐rank tests. Concordance indices were calculated to evaluate the discriminatory power of the staging system. Cox modeling was used to determine the relative impact of T, N, and M classification on survival.

RESULTS

For all patients, there was 5‐year survival discrimination by stage (P < .0001). For patients who underwent pancreatectomy, stage predicted 5‐year survival: stage IA, 31.4%; IB, 27.2%; IIA, 15.7%; IIB, 7.7%; III, 6.8%; IV, 2.8% (P < .0001). The concordance index for the staging system was 0.631 for all patients, 0.613 for those who underwent pancreatectomy, and 0.596 for patients who did not undergo resection. In patients who underwent pancreatectomy, tumor size, nodal status, and distant metastases were independent predictors of survival (P < .0001).

CONCLUSIONS

This is the first large‐scale validation of the pancreatic cancer staging system. AJCC 6^th edition staging guidelines are accurate with respect to survival. Further investigation is needed to integrate new molecular and biochemical markers into the staging scheme. Cancer 2007; 110:738–44. © 2007 American Cancer Society.     

Treatment Outcomes and Survival Study of Gastric Cancer Patients: A Retrospective Analysis in an Endemic Region

Purpose: To present information about prognostic factors of gastric cancer patients treated in our Erzurumcenter including age, gender, tumour location, pathological grade, stage and the effect of treatment on survival.Materials and Methods: This retrospective study was performed on patients who applied to our clinic anddiagnosed as gastric cancer. Age and gender of the patients, primary location, histopathological characteristics,TNM stage of the gastric cancers (GCs), treatment applied, oncological treatment modalities and survivaloutcomes were studied. A univariate analysis of potential prognostic factors was performed with the log-ranktest for categorical factors and parameters with a p value < 0.05 at the univariate step were included in themultivariate regression. Results: A total of 228 patients with a confirmed diagnosis of gastric cancer wereincluded in the study with a male/female ratio of 1.47. Median follow-up period was estimated as 22.3 (range, 3to 96) months. When diagnosis of the patients at admission was analysed, stage III patients were most frequentlyencountered (n=147; 64.5%). One hundred and twenty-six (55.3%) underwent surgical treatment, while 117(51.3%) were given adjuvant chemotherapy. Median overall survival time was 18.0 (±1.19) months. Mean overallsurvival rates for 1, 2, 3 and 5 years were 68±0.031%, 36±0.033%, 24±0.031% and 15.5±0.036%, respectively.Univariate variables found to be significant for median OS in the multivariate analysis were evaluated with Coxregression analysis. A significant difference was found among TNM stage groups, location of the tumour andpostoperative adjuvant treatment receivers (p values were 0.011, 0.025 and 0.001, respectively). Conclusions: Thisstudy revealed that it is possible to achieve long-term survival of gastric cancer with early diagnosis. Besides, inlocally advanced GC patients, curative resection followed by adjuvant concomitant chemoradiotherapy basedon the McDonald regimen was an independent prognostic factor for survival.     

Outcomes of Treatment for HIV-Infected Lymphoma Patients: A National Cancer Database (NCDB) Analysis

BackgroundHuman immunodeficiency virus (HIV) infection may be a predictor of undertreatment of patients with lymphoma. We hypothesized treatment with systemic therapy (SysT) or hematopoietic stem cell transplantation (HCT) in the first-line setting leads to improved outcomes and sought to compare the predictors for treatment and outcomes with non-HIV (HIV−) patients.MethodsPatients with lymphoma diagnosed between 2004 and 2015 were extracted from the National Cancer Database (NCDB). Patients were categorized as HIV+ and HIV−. First-line treatment was categorized as no systemic therapy reported (noSyst), SysT, or HCT. Multivariate analysis to predict treatment and survival was performed.ResultsWe identified 552,513 lymphoma patients, of whom 11,160 HIV+ versus 349,607 HIV− patients were eligible for analysis. Among HIV+, the positive predictors for SysT were insurance and higher income, whereas female sex and minority racial status predicted lower likelihood for SysT. Forty HIV+ patients underwent HCT. Treatment of HIV+ lymphoma patients resulted in improved outcomes: 3-year overall survival 43.6% in noSyst versus 58.1% SysT (hazard ratio [HR] 0.56; 95% confidence interval [CI], 0.52-0.61; P < .005) versus 62.2% HCT (HR 0.42; 95% CI, 0.14-1.3; P = .08). The outcomes were lower compared to non-HIV patients (3-yr overall survival 67.3% with SysT and 62.2% HCT).ConclusionPatients with lymphoma with HIV benefit from SysT when feasible but outcomes are worse than non-HIV patients. HCT should be offered to HIV+ patients with lymphoma in the appropriate clinic setting. Individual characteristics of the patients and complications could not be evaluated in the present study but should be a focus for future research.     

