Real-world assessment of clinical outcomes among first-line (1L) sunitinib (SUN) patients (pts) with metastatic renal cell carcinoma (mRCC) by the international mRCC database consortium (IMDC) risk group.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 610-610 ◽  
Author(s):  
Marie-France Savard ◽  
J Connor Wells ◽  
Jeffrey Graham ◽  
John A. Steinharter ◽  
Bradley Alexander McGregor ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Real World ◽  
Clear Cell ◽  
Risk Group ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Clinical Trial Design ◽  
Risk Groups ◽  
Time To Death ◽  
Poor Risk

610 Background: Prognostic factors such as the IMDC criteria have included all types of targeted therapy. This study assesses clinical outcomes and provide benchmarks for mRCC pts treated specifically with 1L SUN in the real world to provide contemporary benchmarks for outcomes and survival. Methods: Clear cell mRCC pts initiating SUN as 1L therapy between 2010-2018 were included in a retrospective database study. Kaplan Meier analysis was used to estimate median time to treatment discontinuation (TTD) and overall survival (OS: time to death) by IMDC risk groups based on Karnofsky Performance Status < 80%, diagnosis to treatment interval < 1 year, anemia, neutrophilia, hypercalcemia and thrombocytosis. Results: Among 1,769 1L SUN pts with clear cell in the RW clinical database, 318 (18%) had favorable, 1,031 (58%) had intermediate and 420 (24%) had poor IMDC risk. Across the favorable, intermediate, and poor risk groups, pts had similar mean age in years, gender distribution, and year of SUN initiation (age: 63.8, 62.9 and 62.6; male: 74%, 75%, and 72%; SUN initiation year of 2010-2013: all 71%). In the favorable risk group, 99% received nephrectomy vs 88% in intermediate and 66% in poor risk group. Median TTD was 15.0, 8.5, and 4.2 months (mos) in the favorable, intermediate, and poor risk groups, respectively, and was 7.1 mos in the combined intermediate/poor risk groups. Median OS was 52.1, 31.5, and 9.8 mos in the favorable, intermediate, and poor risk groups, respectively, and was 23.2 mos in the combined intermediate/poor risk groups. Conclusions: This real world study based on a contemporary cohort of 1L SUN mRCC pts found a median OS of 52 mos which sets a new benchmark for clear cell mRCC in the favorable risk group. OS in the intermediate and poor risk groups are similar to previous reports. This affects pt counselling and clinical trial design.

Cabozantinib real-world effectiveness in the first through fourth-line settings for the treatment of metastatic renal cell carcinoma (mRCC): Results from the International mRCC Database Consortium (IMDC).

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 639-639
Author(s):  
Chun Loo Gan ◽  
Shaan Dudani ◽  
Connor Wells ◽  
Frede Donskov ◽  
Sumanta K. Pal ◽  
...  
Keyword(s):  
Real World ◽  
Overall Response Rate ◽  
Clear Cell ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Risk Groups ◽  
Characterization Methods ◽  
Poor Risk ◽  
Karnofsky Performance Status Score ◽  
Time To Treatment Failure

639 Background: Cabozantinib (Cabo) is approved for mRCC patients based on the METEOR and CABOSUN trials. The real-world effectiveness of Cabo in mRCC patients in the first- (1L), second- (2L), third- (3L) and fourth-line (4L) settings requires characterization. Methods: This retrospective analysis included mRCC patients who were treated with Cabo and stratified using IMDC risk groups. Overall response rate (ORR), time to treatment failure (TTF), and overall survival (OS) were calculated. Results: A total of 413 patients (82.6% with clear cell and 17.4% non-clear cell) were identified. The median age was 57 years. Overall, 63% of patients had a Karnofsky performance status score of >80 and 82.6% had prior nephrectomy. 23.1%, 75.4% and 88.3% of patients received immunotherapy as a prior line of treatment, before receiving Cabo in the 2L, 3L and 4L settings, respectively. For patients treated with 1L PD(L)1 combination or monotherapy (n=31), 2nd line Cabo had ORR of 20.8%, median TTF of 5.4 months and median OS of 17.4 months. When segregated into IMDC favorable, intermediate, and poor risk groups, the median OS was 34.8 months (95% CI 5.52-NR), 18.0 months (12.3-35.6) and 9.8 months (7.4-20.8), p=0.0088, respectively for 2L Cabo; and 31.5 months (23.6-39.3), 20.5 months (10.1-21.8), and 6.9 months (4.1-10.9), p=<0.0001), respectively for 3L Cabo. Conclusions: The ORR and TTF of Cabo were maintained from the 1L to the 4L therapy settings. In the 2L and 3L settings, the IMDC criteria appropriately stratified patients into favorable, intermediate and poor risk groups for OS. Cabo has activity after first line immunotherapy.[Table: see text]

