Treatment decision and outcome in mRCC patients with different ECOG performance status.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15553-e15553
Author(s):  
Ulrika Harmenberg ◽  
Kajsa Stenmo ◽  
Caroline De Flon ◽  
Peter Wersäll ◽  
Per Sandström
Keyword(s):  
Systemic Therapy ◽  
Performance Status ◽  
Treatment Decision ◽  
Outcome Data ◽  
Phase Iii ◽  
Targeted Agents ◽  
Ecog Performance Status ◽  
Clinical Registry ◽  
Treatment Line ◽  
Ecog Ps

e15553 Background: Phase III studies with targeted agents have shown improved survival for mRCC. There is limited outcome data for the whole mRCC patient group. We collect data in a clinical registry at Karolinska for all patients with mRCC in the Greater Stockholm Region since 2007. Here we present the relationship between ECOG performance status and treatment outcome in this population. Methods: Between 2007 and 2012, 273 patients with mRCC were included in the registry. Patients were divided in two groups: Those that were treated with targeted agents and non- treated patients (symptomatically treated). Results: ECOG PS, available for 63%, was lower for patients treated (n=127) compared to patients not treated with systemic therapy (n=46) (median 1 vs. 2. Median OS from diagnosis to death in respective group was 731 day (n=106) and 269 days (n=55). The median OS from date of first metastasis to death was 500 days and 176 days respectively. In the treated group median OS from start of systemic therapy to death was 321 days. There was a difference in median OS from start of systemic therapy to death between patients who received 1 (n=52)(A), 2 (n=32)(B), 3 (n=16)(C) or > 3 lines (n=6)(D) with a median OS of 160.5 days, 395 days, 641 days and 728.5 days respectively. Mean PS at first line treatment was 1.36 for patients who received only one line and ≤ 1 for patients who received several lines. 13/18 patients with ECOG PS 0 at 1st line received >1 line, corresponding numbers for PS 1, 2 and 3 at 1stline were 21/40, 3/14 and 0/4. The average/ medians ECOG PS at time for the last treatment line were 1.36/1 (A), 1.47/1 (B), 1.64/2 (C) and 1.67/2 (D). Median OS from start of systemic treatment to death was dependent on PS at the start of treatment, ECOG 0 (n=18) 622 days, 1 (n=40) 724 days, ECOG2 (n=14) 226 days, ECOG3 (n=4) 44 days. Irrespective of treatment line, patients with PS 0-1 at initiation of any line of therapy had a 55% chance (47/86) of receiving a subsequent line of treatment, while patients with PS 2-3 only had a 19% chance (7/37). Conclusions: Patients with a good performance status, ECOG 0-1 at treatment start, had longer OS and received more lines of treatment. Patients with ECOG PS 3 could in our hands not be treated at all with targeted agents.

Eligibility of metastatic pancreatic adenocarcinoma (MPA) patients for first-line palliative intent nab-paclitaxel plus gemcitabine (NG) versus FOLFIRINOX (FIO).

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 259-259 ◽  
Author(s):  
Renata D'Alpino Peixoto ◽  
Daniel John Renouf ◽  
Howard John Lim ◽  
Winson Y. Cheung
Keyword(s):  
Performance Status ◽  
Phase Iii ◽  
First Line ◽  
Ecog Performance Status ◽  
Eligibility Criteria ◽  
Pivotal Phase ◽  
Entire Cohort ◽  
Palliative Intent ◽  
Practice Methods ◽  
Ecog Ps

