Sustained Immune Competency and Long Term Molecular Remissions in FL Patients with FLIPI Risk Factors >1, Treated Front Line with R-CHOP Followed by Consolidative 90 Y-Radioimmunotherapy and Maintenance Rituximab

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 3681-3681
Author(s):  
Neil L Berinstein ◽  
Nancy M Pennell ◽  
Mary-Anne Cussen ◽  
Kevin R Imrie ◽  
Eugenia Piliotis ◽  
...  
Keyword(s):  
Risk Factors ◽  
Flow Cytometry ◽  
Follicular Lymphoma ◽  
Complete Response ◽  
Line Treatment ◽  
First Line ◽  
Molecular Remission ◽  
Cell Counts ◽  
First Line Treatment

Abstract Abstract 3681 Introduction: The First-Line Indolent Trial (FIT) demonstrated that administration of a single infusion of 90Y-RIT to follicular lymphoma grade 1 or 2 patients with CR or PR after induction chemotherapy could significantly prolong time to progression versus no further therapy. [JCO 2008;26(32):5156–63]. Recently, Fowler et al (ASH 2011, abstract 99) have reported on a chemoimmunotherapy approach followed by both RIT consolidation and rituximab maintenance for advanced stage FL patients with FLIPI risk factors >2. However, molecular status (PCR for t[14;18]) was not reported beyond one year of follow-up. We report a phase II study of safety and efficacy of 90Y-RIT following R-CHOP chemotherapy in patients with FLIPI=2–5, advanced stage FL. Maintenance rituximab is given every 3 months (m) post 90Y-RIT, for 24 m. Planned accrual is 33 evaluable patients with extensive two year molecular and immunologic follow-up. Novel insights into the biologic and immunologic effects of this combination regimen are presented. The primary endpoint of our study is the final complete response (CR) rate, defined according to the Cheson criteria and measured 3 m after day 1 of the 90Y-RIT therapy. Secondary outcomes included molecular remission and immunologic effects. Methods: In patients who had PCR detectable t[14;18] in baseline diagnostic specimens, quantitative real-time PCR was performed on blood and available bone marrow, at baseline, post 6xR-CHOP and Q 3 months post 90Y-RIT treatment for 24 m. The sensitivity of our PCR assay was 1 in 105cells. Flow cytometry for % B cell clonality was performed at the same time points. T and B cell counts, Ig levels and vaccine serology have been recorded pre and post treatment. Results: We have enrolled 26 patients with a median age of 54 yrs, 80% stage 4, 58%, intermediate FLIPI=2, 42% high FLIPI=3–5. Sixteen of 26 [62%] patients had a complete response (CR/CRu) to R-CHOP and the remaining 10 [40%] showed partial response (PR). One patient died due to sepsis prior to 90Y-RIT. Five patients with a partial response post R-CHOP converted to CRu post 90Y-RIT. A total of 19 of 24 (79%) patients who received 90Y-RIT, achieved CR/Cru. Post 90Y-RIT, three patients have relapsed. One other developed a secondary malignancy by 9m. The treatment has been most favourable for patients with FLIPI=2, where 13/14 (93%) remain progression-free [median follow-up= 32 m, range= 12.5–62 m]. There were no SAEs attributable to the 90Y-RIT treatment. Seventeen patients had PCR detectable t(14:18) translocations. Quantitative PCR measurements were concordant with flow cytometry. Of these, 16, were evaluated post 90Y-RIT and 15/16 (94%) of these patients became PCR negative in blood. Post 90Y-RIT, 2 patients showed increase in PCR levels and relapsed clinically. All remaining pts with PCR markers are PCR negative in blood as far as 24 m post 90Y-RIT. CD3+T cell counts remained normal, but CD19+B cells fell below the 1% detection level by flow cytometry during the two yrs of maintenance therapy post 90Y-RIT. Interestingly, mean IgG levels remained close to normal, but mean IgM levels fell below normal. Memory immune responses to measles and mumps were maintained post chemo-radiotherapy. Antibody titres to Rubella did not change significantly post 90Y-RIT. No HAMA response has been detected in any of the patients. Conclusions: We found effective eradication of follicular lymphoma from the blood and bone marrow of the high risk lymphoma pts with 2 or more FLIPI risk factors with first line treatment of 6xRCHOP and all but one of our evaluable patients (94%) achieved molecular remission in blood post 90Y-RIT. Molecular remission was sustained after 90Y-RIT up to 2 years, considerably longer than that reported by Fowler et al (ASH 2011, abstract 99). Longer follow-up with annual monitoring is planned to determine the precise response duration. The progression-free survival rates are similar or more favourable to previous reports [Blood 2006;108:1504–1508, J Clin Exp Hem. 2012; 52,no. 1]. IgG levels remain close to normal indicating that memory B cells are intact and this was consistent with no significant change in titres to common previously vaccinated pathogens such as rubella. The significance of persistent reductions on IgM levels is unclear. Acknowledgments: This study was sponsored by Bayer Canada and Spectrum Pharmaceuticals. Disclosures: Berinstein: Spectrum Pharma: Clinical Advisory Board Other. Off Label Use: Zevalin for first line treatment of aggressive follicular lymphoma.

