CHOP Alone Compared With CHOP Plus Radiotherapy for Localized Aggressive Lymphoma in Elderly Patients: A Study by the Groupe d’Etude des Lymphomes de l’Adulte

2007 ◽  
Vol 25 (7) ◽  
pp. 787-792 ◽  
Author(s):  
Christophe Bonnet ◽  
Georges Fillet ◽  
Nicolas Mounier ◽  
Gérard Ganem ◽  
Thierry Jo Molina ◽  
...  
Keyword(s):  
Overall Survival ◽  
Elderly Patients ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
Low Risk ◽  
Aggressive Lymphoma ◽  
Treatment Groups ◽  
Involved Field ◽  
To Receive

Purpose Chemoradiotherapy has been considered standard treatment for patients with limited-stage aggressive lymphoma on the basis of trials conducted before the introduction of the International Prognostic Index. To evaluate this approach in elderly patients with low-risk localized lymphoma, we conducted a trial comparing chemoradiotherapy with chemotherapy alone. Patients and Methods Previously untreated patients older than 60 years with localized stage I or II histologically aggressive lymphoma and no adverse prognostic factors of the International Prognostic Index were randomly assigned to receive either four cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) plus involved-field radiotherapy (299 patients) or chemotherapy alone with four cycles of CHOP (277 patients). Results With a median follow-up time of 7 years, event-free and overall survival did not differ between the two treatment groups (P = .6 and P = .5, respectively). The 5-year estimates of event-free survival were 61% for patients receiving chemotherapy alone and 64% for patients receiving CHOP plus radiotherapy; the 5-year estimates of overall survival were 72% and 68%, respectively. In a multivariate analysis, overall survival was affected by stage II disease (P < .001) and male sex (P = .03). Conclusion In this large prospective study, CHOP plus radiotherapy did not provide any advantage over CHOP alone for the treatment of low-risk localized aggressive lymphoma in elderly patients.

scholarly journals Natural History of CNS Relapse in Patients With Aggressive Non-Hodgkin's Lymphoma: A 20-Year Follow-Up Analysis of SWOG 8516—The Southwest Oncology Group

2009 ◽  
Vol 27 (1) ◽  
pp. 114-119 ◽  
Author(s):  
Steven H. Bernstein ◽  
Joseph M. Unger ◽  
Michael LeBlanc ◽  
Jonathan Friedberg ◽  
Thomas P. Miller ◽  
...  
Keyword(s):  
Natural History ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
Aggressive Lymphoma ◽  
Oncology Group ◽  
Southwest Oncology Group ◽  
Cns Prophylaxis ◽  
Cns Relapse ◽  
To Receive

Purpose To investigate the incidence, natural history, and risk factors predictive of CNS relapse in patients with de novo aggressive lymphomas and to evaluate the efficacy of CNS prophylaxis in patients with initial bone marrow (BM) involvement. Patients and Methods We conducted an analysis of CNS events from 20-year follow-up data on 899 eligible patients with aggressive lymphoma treated on Southwest Oncology Group protocol 8516, a randomized trial of CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), MACOP-B (methotrexate, doxorubicin, cyclophosphamide, vincristine, prednisone, and bleomycin), ProMACE (prednisone, methotrexate, doxorubicin, cyclophosphamide, etoposide)-CytaBOM (cytarabine, bleomycin, vincristine, methotrexate), and m-BACOD (methotrexate, bleomycin, cyclophosphamide, etoposide). Patients with BM involvement randomly assigned to receive ProMACE-CytaBOM (63 patients) or m-BACOD (58 patients) were to receive CNS prophylaxis, whereas those randomly assigned to receive CHOP or MACOP-B did not. Results CNS relapse is uncommon (25 of 899 patients), with a cumulative incidence of 2.8%. CNS relapse occurs early (median time to relapse, 5.4 months from diagnosis). Indeed, 20 of 25 patients with CNS relapse relapsed during chemotherapy, or within 6 months of completion. The number of extranodal sites and the International Prognostic Index were predictive of CNS relapse. There was no significant benefit of CNS prophylaxis in patients with BM involvement at diagnosis; however, given the small number of events, the power of this analysis is limited. Conclusion The early occurrence of CNS events suggests that these patients had subclinical disease at initial diagnosis. As such, strategies to better detect and treat patients with subclinical CNS disease at diagnosis would be anticipated to result in a decrease in the incidence of CNS relapse, without subjecting those patients not destined for CNS relapse to unnecessary and potentially toxic prophylaxis strategies.

