Use of inflammation-based scores to optimize the selection of patients with advanced cancer considered for early-phase clinical trials.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e13033-e13033
Author(s):  
David James Pinato ◽  
Chara Stavraka ◽  
Sean Micheal O'Cathail ◽  
Michael Seckl ◽  
Sarah Patricia Blagden
Keyword(s):  
Phase I ◽  
Cox Model ◽  
Performance Status ◽  
Univariate Analysis ◽  
Previous Treatment ◽  
Predictive Performance ◽  
Rank Test ◽  
Discriminative Ability ◽  
Selection Of Patients ◽  
Selection Of

e13033 Background: The presence of adequate organ function, favorable performance status (PS) and exhaustion of standard treatments are the main factors guiding accrual onto Phase I trials. As inflammation is inherent to the pathogenesis and prognosis of cancer we investigated the prognostic and predictive performance of inflammation based indices including the neutrophil (NLR) and platelet to lymphocyte ratio (PLR). Methods: Unselected referrals to the Phase I unit (2007-2011) were considered. Demographic, treatment, staging data and routine blood tests were collected. Patients were defined as high risk if NLR>5 or PLR>300 respectively. Changes in the NLR (ΔNLR) were recalculated at disease reassessment. Kaplan Meier and log rank test were used to assess Progression Free (PFS) and Overall Survival (OS) with each variable. Significant factors were further tested in a multivariate Cox model. C-index was used to calculate the discriminative ability of each score and ROC curves to predict 90 days survival (90DS). Results: We included 126 patients with median age 63 years (range: 22-80); median OS 4.4 months (0.2-39), 36% male; 92% with metastases, 23% PS>1. On univariate analysis LDH>450, PS, NLR≥5, hypoalbuminaemia, NLR normalization (ΔNLR) (p<0.001), >2 previous treatment lines (p=0.01) predicted for OS. After multivariate analysis low albumin, high LDH and ΔNLR remained independent predictors (p<0.05). Shorter PFS was predicted by elevated LDH and ΔNLR (p<0.05). PS and NLR ranked as most accurate predictors of both 90DS with area under the ROC curve values of 0.66 (0.55-0.77) and 0.64 (0.54-0.75) and OS with c-index scores of 0.69 (0.56-0.82) and 0.60 (0.50-0.70). When combined to PS, the NLR improved its accuracy to 0.72 (0.59-0.83). NLR≥5 at screening was associated with advanced PS, low albumin (p<0.002), LDH>450 and >2 metastatic sites (p<0.05). Conclusions: The NLR can improve the selection of patients considered for experimental therapies, with its normalization following treatment predicting for a survival benefit of 7 months in our series.

Prognostic factors for cancer patients with good performance status considered for inclusion in phase I clinical trials

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 2568-2568
Author(s):  
M. Bonneterre ◽  
N. Penel ◽  
M. Vanseymortier ◽  
E. Dansin ◽  
S. Clisant ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Prognostic Factors ◽  
Serum Albumin ◽  
Phase I ◽  
Cancer Patients ◽  
Cox Model ◽  
Performance Status ◽  
Univariate Analysis ◽  
Rank Test ◽  
Phase I Clinical Trials

2568 Background: For investigators, the selection of patients to be considered for phase I clinical trials is difficult, because of the lack of objective criteria for a rational decision-making process. From October 1997 to October 2002, we retrospectively assessed prognostic factors for cancer patients considered for Phase 1 trials. Methods: 148 consecutive patients who had been screened for inclusion in 6 different phase I trials were included in the present study. 70 out of them actually received the phase I treatment. Univariate (Log-Rank test) and multivariate analysis (Cox proportional hazard ratio model) were performed to determine the prognostic factors related to overall survival (OS) after screening. Results: The study comprised 63 men and 85 women, with a median age of 54 (range 23–79). The most frequent primary cancer sites were: breast (38 cases), head and neck (28 cases), lung (18 cases) and colorectal (17 cases). 91 out of them had a performance status PS = 0. The median OS of the 148 patients was 5.7 months (173 days, range 1–2,421). Univariate analysis identified PS = 1, Body Mass Index < 20, liver and visceral metastasis, serum albumin < 38 g/L, lymphocytes count < 0.7 x 109/L and granulocytes count > 7.5 x 109/L as poor prognostic factors. The Cox model identified serum albumin < 38 g/L (HR 2.51 [1.51–4.18], p=0.0001) and lymphocyte count < 0.7 x 109/L (HR 2.27 [1.13–4.62], p=0.024) as independent prognostic variables for OS. All patients presenting with both prognostic factors died within 90 days. Conclusion: We propose a simple model, easily obtained at the patient bedside, which can discriminate patients who have a life expectancy of over 3 months and thus could be enrolled in phase-I anti-cancer trials. No significant financial relationships to disclose.

