Effect of adding immunotherapy (IT) to treatment regimen of mantle cell lymphoma (MCL): Analysis of the National Cancer Data Base (NCDB).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e19022-e19022
Author(s):  
Alaa Altahan ◽  
Eric Vick ◽  
Upama Giri ◽  
Eric Wiedower ◽  
Michael Gary Martin

e19022 Background: There has been some improvement in overall survival (OS) for patients with MCL over the past years [Gordon 2014]. However, side effects of treatment remain a major concern. With introduction of novel therapies like IT, it is imperative to optimize treatment regimens to improve survival while minimizing toxicity. Methods: MCL patients (pts) who were diagnosed in 2013 or later with information available about chemotherapy (CT) and IT and did not receive transplant were extracted from NCDB. Pts were assigned to age categories and were sorted into six groups based on different combinations of CT (none, single agent (SA), and multi-agent (MA)) with or without IT. Cox regression analysis was used to perform multivariate analysis that included age category, sex, race, clinical stage, Charlson/Deyo score, CT, radiation, and IT for each group. Multivariate p values (p) were used to analyze statistical significance. Kaplan Meier method was utilized to analyze OS. T-test was used to compare means (t-p). Results: 1438 total pts were identified with a mean age of 70 (range 24-90); 71% male; 93% white, 4% black, 3% others; 42% with stage III/IV disease. 667 pts did not receive CT or IT, and 40 received IT alone and both of these groups were excluded from further analysis. 52 pts received SA- (without) IT, 206 received SA+(with) IT and 260 pts received MA-IT and 213 MA+IT. Mean age was 72 and 66 for SA and MA groups, respectively (t-p<0.01). Mean OS for SA+IT was 27 months (m) vs SA-IT 16 m (p < 0.01). MA+IT v MA-IT showed no difference in mean OS (25 vs 26 m, respectively, p =0.49). Although there was a significant difference in OS between SA and MA groups without IT (16 vs 25 months, p < 0.01). SA + IT group showed comparable mean OS time to MA + IT (27 vs 26 m, p =0.145). Conclusions: For MCL pts, MA has superior OS to SA group. However, adding IT significantly improves OS for SA group and makes it comparable to MA. Adding IT to MA did not provide significant difference in OS. These results highlight the possibility of achieving same OS with less toxic regimens. Hence further evaluation in a prospective study to optimize treatment while reducing toxicity is warranted.

2021 ◽  
pp. 152660282199672
Author(s):  
Giovanni Tinelli ◽  
Marie Bonnet ◽  
Adrien Hertault ◽  
Simona Sica ◽  
Gian Luca Di Tanna ◽  
...  

Purpose: Evaluate the impact of hybrid operating room (HOR) guidance on the long-term clinical outcomes following fenestrated and branched endovascular repair (F-BEVAR) for complex aortic aneurysms. Materials and Methods: Prospectively collected registry data were retrospectively analyzed to compare the procedural, short- and long-term outcomes of consecutive F-BEVAR performed from January 2010 to December 2014 under standard mobile C-arm versus hybrid room guidance in a high-volume aortic center. Results: A total of 262 consecutive patients, including 133 patients treated with a mobile C-arm equipped operating room and 129 with a HOR guidance, were enrolled in this study. Patient radiation exposure and contrast media volume were significantly reduced in the HOR group. Short-term clinical outcomes were improved despite higher case complexity in the HOR group, with no statistical significance. At a median follow-up of 63.3 months (Q1 33.4, Q3 75.9) in the C-arm group, and 44.9 months (Q1 25.1, Q3 53.5, p=0.53) in the HOR group, there was no statistically significant difference in terms of target vessel occlusion and limb occlusion. When the endograft involved 3 or more fenestrations and/or branches (complex F-BEVAR), graft instability (36% vs 25%, p=0.035), reintervention on target vessels (20% vs 11%, p=0.019) and total reintervention rates (24% vs 15%, p=0.032) were significantly reduced in the HOR group. The multivariable Cox regression analysis did not show statistically significant differences for long-term death and aortic-related death between the 2 groups. Conclusion: Our study suggests that better long-term clinical outcomes could be observed when performing complex F-BEVAR in the latest generation HOR.


