Comprehensive Geriatric Assessment-Adapted Chemotherapy in Elderly Patients (>70 years) with Diffuse Large B-Cell Non-Hodgkin's Lymphoma (DLBCL): Final Results and Long Term Follow-up.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 2684-2684 ◽  
Author(s):  
Umberto Tirelli ◽  
Lucia Fratino ◽  
Monica Balzarotti ◽  
Lilj Uziel ◽  
Annalisa Giacalone ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Geriatric Assessment ◽  
Comprehensive Geriatric Assessment ◽  
Conflicts Of Interest ◽  
Long Term Follow Up ◽  
Good Score ◽  
Grade 3 ◽  
To Receive

Abstract Abstract 2684 Poster Board II-660 Background: R-CHOP is the standard treatment for elderly patients (pts) with DLBCL. Many pts aged 70 years (yrs) or more are unable to receive R-CHOP and the majority of them are excluded from clinical trials. Comprehensive geriatric assessment (CGA) is an useful instrument to predict the clinical outcome of elderly pts with cancer. Within the GOL (Gruppo Oncoematologico Linfomi) we started a phase II study aiming to evaluate feasibility and activity of a CGA-driven chemotherapy for elderly pts with DLBCL Material and methods: Pts with no comorbidity received CHOP/R-CHOP; pts with mild cardiopathy received epirubicin instead of doxorubicin; in pts with moderate/severe cardiopathy the use of anthracyclines was omitted; pts with diabetes did not receive prednisone; in pts with neuropathy vincristine was omitted. The dosage of chemotherapy was decided according to CGA: pts with a good score (ADL=6 and IADL>6) received full doses of CT; pts with an intermediate score (ADL=5 and IADL>4) received 75% of the dose; pts with a poor score (ADL<5 and IADL<5) received 50% of the dose. Results: One hundred pts (41 males and 59 females) have been treated. The median age was 75 yrs and stages III-IV were diagnosed in 51% of pts. 61% of pts received full doses of CT; 25% received 75% of dose and 14% received 50% reduced dose; 86% of pts received an anthracycline and 54% rituximab. Toxicity was quite acceptable. Grade 3–4 neutropenia was observed in 30% of pts, mucositis in 12%, and peripheral neuropathy in 9%. Four toxic deaths were observed. Overall, 81% of pts achieved complete remission; with a median follow-up of 50 months, 20% of them have relapsed. The 5 yr-OS, DFS, EFS are 58%, 78% and 50%. It is remarkable that the 5-year specific survival is 72%. Conclusions: Our results demonstrate that a CGA-driven approach is feasible in elderly pts with DLBCL. This strategy allows to offer a curative approach to all pts with aggressive NHL, avoiding to under treat pts with a potentially cured disease or over treat pts with severe comorbidities. Disclosures: No relevant conflicts of interest to declare.

Comprehensive Geriatric Assessment-Adapted Chemotherapy in 100 Elderly Patients (>70 Years) with Diffuse Large B-Cell Non-Hodgkin’s Lymphoma (DLBCL).

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 2440-2440 ◽  
Author(s):  
Michele Spina ◽  
Monica Balzarotti ◽  
Uziel Lilj ◽  
Ferreri Andres ◽  
Fratino Lucia ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Geriatric Assessment ◽  
Comprehensive Geriatric Assessment ◽  
Cardiac Toxicity ◽  
Skin Toxicity ◽  
Standard Chemotherapy ◽  
Highly Active ◽  
Good Score ◽  
Grade 3