First Evidence for High Incidence of Complete and Sustained Molecular Remissions and Maintenance of Immune Responses in Patients Receiving Consolidation with Y90 Ibritumomab Tiuxetan (90Y-RIT) Post R-CHOP for Newly Diagnosed Advanced Stage High and Intermediate Risk Follicular Lymphoma

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 2701-2701
Author(s):  
Nancy M Pennell ◽  
Matthew Cheung ◽  
Lisa K Hicks ◽  
Eugenia Piliotis ◽  
Kevin R Imrie ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Flow Cytometry ◽  
Immune Responses ◽  
Follicular Lymphoma ◽  
B Cell ◽  
Complete Response ◽  
Advanced Stage ◽  
First Line ◽  
Molecular Remission ◽  
Cell Counts

Abstract Abstract 2701 Introduction: The First-Line Indolent Trial (FIT) demonstrated that administration of a single infusion of 90Y-RIT to follicular lymphoma grade 1 or 2 patients with CR or PR after induction chemotherapy could significantly prolong remissions over no further therapy. Only 13% of patients in that trial received rituximab with their first-line chemotherapy and maintenance rituximab was not administered [JCO 2008;26(32):5156–63]. We report a phase II study of safety and efficacy of 90Y-RIT following R-CHOP chemotherapy in patients with high-risk advanced stage FL. Maintenance rituximab is given every 3 months post 90Y-RIT, for 24 months. The protocol accrues up to 33 evaluable patients. First-time novel insights into the biologic and immunologic effects of this combination regimen are presented. The primary endpoint of our study is the final complete response (CR) rate, defined according to the Cheson criteria and measured 3 months after day 1 of the 90Y-RIT therapy. The CR rate among similar risk advanced stage FL patients after R-CHOP is known to be about 20% [Blood 2005;106(12):3725–32]. The current study is designed to detect a significantly greater response rate of 40% with a p value of 0.05 and a power of 80%. Secondary outcomes included molecular remission and immunologic effects. Since molecular remission is associated with prolonged survival [Blood 105(9): 3428–3433], we analyzed quantitative PCR for up to two years post 90Y-RIT therapy on a subset of patients with baseline PCR detectable t(14:18) lymphoma. Methods: In patients who had PCR detectable t(14;18), quantitative real-time PCR was performed on blood and available bone marrow, at baseline, post 6xR-CHOP and Q 3 months post 90Y-RIT treatment for 24 months. The sensitivity of our PCR assay was 1 in 105 cells. Flow cytometry for % B cell clonality was performed at the same time points. T and B cell counts, Ig levels and vaccine serology have been recorded pre and post treatment. Genotyping of FCGR3A polymorphism was performed. Results: 24 pts have been enrolled with a median age of 54 yrs, 79% stage 4, 63% high FLIPI, 38%, intermediate FLIPI. 10 of 19 [53%] patients had a complete response (CR/CRu) to R-CHOP and the remaining 9 showed partial response (PR). One patient died due to sepsis prior to 90Y-RIT. 5 Patients with a partial response post R-CHOP converted to CRu post 90Y-RIT resulting in 14 of 18 (77%) patients who achieved CR/Cru. One patient progressed 6 m post 90Y-RIT, another relapsed at 12 months. One pt developed a secondary malignancy by 9 m. There were no SAEs attributable to the 90Y-RIT treatment. 16 of 24 (67%) had PCR detectable t(14:18) translocations. Quantitative PCR measurements were concordant with flow cytometry. 18 have been evaluated post 90Y-RIT. 12/13 (92%) of these pts became PCR negative in blood. Post 90Y-RIT, one pt relapsed and showed increase in PCR levels. All remaining pts with PCR markers are PCR negative in blood as far as 24 m post 90Y-RIT. CD3+T cell counts remained normal, but CD19+B cells fell below the 1% detection level by flow cytometry during the two yrs of maintenance therapy post 90Y-RIT. 16 patients have been followed for more than 6 m and 8 pts for 18–24 m with no significant increases in the CD19+ B cell numbers. Interestingly, mean IgG levels remained close to normal, but mean IgM levels fell below normal. Memory immune responses to measles and mumps were maintained post chemo-radiotherapy. Antibody titres to Rubella did not change significantly post 90Y-RIT. Conclusions: We found effective eradication of follicular lymphoma from the blood and bone marrow of the high risk lymphoma pts with first line treatment of 6xRCHOP and all but one of our evaluable patients (92 %) achieved molecular remission in blood post 90Y-RIT. Molecular remission was sustained with maintenance rituximab after 90Y-RIT up to 2 years. Longer follow-up will be necessary to determine the precise response duration. Our molecular response results compare favourably with those of the FIT trial. [JCO 2009;27(34):6094–00]. In our trial, IgG levels remain close to normal indicating that memory B cells are intact and this was consistent with no significant change in titres to common previously vaccinated pathogens such as rubella. A reduction in IgM levels indicating potential functional consequences in mounting primary humoral responses was documented. Disclosures: Off Label Use: Zevalin in first line follicular lymphoma.