A Short Weekly Chemotherapy Regimen (ACOP-B) Followed by Involved Field Radiotherapy in Limited Stage Aggressive Non-Hodgkin Lymphoma. Multicentric Analyses of Toxicity, Efficacy and Long Term Follow up.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 2435-2435
Author(s):  
Maria Giuseppina Cabras ◽  
Roberto Freilone ◽  
Angela Mamusa ◽  
Paolo Dessalvi ◽  
Anna Tonso ◽  
...  
Keyword(s):  
Overall Survival ◽  
Side Effects ◽  
Complete Remission ◽  
Elderly Patients ◽  
Aggressive Lymphoma ◽  
Short And Long Term ◽  
Involved Field ◽  
Involved Field Radiotherapy

Abstract Patients with Ann Arbor stages I and II diffuse large cell lymphoma (DLCL) represent a significant proportion of patients with aggressive lymphoma. Recent clinical research are developing low intensity chemotherapy approach in order to minimize short and long term side effects while maintaining high success rate. Moreover very limited studies are available on elderly patients. Since 1993 we used a brief weekly (six weeks) chemotherapy scheme (Doxorubicin, Cyclophosphamide, Bleomycin, Vincristine and Prednisone = ACOP-B) followed by involved field radiotherapy in patients with localized stage aggressive lymphoma and examined long term results and side effects in a general haematology population without age limit. Two hundred and six consecutive patients (89 females) affected by localized aggressive lymphoma aged from 18 to 85 years old (median 57) treated between January 1st, 1993 and December 31st, 2004 were enrolled in this analysis. Minimum follow up was 18 months. Inclusion criteria was well documented nodal or extranodal stage IA (including bulky) or IIA disease. Bulky disease was defined as a 10 cm or more mass in maximal diameter. Treatment was completed as designed in 183 over 206 patients (88%). Three patients did not complete the six scheduled cycles of chemotherapy: one died during chemotherapy and two because of disease progression. Twenty additional patients did not receive radiotherapy: 12 patients had an initial site of disease totally resected (9 with gastric lymphoma and 3 with small or large bowel lymphoma). One hundred and ninety-seven patients (96%) achieved a complete remission, two patients obtained a partial response; three patients had no response (four patients were not valuable). At a median follow-up 66 months one hundred and seventy patients are alive (82 %) 168 of them free of disease. Twenty-nine patients (15%) experienced relapse after achieving a complete remission. The median time to relapse was 46 months with a very wide range (1–143 months). Among these twenty-nine patients eighteen (62%) are alive and free of lymphoma after second line therapy. Twenty-six (13%) patients have died, 13 (5%) by lymphoma progression, one for toxicity and 12 (6%) from other causes while in complete remission. After 13 years the Kaplan-Meier (K-M) probability of overall survival and disease free survival were 80% (95%CI 72–88%) and 55% (95% CI 33–76%), respectively. We specifically analyzed patients over 60 years: they were 93 (median age 70 years). In this group of elderly patients the treatment was completed as designed in 90% and the 12 years K-M probability of overall survival was 60%. Seven patients presented secondary malignancies which were diagnosed at a median of three years (range 2–8) after chemo-radio therapy. Four patients died by solid neoplasm. Overall incidence of secondary malignancy was 0.68/100/anno. The ACOP-B regimen plus involved field radiotherapy is a short and long term well tolerated and effective chemotherapy scheme for very well defined limited stage aggressive non-Hodgkin lymphomas in all age categories.

