Clinicopathological Prognostic Factors Influencing Survival Outcomes of Vulvar Cancer

Survival Outcomes ◽

Tumor Diameter ◽

Large Tumor ◽

Node Positive ◽

Kaplan Meier ◽

Postmenopausal Status ◽

Vulva Cancer ◽

Tumor Area

Abstract Backgroud: Squamous cell carcinoma (SCCA) is the most common vulva cancer. This study purpose to evaluate the clinicopathological prognostic factors for survival outcomes of this disease after treated with surgery. Methods: All SCCA vulva cancer patients who underwent surgery between January 2006 and December 2017 were reviewed. The clinicopathological factors were analyzed to identify the prognostic factors for the progression-free survival (PFS) and overall survival (OS) using the Kaplan- Meier method and Cox-Proportional Hazard model.Results: One hundred twenty-five patients were recruited with a median age of 57 years. The recurrence rate was 35.2%. Patients with recurrence revealed a significant poorer five-year OS rate than those who did not recur (23.7% vs. 79.4%, P < 0.001). About 58.1% of palpable groin nodes revealed metastasis. The independent poor prognostic factors for PFS were groin node-positive and a tumor diameter more than 25 mm. whereas postmenopausal status, preoperative tumor area more than 11 cm2, and groin node enlargement were independent poor prognostic factors for OS. Conclusion: Groin node-positive and tumor diameter longer than 25 mm. were independent poor prognostic factors for PFS whereas postmenopausal status, large tumor area than 11 cm2, and enlargement of groin nodes were independent poor prognostic factors for OS. Patients with these factors should be closely followed.

Concurrent Comparison of the Prognostic Values of Tumor Budding, Tumor Stroma Ratio, Tumor Infiltrating Pattern and Lymphocyte-to-Monocyte Ratio in Colorectal Cancer Patients

Technology in Cancer Research & Treatment ◽

10.1177/15330338211045826 ◽

2021 ◽

Vol 20 ◽

pp. 153303382110458

Author(s):

Yingcheng Zhang ◽

You Liu ◽

Xiaomei Qiu ◽

Bing Yan

Keyword(s):

Colorectal Cancer ◽

Prognostic Factors ◽

Histological Grade ◽

Tumor Stroma ◽

Tumor Budding ◽

Tumor Diameter ◽

Large Tumor ◽

Lymphocyte To Monocyte Ratio ◽

Kaplan Meier ◽

Colorectal Cancer Patients

Objectives: Tumor budding (TB), tumor stroma ratio (TSR), tumor infiltrating pattern (TIP), and preoperative lymphocyte-to-monocyte ratio (LMR) were previously reported to be useful prognostic factors in colorectal cancer (CRC); however, the correlation among these markers and their individual prognostic potency have not been extensively studied. Methods: A cohort of 147 stage I-IV CRC patients was obtained retrospectively, and the patients were divided into subgroups based on low or high TB/TSR/LMR, TIPa (expansile + intermediate) and TIPb (infiltrative) values. The differences in relapse-free survival (RFS) and overall survival (OS) intervals among these subgroups were determined by Kaplan–Meier analysis followed by log-rank tests. The Cox proportional hazard model was applied for the univariate and multivariate analysis of RFS and OS rates. Results:TB, TIP, and LMR, but not TSR, are useful markers for predicting patient survival. Patients with a poor histological grade and large tumor diameter were more likely to present with high TB, TIPb, and low LMR values; in addition, those with advanced T, N, and TNM stages and elevated preoperative CA199 levels had high TB and TIPb levels. TB, TIP, and LMR were significant prognostic factors for the RFS (TB: HR [hazard ratio] = 2.28, 95% CI = 1.30-4.00, P < .01; TIP: HR = 2.60, 95% CI = 1.46-4.60, P < .01; LMR: HR = 0.79, 95% CI = 0.65-0.96, P = .02) and OS (TB: HR = 2.43, 95% CI = 1.32-4.48, P < .01; TIP: HR = 2.49, 95% CI = 1.34-4.63, P < .01; LMR: HR = 0.79, 95% CI = 0.64-0.98, P = .03) intervals. In addition, TB and LMR were independent prognostic factors for the RFS interval (TB: HR = 1.80, 95% CI = 1.01-3.19, P = .05; LMR: HR = 0.80, 95% CI = 0.67-0.96, P = .01), but only LMR was an independent factor for OS rates (HR = 0.80, 95% CI = 0.65-0.98, P = .03). Conclusion: Although TB, TIP, and LMR are useful prognostic markers for CRC, the LMR is likely to be the only independent prognostic factor for both RFS and OS outcomes in practice.