Predictors of early mortality and validation of novel prognostic models in Asian patients on phase I trials (PIT): A single-center experience.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6618-6618
Author(s):  
Aziah Ahmad ◽  
Whee Sze Ong ◽  
Wan-Teck Lim ◽  
Wai Meng David Tai ◽  
Cindy Lim ◽  
...  
Keyword(s):  
Phase I ◽  
Cox Model ◽  
Prognostic Score ◽  
Univariate Analysis ◽  
Prognostic Models ◽  
Molecular Profile ◽  
Cancer Center ◽  
Cancer Type ◽  
Phase I Trials ◽  
Discriminative Ability

6618 Background: Despite the growing number of clinical trials conducted in Asia and the unique pt demographic and molecular profile of endemic cancers, there is still lacking of studies examining the outcomes of pts on PIT. We examined the characteristics and outcomes of pts enrolled in phase I trials in National Cancer Center Singapore (NCCS). Methods: We reviewed 296 pts enrolled in PIT from 2004-2012 to identify factors that predicted for 90-day mortality and OS. Logistic regression model and Cox proportional hazard model assessed factors associated with 90DM and OS, respectively. The discriminative ability of the RMH prognostic score (LDH, no of met sites, albumin) and the final multivariate Cox model derived in Asian pts was evaluated using Harrell’s concordance index (c-index), and that for the logistic model was based on area under ROC curve (AUC). Internal validation was performed based on simulated data via bootstrapping. Results: Median age 60 (23-85), M:F (65/35%). The commonest cancer type thoracic (56%), GI (24%), head and neck (12%). 57% pt had comorbidities, commonest diabetes (16.6%) and hepatitis B (11.1%). Median no of lines of treatment 2. 20% of pts had known mut status. 15% pts survived less than 90 days from start of trial. Median OS was 9.6 m (95CI 7.8-11.2 m). Based on the RMH prognostic model, pts with score of 0 to 1 had a superior OS (median OS = 12.9 m) compared to those with score of 2 to 3 (OS = 5.7 m) (p < 0.001). The c-index for the RMH prognostic score was 0.64. On univariate analysis, alb<35,LDH>ULN, ≥3 met sites, low BMI, ECOG>0, Na<135,plt>440, Hb<12 and ≥3 lines of chemo were negative prognostic factors. On multivariate analysis, reduced model selection techniques identified alb<35, LDH>ULN, ≥3 met sites, and ≥ 3 prior lines of chemo as independent negative predictors of OS with a bias-corrected of 0.69. For 90DM, we developed a risk normogram based on ECOG, WBC, Na and Hb as continuous predictors with bias-corrected AUC 0.78. Conclusions: We have developed a novel NCCS normogram to predict for 90DM for PIT. The RMH prognostic score can be improved upon with the addition of number of prior lines of chemotherapy, underscoring the importance of early access to phase I trials.

Expression of CD56 Is an Independent Prognostic Factor to Predict Relapse in Acute Myeloid Leukemia with t(8;21): Results of Japan Adult Leukemia Study Group (JALSG) AML97 Protocol.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2511-2511
Author(s):  
Noriyoshi Iriyama ◽  
Yoshihiro Hatta ◽  
Jin Takeuchi ◽  
Yoshiaki Ogawa ◽  
Shigeki Ohtake ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Conflicts Of Interest ◽  
Performance Status ◽  
Univariate Analysis ◽  
Rank Test ◽  
Hematopoietic Stem ◽  
Wbc Count ◽  
Adverse Factor ◽  
Acute Myeloid

