Predictors of radiologic progression free survival (rPFS) during abiraterone acetate (AA) treatment in a randomized phase II study of AA maintenance in combination with docetaxel (D) after disease progression to AA in metastatic castration resistant prostate cancer (mCRPC): ABIDO-SOGUG trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e16536-e16536
Author(s):  
Daniel Castellano ◽  
María José Méndez-Vidal ◽  
Javier Puente ◽  
M Isabel Sáez ◽  
Albert Font Pous ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Lymph Node ◽  
Disease Progression ◽  
Phase Ii ◽  
Cox Regression ◽  
Univariate Analysis ◽  
Castration Resistant Prostate Cancer ◽  
First Line ◽  
Randomized Phase Ii ◽  
Node Involvement

e16536 Background: AA improves OS and rPFS in asymptomatic/minimally symptomatic mCRPC patients. D is currently one of the standard treatments after progression to AA. However, the value of maintaining AA along with D despite progression to AA has not been tested. ABIDO trial aims to evaluate efficacy and safety of AA + D maintenance after disease progression to first line AA in mCRPC. Clinicopathologic features associated with rPFS during first line AA are presented. Methods: ABIDO trial is a randomized, phase II, open-label study with two stages. In stage I pts receive AA (1000 mg + prednisone (P) 10 mg qd) until progressive disease. In the stage II pts will be randomized to receive three-weekly D 75 mg/m2plus P 10 mg/d with (arm A) or without (arm B) AA 1000 mg/d. Pts had no visceral metastases, ECOG PS 0-1, and adequate organ functions. Clinicopathological predictors for rPFS to first line AA were estimated using the Kaplan-Meier method and independent associations were evaluated using Cox regression models. Results: 143 pts were included. Analyzed variables were: median age was 70y, 60% of pts had ECOG 0, 84% bone metastases (18% > 4), 42% BPI score 2-3, 53% Gleason > = 8, 30% PSA > 80 ng/mL, 38% node involvement and 11% had at least one lymph node > = 3 cm; 53% of pts achieved 4 weeks PSA reduction > 50%.Median rPFS was 18 months. Univariate analysis identified as significant variables: PSA, BPI, Gleason, node involvement, 4 weeks PSA reduction > 50%, and total volume of lymph node metastasis. On multivariate analysis, BPI (0-1 vs 2-3) (hazard ratio [HR] 1.81; p = 0.039), Gleason ( < 8 vs > = 8) (HR 2.51; p = 0.005), node involvement (no nodes, nodes < 3 cm and at least 1 node > = 3 cm (HR 2.8; p = 0.001 and 3.57; p = 0.009) and PSA reduction > 50% (HR 3.06; p < 0.001) were independently associated with rPFS. Median rPFS was superior in pts with 3 or more good prognostic factors (14m vs not reached; p < 0.001). Conclusions: BPI, Gleason, node involvement and 4-week PSA response were identified as independent prognostic factors for rPFS in first line AA treated patients. Clinical trial information: NCT02036060.

No relationship is indicated between FHIT expression and clinicopathologic prognostic parameters in early stage cervical carcinoma

2003 ◽  
Vol 13 (2) ◽  
pp. 192-196
Author(s):  
C. Baykal ◽  
A. Ayhan ◽  
A. Al ◽  
K. YÜCE ◽  
A. Ayhan
Keyword(s):  
Overall Survival ◽  
Prognostic Factors ◽  
Lymph Node ◽  
Cox Regression ◽  
Disease Free Survival ◽  
Lymph Node Involvement ◽  
Depth Of Invasion ◽  
Prognostic Parameters ◽  
Node Involvement ◽  
Disease Free