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 587-587 ◽  
Author(s):  
Z. Nahleh ◽  
R. Srikantiah ◽  
R. Komrokji ◽  
M. Safa ◽  
J. Pancoast ◽  
...  

587 Background: The incidence of MBC continues to rise. Few studies have addressed the differences between MBC and female breast cancer (FBC). Treatment for MBC has ben extrapolated from FBC regimens. The VA cancer registry (VACCR) provides a unique source to study MBC. This retrospective analysis aims at comparing the characteristics and outcome of MBC and FBC in the VA population. Methods: We reviewed the VACCR database between 1995 and 2005, for 120 VA medical centers. Primary breast cancer site codes were identified (500–508). Data was entered and analyzed using bio-statistical software SPSS. Results: A total of 3025 patients :612 MBC and 2413 FBC were compared. Mean age at diagnosis was 67 for MBC and 57 for FBC (p <0.005). More MBC patients were black. MBC patients presented with a significantly higher stage of disease, more node positive(N+) and larger tumor size. In MBC, ductal histology was more common while lobular and ductal carcinoma in situ were less common than in FBC. ER + and PR + tumors were significantly more common in MBC (60% vs 52% and 53% vs 47%, P< 0.005). MBC patients received less chemotherapy while no statistical difference in hormonal treatment was observed. The median overall survival (OS) was lower for MBC (7 years vs 9.8 years, p<0.005). OS was not significantly different for stage III and IV while OS was inferior for MBC in stage I (7 yr vs not reached, p 0.005) and stage II (6 vs 8.6yr, p 0.001). In N- tumors, OS was inferior in MBC (6.1 vs 14.6 yr, p<0.005) but not statistically different for N+ tumors . In ER + and PR + tumors, OS was inferior in MBC (7yr vs 8yr and 7.3 yr vs 9.8 yr p<0.005); however, no statistical significance was observed in ER - or PR - tumors. Using Cox regression analysis age, sex, clinical stage, nodal status were statistically independent prognostic factors while race, histology and grade were not. Conclusion: This study suggests differences in the biology, pathology, presentation, and survival between male and female VA breast cancer patients. Survival of MBC patients appears inferior in early stage disease and N- tumors suggesting gender differences in the tumor pathogenesis and biology. In hormone receptor + MBC, survival was also inferior despite similar hormonal treatment practices. This observational study calls for different approach and treatment strategies in MBC. No significant financial relationships to disclose.


2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 378-378
Author(s):  
Jonathan J. Paly ◽  
Phillip John Gray ◽  
Chun Chieh Lin ◽  
Helmneh Sineshaw ◽  
Ahmedin Jemal ◽  
...  