Predictive value of systematic inflammatory response biomarkers (NLR, LMR, PLR) in patients with ovarian cancer.

2017 ◽  
Vol 53 (3) ◽  
pp. 139-146
Author(s):  
Urszula Rychlik ◽  
Ewa Wójcik ◽  
Jadwiga Tarapacz ◽  
Katarzyna Brandys ◽  
Zofia Stasik ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Complete Response ◽  
Response To Treatment ◽  
Line Treatment ◽  
First Line ◽  
Lymphocyte Ratio ◽  
Lymphocyte To Monocyte Ratio ◽  
Progression Of Disease ◽  
First Line Treatment

Introduction: The aim of the study was to assess the prognostic value of indicators calculated on the basis of initial hematology test results of neutrophil, lymphocyte, monocyte and platelet counts (NLR – neutrophil-to-lymphocyte ratio, LMR – lymphocyte-to-monocyte ratio, PLR – platelet-to-lymphocyte ratio) in patients with ovarian cancer and their compliance with the overall response to treatment. Materials and methods: Hematological tests were performed before first course of first-line chemotherapy in 145 patients with ovarian cancer. Response to treatment was assessed according to the RECIST1.1 criteria in all patients. Results: After the completion of first-line treatment, 70 (48.3%) patients had a complete response (CR) to the therapy. In this group, progression of disease occurred in 22 (31.4%) patients during 12 months of follow-up. In the CR group with progression, 17 (77.2%) presented high NLR and PLR levels. Among 48 (68.6%) patients with CR without progression after 12 months of follow-up, high levels of NLR and PLR were observed in 21 (43.8%) and 17 (35.4%) of them, respectively. Low LMRs were observed in 16 (72.7%) patients with progression and 16 (33.3%) without progression. Conclusion: High levels of NLR and PLR and low levels of LMR before treatment seems to predict 12-month disease progression in patients with complete response to first-line treatment.

Mabthera (Rituximab) Plus CVP Chemotherapy for First-Line Treatment of Stage III/IV Follicular Non-Hodgkin’s Lymphoma (NHL): Confirmed Efficacy with Longer Follow-Up.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 350-350 ◽  
Author(s):  
Philippe Solal-Celigny ◽  
Kevin Imrie ◽  
Andrew Belch ◽  
Katherine Sue Robinson ◽  
David Cunningham ◽  
...  
Keyword(s):  
Risk Factors ◽  
Disease Progression ◽  
Phase Iii ◽  
Stage Iii ◽  
Line Treatment ◽  
First Line ◽  
Time To Death ◽  
Kaplan Meier ◽  
First Line Treatment

