Clinical predictors of second-line chemotherapy (ChT) benefit in pancreatic cancer (PC).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15733-e15733
Author(s):  
Ilya Pokataev ◽  
Igor Bazin ◽  
Mikhail Fedyanin ◽  
Alexey Tryakin ◽  
Anna Popova ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Disease Progression ◽  
Proportional Hazards Model ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Prognostic Significance ◽  
Cox Proportional Hazards Model ◽  
Second Line ◽  
Inclusion Criteria ◽  
Prognosis Score

e15733 Background: Second line ChT is shown to improve outcome in selected patients with PC; however there are no approved models predicting its benefit. This retrospective study was aimed to evaluate prognostic factors in patients with PC who had disease progression following 1st line ChT and their value in prediction of 2nd line ChT benefit. Methods: Records of PC patients treated in N.N. Blokhin Russian Cancer Research Center since 2000 to 2015 were analyzed. Inclusion criteria for this retrospective analysis were: morphologically confirmed PC, disease progression after 1st line ChT or adjuvant / induction ChT with ChT-free interval <6 months. The most common clinical factors were evaluated for prognostic significance in the Cox proportional hazards model with overall survival (OS) as the end-point. OS was calculated from the date of progression following previous ChT. Cutoff values for quantitative variables were determined using ROC curve analyses. Results: Records of 172 patients matched the inclusion criteria. Second line ChT was administered in 110 (64%) patients (47% of them received gemcitabine- and/or platinum-based doublets). The Cox multivariate analysis identified two independent prognostic factors: Karnofsky performance status (KPS) ≤70% and neutrophil-to-lymphocyte ratio (NLR) >5 at the time of disease progression after 1st line ChT (Table). Administration of 2nd line ChT improved outcome of patients with favorable prognosis (score ≤1): median OS increased from 1.7 to 5.5 months in groups without (n=23) and with (n=90) ChT, respectively (p=0.02). In patients with poor prognosis (score>1) there were no benefit by administration of 2nd line ChT: medians OS were 2.3 and 1.7 months in groups with (n=20) and without (n=39) ChT, respectively (p=0.23). Conclusions: This novel prognostic model can potentially predict 2nd line ChT benefit in patients with PC, however it needs to be validated in further trials. [Table: see text]

Association of Surgical Resection, Disability, and Survival in Patients with Glioblastoma

2019 ◽  
Vol 80 (04) ◽  
pp. 262-268 ◽  
Author(s):  
Yahya Ahmadipour ◽  
Monika Kaur ◽  
Daniela Pierscianek ◽  
Oliver Gembruch ◽  
Marvin Darkwah Oppong ◽  
...  
Keyword(s):  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Extent Of Resection ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Hazards Model ◽  
Surgical Modality ◽  
Supratotal Resection

Objective Extent of resection (EOR) and Karnofsky Performance Status (KPS) are at odds in glioblastoma (GBM) surgery, that is, the anticipated postoperative disability limits the EOR. This study analyzes the correlation of different surgical modalities with the resulting physical status and survival of patients with GBM. Methods A total of 565 patients with primary GBM were operated on in a single institution between 2006 and 2014. Possible surgical modalities comprised supratotal resection (SLR), gross total resection (GTR; ≥ 95% by volume), tumor debulking (TDB; ≤ 95% by volume), and stereotactic biopsy (SB). Pre- and postoperative KPS before and up to 4 weeks after surgery as well as overall survival (OS) rate were determined retrospectively. Hazard ratio (HR) and 95% confidence intervals were calculated using a Cox proportional hazards model. Results Median postoperative KPS was ≥ 70, irrespective of surgical modality. Mean OS was 12.5 months. Multivariate analysis revealed age ≥ 70 years (HR: 1.93), preoperative KPS < 70 (HR: 2.15), and unmethylation in MGMT promoter (HR: 1.27) as independent factors for worse OS. Regarding surgical modality, SB was associated with the worst survival (HR: 2.3) followed by TDB (HR: 1.36). SLR was inferior to GTR (HR: 1.27). Conclusion Higher EOR in patients with GBM does not seem inevitably correlated with increasing functional impairment, but better survival, provided there is a balanced preoperative indication. Nevertheless, SLR does not seem to be superior to GTR. Whenever possible, maximal safe resection should be considered in patients with GBM, even if an EOR ≥ 95% is not possible.

