Is SLN Biopsy Alone Safe in SLN Positive Breast Cancer Patients?

The Z0011 trial demonstrated no difference in overall survival (OS) and locoregional recurrence in breast cancer patients with a positive sentinel lymph node (SLN) randomized to axillary lymph node dissection (ALND) or no further surgery. The aim of this study was to evaluate locoregional recurrence in a nonrandomized group of SLN positive patients, in whom cALND was not performed, that were retrospectively categorized by the Z0011 eligibility criteria. From two hospital breast cancer databases consisting of 656 consecutive SLN positive breast cancer patients, 88 patients, who did not undergo cALND, were identified. This population was categorized by the Z0011 inclusion criteria (e.g., eligible versus ineligible) and the groups were compared. Thirty‐four patients (38.6%) were retrospectively eligible for omitting cALND according to the Z0011 criteria and 54 (61.4%) were not. The median number of SLNs removed in both groups was 1 (range 1–5). The number of positive SLNs did not differ between the groups. Tumor size was slightly larger in the ineligible group (21 mm versus 19 mm) and 76% of patients in the ineligible group underwent a mastectomy. At a median follow‐up of 26 months (range 1–84 months), one axillary recurrence was observed in the ineligible group versus 0 in the eligible group. Axillary recurrence was low, even in patients who did not meet the Z0011 inclusion criteria. Future trials that randomize Z0011 ineligible patients are needed to investigate long‐term results.     

Survival outcomes after breast-conserving therapy compared with mastectomy for patients with early-stage metaplastic breast cancer: a population-based study of 2412 patients

BackgroundPrevious studies revealed that patients with early-stage metaplastic breast cancer (MBC) underwent mastectomy more often than breast-conserving therapy (BCT) mainly due to the larger tumor size. This study was performed to compare the survival outcomes following BCT versus mastectomy for patients with early-stage MBC.MethodsSurveillance, Epidemiology, and End Results (SEER) database was used to identify women diagnosed with early-stage MBC (T1-3N0-3M0) between 2001 and 2016, who were treated with either BCT or mastectomy. We assessed overall survival (OS) and breast cancer-specific survival (BCSS) using the Kaplan-Meier method and hazard ratios using Cox proportional hazards models.ResultsA total of 2412 MBC patients were identified, 881 (36.5%) of whom underwent BCT and 1531(63.5%) underwent mastectomy. The median follow-up time was 73 months. Most of patients had older age (≥50 years old), larger tumor size, higher American Joint Committee on Cancer (AJCC) stage and hormone receptor negativity. After adjustment for confounding variables, patients who underwent BCT had significantly improved OS (5-year OS: 84.3% vs 62.5%; 10-year OS: 73.0% vs 52.1%; adjusted HR = 0.76, 95%CI: 0.59–0.97, p = 0.028) and BCSS (5-year BCSS: 89.1% vs 70.8%; 10-year BCSS: 83.9% vs 67.5%; adjusted HR = 0.72, 95%CI: 0.53–0.96, p = 0.026) than those who underwent mastectomy, and this improvement remained significant for all T and N stages of MBC except for N2-3 stage.ConclusionBCT conferred improved OS and BCSS compared with mastectomy for patients with early-stage MBC, and the improvement persisted in almost all of the subgroups of different T and N stages.     

Concept: A randomised multicentre trial of first line chemotherapy comparing three weekly cabazitaxel versus weekly paclitaxel in HER2 negative metastatic breast cancer