Abstract Design/Methods: We recently demonstrated in a phase III trial that the addition of rituximab to each of 8 cycles of CVP (R-CVP) chemotherapy significantly improves the clinical outcome of previously untreated patients with stage III/IV CD20 positive follicular NHL when compared to CVP alone (Marcus et al., Blood2005; 105: 1417–23). A multivariate Cox regression analysis of time to progression or death (TTP) showed a treatment benefit in all patient subgroups according to baseline risk factors, except for patients with a baseline hemoglobin level below normal. We now present an updated analysis of all major trial endpoints with 42 months follow-up (FU). Results: A total of 321 patients (median age 53 years) were recruited (159 CVP, 162 R-CVP). Approximately half of the patients had high-risk disease according to the Follicular Lymphoma International Prognostic Index (FLIPI, score 3–5). The median TTP was more than doubled for patients receiving R-CVP compared to CVP alone (33.6 months vs 14.5 months, p<0.0001). Median time to new lymphoma treatment or death (TNLT) was 12.3 months in the CVP group and nearly quadrupled to 46.3 months in the R-CVP group (p<0.0001). Superior response rates for R-CVP were confirmed (CR+CRu rate 41% vs 11%, p<0.0001) with a median response duration (DR) of 13.5 months in the CVP arm versus 37.7 months in the R-CVP arm. Median disease free survival (DFS) in complete responders was 44.8 months for patients receiving R-CVP and 20.5 months in patients receiving CVP alone (p=0.0005). Thirty-five patients in the CVP arm and 23 patients in the R-CVP arm have died. Kaplan-Meier estimates of 3-year OS rates were 81% in the CVP arm and 89% in the R-CVP (p=0.07). Importantly, significantly more patients receiving CVP died due to lymphoma progression compared to patients receiving R-CVP (25 vs 12 deaths, p=0.02). Subgroup analysis for TTP, ORR, DR and OS according to risk factors at baseline are ongoing and will be presented. Conclusion: With longer FU, the combination of 8 cycles of rituximab with CVP chemotherapy continues to provide a major benefit as first line treatment for patients with advanced stage follicular NHL. Kaplan Meier plot of time to death due to disease progression Kaplan Meier plot of time to death due to disease progression

Autologous Stem Cell Transplantation (auto-SCT) as the Treatment of Choice for Follicular Lymphoma Patients in First Relapse: Final Analysis of the Outcome of 175 Patients Treated in the GELA/GOELAMS FL 2000 Study

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 773-773
Author(s):  
Steven Le Gouill ◽  
Sophie De Guibert ◽  
Christelle Volteau ◽  
Marion Fournier ◽  
Franck Morschhauser ◽  
...  
Keyword(s):  
Follicular Lymphoma ◽  
Salvage Therapy ◽  
Final Analysis ◽  
Line Treatment ◽  
First Line ◽  
Interferon Α2a ◽  
First Relapse ◽  
Anti Cd20 ◽  
First Line Treatment

