Panitumumab (Pmab) versus cetuximab (Cmab)/irinotecan (Iri) therapy among patients with KRAS wild-type (wt) metastatic colorectal cancer (MCRC).

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 640-640 ◽  
Author(s):  
Hagen F. Kennecke ◽  
Leo Chen ◽  
C. D. Blanke ◽  
Winson Y. Cheung ◽  
Kimberly Schaff ◽  
...  
Keyword(s):  
Overall Survival ◽  
Performance Status ◽  
Similar Proportion ◽  
Wild Type ◽  
Prognostic Variables ◽  
Ecog Performance Status ◽  
Cancer Centers ◽  
Kaplan Meier ◽  
Previously Treated ◽  
Baseline Characteristics

640 Background: In British Columbia, use of anti-EGFR therapy for KRAS wt MCRC is limited to patients (pts) previously treated with both irinotecan and oxaliplatin. Physicians may choose either Pmab monotherapy or Cmab/Iri combination therapy. We sought to compare the characteristics and outcomes of all pts treated with Pmab/Cmab referred to 5 provincial cancer centers since July, 2009. Methods: Eligible patients received at least one dose of either Pmab (6mg/kg q2w) or Cetuximab (500mg/m2 q2w) plus Iri (180mg/m2 q2w). Baseline characteristics and systemic therapy were prospectively collected, while ECOG and metastatectomy status were retrospectively collected. Kaplan-Meier survival analysis was conducted from the first day of Pmab/Cmab. Results: Among 178 eligible pts, Pmab was chosen 3 times more often than Cmab/Iri (see table). Pts treated with Cmab/Iri were significantly younger and had better performance status than those treated with Pmab. There were no statistically significant differences in other prognostic variables, and a similar proportion received chemotherapy after Pmab vs. Cmab/Iri. Overall survival was slightly longer among patients receiving Cmab/Iri (8.3 mo), vs. Pmab (7.7 mo) (p=.03). Conclusions: Pmab was chosen more often than Cmab/Iri for similarly eligible patients. Cmab/Iri pts were younger, were more likely to have ECOG performance status 0/1 and achieved a modestly longer overall survival. Either regimen appears to be suitable for previously treated pts with KRAS wt MCRC. [Table: see text]

Treatment and overall survival among anti-PD-1-exposed advanced melanoma patients with evidence of disease progression

Immunotherapy ◽  
2021 ◽  
Author(s):  
Cathy A Pinto ◽  
Xinyue Liu ◽  
Xiaoyun Li ◽  
Emilie Scherrer ◽  
Mizuho Kalabis
Keyword(s):  
Overall Survival ◽  
Performance Status ◽  
Treatment Strategies ◽  
Advanced Melanoma ◽  
Ecog Performance Status ◽  
Health Records ◽  
Mek Inhibitors ◽  
Kaplan Meier ◽  
Best Response ◽  
Melanoma Patients

Background: Little is known regarding treatment patterns and overall survival (OS) for patients with advanced melanoma who progress after anti-PD-1 exposure. Methods: The Kaplan–Meier method was used to evaluate OS from electronic health records for patients with advanced melanoma who progressed on anti-PD-1 therapy and received subsequent therapy. Descriptive statistics were used to summarize treatment. Results: A total of 304 patients who progressed after anti-PD-1 therapy received subsequent therapy: 50% immunotherapy, 36% BRAF and/or MEK inhibitors, 14% other therapies. Median OS was 7.2 months (95% CI: 6.4–8.8), with an association (p < 0.01) with best response to baseline anti-PD-1 therapy and further associations with Eastern Co-operative Oncology Group (ECOG) performance status ≤1 (p < 0.001 compared with ECOG ≥2), normal LDH (p < 0.001 compared with elevated levels) and treatment with BRAF and/or MEK inhibitors (p = 0.02 compared with other treatment). There was an association (p < 0.01) of survival with best response to baseline anti-PD-1 therapy. Conclusions: OS for advanced melanoma patients who progress on anti-PD-1 therapy is suboptimal, which highlights the need for further research to develop new medications and optimize treatment strategies.