BackgroundPaclitaxel is commonly used as first-line chemotherapy for HER2-negative metastatic breast cancer (MBC) patients. However, with response rates of 21.5–53.7% and significant risk of peripheral neuropathy, there is need for better chemotherapy.Patients and methodsThis open-label phase II/III trial randomised HER2-negative MBC patients 1:1 to either 6 cycles of three-weekly cabazitaxel (25 mg/m²), or, weekly paclitaxel (80 mg/m²) over 18 weeks.The primary endpoint was progression free survival (PFS). Secondary endpoints included objective response rate (ORR), time to response (TTR), overall survival (OS), safety and tolerability and quality of life (QoL).Results158 patients were recruited. Comparing cabazitaxel to paclitaxel, median PFS was 6.7 vs 5.8 months (HR 0.87; 80%CI 0.70–1.08, P = 0.4). There was no difference in median OS (20.6 vs 18.2 months, HR 1.00; 95%CI 0.69–1.45, P = 0.99), ORR (41.8% vs 36.7%) or TTR (HR 1.09; 95%CI 0.68–1.75, P = 0.7).Grade ≥3 adverse events occurred in 41.8% on cabazitaxel and 46.8% on paclitaxel; the most common being neutropenia (16.5%) and febrile neutropenia (12.7%) cabazitaxel and neutropenia (8.9%) and lung infection (7.6%) paclitaxel. Peripheral neuropathy of any grade occurred in 54.5% paclitaxel vs 16.5% cabazitaxel.Mean EQ-5D-5L single index utility score (+0.05; 95%CI 0.004–0.09, P = 0.03) and visual analogue scale score (+7.7; 95%CI 3.1–12.3, P = 0.001) were higher in cabazitaxel vs paclitaxel.ConclusionsThree-weekly cabazitaxel in HER2-negative MBC does not significantly improve PFS compared to weekly paclitaxel, although it has a lower risk of peripheral neuropathy with better patient reported QoL outcomes. It is well tolerated and requires fewer hospital visits.     

A Retrospective Analysis of the Activity and Safety of Oral Etoposide in Heavily Pretreated Metastatic Breast Cancer Patients

Metastatic breast cancer (MBC) patients derive benefit from chemotherapy, but options become limited after several prior chemotherapeutic regimens. Oral etoposide (VP‐16) has previously been found to be clinically active in MBC patients in phase II trials. However, with increasing availability of other drugs, etoposide use has declined in spite of its unfavorable toxicity profile probably being overestimated. We therefore evaluated the clinical benefit and safety of oral etoposide in a population of MBC patients who had failed multiple regimens of currently used therapies. Sixty‐six patients with MBC previously treated with a median of eight (range 2–13) regimens of therapy were eligible for the study. Patients received 50 mg/day oral etoposide in 20‐day cycles with 1‐week of rest. All patients were evaluated for clinical benefit (clinical benefit rate [CBR], complete response, partial response, and disease stabilization >24 weeks), progression‐free survival (PFS), overall survival (OS), and toxicities. Median PFS was 4 months, CBR was 18% (overall response rate 4%), and median OS from the start of treatment was 11 months. Little clinically significant or high‐grade toxicity were observed. No patients withdrew from treatment due to etoposide‐induced toxicity. The favorable clinical response, low toxicity, and low cost of the drug suggest that etoposide is a viable option for patients with heavily pretreated MBC.     

Living Donor Liver Transplantation Versus Deceased Donor Liver Transplantation for Hepatocellular Carcinoma Within or Beyond the Milan Criteria: Comparable Long-Term Outcomes

BackgroundThe long-term outcomes after living donor liver transplantation (LDLT) vs deceased donor liver transplantation (DDLT) for hepatocellular carcinoma (HCC) remain controversial. We compared the long-term outcomes between LDLT and DDLT in patients with HCCs within or beyond the Milan criteria.MethodsThis retrospective study included 896 patients who underwent liver transplantation (829 LDLTs and 67 DDLTs) for HCC from June 2005 to May 2015. Recurrence-free survival (RFS) and overall survival (OS) were estimated using the Kaplan–Meier method with log-rank test.ResultsRFS at 1, 3, 5, and 10 years after LDLT was 89.6%, 84.6%, 82.4%, and 79.6%, respectively, and, after DDLT, was 92.4%, 86.2%, 82.4%, and 82.4%, respectively, and OS at 1, 3, 5, and 10 years after LDLT was 96.1%, 88.1%, 85.6%, and 82.7%, respectively, and, after DDLT, was 97.0%, 83.6%, 82.1%, and 77.3%, respectively, with no significant differences in RFS (P = .838) or OS (P = .293) between groups. No statistically significant differences after LDLT or DDLT were identified in RFS (89.8% vs 98.1%, respectively, at 5 years; P = .053) or OS (90.4% vs 90.6% , respectively, at 5 years; P = .583) for HCCs meeting the Milan criteria as well as for those beyond the Milan criteria (RFS, 37.8% vs 28.6%, respectively, at 5 years; P = .560 and OS, 57.3% vs 50.0%, respectively, at 5 years; P = .743).ConclusionsPatients who underwent LDLT for HCCs showed comparable long-term outcomes to patients who underwent DDLT. Patients with HCCs within the Milan criteria demonstrated acceptable long-term outcomes after both LDLT and DDLT.     