Neo-Family History Score Is A Novel Biomarker of Pathological Complete Response, Safety, and Survival Outcomes In Patients With Breast Cancer Receiving Neoadjuvant Platinum-Based Chemotherapy: A Retrospective Analysis of Two Prospective Trials

10.21203/rs.3.rs-320211/v1 ◽

2021 ◽

Author(s):

Yaqian Xu ◽

Yanping Lin ◽

Yifan Wu ◽

Yaohui Wang ◽

Liheng Zhou ◽

...

Keyword(s):

Breast Cancer ◽

Logistic Regression ◽

Family History ◽

Pathological Complete Response ◽

Complete Response ◽

Survival Outcomes ◽

Receptor Status ◽

Node Positive ◽

Kaplan Meier ◽

Platinum Based Chemotherapy

Abstract Background: Homologous recombination repair gene mutations are associated with increased platinum-based chemosensitivity, whereas few studies have reported the predictive value of family history of cancer for breast cancer in the neoadjuvant setting. This study aimed to construct a brief and effective novel family history scoring system and explore its association with pathological complete response (pCR), survival outcomes, and safety for locally advanced breast cancer receiving platinum-based neoadjuvant chemotherapy.Methods: A total of 262 patients treated with neoadjuvant cisplatin and paclitaxel were included. Neo-Family History Score (NeoFHS) was calculated according to cancer type, age at diagnosis, kinship, and number of affected relatives. Logistic regression was performed to analyze the association between pCR and NeoFHS. Survival rates were compared by Kaplan-Meier curves, examined by log-rank test and Cox proportional hazard regressions.Results: For all patients enrolled in this study, clinical tumor stage (p=0.048), estrogen receptor status (p=0.001), progesterone receptor status (p=0.036), human epidermal growth factor receptor 2 (HER2) status (p=0.013), and molecular subtype (p=0.016) were significantly related to NeoFHS. The multivariate logistic regression revealed that NeoFHS is an independent predictive factor of pCR (OR=2.262, 95% CI 1.159-4.414, p=0.017), especially in node-positive (OR=3.088, 95% CI 1.498-6.367, p=0.002), hormone receptor-positive (OR=2.645, 95% CI 1.164-6.010, p=0.020), and HER2-negative subgroups (OR=4.786, 95% CI 1.550-14.775, p=0.006). Kaplan-Meier estimates suggested that NeoFHS could serve as an independent prognostic factor for relapse-free survival in the whole group (adjusted HR=0.305, 95% CI 0.102-0.910, p=0.033) and node-positive subgroup (adjusted HR=0.317, 95% CI 0.103-0.973, p=0.045). Furthermore, alopecia (p=0.001), nausea (p=0.001), peripheral neuropathy (p=0.018), diarrhea (p=0.026), constipation (p=0.037) of any grade and leukopenia of grade 3 or greater (p=0.005) were more common in patients with higher NeoFHS.Conclusions: Our study revealed that NeoFHS is a practical and effective biomarker for predicting not only pCR and survival outcomes but also chemotherapy-induced AEs for neoadjuvant platinum-based chemotherapy for breast cancer. It may help screen candidate responders and guide safety managements in the future.

Results of subset analyses on overall survival (OS) from study CA184-043: Ipilimumab (Ipi) versus placebo (Pbo) in post-docetaxel metastatic castration-resistant prostate cancer (mCRPC).

10.1200/jco.2014.32.4_suppl.2 ◽

2014 ◽

Vol 32 (4_suppl) ◽

pp. 2-2 ◽

Cited By ~ 9

Author(s):

Charles G. Drake ◽

Eugene D. Kwon ◽

Karim Fizazi ◽

Alberto Bossi ◽

Alfons JM van den Eertwegh ◽

...