scholarly journals Predictors of Survival in Subtotally Resected WHO Grade I Skull Base Meningiomas

Cancers ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1451
Author(s):  
Michele Da Broi ◽  
Paola Borrelli ◽  
Torstein R. Meling
Keyword(s):  
Skull Base ◽  
Clinical Outcomes ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Multivariable Analysis ◽  
Advanced Age ◽  
Final Visit ◽  
Subtotal Resection ◽  
Who Grade ◽  
Skull Base Meningiomas

Background: Although gross total resection (GTR) is the goal in meningioma surgery, this can sometimes be difficult to achieve in skull base meningiomas. We analyzed clinical outcomes and predictors of survival for subtotally resected benign meningiomas. Methods: A total of 212 consecutive patients who underwent subtotal resection (STR) for benign skull base meningioma between 1990–2010 were investigated. Results: Median age was 57.7 [IQR 18.8] years, median preoperative Karnofsky performance status (KPS) was 80.0 [IQR 20.0], 75 patients (35.4%) had posterior fossa meningioma. After a median follow-up of 6.2 [IQR 7.9] years, retreatment (either radiotherapy or repeated surgery) rate was 16% at 1-year, 27% at 3-years, 34% at 5-years, and 38% at 10-years. Ten patients (4.7%) died perioperatively, 9 (3.5%) had postoperative hematomas, and 2 (0.8%) had postoperative infections. Neurological outcome at final visit was improved/stable in 122 patients (70%). Multivariable analysis identified advanced age and preoperative KPS < 70 as negative predictors for overall survival (OS). Patients who underwent retreatment had no significant reduction of OS. Conclusions: Advanced age and preoperative KPS were independent predictors of OS. Retreatments did not prolong nor shorten the OS. Clinical outcomes in STR skull base meningiomas were generally worse compared to cohorts with high rates of GTR.

PATH-16. EVALUATION OF SEX-BASED DIFFERENCES IN CLINICAL OUTCOMES AND TUMOR GENOMICS IN PATIENTS WITH NEWLY DIAGNOSED IDH-WILDTYPE GLIOBLASTOMA RECEIVING CHEMORADIATION

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi118-vi118
Author(s):  
Diana Shi ◽  
Mary Jane Lim-Fat ◽  
Amin Nassar ◽  
Jared Woods ◽  
Gilbert Youssef ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Methylation Status ◽  
Multivariable Analysis ◽  
Extent Of Resection ◽  
Hazard Ratio ◽  
Newly Diagnosed ◽  
Loss Of Function ◽  
Female Sex