Distal pancreatectomy with celiac artery resection acquires satisfactory survival for locally advanced pancreatic neck/body cancer

Backgrounds As a curative surgical procedure for pancreatic neck-body cancer with invasion to celiac artery (CA), the security and efficacy of distal pancreatectomy (DP) with en bloc resection of the celiac artery (DP-CAR) remain controversial. The purpose of this study was to identify the postoperative outcomes of DP-CAR.MethodsA retrospectively analysis between January 2010 and January2019 was performed in a single center. 21 patients who underwent DP-CAR and 71 patients who underwent traditional DP for pancreatic neck-body cancer were included. Postoperative morbidity, mortality, overall survival (OS) and disease-free survival (DFS) were evaluated.ResultsThere were no significant differences in major complications and mortality between two groups. The patients in DP-CAR group had more T4 tumor (61.9 vs 7.0%, P < 0.001). DP-CAR group had similar R0 resection compared with DP group (71.4% vs 87.3%, P = 0.090). The patients in DP-CAR group suffered more gastric ulcer, DGE and elevated levels of postoperative hepatic enzymes. OS (27.4 vs 32.6 months) and DFS (14.9 vs 19.5 months) between DP-CAR and DP groups were comparative (P = 0.305; P = 0.065).ConclusionsFor the patients who had pancreatic neck-body cancer with invasion to CA, DP-CAR is safety and could achieve satisfactory R0 resection, OS, and DFS.     

Comparison of outcomes between metaplastic and triple-negative breast cancer patients

PurposeMetaplastic breast cancer (MBC) is a rare, aggressive variant of breast cancer that has been associated with poor clinical outcomes, as has triple-negative breast (TNBC) cancer. Limited studies compare the clinical characteristics and prognosis of MBC to TNBC. This study uses a large, contemporary US cancer database to compare clinical characteristics and survival outcomes for patients with MBC to those with TNBC.MethodsThe National Cancer Database was queried for women with cT1-4N1-3M0 MBC or TNBC diagnosed between 2004 and 2013 and treated with definitive surgery. Chi-squared analysis was performed to determine differences between the cohorts. Kaplan-Meier curves compared overall survival (OS), and Cox regression determined patient factors associated with OS.ResultsAltogether, 55,847 patients met the inclusion criteria; 50,705 (90.8%) had TNBC and 5,142 (9.2%) had MBC. Most patients had no comorbid conditions (82%), N0 disease (71%), poorly differentiated histology (77%), received chemotherapy (87%), and received radiation therapy (60%). Amongst all patients, patients with TNBC disease were observed to have greater OS than those with MBC (5-year OS 72.0% vs 55.8%, p < 0.001). The greater observed OS for patients with TNBC persisted when controlling for stage and when comparing propensity score matched cohorts. On Cox regression, lower age, T1 status, N0 status, chemotherapy, TNBC disease, and radiation therapy (RT) were associated with improved OS.ConclusionsMBC had an association with poorer OS compared to TNBC, while RT and chemotherapy receipt were associated with improved OS for patients regardless of stage. Further studies are needed to corroborate the conclusions herein.     