Randomized Comparison of ACVBP and m-BACOD in the Treatment of Patients With Low-Risk Aggressive Lymphoma: The LNH87-1 Study

2000 ◽  
Vol 18 (6) ◽  
pp. 1309-1315 ◽  
Author(s):  
Hervé Tilly ◽  
Nicolas Mounier ◽  
Pierre Lederlin ◽  
Josette Brière ◽  
Brigitte Dupriez ◽  
...  
Keyword(s):  
Group Performance ◽  
Remission Rate ◽  
Performance Status ◽  
International Prognostic Index ◽  
Eastern Cooperative Oncology Group ◽  
Prognostic Index ◽  
Tumor Burden ◽  
Low Risk ◽  
Aggressive Lymphoma ◽  
Standard Regimen

PURPOSE: To compare a short intensified regimen followed by sequential consolidation therapy (doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone [ACVBP]) to the standard regimen of methotrexate, bleomycin, cyclophosphamide, and etoposide (m-BACOD) in patients with low-risk aggressive lymphoma. PATIENTS AND METHODS: A total of 752 patients with intermediate- or high-grade lymphoma and no adverse prognostic factors (Eastern Cooperative Oncology Group performance status of 2 to 4, ≥ two extranodal sites of disease, tumor burden ≥ 10 cm in largest dimension, bone marrow or CNS involvement, Burkitt’s or lymphoblastic subtypes) were registered. Of 673 eligible patients, 332 received ACVBP and 341 received m-BACOD. RESULTS: The complete remission rate was identical (86%) in the two groups. With a median follow-up duration of 7 years, the 5-year failure-free survival (FFS) rate was 65% in the ACVBP group and 61% in the m-BACOD group (P = .16). The 5-year overall survival rate was 75% in the ACVBP group and 73% in the m-BACOD group (P = .47). ACVBP was responsible for more severe and life-threatening infections (P < .01), but m-BACOD caused more pulmonary toxicity (P < .001). The number of treatment-related deaths did not differ between the two regimens. A multivariate analysis indicated that ACVBP was associated with a longer FFS in patients with two or three risk factors of the International Prognostic Index. CONCLUSION: In this population of patients with low-risk aggressive lymphoma, toxicities of the regimens are different, but the rates of response and survival are identical. The survival advantage of ACVBP over standard regimen in patients with advanced disease is suggested by this analysis but remains to be assessed in prospective studies specifically designed for this purpose.

Efficacy of Melphalan and Prednisone Plus Thalidomide in Patients Older Than 75 Years With Newly Diagnosed Multiple Myeloma: IFM 01/01 Trial

2009 ◽  
Vol 27 (22) ◽  
pp. 3664-3670 ◽  
Author(s):  
Cyrille Hulin ◽  
Thierry Facon ◽  
Philippe Rodon ◽  
Brigitte Pegourie ◽  
Lotfi Benboubker ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Survival ◽  
Elderly Patients ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Standards Of Care ◽  
Newly Diagnosed ◽  
Grade 3 ◽  
To Receive

