scholarly journals Early Neutropenia is Associated with Survival in Men with Metastatic Castration-Resistant Prostate Cancer (Mcrpc) When Treated with Cabazitaxel: an Analysis of Tropic Phase III Trial

2014 ◽  
Vol 25 ◽  
pp. iv271
Author(s):  
A. Meisel ◽  
S. von Felten ◽  
J.S. de Bono ◽  
R. De Wit ◽  
O. Sartor ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Phase Iii ◽  
Castration Resistant Prostate Cancer ◽  
Phase Iii Trial ◽  
Castration Resistant

scholarly journals Updated Prognostic Model for Predicting Overall Survival in First-Line Chemotherapy for Patients With Metastatic Castration-Resistant Prostate Cancer

2014 ◽  
Vol 32 (7) ◽  
pp. 671-677 ◽  
Author(s):  
Susan Halabi ◽  
Chen-Yen Lin ◽  
W. Kevin Kelly ◽  
Karim S. Fizazi ◽  
Judd W. Moul ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Prognostic Model ◽  
Risk Groups ◽  
Phase Iii ◽  
Castration Resistant Prostate Cancer ◽  
First Line ◽  
Phase Iii Trial ◽  
Castration Resistant ◽  
Validation Set ◽  
Line Chemotherapy

Purpose Prognostic models for overall survival (OS) for patients with metastatic castration-resistant prostate cancer (mCRPC) are dated and do not reflect significant advances in treatment options available for these patients. This work developed and validated an updated prognostic model to predict OS in patients receiving first-line chemotherapy. Methods Data from a phase III trial of 1,050 patients with mCRPC were used (Cancer and Leukemia Group B CALGB-90401 [Alliance]). The data were randomly split into training and testing sets. A separate phase III trial served as an independent validation set. Adaptive least absolute shrinkage and selection operator selected eight factors prognostic for OS. A predictive score was computed from the regression coefficients and used to classify patients into low- and high-risk groups. The model was assessed for its predictive accuracy using the time-dependent area under the curve (tAUC). Results The model included Eastern Cooperative Oncology Group performance status, disease site, lactate dehydrogenase, opioid analgesic use, albumin, hemoglobin, prostate-specific antigen, and alkaline phosphatase. Median OS values in the high- and low-risk groups, respectively, in the testing set were 17 and 30 months (hazard ratio [HR], 2.2; P < .001); in the validation set they were 14 and 26 months (HR, 2.9; P < .001). The tAUCs were 0.73 (95% CI, 0.70 to 0.73) and 0.76 (95% CI, 0.72 to 0.76) in the testing and validation sets, respectively. Conclusion An updated prognostic model for OS in patients with mCRPC receiving first-line chemotherapy was developed and validated on an external set. This model can be used to predict OS, as well as to better select patients to participate in trials on the basis of their prognosis.

Bone metabolism biomarkers (BMB) and progression-free survival (PFS) in men with metastatic hormone-sensitive prostate cancer (HSPC): SWOG S1216, a phase III trial of androgen deprivation therapy (ADT) with or without orteronel.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 5523-5523
Author(s):  
Primo Lara ◽  
Edward Mayerson ◽  
Erik Gertz ◽  
Catherine Tangen ◽  
Amir Goldkorn ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Progression Free Survival ◽  
Bone Alkaline Phosphatase ◽  
Phase Iii ◽  
Castration Resistant Prostate Cancer ◽  
Disease Extent ◽  
Phase Iii Trial ◽  
Correlative Analysis ◽  
Castration Resistant ◽  
Increased Risk

5523 Background: We previously reported that baseline BMB are independently prognostic for overall survival (OS) in men with castration resistant prostate cancer. We correlated BMB with outcomes in mHSPC as part of S1216, a phase III trial of ADT +/- the novel CYP17 inhibitor orteronel. Methods: Blood was obtained at study entry for bone resorption [C-telopeptide(CTx) & Pyridinoline(PYD)] & formation markers [C-terminal collagen propeptide(CICP) & bone alkaline phosphatase(BAP)]. With prior DSMC approval, patients were sampled to mask potential treatment effect. Logistic regression was used to assess if BMB elevation above median was prognostic for a PFS event w/in 2 years across pooled study treatment arms, adjusting for baseline variables (including disease extent, PSA, age, pre-randomization ADT, & presence of bone mets). An additional interaction term between BMB elevation & presence of bone mets was included; if significant, separate models were developed for men +/- bone mets. Results: Of 1,313 men, 656 were included in this analysis. All 4 BMB levels were higher in men with a PFS event w/in 2 years vs. those with no PFS event. The odds ratio (OR) for a PFS event was significantly higher in men w/ elevated baseline BMB (see table). For BAP, a significant interaction between marker elevation and bone mets was seen (p = 0.003); men w/ bone mets and BAP elevation had an OR of 1.83 for a PFS event in 2 years. Conclusions: In men with newly diagnosed HSPC, elevated baseline levels of BMB were significantly associated with PFS, with about a two-fold increased risk of a progression event w/in 2 years. For CICP, CTx, & PYD, this association was independent of the presence of bone metastases. Baseline BMB levels have strong prognostic value in the mHSPC context. Correlative analysis of BMB & OS is planned. Clinical trial information: NCT01809691 . [Table: see text]

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