Inclusion of premenopausal women in breast cancer clinical trials

BackgroundPatients with premenopausal breast cancer (PMBC) have been historically excluded from some clinical trials because of the limitations of using endocrine therapy (ET) in this population. We analyzed breast cancer randomized clinical trials (RCTs) to determine the rates of and factors associated with inclusion of PMBC patients to provide a benchmark for PMBC inclusion in RCTs moving forward.MethodsUsing ClinicalTrials.Gov, we identified breast cancer phase III RCTs and extracted inclusion criteria and patient enrollment information. Multiple binary logistic regression modeling was used to assess trial-related factors that were associated with PMBC patient inclusion.ResultsOf 170 breast cancer RCTs identified, 131 (77.1%) included PMBC patients. Sixty-five (38.2%) trials analyzed patients with hormone-receptor-positive (HR+) and HER2-negative (HER2-) breast cancer, of which 31 (47.7%) allowed for enrollment of PMBC patients. Lower rates of PMBC inclusion were seen in trials that studied HR+/HER2-patients (47.7% PMBC inclusion in HR+/HER2-trials vs. 94.3% in non-HR+/HER2-trials, aOR 0.07 [95% CI: 0.02–0.19], p < 0.001) and in trials that randomized or mandated ET (44.4% in ET trials vs. 83.2% in non-ET trials, aOR 0.21 [95% CI: 0.10–0.83], p = 0.02). Trials studying chemotherapy (CT) were associated with inclusion of PMBC patients (100% in CT trials vs. 70.5% in non-CT trials, a OR 14.02 [95% CI: 1.54–127.91], p = 0.01). All surgical and radiation therapy clinical trials allowed for the inclusion of PMBC patients in their eligibility criteria.ConclusionsBreast cancer clinical trials should carefully select their enrollment criteria and consider inclusion of premenopausal patients when appropriate.     

Impact of locoregional treatment on survival in patients presented with metastatic breast carcinoma

ObjectivesIn this study, we tried to evaluate the efficacy of locoregional treatment (LRT) in patients with metastatic breast carcinoma (MBC).Materials and methodsThe medical records of 227 patients with MBC at initial presentation between April 1999 and January 2013 were retrospectively evaluated. The median age at diagnosis was 50 years (range, 27–83 years). Thirty-nine patients (17%) had no LRT. Among patients who had LRT, 2 (1%) had locoregional radiotherapy (RT) alone, 54 (29%) had surgery alone [mastectomy, n = 50; breast conserving surgery (BCS), n = 4] and 132 (70%) had surgery (mastectomy, n = 119; BCS, n = 13) followed by locoregional RT.ResultsThe median follow-up time was 35 months (range, 4–149 months). Five-year OS and PFS rates were 44% and 20%, respectively. In both univariate and multivariate analysis LRT per se did not affect OS and PFS rates. However, the 5-year OS and PFS rates were significantly higher in patients treated with locoregional RT than the ones who were not. The corresponding rates were 56% vs. 24% for OS and 27% vs. 7% for PFS (p < 0.001). Median survival was 67 months and 37 months, respectively.ConclusionOur study showed that patients with MBC who received postoperative locoregional RT may have a survival advantage compared with patients who were only treated by surgery. A phase III trial testing the role of adjuvant locoregional RT may help to distinguish patients who will benefit from adjuvant RT.     

Concurrent versus sequential adjuvant chemo-endocrine therapy in hormone-receptor positive early stage breast cancer patients: a systematic review and meta-analysis