scholarly journals Survival after Hematopoietic Stem Cell Transplantation in an Older, Fit Cohort of Patients with Advanced Myelodysplastic Syndromes: The MDS-TAO Study

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 972-972
Author(s):  
Gregory A. Abel ◽  
Haesook T. Kim ◽  
David P. Steensma ◽  
Richard M. Stone ◽  
Angel M. Cronin ◽  
...  
Keyword(s):  
Board Of Directors ◽  
Research Funding ◽  
Performance Status ◽  
Time Dependent ◽  
Ecog Performance Status ◽  
Advisory Committees ◽  
Hematopoietic Stem ◽  
Kaplan Meier ◽  
Baseline Characteristics

Abstract Background: The utility of reduced-intensity conditioning hematopoietic stem cell transplantation (RIC HSCT) for fit elderly patients with advanced myelodysplastic syndromes (MDS) is unclear. Methods: The MDS Transplant-Associated Outcomes Study, or "MDS-TAO," was a prospective longitudinal observational study at the Dana-Farber/Harvard Cancer Center designed to examine survival, quality of life, and other outcomes for RIC HSCT versus non-HSCT approaches for HSCT-eligible patients with advanced MDS ages 60 to 75. All patients who met eligibility criteria were approached in the leukemia or HSCT clinics; 96% agreed to enroll. Inclusion criteria included histologically-confirmed diagnosis of MDS or CMML, and (1) therapy-related disease or (2) Int-2/high IPSS (Greenberg, Blood, 1997), or (3) non-IPSS poor-risk cytogenetics (Haase, Blood, 2007), or (4) severe cytopenia/platelet or red cell transfusion-dependence. Exclusions were (1) comorbidities that in the judgment of the treating physician precluded HSCT eligibility (2) prior donor search and (3) patient unwillingness to consider HSCT. Considering time to transplant as a time-dependent variable, hazard ratio for ultimate HSCT was estimated using Cox regression analysis controlling for age, gender, ECOG performance status, IPSS, IPSS cytogenetic risk group, and year of consent. Landmark analyses at 5 months were conducted to present estimates of overall survival for patients who were alive for at least 5 months and received HSCT versus patients who did not (landmark cohort). Subgroup analyses (e.g., molecular characteristics) are also ongoing. Results: 290 patients were enrolled between May 2011 and May 2018; 24 had less than 1.5 months of follow up after consent and were excluded from this analysis. Of the remaining 266 patients, 143 were deceased at last follow up. Baseline characteristics are presented in the table. The median follow-up time among survivors was 31 months (range 1.9, 84). 102 patients received HSCT, of whom 45 subsequently died; of the 164 patients who have not undergone HSCT, 98 have died. The median time to HSCT among those transplanted (n=102) was 4.6 months. The median follow-up for patients alive and not yet transplanted (n=66) was 24 months (range 1.9, 82). Considering time to HSCT as a time-dependent variable (n=266), the hazard ratio for death in multivariable analysis was 0.63 (95% CI 0.42-0.96, p=0.03). Poor risk IPSS cytogenetic group was the only other factor associated with mortality, HR=1.86 (95% CI 1.15-3.00, p=0.006); age, gender, ECOG performance status, IPSS, and consent year were not. Five months was chosen for the landmark analysis given it was closest to the median time to HSCT. In the landmark cohort (N=229), HSCT patients were more likely to have Int-2/high IPSS at baseline (65% vs 35% for none, p=0.0003). No other baseline characteristics were different. Figure A shows Kaplan-Meier plots for the landmark cohort, comparing 54 who received HSCT ≤ 5 months versus 175 patients who did not receive a transplant within 5 months (log rank p=0.04). Figure B shows Kaplan-Meier plots for HSCT comparing 99 patients who received HSCT at any time during follow-up versus 130 patients who did not (log rank p=0.005). Conclusion: In this large cohort of fit elderly patients with advanced MDS, a treatment strategy that included HSCT was associated with better overall survival. Table Table. Disclosures Ho: Jazz Pharmaceuticals: Consultancy. DeAngelo:Incyte: Consultancy, Honoraria; Glycomimetics: Research Funding; Amgen: Consultancy; ARIAD: Consultancy, Research Funding; Blueprint Medicines: Honoraria, Research Funding; Amgen: Consultancy; Shire: Honoraria; Takeda: Honoraria; BMS: Consultancy; Blueprint Medicines: Honoraria, Research Funding; Incyte: Consultancy, Honoraria; Glycomimetics: Research Funding; ARIAD: Consultancy, Research Funding; Pfizer Inc: Consultancy, Honoraria; Novartis Pharmaceuticals Corporation: Consultancy, Honoraria; BMS: Consultancy. Antin:Jazz Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees. Soiffer:Jazz Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees.