Abstract BACKGROUND We evaluated sex-based differences in clinical outcomes and tumor genomics in patients with newly-diagnosed GBM. METHODS We reviewed 665 IDH-wild type GBM patients with Karnofsky Performance Status (KPS) ≥60 treated at our institution from 2010-2019 including; 585 patients with targeted exome sequencing of 447 cancer associated genes (OncoPanel). Deleterious mutations were defined as homozygous deletions or loss of function mutations of known tumor suppressors (as reported in TCGA, ≥ 3 times in the COSMIC database, or predicted as “damaging” in SIFT and/or “probably damaging” in Polyphen 2) or known oncogenic mutations in proto-oncogenes (reported in TCGA or ≥ 3 times in COSMIC). RESULTS There were 384 (57.7%) males and 281 (42.3%) females. Median OS was 22.5 months for females and 19.3 months for males (hazard ratio [HR] 0.81, 95% CI 1.03-1.48, p = 0.02). On multivariable analysis adjusted for age, KPS ≥90, extent of resection, and MGMT methylation status, female sex (adjusted hazard ratio 0.78, 95% CI [0.64-0.95], p = 0.015) was associated with improved OS. Superior OS in females was observed in MGMT-unmethylated patients (HR 0.69, 95% CI [0.54-0.90], p = 0.005) but not MGMT-methylated patients. Thirteen genes were deleteriously altered in ≥5% of our cohort: CDK4 (12.1% male vs. 7.8% female), CDKN2A (46.5% vs. 45.7%), CDKN2B (41.8% vs. 43.3%), EGFR (34.7% vs. 40.0%, MTAP (18.2% vs. 18.8%), NF1 (11.5% vs. 9.4%), PTEN (28.2% vs. 29.8%), TP53 (28.2% vs. 30.2%), RB1 (5.6% vs. 6.5%), MDM4 (6.2% vs. 5.7%), ATM (5.9% vs. 3.7%), MDM2 (7.4% vs. 4.1%), PIK3R1 (6.2% vs. 4.1%). There were no differences in frequency of mutations in these individual genes between males and females (χ 2 [1, N=585] = 0.05-2.86, p = 0.09-0.86). CONCLUSIONS Female sex is associated with improved survival. We did not identify sex-based differences in deleterious genomic alterations amongst commonly altered genes in GBM.

Safety and efficacy outcomes with nivolumab plus ipilimumab in patients with advanced renal cell carcinoma and low Karnofsky performance status: Results from the CheckMate 920 trial.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 315-315
Author(s):  
Thomas E. Hutson ◽  
Bradley Curtis Carthon ◽  
Jeffrey Yorio ◽  
Sunil Babu ◽  
Heidi Ann McKean ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Renal Cell Carcinoma ◽  
Clinical Trials ◽  
Adverse Events ◽  
Clear Cell ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Objective Response ◽  
Safety And Efficacy ◽  
Grade 3

315 Background: Combination therapy with nivolumab + ipilimumab (NIVO+IPI) has demonstrated long-term efficacy and tolerability for patients (pts) with previously untreated advanced renal cell carcinoma (aRCC). Most pivotal clinical trials in pts with aRCC have excluded pts with low Karnofsky performance status (KPS; < 70%). CheckMate 920 is a multi-arm, phase IIIb/IV, open-label clinical trial of NIVO+IPI treatment in pts enrolled in a community practice setting with aRCC and a high unmet medical need. We present safety and efficacy results for the cohort of pts with aRCC of any histology and KPS 50%–60% from CheckMate 920 (NCT02982954). Methods: Pts with previously untreated advanced/metastatic RCC and KPS 50%–60% received NIVO 3 mg/kg + IPI 1 mg/kg Q3W × 4 doses followed by 480 mg NIVO Q4W for ≤ 2 years or until disease progression/unacceptable toxicity. The primary endpoint was incidence of grade ≥ 3 immune-mediated adverse events (imAEs) within 100 days of last dose of study drug. Key secondary endpoints included progression-free survival (PFS) and objective response rate (ORR) by RECIST v1.1 (both per investigator). Exploratory endpoints included overall survival (OS). Results: Of 25 treated pts with KPS 50%–60%, 76% were men; median age was 67 years (range, 34–81). IMDC risk was favorable in 0%, intermediate in 32%, and poor in 68% of pts; 84% had clear cell and 16% had non-clear cell RCC histology. With a minimum follow-up of 25 months, median duration of therapy (95% CI) was 2.3 months (2.1–7.7) for NIVO and 2.1 months (2.1–2.1) for IPI. The median number of doses (range) received was 4 (1–27) for NIVO and 4 (1–4) for IPI; 76% of pts received ≥ 4 NIVO doses and 68% received all 4 IPI doses. The only grade 3–4 imAEs by category were hepatitis (4.0%) and adrenal insufficiency (4.0%). No grade 5 imAEs occurred. Overall, 4 (16%) pts discontinued due to any-grade adverse events (n = 1 each for elevated AST, malignant neoplasm progression, back pain, and acetabulum fracture). Of 18 evaluable pts, ORR was 33.3% (95% CI, 13.3–59.0); no pts had a complete response and 6 had partial response. Median time to objective response was 4.5 months (range, 2.5–24.7). Median duration of objective response was 20.6 months (range, 0.03+–24.2+). Median PFS was 4.6 months (95% CI, 2.5–14.8). Median OS was 15.6 months (95% CI, 5.3–25.1). Conclusions: NIVO+IPI demonstrated an acceptable safety profile and promising antitumor activity in pts with previously untreated aRCC and KPS 50%–60%. The combination was tolerated at a dose intensity similar to that observed in clinical trials conducted in pts with higher KPS (≥ 70%). These data support the value of NIVO+IPI in pts who may not be considered ideal candidates for this therapy and consequently may have limited treatment options. Clinical trial information: NCT02982954 .