Purpose Until recently, melphalan and prednisone were the standards of care in elderly patients with multiple myeloma. The addition of thalidomide to this combination demonstrated a survival benefit for patients age 65 to 75 years. This randomized, placebo-controlled, phase III trial investigated the efficacy of melphalan and prednisone plus thalidomide in patients older than 75 years with newly diagnosed myeloma. Patients and Methods Between April 2002 and December 2006, 232 previously untreated patients with myeloma, age 75 years or older, were enrolled and 229 were randomly assigned to treatment. All patients received melphalan (0.2 mg/kg/d) plus prednisone (2 mg/kg/d) for 12 courses (day 1 to 4) every 6 weeks. Patients were randomly assigned to receive 100 mg/d of oral thalidomide (n = 113) or placebo (n = 116), continuously for 72 weeks. The primary end point was overall survival. Results After a median follow-up of 47.5 months, overall survival was significantly longer in patients who received melphalan and prednisone plus thalidomide compared with those who received melphalan and prednisone plus placebo (median, 44.0 v 29.1 months; P = .028). Progression-free survival was significantly prolonged in the melphalan and prednisone plus thalidomide group (median, 24.1 v 18.5 months; P = .001). Two adverse events were significantly increased in the melphalan and prednisone plus thalidomide group: grade 2 to 4 peripheral neuropathy (20% v 5% in the melphalan and prednisone plus placebo group; P < .001) and grade 3 to 4 neutropenia (23% v 9%; P = .003). Conclusion This trial confirms the superiority of the combination melphalan and prednisone plus thalidomide over melphalan and prednisone alone for prolonging survival in very elderly patients with newly diagnosed myeloma. Toxicity was acceptable.

Elderly patients with aggressive non-Hodgkin's lymphoma: disease presentation, response to treatment, and survival--a Groupe d'Etude des Lymphomes de l'Adulte study on 453 patients older than 69 years.

1997 ◽  
Vol 15 (8) ◽  
pp. 2945-2953 ◽  
Author(s):  
Y Bastion ◽  
J Y Blay ◽  
M Divine ◽  
P Brice ◽  
D Bordessoule ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Hodgkin’S Lymphoma ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
Hodgkin's Lymphoma ◽  
Aggressive Lymphoma ◽  
Prognostic Parameters ◽  
Aggressive Disease ◽  
Non Hodgkin’S Lymphoma ◽  
Non Hodgkin's Lymphoma

PURPOSE To clarify disease characteristics and optimal treatment for elderly patients with non-Hodgkin's lymphoma (NHL), we performed a randomized trial in 453 patients older than 69 years with aggressive lymphoma. PATIENTS AND METHODS Two hundred twenty patients received cyclophosphamide 750 mg/m2, teniposide (VM-26) 75 mg/m2, and prednisone 40 mg/m2/d for 5 days (CVP) and 233 patients received CVP plus pirarubicin (THP-doxorubicin) 50 mg/m2 (CTVP), each for six courses every 3 weeks. RESULTS The median age was 75 years. Most patients had clinically aggressive disease; 30% had one and 53% two or three adverse prognostic parameters as defined by the International Prognostic Index. More patients on the CTVP arm had an elevated lactic dehydrogenase (LDH) level, but the two groups were otherwise well balanced. CTVP treatment was more frequently associated with leukopenia, thrombocytopenia, and infectious complications. Death during chemotherapy occurred in 16% and 21% of patients on the CVP and CTVP arms, respectively (not significant). Forty percent of patients achieved a complete response (CR): 47% on CTVP and 32% on CVP (chi2 = 20.98, P = .0001). The median time to treatment failure (TTF) was 7 months for CTVP versus 5 months for CVP (log-rank test, P < .05). The median survival time was 13 months in both groups; however, the 5-year survival rate was 26% with CTVP versus 19% with CVP (chi2 = 4.68, P < .05). Lymphoma progression was the primary cause of death. CONCLUSION Elderly patients with aggressive lymphoma have an aggressive disease with adverse prognostic parameters at the time of diagnosis. Slightly longer survival was observed for patients treated with an anthracycline-containing regimen.

