The incidence and impact of comorbidity on survival and selection of initial treatment in elderly patients (pts) with head and neck cancer (HNC)

6065 Background: Comorbidity has been shown to be a determinant of survival and treatment selection in various cancers including HNC. Higher comorbidity index is associated with higher utilization of non-curative intent treatment. Methods: In this retrospective study we analyzed 182 consecutively treated HNC pts >65 years (y) old at the Dallas VAMC from January 2000 through June 2007. Comorbidity was assessed with the Charlson Comorbidity Index (CCI). Treatment was classified as curative intent versus non-curative intent. The goals were 1) to demonstrate burden of comorbidity and 2) to demonstrate the impact of comorbidity on overall survival and selection of initial treatment in elderly HNC pts. Results: Pts characteristics: 100% male; 80% white, 19.5% Black, 0.5% Hispanic; median age 72y (range 65–87); 3% stage 0, 26% stage I, 20% stage II, 18% stage III, 30% stage IV, 2% unknown; primary site - 30% oral cavity, 4% hypopharnyx, 22% oropharynx, 38% larynx, 4% other, 1% unknown; treatment - 26% radiation only, 44% surgery (S), 21% chemoradiation (CR), 9% no treatment; Median CCI -2 (range 0–11); 61% had CCI score 0–2 and 39% had CI score > 3. Median overall survival was 883 days (SE 19.31 days). Rate of curative vs. non-curative intent treatment was 80% vs. 20% respectively. Pts with CCI score 0–2 had a non-significant higher rate of curative intent treatment than pts with CCI score > 3 (83.8% vs. 74.6% p = 0.13). In multivariate analysis including CCI, age, race, alcohol use, primary site, treatment, and stage, only advanced clinical stage had significant prognostic importance (HR 1.66; 95% CI, 1.29 to 2.14; p < 0.0005). The HR for CCI was 1.11 (95% CI, .99–1.24; p = 0.08). In separate multivariate analyses of pts treated with S and pts treated with CR, CCI was not a significant predictor of survival with HR of .88 (95% CI, .69–1.11; p = 0.29) and 1.13 (95% CI, .83–1.53; p = 0.44), respectively. Conclusions: In our population of elderly HNC pts, CCI and age had no significant impact on survival or selection of curative intent treatment. Additional study is required to better define appropriate candidates for curative intent treatment in this population. No significant financial relationships to disclose.

Download Full-text

The impact of the patient’s condition, diagnostic procedures and treatment on the survival of carcinoma of unknown primary site patients

Cancer Management and Research ◽

10.2147/cmar.s204346 ◽

2019 ◽

Vol Volume 11 ◽

pp. 6603-6614 ◽

Cited By ~ 1

Author(s):

Karolina Dorobisz ◽

Iwona Wlodarska-Polinska ◽

Katarzyna Pazdro-Zastawny ◽

Tomasz Rutkowski ◽

Piotr Palka ◽

...

Keyword(s):

Diagnostic Procedures ◽

Primary Site ◽

Unknown Primary ◽

Unknown Primary Site ◽

Carcinoma Of Unknown Primary ◽

The Impact

Download Full-text

283 The impact of charlson’s comorbidity index in overall survival for advanced epithelial ovarian cancer

10.1136/ijgc-2019-igcs.283 ◽

2019 ◽

Author(s):

R Nunes ◽

H Mantoan ◽

B Goncalves ◽

C Faloppa ◽

L Kumagai ◽

...

Keyword(s):

Ovarian Cancer ◽

Overall Survival ◽

Epithelial Ovarian Cancer ◽

Comorbidity Index ◽

Advanced Epithelial Ovarian Cancer ◽

The Impact

Download Full-text

Hematopoietic Stem Cell Transplant Comorbidity Index (HCT-CI) Scores Correlates with Increased Readmissions and Days In Hospital In Patients Undergoing Myeloablative Hematopoietic Stem Cell Transplant

Blood ◽

10.1182/blood.v116.21.4748.4748 ◽

2010 ◽

Vol 116 (21) ◽

pp. 4748-4748

Author(s):

Szwed A. Ellen ◽

Jack W. Hsu ◽

Wei Hou ◽

Randy A. Brown ◽

Christopher R. Cogle ◽

...