Randomized clinical trials and real life studies: Comparison of baseline characteristics of patients in oral target therapies for renal cell carcinoma

2021 ◽  
pp. 107815522110055
Author(s):  
Ruggero Lasala ◽  
Fiorenzo Santoleri ◽  
Alessia Romagnoli ◽  
Felice Musicco ◽  
Paolo Abrate ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Randomized Clinical Trials ◽  
Performance Status ◽  
Relevant Literature ◽  
Real Life ◽  
Ecog Performance Status ◽  
Target Therapies ◽  
Baseline Characteristics

Introduction Pivotal Randomized Controlled Trials (RCTs) constitute scientific evidence in support of therapeutic choices when a drug is authorized in the market. In RCTs, patients are selected in a rigorous manner, in order to avoid bias that may influence efficacy assessments. Therefore, patients who take the drug in Real Life Studies (RLSs) are not the same as those participating in RCTs, which, in turn, leads to low data transferability from RCTs to RLS. The objective of this study was to evaluate the differences between RCTs and RLS, in terms of patient baseline characteristics. Materials and Methods Our study includes all oral target therapies for RCC (Renal Cell Carcinoma) marketed in Europe before March 31, 2019. For each treatment, we considered both RCTs and RLSs, the former gathered from Summary of Product Characteristics published on the European Medicine Agency (EMA) website, and the latter yielded by our search in relevant literature. For each drug considered, we then compared the baseline characteristics of patients included in the RCT samples with those of the samples included in the RLSs using the Chi-squared and Mann-Whitney tests. Results We considered six medicines, for a total of 9 pivotal RCTs and 31 RLSs. RCTs reported the same type of patient baseline characteristics, whereas RLSs are more varied in reporting. Some patient baseline characteristics (metastases, previous treatments, etc.) were significantly different between RCTs and RLs. Other characteristics, such as ECOG Performance Status, brain metastases, and comorbidities, liver and kidney failure, are comprised in exclusion criteria of RCTs, though are included in RLS. Discussion and Conclusion: While evaluating equal treatments for the same indications, RCTs and RLSs do not always assess patients with the same characteristics. It would be necessary to produce evidence from RLSs so as to have an idea of treatment effectiveness in patients groups that are not eligible or underrepresented in RCTs.

Initial experience of TAS-102 chemotherapy in Australian patients with chemorefractory metastatic colorectal cancer.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 71-71
Author(s):  
Azim Jalali ◽  
Hui-Li Wong ◽  
Rachel Wong ◽  
Margaret Lee ◽  
Lucy Gately ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Febrile Neutropenia ◽  
Metastatic Colorectal Cancer ◽  
Real World ◽  
Performance Status ◽  
Progression Free Survival ◽  
Median Number ◽  
Ecog Performance Status ◽  
Number Of Patients