Prognostic factors for overall survival (OS) in patients with metastatic renal cell carcinoma (RCC) treated with vascular endothelial growth factor (VEGF)-targeted agents: Results from a large multicenter study

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5041-5041
Author(s):  
D. Y. Heng ◽  
W. Xie ◽  
M. M. Regan ◽  
T. Cheng ◽  
S. North ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Large Population ◽  
Cox Proportional Hazards Model ◽  
Parameter Estimates ◽  
Targeted Agents ◽  
Anti Vegf ◽  
Risk Categories ◽  
Metastatic Rcc

5041 Background: Prognostic factors (PF) for OS have yet to be fully defined for patients with metastatic RCC in the era of VEGF-targeted therapy. This study identifies PFs in this population and updated survival and validation results are presented. Methods: Baseline characteristics and outcomes on anti-VEGF-naïve metastatic RCC patients were collected from three US and four Canadian centers. Using a Cox proportional hazards model, 3 risk categories for predicting survival were identified on the basis of 6 pretreatment clinical features. Results: Six-hundred forty-five patients were included. The median (m) OS was 22 months (95% CI: 20.0–24.8) with a median follow-up of 25 months. Patients were treated with sunitinib (n = 396), sorafenib (n = 200) or bevacizumab (n = 49); 33% had prior immunotherapy. Four of the five PFs previously identified by MSKCC were independent predictors of short survival, including hemoglobin below the lower limit of normal (LLN) (p < 0.0001), corrected calcium above the upper limit of normal (ULN) (p = 0.0006), Karnofsky performance status <80% (p < 0.0001) and time from initial diagnosis to initiation of therapy ULN (pULN (p = 0.012) were independent adverse PFs. Patients were assigned one point for each poor PF and were segregated into three risk categories: favorable-risk (0 PFs, n = 133) median OS (mOS) 37.0 months; intermediate-risk (1 - 2 PFs, n = 292) mOS 28.5 months; and poor-risk (3–6 PFs, n = 139) mOS 9.4 months (log rank p < 0.0001). This model produced a c-index of 0.74 and the bootstrap procedure confirmed good internal validity. The discriminatory ability of the model and its parameter estimates were not affected after adjusting for prior use of immunotherapy or the type of anti-VEGF drug used. Conclusions: These data validate components of the MSKCC model with the addition of platelet and neutrophil counts. This model derived from a large population can be incorporated into patient care and clinical trials of VEGF-targeted agents. [Table: see text]

scholarly journals Prognostic Significance of Serum Proangiogenic Molecules in Patients withDe NovoNon-Hodgkin Lymphomas

2012 ◽  
Vol 2012 ◽  
pp. 1-5 ◽  
Author(s):  
Pairaya Rujirojindakul ◽  
Arnuparp Lekhakula
Keyword(s):  
Proportional Hazards Model ◽  
De Novo ◽  
Remission Rate ◽  
Performance Status ◽  
Bone Marrow Involvement ◽  
Prognostic Significance ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Poor Performance Status ◽  
The Mean

This study was aimed to assess the clinical significances of the serum VEGF and bFGF in Thai patients withde novoNHL. Serum VEGF and bFGF concentrations were measured from 79 adult patients with newly diagnosed stage 2–4 non-Hodgkin lymphomas by quantitative sandwich enzyme immunoassay. At the time of diagnosis, the serum VEGF concentrations from 79 patients ranged from 72.0 to 2919.4 pg/mL, with a mean of 668.0 pg/dL. The serum bFGF concentrations ranged from undetectable to 2919.4 pg/mL, with a mean of 12.15 pg/dL. Multivariate analysis identified higher than the mean of serum VEGF, B symptoms, bulky diseases, anemia, and treatment with CHOP or R-CHOP as independent variables influencing the complete remission rate. From a Cox proportional hazards model, variables independently associated with overall survival were bone marrow involvement, more extranodal involvement, poor performance status, anemia, and higher than the mean of serum bFGF.