Postremission Therapy in Adult Acute Myeloid Leukemia (AML): A Randomized Comparison of Intensified Consolidation Therapy without Maintenance Therapy Against Conventional Consolidation with Maintenance Therapy -JALSG AML-97 Trial-.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 868-868 ◽  
Author(s):  
Shuichi Miyawaki ◽  
Hisashi Sakamaki ◽  
Shigeki Ohtake ◽  
Fumiharu Yagasaki ◽  
Kinuko Mitani ◽  
...  
Keyword(s):  
Maintenance Therapy ◽  
Induction Therapy ◽  
Risk Group ◽  
Randomized Study ◽  
Risk Groups ◽  
Consolidation Therapy ◽  
Poor Risk ◽  
Short Course ◽  
To Receive ◽  
Good Risk

Abstract Between 1997 and 2001, JALSG conducted a randomized study to assess the optimal post remission therapy for adult AML in the first CR. The JALSG AML97 enrolled 809 previously untreated AML patients (pts) aged 15–64 yrs. Induction therapy consisted of cytarabine (100mg/m2 day1–7) and idarubicin (IDR 12mg/m2 day1– 3). If the patients did not achieve remission after the first induction therapy, the same therapy was given once more. Pts were categorized into good, intermediate or poor risk groups by risk factors based on the previous JALSG AML studies. All CR pts were randomized to receive either the intensified short course post remission regimen (arm A) or the conventional JALSG’s post remission regimen for AML including maintenance therapy (arm B). Arm A: 1) AraC 200mg/m2 day1–5+ Mitoxantrone (MTZ) 7mg/m2 day1–3, 2) AraC 200mg/m2 day1–5+Daunorubicin (DNR) 50mg/m2 day1–3, 3) AraC 200mg/ m2 day1–5+ Aclacinomycin (ACR) 20mg/m2 day1–5, 4) AraC 200mg/m2 day1–5+ Etoposide (ETP) 100mg/m2 day1–5 + Vincristine (VCR) 0.8mg/m2 day 8 + Vindesine (VDS) 2 mg/m2 day10. Arm B: 1) AraC 200mg/m2 day1–5 + MTZ 7mg/m2 day1–3, 2) Behenoyl AraC (BHAC) 200mg/m2 day1–7 + ETP 100mg/m2 day1–5 + DNR 50mg/m2 day1–3 + 6 mercptopurine (6MP) day1–7, 3) BHAC 200mg/m2 day1–7 + ACR 14mg/m2 day1–7, and then 6 courses maintenance therapy: 1) BHAC 170mg/m2 day1–5 + DNR 50mg/m2 day1,4+6MP day1–7, 2) BHAC 170mg/m2 day1–5 + MTZ 5mg/m2 day1–3, 3) BHAC 170mg/m2day1–5 + ETP 80mg/m2 day1,5,7 + VDS 2mg/m2 day1,8, 4) BHAC 170mg/m2 day1–5 + ACR 14mg/m2 day1–4 + 6MP day1–7, 5) BHAC 170mg/m2 day1–5 + DNR 50mg/m2 day1–4 + 6MP day1–7, 6) BHAC 170mg/m2 day1–5 + ETP 80mg/m2 day1,5,7 + VDS 2mg/m2 day1,8. Result: Of the 809 pts registered, 789 pts (median age: 45 years) were evaluable. 621 pts (78.7%) achieved CR after one or two courses of induction therapy. The 5-year OS rate of arm A was 45.6% and of arm B 53.2% (p=0.3259). The 5-year DFS rate of CR patients was 34.8% in arm A and 28.9% in arm B (p=0.4978). Among the good risk group, the 5-year OS rate of arm A was 62.1% and of arm B 70.2% (p=0.5068), and the 5-year DFS rate of arm A was 53.4% and of arm B 42.0% (p=0.3719). Among the intermediate risk group, the 5-year OS rate of arm A was 35.6% and of arm B 45.5% (p=0.4776), and the 5-year DFS rate of arm A was 26.0% and of arm B 26.1% (p=0.9653). Among the poor risk group, the 5-year OS rate of arm A was 29.7% and of arm B was 33.4% (p=0.6523), and the 5-year DFS rate of arm A was 20.4% and of arm B was 13.5% (p=0.6339). In conclusion: JALSG’s conventional post remission therapy consisting of 3 courses of consolidation and 6 courses of maintenance therapy could be replaced by a shorter duration of intensified consolidation therapy.