71 Background: For patients with refractory metastatic colorectal cancer (mCRC) treatment with Trifluridine/Tipiracil, also known as TAS-102, improves overall survival. In Australia, TAS-102 was initially made available locally through patients self-funding, later via an industry sponsored Medicine Access Program (MAP) and then via the Pharmaceutical Benefits Scheme (PBS). This study aims to investigate the efficacy and safety of TAS-102 in real world Australian population. Methods: A retrospective analysis of prospectively collected data from the Treatment of Recurrent and Advanced Colorectal Cancer (TRACC) registry was undertaken. The characteristics and outcomes of patients receiving TAS-102 were assessed and compared to all TRACC patients and those enrolled in the registration study (RECOURSE). Results: Across 13 sites, 107 patients were treated with TAS-102 (non-PBS n = 27, PBS n = 80), The median number of patients per site was 7 (range: 1-17). The median age was 60 years (range: 31-83), compared to 67 for all TRACC patients and 63 for RECOURSE. Comparing registry TAS-102 and RECOURSE patients, 75% vs 100% were ECOG performance status 0-1, 74% vs 79% had initiated treatment more than 18 months from diagnosis of metastatic disease and 39% vs 49% were RAS wild type. Median time on treatment was 10.4 weeks (range: 1.7-32). Median clinician assessed progression-free survival was 3.3 compared to RECIST defined PFS of 2 months in RECOURSE study, while median overall survival was the same at 7.1 months. Two patients (2.3%) had febrile neutropenia and there were no treatment-related deaths in the real-world series, where TAS102 dose at treatment initiation was at clinician discretion. In the RECOURSE study there was a 4% febrile neutropenia rate and one treatment-related death. Conclusions: TRACC registry patients treated with TAS102 were younger than both TRACC patients overall and those from the RECOURSE trial. Less strict application of RECIST criteria and less frequent imaging may have contributed to an apparently longer PFS. However overall survival outcomes achieved with TAS102 in real world patients were comparable to findings from this pivotal trial with an acceptable rate of major adverse events.

Impact of ECOG performance status on recurrent/metastatic head and neck squamous cell carcinomas treated with anti-PD1 inhibitors.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18004-e18004
Author(s):  
Cameron Chalker ◽  
Vicky Wu ◽  
Jenna M. Voutsinas ◽  
Victoria Hwang ◽  
Christina S Baik ◽  
...  
Keyword(s):  
Overall Survival ◽  
Clinical Outcomes ◽  
Squamous Cell ◽  
Smoking Status ◽  
Demographic Data ◽  
Performance Status ◽  
Univariate Analysis ◽  
Single Agent ◽  
Ecog Performance Status ◽  
Hpv Status