Keyword(s):

Overall Survival ◽

Stem Cell ◽

Hematopoietic Stem Cell ◽

Hematopoietic Stem Cell Transplant ◽

Stem Cell Transplant ◽

Cell Transplant ◽

Hematopoietic Stem ◽

Conditioning Regimens ◽

Comorbidity Index ◽

The Impact

Abstract Abstract 4748 Hematopoietic Stem Cell Transplant Comorbidity Index (HCT-CI) Scores Correlates with Increased Readmissions and Days in Hospital in Patients Undergoing Myeloablative Hematopoietic Stem Cell Transplantation. Ellen Szwed, Jack W. Hsu, Wei Hou, Randy A. Brown, Christopher R. Cogle, John W. Hiemenz, W Stratford May, Jan S. Moreb, Baldeep Wirk, John R. Wingard. The hematopoietic stem cell transplant comorbidity index (HCT-CI) was developed to assess the impact of comorbidities in allogeneic stem cell transplant (AlloSCT) recipients. It has been shown to correlate with non-relapse mortality and overall survival in both the myeloablative, non-myeloablative (NMA), and reduced intensity (RIC) settings, regardless of graft source. However, the economic impact of allogeneic transplant in patients with comorbidities has not been assessed. We retrospectively analyzed 181 consecutive patients who underwent AlloSCT from an HLA identical sibling following either myleoablative (n= 109) or NMA/RIC (n=71) conditioning regimens between January 2001 and December 2008. The HCT-CI score was calculated according to the method of Sorror, et al. (Sorror ML, et al. Blood. 2005 106: 2912–2919). Median follow-up of the entire cohort was 2 years. As previously published, there was a statistically significant correlation between HCT-CI and both non-relapse mortality (HR = 1.147, p = 0.0170,) and overall survival (HR = 1.152, p=0.0001) at 2-years of 23% and 50% respectively. We found statistically significant correlations between the HCT-CI score and total number of hospital readmissions (mean = 1.92; r=0.192; p = 0.0098) and total days in hospital after initial discharge from hospital after stem cell infusion (mean = 22.4 days; r=0.156; p = 0.036). Interestingly, the correlation for number of hospital days did not become statistically significant until 180 days or greater after transplantation. There was no correlation between HCT-CI with graft source, relapse or graft-vs.-host disease. When we stratified the HCT-CI to either myeloablative (N=109) or NMA/RIC (N=71) conditioning regimens, the correlations between the HCT-CI and both non-relapse mortality and overall survival were still statistically significant. The differences in days of hospitalization remained statistically significant in the myeloablative setting, but not in the NMA/RIC setting. In conclusion, our analysis of AlloSCT recipients found a correlation between the HCT-CI and the number of readmissions and hospital length of stay for myeloablative but not NMA/RIC conditioning regimens, suggesting a higher HCT-CI score results in greater use of hospital resources and costs. The increase in resource utilization is greater after the immediate post-transplant period. Whether these conclusions also apply in other transplant settings will need to be investigated. Disclosures: No relevant conflicts of interest to declare.

Download Full-text

Evaluation of Patient Outcome Benefits and Resource Utilization Associated with a Hematopathologist-Directed Workflow for Diagnosis of Hematological Malignancies

Blood ◽

10.1182/blood.v118.21.3127.3127 ◽

2011 ◽

Vol 118 (21) ◽

pp. 3127-3127

Author(s):

John F Leite ◽

Sudipto Sur ◽

Bashar Dabbas ◽

James Gilmore ◽

Sally Haislip ◽

...