Abstract Abstract 2511 Background: Although prognosis of acute myeloid leukemia (AML) with t(8;21) is better than other types of AML, outcome of the patients has not been satisfied. Previously, aberrant antigen expression has been reported as risk factor for AML with t(8;21). However, in the reported series, number of cases was not large enough and chemotherapy regimens were variable. We investigated the association of prognosis and several biomarkers including immunophenotype, WBC count, age, and performance status for large number of AML patients with t(8;21) uniformly treated in JALSG AML97 regimen. Patients and Methods: Seven hundred eighty-nine eligible AML patients were evaluated for the multicenter JALSG AML97 study. Adult patients with de novo AML except for APL, ages 15–64 years, were registered consecutively from 103 institutions that participated in JALSG from December 1997 to July 2001. One hundred forty-four patients with AML with t(8;21) were analyzed in this study with a median 1205 days of observation term from diagnosis. Complete remission (CR), relapse-free survival (RFS), and overall survival (OS) rates were analyzed by Fisher's exact test and log-rank test. Factors that would affect clinical outcome were analyzed by multivariate Cox proportional hazard regression model. Results: AML with t(8;21) frequently expressed CD19, CD34, and CD56 compared to other subtypes of AML. CD11b was rarely expressed. Expression of CD19 favorably affected on CR rate (96% in CD19 positive and 87% in negative patients, p<0.05). Univariate analysis showed WBC>20×109/L, CD19 negativity, and CD56 positivity were adverse factors for RFS. CD56 expression was the only independent adverse factor for RFS by multivariate analysis (73.7% in CD56 negative and 48.2% in CD56 positive patients at 3 yrs) although its expression did not affect on OS. There was no difference of age, sex, WBC count, presence or absence of Auer rod, performance status, or CD15 expression between CD56 positive and negative cases. Expression of CD19 was more common in CD56 negative patients (50% in CD56 negative and 30.6% in CD56 positive patients, p<0.05). Conclusions: We demonstrated that the expression of CD56 was a distinctive adverse factor in a large number of AML patients with t(8;21) treated with JALSG AML97 regimen. CD56 positive AML patients with t(8;21) are possible candidates for hematopoietic stem cell transplantation. Disclosures: No relevant conflicts of interest to declare.

Outcome of colon cancer patients with synchronous metastases

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 4029-4029
Author(s):  
I. Sobhani ◽  
F. Roudot-Thoraval ◽  
F. Mesli ◽  
B. Landi ◽  
T. Aparicio ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Cancer Patients ◽  
Cox Model ◽  
Univariate Analysis ◽  
Colon Surgery ◽  
Teaching Hospitals ◽  
Rank Test ◽  
Metastatic Colon Cancer ◽  
Curative Surgery ◽  
Synchronous Metastases

4029 Background: Metastatic colon cancer patients may undergo chemotherapy without colon surgery. However, the outcome of patients has not been evaluated and antiagiogenic agents can not be given. The aim of the present cohort study was to analyse factors influencing patients’ survival. Methods: Consecutive patients [N=228, mean age (sd) 64 (12) yrs, median follow-up 20 mths;84 females] treated in 6 teaching hospitals received chemotherapy for metastatic colonic cancer, either as the first step, or after surgery. Progressive free survival (PFS) was estimated using Kaplan-Meïer method. Factors associated with PFS were tested by means of Log rank test and results are presented in terms of medians of survival (95% CI). Factors independently related to PFS were tested using a Cox model and results are presented as hazard ratio. Results: 105 patients with colon cancer and synchronous metastatsis underwent colon surgery prior to chemotherapy (68 males, mean age 64 yrs) when 123 patients were treated first by chemotherapy ± biotherapy (76 males, mean age 63 yrs). By univariate analysis, following factors were significantly associated with PFS: surgery first 25.5 (18.6 - 32.5) vs chemotherapy first 18.3 (14.7 - 21.9) mths p = 0.006; curative surgery: yes 35.7 (29.6 - 41.8) vs no 18.4 (15.6 - 21.2) mths p < 0.001; tumour histological differentiation : no : 13.4 (6.2 - 20.6) vs well : 24.7 (20.4 - 29.1) mths p<0.001; synchronous metastases: liver only 25.5 (20.5 - 30.6) vs peritonea&nodes : 18.4 (10.6 - 26.1) vs pulmonary & other sites : 16.5 (14.7 - 18.3) mths p < 0.0001; need for colonic stent: yes 16.4 (9.3 - 23.5) vs no 23.9 (21.1 - 26.7) months p < 0.0001; antiangiogenic drug: yes 36.6 (28.7 - 44.5) vs no : 20.7 (18.3 - 23.1) p = 0.033. After Cox multivariate analysis five independent factors were found to be associated with PFS. Conclusions: Colon surgery before chemotherapy plus bevacizumab appears to be the more appropriate choice, and associated with longer PFS, especially for those patients with well differentiated tumours and synchronous liver metastases. [Table: see text] No significant financial relationships to disclose.