e18004 Background: Anti-PD1 checkpoint inhibitors (ICI) represent an established standard of care for patients with recurrent/metastatic head & neck squamous cell carcinoma (RMHNSCC). Landmark studies excluded patients with ECOG performance status (PS) ≥ 2; the benefit of ICI in this population is therefore unknown. Methods: We retrospectively reviewed RMHNSCC patients who received at least 1 dose of ICI at our institution. Demographic data and clinical outcomes were obtained; the latter included objective response to ICI (ORR), physician-documented CTCAE grade 2+ toxicity (irAE), and any unplanned hospitalization within 100-days of last ICI dose (UH). Associations between demographic data and clinical outcomes were explored using both uni- and multivariate analysis. Overall survival (OS) was estimated using a Cox proportional hazards model; ORR, irAE, and UH were evaluated with logistic regression. This project was approved by our institutional IRB. Results: We identified 152 RMHNSCC patients who were treated with ICI between 1/2013 and 1/2019. ECOG PS was 0 in 42 (27%), 1 in 75 (50%), 2 in 27 (18%), 3 in 2 (1%), and unknown in 6 (4%) patients. The median age was 61 (range: 25 - 90). 124 (82%) were male, 124 (82%) were white, and 69 (45%) were never-smokers. The most common primary sites were the oropharynx (n = 59, 40%), oral cavity (n = 39, 26%), nasopharynx (n = 11, 7%), and larynx (n = 10, 6%). 54 (36%) were p16+ oropharynx cancers. CPS score was available in 10 (6.6%). Single agent ICI was received by 118 (77%) patients. 66 (44%) had a documented irAE and 54 (36%) had an UH. A multivariate model for OS containing PS, smoking status and HPV status showed a strong association between inferior OS and ECOG 2/3 compared to 0/1 (p < 0.001; HR = 3.30, CI = 2.01-5.41), as well as former (vs. never) smoking status (p < 0.001; HR = 2.17, CI = 1.41-3.35). Current smoking (p = 0.25) did not reach statistical significance. On univariate analysis, poor PS was associated with inferior ORR (p = 0.03; OR = 0.25, CI = 0.06-0.77) and increased UH (p = 0.04; OR = 2.43, CI = 1.05—5.71). There was no significant association between irAE and any patient characteristic. Conclusions: We observed inferior overall survival among ICI-treated RMHNSCC patients with ECOG 2/3 in our single-institution, retrospective series. Our findings help frame discussion of therapeutic options in this poor-risk population. Further study must be done to determine which interventions are of greatest benefit for RMHNSCC patients with declining performance status.

Activity of Yttrium 90 (90Y) Ibritumomab Tiuxetan (Zevalin®) in 22 Patients with Relapsed and Refractory Mantle Cell Lymphoma (MCL).

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 2452-2452 ◽  
Author(s):  
Anas Younes ◽  
Barbara Pro ◽  
Maria A. Rodriguez ◽  
Jorge E. Romaguera ◽  
Peter McLaughlin ◽  
...  
Keyword(s):  
Cell Lymphoma ◽  
Performance Status ◽  
B Cell Lymphoma ◽  
Cns Lymphoma ◽  
Ibritumomab Tiuxetan ◽  
Ecog Performance Status ◽  
Bulky Disease ◽  
Platelet Counts ◽  
Previously Treated ◽  
Yttrium 90

Abstract Background: The management of MCL is a significant therapeutic challenge, especially in patients with relapsed or refractory disease, who are generally refractory to salvage chemotherapy. Although recent studies have shown the clinical utility of radioimmunotherapy (RIT) in relapsed and transformed indolent B-cell lymphoma, the clinical efficacy of this treatment modality in patients with MCL is unknown. We report the results of an ongoing phase II clinical trial of yttrium 90 ibritumomab tiuxetan (Zevalin®) in patients with relapsed and refractory MCL. Patients and Methods: Patients with relapsed or refractory MCL with measurable disease, age ≥18 years, and performance status &lt;3 were eligible. Patients were required to have adequate function of the bone marrow (ANC ≥1,500/mm3, platelets ≥100,000/mm3), liver, and kidneys. Patients were excluded if they had prior stem cell transplantation, RIT, CNS lymphoma, HIV infection, pleural effusion, HAMA reactivity, or circulating lymphoma cell count &gt;5000/mm3. Patients with pretreatment platelet counts ≥150,000/mm3 received a dose of Zevalin at 0.4 mCi 90Y/kg (maximum dose 32 mCi), whereas those with platelet counts &lt;150,000/mm3 received 0.3 mCi 90Y/kg. Results: Twenty-two patients were enrolled and all qualified for evaluation of treatment response and toxicity. The median age was 67 years (range 51–77), and 18 patients were male. All patients had an ECOG performance status of 0 or 1 and had been previously treated with rituximab with or without other chemotherapy. The median number of prior regimens was 3 (range 1–6). Fourteen patients were previously treated with Hyper-CVAD alternating with MTX/Ara-C, 21 previously received rituximab, and 5 previously received bortezomib. Zevalin treatment was generally well tolerated, with the most common toxicities being hematologic. Objective responses were observed in 8 of 22 patients (36%), including 3 CR and 2 CRu. Seven of the eight responding patients were previously treated with 3 or less treatment regimens, and all responding patients did not have bulky disease, with the largest lesion measuring 3 cm or less. Median time to progression for CR/CRu patients was 6 months. Conclusion: The observed responses to Zevalin in heavily pretreated patients with MCL are promising, but the duration of responses has been short. Furtherinvestigation is warranted after first or second relapse, and in conjunction with front-line therapy.