Impact of Cytogenetics Risk on Outcome after Reduced Intensity Conditioning (RIC) Allogeneic Stem Cell Transplantation (allo-SCT) from An HLA Identical Sibling for Patients with Acute Myeloid Leukemia (AML) in First Complete Remission (CR1)

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 345-345
Author(s):  
Mohamad Mohty ◽  
Myriam Labopin ◽  
Noel-Jean Milpied ◽  
Jan J. Cornelissen ◽  
Didier Blaise ◽  
...  
Keyword(s):  
Stem Cell ◽  
Risk Group ◽  
Conditioning Regimen ◽  
Early Death ◽  
Risk Groups ◽  
New Drugs ◽  
Intermediate Group ◽  
Poor Risk ◽  
The Poor ◽  
The Impact

Abstract Allo-SCT is a well established therapy for adult patients with AML. In the setting of standard myeloablative allo-SCT, the fear of early death as a result of the procedure led to the restriction of allo-SCT in CR1 to patients who presented with high risk AML features, especially taking into account the impact of cytogenetics risk on outcome determining standard (good)-, intermediate-, and poor-risk populations. In the last decade, RIC allo-SCT has emerged as an attractive modality to decrease toxicity and widen the spectrum of AML patients who are candidate to allo-SCT. However, the issue of possible higher relapse rates after RIC allo-SCT, and continuous improvements in non-allo-SCT strategies, raise concern about the utility of this approach in AML patients in CR1 (e.g. in comparison to intensive chemotherapy and new drugs). Of note, no large studies have yet assessed the impact of cytogenetics risk on outcome in the context of RIC allo-SCT. This report describes the results of 378 AML patients (185 males) transplanted in CR1 using a RIC regimen and reported to the EBMT registry between 2000 and 2007, and for whom detailed cytogenetics data were available. All patients received RIC allo-SCT from an HLA identical sibling. RIC was defined as Busulfan conditioning regimens containing &lt; 8mg/kg total dose, or TBI &lt;6 Gy: The median age at time of allo-SCT was 55 (range, 18–74) y. The median intervals from AML diagnosis to CR1 and from CR1 to RIC allo- SCT were 45 and 155 days respectively. In this series, 21 patients (6%) belonged to the good cytogenetics risk group, while 304 patients (80%) and 53 patients (14%) belonged to the intermediate and poor cytogenetics risk groups respectively. Age, year of transplant, WBC at diagnosis, gender, CMV serostatus, stem cell source, and RIC regimen type were comparable between all three groups. The M5-6-7 FAB subgroup was significantly higher in the poor risk group (30% vs. 20% in the intermediate group). With a median follow-up of 24 (range, 1–93) months, the KM estimates of 2 years leukemia-free survival (LFS) were 64+/−4, 57+/-3 and 38+/−7% in the good-, intermediate-, and poor-risk subgroups respectively (P=0.003). In multivariate analysis, cytogenetics was not significantly associated with non-relapse mortality. However, relapse incidence was significantly influenced by the cytogenetics risk groups (P=0.0001) and a higher WBC at diagnosis (P=0.001). Finally, LFS was significantly influenced by the cytogenetics risk groups (P=0.004), a higher WBC at diagnosis (P=0.006), and year of transplant (P=0.04). Despite its retrospective nature, results from this large study strongly suggest that RIC allo-SCT from an HLA-matched sibling donor is a valid option for AML patients in CR1 not eligible for standard allo-SCT. As it has been shown in the setting of myeloablative conditioning allo-SCT, patients from the poor cytogenetics risk group had increased relapse incidence and decreased LFS rate after RIC allo-SCT. Therefore, prospective strategies such as use of new drugs, intensification of conditioning regimen, post HST immunotherapy should be investigate to improve current results in this group.