Keyword(s):

Prognostic Factors ◽

Statistical Significance ◽

Castration Resistant Prostate Cancer ◽

Free Survival ◽

Prognostic Features ◽

Castration Resistant ◽

Kaplan Meier ◽

To Receive ◽

Clinical Trial Information

2 Background: The CA184-043 phase 3 study did not reach statistical significance for its primary endpoint of OS (HR=0.85, p=0.053). However, antitumor activity was observed in other efficacy endpoints, including progression-free survival. Prespecified subset analyses were performed to understand if any prognostic features may identify mCRPC patients (pts) more likely to benefit from Ipi treatment. Methods: 799 pts were randomized to receive a single dose of radiotherapy (RT) followed by either Ipi (N=399) or Pbo (N=400). Prespecified subset analyses based on Kaplan-Meier/Cox methodology were performed using known prognostic factors for OS in mCRPC. Results: Prespecified subset analyses suggested that Ipi may be more active in pts with favorable prognostic factors, including no visceral disease, alkaline phosphatase <1.5 ULN, and hemoglobin ≥11 g/dL (Table). The safety profile in this study was consistent with previous reports of Ipi. Conclusions: Based on these subset analyses, Ipi added to RT appears to have greater activity than RT alone in pts with a favorable prognostic profile. These results support continued investigation of Ipi in the ongoing CA184-095 study in chemotherapy-naive mCRPC pts. Clinical trial information: NCT00861614. [Table: see text]

Survival Outcomes and Prognostic Factors of Open Partial Laryngeal Surgery: A Thirty Years’ Experience

Annals of Otology Rhinology & Laryngology ◽

10.1177/0003489420905616 ◽

2020 ◽

Vol 129 (7) ◽

pp. 669-676

Author(s):

Oreste Gallo ◽

Angelo Cannavicci ◽

Chiara Bruno ◽

Giandomenico Maggiore ◽

Luca Giovanni Locatello

Keyword(s):

Prognostic Factors ◽

Correct Selection ◽

Survival Outcomes ◽

Surgical Strategies ◽

Risk Of Death ◽

Laryngeal Surgery ◽

Kaplan Meier ◽

Surgical Expertise ◽

Institutional Experience

Background: Open partial laryngeal surgery (OPLS) represents a wide array of procedures that can be fitted to treat different types of laryngeal cancer (LC). We would like to present our 30-years’ institutional experience, to analyze survival outcomes and to critically discuss prognostic factors. Methods: We reviewed all cases of OPLS performed at our Institution from 1982 to 2016 for LC. Survival analysis by Kaplan–Meier estimate was performed and prognostic variables by multivariate analysis were identified. Results: Mean follow-up time was 68.3 months, 30-day mortality 0.2%, subsequent functional total laryngectomy (TL) was 1.01%. Over 80% of cases were stage I to II. We had 25 local, 62 regional and eight distant recurrences. Local control was 94.9%, overall survival (OS) was 83.4% and disease-specific survival (DSS) was 87.7%. The two major risk factors significantly associated with the risk of death were cT and cN stage. CONCLUSIONS: We have confirmed that OPLS represents an oncologically sound option in the treatment of LC despite the emergence of non-surgical strategies and new transoral mininvasive techniques. Our results highlight that accurate staging, correct selection of the patient and a strong surgical expertise are of paramount importance in this type of surgery.

Re-challenge with BRAF-directed treatment: A multi-institutional retrospective study.

10.1200/jco.2017.35.15_suppl.9512 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. 9512-9512 ◽

Cited By ~ 4

Author(s):

Sara Valpione ◽

Matteo S. Carlino ◽

Joanna Mangana ◽

Meghan Mooradian ◽

Grant A. McArthur ◽

...

Keyword(s):

