Survival Benefit In Women Research Articles

Estimating the overall survival benefit of adjuvant chemo-endocrine therapy in women over age 50 with pT1-2N0 early stage breast cancer and 21-gene recurrence score ≥26: A National Cancer Database analysis.

Validation studies of the 21-gene recurrence score (RS) previously demonstrated that adjuvant chemotherapy plus endocrine therapy (CET) was associated with a significant survival benefit in women with node negative breast cancer (BC) and RS >31. However, the TAILORx trial, did not quantify the benefit of adjuvant CET in older women with node negative hormone receptor positive (HR+) BC with RS ≥26. We hypothesized that CET would be associated with improved overall survival (OS) compared to endocrine therapy (ET) in women >50 with HR+/HER2-node negative BC and RS ≥26. The National Cancer Database (NCDB) was queried to identify women >50 with RS ≥26 ER+/HER2-BC pT1-2N0M0. Chi-square and logistic regression analysis determined the difference between ET and CET. OS was analyzed using a multivariable Cox model. We included 16,745 women-4740 (28.3%) received ET and 12,005 (71.7%) received CET. Women who received CET had: moderately (OR = 1.853, p < 0.001) or poorly/undifferentiated tumors (OR = 3.875, p < 0.001), pT2 (OR = 1.356, p < 0.001), or lymph-vascular invasion (OR = 1.206, p = 0.001). After accounting for demographic and oncologic factors, 5-year OS rates were significantly superior in women receiving CET vs. ET alone (95.4% vs. 92.0%, Hazard Ratio = 0.680, p < 0.001). We observed that CET was associated with a clinically and statistically significant higher OS compared to ET alone in women >50 years of age with RS ≥26 pT1 and pT2 N0M0 HR+/HER2-breast cancer, and which suggests that cytotoxic chemotherapy has an impact on reducing mortality that is independent of induction of premature ovarian failure.

Drug Discovery and Development of Recently Approved Drugs: Tisotumab Vedotin

Recurrent or metastatic cervical cancer is the primary reason for dying in the female population. Although advanced research in immunization may provide a potential treatment for cervical cancer, it is still one of the usual fetal female cancers globally. Previous studies on bevacizumab and chemotherapy provided efficient treatments with a survival benefit for women, but different strategies are needed to increase the overall survival rate of this cancer. Tisotumab vedotin is an investigative and pioneering immunoglobulin-medicine combination that targets tissue factor (TF), a protein in high concentrations in various solid tumours. Tisotumab vedotin bonds to tissue factor on aimed cells and then releases monomethyl auristatin E (MMAE). In addition, Tisotumab vedotins direct cytotoxicity may increase nearby tumour cells spectator toxicity and various immune-linked effects. This paper will discuss previous studies on Tisotumab vedotin, and their data will be analyzed further. The improvement toward this treatment will be proposed as well. This paper aimed to establish a thorough understanding and further analysis of the previous clinical trials and findings on Tisotumab vedotin.

Outcomes of Complex Percutaneous Cardiac Interventions in Women.

Complex percutaneous cardiac intervention (PCI) is a growing procedure in modern day cath labs. The treated population is often older, with multiple comorbidities, complex coronary anatomy, left ventricular dysfunction, and possibly concomitant valvular heart disease and/or cardiogenic shock. As such, PCI of bifurcations, chronic total occlusions, and atherectomy coronary interventions are becoming more common. The outcomes in terms of acute procedural success, procedure-related complications, and long-term mortality or heart failure hospitalizations are important to consider. Unfortunately, to date there is a paucity of data identifying sex and gender disparities following such interventions. With respect to bifurcation lesions, women usually have more comorbidities with less complex coronary anatomy. However, despite less complex anatomy, women have a significantly increased risk of MI. These differences are also noted with left main stem and multivessel disease, during which women appear to have a trend towards worse outcomes following PCI compared with coronary artery bypass grafting. Randomized trials have revealed that women present with increased cardiovascular risk factors, which may contribute to adverse longer-term outcomes. Revascularization of women with concomitant valvular heart disease is particularly challenging because the existing data are conflicted on not only the indication, but also the timing of revascularization. Similarly, women undergoing PCI of calcified lesions with drug-eluting stents have a worse clinical profile and remain at increased ischemic risk. The lower incidence of coronary calcification in women, combined with the under-representation of women in randomized trials, poses a real challenge when attempting to address safety and survival benefit in women undergoing complex interventions. This warrants dedicated trials exploring the safety and efficacy of complex interventions in women.