In this study we investigated FHIT (Fragile Histidine Triad) protein alterations in cervical carcinomas to assess the relation of this gene with cervical cancer. Eighty-eight patients with surgically treated FIGO (International Federation of Gynecology and Obstetrics) stage IB carcinomas of the cervix were included in this study. Clinicopathologic prognostic factors were compared with FHIT expression status. Disease-free and overall survival was evaluated according to prognostic factors and FHIT expression. The FHIT gene was found to be depressed in 53% (47/88) of the tumors. None of the clinicopathologic prognostic parameters showed a correlation with FHIT expression. Univariate survival analysis with the Kaplan-Meier method showed that only the age of the patient is significantly correlated with disease-free survival. Interestingly, when the same analysis was done for 5-year overall survival; diameter of the primary tumor, depth of invasion, occurrence of lymph node involvement, and number of metastatic lymph nodes were found to be statistically significant. Furthermore, multivariate analysis with Cox regression revealed that lymph node involvement was the only independent variable for 5-year overall survival. In the present study there was no statistical correlation between FHIT expression and clinicopathologic prognostic factors or survival figures of the patients. These findings may be explained with the carcinogenic role of FHIT in tumoral progression but not in the tumoral development that takes place after the carcinogenetic period.

Impact of surgery and chemotherapy on survival in patients with advanced cholangiocarcinoma: A multivariate analysis in a cohort of 242 consecutive patients

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4133-4133
Author(s):  
C. Dreyer ◽  
C. Le Tourneau ◽  
S. Faivre ◽  
V. Paradis ◽  
Q. Zhan ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Prognostic Factors ◽  
Lymph Node ◽  
Median Survival ◽  
Tumor Size ◽  
Positive Impact ◽  
Univariate Analysis ◽  
Lymph Node Involvement ◽  
Node Involvement ◽  
The Impact

4133 Background: Cholangiocarcinoma remains an orphan disease for which prospective studies are missing to evaluate the impact of systemic chemotherapy on survival. Methods: Univariate and multivariate analysis of parameters that might impact survival were analyzed in a cohort of 242 consecutive patients with cholangiocarcinoma treated in a single institution between 2000 and 2004. Variables were WHO performance status (PS), age, symptoms, tumor size, extent of the disease, lymph node involvement, site of metastasis, tumor markers, pathology, and type of treatment including surgery, chemotherapy and radiotherapy. Results: Statistically significant prognostic factors of survival in univariate analysis are displayed in the table : In multivariate analysis, PS, tumor size and surgery were independent prognostic factors. Subgroup analysis demonstrated that in patients with advanced diseases (lymph node involvement, peritoneal carcinomatosis and/or distant metastasis), patients who had no surgery benefited of chemotherapy (median survival 13.1 versus 7.4 months in patients with/without chemotherapy, p = 0.006). Moreover, survival was further improved when patients could benefit of chemotherapy following total and/or partial resection (median survival 22.9 versus 13.0 months in patients with/without chemotherapy, p = 0.03). Conclusions: This study strongly suggests the positive impact on survival of multimodality approaches including surgery and chemotherapy in patients with advanced cholangiocarcinoma. [Table: see text] No significant financial relationships to disclose.

Analysis of prognostic factors in advanced pancreatic cancer (APDAC) patients (pts) undergoing to first-line nab-paclitaxel (Nab-P) and gemcitabine (G) treatment.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 412-412 ◽  
Author(s):  
Guido Giordano ◽  
Vanja Vaccaro ◽  
Eleonora Lucchini ◽  
Paola Bertocchi ◽  
Francesca Bergamo ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Primary Tumor ◽  
Cox Regression ◽  
Univariate Analysis ◽  
Advanced Pancreatic Cancer ◽  
Prognostic Impact ◽  
First Line ◽  
Primary Tumor Site ◽  
Clinical Records ◽  
Ecog Ps