259 Background: The ACCORD 11 and the MPACT trials recently showed superiority of FIO and NG over gemcitabine alone, respectively. However, both trials had strict inclusion criteria. The aim of this study was to determine the proportion of patients (pts) with MPA who would be potentially eligible for first-line palliative intent chemotherapy with FIO and NG in routine clinical practice. Methods: 473 consecutive pts who presented with MPA and initiated palliative chemotherapy with gemcitabine from 2000 to 2011 at the BC Cancer Agency were identified using the provincial pharmacy database. Clinicopathological variables and treatment outcomes were retrospectively collected and compared among groups. Eligibility criteria for each regimen were in accordance with the criteria as described in the respective pivotal phase III trials. Results: In total, median age was 66 years (range 34–89) and 258 (55%) were men. Only 24.7% of the pts would be eligible for FIO as compared to 45.2% for NG. The main reasons for ineligibility for FIO were ECOG performance status (PS) ≥ 2 (56.5%), age > 76 years (19.0%), and bilirubin > 1.5 times the upper limit of the normal range (ULN) (18.6%). The main reasons for ineligibility for NG were bilirubin > ULN (24.5%), ECOG PS ≥ 3 (14.6%), and cardiac dysfunction (13.8%). Median overall survival (OS) for the entire cohort treated with gemcitabine was 5.8 months (95% CI 5.4-6.2). On univariate analyses, eligible pts for FIO had longer median OS than ineligible pts (8.6 vs 4.7 months, p<0.001). Eligible pts for NG also had longer median OS than those deemed ineligible (6.7 vs 4.9 months, p=0.008). After accounting for ECOG PS in the multivariate model, eligibility for either FIO or NG no longered predicted for better OS. Conclusions: In ourpopulation-based analysis, almost twice as many pts would be eligible for NG when compared to FIO, mostly due to ECOG PS. The longer OS observed in the FIO-eligible population likely reflects the exclusion of ECOG PS 2 pts.

Age, gender, and performance status effects on efficacy of 3 versus 6 months of adjuvant oxaliplatin and fluoropyrimidine chemotherapy for stage III colon cancer: Phase III ACHIEVE trial as part of the IDEA collaboration.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 731-731
Author(s):  
Takeshi Kato ◽  
Takayuki Yoshino ◽  
Takeharu Yamanaka ◽  
Masahito Kotaka ◽  
Dai Manaka ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Treatment Duration ◽  
Performance Status ◽  
Disease Free Survival ◽  
Female Gender ◽  
Phase Iii ◽  
Stage Iii ◽  
Ecog Performance Status ◽  
Subgroup Analyses ◽  
Ecog Ps

731 Background: ACHIEVE, a part of the IDEA collaboration, was a multicenter trial randomizing patients with stage III resected colon cancer to either 3 versus 6 months of mFOLFOX6/CAPOX. The primary endpoint was disease-free survival (DFS). We previously reported that the hazard ratios (HRs) of 3 versus 6 months duration in this study according to risk stage (low-risk [T1-3 and N1] or high-risk [T4 or N2]) and regimen (mFOLFOX6 or CAPOX) as well as in overall population were consistent with those observed in the whole IDEA. Methods: ACHIEVE enrolled 1313 patients in Japan between August 2012 and June 2014, out of whom 1291 pts were analyzed for efficacy analysis. As of June 2017, 291 DFS events were observed with a median follow-up time of 39 months. The HR of DFS in the overall population was 0.95 (0.76—1.20) with a 3-year DFS of 80% in 3 months arm and 78% in 6 months arm. In the current study, we investigated subgroup analyses for DFS including age, gender, and ECOG performance status (PS). Results: Outcomes of subgroup analyses are summarized in the Table. With regard to HRs and upper bound on the confidence intervals, the trend of 3 months arm being slightly inferior to 6 months arm in patients with an age of ≥70, female gender, and an ECOG PS of 1; however, there was no evidence of significant interaction across treatment duration and the subgroups. Conclusions: The treatment duration effect did not depend on age, gender, and ECOG PS. Further results according to risk stage and regimen will be presented. Clinical trial information: UMIN 000008543. [Table: see text]