Impact of residual disease as a prognostic factor for survival in women with advanced epithelial ovarian cancer after primary surgery.

Impact of residual disease as a prognostic factor for survival in women with advanced epithelial ovarian cancer after primary surgery.

Survival and long-term surgical outcomes after colorectal surgery: are there any gender-related differences?

Colorectal cancer (CRC) incidence and mortality seems to be lower in women than in men. The present study aims to evaluate the impact of gender on CRC diagnosis, treatment, and survival. This is a retrospective cohort study based on a single-center dataset of CRC patients from the University Hospital of Trieste (Italy). Data of 1796 consecutive CRC patients referred to our center from November 11th, 2004, to December 31st, 2017, were analyzed. Right-sided carcinomas are more frequent in women than in men; furthermore, women had a lower surgical complication rate. Men showed a higher 5- and 10-year mortality. This survival benefit for women was observed independently of the tumor localization. The 5-year hazard ratio (HR) for women vs men was 0.776 (p 0.003), and after 10-year 0.816 (p 0.017). Regarding the disease-free survival (DFS), 5 and 10-year HR was 0.759 (p 0.034) and 0.788 (p 0.07), respectively. On multivariable analysis, respecting tumor localization, the odds of female gender were higher than man with right colon disease. Male gender was more independently associated with age at the surgery time. Women survival advantage was higher than men, except for patients older than 80. Surgical outcome and survival after CRC surgical treatment seem to be gender related. For this reason, gender could play an important role in CRC diagnosis and therapy, allowing an earlier diagnosis in women.

Abstract 14472: Indications for ICD Implantation Differ Between Women and Men

Introduction: The impact of gender on ICD implantation practice and survival remain a topic of controversy. We analysed differences between men and women in patients implanted with an ICD in Belgium. Methods: The Belgian governmental health care institution (RIZIV/INAMI) keeps track of every ICD implantation by a digital registry. Participation is mandatory for reimbursement. From this registry, we analysed all new ICD implantations between 01/02/2010 and 31/01/2019 in Belgian patients. We compared men with women for baseline patient characteristics. We used a Chi 2 test for categorical variables (NYHA class, primary vs secondary prevention, underlying heart disease, type of device, QRS duration, presence of atrial fibrillation, diabetes and other comorbidity, center volume, population density and average income of the area of residency) and a Mann-Whitney U test for continuous variables [age and ejection fraction(EF)]. We used the Bonferroni method to correct for multiple testing. Secondly, we performed a Kaplan-Meier analysis. At last, we performed a multivariate logistic regression for 3-year and total mortality. Results: Only 3146 (20.8%) on 14747 implantations were in women. Women were significantly younger and had a better EF compared to men. Except for oncological history, women had less comorbidities (table 1). More women functioned in NYHA class &gt; II and had a QRS &gt; 150ms, which was consistent with a higher CRT-D vs VVI/DDD ratio. Kaplan-Meier showed a survival benefit in women (log-rank, p=&lt;0.001). Further exploration with multivariate logistic regression showed that female gender was significant protective for long-term total mortality, but not for short-term 3-year mortality. Conclusions: Only a minority of patients implanted with a new ICD in Belgium are women. Their clinical profile differs from men. Their long-term survival is better, which can in part be explained by differences in indications and comorbidities.