412 Background: Nab-P + G combination represents an optimal first line therapeutic option in APDAC. Actually we have no parameters to predict prognosis in pts receiving this regimen. Here we present data of a multicentre retrospective analysis evaluating prognostic impact of clinical or biological factors in a cohort of APDAC pts treated with Nab-P + G first line CT. Methods: Clinical records of 118 APDAC pts receiving first line Nab-P + G were retrospectively reviewed. Overall survival (OS) and progression free survival (PFS) were evaluated with Kaplan Meier method with 95% CI and curves were compared with log-rank test. Cox-regression model was applied to the data with univariate and multivariate approach. Variables included in analysis were age, gender, ECOG PS, primary tumor site, liver metastases, multiple metastatic sites, baseline CA19-9, bilirubin levels, neutrophil/lymphocyte ratio (NLR), CA19-9 decrease > 50%, biliary stent and symptomatic disease. Results: Median age was 66 (37 - 83), M/F:65/53, ECOG PS 0/1/2: 51/46/21 respectively. 4 complete and 27 partial responses were observed with 26% response rate (RR). Median OS and PFS were 11 months (95% CI 9.58 – 12.41) and 7 months ( 95% CI 5.96 – 8.03) respectively. When considered at univariate analysis primary tumor location to the head, ECOG PS of 2, bilirubin levels higher than median and NLR ≥ 5 had a bad prognostic impact both on PFS and OS. Differently, CA19-9 decrease > 50% was considered a positive prognostic factor for PFS and OS. Multivariate analysis confirmed the negative role of NLR ≥ 5 respect of PFS (HR 3.21; 95%CI 1.61 – 5.68, p = 0.002) and OS (HR 3.38; 95%CI 1.88 – 5.79, p = 0.001) and positive impact of CA19-9 decrease > 50% on PFS (HR 0.37; 95% CI 0.11 – 0.68, p=0.006) and OS (HR 0.53; 95% CI 0.15 – 0.97, p=0.005), as independent prognostic factors. Conclusions: This analysis suggest that in APDAC pts receiving first line Nab-P + G, high NLR value (≥5) could be considered an easy detectable, independent parameter to predict poor outcomes in terms of PFS and OS. Furthermore CA19-9 reduction > 50% from baseline may be, in absence of other clinical and molecular parameters, an early marker of good prognosis.

scholarly journals Efficacy of Apatinib Combined with FOLFIRI in the First-Line Treatment of Patients with Metastatic Colorectal Cancer

2021 ◽  
Author(s):  
Xuetong Rong ◽  
Haiyi Liu ◽  
Hongmei Yu ◽  
Jian Zhao ◽  
Jie Wang ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Prognostic Factors ◽  
Metastatic Colorectal Cancer ◽  
Cox Regression ◽  
Univariate Analysis ◽  
Line Treatment ◽  
Efficacy And Safety ◽  
First Line ◽  
Kaplan Meier ◽  
First Line Treatment

Abstract Objective: To evaluate the efficacy and safety of apatinib combined with FOLFIRI in the first-line treatment of advanced metastatic colorectal cancer (mCRC) and explore potential factors of efficacy. Methods: Twenty mCRC patients treated at Affiliated Cancer Hospital of Shanxi Medical University from March 2017 to March 2019 were included according to the enrolment criteria. They provided informed consent and were treated with apatinib combined with FOLFIRI according to the scheduled regimen until disease progression or unacceptable toxicity occurred. The primary endpoint was OS. The secondary endpoints included PFS, ORR, DCRand safety. OS and PFS were calculated using Kaplan-Meier curves. Univariate and multivariate Cox regression analyses were used to evaluate independent prognostic factors of OS and PFS. R was used to determine cut-off values for biochemical indicators. Forest maps were drawn for Cox univariate results and the relationships between NLR and ECOG, which were significant in univariate analysis, and OS were represented by Kaplan-Meier curves. Results: The median OS and PFS were 16.135 months (95% CI: 9.211–22.929) and 6 months (95% CI: 5.425–6.525). Multivariate Cox analysis showed that NLR and CEA were independent prognostic factors. The most common grade 3–4 adverse events were hypertension, diarrhoea, increased alkaline phosphatase, decreased leukocytes and decreased neutrophils. Conclusion: Apatinib combined with FOLFIRI for the first-line treatment of advanced unresectable mCRC showed good efficacy and safety. The baseline NLR was predictive of efficacy, and a low baseline NLR (HR: 0.2895, P=0.0084) was associated with improved OS.

Risk factors predicting colorectal cancer recurrence in a Latin American population.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e15180-e15180
Author(s):  
Jorge Leon ◽  
Fernando Namuche ◽  
Paola Catherine Montenegro ◽  
Claudio J. Flores
Keyword(s):  
Colorectal Cancer ◽  
Lymph Node ◽  
Latin American ◽  
Tumor Size ◽  
Cox Regression ◽  
Univariate Analysis ◽  
Lymph Node Involvement ◽  
Stage I ◽  
Rank Test ◽  
Node Involvement