BackgroundAlthough in clinical practice adjuvant chemotherapy (CT) and endocrine therapy (ET) are administered sequentially in patients with hormone-receptor positive breast cancer, the optimal timing, i.e. concurrent or sequential administration, of these treatments has been scarcely investigated. To better clarify this issue we conducted a systematic review and meta-analysis of randomized studies comparing these two modalities of administrations in terms of disease-free survival (DFS) and overall survival (OS).MethodsRelevant studies were identified by searching PubMed, Web of Knowledge and the proceedings of the major conferences with no date restriction up to March 2016.The summary risk estimates (pooled hazard ratio [HR] and 95% confidence intervals [CI]) for DFS and OS were calculated using random effect models (DerSimonian and Laird method).ResultsA total of three randomized studies were eligible including 2021 breast cancer patients. Overall, 755 DFS events were observed, 365 in the sequential arm and 390 in the concomitant arm, with a pooled HR of 0.95 (95% CI = 0.76 to 1.18, P = 0.643).No association between timing of treatment and OS was observed (HR = 0.95; 95% CI = 0.80 to 1.12, P = 0.529).ConclusionOur pooled analysis showed no association between the timing of administration of adjuvant CT and ET and DFS and OS in breast cancer patients candidates for both adjuvant treatments. Because of the small number of published trials, the lack of data on the timing with modern adjuvant treatments, i.e. taxane-containing CT and aromatase inhibitors, this topic remain still controversial and requires further studies to be clarified.     

Living donor liver transplantation or resection for Child‐Pugh A hepatocellular carcinoma patients with multiple nodules meeting the Milan criteria

The optimum primary treatment strategy for early hepatocellular carcinoma (HCC) patients with multiple nodules remains unclear. We aimed to compare the outcomes of living donor liver transplantation (LDLT) with that of liver resection (LR) for early Child‐Pugh A HCC patients with multiple nodules meeting the Milan criteria. From January 2007 to July 2012, 67 of 375 patients with early HCC in our centre fulfilled the inclusion criteria (group LDLT, n = 34 versus group LR, n = 33). Patient and tumour characteristics, operative data, postoperative course and outcomes were analysed retrospectively. The postoperative mortality and rate of major complications were similar in both groups. The 5‐year overall survival (OS; 76.5% vs. 51.2%, P = 0.046) and recurrence‐free survival (RFS; 72.0% vs. 19.8%, P = 0.000) were better in group LDLT than that in group LR. The 5‐year OS and RFS were similar between patients with tumours located in the same lobe (TSL) and those in the different lobes (TDL) after LDLT, whereas the 5‐year RFS was better in patients with tumours in TSL (30.6% vs. 0%, P = 0.012) after LR. In conclusion, primary LDLT might be the optimum treatment for early HCC patients with multiple nodules meeting the Milan criteria.     

Palbociclib dose reductions and the effect on clinical outcomes in patients with advanced breast cancer

BackgroundThis study aimed to provide insights into the real-world use of palbociclib, dose reductions, and drug effectiveness in (older) patients with advanced breast cancer (BC).Patients and methodsPatients with advanced BC treated with palbociclib from 2017 to 2020 were included. The Kaplan-Meier method was used to calculate time to next treatment (TTNT) and overall survival (OS) for patients with or without dose reductions. These clinical outcomes were also compared in subgroup analyses for older patients (≥70 years) and younger patients (<70 years) and for patients discontinuing palbociclib early (<4 administrations).ResultsA total of 598 patients with advanced BC were included, with a median age of 64 years. Palbociclib dose reductions occurred in 33% of all patients. Early discontinuation of palbociclib without dose reductions occurred in 23% of the patients. Patients who required a palbociclib dose reduction were older (median age 67 years vs. 63 years). Patients with dose reductions had a significantly higher TTNT of 16.9 vs. 11.4 months (p < 0.001) and median OS of 29.7 vs. 21.9 months (p = 0.003) compared to patients without dose reductions. The TTNT in older patients was significantly longer (16.9 vs. 11.6 months, p = 0.013) than younger patients, but OS was similar (20.7 vs. 26.7 months, p = 0.051).ConclusionPalbociclib dose reductions occurred in real-world practice similarly to the PALOMA-3 trial. Patients with dose reductions had no poorer outcomes compared to patients not requiring a dose reduction. Older patients treated with palbociclib had more frequent dose reductions, but this did not appear to affect OS.     