Abstract This study reports the final analysis of the outcome of relapsed/progressive patients who participated in the FL2000 trial. The FL2000 prospective trial evaluated the combination of rituximab with chemotherapy plus interferon as a first line treatment of follicular lymphoma (FL) patients (pts). Untreated high tumor burden pts (n=359) were randomly assigned to receive either 12 × CHVP (cyclophosphamide, adriamycin, etoposide and prednisolone) plus interferon-α2a over 18 months (Arm A) or 6 × CHVP combined with 6 × rituximab and interferon for the same time period (Arm B). The final analysis (Salles et al. ASH 2007) confirmed the superiority of Arm B. Second line treatment was left at the discretion of the investigators. PATIENTS CHARACTERISTICS: All of the 175 relapsed/refractory FL2000 pts were considered for the purpose of this analysis. Patients had a confirmed FL. Sixty-three pts experienced progression while on therapy (26 during induction phase and 37 during consolidation phase), while 112 progressed after completion of their first line treatment (follow-up period). At time of first progression, median age was 60 (range, 25– 75) y. 105 patients were initially randomized in Arm A and 70 in Arm B. Median time from diagnosis to progression for pts who experienced relapse/progression after completion of the first line treatment was 2.75 y. In all, 154 pts received salvage therapy at first relapse/progression: a cytarabine-based regimen in 24% of cases, an alkylating agent-based regimen in 23%, an anthracycline-based regimen in 22% and a fludarabine-based regimen in 16.5%. Fifty-three pts did not receive anti-CD20 (with or without chemotherapy) at that time, including 24 ps initially randomized in arm A. Finally, 42 pts could proceed to auto-SCT at first relapse. RESULTS: After salvage therapy, 80 pts reached CR/CRu and 23 reached PR (missing data, 20%). The median follow-up (calculated from time of first progression) is 30.8 m. The 3- and 5-year progression-free survival (PFS) estimates were 50% and 26%, respectively. The 3- and 5-year overall survival (OS) estimates were 72% and 52%, respectively. When taking into account the initial randomization, no differences in OS and PFS were observed between arm A and B. In univariate analysis, 5 parameters significantly influenced PFS and OS: younger age (p=0.035 and p=0.004; respectively), relapse/progression occurring during the follow-up period (p=0.001 and p=0.0004; respectively), low FLIPI score at diagnosis (p=0.015 and p=0.004; respectively), and actual performance of auto-SCT (p=0.0015 and p=0.001; respectively). Of note, an anti-CD20- containing therapy improved the PFS (p=0.005). In multivariate analysis, 3 parameters remained significant for PFS: period of relapse/progression (p=0.0001); an anti-CD20 containing therapy (p=0.03) and auto-SCT (p=0.002). 2 parameters remained significant for OS: period of relapse/progression (p=0.0001) and auto-SCT (p=0.0001). The 3-year OS for patients younger than 70 years who received ASCT was 92% compared to 59% for other patients (p=0.0001) CONCLUSION: These results suggest that Rituximab should be included in the salvage regimen for relapsed FL, even for those patients who previously received Rituximab. Furthermore, such pts may benefit from auto-SCT both in terms of PFS and OS. Therefore, a Rituximab-based chemotherapy regimen followed by auto-SCT is likely to be the standard of care for eligible relapsed/refractory FL patients.

Management of Grade 3B Follicular Lymphoma (FL) Outside Clinical Trials: A Multicentric Retrospective Analysis on Behalf of Fondazione Italiana Linfomi (FIL)

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 2716-2716
Author(s):  
Barbara Botto ◽  
Federica Cavallo ◽  
Manuela Zanni ◽  
Antonella Anastasia ◽  
Chiara Rusconi ◽  
...  
Keyword(s):  
Overall Survival ◽  
Follicular Lymphoma ◽  
Retrospective Analysis ◽  
Progression Free Survival ◽  
Line Treatment ◽  
First Line ◽  
Free Survival ◽  
Rituximab Maintenance ◽  
First Line Treatment

Abstract Introduction: Follicular lymphoma grade 3 is recognized as a distinct entity in the World Health Organization classification of lymphoma. It is further classified into grade 3a and 3b depending on percentage of centroblasts. There is no consensus about its clinical course because some studies indicate an indolent behavior but others describe a more aggressive. Large systematic studies are missing in particular for 3b follicular lymphoma which is often considered as a separate entity. Methods: We performed a retrospective multicentric study on a group of 3b FL patients diagnosed in nine Italian FIL centers between November 2002 and January 2015. Planned inclusion criteria at enrollment were first line Rituximab containing regimen treatment and diagnostic samples availability for central pathologic review. Aim of the study was to determine clinical response, OS and PFS. Tumor response was based on the International Working Group response criteria. Survival analysis was performed with Kaplan-Meier method. Results: We enrolled a total of 51 patients, 50 evaluable for response at the time of analysis; median age was 62 yrs (range 48-71), 29 (56%) in stage III-IV, 10 (20%) with B symptoms. First line treatment was R-CHOP in the majority of patients 47 (92%), R-Bendamustine and R-CVP in 2 (4%) respectively. Seven patients (14%) received Rituximab maintenance after first line, six (12%) underwent high dose chemotherapy and autologous stem cell transplant (ASCT) as consolidation therapy and 5 (10%) were treated with local radiotherapy on residual disease. We observed CR in 48 patients (96%), PR in 1 (2%), PD in 1(2%). Ten patients relapsed or progressed after first line treatment and four of them died, three for progressive disease and one due to senile dementia while in CR. No relapses were recorded in pts receiving Rituximab maintenance but the advantage was not statistically significant and the number of patients receiving maintenance was low. With a median follow up of 63 months from diagnosis (IQR 33-82), 3-yrs PFS and OS rates were 82% and 93% (fig 1 and 2) with the evidence of a plateau in both survival curves after 5 years observation. Central pathologic review is ongoing. Conclusion: With the limit of a retrospective analysis our study confirms the clinical benefit of a combined modality treatment with Rituximab plus antracycline-containing chemotherapy in patients with 3b FL. Our results compare favorably with those previously reported in studies without Rituximab, that failed to show a plateau with 3-yrs PFS ranging between 22% and 52%. This results need to be confirmed with a longer follow up and after the planned pathologic review. Figure 1. Progression-Free Survival. Median Follow-up 62 months (IQR 33-82). Figure 1. Progression-Free Survival. Median Follow-up 62 months (IQR 33-82). Figure 2. Overall Survival. Median Follow-up 63 months. Figure 2. Overall Survival. Median Follow-up 63 months. Disclosures No relevant conflicts of interest to declare.