Real-world outcomes of underrepresented patient populations treated with immune checkpoint inhibitors (ICIs): African American descent, poor ECOG performance status, and chronic viral infections.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 2587-2587 ◽  
Author(s):  
Neil J. Shah ◽  
Matthew Blackburn ◽  
Michael R Cook ◽  
Anas Belouali ◽  
Michael Serzan ◽  
...  
Keyword(s):  
African American ◽  
Viral Infections ◽  
Checkpoint Inhibitors ◽  
Performance Status ◽  
Outcome Data ◽  
Viral Reactivation ◽  
Ecog Performance Status ◽  
Chronic Viral Infections ◽  
Grade 3 ◽  
Ecog Ps

2587 Background: ICIs have now become standard of care treatment for multiple malignancies. However, patients (pts) who are African American decent (AA), have a poor ECOG performance status (PS) or chronic viral infections [human immunodeficiency virus (HIV), hepatitis B (HBV) and hepatitis C (HCV)] were underrepresented in early clinical trials with ICIs and outcome data in these pt populations is not well reported. Methods: We performed a retrospective analysis of pts treated with ICIs (anti-PD(L)-1, anti-CTLA-4, or combination ICIs) across five MedStar Health hospitals from January 2011 to April 2018. Investigator-assessed best responses were noted. CTCAE v4.03 was used to capture immune-related adverse events (irAEs). Results: We identified 765 pts treated with 829 unique ICIs therapies across different malignancies. A total of 203 AA pts, 178 pts with a pre-treatment ECOG PS ≥2, 21pts with HIV, and 50 pts with HBV/HCV were noted. Any grade and grade ≥ 3 irAEs in the HIV cohort were 24% and 10% with an ORR of 29%. Any grade and grade ≥ 3 irAEs in HBV/HCV were 50% and 26% with an ORR of 21%. No viral reactivation or changes in pts anti-viral medications were noted during ICIs treatment. The ORR in AA pts was 35%. Any grade and grade ≥ 3 irAEs in the AA cohort were 27% and 8%, respectively. The ORR in pts with ECOG PS ≥2 was 14%. Any grade and grade ≥ 3 irAEs in this cohort were 20% and 4%. Similar trends were seen in the subset of patients with NSCLC treated with anti-PD(L)1 monotherapy (Table). Outcomes of NSCLC pts treated with anti-PD(L)-1 monotherapy. Conclusions: ICI therapy was not associated with any new safety signal in the above underrepresented populations. Prospective studies are needed to validate this data.[Table: see text]

Impact of age on safety and efficacy of first-line FOLFOXIRI/bevacizumab in mCRC: A pooled analysis of TRIBE and TRIBE2 studies.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 3536-3536
Author(s):  
Federica Marmorino ◽  
Daniele Rossini ◽  
Giuseppe Aprile ◽  
Mariaelena Casagrande ◽  
Sara Lonardi ◽  
...  
Keyword(s):  
Febrile Neutropenia ◽  
Performance Status ◽  
Primary Prophylaxis ◽  
Pooled Analysis ◽  
Relative Increase ◽  
Phase Iii ◽  
First Line ◽  
Ecog Performance Status ◽  
Safety And Efficacy ◽  
Ecog Ps