Biologic and Prognostic Significance of Dermal Ki67 Expression, Mitoses, and Tumorigenicity in Thin Invasive Cutaneous Melanoma

2005 ◽  
Vol 23 (31) ◽  
pp. 8048-8056 ◽  
Author(s):  
Phyllis A. Gimotty ◽  
Patricia Van Belle ◽  
David E. Elder ◽  
Todd Murry ◽  
Kathleen T. Montone ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Growth Phase ◽  
Proportional Hazards Model ◽  
Prognostic Significance ◽  
Risk Groups ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Central Feature ◽  
Prognostic Information ◽  
Ki67 Expression

Purpose Tumor cell proliferation is a central feature of melanoma progression. In this study, we characterized three biomarkers of proliferation (Ki67 expression, dermal mitotic rate [MR], and tumorigenicity) in thin (≤ 1.00 mm) primary cutaneous melanomas and examined their association with prognosis. Patients and Methods We used immunohistochemistry to determine Ki67 expression using the monoclonal antibody MIB-1 in lesions from a prospective cohort that included 396 patients with thin invasive primary melanomas seen between 1972 and 1991. A multivariate Cox proportional hazards model was used to define independent prognostic factors, and recursive partitioning was used to develop a prognostic tree identifying risk groups. Results Dermal Ki67 expression was lower than epidermal Ki67 expression in radial growth phase (RGP) melanomas (n = 171), and dermal Ki67 expression and MR were higher in tumorigenic vertical growth phase (VGP) melanomas (n = 193) compared with RGP and nontumorigenic VGP melanomas (n = 42). Dermal Ki67 expression, MR greater than 0, growth phase, thickness, ulceration, tumor-infiltrating lymphocytes, and sex were associated with metastasis at 10 years, however, only dermal Ki67 expression, MR greater than 0, and sex were independent prognostic factors. Two high-risk groups were identified: men and women with dermal MR greater than 0 and dermal Ki67 expression ≥ 20% in tumor cells and men with MR greater than 0 and Ki67 expression less than 20%, with 10-year metastasis rates of 39% and 20%, respectively. Conclusion Proliferation slows as melanoma cells enter the dermis and then increases with the onset of tumorigenic VGP. Ki67 expression and dermal MR provide independent prognostic information that can potentially be used in risk-based management of patients.

Comparison of cisplatin (CDDP) and radiation (RT) to cetuximab (C) and RT for locally advanced head and neck cancer (LAHNC): A preliminary analysis

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 6042-6042
Author(s):  
L. Koutcher ◽  
M. Fury ◽  
S. Wolden ◽  
Z. Zhang ◽  
Q. Mo ◽  
...  
Keyword(s):  
Proportional Hazards Model ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Patient Choice ◽  
Definitive Treatment ◽  
Drug Choice

6042 Background: Both concurrent CDDP/RT and C/RT have been shown in randomized trials to yield superior disease control compared to RT alone in LAHNC, but no randomized trial has compared them. We evaluated our center's experience with these regimens. Methods: From 3/1/06 - 4/1/08, 175 patients were retrospectively identified who received definitive treatment for LAHNC with CDDP (planned total dose 100 mg/m2 Q3 weeks X 3) and RT (n = 125) or C (400 mg/m2 load; 250 mg/m2 weekly) and RT (n = 50). Patients who received prior RT, additional systemic therapy, and/or surgery to the primary site were excluded. C was given for the following reasons: auditory 30%, renal 4%, cardiac 2%, performance status 18%, patient choice 16%, neuropathy 4%, unknown 2%, and a combination of factors 24%. The median age: CDDP group 56, 6% >71; C group 66.5, 40% >71. Additional CDDP and C features: male sex, 86 v 78%; stage IV, 70 v 68%; and oropharynx, 78 v 70%. Median RT dose (70 Gy), RT length (46 days), and Karnofsky performance status (KPS) (90%) were the same; alcohol/tobacco use was similar. Results: At a median follow up of 18.7 months, with death without local failure (LF) as a competing risk, the 18 month LF incidence rate was 2.5% in the CDDP group and 43.3% in the C group (p < 0.0001), with the latest event occurring at 16.5 months. The 18 month disease-free survival (DFS) and overall survival (OS) rates were 85.7 v 40.9%, and 96.8 v 73.1%, in favor of CDDP (p < 0.0001 for both). Initially, 21 variables were assessed for significance, and when Cox proportional hazards model was used for multivariate analysis to address prognostic imbalances, treatment with CDDP still predicted for improved LF, DFS, and OS (p < 0.0001 for LF and DFS; p = 0.0017 for OS). For OS analysis, the concordance probability estimates were .67 for using drug choice alone and .80 for using drug choice, T stage, RT dose, and KPS. Conclusions: CDDP/RT and C/RT were used to treat somewhat different populations with LAHNC. The observed superiority of CDDP/RT compared to C/RT in LF, DFS, and OS may reflect patient selection issues. However, preliminary multivariate modeling suggests that CDDP/RT remains the preferred option for fit patients pending further analyses and prospective studies comparing these regimens. [Table: see text]