Melphalan 200mg/m2 (MEL 200) and MEL 140/DT-PACE Are Equally Effective in Multiple Myeloma (MM), While the Latter Is Less Toxic.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 839-839 ◽  
Author(s):  
Guido Tricot ◽  
Maureen Reiner ◽  
Maurizio Zangari ◽  
Frits van Rhee ◽  
Bart Barlogie
Keyword(s):  
Febrile Neutropenia ◽  
Prior Therapy ◽  
Study Enrollment ◽  
Kaplan Meier ◽  
Rapid Responses ◽  
Preparative Regimen ◽  
Previously Treated ◽  
Baseline Characteristics ◽  
Grade 3 ◽  
Induction Cycle

Abstract MEL 200 is now generally accepted to represent the best preparative regimen for autotransplantation in MM patients. We have previously reported that DT-PACE is very effective in inducing rapid responses even in high risk myeloma (JCO 2003, 31: 73–80). The present study aimed at comparing outcome and toxicity of previously treated (≥ 2 cycles of prior therapy) MM patients, who were randomized to tandem transplants with either MEL 200 or MEL 140 plus full dose DT-PACE administered over two days (MEL/DT-PACE). The treatment in both arms consisted of one induction cycle with DT-PACE, followed by tandem transplants (randomized), one consolidation cycle with DT-PACE and 2 years of maintenance therapy with dexamethasone (20mg/d, days 1–4, every 3 weeks) plus thalidomide 100mg/day. 97 patients were enrolled; 93 collected sufficient stem cells for transplantation and were randomized to MEL 200 (N=48) or MEL140/DT-PACE (N=45). Event-free (EFS) and overall survival (OS) were analyzed using Kaplan-Meier plots. Graphs were compared with logrank statistics. Median age was 57 years. Prior to study enrollment β2M was ≥ 4mg/L in 28%; CRP ≥ 4 mg/L in 59%; LDH ≥ 250 U/L in 16%. 16% had &gt; 12 months preceding therapy and 27% showed abnormal metaphase cytogenetics. Baseline characteristics were similar in both groups, except for a trend of more patients with β2M ≥ 4mg/: in the MEL 200 arm (p=0.09). 100% of randomized patients proceeded to the first transplant and 82% to a second; 87% in the MEL/DT-PACE and 77% in the MEL 200 arm (p=0.23). The CR rates were identical (44% and 42%, respectively). EF/OS at 3 years were 51%/71% in the MEL/DT-PACE arm and 55%/79% in the MEL 200 arm (p=.89/.73) (Figure 1). Recovery of ANC &gt; 500μl plus platelets &gt; 20,000/μl untransfused, was comparable after the first (p=0.21) and second transplant (p=0.17). Grade 3–5 toxicity was lower in the MEL/DT-PACE arm in terms of mucositis (p=.006) and febrile neutropenia (p=.001). We conclude that both preparative regimens, MEL 200 and 140 with the addition of DT-PACE, appear equally effective in previously treated MM patients. However, the Mel 140 resulted in a significantly lower incidence of mucositis and febrile neutropenia and may thus be preferred in patients not in excellent clinical condition prio to transplantation. Figure Figure