3536 Background: FOLFOXIRI/bevacizumab is a valuable upfront option in mCRC based on results of phase III TRIBE and TRIBE2 studies: 1187 pts aged 18–70 years with ECOG performance status (PS) ≤ 2 or between 71–75 years with an ECOG PS of 0 were randomized to receive first-line FOLFOXIRI/bevacizumab or a doublet (FOLFIRI in TRIBE and mFOLFOX6 in TRIBE2)/bevacizumab. Here, we aimed at assessing the effect of the intensification of the upfront chemotherapy (triplet versus doublet) in terms of safety and efficacy in pts aged < 70 versus 70-75. Methods: Subgroup analyses for ORR, PFS, G3/4 overall adverse events (AEs), chemo-related and bevacizumab-related AEs were performed according to baseline age. Results: 182 (15%) out of 1187 pts were 70-75 years old (97 in the FOLFOXIRI/bevacizumab and 85 in the doublets/bevacizumab arms). The benefit provided by the intensification of the upfront chemotherapy was independent of the age subgroup in terms of both ORR (p for interaction = 0.684) and PFS (p for interaction = 0.634). The risk of overall and chemo-related G3/4 AEs was increased with the triplet independently of age (p for interaction = 0.736 and 0.790), while no difference in bevacizumab-related AEs was observed in both subgroups (p for interaction = 0.566). In the overall population, as compared to younger pts, those aged 70-75 were more susceptible to overall G3/4 AEs (70% vs 57%, p = 0.001). In the FOLFOXIRI/bevacizumab arm a higher incidence of G3/4 diarrhea (27% vs 17%, p = 0.016) and febrile neutropenia (16% vs 6% p = 0.001) and a lower incidence of all grade nausea (51% vs 65%, p = 0.009) and vomiting (26% vs 44% p = 0.001) were reported among elderly pts. Conclusions: The activity and efficacy of FOLFOXIRI/bevacizumab are confirmed among selected pts between 70 and 75 years old, with a relative increase in the risk of chemo-related AEs similar to that of younger pts. However, elderly pts are more susceptible to experience AEs independently of the treatment arm. Considering the increased incidence of febrile neutropenia and diarrhea with FOLFOXIRI/bevacizumab, the use of G-CSF as primary prophylaxis or an initial dose reduction of irinotecan and 5-fluorouracil might be considered in this population.

Randomized, multicenter, open-label, phase III study of the BTK inhibitor ibrutinib versus chlorambucil in patients 65 years or older with treatment-naive CLL/SLL (RESONATE-2, PCYC-1115-CA).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. TPS7130-TPS7130 ◽  
Author(s):  
Jan Andreas Burger ◽  
Paolo Ghia ◽  
Aaron Polliack ◽  
Constantine Tam ◽  
Deepali Suri ◽  
...  
Keyword(s):  
Performance Status ◽  
Single Agent ◽  
Unmet Need ◽  
Previous Treatment ◽  
Phase Iii ◽  
Open Label ◽  
Ecog Performance Status ◽  
Treatment Naïve ◽  
Phase Iii Study ◽  
Ecog Ps

TPS7130 Background: There is an unmet need for safer and more effective therapies for CLL patients who are older/have comorbidites. Ibrutinib, a small molecule inhibitor of BTK, has demonstrated single-agent activity in CLL in the Ph 1b/2 study, PCYC-1102-CA. Treatment-naïve (TN) patients aged >= 65 yrs (n=31) experienced an estimated PFS and OS of 96% at 26 months; ORRs per iwCLL were: 10% CR, 58% PR, and 13% PR with lymphocytosis (Byrd, ASH 2012). AEs were generally Grade 1/2, most commonly diarrhea. Incidence of Grade 3/4 hematologic toxicities was low. These findings support a phase III study of ibrutinib in older patients with treatment-naïve CLL/SLL. Methods: The ongoing study is a randomized, multicenter, open label Ph 3 study comparing safety and efficacy of ibrutinib vs. chlorambucil in TN patients aged >= 65 yrs with CLL/SLL. Approximately 272 patients will be randomized in 1:1 ratio to receive either chlorambucil or ibrutinib, stratified for ECOG PS and Rai stage. Oral chlorambucil will be administered at 0.5 mg/kg on Days 1 and 15 of each 28-day cycle, for up to 12 cycles. Ibrutinib 420 mg q.d. will continue until PD or unacceptable toxicity. Key incl. criteria include age >= 65 yrs, active disease requiring treatment per iwCLL, measurable nodal disease by CT, ECOG performance status 0-2, and adequate organ function (ANC ≥1,000/μL, platelets ≥50,000/μL, creatinine clearance ≥30 mL/min). Key excl. criteria include Richter’s transformation, del(17p13.1) or previous treatment for CLL/SLL. The primary endpoint of the study is PFS, assessed by Independent Review Committee (IRC). Secondary endpoints include ORR, MRD-negative CRs, fatigue by FACIT-F, hematological improvement, safety, and tolerability. Subjects who relapse on PCYC-1115 will be enrolled on PCYC-1116 for long term follow up. Second line therapy is investigator choice; ibrutinib will be made available for patients who experience IRC-confirmed PD ≤12 months of completing chlorambucil therapy, if they meet the treatment criteria. Approximately 85 sites will enroll patients in North America, Europe, Israel, Australia/New Zealand and China. Enrollment began in Q1 2013. Clinical trial information: NCT01722487.