Keyword(s):

Overall Survival ◽

Patient Outcomes ◽

Resource Utilization ◽

Analytical Framework ◽

National Study ◽

Regional Study ◽

Cancer Specialists ◽

One Year ◽

The Impact ◽

Selection Of

Abstract Abstract 3127 Background: Traditionally, the appropriate selection of diagnostic tests is determined solely by the ordering clinician. This can be quite challenging in the case of hematological malignancies, where guidelines require detailed correlation between molecular, morphologic and immunologic results for accurate classification. We have undertaken a study to determine the impact of including a hematopathologist in the initial test selection and case management. Our working hypothesis is that this should improve the timeliness and accuracy of diagnoses. Therefore, an analytical framework based on measuring patient outcomes and resource utilization is feasible to compare diagnostic workflows. We compared outcomes and resource utilization between cohorts of patients in which diagnosis was obtained using the traditional or hematopathologist supplemented workflows. Two studies were performed: the first utilized a smaller regional electronic health record (EHR) database from a Southeast US practice, affording a higher degree of practice and demographics uniformity, the second utilized a more heterogeneous national US claims database. Patients were matched by ultimate diagnosis and demographics and all studies were retrospective. Methods: In the first regional cohort, we studied 791 patients collected between 2007 and 2009 and required a minimum of one year of data post bone marrow biopsy to be available. The patients had a diagnostic evaluation by a hematopathologist-managed workflow (Test, n=640) or by laboratories that follow a traditional diagnostic workflow (Control, n=151). Patients were matched by gender, age, ethnicity, ECOG status and diagnosis. Outcomes were assessed as overall survival and transfusion dependence. Resource utilization (lab tests and supportive therapeutics) was also evaluated. As a sensitivity analysis, outcomes of 19, 416 patients from the national cohort were evaluated using patients collected between 2006 and 2008. These patients had a diagnostic evaluation by a hematopathologist-managed workflow (Test, n=3, 236) or by laboratories that follow a traditional diagnostic workflow (Control, n=16, 180). Patients were matched by gender, age, ethnicity, geography, payer type, Charlson co-morbidities and diagnosis. Results: Overall survival benefit for the regional EHR-based study was not observed beyond statistical significance (p=0.564, HR=0.530; 95%CI=0.233–1.205) although a strong trend favoring the Test cohort could be observed. In the national study, where claims data over one year was available for a greater proportion of patients, improved overall survival (p=0.050, HR=0.634; 95%CI=0.402–1.001) for Test cohort patients could be discerned. Test cohort patients exhibited improved transfusion dependence (p=0.009; HR=0.455, 95% CI=0.252–0.824) in the regional study, but this effect was not observed in the national study set (p=0.644; HR=0.959, 95% CI=0.803–1.145). Resource utilization was assessed in the regional study and Test cohort patients appear associated with significantly reduced resource utilization: lab tests (p<0.0001), ancillary procedures (p<0.0001), therapeutics (p<0.0001) and erythropoietin stimulating agents (p<0.0001). Conclusions: We present an analytical framework by which the impact on patient outcomes can be evaluated as a function of adding a hematopathologist in the selection of diagnostic tests and case management. Our initial results using EHR records from a multi-site single practice, and claims data from a national database, suggest that differences in outcomes and resource utilization can be discerned as a function of diagnostic workflow. Though we have done our best to reduce the possibility of distortion by confounding variables and unidentified bias, we hope that this study will provide the impetus for further replication across multiple cohorts, labs and prospective trials in the future. Disclosures: Leite: Genoptix-Novartis: Employment. Sur:Genoptix-Novartis: Consultancy. Dabbas:Genoptix-Novartis: Employment. Gilmore:Georgia Cancer Specialists: Employment. Haislip:Georgia Cancer Specialists: Employment. Nerenberg:Genoptix-Novartis: Employment.

Download Full-text

Complete Remissions (CRs) with Azacitidine Regimens Compared to Crs with 7+3 Induction Chemotherapy and the Effect on Overall Survival

Blood ◽

10.1182/blood.v128.22.1613.1613 ◽

2016 ◽

Vol 128 (22) ◽

pp. 1613-1613 ◽

Cited By ~ 2

Author(s):

Megan Othus ◽

Mikkael A Sekeres ◽

Sucha Nand ◽

Guillermo Garcia-Manero ◽

Frederick R. Appelbaum ◽

...