Comparison between doublet agents versus single agent in metastatic breast cancer patients previously treated with an anthracycline and a taxane: A meta-analysis of four phase III trials

AimTo compare doublet agents with single agent as salvage treatment in metastatic breast cancer (MBC) patients pre-treated with an anthracycline and a taxane.MethodsWe systematically searched for randomised clinical trials that compared doublet agents with single agent in MBC patients pre-treated with an anthracycline and a taxane. The primary end point was overall survival (OS). Secondary end points were progression-free survival, overall response rate and grade 3 or 4 toxicity. Data were extracted from the studies by two independent reviewers. The meta-analysis was performed by Stata version 10.0 software (Stata Corporation, College Station, TX, USA).ResultsFour trials comprising 2373 patients were eligible for inclusion. Meta-analysis showed that there was significant improvement in progression-free survival (PFS) (hazard ratio (HR) 0.79, 95% confidence interval (CI) 0.72–0.86, P = 0.000) and overall response rate (risk ratio (RR) 1.47, 95%CI 1.13–1.91; p = 0.004) in doublet agents group, though the pooled HR for OS (HR 0.96, 95%CI 0.87–1.05; p = 0.356) showed no significant difference. Subgroup analysis also favoured capecitabine-based doublet agents therapy in terms of PFS (HR 0.77, 95%CI 0.70–0.86; p = 0.000) and overall response rate (ORR) (RR 1.65, 95%CI 1.06–2.56; p = 0.026), but gemcitabine-based doublet agents therapy gained no clinical benefits. There were more incidences of grade 3 or 4 anaemia (RR 1.610, 1.212–2.314, p = 0.01), neutropenia (RR 2.239, 1.231–4.071, p = 0.008), thrombocytopaenia (RR 2.401, 1.595–3.615, p = 0.000), fatigue (RR 2.333, 1.338–4.006, p = 0.000) and nausea and vomiting (RR 2.233, 1.558–3.199, p = 0.000) in the combination group. With regard to the risk of grade 3 or 4 stomatitis (RR 1.666, 0.818–3.392, p = 0.160), diarrhoea (RR 0.739, 0.542–1.008, p = 0.056) and hand–foot syndrome (RR 1.002, 0.835–1.203, p = 0.983), equivalent frequencies were found between the two groups.ConclusionCombination chemotherapy offered a significant improvement in PFS and ORR in patients with MBC pre-treated with an anthracycline and a taxane but did not benefit OS. With present available data from randomised clinical trials, we were still unable to clearly set the role of combination therapy in the treatment of MBC in this setting.     

Effects of locoregional radiotherapy in patients with metastatic breast cancer

ObjectivesThis study aims to assess the clinical outcomes of patients with metastatic breast cancer (MBC) who underwent local radiation therapy (RT) for the primary site.Material and methodsBetween 2005 and 2013, we retrospectively evaluated patients with MBC who received breast or chest wall RT with or without regional lymph node irradiation.Results2761 patients with breast cancer were treated with RT. Of them, 125 women with stage IV breast carcinoma were included. The median follow-up was 15 months (ranging from 3.8 to 168 months), when 54.7% of the patients had died; local progression was observed in 22.8% of the patients. The mean overall survival (OS) and local progression free survival (LoPFS) were 23.4 ± 2.4 months and 45.1 ± 2.9 months, respectively. Three- and five-year overall survival rates were, respectively, 21.2% and 13.3%. Local progression free survival was the same, 67.3%, at three and five years, respectively. Karnofsky Performance Status (KPS) (p = 0.015), number of metastatic sites (p = 0.031), RT dose (p = 0.0001) and hormone therapy (p = 0.0001) were confirmed as independent significant variables correlated with OS. The variables that were independently correlated with LoPFS were the number of previous chemotherapy lines (p = 0.038) and RT dose (p = 0.0001).ConclusionRT of the primary site in patients with MBC is well tolerated. The factors that presented positive impact on survival were good KPS, low disease burden (1–3 metastatic sites), and the use of hormone therapy.     