Factors influencing survival in inflammatory breast cancer.

2014 ◽  
Vol 32 (26_suppl) ◽  
pp. 136-136
Author(s):  
Julie A. Cupp ◽  
Diane Liu ◽  
Yu Shen ◽  
Naoto T. Ueno ◽  
Ricardo H. Alvarez ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Inflammatory Breast Cancer ◽  
Poor Prognosis ◽  
Cox Model ◽  
Univariate Analysis ◽  
Progression Free Survival ◽  
Rank Test ◽  
Rapid Progression ◽  
Progression Of Disease ◽  
Delay In Treatment

136 Background: Inflammatory breast cancer (IBC) is a rare and aggressive form of breast cancer associated with poor prognosis, characterized by rapidly growing mass, skin changes, and regional adenopathy. The objective of this study was to determine if delay in treatment influenced survival in IBC patients. Methods: A prospective IBC database identified 93 women with stage III IBC who received care at MD Anderson from 2007 - 2012 and were retrospectively reviewed. All patients received neoadjuvant chemotherapy followed by surgery, unless progression of disease was noted, and postmastectomy radiation. Impact of time from onset of symptoms to chemotherapy or to surgery on overall survival (OS) and progression free survival (PFS) were evaluated after adjusting for the baseline covariates in the Cox model. Results: A majority of patients were white (77.4%) with an average age of 54 years. Average days from onset of symptoms to first chemo is 95 (range 16 – 387) and to surgery is 283 (range 184 – 585). Four patients had progression while on chemo. There were 14 deaths with median follow up of 2.6 years from diagnosis. In univariate analysis, delay in treatment, > 90 days from onset of symptoms to chemo, did not affect OS or PFS. Obtaining negative margins was statistically significant for OS and PFS measured from first chemo (p=0.005 and p=0.007). Positive HER-2 status was associated with longer PFS time from chemo (p=0.02, log-rank test) and from surgery (p=0.009). Positive progesterone receptor (PR) was found to be statistically significantly associated with longer OS time from chemo (p=0.01) and from surgery (p=0.03). Clinical and imaging response to chemo were associated with better OS (p=0.007 and p=0.005) and pathologic response was marginally associated with improved OS and PFS (p=0.07 and p=0.06), both measured from surgery. In multivariate Cox model, adjusting for PR or HER2, days from onset of symptoms to chemo or surgery did not have significant impact on OS or PFS. Conclusions: While traditionally delay diagnosis and treatment is considered one of the factors associated with poor prognosis, our study suggests otherwise. However, due to such rapid progression of disease, early diagnosis is still important in the overall management of patients diagnosed with IBC.

Camrelizumab plus apatinib in patients with advanced cervical cancer: A multicenter, open-label, single-arm, phase II trial.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 6021-6021
Author(s):  
Chunyan Lan ◽  
Xin Huang ◽  
Jing-Xian Shen ◽  
Yin Wang ◽  
Ying Xiong ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Kinase Inhibitor ◽  
Performance Status ◽  
Objective Response ◽  
Previous Treatment ◽  
Rank Test ◽  
Advanced Cervical Cancer ◽  
Open Label ◽  
Ecog Performance Status ◽  
Grade 3