Prognostic Factors ◽

Cox Regression ◽

Acquired Resistance ◽

Complete Response ◽

Subsequent Treatment ◽

Disease Stage ◽

Kaplan Meier ◽

Clinically Significant ◽

Metastatic Sites

9512 Background: Most patients treated with BRAF inhibitors (BRAFi) +/- MEK inhibitors (MEKi) eventually progress on treatment. Along with genetic acquired resistance, epigenetic mechanisms that could be reversed after BRAFi discontinuation have been described. The purpose of this study was to analyse outcomes for patients (pts) retreated with BRAF-directed therapy. Methods: 116 pts who received BRAFi based therapy and, after a break, were re-challenged with BRAFi +/- MEKi treated at 14 centres in Europe, US, and Australia were analysed for progression free survival (PFS) and response rate (RR), as well as factors predicting overall survival (OS) (demographics, disease stage, treatment, LDH level, duration of first BRAFi treatment, reason for first BRAFi discontinuation and interval between BRAFi stop and re-challenge). Multivariate Cox regression, regression trees and Kaplan Meier method were used. Results: Median duration of 1st BRAFi +/- MEKi treatment was 9.4 months (mts) and 7.7 mts for the subsequent treatment after discontinuation (immunotherapy 72%, other 17 %, drug holiday 11%). Brain metastases were present in 51 pts (44%). RR to re-challenge with BRAFi +/- MEKi was 43%: complete response (CR) 3%, partial response (PR) 39%, stable disease 24% and progressive disease (PD) 30%, 4% missing. Of 80 pts who previously discontinued BRAFi for PD, 31 (39%) responded (30 PR and 1 CR). Median OS from retreatment was 9.8 mts. Independent prognostic factors for survival at re-challenge included number of metastatic sites (HR = 1.32 for each additional organ with metastases, p < .001), LDH (HR = 1.37 for each multiple of the upper normal limit, p < .001), while combination of BRAFi+MEKi conferred a better prognosis vs BRAFi alone (HR = 0.5, p = .006). Pts with < 3 metastatic sites treated with BRAFi and MEKi had a better survival (median OS not reached) and pts with ≥ 3 metastatic sites and raised LDH treated with BRAFi alone had the worse outcome (median OS 4 mts). Number of metastatic sites (HR = 1.44, p < .001) and combination of BRAFi and MEKi (HR = 0.45, p < .001) were independent prognostic factors for PFS (median 5.0 mts). Conclusions: Re-challenge with BRAFi +/- MEKi induces a clinically significant response and should be considered for selected cases.

Potential prognostic factors in progression-free survival for patients with cervical cancer

BMC Cancer ◽

10.1186/s12885-021-08243-3 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Hui-Hui Chen ◽

Wei-Yu Meng ◽

Run-Ze Li ◽

Qing-Yi Wang ◽

Yu-Wei Wang ◽

...

Keyword(s):

Cervical Cancer ◽

Prognostic Factors ◽

Lymph Nodes ◽

Cancer Patients ◽

Survival Curve ◽

Curve Analysis ◽

Free Survival ◽

Kaplan Meier ◽

Initial Symptoms

Abstract Background Cervical cancer continues to be one of the leading causes of cancer deaths among females in low and middle-income countries. In this study, we aimed to assess the independent prognostic value of clinical and potential prognostic factors in progression-free survival (PFS) in cervical cancer. Methods We conducted a retrospective study on 92 cervical cancer patients treated from 2017 to 2019 at the Zhuhai Hospital of Traditional Chinese and Western Medicine. Tumor characteristics, treatment options, progression-free survival and follow-up information were collected. Kaplan–Meier method was used to assess the PFS. Results Results showed that the number of retrieved lymph nodes had a statistically significant effect on PFS of cervical cancer patients (P = 0.002). Kaplan-Meier survival curve analysis showed that cervical cancer patients with initial symptoms age 25–39 had worse survival prognoses (P = 0.020). And the using of uterine manipulator in laparoscopic treatment showed a better prognosis (P < 0.001). A novel discovery of our study was to verify the prognostic values of retrieved lymph nodes count combining with FIGO staging system, which had never been investigated in cervical cancer before. According to the Kaplan-Meier survival curve analysis and receiver operating characteristic (ROC) curve analysis, significant improvements were found after the combination of retrieved lymph nodes count and FIGO stage in predicting PFS for cervical cancer patients (P < 0.001, AUC = 0.826, 95% CI: 0.689–0.962). Conclusion Number of retrieved lymph nodes, initial symptoms age, uterine manipulator, and retrieved lymph nodes count combining with FIGO staging system could be potential prognostic factors for cervical cancer patients.

Osteosarcoma of the Pelvis: Experience of the Cooperative Osteosarcoma Study Group

10.1200/jco.2003.01.142 ◽

2003 ◽

Vol 21 (2) ◽

pp. 334-341 ◽

Cited By ~ 209

Author(s):

Toshifumi Ozaki ◽

Silke Flege ◽

Matthias Kevric ◽

Norbert Lindner ◽

Rainer Maas ◽

...

Keyword(s):