Gender differences and survival after an out-of-hospital cardiac arrest: a systematic review and meta-analysis.

Patients who experience out-of-hospital cardiac arrest (OHCA) have unacceptably high mortality rates. It remains unclear whether gender has an association with survival in this regard. Hence, we aimed to investigate the association between gender and survival by conducting a systematic review and meta-analysis. The databases of PubMed, Embase, and Cochrane Database of Systematic Reviews were searched from inception to 17 March, 2020. Studies assessing the association between gender and survival to discharge or 30-day survival after OHCA were included. Two reviewers independently assessed the eligibility of the identified studies. The random-effects model was used to pool data, and the outcome was reported as odds ratios (ORs) and 95% confidence intervals, as the relative measure of association. Twenty-three eligible studies enrolling 897,805 patients were included in this systematic review. Overall, women were older and less likely to experience arrest in public places. When arrest occurred, women had less initial shockable rhythm, were less likely to be witnessed by bystanders, and were less likely provided with CPR compared with men. After admission, women underwent less coronary angiography, percutaneous coronary angiography, and targeted temperature management therapy. Eleven studies with ORs were pooled, showing a significant survival benefit in women (OR = 1.08, p < 0.05, I2 = 52.3%). In the subgroup analysis, both premenopausal women (< 50years) (OR = 1.42, p < 0.001, I2 = 0%) and postmenopausal women (≥ 50years) (OR = 1.07, p < 0.05, I2 = 16.4%) had higher odds of survival compared with age-matched men. Despite the unfavorable factors, the pooled results showed a significant survival benefit in women after OHCA, especially in premenopausal women.

EARLY real-world treatment and dosing patterns of ribociclib for metastatic breast cancer (mBC): A retrospective observational study.

e13059 Background: Ribociclib and abemaciclib in combination with endocrine therapy have demonstrated survival benefit in women with HR-positive/HER2-negative mBC. This study assessed early real-world treatment and dosing patterns of ribociclib for mBC in a US community oncology setting. Methods: This was a retrospective, observational, descriptive study of female mBC patients initiating treatment with ribociclib between March 1, 2017 and September 30, 2018 within the US Oncology Network (USON) and followed through December 31, 2018. USON’s iKnowMed (iKM) EHR database was used to identify patients and medical chart data review was conducted to abstract treatment information. Descriptive analyses were performed to assess patient and treatment characteristics. Results: A total of 161 patients were selected for chart review, of which 116 patients who received ribociclib were confirmed as eligible. The mean age of patients at initiation of treatment was 66 (SD 14) years. Among patients with documented menopausal status, 90% were post-menopausal, and 10% were pre-menopausal. Among patients with documented receptor status, 99% were ER+/HER2-. Patients most commonly initiated ribociclib in the first-line setting (1L n = 52, 2L n = 30, 3L n = 9, 4L+ n = 25) and in combination with letrozole (n = 33, 28.4%). Eastern Cooperative Oncology Group (ECOG) performance score at time of ribociclib initiation was 0-1 in 60.4% of patients. Documented metastatic sites were present in bone (35.3%), lung (8.6%), and liver (6%). The most common comorbidities documented within 6 months of treatment initiation were cardiovascular disease (53.4%), diabetes (19%), and depression (18.1%). Overall, 46.6% (n = 54) of patients received prior neoadjuvant or adjuvant chemotherapy and 32.8% patients (n = 38) received prior neoadjuvant or adjuvant endocrine therapy. 95% of patients started at the full dose of 600mg. One-fourth of patients (n = 29) had a dose-hold and 27.6% (n = 32) patients experienced a dose reduction with ribociclib therapy. Conclusions: This study represents early ribociclib uptake in a real-world setting in the US. Early utilization demonstrates patients receiving ribociclib are older and sicker than those in pivotal clinical trials. Substantial heterogeneity in ribociclib initiation by LOT was observed.