378 Background: Testicular seminoma is the most common solid tumor seen in patients aged 15-35 and disease specific survival approaches 100% in controlled studies, even for those with node-positive disease. We sought to describe modern practice patterns as well as survival outcomes and factors associated with receipt of adjuvant therapy for patients presenting with initial clinical stage (CS) IIA/B disease. Methods: Data on patients diagnosed with CS IIA/B testicular seminoma from 1998-2011 were extracted from the National Cancer Data Base. Demographic, clinical, treatment, payer characteristics were evaluated using multivariate logistic regression to identify factors associated with receipt of chemotherapy or adjuvant radiation therapy (ART) within 6 months of orchiectomy. Five-year Kaplan-Meier overall survival (OS) by CS and treatment was calculated. Results: In total, 2,185 patients with CS II A/B were included. Management included orchiectomy alone (11.35%), adjuvant chemotherapy (27.46%), or ART (52.72%). In multivariate analysis, receipt of orchiectomy plus ART rather than adjuvant chemotherapy was more likely with CS IIA status (OR 2.4, p < 0.01), treatment outside of teaching or NCI network institution (OR 1.9-2.8, p < 0.02), or tumor size ≥4cm (OR 1.6, p < 0.01). Receipt of ART was less likely in Hispanic patients (OR 0.6, p=0.03) or in those diagnosed from 2006-2011 (OR 0.5, p < 0.01). Five-year OS for all patients was 97.2% for orchiectomy + ART, and 93.9% for orchiectomy + chemotherapy (log-rank p = 0.01). For CS IIA patients, 5-year OS was 98.3% for orchiectomy + ART versus 93.6% for orchiectomy + chemotherapy (log-rank p < 0.01). Differences in OS for CS IIB treated with chemotherapy or ART were not statistically significant. Conclusions: Consistent with national guideline recommendations, our analysis suggest that compared to chemotherapy, ART is associated with a survival advantage for CS IIA patients. Chemotherapy or ART showed no significant difference in effectiveness in patients with CS IIB. Disease bulk, race, treatment center type, and time period are associated with choice of adjuvant therapy. Longer follow-up and validation of these results is needed to account for late effects of treatment.


2017 ◽  
Vol 27 (6) ◽  
pp. 1171-1177 ◽  
Author(s):  
Andrew T. Wong ◽  
Yi-Chun Lee ◽  
David Schwartz ◽  
Anna Lee ◽  
Meng Shao ◽  
...  

ObjectiveClinical outcomes for patients with uterine carcinosarcoma are poor after surgical management alone. Adjuvant therapies including chemotherapy (CT) and/or radiation therapy (RT) have been previously investigated, but the optimal management of this disease remains controversial. The purposes of this study were to analyze the patterns of use of adjuvant CT and RT and to assess the impact on survival of each of these treatment regimens using the National Cancer Data Base.Methods/MaterialsThe National Cancer Data Base was queried for patients given a diagnosis of uterine carcinosarcoma confined to the pelvis who underwent total hysterectomy/bilateral salpingo-oophorectomy between 2004 and 2011. Patients were excluded if they survived less than 4 months after diagnosis. Data regarding CT and RT use were collected. Overall survival (OS) was analyzed using the Kaplan-Meier method. Multivariable Cox regression analysis was performed to evaluate the effect of covariates on OS.ResultsA total of 4906 patients were included in this study. Median age was 67 years (interquartile range, 60–75 years). Median follow-up was 28.9 months (interquartile range, 15.4–52.9 months). There were 1777 patients (36.2%) who received no adjuvant treatment, 971 (19.8%) who received CT alone, 1060 (21.6%) who received RT alone, and 1098 (22.4%) who received both RT and CT. The 5-year OS for patients receiving no adjuvant therapy, adjuvant RT alone, adjuvant CT alone, and combined CT and RT were 44.9%, 47.1%, 47.5%, and 62.9%, respectively. On pairwise analysis, combined CT and RT was associated with improved survival compared with all other subgroups (P < 0.001). On multivariable Cox regression analysis, combined CT and RT (hazard ratio, 0.50; 95% confidence interval, 0.44–0.57; P < 0.001) and CT alone (hazard ratio, 0.78; 95% confidence interval, 0.69–0.88; P < 0.001) were significantly associated with improved OS, whereas RT alone was not.ConclusionsCombination therapy with CT and RT was associated with significantly improved 5-year OS compared with no further therapy, RT alone, or CT alone.


Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 4703-4703
Author(s):  
Stefano Sacchi ◽  
Samantha Pozzi ◽  
Luigi Marcheselli ◽  
Alessia Bari ◽  
Stefano Luminari ◽  
...  