ProCAID: A randomized double-blind phase II clinical trial of capivasertib (C) in combination with docetaxel and prednisolone chemotherapy (DP) in metastatic castration-resistant prostate cancer (mCRPC).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 5520-5520
Author(s):  
Simon J. Crabb ◽  
Gareth Owen Griffiths ◽  
Ellice Marwood ◽  
Denise Dunkley ◽  
Nichola Downs ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Disease Progression ◽  
Phase Ii ◽  
Proportional Hazards Model ◽  
Performance Status ◽  
Cox Proportional Hazards Model ◽  
Double Blind ◽  
Pathway Activation ◽  
Activation Status

5520 Background: DP extends survival in mCRPC, but clinical benefit is modest. PI3K/AKT/PTEN pathway activation is common in mCRPC contributing to disease progression and DP resistance. C is a pan-AKT inhibitor. Pre-clinical data indicate activity in prostate cancer and synergism with DP. This phase II trial combined C with DP in mCRPC. Methods: Key eligibility criteria: histologically or cytologically proven measurable or evaluable mCRPC, suitable for treatment with DP for PSA and/or radiographic disease progression, ECOG performance status 0-1, no prior chemotherapy for mCRPC, not requiring insulin or > 2 oral hypoglycaemic drugs for diabetes mellitus. Treatment: up to 10 cycles of DP (D: 75 mg/m2 IV, day 1; P: 5 mg bd oral, day 1 – 21) and random assignment (1:1, double blind) to oral C (320 mg twice daily, 4 days on/3 days off, from cycle 1, day 2) or matched placebo to disease progression. Primary endpoint: progression free survival (PFS; comprising PSA, radiographic or clinical progression, new cancer therapy or death; PCWG2 criteria) in the intent to treat (ITT) population. Secondary endpoints included overall survival (OS) and safety. PFS and OS were also assessed by composite biomarker (B) subgroup for PI3K/AKT/PTEN pathway activation status (NGS/IHC on archival tumour, contemporaneous ctDNA). Statistics: designed to detect a 50% increase in median PFS (6 to 9 months (mo)) between the placebo and C arms (90% power, 20% 1-sided alpha) by Cox proportional hazards model. Registration: ISRCTN 69139368. Results: 150 patients were randomised to 01/2019. Median follow up 16.77 months (IQR 12.0-26.5). PFS and OS by ITT and B status, are shown in the table (NR, not reached; CI confidence interval). Grade 3–4 adverse events (AE) were equally common between arms (62.2%). The most common AEs were diarrhoea, fatigue and nausea. Conclusions: Adding C to DP did not extend PFS. The OS secondary endpoint was significantly increased. PFS and OS results were consistent irrespective of PI3K/AKT/PTEN pathway activation status. Clinical trial information: 69139368 . [Table: see text]

scholarly journals Prognostic significance of the albumin-to-globulin ratio for advanced urothelial carcinoma treated with pembrolizumab: a multicenter retrospective study

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Satoru Taguchi ◽  
Taketo Kawai ◽  
Tohru Nakagawa ◽  
Yu Nakamura ◽  
Jun Kamei ◽  
...  
Keyword(s):  
Urothelial Carcinoma ◽  
Proportional Hazards Model ◽  
Risk Model ◽  
Characteristic Curve ◽  
Performance Status ◽  
Prognostic Significance ◽  
Cox Proportional Hazards Model ◽  
Cancer Specific Survival ◽  
Advanced Urothelial Carcinoma ◽  
Albumin To Globulin Ratio