Comparison of Baseline Characteristics and Outcomes in Men Versus Women With Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation

Female gender has been linked to increased risk of adverse events after surgical aortic valve replacement; however, the evidence regarding the role of gender differences on clinical outcomes in patients who underwent transcatheter aortic valve implantation (TAVI) is still debated. This retrospective study included 910 consecutive patients with severe, symptomatic aortic stenosis who underwent TAVI in 2 institutions from January 2012 to July 2016. The primary end point was all-cause mortality at 1 year after TAVI in women versus men. Women had a higher incidence of in-hospital vascular complications (7.8% vs 4.1%) and major or life-threatening bleeding (4.0% vs 1.6%) than men. At 1 year, women showed a lower mortality rate than men (7.0% vs 12.7%, adjusted hazard ratio [HR] 0.42, 95% confidence interval [CI] [0.23 to 0.76], p = 0.004). When stratifying by specific subgroups of interest, the survival benefit in women persisted in (1) patients with a Society of Thoracic Surgery risk score ≤ 8 (adjusted HR 0.35, 95% CI [0.14 to 0.88], p = 0.026); (2) patients treated with first-generation devices (adjusted HR 0.46, 95% CI [0.24 to 0.86], p = 0.016); and (3) patients treated with balloon-expandable valves (adjusted HR 0.40, 95% CI [0.19 to 0.86], p = 0.019). In conclusion, in this large patient cohort, women had lower 1-year mortality after TAVI than men, particularly with an STS score ≤ 8, or treated with first-generation and balloon-expandable devices.

Impact of adjuvant chemotherapy on survival of women with T1N0M0, hormone receptor negative breast cancer

BackgroundThe benefit of adjuvant chemotherapy in women with T1N0M0 breast cancers is unclear. While gene expression-based prognostic assays may aid management of women with early estrogen receptor (ER) positive tumors, therapeutic decision-making in women with early stage ER negative tumors remains fraught with difficulties. We investigated the association between adjuvant chemotherapy and overall survival in women with T1N0M0, hormone receptor negative breast cancers. MethodAll newly diagnosed breast cancer patients with node-negative and hormone receptor negative tumors measuring≤2cm at the University Malaya Medical Centre (Malaysia) from 1993 to 2013 were included. Mortality of patients with and without adjuvant chemotherapy were compared and adjusted for possible confounders using propensity score. ResultsOf 6732 breast cancer patients, 341 (5.1%) had small (≤2cm), node-negative and hormone receptor negative tumors at diagnosis. Among them, only 214 (62.8%) received adjuvant chemotherapy. Five-year overall survival was 88.1% (95% confidence interval (CI): 82.0%–94.2%) for patients receiving chemotherapy and 89.6% (95% CI: 85.1%–94.1%) for patients without chemotherapy. Chemotherapy was not associated with survival following adjustment for age, ethnicity, tumor size, tumor grade, HER2 status, lympho-vascular invasion, type of surgery and radiotherapy administration. However, chemotherapy was associated with a significant survival advantage (adjusted hazard ratio: 0.35, 95%CI: 0.14–0.91) in a subgroup of women with high-grade tumors. ConclusionAdjuvant chemotherapy does not appear to be associated with a survival benefit in women with T1N0M0, hormone receptor negative breast cancer except in those with high-grade tumors.

Self-assessment questions

A 51-year-old woman with a BMI of 44 is diagnosed with an early stage endometrial cancer at hysteroscopy performed for chaotic perimenopausal bleeding. She attends the gynaecology oncology clinic to discuss her condition and plan her treatment. She is very anxious and has searched extensively on the internet for information about endometrial cancer before meeting with you. Which one of the following statements is true regarding her potential treatment?A)Adjuvant radiotherapy provides no survival benefit in women with early stage endometrial cancer.B)Pelvic lymphadenectomy has an established therapeutic benefit in women with early stage, low grade endometrial cancer.C)Systemic progestogens have a role in adjuvant treatment following surgery for endometrial cancer.D)For young women, in whom complete response has been achieved with systemic progestogens, follow up with 6 monthly hysteroscopies should be recommended when child bearing is complete.E)Women with menopausal symptoms following surgery for endometrial cancer should never be prescribed Hormone Replacement Therapy.