Prognostic Factors ◽

Survival Rates ◽

Surgical Margin ◽

Local Therapy ◽

Surgical Excision ◽

Study Group ◽

Large Tumor ◽

Primary Tumor Site ◽

Definitive Surgery

Purpose: To define patients and tumor characteristics as well as therapy results, patients with pelvic osteosarcoma who were registered in the Cooperative Osteosarcoma Study Group (COSS) were analyzed. Patients and Methods: Sixty-seven patients with a high-grade pelvic osteosarcoma were eligible for this analysis. Fifteen patients had primary metastases. All patients received chemotherapy according to COSS protocols. Thirty-eight patients underwent limb-sparing surgery, 12 patients underwent hemipelvectomy, and 17 patients did not undergo definitive surgery. Eleven patients received irradiation to the primary tumor site: four postoperatively and seven as the only form of local therapy. Results: Local failure occurred in 47 of all 67 patients (70%) and in 31 of 50 patients (62%) who underwent definitive surgery. Five-year overall survival (OS) and progression-free survival rates were 27% and 19%, respectively. Large tumor size (P = .0137), primary metastases (P = .0001), and no or intralesional surgery (P < .0001) were poor prognostic factors. In 30 patients with no or intralesional surgery, 11 patients with radiotherapy had better OS than 19 patients without radiotherapy (P = .0033). Among the variables, primary metastasis, large tumor, no or intralesional surgery, no radiotherapy, existence of primary metastasis (relative risk [RR] = 3.456; P = .0009), surgical margin (intralesional or no surgical excision; RR = 5.619; P < .0001), and no radiotherapy (RR = 4.196; P = .0059) were independent poor prognostic factors. Conclusion: An operative approach with wide or marginal margins improves local control and OS. If the surgical margin is intralesional or excision is impossible, additional radiotherapy has a positive influence on prognosis.

Markers of Prognosis for Early Stage Cervical Cancer Patients (Stage IB1, IB2) Undergoing Surgical Treatment

Frontiers in Oncology ◽

10.3389/fonc.2021.659313 ◽

2021 ◽

Vol 11 ◽

Author(s):

Chen Xu ◽

Tie Ma ◽

Hongzan Sun ◽

Xiaohan Li ◽

Song Gao

Keyword(s):

Cervical Cancer ◽

Cancer Patients ◽

Clinical Decision Making ◽

Early Stage ◽

Roc Curves ◽

Large Tumor ◽

Hpv 16 ◽

Calibration Curves ◽

Kaplan Meier

BackgroundFor individuals with cervical cancer, large tumor volume, lymph node metastasis, distant metastasis, and parauterine infiltration are usually associated with a poor prognosis. Individuals with stage 1B1 and 1B2 cervical cancer usually do not have these unfavorable prognostic factors. Once the disease progresses, the prognosis becomes extremely poor. Therefore, investigating the prognostic markers of these cervical cancer patients is necessary for treatment.MethodsThis retrospective study included 95 cervical cancer patients treated with surgery. The patients were divided into progressor and non-progressor groups according to postoperative follow-up results. T-test (or Mann−Whitney U test), chi-squared test (or Fisher’s exact test) and receiver operating characteristic (ROC) curves were used to evaluate imaging, hematology, and clinicopathological index differences between the two groups. Cox analysis was performed to select the independent markers of progression-free survival (PFS) when developing the nomogram. Validation of the nomogram was performed with 1000 bootstrapped samples. The performance of the nomogram was validated with ROC curves, generated calibration curves, and Kaplan-Meier and decision curve analysis (DCA).ResultsCervical stromal invasion depth, lymphovascular space invasion (LVSI), human papilloma virus (HPV-16), Glut1, D-dimer, SUVmax and SUVpeak showed significant differences between the two groups. Multivariate Cox proportional hazard model showed SUVpeak (p = 0.012), and HPV-16 (p = 0.007) were independent risk factors and were used to develop the nomogram for predicting PFS. The ROC curves, Kaplan-Meier method, calibration curves and DCA indicated satisfactory accuracy, agreement, and clinical usefulness, respectively.ConclusionsSUVpeak level (≥7.63 g/cm3) and HPV-16 negative status before surgery were associated with worse PFS for patients with cervical cancer. Based on this result, we constructed the nomogram and showed satisfactory performance. Clinically, individualized clinical decision-making can be performed on patients based on this result.

Surgical Resection is An Effective Therapy for Single Large Hepatocellular Carcinom

10.21203/rs.3.rs-909527/v1 ◽

2021 ◽

Author(s):

Pojen Hsiao ◽

Jen-Hao Yeh ◽

Chao-Ming Hung ◽

Hung-Yu Lin ◽

TaoQian Tan ◽

...