AbstractAlthough the albumin-to-globulin ratio (AGR) is a promising biomarker, no study has investigated its prognostic significance for advanced urothelial carcinoma (UC). This study conformed to the REporting recommendations for tumor MARKer prognostic studies (REMARK) criteria. We retrospectively reviewed 176 patients with advanced UC treated with pembrolizumab between 2018 and 2020. We evaluated the associations between pretreatment clinicopathological variables, including the AGR and performance status (PS), with progression-free survival, cancer-specific survival, and overall survival. The Cox proportional hazards model was used for univariate and multivariable analyses. The AGR was dichotomized as < 0.95 and ≥ 0.95 based on receiver operating characteristic curve analysis. After excluding 26 cases with missing data from the total of 176 cases, 109 (73%) patients experienced disease progression, 75 (50%) died from UC, and 6 (4%) died of other causes (median survival = 12 months). Multivariate analyses identified PS ≥ 2 and pretreatment AGR < 0.95 as independent poor prognostic factors for all endpoints. Furthermore, a prognostic risk model incorporating these two variables achieved a relatively high concordance index for all endpoints. This is the first report to evaluate the significance of AGR in advanced UC. Pretreatment AGR < 0.95 may serve as a prognostic marker for advanced UC treated with pembrolizumab.

scholarly journals A Nomogram Predicts Individual Prognosis in Patients With Newly Diagnosed Glioblastoma by Integrating the Extent of Resection of Non-Enhancing Tumors

2020 ◽  
Vol 10 ◽  
Author(s):  
Zhe Zhang ◽  
Zeping Jin ◽  
Dayuan Liu ◽  
Yang Zhang ◽  
Chunzhao Li ◽  
...  
Keyword(s):  
Dna Methyltransferase ◽  
Proportional Hazards Model ◽  
Predictive Accuracy ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Extent Of Resection ◽  
Cox Proportional Hazards Model ◽  
Newly Diagnosed ◽  
Discriminative Ability ◽  
Newly Diagnosed Glioblastoma

BackgroundThe extent of resection of non-contrast enhancing tumors (EOR-NCEs) has been shown to be associated with prognosis in patients with newly diagnosed glioblastoma (nGBM). This study aimed to develop and independently validate a nomogram integrated with EOR-NCE to assess individual prognosis.MethodsData for this nomogram were based on 301 patients hospitalized for nGBM from October 2011 to April 2019 at the Beijing Tiantan Hospital, Capital Medical University. These patients were randomly divided into derivation (n=181) and validation (n=120) cohorts at a ratio of 6:4. To evaluate predictive accuracy, discriminative ability, and clinical net benefit, concordance index (C-index), receiver operating characteristic (ROC) curves, calibration curves, and decision curve analysis (DCA) were calculated for the extent of resection of contrast enhancing tumor (EOR-CE) and EOR-NCE nomograms. Comparison between these two models was performed as well.ResultsThe Cox proportional hazards model was used to establish nomograms for this study. Older age at diagnosis, Karnofsky performance status (KPS)&lt;70, unmethylated O6-methylguanine-DNA methyltransferase (MGMT) status, wild-type isocitrate dehydrogenase enzyme (IDH), and lower EOR-CE and EOR-NCE were independent factors associated with shorter survival. The EOR-NCE nomogram had a higher C-index than the EOR-CE nomogram. Its calibration curve for the probability of survival exhibited good agreement between the identical and actual probabilities. The EOR-NCE nomogram showed superior net benefits and improved performance over the EOR-CE nomogram with respect to DCA and ROC for survival probability. These results were also confirmed in the validation cohort.ConclusionsAn EOR-NCE nomogram assessing individualized survival probabilities (12-, 18-, and 24-month) for patients with nGBM could be useful to provide patients and their relatives with health care consultations on optimizing therapeutic approaches and prognosis.

scholarly journals Prognostic Significance of the Albumin-to-globulin Ratio for Advanced Urothelial Carcinoma Treated with Pembrolizumab: A Multicenter Retrospective Study

2021 ◽  
Author(s):  
Satoru Taguchi ◽  
Taketo Kawai ◽  
Tohru Nakagawa ◽  
Yu Nakamura ◽  
Jun Kamei ◽  
...  
Keyword(s):  
Urothelial Carcinoma ◽  
Proportional Hazards Model ◽  
Risk Model ◽  
Characteristic Curve ◽  
Performance Status ◽  
Prognostic Significance ◽  
Cox Proportional Hazards Model ◽  
Cancer Specific Survival ◽  
Advanced Urothelial Carcinoma ◽  
Albumin To Globulin Ratio

