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Eur Urol. 2014 Oct 6. pii: S0302-2838(14)00969-5. doi: 10.1016/j.eururo.2014.09.032. [Epub ahead of print] Survival with Newly Diagnosed Metastatic Prostate Cancer in the \"Docetaxel Era\": Data from 917 Patients in the Control Arm of the STAMPEDE Trial (MRC PR08, CRUK/06/019). James ND1, Spears MR2, Clarke NW3, Dearnaley DP4, De Bono JS4, Gale J5, Hetherington J6, Hoskin PJ7, Jones RJ8, Laing R9, Lester JF10, McLaren D11, Parker CC4, Parmar MK2, Ritchie AW2, Russell JM12, Strebel RT13, Thalmann GN14, Mason MD10, Sydes MR2. Author information Abstract BACKGROUND: Prostate cancer (PCa) is the second most common disease among men worldwide. It is important to know survival outcomes and prognostic factors for this disease. Recruitment for the largest therapeutic randomised controlled trial in PCa-the Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy: A Multi-Stage Multi-Arm Randomised Controlled Trial (STAMPEDE)-includes men with newly diagnosed metastatic PCa who are commencing long-term androgen deprivation therapy (ADT); the control arm

provides valuable data for a prospective cohort.

OBJECTIVE:

Describe survival outcomes, along with current treatment standards and factors associated with prognosis, to inform future trial design in this patient group.

DESIGN, SETTING, AND PARTICIPANTS:

STAMPEDE trial control arm comprising men newly diagnosed with M1 disease who were recruited between October 2005 and January 2014.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS:

Overall survival (OS) and failure-free survival (FFS) were reported by primary disease characteristics using Kaplan-Meier methods. Hazard ratios and 95% confidence intervals (CIs) were derived from multivariate Cox models.

RESULTS AND LIMITATIONS:

A cohort of 917 men with newly diagnosed M1 disease was recruited to the control arm in the specified interval. Median follow-up was 20 mo. Median age at randomisation was 66 yr (interquartile range [IQR]: 61-71), and

median prostate-specific antigen level was 112 ng/ml (IQR: 34-373). Most men (n=574; 62%) had bone-only metastases, whereas 237 (26%) had both bone and

soft tissue metastases; soft tissue metastasis was found mainly in distant lymph nodes. There were 238 deaths, 202 (85%) from PCa. Median FFS was 11 mo; 2-yr FFS was 29% (95% CI, 25-33). Median OS was 42 mo; 2-yr OS was 72% (95% CI, 68-76). Survival time was influenced by performance status, age, Gleason score, and metastases distribution. Median survival after FFS event was 22 mo. Trial eligibility criteria meant men were younger and fitter than general PCa population.

CONCLUSIONS:

Survival remains disappointing in men presenting with M1 disease who are started on only long-term ADT, despite active treatments being available at first failure of ADT. Importantly, men with M1 disease now spend the majority of their remaining life in a state of castration-resistant relapse.

PATIENT SUMMARY:

Results from this control arm cohort found survival is relatively short and highly influenced by patient age, fitness, and whereprostate cancer has spread in the body.

Copyright © 2014. Published by Elsevier B.V.

KEYWORDS:

Control arm cohort; Hormone-naïve; Metastatic; Natural history; Prognostic

factors; Prospective data; Prostate cancer; Survival; Time to progression Treatment of metastatic spinal tumors by percutaneous vertebroplasty versus percutaneous vertebroplasty combined with interstitial implantation of 125I seeds 1. Zuozhang Yang1⇑ 2. Dakuan Yang2 3. Lin Xie1 4. Yuqing Sun3 5. Yunchao Huang1 6. Hongpu Sun1 7. Pengjie Liu1 8. Zhongxiong Wu1 1. 1Department of Orthopedics, Tumor Hospital of Yunnan Province, Third Affiliated Hospital of Kunming Medical College, Kunming, Yunnan, P. R. China 2. 2Second Affiliated Hospital of Kunming Medical College, Kunming Yunnan, P.

R. China

3. 3Department of Orthopedic Oncology, Beijing Jishuitan Hospital, Beijing, P. R. China

1. Zuozhang Yang, Department of Orthopedics, Tumor Hospital of Yunnan Province, Third Affiliated Hospital of Kunming Medical college, Kunming, Yunnan 650118, P. R. China (tel. +86 871 8221157, fax. +86 871 8221157, e-mail. yangzuozhang@163.com)

Abstract Background: As the most frequent bone metastasis, spinal metastases cause severe pain and damage to vertebral bodies such as spinal osteolytic destruction and compression fractures. To avoid the trauma and complications of open surgery, a minimally invasive procedure, percutaneous vertebroplasty (PVP), has recently been developed to treat metastatic spinal tumors.

Purpose: To analyze the treatment outcomes of metastatic spinal tumors by percutaneous vertebroplasty (PVP) alone or PVP combined with interstitial implantation of 125I seeds.

Material and Methods: 80 patients with metastatic spinal tumors were randomized to receive PVP alone (40 cases) or PVP combined with 125I seed implantation (40 cases). Digital subtraction angiography (DSA)-guided

vertebroplasty was performed under local anesthesia, and acrylic bone cement was injected into the vertebra through a bone trocar to the center of the lesion, with or without simultaneous interstitial implantation of 125I seeds.

Results: At 6-month follow-up, PVP combined with 125I seed implantation resulted in zero cases with complete relief (CR), 36 with partial relief (PR), four with no changes (NC), and zero with progression of disease (PD), while PVP alone without seed implantation resulted in 0 CR, 31 PR, 7 NC, and 2 PD. While the combined-treatment group and the single-PVP group showed overall clinical benefit rates without significant difference (100% and 95.0%, respectively), their visual analogue pain scales (VAS; 2.26±1.05 and 5.41±0.94, respectively) and Karnofsky performance scores (KPS; 92.5±7.1 and 87.7±7.3, respectively) were significantly different after treatment (P = 0.028 and P = 0.009, respectively). Patients in both groups had 1-year follow-up, and the mean time to tumor progression (TTP) was 9.0 and 8.9 months, respectively (not significant).

Conclusion: PVP is a minimally invasive procedure with small wounds and minor complications. It is effective in the alleviation of pain in metastatic spinal tumor patients, and its clinical outcomes can be enhanced by the combination of interstitial implantation of 125I seeds.

Methods and Materials

Data from 223 men in the Cancer of the Prostate Strategic Urologic Research Endeavor database who received androgen deprivation therapy (ADT) concurrent with BT for intermediate- or high-risk prostatic adenocarcinoma were included; 159 (71%) received MAB, and 64 (29%) monotherapy (luteinizing

hormone-releasing hormone agonist or anti-androgen alone). Cox regression analysis was performed to assess whether the choice of ADT was associated with disease recurrence adjusting for known prognostic factors.

Results

Men who received MAB had similar Gleason scores, T categories, and pretreatment prostate-specific antigen as those who received monotherapy. After a median follow-up of 49 months, the use of MAB was not associated with a

decrease in the risk recurrence (p = 0.72), after adjusting for known prognostic factors. A higher PSA at diagnosis (p = 0.03) and younger age at diagnosis (p < 0.01) were associated with increased recurrence risk. The 3-year recurrence free survival was 76% for patients in both monotherapy and MAB groups.