Regorafenib (REG) in patients with hepatocellular carcinoma (HCC) progressing following sorafenib: An ongoing randomized, double-blind, phase III trial.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. TPS4163-TPS4163
Author(s):  
Ann-Lii Cheng ◽  
Richard S. Finn ◽  
Masatoshi Kudo ◽  
Josep M. Llovet ◽  
Shukui Qin ◽  
...  
Keyword(s):  
Systemic Therapy ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Phase Iii ◽  
Open Label ◽  
Double Blind ◽  
Sorafenib Treatment ◽  
Phase Iii Trial ◽  
Ecog Ps

TPS4163 Background: Sorafenib is the accepted first-line systemic therapy for HCC, but no standard option is available for patients with tumor progression following sorafenib. An open-label phase II study suggested that REG, a multikinase inhibitor, had an acceptable safety profile and showed evidence of antitumor activity in patients with progressive HCC (Bolondi et al. Eur J Cancer 2011; 47 [Suppl 1]: abstract 6.576): disease control was achieved in 26/36 patients (72%) and median time to progression (TTP) was 4.3 months; median overall survival (OS) was 13.8 months. On the basis of these promising data, a phase III trial was designed. Methods: This randomized, double-blind, placebo (PBO)-controlled, multinational study (ClinicalTrials.gov identifier NCT01774344) will assess the efficacy and tolerability of REG vs PBO in patients with HCC that has progressed following sorafenib treatment (target n=530). Inclusion criteria include Barcelona Clinic Liver Cancer stage B or C disease, Child–Pugh A liver function, and Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1. Patients who discontinued sorafenib ≥8 weeks before study entry or who received other previous systemic therapy for HCC will be excluded. Patients will be randomized in a 2:1 ratio to receive REG 160 mg or matching PBO OD for weeks 1–3 of each 4-week cycle; all patients will also receive best supportive care. Treatment will continue until disease progression, death, intolerable toxicity, or patient/investigator decision to stop. Doses of study drug may be delayed or reduced to manage clinically significant drug-related toxicities. The primary endpoint is OS; secondary endpoints are TTP, progression-free survival, tumor response, and safety. Analysis will be according to randomized group, stratified by geographic region (Asia vs rest of world), ECOG PS (0 vs 1), alfa-fetoprotein level (<400 vs ≥400 ng/ml), extrahepatic disease (yes vs no), and macrovascular invasion (yes vs no). In addition, blood, plasma, and archival tissue will be assessed for pharmacokinetic and biomarker analyses, and health-related quality of life and health utility will be measured. Clinical trial information: NCT01774344.