Impact of dose-escalated radiation on overall survival in men with nonmetastatic prostate cancer.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 28-28
Author(s):  
Anusha Kalbasi ◽  
Jiaqi Li ◽  
Abigail T. Berman ◽  
Samuel Swisher-McClure ◽  
Marc C. Smaldone ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
High Risk ◽  
Standard Dose ◽  
Low Risk ◽  
External Beam Radiation ◽  
Risk Category ◽  
Beam Radiation ◽  
Treatment Groups

28 Background: Infive publishedRCTs, dose-escalated external beam radiation therapy (EBRT) for prostate cancer resulted in improved biochemical and local control. However, the question of whether dose escalation improves overall survival (OS) remains unanswered. We examined OS among men with non-metastatic prostate cancer undergoing EBRT in the modern era. Methods: Using the National Cancer Database (NCDB), we conducted non-randomized comparative effectiveness studies of dose-escalated versus standard-dose EBRT in men diagnosed from 2004-2006 in three analytic cohorts defined by NCCN risk category: low- (N=12,848), intermediate- (N=14,966) or high-risk (N=14,587) prostate cancer. We categorized patients in each risk cohort into 2 treatment groups: standard-dose (68.4 Gy to <75.6 Gy) or dose-escalated (≥75.6 Gy to 90 Gy) EBRT. The primary outcome was time to death from any cause, measured from diagnosis to NCDB date of death or end of follow-up (December 31, 2011). We compared OS between treatment groups in the three analytic cohorts using Cox proportional hazard models. Inverse probability weighted propensity score methods were used to balance differences between treatment groups in age, race, year of diagnosis, AJCC T- and N-stage, PSA, Gleason score, androgen deprivation therapy, IMRT use, comorbid disease, income, insurance, urban/rural location, facility type and facility volume. In secondary analyses, we evaluated dose response for survival by categorizing dose in approximately 2 Gy increments. Results: Median follow up for survivors was between 73 and 74 months in all three risk cohorts. Dose-escalated EBRT was associated with improved survival in the intermediate-risk (adjusted HR 0.81, 95% CI 0.77 and 0.85, p<0.0001) and high-risk groups (aHR 0.85, 95% CI 0.81 and 0.89, p<0.0001), but not the low-risk group (aHR 0.99, 95% CI 0.92-1.06, p=0.803). For every incremental ~2Gy increase in dose, there was a 9% (95% CI 6% – 11%, p<0.0001) and 7% (95% CI 3% - 10%, p=0.004) reduction in the hazard of death for intermediate- and high-risk patients, respectively. Conclusions: Dose-escalated EBRT is associated with improved survival in men with intermediate- and high-risk, but not low-risk, prostate cancer.

What Is the Appropriate Dose Attenuation System of RCHOP for Elderly DLBCL Patients? - A Single Institutional Analysis in 115 Cosecutive Patients From Japan -

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 3639-3639
Author(s):  
Akira Tanimura ◽  
Risen Hirai ◽  
Atsushi Sato ◽  
Miki Nakamura ◽  
Masataka Takeshita ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Prognostic Factors ◽  
Elderly Patients ◽  
Conflicts Of Interest ◽  
Univariate Analysis ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
B Cell Lymphoma ◽  
Age Related