6021 Background: Camrelizumab is a fully humanized, monoclonal antibody against PD-1. We aimed to assess the efficacy and safety of camrelizumab plus apatinib, a tyrosine kinase inhibitor targeting VEGFR2, in patients with advanced cervical cancer. Methods: In this open-label, single-arm, phase 2 study done at four centres in China, eligible patients were aged 18–70 years, had an ECOG performance status of 0 or 1, progressed after at least one line of systemic chemotherapy for metastatic, recurrent or persistent cervical cancer, and had measurable disease. Patients received camrelizumab 200 mg every 2 weeks and apatinib 250 mg once daily. Treatment continued until disease progression, unacceptable toxicity, and withdrawal of consent. The primary endpoint was the objective response rate (ORR) assessed by RECIST version 1.1. An optimal Simon two-stage design was employed to test the null hypothesis of a 17% ORR versus 35% alternative (1-sided alpha 0.10, 80% power), if > 3 responses out of the first 16 patients were observed, then the study would continue to enroll a total of 44 patients. Results: Between Jan 21st, 2019, and Aug 1st, 2019, 45 patients were enrolled and received study treatment (safety population). The median age was 51 (range, 33–67) years. Median previous treatment lines were 2 (range, 1–4). As of Jan 22, 2020, median follow-up was 9.2 months (range, 2.4–12.2). 25 (59.5%; 95%: CI 44.7–74.4) of 42 patients who had at least one post-baseline tumor assessment (efficacy evaluable population) achieved an objective response, including two (4.8%) complete response, and 23 (54.8%) partial response. Median duration of response was not reached. The disease control rate was 88.1% (37/42). Median progression-free survival (PFS) was 7.6 months (95% CI: 5.8–not reached). 31 (68.9%) patients had grade ≥ 3 treatment-related adverse events (TRAEs). Grade ≥ 3 TRAEs occurring in ≥ 5% of patients were hypertension (24.4%), anemia (20.0%), fatigue (15.6%), γ-glutamyltransferase increased (13.3%), neutropenia (6.7%), and thrombocytopenia (6.7%). In post-hoc analyses, objective response was noted in 20 (69%) of 29 patients with PD-L1-positive tumors, and in 5 (50.0%) of 10 patients with PD-L1-negative tumors (Chi-square test, P = 0.281). PFS was longer in patients with PD-L1-positive tumors than patients with PD-L1-negative tumors (median PFS: 9.6 versus 5.3 months; log-rank test, P = 0.017). Conclusions: Camrelizumab plus apatinib showed promising antitumor activity and tolerable toxicities in patients with advanced cervical cancer. Clinical trial information: NCT03816553.

Identification of prognostic factors in patients with brain metastases: A review of 493 patients

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 11516-11516
Author(s):  
B. P. Baltalarli ◽  
D. Yalman ◽  
O. Akagündüz ◽  
Z. Ozsaran ◽  
Y. Anacak ◽  
...  
Keyword(s):  
Brain Metastases ◽  
Cox Regression ◽  
Univariate Analysis ◽  
Whole Brain Radiotherapy ◽  
Late Toxicity ◽  
Female Gender ◽  
University Hospital ◽  
Rank Test ◽  
Brain Radiotherapy ◽  
Selection Of

11516 Background: Choice of treatment for an individual patient with brain metastases is based on a number of factors: number and localization of brain metastases, systemic tumor activity, performance score, and age are major determinants for selection of treatment modality. Future trials in patients with brain metastases depend on selection of patients with favorable prognosis to allow adequate long-term follow-up to draw conclusions about survival and late toxicity, further stressing the importance of prognostic parameters. Our aim is to report the outcome of patients with brain metastases from solid tumors treated with whole brain radiotherapy (WBRT) in a single institution and identify the prognostic subgroups who will benefit from treatment. Methods: The records of 493 patients with brain metastases who had been admitted for WBRT in the Department of Radiation Oncology in Ege University Hospital between January 1997 and December 2002 was retrospectively evaluated. WBRT at this institution comprised of parallel opposed lateral fields, dosed to the midplane in a cobalt 60 teletherapy device. Radiotherapy fractionation were 10 fr. × 3 Gy, 5 fr × 4 Gy and 2 fr. × 8 Gy. Survival was calculated using the Kaplan-Meier method. Cox regression modeling was used for multivariate analysis and prognostical factors were determined on the basis of log rank test (SPSS 10.00 version). Results: Clinical response evaluation revealed that 254 patients (51%) had response to tretament whereas 104 patients (21.1%) had stable response and the other 43 patients (8.7%) had progressive disease.The median survival was 3 months (1–62 months) and 6 months survival was 41% and one year survival was 19%. Univariate analysis revealed that prognostical factors for survival were younger age (age <57) (p=0.043), female gender (p=0.019) and operation (p=0.0004), and for multivariant analysis female gender (p=0.027) and operation were determined (p=0.000). Conclusion: The prognosticators for survival in this retrospective analysis for patients with brain metastases are age, gender and operation. These factors affecting survival must be taken into consideration when the therapeutic management is to be made. And they may allow better selection of individual treatments. No significant financial relationships to disclose.