A Simple Stratification Factor Prognostic for Survival in Advanced Cancer: The Good/Bad/Uncertain Index

2001 ◽  
Vol 19 (15) ◽  
pp. 3539-3546 ◽  
Author(s):  
Jeff A. Sloan ◽  
Charles L. Loprinzi ◽  
John A. Laurine ◽  
Paul J. Novotny ◽  
Delfino Vargas-Chanes ◽  
...  
Keyword(s):  
Cox Model ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Good Prognosis ◽  
Phase Iii ◽  
Treatment Variable ◽  
Ecog Performance Status ◽  
Lung Cancers ◽  
Oncology Clinical Trials ◽  
Ecog Ps

PURPOSE: This article summarizes the third step of a research program to identify variables that supplement the predictive power of the the Eastern Cooperative Oncology Group (ECOG) performance status (PS) for survival. The objective was to produce a simple, practical, stratification factor for phase III oncology clinical trials involving patients with advanced malignant disease. PATIENTS AND METHODS: A questionnaire was administered to 729 patients with metastatic colorectal or lung cancers. Patients provided a Karnofsky index and appetite rating while physicians provided a survival estimate and the ECOG-PS. Scores for each item were categorized as having a positive, neutral, or negative indication for survival. A patient was classified as having a relatively good prognosis if three or more of the four items showed a positive indication, a bad prognosis if three or more items were negative, and an uncertain prognosis otherwise (Good/Bad/Uncertain [GBU] index). RESULTS: The GBU index improved on the prognostic power of a Cox model quartile index and PS alone and increased the accuracy of survival classification estimates by 5% to 10% more than ECOG-PS alone. For patients with PS of 0 or 1, significant survival patterns exist between GBU groups (P= .002 and .0001, respectively). CONCLUSION: The GBU index may be recommended as a supplementary stratification factor for certain future phase III trials in metastatic lung or colorectal cancer where patient heterogeneity is a particular concern. The GBU represents a relatively modest increase to the cost and patient burden of a clinical trial given the additional control that is achieved over the potentially confounding concomitant to the treatment variable.

Bevacizumab improves outcomes of patients with metastatic colorectal cancer (mCRC) treated with IFL with or without bevacizumab (BV) independent of baseline risk

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 3539-3539
Author(s):  
F. Kabbinavar ◽  
A. Zurlo ◽  
C. Irl ◽  
H. Hurwitz
Keyword(s):  
Performance Status ◽  
Risk Groups ◽  
Phase Iii ◽  
Baseline Risk ◽  
First Line ◽  
Tumour Site ◽  
Ecog Performance Status ◽  
Cell Counts ◽  
Wbc Count ◽  
Ecog Ps

3539 Background: It has been reported that patients with mCRC obtain benefit from BV independent of baseline risk factor status. Analysis of 3,825 patients treated with 5-FU/LV in 19 randomised trials conducted by Koehne et al. [Ann Oncol 2002;13:308–17] showed that four baseline prognostic variables can be used to categorise patients into three prognostic groups with different overall survival (OS). We have retrospectively applied this model to data from a phase III trial of first-line IFL with placebo or BV (AVF2107g). Methods: Data on ECOG performance status (PS), tumour site, alkaline phosphatase (AP) levels and white blood cell counts (WBC) were prospectively collected for the 813 patients randomised in AVF2107g. These data were retrospectively used to categorise patients in the IFL/placebo (n=411) and IFL/BV (n=401; data not available for 1 patient) arms into three risk groups: Low - ECOG PS 0/1, one tumour site; intermediate - ECOG PS 0/1, >1 tumour site, AP level <300U/L, or ECOG PS >1, low WBC count, one tumour site; high - ECOG PS 0/1, >1 tumour site, AP level >300U/L, or ECOG PS >1, high WBC count, >1 tumour site. Median OS and PFS in these groups were calculated. Results: OS (Table) and PFS were significantly longer in the IFL/BV groups compared to the IFL/placebo groups, as well as in the lower compared to the higher risk groups in both arms. Conclusions: The analysis supports previous analyses showing that adding BV to IFL improves OS independent of baseline patient risk. Furthermore, high-risk patients, who are less likely to benefit from IFL, benefit from IFL/BV. The model developed by Koehne et al may be applicable to regimens other than 5-FU/LV and validates the efficacy of BV first line in mCRC. [Table: see text] [Table: see text]

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