e15180 Background: The incidence of colorectal cancer (CRC) in Peru has increased in the last decades. In our population more than 80% of patients are stage I-III. Recurrence is one of the most important factors to consider in the survival of CRC patients. The aim of this study was to identify which factors influence in the recurrence of CRC in our population. Methods: We retrospectively reviewed the electronic medical records of 506 patients with stage I-III CRC from one specialized Peruvian cancer center between 2006 and 2016. Survival analysis (with recurrence as the event to evaluate) was performed with Kaplan Meier curves and Long-rank test. We use a preliminary univariate analysis to do the multivariate analysis with Cox regression. We performed a ROC curve analysis to determine an appropriate cut-off value for the tumor size (≥4.2). Results: In the univariate analysis we found that sidedness, tumor size (cut-off ≥4.2), CEA, lymph node involvement, stage, histological grade, LVI, PNI, and chemotherapy were statistically significant. In the multivariate model, tumor size [HR, 1.462; 95% CI, 1.065-2.217; p<0.05], lymph node involvement [HR, 0.136; 95% CI,0.41-0.447; p<0.001], and stage III [HR, 0.003; 95% CI, 0.263-0.758; p<0.05] retained a significant association and were independent factors with relapse disease. Conclusions: In stage I-III CRC pts it is important to evaluate tumor size, lymph node involvement and clinical stage as they are possible prognostic factors that will help our diagnosis and treatment along with other standard features.

A multicentric phase II randomized trial of docetaxel (D) plus enzalutamide (E) versus docetaxel (D) as first-line chemotherapy for patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): CHEIRON study.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 148-148 ◽  
Author(s):  
Orazio Caffo ◽  
Erica Palesandro ◽  
Franco Nole ◽  
Donatello Gasparro ◽  
Claudia Mucciarini ◽  
...  
Keyword(s):  
Disease Control ◽  
Randomized Trial ◽  
Disease Progression ◽  
Phase Ii ◽  
Objective Response ◽  
Castration Resistant Prostate Cancer ◽  
First Line ◽  
Eligibility Criteria ◽  
Visceral Metastases ◽  
Grade 3

148 Background: D and E demonstrated to be efficacious in the treatment of mCRPC pts. Due to different antitumor mechanism of action of these agents, it could be postulated that their combination can improve disease control. CHEIRON study tried to demonstrate the candidate efficacy of chemo-hormonal combination D+E versus D in mCRPC first-line. Methods: Eligibility criteria included untreated mCRPC diagnosis, ECOG PS ≤ 2, adequate renal, hepatic and hematological functions. Pts were randomized to receive D 75 mg/m2 IV d1 q3w plus prednisone 5 mg PO BID for 8 courses alone or plus E 160 mg PO daily for 24 weeks. Stratification criteria were presence of pain and visceral metastases. The primary endpoint of the study was the rate of pts without disease progression (according to PCWG2) at 6 mos after randomization. Results: Between 09/2014 and 10/2017, 246 pts (median age 70 years, range 44-88, pain reported by 54 pts, visceral metastases present in 50 pts) were randomized to DE (120) or D (126). The rate of pts without disease progression at 6 mos was significantly higher in DE arm compared to D arm [87.3% (CI95% 64-80) vs 72.6% (CI95% 80-92); p = 0.006). Similarly, a higher proportion of DE pts achieved a PSA reduction ≥ 50% compared to the baseline values compared to the D pts [92.2%(CI95% 61-77) vs 70.0%(CI95% 86-96); p < 0.0001). No differences were observed in terms of objective response rate. Major haematological toxicities consisted of grade 3-4 anemia (3 pts DE – 1 pt D) and grade 3-4 neutropenia (23 pts DE – 19 pts D); febrile neutropenia was observed in 10 DE pts and in 5 D pts. At a median follow-up of 20 mos, the median progression free survival was 11.3 mos (CI95% 10.0-12.7) and 9.1 mos (CI95% 8.9-9.2) in DE and D arm, respectively (p = 0.004). In D arm the median overall survival was 30.5 mos (CI95% 24.1-36.8) compared to 28.7 mos (CI95% 20.7-36.6) of the experimental arm (p NS). Conclusions: From the present study, the first phase II randomized trial testing the addition of a new generation hormone agent to D, DE improved the 6-mo disease control with a prolongation of PFS compared to the standard chemotherapy. Clinical trial information: NCT02453009.

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