Effect of metastasis surgery on overall survival in patients (pts) with advanced soft tissue sarcoma (ASTS): A subanalysis of the PALSAR trials.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 10035-10035
Author(s):  
Nuria Kotecki ◽  
Binh Bui Nguyen ◽  
Jean-Yves Blay ◽  
Simone Mathoulin-Pelissier ◽  
Christine Chevreau ◽  
...  
Keyword(s):  
Overall Survival ◽  
Multivariate Analysis ◽  
Liver Metastasis ◽  
Cox Model ◽  
Performance Status ◽  
Univariate Analysis ◽  
High Dose ◽  
Line Treatment ◽  
Primary Location

10035 Background: The role of surgery in pts with ASTS remains controversial. We have conducted an exploratory retrospective analysis of the role of metastasis surgery in ASTS pts receiving 1st-line chemotherapy (CT). Methods: The database includes all pts enrolled in PALSAR-1 and PALSAR-2 trials [Fayette 2009; Bui-Nguyen 2011], treated with dose-intensified MAID or high-dose CT with peripheral blood stem cells support as 1st-line treatment of ASTS. In our analysis, the primary endpoint is overall survival (OS). Log-ranks are used for univariate analysis and Cox model for multivariate analysis. Impact of treatments had been evaluated after adjustment to confounders (Cox Model). Confounders were defined as parameters with significantly different distribution in pts who underwent metastasis surgery and those who did not (p<0.05) and significantly associated with OS (p<0.05). Results: The database consists of 410 pts (160 in PALSAR-1 and 248 in PALSAR-2) with a median age of 43. Among them, 77 patients (18%) underwent metastasis surgery. At the end of the treatment, 61 pts experienced complete response (CR), 45 with CT alone and 16 with metastasis surgery and CT. The median follow-up was 29 months. The median OS was 35.7 months (29.9-41.5). The following parameters are associated with longer OS in univariate analysis: primary location (p=0.0001), performance status (p=0.010) and absence of liver metastasis (p=0.001). We identified 4 factors associated with metastasis surgery (n=76): limb/trunk primaries, young age, absence of liver metastasis and absence of progression of the target lesions after 4 cycles. The sole identified confounder was primary location. In multivariate analysis the 2 categories of patients experiencing significant longer OS are those with CR without surgery (HR=2.2, [1.7-5.8], p=0.0001) and those with CR following metastasis surgery (HR=3.8, [2.3-6.2], p=0.0001). Conclusions: Among the pts with ASTS receiving poly-CT as 1st-line treatment, the OS of pts experiencing CR with or without metastasis surgery appears similar. Metastatis surgery without CR does not offer significant OS advantage.

Immunohistochemical (IHC) sub-classification of 105 triple negative breast cancers (TNBC).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e12577-e12577
Author(s):  
Marion Stacoffe ◽  
Armelle Vinceneux ◽  
Flavie Arbion ◽  
Helene Vegas ◽  
Gaelle Fromont ◽  
...  
Keyword(s):  
Survival Data ◽  
Triple Negative ◽  
Cox Model ◽  
Univariate Analysis ◽  
Disease Free Survival ◽  
Rank Test ◽  
Mixed Group ◽  
Triple Negative Phenotype ◽  
Negative Phenotype

e12577 Background: Molecular data have shown that TNBC was a heterogeneous group of tumors. The objective was to evaluate prognosis of IHC sub-classification adapted from molecular model. Methods: We used IHC sub-classification based on positivity for androgen receptor (AR) (Roche, SP 107), cytokeratine 5/6 (CK) (Dako, D5/16B4) and Epidermal growth factor receptor (EGFR) (Biosd, 31G7). Samples with more than 10% AR nuclear immunostaining were considered positive. Threshold for CK and EGFR was 1%. We distinguished 4 groups of tumors: AR phenotype (AR+, EGFR-, CK5/6-), basal-like phenotype (AR-, EGFR+/-, CK5/6 +/-), triple-negative phenotype (AR-, EGFR-, CK5/6-) and mixed group (AR+, EGFR+/-, CK5/6 +/-). Tissue micro-array blocks were constructed with samples from a retrospective cohort treated in adjuvant setting for non metastatic TNBC in a single institution from 2003 to 2013. Survival data were estimated by the Kaplan-Meier method and compared by the log-rank test in univariate analysis. Multivariate analysis including tumor size (T), lymph nodes status (N) and lymphovascular invasion (LVI) was performed using Cox model. Results: 105 patients were followed-up for a median period of 56.3 months [6-155]. Median age was 54 years [29-80]. 57.1% were stage pT1, 41.9% were pN+ and 37,1% presented LVI. 11 patients were classified as AR phenotype, 35 as basal-like, 46 as triple-negative phenotype and 13 as mixed group. 18 patients developed metastases: 3/11 AR, 5/35 basal-like, 6/46 triple-negative and 4/13 mixed group. No difference was observed between TNBC subgroups in terms of disease free survival DFS (p = .98) and overall survival OS (p = .86). T, N and LVI were the only prognostic factors (p = .05, p = .05 and p = .046 respectively). Conclusions: We found no impact of IHC sub-classification of TNBC. Correlation between IHC and molecular biology is in progress.