Abstract Rituximab plus CHOP (R-CHOP) is the standard chemotherapy (CT) regimen for elderly patients (pts) with CD20 positive DLBCL. However, many pts aged 70 years (yrs) or more are often unable to received R-CHOP and the majority of them are excluded from clinical trials. Moreover, comprehensive geriatric assessment (CGA) has been demonstrated a useful instrument to predict the clinical outcome of elderly pts with cancer even if it has never been tested in a prospective way. Within the GOL (Gruppo Oncoematologico Linfomi) from June 2000 to March 2006 we started a phase II prospective study with the aim to evaluate the feasibility and activity of a CGA-driven CT for elderly pts with DLBCL. Rituximab was used in all pts after its introduction in the marketing in Italy (February 2002). Pts with no comorbidity received CHOP or R-CHOP; in pts with mild cardiopathy epirubicin was used instead of doxorubicin (CEOP or R-CEOP); in pts with moderate or severe cardiopathy the use of antracyclines was omitted (CVP or R-CVP); pts with diabetes didn’t receive prednisone (CHO,CEO or R-CHO,R-CEO); pts with neuropathy received CHP or R-CHP or CEP or R-CEP (vincristine was omitted). Moreover, the dosage of CT was decided according to the CGA: pts with a good score of CGA (i.e. ADL=6 and IADL>6) received full doses of CT; pts with an intermediate score (ADL=5 and IADL>4) received 75% of the planned dose; pts with a poor score (ADL<5 and IADL<5) received 50% of the planned dose. All pts received prophylactic filgrastim. One hundred pts (41 males and 59 females) have been treated and no patient was excluded from this approach. The median age was 75 yrs (range 70–89) and stages III–IV were diagnosed in 51% of pts. Sixty-one per cent of pts received full doses of CT; 25% of pts received 75% of planned dose and 14% of pts 50% reduced dose of CT. Overall, 86% of pts received an antracycline (doxorubicin in 56% and epirubicin in 30%) and 54% of pts received rituximab plus CT. The following regimens were used: R-CHOP 22%, CHOP 16%, 75%-R-CHOP 10%, 75%-CHOP 8%, CEOP 11%, R-CEOP 4%, 75%-R-CEOP 9%, 75%-CEOP 6%. The remaining pts received CVP in 5% of cases and reduced R-CVP in 9% of cases. The toxicity was quite acceptable. Grade 3–4 neutropenia was observed in 29% of pts, mucositis in 13%, peripheral neuropathy in 9%, febrile neutropenia in 13%, cardiac toxicity in 3% and skin toxicity in 1%. Four toxic deats were observed (2 septic shock, 1 acute respiratory failure and 1 acute myocardial infarction). Overall, 76% of pts achieved a complete remission (CR) and with a median follow-up of 24 months (range 1–71 months) only 16% of them have relapsed. Seventy-three pts are alive and 63% are alive in CR. Our results demonstrated that a CGA-driven approach is feasible and highly active in elderly pts with DLBCL. Moreover this strategy allows a potentially curative approach to all pts with aggressive NHL avoiding both to under-treat elderly pts with a curable disease and to over-treat elderly pts with comorbidities.

Follow-up Analysis of a Randomized Comparison of Prolonged Myelosuppressive Maintenance Therapy Versus Intensive Consolidation Therapy as Postremission Therapy in AML.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 1056-1056
Author(s):  
Utz O. Krug ◽  
Maria Cristina Sauerland ◽  
Bernhard J Woermann ◽  
Wolfgang Berdel ◽  
Wolfgang Hiddemann ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Maintenance Therapy ◽  
Relapse Free Survival ◽  
Free Survival ◽  
Significant Difference ◽  
Long Term Follow Up ◽  
Postremission Therapy ◽  
To Receive