Abstract Although the albumin-to-globulin ratio (AGR) is a promising biomarker, no study has investigated its prognostic significance for advanced urothelial carcinoma (UC). This study conformed to the REporting recommendations for tumor MARKer prognostic studies (REMARK) criteria. We retrospectively reviewed 176 patients with advanced UC treated with pembrolizumab between 2018 and 2020. We evaluated the associations between pretreatment clinicopathological variables, including the AGR and performance status (PS), with progression-free survival, cancer-specific survival, and overall survival. The Cox proportional hazards model was used for univariate and multivariable analyses. The AGR was dichotomized as < 0.95 and ≥ 0.95 based on receiver operating characteristic curve analysis. After excluding 26 cases with missing data from the total of 176 cases, 109 (73%) patients experienced disease progression, 75 (50%) died from UC, and 6 (4%) died of other causes (median survival = 12 months). Multivariate analyses identified PS ≥ 2 and pretreatment AGR < 0.95 as independent poor prognostic factors for all endpoints. Furthermore, a prognostic risk model incorporating these two variables achieved a relatively high concordance index for all endpoints. This is the first report to evaluate the significance of AGR in advanced UC. Pretreatment AGR < 0.95 may serve as a prognostic marker for advanced UC treated with pembrolizumab.

Multivariate analysis including biomarkers in the phase III RADIANT-2 study of octreotide LAR plus everolimus (E+O) or placebo (P+O) among patients with advanced neuroendocrine tumors (NET).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4014-4014 ◽  
Author(s):  
James C. Yao ◽  
John D. Hainsworth ◽  
Edward M. Wolin ◽  
Marianne E. Pavel ◽  
Eric Baudin ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Prognostic Factors ◽  
Proportional Hazards Model ◽  
Performance Status ◽  
Univariate Analysis ◽  
Primary Site ◽  
Cox Proportional Hazards Model ◽  
Bone Involvement ◽  
Phase Iii ◽  
Rank Test

4014 Background: In this large phase III trial, median progression-free survival (PFS) improved by 5.1 mo with E+O compared to P+O in patients (pts) with NET associated with carcinoid syndrome. Baseline imbalances including WHO performance status (PS) and primary site favoring P+O confounded primary analysis. Chromogranin A (CgA) and 5-hydroxyindoleacetic acid (5-HIAA) are important biomarkers in NET. Analyses were performed to identify prognostic factors and adjust for baseline imbalances. Methods: Pts were randomized to E+O (n=216) or P+O (n=213). Potential prognostic factors including baseline CgA (≤2×ULN vs >2×ULN), baseline 5-HIAA (≤median vs >median at baseline), age (<65 vs ≥65), gender, race, WHO PS (0 vs 1, 2), primary site (lung vs other), prior somatostatin analog use (yes vs no), duration from diagnosis (<6 mo, 6-24 mo, 2-5 yr, >5 yr), and organs involved (liver, bone) were assessed in univariate analysis using the log rank test and stepwise regression using Cox proportional hazards model. Results: Median PFS (mo) was significantly longer for pts with nonelevated CgA (27 vs 11; p<.001) and nonelevated 5-HIAA (17 vs 11; p<.001). Analyses also indicated age (14 vs 12; p=.01), WHO PS (17 vs 11; p=.004), liver involvement (14 vs not reached; p=.02), bone metastases (8 vs 15; p<.001), and lung as primary site (11 vs 14; p=.06) as potentially prognostic. Multivariate analysis indicated that significant prognostic factors for PFS included baseline CgA (HR, 0.47; CI, 0.34-0.65; p<.001), WHO PS (HR, 0.69; CI, 0.52-0.90; p=.006), bone involvement (HR, 1.52; CI, 1.06-2.18; p=.02), and lung as primary site (HR, 1.55; CI, 1.01-2.36; p=.04). Adjusted for covariates, a 38% reduction in risk of progression was observed for E+O (HR, 0.62; 95% CI, 0.51-0.87; p=.003). Conclusions: In the phase III RADIANT-2 trial, baseline CgA levels, WHO PS, lung as primary site, and bone involvement were important prognostic factors. Exploratory analysis adjusted for these prognostic factors indicated significant benefit of everolimus therapy.

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