Primary Radical Prostatectomy or Ablative Radiotherapy as Protective Factors for Patients With mCRPC Treated With Radium-223 Dichloride: An Italian Multicenter Study

BackgroundWe investigated, in a real-life setting, the prognostic relevance of previous primary treatment (radical prostatectomy [RP] or external beam radiotherapy [EBRT]) on overall survival for patients with metastatic castration-resistant prostate cancer (mCRPC) treated with radium-223 (²²³Ra).Materials and MethodsIn the present multicenter retrospective study, we enrolled 275 consecutive patients. The demographic and clinical data and mCRPC characteristics were recorded and evaluated at baseline and at the end of treatment or progression. ²²³Ra was administered according to the current label authorization until disease progression or unacceptable toxicity. We divided the whole cohort into 2 groups: those who had undergone primary radical prostatectomy or ablative radiotherapy (RP/EBRT) and those who had not received previous primary treatment (NO).ResultsOf the 275 patients, 128 (46.5%) were alive and undergoing monitoring at the last follow-up examination, 103 (37.4%) had stopped treatment because of disease progression or the onset of comorbidities, and 147 (53.5%) had died during the study period. Of the 275 patients, 132 were in the RP/EBRT group (48%), of whom 93 had undergone RP and 76 had undergone ablative EBRT, and 143 patients were in the NO group (52%). The data showed a clear advantage for the patients in the RP/EBRT group compared with those in the NO group, with an estimated median survival of 18 versus 11 months, respectively (P < .001). The results from the multivariate analysis corroborated this trend, with a hazard ratio of 0.7 (P = .0443), confirming the better outcome for the RP/EBRT group.ConclusionsPrevious radical treatment provides a protective role for patients with mCRPC undergoing ²²³Ra treatment.     

The Effect of Treatment Sequence on Overall Survival for Men With Metastatic Castration-resistant Prostate Cancer: A Multicenter Retrospective Study

IntroductionWe aimed to evaluate the treatment sequence for patients with metastatic castration-resistant prostate cancer (mCRPC) in real-world practice and compare overall survival in each sequential therapy.Patients and MethodsWe retrospectively evaluated 146 patients with mCRPC who were initially treated with androgen deprivation therapy as metastatic hormone-naive prostate cancer in 14 hospitals between January 2010 and March 2019. The agents for the sequential therapy included new androgen receptor-targeted agents (ART: abiraterone acetate or enzalutamide), docetaxel, and/or cabazitaxel. We evaluated the treatment sequence for mCRPC and the effect of sequence patterns on overall survival.ResultsThe median age was 71 years. A total of 35 patients received ART-ART, 33 received ART-docetaxel, 68 received docetaxel-ART, and 10 received docetaxel-cabazitaxel sequences. The most prescribed treatment sequence was docetaxel-ART (47%), followed by ART-ART (24%). Overall survival calculated from the initial diagnosis reached 83, 57, 79, and 37 months in the ART-ART, ART-docetaxel, docetaxel-ART, and docetaxel-cabazitaxel, respectively. Multivariate Cox regression analyses showed no significant difference in overall survival between the first-line ART (n = 68) and first-line docetaxel (n = 78) therapies (hazard ratio [HR], 0.84; P = .530), between the ART-ART (n = 35) and docetaxel-mixed (n = 111) sequences (HR, 0.82; P = .650), and between the first-line abiraterone (n = 32) and first-line enzalutamide (n = 36) sequences (HR, 1.58; P = .384).ConclusionThe most prescribed treatment sequence was docetaxel followed by ART. No significant difference was observed in overall survival among the treatment sequences in real-world practice.     

Survival Outcomes in Breast Cancer Patients With Low Estrogen/Progesterone Receptor Expression

IntroductionThe prognostic value of low estrogen and progesterone receptors expression (ER/PgR 1%-10%) in early breast cancer patients is still unclear.Patients and MethodsWe retrospectively analyzed 1424 consecutive patients with HER2/neu-negative and low endocrine receptors expression early breast cancer, submitted to surgery at the European Institute of Oncology between January 1995 and December 2009. Patients were classified according to the percentage of ER/PgR expression using immunohistochemistry. Group 1 with ER/PgR < 1%, and group 2 with ER/PgR 1% to 10%.ResultsGroup 1 (ER/PgR < 1%) included 1300 patients, and group 2 (ER/PgR 1%-10%) 124 patients. Median follow-up time was 74 months (range, 3-192 months). The 5-year disease-free survival (DFS) rate was 74% (95% confidence interval [CI], 72%-77%) for group 1, and 79% (95% CI, 70%-86%) for group 2 (P = .16). The 5-year overall survival (OS) rate was 86% (95% CI, 84%-88%) in group 1 and 90% (95% CI, 83%-95%) in group 2 (P = .13). In patients without lymph node involvement, the 5-year OS rate was 92% (95% CI, 89.5%-93.6%) for group 1 and 98% (95% CI, 90.2%-99.8%) for group 2 (P = .061). One hundred ten patients received endocrine therapy with no significant effect on DFS (P = .36) and OS (P = .30).ConclusionThe ER/PgR 1%-10% group had a slight, but not statistically significant, better prognosis than the ER/PgR <1% group. Further studies are needed to identify the appropriate clinical approach in this subset of patients with low ER/PgR expression (ER/PgR 1%-10%), HER2-negative early breast cancer.