Abstract Abstract 1056 Poster Board I-78 Introduction: We previously showed that a prolonged myelosuppressive maintenance chemotherapy was superior to S-HAM as a postremission therapy in patients > 16 years of age with AML after a TAD-HAM double induction therapy and TAD consolidation chemotherapy with regard to relapse-free survival (RFS) and borderline significance of the overall survival (OS) in responding patients (Buchner et al., JCO 2003, 21:4496-4504). Here we present long-term follow-up data with a median follow-up of 7.9 years from diagnosis and 7.1 years from the date of complete remission. Patients and Methods: Eight hundred thirty-two patients (median age, 54 years; range, 16 to 82 years) with de novo AML were upfront randomized in the AMLCG1992 study of the German AML Co-operative Group to receive 6-thioguanine, cytarabine, and daunorubicin (TAD) plus cytarabine and mitoxantrone (HAM; cytarabine 3 g/m2 [age < 60 years] or 1 g/m2 [age ≥ 60 years] x 6 (HAM in patients ≥ 60 years only in case of blast persistence on day 16 of therapy) induction, TAD consolidation, and monthly maintenance with cycles of cytarabine combined with either daunorubicin (course 1), 6-thioguanine (course 2), cyclophosphamide (course 3), and again 6-thioguanine (course 4), and restarting with course 1 for 3 years, or to receive TAD-HAM-TAD and one course of intensive consolidation with sequential HAM (S-HAM) with cytarabine 1 g/m2 (age < 60 years) or 0.5 g/m2 (age ≥ 60 years) x 8 instead of maintenance. Results: A total of 576 patients (69.2%) achieved a complete remission (CR) those were 294 of 429 (68.5%) patients randomized to receive maintenance and 282 of 403 (70.0%) patients randomized to receive intensive consolidation S-HAM (p=n.s.). 190 patients received maintenance therapy as intended and 135 patients received an intensive consolidation therapy as intended. This prolonged follow-up analysis verified the superior relapse-free survival in all patients in the maintenance arm (10-year RFS 30.0 ± 5.6 versus 19.9 ± 6.1 %, p = 0.015). Stratified by age, the 10-year RFS was superior in younger patients < 60 years (36.9 ± 7.1 versus 25.2 ± 8.0 %, p = 0.038) and borderline significant in elderly patients (17.2 ± 4.5 versus 6.8 ± 6.2 %, p = 0.075). A subgroup analysis of known risk groups (lactate dehydrogenase (LDH) level < 700U/l versus ≥ 700U/l at diagnosis, cytogenetic risk profile, bone marrow blasts on day 16 after the start of the induction therapy) revealed a superior RFS in the subgroup of patients with LDH level > 700 U/l at diagnosis (33.5 ± 12.3 versus 18.2 ± 9.5 %, p = 0.043). This superior RFS also translated into a superior 10-year relapse-free interval (RFI) of all responding patients in the maintenance arm (35.7 ± 6.3 versus 27.6 ± 5.9 %, p = 0.015) with borderline significance in younger patients (42.9 ± 7.4 versus 35.0 ± 7.4 %, p = 0.053) and a significant difference in elderly patients (20.6 ± 10.0 versus 8.4 ± 7.5 %, p = 0.043). In this updated analysis, there was a trend, but no significant difference in the OS (maintenance arm: 10-year OS 24.3 ± 4.8, intensive consolidation arm: 19.7 ± 4.7 %, p = 0.148), and we verified a trend for a better OS in responding patients for the maintenance arm (10-year OS in responding patients 33.6 ± 7.5 versus 28.5 ± 6.2 %, p = 0.093). The event-free survival (EFS) also showed a trend towards better EFS in the maintenance arm (10-year EFS 20.7 ± 4.2 versus 14.8 ± 4.1 %, p = 0.082) which was significant in elderly patients (10-year EFS 10.5 ± 5.5 versus 3.9 ± 3.7 %, p = 0.044). Discussion: This updated analysis with a long-term follow-up of median 7.9 years from diagnosis and 7.1 years from CR verified the superior RFS and the trend for enhanced OS in responding patients. These results suggest the superiority of a prolonged monthly myelosuppressive maintenance therapy as compared to intensive consolidation S-HAM after TAD-HAM induction and TAD consolidation. Disclosures: No relevant conflicts of interest to declare.

Long Term Follow-Up of the Gimema GSI 103 AMLE Randomized Trial: Daunoxome Seems To Improve Disease-Free Survival (DFS) of Elderly Patients with Acute Myelogenous Leukemia (AML).

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 1979-1979 ◽  
Author(s):  
Roberto Latagliata ◽  
Massimo Breccia ◽  
Simona Iacobelli ◽  
Paola Fazi ◽  
Giovanni Martinelli ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Univariate Analysis ◽  
Myelogenous Leukemia ◽  
Phase Iii ◽  
Induction Treatment ◽  
Induction Phase ◽  
Long Term Follow Up ◽  
To Receive

Abstract The GSI 103 AMLE was a randomized phase III clinical trial to explore the efficacy of DaunoXome (DNX) versus Daunorubicin (DNR) standard treatment in AML elderly patients. From 10/2001 to 2/2004, 301 patients aged 61 to 75 years with a diagnosis of AML according to WHO classification and eligible for intensive chemotherapy were enrolled in this trial by 39 GIMEMA Centers. Patients were randomized to receive induction treatment with DNR (45 mg/sqm day 1 to 3) or DNX (80 mg/sqm day 1 to 3) plus AraC (100 mg/sqm day 1 to 7 by continuous infusion): as consolidation therapy, patients in CR received a further course of the assigned induction treatment. After the consolidation course, patients in CR underwent a 2nd randomization independently from the 1st random, to receive as maintenance therapy either AraC (20 mg twice daily day 1 to 10) plus all-trans retinoic acid (ATRA) (45 mg/sqm day 1 to 10) every 28 days for a maximum of 12 cycles (Arm A) or no further treatment (Arm B). 153 patients were enrolled in the DNR arm and 148 in the DNX arm: the two arms were comparable as to relevant patient characteristics, including karyotype. In the DNR arm, 77 patients (50.3%) achieved CR, 56 (36.6%) were resistant and 20 (13.1%) died during induction (ID). In the DNX arm, 73 patients (49.3%) achieved CR, 47 (31.8%) were resistant and 28 (18.9%) died during induction. Differences between the two arms at univariate analysis were not statistically significant either considering the 3 different types of response or considering ID versus other (Chi-square 0.34 and 0.17 respectively). After CR, the effect of DNX seems to be time-related, due to higher incidence of early deaths in CR (11% vs 3%, p=0.053) and lower incidence of relapse beyond 6 months (at 24 months 60% vs 80%, p=0.064). This translates in a cross of the OS and DFS curves between the two arms, with initial advantage for the DNR arm followed by an advantage for DNX arm after 12 months from diagnosis. A time-dependent covariate Cox model and a landmark analysis on patients in CR after 6 months revealed a better outcome of DNX patients (p= 0.029 and p=0.092, respectively) in the long term DFS follow-up. No difference has been observed in the DFS curves according to maintenance randomization. In conclusion, DNX is as effective as DNR in the induction phase of AML elderly patients, with a trend of increased early toxicity (ID + deaths in CR): however, DNX seems to improve the OS and DFS in the long-term follow-up of these patients, due to a reduction of late relapses. Further trials in more selected elderly patients or in younger patients will be helpful to define the exact role of DNX in AML.

