Prognostic factors for survival in the phase III TROPIC trial.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 102-102
Author(s):  
A. Oliver Sartor ◽  
Stéphane Oudard ◽  
Mustafa Ozguroglu ◽  
Steinbjorn Hansen ◽  
Jean-Pascal H. Machiels ◽  
...  

102 Background: In TROPIC ( NCT00417079 ) 755 men were randomized (378 cabazitaxel/prednisone [CbzP]; 377 mitoxantrone/prednisone [MP]). Treatment arms were well balanced; ECOG PS 0–1 (93% CbzP vs 91% MP), measurable disease (53% vs 54%), baseline pain (46% vs 45%) and ≤ 6 months from last dose of docetaxel (D) to randomization (62% vs 72%). CbzP significantly improved overall survival (OS) in mCRPC pts who progressed on or after D treatment compared with MP (HR 0.70; CI 0.59–0.83; P < 0.0001). We investigated overall prognosis and performed a multivariate analysis of factors implicated in OS from this robust dataset. Methods: A univariate analysis of a variety of factors followed by a multivariate analysis of all factors was conducted. Interactions with treatment arms were explored. Cox proportional hazard models were used to examine the effect of treatment and prognostic factors on OS. Results: In addition to the significant effect of treatment received, the univariate analysis identified ECOG PS and measurable disease at baseline, time from last dose of D to randomization, time of progression after last D treatment and pain scores at baseline as significant prognostic factors for OS. Interactions of each of these factors with the treatment were not statistically distinct, suggesting that CbzP survival benefit was consistent among the subgroups defined by these factors. After adjustments for all prognostic factors, multivariate analysis identified ECOG PS 2, measurable disease, time of last dose of D to randomization (≤ 6 months vs > 6 months) and presence of baseline pain as statistically significant prognostic factors. Following adjustments, the treatment effect on survival (CbzP vs MP) remained statistically significant (Table). Conclusions: ECOG PS, measurable disease at baseline, time from last D dose to randomization, baseline pain and CbzP treatment predicted OS in patients in the TROPIC study in a multivariate analysis. [Table: see text]

1999 ◽  
Vol 17 (8) ◽  
pp. 2499-2499 ◽  
Author(s):  
Didier Decaudin ◽  
Eric Lepage ◽  
Nicole Brousse ◽  
Pauline Brice ◽  
Jean-Luc Harousseau ◽  
...  

PURPOSE: To identify the prognostic factors that influence overall survival (OS) in patients with stage III-IV follicular lymphomas and evaluate the clinical usefulness and the prognostic value of the International Prognostic Index (IPI). PATIENTS AND METHODS: Four hundred eighty-four patients with Ann Arbor stage III-IV follicular lymphomas treated in two phase III trials from 1986 to 1995 were screened for this study. All histologic slides were reviewed by two hematopathologists. The influence of the initial parameters on survival was defined by univariate (log-rank test) and multivariate (Cox model) analyses. RESULTS: The poor prognostic factors for OS (age > 60 years, “B” symptom(s), ≥ two extranodal sites, stage IV disease, tumor bulk > 7 cm, at least three nodal sites > 3 cm, liver involvement, serous effusion-compression or orbital/epidural involvement, and erythrocyte sedimentation rate > 30 mm/h) that were significant in univariate analysis were subjected to multivariate analysis. Three factors remained significant: B symptom(s) (risk ratio = 1.80), age greater than 60 years (risk ratio = 1.60), and at least three nodal sites greater than 3 cm (risk ratio = 1.71). When the IPI was applied to these patients, the score was 1, 2, 3, and 4-5 in 49%, 39%, 11%, and 2%, respectively, and it was significant for progression-free survival (P = .002) and OS (P = .0001). CONCLUSION: Three prognostic factors for poor OS were identified: B symptoms, age greater than 60 years, and at least three nodal sites greater than 3 cm. The IPI was prognostic for OS, but in this population, a very low number of patients belonged to the high-risk groups.


2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 180-180
Author(s):  
Daisuke Takahari ◽  
Narikazu Boku ◽  
Junki Mizusawa ◽  
Kenichi Nakamura ◽  
Yasuhide Yamada ◽  
...  