Long-term follow-up of patients with metastatic breast cancer treated by trastuzumab: Impact of institutions

PurposeTrastuzumab in Human Epidermal growth Receptor 2-positive (HER2+) metastatic breast cancer (MBC) was established as standard therapy since 2001. The objective of this study was to search for significant prognostic factors in patients with HER2+ MBC treated by trastuzumab taking into account the institution where the treatment was given.Patients & methodsAll patients with HER2+ MBC treated by trastuzumab between 2001 and 2010 in the 8 hospitals of Franche Comte region were analysed. Univariate and multivariate analysis were conducted to search for factors related to overall survival (OS).ResultsAmong 1234 patients with MBC treated by chemotherapy between 2001 and 2010, 217 patients received trastuzumab. In this subset, the median age was 60 years, 8% and 38% had brain and liver metastases at first occurrence of MBC, 36% of, tumours were hormonal receptors positive. Patients were treated in 48% and 52% of cases in specialized and in general hospitals, respectively. The median OS length was 45.2 months (IQR 23.2–89.3 months). In univariate analysis the following factors were significantly related to favourable OS: inclusion in clinical trials, treatment in a specialized hospital, positive hormonal receptors status, age <50. In multivariate analysis remained significant: treatment in specialized hospital (aHR 0.78; 95%CI 0.64–0.94; p = 0.03) and age <50 (aHR 0.76; 95%CI 0.59–0.95; p = 0.02).ConclusionExposure to trastuzumab erases all established prognostic factors at the metastatic setting. The fact that patients treated in specialized hospitals presented a longer survival emphasizes the dramatic impact of this therapy and the relevance to optimize its use.     

Prognostic value of hypocholesterolemia in patients with gastric cancer

BackgroundAccording to previous studies, low serum total cholesterol (TC) is associated with higher cancer incidence and mortality. However, the prognostic implications of preoperative TC in patients with gastric cancer (GC) remain to be determined.MethodsA total of 1251 patients with GC, who underwent radical gastrectomy between 2005 and 2008, were recruited. Propensity score weighting (PSW) based on a generalized boosted method (GBM) was used to control for selection bias.ResultsAfter balancing the preoperative and operative covariates, low TC was associated with high incidence of complications (severe complication rate: 15.2% (Low TC) vs. 4.7% (Normal TC) vs 5.5% (High TC); p = 0.004). In multivariable analysis, lowering TC was associated with poor OS and RFS in weighted population. [OS: hazard ratio (HR) = 0.92; 95% CI = 0.867–0.980; P = 0.009 and RFS: HR = 0.93; 95% CI = 0.873–0.988; P = 0.02].ConclusionsPreoperative TC is a useful predictor of postoperative survival and postoperative complications in patients with stage I–III GC and may help to identify high-risk patients for rational therapy, including nutritional support, and timely follow-up.     

Real world initial palliative treatment patterns and clinical outcomes in premenopausal patients with hormone receptor-positive,HER2-negative metastatic breast cancer: A study of the National Cancer Center,China

BackgroundTo observe whether guideline non-adherence in initial palliative treatment choices for premenopausal hormone receptor-positive (HR+), HER2-negative metastatic breast cancer (MBC) patients result in worse clinical outcomes in the Chinese population.MethodsThe China National Cancer Center database was used to identify 2194 patients diagnosed between 2004 and 2015. A total of 451 premenopausal patients with HR + HER2- MBC were included. Clinicopathological features and survival information were extracted. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan–Meier method and compared using log-rank test.ResultsThe number of patients receiving initial chemotherapy, endocrine therapy and chemo-endocrine therapy were 222 (49.2%), 80 (17.7%), and 149 (33.0%), respectively. Patients receiving initial chemotherapy were more likely to be luminal B subtype, had more de novo stage IV disease and more liver metastasis, compared with patients receiving initial endocrine therapy. Both PFS and OS were significantly longer for chemo-endocrine therapy group (median PFS 18.9 months and OS 75.0 months), than for endocrine therapy group (median PFS 11.7 months and OS 53.5 months), and chemotherapy group (median PFS 7.1 months and OS 43.9 months). In multivariate analysis, none of the three treatment strategies were independently associated with PFS or OS.ConclusionIn real world, a high percentage of premenopausal patients with HR + HER2- disease received chemotherapy as initial palliative treatment in China, which was not associated with worsened survival. Further studies with larger sample size across China are needed to explore the relationship between this guideline non-adherence and clinical outcomes.     