Keyword(s):

Overall Survival ◽

Prognostic Factors ◽

Research Funding ◽

Cox Regression ◽

Intensive Therapy ◽

Univariate Analysis ◽

Multivariable Analysis ◽

Curative Intent ◽

Kaplan Meier ◽

The Impact

Abstract Background: CR and CR with incomplete count recovery (CRi) are associated with prolonged overall survival (OS) for acute myeloid leukemia (AML) patients (pts) treated with curative-intent, induction therapy. For AML pts treated with azacitidine (AZA), response (CR, partial response, marrow CR, or hematologic improvement) is also associated with prolonged OS. We evaluate whether patients given AZA for myelodysplastic syndromes (MDS) or AML had longer OS if they achieved CR. We also compare the effect size of CR on OS between AZA regimens and 7+3. Patients and Methods: We analyzed four SWOG studies: S1117 (n=277) was a randomized Phase II study comparing AZA to AZA+lenalidomide or AZA+vorinostat for higher-risk MDS and CMML pts (median age 70 years, range 28-93); S0703 (n=133) treated AML pts not eligible for curative-intent therapy with AZA+mylotarg (median age 73 years, range 60-88). We analyzed the 7+3 arms of S0106 (n=301 were randomized to 7+3, median age 48 years, range 18-60) and S1203 (n=261 were randomized to 7+3, median age 48 years, range 19-60). CR was defined per 2003 International Working Group criteria. In S1117 CR was assessed every 16 weeks and patients remained on therapy until disease progression. In S0703, S0106, and S1203 CR was assessed following 1-2 induction cycles; patients not achieving CR (S0106) or CRi (S0703 and S1203) were removed from protocol treatment. OS was measured from date of study registration. To avoid survival by response bias, we performed landmark analyses of OS. We present results based on the study-specific landmark date that 75% of pts who eventually achieved a CR had done so (S1117 144 days, S0703 42 days, S0106 44 days, S1203 34 days). Pts who did not achieve CR by this date were analyzed with pts who never achieved CR. Pts who died or were lost to follow-up before this date were excluded from analyses. As a sensitivity analysis we also analyzed based on the 90% date; results were not materially different. Log-rank tests were used to compare survival curves and Cox regression models were used for multivariable modeling including baseline prognostic factors age, sex, performance status, white blood cell count, platelet count, marrow blast percentage, de novo disease (versus antecedent MDS or therapy-related disease), study arm (for S1117 only), and cytogenetic risk (IPSS criteria for S1117, SWOG criteria for S0703, S0106, and S1203). The following analysis considers morphologic CR only. S0106 treated CR with incomplete count recover (CRi) pts as treatment failures (S0703 and S1203 did not) and CRi was not defined for S1117. Hematologic improvement was only defined for S1117 patients. Results: In univariate analysis, CR was significantly associated with prolonged survival among MDS pts treated with azactidine on S1117 (HR=0.55, p=0.017), confirming the results seen in AML pts treated with azacitidine (and mylotarg, S0703, HR=0.60, p=0.054) and 7+3 (S0106 HR=0.44, p<0.001; S1203 HR=0.32, p<0.0001) (Figure 1). For each study this relationship remained significant in multivariable analysis controlling for baseline prognostic factors (S1117 HR=0.25, p<0.001; S0703 HR=0.64, p=0.049; S0106 HR=0.45, p<0.001; S1203 HR=0.41, p<0.001). There was no evidence that the impact of CR varied across the four cohorts (interaction p-value = 0.76). In the full cohort, the effect of CR was associated with a HR of 0.45 (Table 1). Conclusion: Adjusting for pt characteristics, achievement of morphologic CR was associated with a 60% improvement in OS, on average, compared to that seen in pts who don't achieve a CR, regardless of whether pts were treated with 7+3 or AZA containing regimens, and suggesting that value CR is similar of whether pts receive more or less "intensive" therapy for these high grade neoplasms. Support: NIH/NCI grants CA180888 and CA180819 Acknowledgment: The authors wish to gratefully acknowledge the important contributions of the late Dr. Stephen H. Petersdorf to SWOG and to study S0106. Figure 1 Kaplan-Meier plots of landmark survival by response. Figure 1. Kaplan-Meier plots of landmark survival by response. Table 1 Multivariable analysis, N=878 Table 1. Multivariable analysis, N=878 Disclosures Othus: Glycomimetics: Consultancy; Celgene: Consultancy. Sekeres:Celgene: Membership on an entity's Board of Directors or advisory committees. Erba:Millennium Pharmaceuticals, Inc.: Research Funding; Amgen: Consultancy, Research Funding; Seattle Genetics: Consultancy, Research Funding; Agios: Research Funding; Gylcomimetics: Other: DSMB; Juno: Research Funding; Daiichi Sankyo: Consultancy; Sunesis: Consultancy; Pfizer: Consultancy; Ariad: Consultancy; Jannsen: Consultancy, Research Funding; Incyte: Consultancy, DSMB, Speakers Bureau; Celator: Research Funding; Astellas: Research Funding; Celgene: Consultancy, Speakers Bureau; Novartis: Consultancy, Speakers Bureau.