Obesity Is Poor Prognostic Factor in Lower Risk Myelodysplastic Syndrome

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 5018-5018
Author(s):  
Asmita Mishra ◽  
Dana E Rollison ◽  
Najla H Al Ali ◽  
Maria Corrales-Yepez ◽  
Pearlie K Epling-Burnette ◽  
...  
Keyword(s):  
Overall Survival ◽  
Prognostic Factor ◽  
Myelodysplastic Syndrome ◽  
Lower Risk ◽  
Cox Regression ◽  
Cancer Center ◽  
Kaplan Meier ◽  
Baseline Characteristics ◽  
Md Anderson ◽  
The Impact

Abstract Abstract 5018 Background: Obesity was associated with a more than 2-fold greater risk of myelodysplastic syndrome (MDS) in a recent epidemiological study (Ma et al, Am J Epidemiol. 2009 June 15; 169(12): 1492–1499). The impact of obesity on outcome of disease in patients with an established diagnosis of MDS has not been studied. We examined the prognostic value of obesity in a large cohort of lower risk MDS patients treated at the Moffitt Cancer Center (MCC). Methods: Data were collected retrospectively from the Moffitt Cancer Center (MCC) MDS database and individual charts reviewed. The primary objective was to evaluate the impact of obesity on overall survival (OS) in lower risk patients with MDS. Patients with low or intermediate-1 (int-1) risk disease by International Prognostic Scoring System (IPSS) were included. Obesity was defined as a body mass index (BMI) ≥ 30 (Standard definition) measured at time of referral to MDS program at MCC. Patients were divided into two groups according to BMI ≥ 30 or BMI < 30. All analyses were conducted using SPSS version 19.0. Chi square and independent t-test were used to compare baseline characteristics between the 2 groups for categorical and continuous variables, respectively. The Kaplan–Meier method was used to estimate median overall survival. Log rank test was used to compare Kaplan–Meier survival estimates between two groups. Cox regression was used for multivariable analysis. Results: Between January 2001 and December 2009, 479 low/int-1 IPSS risk MDS patients were included. Among those, 132 (27.6%) had BMI ≥ 30 and 325 (67.8%) had BMI <30; BMI was missing in 22 patients (4.6%). The baseline characteristics between the two groups were comparable. No difference was noted in mean age, WHO subtype, karyotype, MD Anderson risk model group, red blood cell transfusion dependency (RBC-TD), or serum ferritin (Table-1). The median OS was 59 mo (95%CI 48–70) in patients with BMI <30 compared to 44 (95%CI 38–50) in patients with BMI ≥ 30. (p=0.03). There was no difference in rate of AML transformation according to BMI, 12.9% and 15.7% respectively for BMI ≥ 30 and BMI <30. (P=0.3). In Cox regression analysis obesity predicted inferior OS (Hazard ratio (HR) 1.7 (95%CI 1.15–2.4) (P=0.007) after adjustment for age, MD Anderson risk group, serum ferritin, RBC-TD, use of hypomethylating agents and tobacco use. Conclusion: Our data suggest that obesity is an independent adverse prognostic factor for OS in patients with lower risk MDS. Obesity may be associated with other comorbidities and metabolic dearrangements that contribute to the pathogenesis of the underlying disease. Disclosures: No relevant conflicts of interest to declare.

Primary Splenic Diffuse Large B-Cell Lymphoma (PS-DLBCL): Splenectomy Improves Survival

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 4439-4439 ◽  
Author(s):  
Osnat Bairey ◽  
Lev Shvidel ◽  
Chava Perry ◽  
Eldad J Dann ◽  
Rosa Ruchlemer ◽  
...  
Keyword(s):  
Overall Survival ◽  
Performance Status ◽  
B Cell Lymphoma ◽  
Stage I ◽  
Event Free Survival ◽  
Ecog Performance Status ◽  
Free Survival ◽  
Large B Cell Lymphoma ◽  
The Mean ◽  
Ecog Ps