Abstract Some data suggest that there are been no improvement in survival of FL Pts in the last three decades of the 20th century. However that review ended in 1992, before the introduction of R treatment. Most recently reported data, show that evolving chemotherapies, including the incorporation of R has led to outcome improvement. Between 1994 and 2004, 344 Pts with FL were enrolled in different GISL Trials. For the purpose of this study we considered 270 Pts with similar characteristics enrolled in trials including or not R. The first group accounts for 176 naive Pts treated with Antracycline plus Fludarabine containing regimens (Cohort #1: 125 Pts) or plus R (Cohort #2: 51Pts). The second group accounts for 99 relapsed Pts treated with Antracycline plus Fludarabine containing regimens (Cohort #3: 40 Pts) or plus R (Cohort #4: 59 Pts). To evaluate the impact of the incorporation of R in front line and salvage therapies we assessed the patients OS, FFS, TTF, SAR in these different Cohorts of Pts. Descriptive analysis of prognostic features showed differences in the distribution among groups. To compensate for these variations we also performed Cox regression analysis. Previously Untreated patients. Regarding group #1 and #2 that enrolled Pts with clinical stage IIB, III and IV, FFS and OS according to treatment did not show any statistical differences. The univariate analysis of baseline clinical features showed an impact on OS and FFS for clinical stage, LDH level, involvement of more than 4 nodal sites and presence of extranodal involvement. The prevalence of this characteristics were higher in group #2 than group #1. Thus the FFS from group #2 vs. group #1 was adjusted for variation in prognostic features by Cox regression analysis, that shows a failure Hazard Radio reduction (HR) of 40 % in Pts who received R. Because of difference in follow up (FU) (49 months in Cohort #1 vs 21 months in Cohort #2), to evaluate differences in OS we utilized exact Log Rank test for unequal FU. So far, a trend exists for better OS in R treated patients, although the difference is not statistically significant. Relapsed Patients. Clinical characteristics were similar in the two Cohorts of pts. TTF was better in R treated Pts and the difference was statistically significant (66% vs. 53% at 3 yrs, p=0.023) The analysis of SAR demonstrated a better result for R Cohort with a statistically significant difference (88% vs. 68% at 3 yrs, p=0.022). OS according to treatment protocol, showed advantage for patients in R Cohort and the difference was statistically significant (92% vs. 70% at 5 yrs, p=0.004). Conclusion. In naïve patients our retrospective analysis showed a reduction of HR for FFS and a trend toward better OS in R treated Pts. In relapsed Pts all outcome parameters as OS, TTF and SAR had significant improvement in the Cohort treated with R. Although any conclusions between nonrandomized groups maybe subject to differences in observed and unobserved prognostic features, we believe that improvement have occurred in the management of FL Pts with the introduction of combined chemotherapy with R.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 9088-9088
Author(s):  
Thomas A. Hensing ◽  
Xiaofei F. Wang ◽  
Junheng Gao ◽  
Tom Stinchcombe ◽  
Michael V. Knopp ◽  
...  