Randomized trial of thoracic radiotherapy with or without concurrent daily low-dose carboplatin in elderly patients with locally advanced non-small cell lung cancer (NSCLC): Long-term follow-up of Japan Clinical Oncology Group (JCOG) Study JCOG0301.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 8532-8532 ◽  
Author(s):  
Shinji Atagi ◽  
Junki Mizusawa ◽  
Satoshi Ishikura ◽  
Toshiaki Takahashi ◽  
Hiroaki Okamoto ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Advanced Nsclc ◽  
Locally Advanced ◽  
Late Toxicity ◽  
Initial Report ◽  
Locally Advanced Nsclc ◽  
Long Term Follow Up ◽  
Grade 3

8532 Background: In the phase III JCOG0301 trial, concurrent chemoradiotherapy (CRT) was compared with radiotherapy (RT), demonstrating clinically significant survival benefits in elderly patients with locally advanced NSCLC after a median follow-up of 19.4 months. However, the long-term patterns and cumulative incidences of toxicity associated with CRT and RT are poorly understood for elderly patients. We report long-term survival data and late toxicities after a minimum follow-up of 6.4 years. Methods: Eligible patients were older than 70 years and had unresectable stage III NSCLC. They were randomly assigned to RT alone (RT arm: irradiation with 60 Gy in 30 fractions) or CRT (CRT arm: the same RT with additional concurrent use of carboplatin 30 mg/m2 per fraction up to the first 20 fractions). The primary endpoint was overall survival (OS). Prognosis and adverse events data were collected beyond those in the initial report of this trial. Kaplan-Meier survival curves and 3- and 5-year survival proportions were calculated. Late toxicities were defined as occurring later than 90 days after RT initiation. Results: From September 2003 to May 2010, 200 patients (RT arm, n = 100; CRT arm, n = 100) were enrolled. Consistent with the initial report, the CRT arm had better OS than the RT arm (HR = 0.743, 95% CI = 0.552 – 0.998, one-sided p = 0.0239 by stratified log-rank test). In the RT and CRT arms, median OS was 16.5 and 21.7 months, 3-year survival was 16.3% and 34.3%, and 5-year survival was 9.2% and 15.2%, respectively. %Grade 3/4 late toxicities were 7.4% (heart 2.1%, lung 5.3%) in the RT arm (n = 94) and 7.5% (esophagus 1.1%, lung 6.5%) in the CRT arm (n = 93). No additional cases of late toxicity (Grade 3/4) were seen since the initial report. There were 7 treatment-related deaths, all of which were recorded in the initial report: 4 (4.0%) in the RT arm and 3 (3.0%) in the CRT arm. Conclusions: Long-term follow-up confirms the survival benefits of CRT for elderly patients with locally advanced NSCLC. There was no observed increase in late toxicity with CRT, as compared with RT alone. Clinical trial information: 00132665.

Targeting frail older adults for outpatient comprehensive geriatric assessment and management services: An overview of concepts and criteria

2002 ◽  
Vol 12 (1) ◽  
pp. 82-92 ◽  
Author(s):  
Faranak Aminzadeh ◽  
William B Dalziel ◽  
Frank J Molnar
Keyword(s):  
Clinical Trials ◽  
Geriatric Assessment ◽  
Comprehensive Geriatric Assessment ◽  
Older Persons ◽  
Diagnostic Process ◽  
Functional Capabilities ◽  
Long Term Follow Up ◽  
Meta Analyses

Comprehensive geriatric assessment (CGA) has been defined as ‘a multidimensional, often interdisciplinary, diagnostic process intended to determine a frail elderly person’s medical, psychosocial, and functional capabilities and problems, with the objective of developing an overall plan for treatment and long-term follow-up’. Evidence from recent meta-analyses of clinical trials of the effectiveness of CGA programmes suggest that older persons may experience a variety of health benefits from these comprehensive services.