Abstract Introduction: Although the spleen is involved in about a third of patients with non-Hodgkin's lymphoma (NHL), primary splenic diffuse large B-cell lymphoma (PS-DLBCL) is rare having a reported incidence of less than 1% of all NHL. Most of the described series include small numbers of patients before the rituximab era and the role of splenectomy treatment in addition to immuno-chemotherapy is unknown. Methods: Data were retrospectively collected for 87 patients (pts) with PS-DLBCL treated in 7 medical centers in Israel during the years 1982-2013. Patients presenting with systemic disease with splenic involvement or those having a diagnostic biopsy from other nodal or extranodal disease were excluded. Results: The mean age was 59.6 years (range, 24-89 years); 57.5% were male. Abdominal pain was reported in 61 pts (81%), B symptoms in 49 pts (59%), ECOG performance status 0 - 1 in 85%. Stage I disease was recorded in 28%, II in 33%, III in 18%, and IV in 21%. Thrombocytopenia (<100,000/µl) was recorded in only 6 pts. Lactic dehydrogenase levels (LDH) were elevated in 69 pts (84%). Favorable International Prognostic Index (IPI) 0-2 was recorded in 62 pts (72%). The mean splenic length was 17.34±6 cm (range 7- 37 cm) and the mean splenic weight was 1216 gm±1243 gm (range 180-6000 gm). A splenic mass was found in 97% of pts, and its mean size was 9.26 cm (range 3-18 cm). The diagnostic procedure was core needle biopsy in 46 pts and splenectomy in 39 pts: 27 underwent open splenectomy and 12 laparoscopic splenectomy. Splenectomized pts had lower IPI (p<0.05) and lower stage (p<0.05) compared to non-splenectomized pts. Treatment: The CHOP regimen was given to 80 pts (92%), DA-EPOCH was given to 2 pts (2%) and 5 pts (6%) received other regimens. Rituximab was given to 68 pts (78%). Complete response was achieved in 67 pts (80%) and partial response in 8 (9%). Relapse occurred in 17 pts (22%). Survival: The median follow-up time was 7 years (range 0-19.4 years). During this period 24 pts died (27.5%). The 5-year overall survival (OS) was 76.6±4.9% and 5-year event-free survival (EFS) 67.2±5.5%. Splenectomy at diagnosis improved survival: the 5-year EFS was 85.4±6% and 54.7±8% for splenectomized and non-splenectomized pts respectively (p=0.02) and the 5-year OS was 91.2±5% and 67.9±7% respectively (p=0.08). For the 53 pts with stage I-II disease, both 5-year EFS and OS were better in the splenectomized pts (p<0.02, Fig 1). The 5-year EFS and OS in pts with stage I and II disease that were splenectomized at diagnosis was 89.6±6% and 96.4±3.5% as compared with 50.5±11% and 63.2±11% in pts who were not splenectomized (p=0.012 and 0.009). The EFS and OS were not influenced by the stage of the disease. Overall survival was associated with B symptoms (p=0.02), weight loss (p=0.04) and ECOG performance status (p=0.03). In a multivariate model, low ECOG PS and splenectomy independently predicted a better EFS (p=0.03 and 0.02 respectively), however for OS, low ECOG PS independently predicted better OS (p=0.03), while splenectomy had only marginal effect on the OS (p=0.056). Conclusions: In our group of pts, PS-DLBCL generally presented with abdominal pain, high LDH and a splenic mass. We demonstrate for the first time that splenectomy at diagnosis improves survival in early stages of PS-DLBCL. Our study is a retrospective one. Therefore, until prospective studies prove that early splenectomy in PS-DLBCL is beneficial in terms of overall survival, the risk and benefit of performing splenectomy should be weighed for each patient. Fig 1: (A) Event-free survival and (B) Overall survival in patients with primary splenic DLBCL and stages I - II disease who did or did not undergo splenectomy at diagnosis. Fig 1:. (A) Event-free survival and (B) Overall survival in patients with primary splenic DLBCL and stages I - II disease who did or did not undergo splenectomy at diagnosis. Figure 2 Figure 2. Disclosures No relevant conflicts of interest to declare.

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