The efficacy and safety of paclitaxel plus bevacizumab therapy in breast cancer patients with visceral crisis

BackgroundVisceral crisis in metastatic breast cancer (MBC) is defined as severe organ dysfunction requiring rapidly efficacious therapy. Although weekly paclitaxel plus bevacizumab (wPTX + BV) achieves a high response rate in human epidermal growth factor receptor 2 (HER2)-negative MBC, the efficacy and safety of wPTX + BV for visceral crisis is unclear.MethodsWe retrospectively investigated patients with MBC with visceral crisis who received wPTX + BV. Visceral crisis was defined as follows: liver dysfunction (aspartate or alanine aminotransferase >200 U/L or total bilirubin >1.5 mg/dl), respiratory dysfunction (carcinomatous lymphangiomatosis, SpO₂ <93% in ambient air or required thoracentesis), superior vena cava (SVC) syndrome, or bone marrow carcinomatosis. The primary outcome was the proportion of patients on-treatment with wPTX + BV after 12 weeks. We also investigated time to treatment failure (TTF), overall survival (OS), objective response rate (ORR), and adverse events.ResultsA total of 44 patients with respiratory dysfunction (n = 29), liver dysfunction (n = 10), bone marrow carcinomatosis (n = 7), and SVC syndrome (n = 2) were eligible for this investigation. The proportion of patients on-treatment with wPTX + BV after 12 weeks was 63% (30/44), and the other patients discontinued wPTX + BV because of adverse events (n = 5) and disease progression (n = 9). Median TTF and OS, and the ORR were 131 days and 323 days, and 41%, respectively. No treatment-related death occurred.Conclusion: wPTX + BV achieved favorable efficacy and safety for treating patients with visceral crisis and may therefore be considered an option for the treatment of this acutely severe clinical condition.     

Clinical outcomes and treatment practice patterns of patients with HER2-positive metastatic breast cancer in the post-trastuzumab era

BackgroundTrastuzumab is associated with improvements in overall survival (OS) among patients with HER2-positive metastatic breast cancer (MBC); however disease course and patterns of care in individual patients are highly variable.Methods113 HER2-positive patients diagnosed with MBC from 1999 to 2005 who received trastuzumab-based therapy were retrospectively identified to allow for a minimum of 5 years of follow-up time. Median OS and median duration of therapy were determined using Kaplan–Meier methodology and group comparisons were based on the log-rank test. Hazard ratios (HR) were obtained using a Cox proportional hazards model.ResultsMedian OS was 3.5 years (95% CI 3.0–4.4) from time of initiation of first therapy in the metastatic setting. On univariate analysis, central nervous system (CNS) disease at first recurrence was associated with a shorter OS compared with liver and/or lung metastases or other sites (CNS: 1.9 years CI 0.1–5.9, liver/lung: 3.2 years CI 2.5–4.2, other: 4.6 years CI 2.7–8.0; p = 0.05), however, this was not predictive of survival outcome in multivariate analysis. CNS metastases developed in 62 (55%) patients by the time of death or last follow-up. Median duration of therapy was similar up to 6 lines of treatment, and ranged from 5.2 months to 7.2 months.ConclusionsThe natural history of HER2-positive MBC has evolved with trastuzumab-based therapy with median OS now exceeding 3 years. CNS disease is a major problem with continued risk of CNS progression over time. Patients demonstrate clinical benefit to multiple lines of HER2-directed therapy.