180 Background: In advanced gastric cancer (AGC), there are many reports about prognostic factors for overall survival (OS), and we have proposed a prognostic index using four prognostic factors (PS, number of metastatic sites, prior gastrectomy and ALP; Oncologist 2014) based on a phase III trial JCOG 9912 for the first-line treatment (Lancet Oncol. 2009). However, there is no report about prognostic factors for progression free survival (PFS). In this ancillary study, we explored whether prognostic factors are similar or not between OS and PFS. Methods: The subjects of this study were selected from the JCOG9912 which intended to confirm the superiority of irinotecan plus cisplatin (IP) and the non-inferiority of S-1 to5-FU for patients with AGC. Of all enrolled patients in JCOG9912, those who had target lesions and whose complete data were available were analyzed with multivariate analysis using Cox proportional hazard model. Results: 492 out of the 703 pts of JCOG9912 were analyzed, who received either 5-FU (n=163), IP (n=164) or S-1(n=165). The median PFS was 3.7 months for all the subjects, and 2.2 months for 5-FU, 4.9 months for IP and 3.8 months for S-1. Multivariate analysis in all 492 analyzed patients demonstrated seven independent prognostic factors for PFS (Table). Prognostic factors in each treatment were; sex (HR 1.66, 95%CI 1.11-2.49), PS (1.51, 1.04-2.18), Ca (0.39, 0.17-0.86), GPT (2.46, 1.30-4.66) and LDH (1.67, 1.16-2.48) in 5-FU, sex (1.77, 1.10-2.86) in IP, and Na (2.00, 1.01-3.99) and creatinine clearance (0.37, 0.15-0.93) in S-1. Conclusions: There were no common prognostic factors among the three treatment regimens. Prognostic factors for PFS may be different by treatment regimen, although further investigations with larger sample size are needed. [Table: see text]


2019 ◽  
Author(s):  
Wei Hu ◽  
Jiao Zhou ◽  
Wenbo Zhou ◽  
Lun Wu ◽  
Shaohua Sun ◽  
...  

Abstract Background Patients with Pancreatic cancer (PC) have worse survival than patients with any other gastrointestinal malignancy. In present study, it is aim to investigate the prognostic factors of pancreatic carcinoma after curative resection . Methods 72 cases suffered from pancreatic carcinoma or periampullary carcinoma received curative, nine clinicopathologic factors that could possibly influence survival for postoperative mortality and overall survival were selected for univariate analysis and multivariate analysis using Cox proportional hazard mode. Results Univariate analysis showed that major factors of influence survival were size of the tumor, lymph node metastasis, and grade of differentiation (P<0.05). Multivariate analysis showed that lymph node metastasis and size of the tumor were the most important prognostic factors by multivariate analysis using the Cox proportional hazard model (P<0.01). Conclusions Prognostic factors of pancreatic carcinoma after resection are closed related to lymph node metastasis and the size of the tumor.


2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 590-590
Author(s):  
Dirk Arnold ◽  
Wilfried Grothe ◽  
Dirk Tummes ◽  
Manfred Kindler ◽  
Volker Petersen ◽  
...  

590 Background: Bev+CT has been shown to improve OS vs. CT alone in phase III and IV mCRC studies. However, as only a subset of pts experience OS >30 months (m), clinical factors may help to identify pt groups with the largest potential benefit. Methods: This large observational study included pts receiving bev with various first-line CT regimens in Germany from 2005–2009, with predefined assessment of OS, progression free survival (PFS), toxicity and 22 baseline variables, including pt characteristics, pre-treatment duration/procedures, blood parameters, tumour characteristics. Pts with long-term OS (defined as OS >30m) were compared to those with OS <30m. Surviving pts with observations <30m were defined as ‘censored’. Association between variables and OS was explored by univariate analyses and then multivariate analysis (logistic regression) to find independent variables for long-term OS. Results: 392 (22%) out of 1777 eligible pts had OS >30m (195 events, median OS 46.8m), 717 pts (40%) had OS <30m (median OS 14.3m), and 688 (38%) pts were censored. Median PFS was 17.7m (329 events) for pts with OS >30m, 7.7m for pts with OS <30m, and 11.8m (313 events) for censored pts. In the univariate analysis, nine variables were associated with OS >30m: age (continuous variable; p=0.0008), ECOG PS (0 vs. 1–4; p=0.0025), WBC <8.0/nL (p=0.013), CEA <20ng/mL(p<0.0001), single metastatic site (p<0.0001), initial pT4 vs. others (p<0.0001), pN0 vs. pN1/2 (p=0.0002), initial M0 vs. M1 (p=0.0021), grading G1/2 vs. G3/4 (p<0.0001). Independent variables for pts with OS <30m were found in the multivariate analysis. Conclusions: In general, the prognostic factors identifying long-term survivors in the CT only era are confirmed in this large cohort with bev treatment. However, the predominant role of grading and CEA level are remarkable. [Table: see text]