Elderly AML Patients Treated with Intensive Chemotherapy- Developing A Prognostic Scoring System. A Study On 381 Patients From British Columbia

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 2561-2561
Author(s):  
Satish Krishnan ◽  
Huihua Li ◽  
Yasser R Abou Mourad ◽  
Michael J. Barnett ◽  
Raewyn Broady ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Induction Chemotherapy ◽  
Cox Regression ◽  
Risk Group ◽  
Performance Status ◽  
Risk Groups ◽  
Remission Induction ◽  
Intensive Chemotherapy ◽  
Consolidation Chemotherapy ◽  
Elderly Aml

Abstract Abstract 2561 Introduction. AML in patients above age 60 is associated with adverse outcomes compared to younger patients. This is due to the higher incidence of adverse risk cytogenetic changes, poor performance status and end organ function that precludes patients from receiving intensive chemotherapy. Large population based studies have reported 5yr survival rates of 5–8% even in patients receiving standard ‘3+7’ induction chemotherapy. Our study looks at the effect of disease and patient characteristics on outcomes in elderly AML patients who received remission induction chemotherapy in the hope of predicting which individuals would benefit most from this treatment. Patients and Methods. Retrospective data was collected from 381 patients > age 60 who underwent conventional cytarabine and daunorubicin (7+3) induction and consolidation chemotherapy after clinical evaluation suggesting they were fit for such treatment, from Jan 1990 to Sept 2009. The follow up duration ranged from 6m–19.5 years. The data collected were age, ECOG performance status,Haematopoetic stem cell transplant comorbidity Index (HCI) (Sorror et al Blood 2005;106:2912),WBC at presentation, bone marrow blast percentage, antecedent hematologic disease (AHD), Cytogenetic risk group by MRC(UK) criteria, remission status, date of relapse, mortality and overall survival (OS). Statistical analysis was performed to determine variables affecting OS using Cox regression analysis. Multivariate Cox regression coefficients were used to generate a nomogram to predict OS based on Akaike's information criterion. Results. The CR rates in the 3 MRC risk groups were 95%,75% and 40% respectively. The 8 week mortalities in the 3 risk groups 10%,8%and 29% respectively. The 3 month survival was 85%, 1year 50% and 5yr 16% for the patients as a whole. Multivariate analysis showed that age at diagnosis, WBC, cytogenetic risk group and AHD affect OS while sex, ECOG, HCI and BM blast count do not. Using the 4 variable significantly predicting OS a nomogram was developed. Its ability to predict OS of individual patients was evaluated using bootstrapping of a set of 200 resamples. To use the nomogram, draw a line straight upwards to the points axis to determine the number of points received for each of the 4 variables. The sum of these numbers is located on the Total Points axis, and a line is drawn downward to the survival axes to determine the likelihood of 1-, 3- or 5-year OS Discussion. AML in patients > age 60 is typically associated with a poor outcome after intensive chemotherapy. However, even among this high risk group results are heterogeneous. This is illustrated in our study where the CR rate and induction mortality varied substantially across cytogenetic risk groups. In addition to the cytogenetic risk group we found age, WBC at diagnosis and the present of AHD to have prognostic value in this elderly group. However, the HCI was not predictive of survival in these AML patients > age 60 receiving standard induction and consolidation chemotherapy. The prognostic patient factors identified in multivariate analysis are easily available in newly-diagnosed AML patients, usually before decisions regarding initial therapy must be made. If confirmed in a larger prospective study, the nomogram we have developed will help clinicians predict the expected survival following intensive chemotherapy, thus helping the patient to make an informed choice regarding risk vs benefit. Disclosures: Sutherland: Centocor Ortho Biotech research & Development: Research Funding.