Abstract Abstract 3639 Background: The combination therapy of RCHOP [rituximab (R), cyclophosphamide (CY), doxorubicin (DOX), vincristine (VCR), and prednisone (PSL)] is a standardized treatment for diffuse large B-cell lymphoma (DLBCL). However, its clinical outcome is worse in elderly patients because of comorbidities, age-related decrease in organ function, and impaired drug metabolism. If possible, the dose of RCHOP in elderly patients and patients with comorbidities should be adjusted appropriately. Since 2005, we have used a unified dose attenuation system for RCHOP according to the age and comorbidities of patients. This study retrospectively verified this system. Patients/Methods: We analyzed 115 consecutive DLBCL patients treated at our institute from September 2001, when rituximab was approved in Japan, to December 2010. From September 2001 to August 2005, 33 patients received dose adjustment of RCHOP according to the physician's discretion (PHY group). From September 2005, 82 patients received RCHOP according to the unified dose attenuation system (UNI group). In the UNI group, patients younger than 60 years received the standard RCHOP dose [R, 375 mg/m2; CY, 750 mg/m2; DOX, 50 mg/m2; VCR, 1.4 mg/m2 (max 2.0 mg/body); PSL, 100 mg/m2]. In patients older than 60 years, the doses of CY, DOX, VCR, PSL, and R were attenuated as shown in Table 1. In addition to age, the doses of CY, DOX, and VCR were adjusted according to organ functions (Table 2). The two groups were compared statistically. Results: The median age of patients was 70 years (range, 38–91), with 70.4% of patients classified as stage III or IV DLBCL, 40.4% with an international prognostic index (IPI) score of 0–2, and 70.2% with a ECOG performance status (PS) of 0 or 1. Low serum albumin levels (under normal range) were observed in 50.5% patients, and a high Charlson comorbidity index (CCI) score of >1 was found in 58.3%. The characteristics of the patients in the two groups were almost similar. The UNI system was completed in 94% of patients. The complete response (CR) rate was 63% in all patients (UNI group, 73%; PHY group, 39%; P = 0.0006). Univariate analysis revealed that better prognostic factors for CR were a low IPI score, better PS, and the UNI group. In the multivariate analysis, only the UNI group was a significantly better prognostic factor for CR. With a median follow-up of 26 months, the 5-year event-free survival (EFS) and overall survival (OS) were 39.3% and 68% in all patients, 43% and 72% in the UNI group, and 27% and 59% (5-year EFS; P = 0.0083, 5-year OS; P = 0.16) in the PHY group, respectively. Multivariate analysis showed that better prognostic factors for EFS were a low IPI score, a low CCI score, and the UNI group, and that for OS were low IPI and low CCI scores. In elderly patients aged >70 years (N = 59), the CR rates were 81% and 13% in the UNI and PHY groups, respectively (P = 0.0004), with OS in the UNI group being longer than that in the PHY group (72% vs. 59%; P = 0.02; Fig.1). In the UNI group, patient age did not affect the CR rate (<70, 71% vs. 70–79, 83% vs. >79, 79%; P = 0.56) or 5-year OS (<70, 76% vs. 70–79, 70% vs. >79, 66%; P = 0.58). The actual dose of CY, DOX, and VCR compared with the standard RCHOP dose was 64% and 26%, 63% and 16%, and 63% and 21% in the UNI and PHY groups, respectively. Disease progression during treatment, discontinuation of therapy, and death during treatment were observed in 10% and 15%, 5% and 24%, and 5% and 3% in the UNI and PHY groups, respectively. Nineteen patients (23%) from the UNI group died over a median follow-up of 15 months, while 15 patients (45%) of the PHY group died over a median follow-up period of 29 months. Lymphoma-related deaths were 12 (14%) in the UNI group and 8 (24%) in the PHY group. Five secondary primary malignancies (SPM) were observed (1 colon cancer and 1 breast cancer in the PHY group, and 1 lung cancer and 2 myelodysplastic syndrome in the UNI group). Four deaths were related to SPM. Conclusion: The unified dose attenuation system determined by the patients' age and comorbidities may achieve an effective dose level and better prognosis in elderly DLBCL patients. Disclosures: No relevant conflicts of interest to declare.

Randomized Comparison of Cladribine Single (C) or in Combination with Cyclophosphamide (CC), and COP in Previously Untreated Low Grade B-Cell Non-Hodgkin Lymphoma Patients.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 2481-2481
Author(s):  
E. Kalinka ◽  
J. Wajs ◽  
K.S. Sulek ◽  
M. Blasinska-Morawiec ◽  
P. Centkowski ◽  
...  
Keyword(s):  
B Cell ◽  
Hodgkin Lymphoma ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
Low Grade ◽  
Non Hodgkin Lymphoma ◽  
Not Otherwise Specified ◽  
Ann Arbor ◽  
To Receive