Progress of treatment of an advanced and recurrent endometrial uterine carcinoma

The purpose of the current study was to detect the potential therapeutic role of a survival benefit for women with advanced and recurrent endometrial carcinoma for their poor prognosis. A number of published studies for women with advanced and recurrent endometrial cancers were reviewed. We found that surgery had been the primary treatment of choice for an endometrial carcinoma. Where disease has spread to the uterine cervix, extended or radical surgery may be curative. The systematic lymph node resection improves the survival of women with intermediate/high-risk endometrioid uterine cancer, especially non-endometrioid carcinoma. The omentectomy may be beneficial for non-endometrioid cancer. A number of studies report a survival benefit from surgical cytoreduction in women with advanced and recurrent disease, although the degree of surgical effort is required in order to achieve an optimal result varies. Laparoscopic and robotic surgical staging for uterine cancer might be considered as a standard of care for endometrial cancer without extra-uterine metastasis. Laparotomy should be the first choice for extra-uterine metastasis and recurrent disease. Adjuvant radiotherapy and chemotherapy have a potential role in the management of high-risk, advanced, and recurrent disease. Efficacy of targeted and endocrinal treatment in women with advanced and recurrent endometrial cancer has been proved. Key words: Endometrial neoplasms/TH; Hysterectomy; Lymph node excision; Omentum; Chemotherapy, adjuvant; Radiotherapy, adjuvant; Review

Is Wide Excision Alone an Appropriate Therapy for DCIS?

With the widespread use of screening mammography, the number of ductal carcinoma in situ (DCIS) cases has increased dramatically. Current treatment includes wide local excision (WLE) and adjuvant radiation therapy (RT). The benefit of RT in decreasing local recurrence was established based on the results of four randomized trials and a subsequent meta-analysis. However, RT has a number of side effects and no demonstrated survival benefit in women with in situ breast cancer. This review explores the current literature on the management of DCIS with WLE alone. Although there is insufficient evidence to identify truly low-risk DCIS based on histopathological and immunohistochemical factors, emerging data appear promising in understanding the biological behavior of DCIS. In particular, the Oncotype DX DCIS Score, a multigene assay, predicts local recurrence in women treated with WLE. Risk stratification of DCIS to guide treatment decisions remains elusive, but one of great importance in tailoring therapies to the biology of this heterogeneous disease.

Survival benefit in women with BRCA1 mutation or familial risk in the MRI screening study (MRISC).

Adding MRI to annual mammography screening improves early breast cancer detection in women with familial risk or BRCA1/2 mutation, but breast cancer specific metastasis free survival (MFS) remains unknown. We compared MFS of patients from the largest prospective MRI Screening Study (MRISC) with 1:1 matched controls. Controls, unscreened if<50 years, and screened with biennial mammography if ≥50 years, were matched on risk category (BRCA1, BRCA2, familial risk), year and age of diagnosis. Of 2,308 MRISC participants, breast cancer was detected in 93 (97 breast cancers), who received MRI <2 years before breast cancer diagnosis; 33 BRCA1 mutation carriers, 18 BRCA2 mutation carriers, and 42 with familial risk. MRISC patients had smaller (87% vs. 52% <T2, p < 0.001), more often node negative (69% vs. 44%, p = 0.001) tumors and received less chemotherapy (39% vs. 77%, p < 0.001) and hormonal therapy (14% vs. 47%, p < 0.001) than controls. Median follow-up time was 9 years (range 0-14). Breast cancer metastasized in 9% (8/93) of MRISC patients and in 23% (21/93) of controls (p = 0.009). MFS was better in MRISC patients overall (log-rank p = 0.008, HR 0.36, 95% CI 0.16-0.80), with familial risk (log-rank p = 0.024, HR: 0.21, 95% CI 0.04-0.95), and in BRCA1 mutation carriers (log-rank p = 0.055, HR 0.30, 95% CI 0.08-1.13). MFS remained better in MRISC patients after lead time correction (log-rank p = 0.020, HR 0.40, 95% CI 0.18-0.90). Overall survival was non-significantly better in MRISC patients (log-rank p = 0.064, HR 0.51, CI 0.24-1.06). Annual screening with MRI and mammography improves metastasis free survival in women with BRCA1 mutation or familial predisposition.