Keyword(s):

Prognostic Factors ◽

Liver Disease ◽

Surgical Resection ◽

Initial Treatment ◽

Cox Regression ◽

Therapeutic Strategies ◽

Cox Regression Analysis ◽

Class A ◽

Kaplan Meier

Abstract Background Identifying prognostic factors and therapeutic strategies for single large hepatocellular carcinoma (HCC) is crucial. This retrospective study investigated prognostic factors in patients with single large HCC (≥5 cm) and Child–Pugh (CP) class A liver disease and recommended therapeutic strategies. Methods In total, 305 patients with single large HCC and CP class A liver disease but without distant metastasis or macrovascular invasion were included. Their clinicopathological data, overall survival (OS), and progression-free survival (PFS) were recorded. OS and PFS rates were analyzed using the Kaplan–Meier method and Cox regression analysis. Results In this study, 77.8% of the patients were men; the median age was 63 years. Approximately 34.1% of the patients had cirrhosis and 89.6% had CP class A5 disease. The most common initial treatment was resection (49.5%), followed by transarterial chemoembolization (TACE; 48.2%). OS and PFS rates 1, 5, and 10 years after initial treatment were 88.6%, 58.0%, and 46.8% and 73.6%, 48.2%, and 31.3%, respectively. OS and PRS rates were significantly higher in patients receiving surgical resection than in those receiving TACE. The 1-, 5-, and 10-year OS rates were 94.6%, 76.7%, and 66.7% after resection and 83.1%, 39.0%, and 26.6% after TACE. The 1-, 5-, and 10-year PRS rates were 82.5%, 55.7%, and 51.0% after resection and 64.3%, 40.5%, and 22.7% after TACE. In multivariate analysis, CP class A5/6 (A5 vs. A6; hazard ratio [HR]: 0.23; 95% confidence interval [CI]: 0.15–0.38, P < 0.001) and initial treatment (resection vs. TACE; HR: 0.22; 95% CI: 0.15–0.36, P < 0.001; resection vs. other treatments; HR: 0.37; 95% CI: 0.17–0.65, P = 0.016) were significantly associated with OS. In addition, CP class A5/6 (A5 vs. A6; HR: 0.32; 95% CI: 0.18–0.56, P < 0.001) and initial treatment (resection vs. TACE; HR: 0.30; 95% CI: 0.16–0.51, P < 0.001; resection vs. other treatments; HR: 0.51; 95% CI: 0.26–0.81, P = 0.042) were significantly associated with PFS. Conclusion Surgical resection achieved significantly higher OS and PRS rates than TACE. Surgical resection is an effective and safe therapy for single large HCC.

Impact of crossover and baseline prognostic factors on overall survival (OS) with abiraterone acetate (AA) in the COU-AA-302 final analysis.

10.1200/jco.2015.33.7_suppl.142 ◽

2015 ◽

Vol 33 (7_suppl) ◽

pp. 142-142

Author(s):

Charles J. Ryan ◽

Matthew Raymond Smith ◽

Karim Fizazi ◽

Fred Saad ◽

Cora N. Sternberg ◽

...

Keyword(s):

Prognostic Factors ◽

Specific Antigen ◽

Final Analysis ◽

Parameter Estimate ◽

Abiraterone Acetate ◽

Rank Test ◽

Risk Of Death ◽

Kaplan Meier ◽

The Difference

142 Background: AA + prednisone (P) significantly increased OS, time to opiate use, and was well tolerated at the COU-AA-302 final analysis. Here we further characterize OS benefit adjusting for crossover therapy and for baseline prognostic factors. Methods: Patients (N = 1,088) were randomized 1:1 to receive AA (1 g) + P (5 mg po BID) vs P. Co-primary end points were radiographic progression-free survival and OS. Median time to events with 95% CI was estimated using the Kaplan-Meier method. Stratified log-rank test was used to test the difference in treatment effect. Adjustment for crossover utilized the iterative parameter estimate (IPE) and impact of baseline prognostic factors was examined via the multivariate Cox proportional hazard model. Results: With a median follow-up of 49.2 months and 741 deaths (96% of required), AA + P significantly reduced the risk of death vs P (19%) and prolonged median OS (34.7 vs 30.3 months) (Table). 44% of patients initially receiving P alone subsequently received AA + P as crossover per protocol (17%) or as subsequent therapy (27%). IPE adjustment resulted in a 26% reduction in the risk of death (Table). By multivariate analysis, AA + P treatment led to a 21% reduction in the risk of death; baseline prostate-specific antigen (PSA), lactate dehydrogenase (LDH), hemoglobin, alkaline phosphatase (ALP), bone metastases, and age were significant OS prognostic factors (Table). Conclusions: AA + P yielded a statistically significant improvement in OS. Greater improvement in OS was observed after adjusting for the 44% of patients originally on P who ultimately received AA + P. Adjusting for baseline prognostic factors also demonstrated an AA + P OS benefit. Clinical trial information: NCT00887198. [Table: see text]