Activity of MVA 5T4 alone or in combination with either interleukin-2 (IL-2) or interferon-α (IFN) in patients (Pts) with metastatic renal cell cancer (MRCC)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 3069-3069
Author(s):  
A. Cao ◽  
J. Hernandez-McClain ◽  
J. Willis ◽  
R. Harrop ◽  
W. Shingler ◽  
...  
Keyword(s):  
Clear Cell ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Cell Cancer ◽  
Single Agent ◽  
Locally Advanced ◽  
Interleukin 2 ◽  
Future Research ◽  
Interferon Α ◽  
Clinical Activity

3069 Background: MVA 5T4 consists of the highly attenuated modified Vaccinia Ankara virus containing the gene encoding the human TAA 5T4. Ninety percent or more of RCCs overexpress the 5T4 antigen. A series of clinical trials were conducted to evaluate the effectiveness of MVA 5T4 as a single agent or in combination with Interleukin-2 or Interferon Alpha 2B. Methods: Eligibility: pathologic diagnosis of clear cell or papillary RCC, progressive measurable metastases, any prior therapy, adequate physiologic parameters, Karnofsky performance status (KPS) = 80%, and no active CNS involvement. A regimen of MVA 5T4 alone or in combination with IFN or IL-2 was given. Results: A total of 41 patients received MVA 5T4 alone or in combination. 33 patients received MVA 5T4 with low dose IL-2 or IFN. 23 pts had clear cell; 12 papillary; 5 mixed clear cell; and 1 mixed papillary. 19 pts continue to receive therapy. 2 pts (both clear cell RCC) developed complete responses, 3 pts/partial responses (2 clear cell, 1 papillary) 8 pts/stable for 3+months and 6 pts are too early to be staged at this time. Median duration of therapy is 3.0+ (1+-13+) months. Conclusion: Although comparable antibody response were observed in papillary and clear cell histotypes, clear cell patients appeared to be more likely to respond in terms of clinical benefit parameters, to be presented. Of note is that preliminary analysis of clear cell patients suggests a relationship between the anti-5T4 immune response and tumor response. With the immunological potency and encouraging clinical activity, the future research will focus on the phase 3 randomized, double-blind, placebo controlled parallel group study to investigate whether MVA 5T4, added to first line standard of care therapy, prolongs the survival of patients with locally advanced or metastatic clear cell as well as studies to further optimize MVA 5T4 potency. [Table: see text]

Conditional survival (CS) for patients with metastatic renal cell carcinoma (mRCC) treated with vascular endothelial growth factor (VEGF)-targeted therapy (TT): Results from the International mRCC Database Consortium.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 358-358
Author(s):  
Toni K. Choueiri ◽  
Wanling Xie ◽  
Lauren Christine Harshman ◽  
Georg A. Bjarnason ◽  
Jennifer J. Knox ◽  
...  
Keyword(s):  
Risk Group ◽  
Risk Groups ◽  
Vascular Endothelial ◽  
Conditional Survival ◽  
Prognostic Information ◽  
Poor Risk ◽  
The Poor ◽  
Changes Over Time ◽  
Endothelial Growth Factor ◽  
Over Time

358 Background: Survival estimates for patients with mRCC are traditionally reported from the time of TT initiation. These survival projections, however, may not be applicable to patients who have already survived a period of time after initiating therapy. CS accounts for elapsed time since starting therapy, providing more relevant prognostic information. Methods: Data on 1673 patients treated with first-line VEGF TT between 4/7/2003 and 10/12/2010 was analyzed. Median follow up for patients still alive is 20.1 months. Conditioned survival was calculated on the set of patients alive or on TT at 3 months and using 3 months increments for up to 18 months. Results: The 2-year CS probability tends to slightly improve from 44 to 51% when conditioned on having already survived 0 to18 months since initiation of TT, respectively. The Heng et al (JCO 2009) risk criteria (defined at therapy initiation) retains prognostic ability over time independent of previous survival time or previous time on TT up to 18 months (p<0.0001 for all comparisons). In the subgroup analysis stratified by Heng risk groups, 2-year CS minimally changes over time in the favorable (FAV) and in the intermediate (INT) groups, but in the poor risk group, the 2-year CS improves from 11% initially to 33% after 18 months. When conditioned on time on TT, 2-year CS improves from 44% to 68% overall, from 74% to 90% in the FAV risk group, 49% to 57% in the INT risk group and 11% to 73% in the poor-risk group. Conclusions: Conditional survival may be a more relevant measure of prognosis for those who have already survived or have been on TT for a period of time. The largest improvement was seen in patients in the poor risk group. [Table: see text]

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