Download Full-text

Variations in serum vitamin D status during cancer chemotherapy.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.e19550 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. e19550-e19550

Author(s):

Bogda Koczwara ◽

Richard John Woodman ◽

Laisa Vicki Teleni ◽

Michael Kimlin ◽

Euan Thomas Walpole ◽

...

Keyword(s):

Vitamin D ◽

Demographic Data ◽

Serum Vitamin ◽

Sun Exposure ◽

Unknown Primary ◽

Curative Intent ◽

Serum Vitamin D ◽

Vitamin D Levels ◽

The Impact ◽

Low Serum

e19550 Background: Low serum vitamin D in cancer patients has been associated with inferior cancer outcomes and bone loss. The impact of chemotherapy on vitamin D levels is not known. We examined serum vitamin D levels during chemotherapy to identify magnitude and predictors of change. Methods: A prospective study of chemotherapy naïve patients commencing chemotherapy in two different sun exposure areas. Vitamin D (25(OH)D) deficiency was defined as ≤25 nmol/L and insufficiency 26-50 nmol/L. Demographic data, nutrition, sun exposure, season and biochemical parameters were collected at baseline 6 weeks (6W) and 12 weeks (12W) since commencement of treatment. The effects were assessed using a multivariate multilevel linear regression model that also included age, gender and BMI. Results: 82 Caucasian and 3 indigenous patients were enrolled. Median age was 57 (21-85) years. Forty-nine (58%) were female; 54 (65%) were treated with curative intent. Tumours included 29 (34%) breast,12 (14%) colorectal, 9 (11%) lymphomas, 7 (8%) leukemias, 7 (8%) lung, 5 (6%) ovarian, 3 (4%) testis, 3 (4%) unknown primary and 10 (11%) others. Median weight was 75 kg (50-151) and median BMI was 26.9 kg/m2 (17.7- 44.5). Seventy-six (89%) and 55 (65%) patients were receiving chemotherapy treatment at 6W and 12W respectively. Mean (±SD) serum 25(OH)D at baseline was 49.2±22.3 nmol/L. Ten (12%) patients were vitamin D deficient at baseline and a further 33 (41%) had insufficient levels. Mean serum 25(OH)D status was higher in higher sun exposure locations (61.9±22.1 nmol/L vs 42.2±19.2 nmol/L, p<0.001), varied according to season (spring=46.9±20.3 nmol/L, summer=50.8±18.2 nmol/L, fall=76.4±25.2 nmol/L, winter=36.5±15.7 nmol/L, p<0.001) and changed with treatment period (baseline=49.2±22.3 nmol/L, 6W=40.9±19.0 nmol/L, 12W=45.9±19.7 nmol/L, p=0.002). There was no association between 25(OH)D status and age, gender, BMI or nutritional status. Conclusions: Chemotherapy is associated with a fall in serum 25(OH)D. Further research is needed to determine the underlying mechanism, the impact of low serum 25(OH)D on patient outcomes and the potential role for screening and vitamin D supplementation in this group.