Contralateral mastectomy in young women with breast cancer: A population-based analysis of predictive factors and clinical impact.

82 Background: Contralateral mastectomy (CM) has recently been shown to be associated with survival benefit in women with breast cancer. The objectives of the present study were to describe factors predictive of CM in young women (≤35 years old) with invasive breast cancer and evaluate its impact on survival, in a large population based cohort. Methods: All women diagnosed with invasive breast cancer aged ≤35 from 1994 – 2003 treated with mastectomy were identified from the Ontario Cancer Registry. Patient demographics, complete tumour and treatment characteristics were abstracted from primary chart review. Cox proportional hazard regression was performed to assess factors associated with performance of CM and its effect on recurrence and overall survival, performance of CM was modeled as a time varying co-variate. The models were controlled for known predictors including age, tumor size, nodal status, ER/PR, LVI, histologic grade, systemic therapy and adjuvant radiation. Results: There were 628 women identified. Of these, 101 underwent a CM (16.1%). On multivariable analysis, factors predictive of CM were negative lymph node status (HR: 1.74, 95% CI [1.052-2.872]; p-value = 0.031) and negative estrogen receptor status (HR: 2.7, 95% CI [1.314-5.736]; p-value = 0.007). After a median follow up of 11 years, no significant survival benefit was observed in women undergoing CM compared to those who did not (HR: 0.95, 95% CI [0.61-1.46], p-value = 0.80). Conclusions: Performance of CM in young women with invasive breast cancer did not result in a significant survival benefit, compared to those without CM. Factors found to be predictive of performance of CM negative lymph node status and negative estrogen receptor status. Further studies are needed to determine if a subset of young women might benefit from CM.

Influence of sex on outcome following transcatheter aortic valve implantation (TAVI): systematic review and meta-analysis.

Sex differences exist in pathogenesis, clinical presentation, and outcome in aortic stenosis (AS). However, only limited information is available concerning sex differences in transcatheter aortic valve implantation (TAVI). The aim of the present study is a comprehensive meta-analysis of studies that investigate differences between men and women in outcome after TAVI. We screened PUBMED, MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials. Inclusion criteria were: AS treated with all forms of TAVI, studies specifically targeting sex/gender differences, and at least 2 of the following outcome data: 30-day all-cause death, mortality during follow-up, major vascular complications, major bleeding, pacemaker, or stroke rate (<30 days). Studies were excluded if they considered female gender merely in subgroup analysis. We included 14 observational studies with a total of 7,973 patients (4,242 women, 3,731 men). At 30 days (12 studies, 3,044 women, 2,784 men), female sex was associated with a significantly lower mortality rate (odds ratio [95% confidence interval] 0.78 [0.64, 0.96]). Of the 14 studies included for analysis, 12 provided data on mortality during follow-up that likewise show a survival advantage for women (OR 0.70 [0.59, 0.82]). Whereas the major vascular complication rate was greater in women (11 studies, 3,731 women, 3,342 men; OR 1.72 [1.41, 2.09]), major bleeding (8 studies, 2,124 women, 2,100 men; OR 1.13 [0.95, 1.33]) was not. Pacemaker and stroke rate were not significantly different between the groups. In treatment with TAVI, there is evidence for a significantly greater overall survival benefit in women over men.