Abstract To comparatively assess first-line treatment with cladribine single (C) or in combination with cyclophosphamide (CC), and COP (cyclophosphamide, vincristine, prednisone) in low grade B-cell non-Hodgkin lymphoma (NHL), previously untreated patients (pts) with Ann Arbor stage II-IV were randomly allocated to receive 6 monthly courses of either C, CC, or COP. End points were treatment response, freedom from progression (FFP) and overall survival (OS), and tolerance. From June 1, 2000 to June 30, 2005, 196 pts were randomized in 17 centers. Of 153 pts for whom data is available, 55 (36%) were diagnosed as small lymphocytic, 11 lymphoplasmocytoid (7%), 37 marginal-zone (24%), 42 follicular (27.5%), and 8 not otherwise specified low grade B-cell NHL (5.5%). Randomization constituted comparable groups, including International Prognostic Index variables. Compared to C and CC, COP induced lower overall response rates (75%, 90%, 50%, χ2 =7.9 p<.005), including lower complete remission rates (38%, 62%, 9.5%, χ2=19.2 p<.0001). With a median follow-up of 15 months, FFP was superior in patients receiving cladribine-containing regimens (χ2 = 21.8, log-rank p<.0001). No difference in median OS was observed. Incidences of infections (9% versus 3.5% versus 7%) and non-hematological side effects (7.5% versus 3.5% versus 7%) were similar in the randomized groups, whereas CC but not C induced more frequent peripheral cytopenias compared to COP (30% versus 11%, p=.034). This resulted in higher frequency of prolongation of intervals between CC versus COP treated pts (respectively 45% and 21%, χ2=6.04 p=.014) and C versus CC treated pts (respectively 26% and 45%, χ2=4.24, p=.039). Dose reductions because of hematological or other toxicity were comparable in C (9.5%), CC (20%), and COP (21%) groups. Although final results warrant completed data for all randomised pts with longer follow-up, similar tolerance and higher efficacy of cladribine-based regimens over COP provide rationale to combine C or CC with rituximab in future clinical trials.

Rituximab Combined with Chemotherapy and Interferon in Follicular Lymphoma Patients: Final Analysis of the GELA-GOELAMS FL2000 Study with a 5-Year Follow-Up.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 792-792 ◽  
Author(s):  
Gilles Andre Salles ◽  
Nicolas Mounier ◽  
Sophie de Guibert ◽  
Franck Morschhauser ◽  
Chantal Doyen ◽  
...  
Keyword(s):  
Overall Survival ◽  
Follicular Lymphoma ◽  
Chemotherapy Regimen ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
Response To Therapy ◽  
Event Free Survival ◽  
Free Survival ◽  
Interferon Α2a

Abstract Background. The FL2000 study evaluated the combination of the anti-CD20 monoclonal antibody rituximab with chemotherapy plus interferon in the first line treatment of follicular lymphoma patients. Methods. Untreated follicular lymphoma patients (n=359) presenting with a high tumor burden were randomly assigned to receive either 12 courses of the chemotherapy regimen CHVP (cyclophosphamide, adriamycin, etoposide and prednisolone) plus interferon-α2a (CHVP+I arm) over 18 months or 6 courses of the same chemotherapy regimen combined with 6 infusions of 375 mg/m2 of rituximab and interferon for the same time period (R-CHVP+I arm). The primary endpoint of the study was event free survival and all results are shown as intent to treat. Results. Six months after treatment initiation, 156 out of 183 (85%) and 164 out of 175 (94%) patients had a response to therapy in the CHVP+I and R-CHVP+I study arm, respectively (P=.009). At the end of the 18 months treatment period, 59% and 75% of the patients were respectively in CR or CRu in the CHVP+I and R-CHVP+I arm (P<.05). After a median follow-up of five years, event-free survival (EFS) estimates were respectively 37% [95% C.I. 29 – 44] and 53% [95% C.I. 45 – 60] in the CHVP+I and R-CHVP+I arm (P=.0004). Response duration in CR/CRu or PR patients at the end of the 18 months treatment was also improved in the R-CHVP+I arm (P=.012). 5-year overall survival (OS) estimates were not statistically different in the CHVP+I (79%) [95% C.I. 72 – 84]) and R-CHVP+I (84% [95% C.I. 78 – 84]) arms. The Follicular Lymphoma International Prognostic Index (FLIPI) score allowed separation of the whole study population into 3 different risk categories with significantly different outcome for each group both for 5 year EFS and OS (P<.0001, respectively each). In a multivariate regression analysis, event free survival was significantly influenced by both the FLIPI score (HR=2.08; 95% C.I. [1.6 – 2.8]) and the treatment arm (HR=0.59; 95% C.I. [0.44 – 0.78]). In an exploratory analysis considering the 187 patients with a low/intermediate (<3) FLIPI score, the outcome according to each treatment arm was not statistically different while the benefit of the rituximab combination was highly significant in term of EFS (P=.0002) and OS (P=.025) in the 162 patients with a high (≥3) FLIPI score. Conclusions. These results extend our previous interim analyses and confirm that with a five year follow-up, the combination of rituximab with CHVP+I provides superior disease control in follicular lymphoma patients despite a shorter duration of chemotherapy. However, this combination appears to benefit essentially to high risk patients for whom overall survival is also significantly improved.