Download Full-text

The relationship between pathologic nodal disease and residual tumor viability (RV) in patients with locoregionally advanced (LRA) adenocarcinoma (ACA) of the esophagus and gastroesophageal junction (E/GEJ) receiving induction chemotherapy, surgery, and postoperative chemoradiotherapy (CRT).

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.3_suppl.165 ◽

2015 ◽

Vol 33 (3_suppl) ◽

pp. 165-165

Author(s):

Michael J. McNamara ◽

Lisa A. Rybicki ◽

Cristina P. Rodriguez ◽

Gregory M.M. Videtic ◽

Kevin L. Stephans ◽

...

Keyword(s):

Induction Chemotherapy ◽

Clinical Stage ◽

Gastroesophageal Junction ◽

Multivariable Analysis ◽

Residual Tumor ◽

Nodal Disease ◽

Curative Intent ◽

Kaplan Meier ◽

Poor Outcomes ◽

The Impact

165 Background: A complete pathologic response to induction CRT has been identified as a favorable prognostic factor for patients with LRA ACA of the E/GEJ. Less is known, however, about the impact of pathologic regression after induction chemotherapy. Methods: Between 2/08 and 1/12, 60 evaluable patients with ACA of the E/GEJ enrolled in a phase II trial of induction chemotherapy, surgery, and post-operative CRT. Eligibility required a clinical stage of T3 or N1 or M1a (AJCC 6th). Induction chemotherapy with epirubicin 50mg/m2 d1, oxaliplatin 130mg/m2 d1, and fluorouracil 200mg/m2/day continuous infusion for 3 weeks, was given every 21 days for 3 courses and was followed by surgical resection. Adjuvant CRT consisted of 50-55Gy @ 1.8-2.0 Gy/d and 2 courses of cisplatin (20mg/m2/d) and fluorouracil (1000mg/m2/d) over 4 days during weeks 1 and 4 of radiotherapy. RV was defined as the amount of remaining tumor in relation to acellular mucin pools and scarring. Results: Of the 60 evaluable patients, 54 completed induction therapy and underwent curative intent surgery. The Kaplan-Meier (KM) projected 3 year OS for patients with pathologic N0 (n=20), N1 (n=12), N2 (n=13), and N3 (n=9) disease is 73%, 57%, 35%, and 0% respectively (p<0.001). The KM projected 3 year OS of patients with low (0-25%, n=19), intermediate (26-75%, n=26), and high (>75%, n=9) RV was 67%, 42%, and 17% respectively (p=0.004). On multivariable analysis, both the pN descriptor and RV were independently prognostic for OS. In patients with less nodal dissemination (N0/N1), RV was prognostic for OS [3yr OS 85% (0-25% viable) v 51% (>25% viable), p=0.028]. Outcomes were poor, however, for patients with advanced nodal disease (N2/N3) regardless of RV [3yr OS 20% (0-25% viable) v 21% (>25% viable), p=0.55]. Conclusions: RV and the pN descriptor after induction chemotherapy are independent pathologic prognostic factors for OS in patients with LRA ACA of the E/GEJ. Patients with extensive nodal disease, however, have poor outcomes irrespective of viability. Clinical trial information: NCT00601705.

Download Full-text

PROSPER: A phase III randomized study comparing perioperative nivolumab (nivo) versus observation in patients with localized renal cell carcinoma (RCC) undergoing nephrectomy (ECOG-ACRIN 8143).

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.7_suppl.tps684 ◽

2019 ◽

Vol 37 (7_suppl) ◽

pp. TPS684-TPS684 ◽

Cited By ~ 3

Author(s):

Lauren Christine Harshman ◽

Maneka Puligandla ◽

Naomi B. Haas ◽

Mohamad Allaf ◽

Charles G. Drake ◽

...