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4014-4014 ◽  
Author(s):  
James C. Yao ◽  
John D. Hainsworth ◽  
Edward M. Wolin ◽  
Marianne E. Pavel ◽  
Eric Baudin ◽  
...  

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.


2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 157-157 ◽  
Author(s):  
James C. Yao ◽  
John D. Hainsworth ◽  
Edward M. Wolin ◽  
Marianne E. Pavel ◽  
Eric Baudin ◽  
...  

157 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. Randomization 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 randomization 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), 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 a stepwise regression using Cox proportional hazards model. Results: Randomization resulted in significant imbalance in baseline CgA (median [ng/mL], 251 E+O vs 137 P+O). 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 for everolimus therapy.


Cancers ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 712
Author(s):  
Joohee Lee ◽  
Young Seok Cho ◽  
Jhingook Kim ◽  
Young Mog Shim ◽  
Kyung-Han Lee ◽  
...  

Background: Imaging tumor FDG avidity could complement prognostic implication in thymic epithelial tumors. We thus investigated the prognostic value of volume-based 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET)/CT parameters in thymic epithelial tumors with other clinical prognostic factors. Methods: This is a retrospective study that included 83 patients who were diagnosed with thymic epithelial tumors and underwent pretreatment 18F-FDG PET/CT. PET parameters, including maximum and average standardized uptake values (SUVmax, SUVavg), metabolic tumor volume (MTV), and total lesion glycolysis (TLG), were measured with a threshold of SUV 2.5. Univariate and multivariate analysis of PET parameters and clinicopathologic variables for time-to-progression was performed by using a Cox proportional hazard regression model. Results: There were 21 low-risk thymomas (25.3%), 27 high-risk thymomas (32.5%), and 35 thymic carcinomas (42.2%). Recurrence or disease progression occurred in 24 patients (28.9%). On univariate analysis, Masaoka stage (p < 0.001); histologic types (p = 0.009); treatment modality (p = 0.001); and SUVmax, SUVavg, MTV, and TLG (all p < 0.001) were significant prognostic factors. SUVavg (p < 0.001) and Masaoka stage (p = 0.001) were independent prognostic factors on multivariate analysis. Conclusion: SUVavg and Masaoka stage are independent prognostic factors in thymic epithelial tumors.


2021 ◽  
Vol 108 (Supplement_3) ◽  
Author(s):  
G Martínez Izquierdo ◽  
A R Arnaiz Pérez ◽  
E Escolano Fernández ◽  
M Merayo Álvarez ◽  
B Carrasco Aguilera ◽  
...  

Abstract INTRODUCTION Renal cell carcinoma (RCC) represents 3% of overall malignant neoplasms in adults. However, its aetiology has not been clearly established. Although surgery represents the cornerstone in treatment, recurrence postoperative rates are around 20-30%, what implies prognostic factors search must be mandatory in order to help to plan de follow-up and the different adjuvant therapy possibilities available in case they were necessary. MATERIAL AND METHODS A retrospective observational study was carried out in 110 patients who underwent radical nephrectomy between 2004 and 2018, with the aim of identifying possible prognostic factors of recurrence of RCC after these surgeries. Preoperative data (epidemiological, comorbidities and laboratory tests), surgical, pathological and variables related to follow-up were taken into account. A univariate and multivariate analysis were performed, using chi-square test and logistic regression, respectively. RESULTS The median follow-up time was 53.5 months (SD = 35.8), time in which 19 patients had a recurrence of RCC after radical nephrectomy (17.2%). Histopathological items such as the surgical piece size, the nodal and microvascular invasion, the renal sinus invasion and the presence of necrosis in the surgical piece were associated with RCC recurrence in the univariate analysis, while only the presence of necrosis in the surgical piece showed a significant result in the multivariate analysis (p = 0.004). CONCLUSIONS Histopathological analysis, highlighting the presence of necrosis in the histological sample, was proved to be the main risk factor of RCC recurrence.