Sex differences in ICD benefit

BackgroundImplantable cardioverter defibrillators (ICD) have been demonstrated to improve survival, but a considerable number of patients never receive appropriate therapy. The influence of sex on ICD effectiveness in primary prophylactic ICD therapy is unclear. SummaryUntil now, guideline recommendations are equal for men and women, yet only an average of 20% of enrolled patients in large randomized ICD studies were women. Epidemiological data from the Framingham Heart Study exhibit lower incidences of SCD in women (≈50%). This difference is in only in part owed to less severe underlying cardiac disease or comorbidities but it persists after correction of confounding factors. Several of the large randomized studies have conducted gender substudies. In MADIT-II, the survival benefit for women was similar as for men, although the risk of appropriate ICD therapy was lower for women. In SCD-HeFT and DEFINITE, the survival benefits for women were less compared to men, or not existent. Trends were contradictingly summarized by two meta-analyses. By this important post-hoc research, important hypotheses for prospective work in the ICD subgroup of women are generated. At the same time, it is undisputed that the complication rate of ICD implantations is higher in women. The largest ICD registry to date Ontario (Canada) confirms the lower appropriate shock rate in women but found no differences in total mortality. ConclusionsFurther subgroup analyses of large ICD cohorts by sex are needed, as well as studies investigating the influence of sex on ICD treatment – and potentially ICD indication – prospectively.

Survival Outcomes for Patients With Pelvic Lymph Node-Positive Stage IVB Vulvar Cancer: Time to Reconsider the FIGO Staging System?

with and without radiation following surgery in patients with vulvar cancer. Materials/Methods: Using the Surveillance, Epidemiology, and End Results (SEER) database, we identified node-positive women with squamous cell carcinoma of the vulva treated with and without external beam radiation following surgery. OS was compared using the Kaplan-Meier approach, log-rank tests and Cox proportional hazards models. Results: From 1988 2008, 420 patients received surgery alone vs 753 women who received adjuvant radiation. Patient characteristics were well balanced between comparison groups, including tumors or > than 2 cm, grade, marital status, provider type, and AJCC stage. Both groups also had similar incidence of biopsy of any kind, lymph node dissection, median number of nodes excised, and type of surgery. Women who did not receive adjuvant radiation were older (median age: 75 vs 70 y, p < 0.01) and had a higher proportion of whites (94% vs 89%, p Z 0.01). Median survivor follow-up was 45 m (range, 0 236 m). Adjuvant radiation was associated with OS across all node-positive patients (22 vs 29 m, p < 0.01), as well as in the subset of women with just one positive lymph node (37 vs 70 m, p < 0.01) or 2+ positive lymph nodes (14 vs 18 m, p < 0.01). On multivariable Cox regression with adjustment for age and race, adjuvant radiation (95% CI 0.85 0.96), diameter (CI 1.28 2.01), the number of positive nodes (CI 1.06 1.11), and the ratio of positive-to-excised nodes (CI 1.61 2.98) were all associated with OS (p < 0.01 for each). Conclusions: In this comparative effectiveness study of a large cohort of node-positive squamous cell carcinoma of the vulva, we found that adjuvant radiation is associated with OS. Studies have reported that adjuvant radiation may provide a survival benefit in women with 2+ positive lymph nodes. Our findings suggest patients with one positive lymph node also may benefit from adjuvant radiation. Author Disclosure: E. Xanthopoulos: None. N. Mitra: None. S. Grover: None. M.N. Corradetti: None. M. Mangaali: None. M. Heskel: None. L. Lin: None.

Adjuvant radiation therapy in node-positive vulvar cancer.