Overall survival (OS) results of a phase III randomized trial of standard-of-care therapy with or without enzalutamide for metastatic hormone-sensitive prostate cancer (mHSPC): ENZAMET (ANZUP 1304), an ANZUP-led international cooperative group trial.

2019 ◽  
Vol 37 (18_suppl) ◽  
pp. LBA2-LBA2 ◽  
Author(s):  
Christopher Sweeney ◽  
Andrew James Martin ◽  
Robert Richard Zielinski ◽  
Alastair Thomson ◽  
Thean Hsiang Tan ◽  
...  
Keyword(s):  
Overall Survival ◽  
A Priori ◽  
Standard Of Care ◽  
Phase Iii ◽  
P Value ◽  
Serious Adverse Events ◽  
Treatment Groups ◽  
Hormone Sensitive ◽  
To Receive

LBA2 Background: Testosterone suppression (TS) is the backbone of treatment for mHSPC. OS is improved by the addition of early docetaxel (DOC) or abiraterone to TS. ENZAMET assessed the effects of enzalutamide (ENZA), a potent androgen receptor (AR) inhibitor, versus a nonsteroidal anti-androgen (NSAA: bicalutamide, nilutamide, or flutamide) in addition to SOC (TS with or without DOC) in mHSPC. Methods: Men with mHSPC were randomly assigned 1:1 to receive TS plus either ENZA or NSAA. Randomization was stratified by: volume of disease (high vs low, according to CHAARTED); planned early DOC; planned anti-resorptive therapy, comorbidity score (ACE-27), and study site. The primary endpoint was overall survival. Accrual of 1100 men provided 80% power to detect a 25% reduction in the hazard of death (HR 0.75) with up to 4 interim analyses (IA), the first planned to occur after 235 deaths (50% of total information with a critical p-value threshold <0.0031 by the Lan-DeMets alpha-spending approach with O’Brien-Fleming type shape). Subgroup analyses to assess possible modulation of the treatment effect were specified a priori and included planned early docetaxel (yes vs no) and volume of disease (high vs low). Results: We randomly assigned 1125 patients from 31MAR14 to 24MAR17. The treatment groups were well balanced for all important baseline factors. Criteria for early reporting were met at the first IA (28FEB2019) after a median follow-up of 33 months. Overall survival was prolonged by ENZA (see below). At 3 years, 36% NSAA vs 64% ENZA were still on their assigned study treatment. Serious adverse events (regardless of attribution) within 30 days of study treatment occurred in 42% ENZA vs 34% NSAA, commensurate with the different durations of study treatment. Conclusions: ENZA significantly improved OS when added to SOC in mHSPC. The benefits appeared lower in those planned to receive early DOC. Results of analyses with updated follow-up triggered by this IA will be presented. Clinical trial information: NCT02446405. [Table: see text]

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