Nivolumab (NIVO) plus ipilimumab (IPI) versus chemotherapy (chemo) as first-line (1L) treatment for advanced non-small cell lung cancer (NSCLC): 4-year update from CheckMate 227.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9016-9016
Author(s):  
Luis G. Paz-Ares ◽  
Tudor-Eliade Ciuleanu ◽  
Jong-Seok Lee ◽  
Laszlo Urban ◽  
Reyes Bernabe Caro ◽  
...  
Keyword(s):  
Advanced Nsclc ◽  
Performance Status ◽  
Stage Iv ◽  
Ecog Performance Status ◽  
Programmed Death ◽  
Long Term Follow Up ◽  
To Receive ◽  
Clinical Trial Information

9016 Background: 1L NIVO + IPI was shown to provide durable long-term overall survival (OS) benefit vs chemo regardless of tumor programmed death ligand 1 (PD-L1) expression in patients (pts) with advanced NSCLC in CheckMate 227 Part 1 (NCT02477826); 3-year OS rates were 33% vs 22% in pts with PD-L1 ≥ 1% (HR, 0.79 [95% CI, 0.67–0.93]) and 34% vs 15% in pts with PD-L1 < 1% (HR, 0.64 [95% CI, 0.51–0.81]). Here we report updated results from the study with 4 years’ minimum follow-up. Methods: Adults with previously untreated stage IV / recurrent NSCLC, no known EGFR/ ALK alterations , and ECOG performance status ≤ 1 were enrolled; pts were stratified by squamous (SQ) and non-squamous (NSQ) histology. Pts with PD-L1 ≥ 1% (n = 1189) were randomized 1:1:1 to receive NIVO (3 mg/kg Q2W) + IPI (1 mg/kg Q6W), NIVO alone (240 mg Q2W), or chemo. Pts with PD-L1 < 1% (n = 550) were randomized 1:1:1 to receive NIVO + IPI, NIVO (360 mg Q3W) + chemo, or chemo. OS with NIVO + IPI vs chemo in pts with PD-L1 ≥ 1% was the primary endpoint. Results: With minimum follow-up of 49.4 months (database lock, Feb 18, 2021), pts were at least 2 years beyond the protocol-specified end of immunotherapy treatment. Pts with PD-L1 ≥ 1% continued to show durable benefit with NIVO + IPI vs chemo (HR, 0.76 [95% CI, 0.65–0.90]); 4-year OS rates were 29% (NIVO + IPI), 21% (NIVO), and 18% (chemo). At 4 years, 14% (NIVO + IPI), 10% (NIVO), and 4% (chemo) remained progression free. Among responders, 34%, 30%, and 7% remained in response, respectively. In an exploratory analysis in pts with PD-L1 ≥ 50%, 4-year OS rates were 37% (NIVO + IPI), 26% (NIVO), and 20% (chemo). In pts with PD-L1 < 1%, OS HR for NIVO + IPI vs chemo was 0.64 (95% CI, 0.51–0.81); 4-year OS rates were 24% (NIVO + IPI), 13% (NIVO + chemo) and 10% (chemo). At 4 years, 12% (NIVO + IPI), 7% (NIVO + chemo), and 0% (chemo) remained progression free. Among responders, 31%, 13%, and 0% remained in response, respectively. Among pts who progressed on NIVO + IPI vs chemo, 7% vs 40% (PD-L1 ≥ 1%), and 9% vs 33% (PD-L1 < 1%), received subsequent immunotherapy. Benefit with NIVO + IPI vs chemo was observed for both SQ and NSQ histology (Table). With long-term follow-up, no new safety signals were identified. Conclusions: With 4 years’ minimum follow-up, 1L NIVO + IPI continued to provide durable, long-term OS benefit vs chemo in pts with advanced NSCLC regardless of PD-L1 expression or histology. Clinical trial information: NCT02477826. [Table: see text]

Progression of aortic stenosis in elderly patients over long-term follow up

2013 ◽  
Vol 167 (4) ◽  
pp. 1226-1231 ◽  
Author(s):  
L.G. Kearney ◽  
M. Ord ◽  
B.F. Buxton ◽  
G. Matalanis ◽  
S.K. Patel ◽  
...  
Keyword(s):  
Aortic Stenosis ◽  
Elderly Patients ◽  
Long Term Follow Up
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