Keyword(s):

Quality Of Life ◽

Overall Survival ◽

Immune System ◽

Clinical Outcomes ◽

Clinical Stage ◽

Randomized Study ◽

Phase Iii ◽

The Impact ◽

Metastatic Rcc

TPS684 Background: The anti-PD-1 antibody nivo improves overall survival in metastatic RCC and is well tolerated. There is no standard adjuvant systemic therapy that increases overall survival (OS) over surgery alone for non-metastatic RCC. Priming the immune system prior to surgery with anti-PD-1 has shown an OS benefit compared to a pure adjuvant approach in mouse solid tumor models. The PROSPER RCC trial aims to improve clinical outcomes by priming the immune system prior to nephrectomy with neoadjuvant nivo and continued engagement with adjuvant blockade in patients with high risk M0 RCC compared to surgery alone. Methods: This global, unblinded, phase 3 National Clinical Trials Network study is currently accruing patients with clinical stage ≥T2 or node positive M0 RCC of any histology. Tumor biopsy prior to randomization is mandatory to ensure RCC and permits in depth correlative science. The investigational arm will receive two doses of nivo 240mg prior to surgery followed by adjuvant nivo for 9 months (q2 wks x 3 mo followed by 480mg q4 wks x 6 mo). The control arm will undergo standard nephrectomy followed by observation. Randomized patients are stratified by clinical T stage, node positivity, and histology. To enhance accrual and patient quality of life, key upcoming amendments are being instituted. These include biopsy only in the nivo arm, allowance of oligometastatic disease and bilateral renal masses that can be fully resected/ablated, and change of nivo dosing to q4 wks (1 neoadj; 9 adj). With accrual of 766 patients, there is 84.2% power to detect a 14.4% absolute benefit in recurrence-free survival (RFS) at 5 years assuming the ASSURE historical control of ~56% to 70% (HR = 0.70). The study is also powered to evaluate a significant increase in overall survival (HR 0.67). Safety, feasibility, and quality of life endpoints critical to adjuvant therapy considerations are incorporated. PROSPER RCC embeds a wealth of translational work aimed at investigating the impact of the baseline immune milieu, the changes induced by neoadjuvant anti-PD-1 priming, and how both correlate with clinical outcomes. Clinical trial information: NCT03055013.

Download Full-text

Comparison of the Freiburg and Charlson Comorbidity Indices in Predicting Overall Survival in Elderly Patients with Newly Diagnosed Multiple Myeloma

BioMed Research International ◽

10.1155/2014/437852 ◽

2014 ◽

Vol 2014 ◽

pp. 1-11 ◽

Cited By ~ 8

Author(s):

Sung Min Kim ◽

Moon Jin Kim ◽

Hyun Ae Jung ◽

Kihyun Kim ◽

Seok Jin Kim ◽

...

Keyword(s):

Multiple Myeloma ◽

Overall Survival ◽

Elderly Patients ◽

Performance Status ◽

Solid Cancer ◽

Newly Diagnosed ◽

History Of ◽

Comorbidity Index ◽

And Performance ◽

The Impact

Multiple myeloma occurs primarily in elderly patients. Considering the high prevalence of comorbidities, comorbidity is an important issue for the management of myeloma. However, the impact of comorbidity on clinical outcomes has not been fully investigated. We retrospectively analyzed patients with newly diagnosed myeloma. Comorbidities were assessed based on the Charlson comorbidity index (CCI) and the Freiburg comorbidity index (FCI). The CCI is a summary measure of 19 comorbid conditions. FCI is determined by performance status, renal impairment, and lung disease. This study included 127 patients with a median age of 71 years. Approximately half of the patients had additional disorders at the time of diagnosis, and diabetes mellitus was the most frequent diagnosis (18.9%). The most significant factors for prognosis among patient-related conditions were a history of solid cancer and performance status (ECOG ≥ 2). The FCI score was divided into 3 groups (0, 1, and 2-3), and the CCI score was divided into 2 groups (2-3 and ≥4). FCI was a strong prognostic tool for OS (P>0.001) and predicted clinical outcome better than CCI (P=0.059). In conclusion, FCI was more useful than CCI in predicting overall survival in elderly patients with myeloma.

Download Full-text