2022 ◽  
Author(s):  
Bo-Wen Zheng ◽  
Bo-Yv Zheng ◽  
Hua-Qing Niu ◽  
Xiao-Bin Wang ◽  
Guo-Hua Lv ◽  
...  

Abstract Background The clinical characteristics and prognostic factors of axial chondroblastoma (ACB) are still poorly understood. Purpose To characterize clinicopathological characteristics in a large ACB cohort and investigate their correlation with survival. We also sought to compare these results with extra-axial CB (EACB). Methods Our institution's local database was retrospectively reviewed and included a total of 132 CB patients, including 61 ACB patients and 71 EACB patients. Immunohistochemistry was used to assess the expression levels of Vimentin (Vim), S100, and cytokeratin (CK) on tumor cells in 132 tissue specimens. Results Overall, ACB and EACB had similar characteristics, except for older age and tumor size, as well as higher Vim expression, incidence of surrounding tissue invasion and postoperative sensory or motor dysfunction. Whereas wide resection and absence of invasion of surrounding tissues were consistently associated with favorable survival in the ACB and EACB cohorts in univariate analysis, most parameters showed differential prognostic significance between the 2 groups. Significant prognostic factors for local recurrence-free survival in multivariate analysis included the type of resection and chicken-wire calcification in the ACB cohort. Multivariate analysis of overall survival demonstrated that the type of resection was a significant predictor in the ACB cohort, whereas the type of resection and postoperative sensory or motor dysfunction were predictive of overall survival in the EACB group. Conclusion These data suggest that there may be distinct biological behaviors between ACB and EACB and may provide useful information to better understand the prognostic characteristics of patients with ACB and to improve outcome prediction in patients with ACB.


2020 ◽  
Vol 33 (Supplement_1) ◽  
Author(s):  
J Liu ◽  
Y Wang

Abstract   The efficacy of neo-adjuvant chenmotherapy (NCT) and adjuvant chemotherapy (ACT) for squamous cell carcinoma (SCC) of the esophagus has not been fully expounded. This study analyzed the prognostic factors of patients who underwent esophagectomy for SCC of the thoracic esophagus, specially focused on NCT and ACT. Methods From January 2008 to January 2016, 1075 consecutive patients underwent esophgagectomy for stage T3-T4 SCC of the thoracic esophagus. Propensity-score matching (PSM) analyses were conducted in patients who underwent NCT, surgery alone (SA) and ACT. After PSM, there were 83 patients in NCT, 249 patients in SA and 249 patients in ACT group. Postoperative outcomes and prognostic factors of patients in the three groups were analyzed. Univariate analysis was performed using the Kaplan–Meier method and multivariate analysis using the Cox proportional hazard model. Differences were considered to be statistically significant when P &lt; 0.05. Results The incidence of main postoperative complications was 9.6% (8/83) in NCT group compared to 6.8% (34/498) in SA and ACT groups (P = 0.834). In NCT group, 20 patients (24.1%) were downstaged by NCT and 63 patients (75.9%) remained stable. The 3-year survival rate of the entire group was 51.0%, and the 5-year survival rate was 33.4%. The 5-year survival rate was 32.2% in NCT group, 50.9% in ACT, and 19.5% in SA patients. In univariate analysis, both NCT and ACT were associated with long-term survival. In multivariate analysis, however, ACT rather than NCT was independent prognostic factor. Conclusion This study supports the use of postoperative ACT for patients with stage T3 or T4 SCC of the thoracic esophagus, but the effect of NCT needs further study.


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