9088 Background: KEYNOTE-024 established single-agent P as a 1st-line option for pts with metastatic NSCLC without targetable alterations and PD-L1 tumor proportion score (TPS) ≥ 50%. KEYNOTE-189 and 407 established concurrent C + P as a treatment option irrespective of PD-L1 expression. In this randomized phase II selection trial, we explored sequencing of C and P in this pt. population. Methods: Eligible pts were randomized 1:1 to (arm A) C (carboplatin (AUC 6) + pemetrexed 500 mg/m2 (non-squamous) or paclitaxel 200 mg/m2 (squamous)) x 4 cycles followed by P 200 mg x 4 cycles, or the reverse sequence (arm B) of P x 4 cycles followed by C x 4 cycles. After 8 cycles, pts on both arms were eligible to receive maintenance P for up to 24 months. Primary endpoint was objective response rate (ORR) per RECIST 1.1 by independent review. Secondary endpoints included progression free survival (PFS) per RECIST 1.1 and overall survival (OS). Efficacy endpoints were also evaluated by PD-L1 expression. Results: 89 pts (47 arm B & 42 arm A) were enrolled and are included in the analysis (PD-L1 TPS 0/1-49%/≥50% = 24 pts (34%)/25 pts (36%)/21 pts (30%)). There was no significant difference in ORR (36% vs 38%, p = 0.829), median PFS (2.7 vs 5.5 months (mo), HR 1.25, 95% CI 0.77-2.02, p = 0.363) or OS (13.1 vs 19.8 mo, HR 1.25, 95% CI 0.69-2.25, p = 0.4573), arm B (Px4→C) vs arm A (Cx4→P). Multivariable Cox regression analysis demonstrated significant interaction between treatment and PD-L1 TPS ( < 50% vs ≥ 50%) for PFS (HR 6.76, 95% CI 2.14-21.35, p = 0.0011) and a trend for OS (HR 5.02, 95% CI 0.92-27.55, p = 0.0632), arm B vs arm A. Incidence of grade ≥3 adverse events was 71% for arm A and 65% for arm B. No new safety signals were observed. Conclusions: In pts with stage IV NSCLC and PD-L1 TPS ≥ 50% there was an observed improvement in PFS and OS in favor of C followed by P vs P x 4 followed by C. Given small # of pts and trial design, this observation should be considered hypothesis-generating, but supports further exploration of sequential C + P in this setting. Support:Merck Sharp & Dohme Corp.; https://acknowledgments.alliancefound.org Clinical trial information: NCT02591615.


2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 79-79
Author(s):  
Basem Azab ◽  
Francisco Igor Macedo ◽  
Omar Picado ◽  
Caroline Ripat ◽  
Dido Franceschi ◽  
...  

79 Background: There are conflicting reports on the value of the extent of post neoadjuvant chemoradiation (NCRT) lymphadenectomy (LND) in locally advanced esophageal adenocarcinoma (E-ADC) and squamous cell carcinoma (E-SCC). We sought to study the impact of LND variables [positive and total lymph node (LN) number and LN ratio (LNR)] on oncological outcomes in these patients. Methods: The National Cancer Data Base 2004-2014 was queried for patients with NCRT followed by esophagectomy. The median examined LN number was used to divide the patients into a higher (> 12) and lower (≤ 12) LND groups. The primary outcome was overall survival (OS) and secondary outcomes were 30- and 90-day postoperative mortality. Results: A total 4708 patients were included. The median of positive, negative LN, and LNR were and (0, 11, 0%). The median and 5-year OS for higher LND group were higher than the lower LND group (39 vs. 32 months, 38% vs. 34%), p < 0.0001. OS was not significantly different among E-SCC subset or among those who achieved pathological complete response (pCR). The higher LND group had better 30- and 90-day postoperative mortality rates (61/2335 = 2.6%, 141/2308 = 6.1%) than lower LND group (86/2262 = 3.8%, 184/2251 = 8.2%), p = 0.01 and 0.001, respectively . In multivariate Cox regression analysis, higher LND group (HR 0.88, 95% CI 0.81-0.96, p = 0.004) and LNR (per 10% increase: 1.11, 95% CI 1.09-1.13, p < 0.0001) were significant predictor of OS. Conclusions: The LND (> 12 examined LN) remains as a crucial treatment goal after NCRT with potential survival benefit, especially among E-ADC and those did not achieve pCR.


Author(s):  
Till Joscha Demal ◽  
Lennart Bax ◽  
Jens Brickwedel ◽  
Tilo Kölbel ◽  
Eik Vettorazzi ◽  
...  