Clinicopathological characteristics and outcome of plasmablastic lymphoma patients: A single-center retrospective analysis.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e20034-e20034
Author(s):  
Anna P Dabrowska-Iwanicka ◽  
Joanna Romejko-Jarosinska ◽  
Lukasz Targonski ◽  
Martyna Kotarska ◽  
Monika Swierkowska ◽  
...  
Keyword(s):  
Subcutaneous Tissue ◽  
Performance Status ◽  
Univariate Analysis ◽  
Progression Free Survival ◽  
Clinicopathological Characteristics ◽  
Plasmablastic Lymphoma ◽  
Rank Test ◽  
Single Center ◽  
Ecog Performance Status ◽  
Reported Data

e20034 Background: Plasmablastic lymphoma (PBL) is a rare CD20-negative lymphoma with an aggressive clinical course and short median survival ranging from 9 to 32 months. It is often associated with HIV infection but it also affects immunocompetent patients. Due to the rare occurrence most data comes from small, retrospective series. Methods: This is a retrospective single-center analysis of PBL patients (pts) referred to MSCNRIO between 2003-2019. Diagnosis was established according to the WHO 2017 classification criteria. Kaplan–Meier method was used for calculating overall survival (OS) and progression-free-survival (PFS) and the log-rank test for comparisons. Univariate analysis of prognostic factors was carried out. Results: 24 pts with a diagnosis of PBL were included. The median age at diagnosis was 54 years (range 29-90). 15 pts (63%) were men. LDH was elevated in 10 pts (41%). Stage III or IV was reported in 21 (87.5%) pts, IPI score of 3-5 in 12 (50%) and ECOG performance status > 1 in 7 pts (29%). 20 pts (83.3%) had extranodal involvement, including oropharynx (n = 12), gastrointestinal tract (n = 1), bone marrow (n = 7), skeletal bone (n = 9), central nervous system (n = 3), skin and subcutaneous tissue (n = 2). Only 3 pts (13%) were infected by HIV, 2 had history of immunosuppressive therapy. Pathologically, all cases were negative for CD20 and positive for CD38 or CD138 expression. Ki67 > 90% was noted in 16 cases (66%). 11 pts received CHOP chemotherapy, 3 pts - thalidomide- and 4 pts - bortezomib-based regimens, 1 was treated with both agents. 4 pts received different protocols; 1 pt received no treatment. CR was observed in 8 pts (33%), PR in 6 (25%) and no response in 10 (42%). 2 pts received ASCT in the 1st remission. 17 pts (71%) experienced relapsed/progressive disease. 16 pts died: 11 from disease progression, 2 from other neoplasm. With a median follow-up of 20 months (range 2-122) median OS was 21 months and 2-year OS rate was 46% (95%C.I 27%, 65%). 2-year PFS rate was 37% (95% C.I. 17%, 57%), with median PFS 12 months (range 0.7-105). On univariate analysis there was a trend for correlation of high IPI with PFS; (95%C.I 0.99-1.03, P= 0.08). Achieving CR significantly correlated with better OS (HR 5; 95% C.I. 1.41-17; P= 0.01)) and PFS (HR 5.1, 95%C.I. 1.4, 18; P= 0.004). Conclusions: Our results confirm other reported data on PBL. Patients in our cohort shared typical clinical features but majority of them were immunocompetent. PBL prognosis remains poor despite incorporating novel agents into treatment and requires new therapeutic approaches.

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