5609 Background: Adjuvant radiation (RT) has been demonstrated to improve overall survival (OS) in vulvar cancer patients with 2+ positive lymph nodes, but its role in patients with one positive lymph node is uncertain. We report on the largest and longest study of survival in patients with and without radiation following surgery in patients with vulvar cancer. Methods: Using the Surveillance, Epidemiology, and End Results (SEER) database, we identified node-positive women with squamous cell carcinoma of the vulva treated with and without external beam radiation following surgery. The Kaplan-Meier approach, log-rank tests and Cox modeling assessed OS. Results: All results are listed as women without vs with adjuvant radiation. From 1988 – 2008, 420 patients received surgery alone vs 753 women who received adjuvant radiation. Patient characteristics were well balanced across cohorts, including tumors ≤ or &gt; than 2 cm (p = 0.31), grade (p = 0.41), marital status (p = 0.20), provider type (p = 0.49), and AJCC stage (p = 0.35). Both groups also had similar incidence of biopsy of any kind (p = 0.40), lymph node dissection (p = 0.77), median number of nodes excised (p = 0.12), and type of surgery (p = 0.49). Median age (75 vs 70 y, p &lt;0.01) and race (94% vs 89% white, p = 0.01) were adjusted using Cox regression. Median survivor follow-up was 45 m (range 0 - 236 m). Adjuvant radiation was associated with survival across all node-positive patients (22 vs 29 m, p &lt;0.01), as well as in the subset of women with just one positive lymph node (37 vs 70 m, p &lt;0.01) or 2+ positive lymph nodes (14 vs 18 m, p &lt;0.01). On multivariable Cox regression, adjuvant radiation (95% CI 0.85 - 0.96), diameter (CI 1.28 - 2.01), marital status (CI 0.65 - 0.93), the number of positive nodes (CI 1.06 - 1.11), and the ratio of positive-to-excised nodes (CI 1.61 - 2.98) were all associated with survival (p &lt;0.01 for each). Conclusions: The largest cohort study of node-positive squamous cell carcinoma of the vulva suggests adjuvant radiation is associated with OS.Studies have reported that adjuvant radiation may provide a survival benefit in women with 2+ positive lymph nodes. Our findings suggest patients with one positive lymph node also may benefit from adjuvant radiation.

Multiple chemotherapy (CT) lines in metastatic breast cancer (MBC): Which survival benefit for women with hormone receptor (HR)-positive disease?

589 Background: Although the development of modern systemic therapies has clearly improved outcome of patients with MBC, the true impact of further CT on overall survival (OS) and QoL of these women is still debated. The aim of this study was to determine which benefit could be brought by successive CT lines in patients with HR-positive disease, aiming to identify factors affecting outcome and survival. Methods: This retrospective analysis included 980 women treated with CT for MBC at our Institution over a eight year period (July 2000-July 2008). With OS data updated in March 2010, the median follow-up was 146 months (range 48-198), OS and time to treatment failure (TTF) were calculated according to the Kaplan-Meyer method for each CT line. Cox proportional hazards model was used to identify factors that could influence TTF and OS. Results: Median OS evaluated from day 1 of each CT line decreased with the line number from 34.8 months for first line to 8.2 months for 7 or more lines). Median TTF ranged from 9.2 months to 7.8 and 6.4 months for the first, second and third line, respectively, with no significant decrease observed beyond the third line (median 5.2 months, range 4.8-6.2). No statistically significant difference was found between HR-positive and HR-negative patients in terms of OS and TTF by each CT line. In univariate analysis factors positively linked to a longer duration of TTF for each CT line were positive hormonal receptor status, more than 3 hormonotherapy lines, absence of liver metastasis, adjuvant CT exposure, response to CT for the metastatic disease; in the multivariate analysis the duration of TTF for each CT line was the only one factor with significant impact on survival benefit for subsequent treatments, in both HR-positive and negative populations (p&lt;0.001). Conclusions: Our results support the benefit of multiple lines of CT in a significant subset of women treated for MBC, since each CT line may contribute to a longer OS. Of interest, such a benefit was also observed for patients with HR-positive disease, although the number of hormonotherpy lines received did not significantly influence the outcome.