Abstract OBJECTIVES The goal of this study was to determine the outcome of patients undergoing an elective frozen elephant trunk (FET) procedure as a redo operation following previous cardiac surgery. METHODS One hundred and eighteen consecutive patients underwent FET procedures between October 2010 and October 2019 at our centre. Patients were registered in a dedicated database and analysed retrospectively. Clinical and follow-up characteristics were compared between patients undergoing a FET operation as a primary (primary group) or a redo procedure (redo group) using logistic regression and Cox regression analysis. Emergency procedures (n = 33) were excluded from the analysis. RESULTS A total of 36.5% (n = 31) of the FET procedures were redo operations (redo group) and 63.5% (n = 54) of the patients underwent primary surgery (primary group). There was no significant difference in the 30-day mortality [primary group: 7.4%; redo group: 3.2%; 95% confidence interval (CI) (0.19–35.29); P = 0.63] and the 3-year mortality [primary group: 22.2%; redo group: 16.7%; 95% CI (0.23–3.23); P = 0.72] between redo and primary cases. Furthermore, the adjusted statistical analysis did not reveal significant differences between the groups in the occurrence of transient or permanent neurological deficit, paraplegia, acute renal failure and resternotomy. The redo group showed a higher rate of recurrent nerve palsy, which did not reach statistical significance [primary group: 3.7% (n = 2); redo group: 19.4% (n = 6); P = 0.091]. CONCLUSIONS Elective FET procedures as redo operations performed by a dedicated aortic team following previous cardiac surgery demonstrate an adequate safety profile.


MedPharmRes ◽  
2018 ◽  
Vol 2 (2) ◽  
pp. 5-20
Author(s):  
Vu Ho ◽  
Toan Pham ◽  
Tuong Ho ◽  
Lan Vuong

IVF carries a considerable physical, emotional and financial burden. Therefore, it would be useful to be able to predict the likelihood of success for each couple. The aim of this retrospective cohort study was to develop a prediction model to estimate the probability of a live birth at 12 months after one completed IVF cycle (all fresh and frozen embryo transfers from the same oocyte retrieval). We analyzed data collected from 2600 women undergoing in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) at a single center in Vietnam between April 2014 and December 2015. All patients received gonadotropin-releasing hormone (GnRH) antagonist stimulation, followed by fresh and/or frozen embryo transfer (FET) on Day 3. Using Cox regression analysis, five predictive factors were identified: female age, total dose of recombinant follicle stimulating hormone used, type of trigger, fresh or FET during the first transfer, and number of subsequent FET after the first transfer. The area under the receiver operating characteristics curve for the final model was 0.63 (95% confidence interval [CI] 0.60‒0.65) and 0.60 (95% CI 0.57‒0.63) for the validation cohort. There was no significant difference between the predicted and observed probabilities of live birth (Hosmer-Lemeshow test, p > 0.05). The model developed had similar discrimination to existing models and could be implemented in clinical practice.


Author(s):  
Philip J. Johnson ◽  
Sofi Dhanaraj ◽  
Sarah Berhane ◽  
Laura Bonnett ◽  
Yuk Ting Ma

Abstract Background The neutrophil–lymphocyte ratio (NLR), a presumed measure of the balance between neutrophil-associated pro-tumour inflammation and lymphocyte-dependent antitumour immune function, has been suggested as a prognostic factor for several cancers, including hepatocellular carcinoma (HCC). Methods In this study, a prospectively accrued cohort of 781 patients (493 HCC and 288 chronic liver disease (CLD) without HCC) were followed-up for more than 6 years. NLR levels between HCC and CLD patients were compared, and the effect of baseline NLR on overall survival amongst HCC patients was assessed via multivariable Cox regression analysis. Results On entry into the study (‘baseline’), there was no clinically significant difference in the NLR values between CLD and HCC patients. Amongst HCC patients, NLR levels closest to last visit/death were significantly higher compared to baseline. Multivariable Cox regression analysis showed that NLR was an independent prognostic factor, even after adjustment for the HCC stage. Conclusion NLR is a significant independent factor influencing survival in HCC patients, hence offering an additional dimension in prognostic models.


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