Long-Term Follow-Up of Patients With Newly Diagnosed Follicular Lymphoma in the Prerituximab Era: Effect of Response Quality on Survival—A Study From the Groupe d'Etude des Lymphomes de l'Adulte

2010 ◽  
Vol 28 (5) ◽  
pp. 822-829 ◽  
Author(s):  
Emmanuel Bachy ◽  
Pauline Brice ◽  
Richard Delarue ◽  
Nicole Brousse ◽  
Corinne Haioun ◽  
...  
Keyword(s):  
Follicular Lymphoma ◽  
Tumor Burden ◽  
Line Treatment ◽  
Newly Diagnosed ◽  
First Line ◽  
Response Quality ◽  
Long Term Follow Up ◽  
First Line Treatment

Purpose First-line treatment for patients with newly diagnosed follicular lymphoma (FL) still remains debated, even in the rituximab-based combination therapy era. Few studies have addressed the question whether complete remission (CR) translates into better survival. The aim of this study was to assess the long-term follow-up of prospectively treated patients with FL and the potential correlation between response quality to first-line treatment and overall survival (OS). Patients and Methods Data from 536 patients with FL with low (n = 193) or high (n = 343) tumor burden enrolled from October 1986 to May 1995 in the French and Belgian GELF86 studies were analyzed. Data from these trials have been previously reported for low–tumor burden and high–tumor burden patients. Results Median follow-up was 14.9 years, and median OS was 9.8 years. Treated patients who achieved a complete response (CR; n = 194; 45%) had a significant longer OS than those only reaching a partial response (PR; n = 168; 39%) throughout treatment (hazard ratio [HR], 0.55; 95% CI, 0.42 to 0.72; P < .001) in an univariate time-dependent Cox model. Similar findings were found when response to treatment (CR v PR) was adjusted for potentially confounding factors in a multivariate model (HR, 0.53; 95% CI, 0.38 to 0.73; P < .001). Conclusion These data provide a long follow-up of these patients' cohorts and indicate that a better response to first-line treatment translates into an improved survival for patients with FL. Therefore, response-adapted therapy aiming to achieve a CR should be considered as first-line treatment.

Phase IIb trial of fluorouracil, leucovorin, oxaliplatin, and paclitaxel (POF) compared with fluorouracil, feucovorin, and irinotecan (IF) as first-line treatment for advanced gastric cancer (AGC)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15642-e15642
Author(s):  
R. Lin ◽  
Q. Chen ◽  
N. Fan ◽  
Y. Ye ◽  
Z. Guo ◽  
...  
Keyword(s):  
Gastroesophageal Junction ◽  
Complete Response ◽  
Patient Choice ◽  
Hematological Toxicity ◽  
Line Treatment ◽  
First Line ◽  
Peripheral Neurotoxicity ◽  
Grade 3 ◽  
First Line Treatment

e15642 Background: Primary results of POF as 1st and 2nd line treatment for AGC have been presented at ASCO 2007 and 2008. We report here data on the feasibility and the toxicity of POF versus IF(Dank, et al, ASCO 2005) in 1st line treatment of AGC. Methods: Patients with previously untreated, advanced, unresectable, and histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction were randomly assigned to POF or IF regiment. Treatment was continued until disease progressed, unacceptable toxicity, or patient choice. Results: 25 patients were entered in this study between March 2007 and July 2007: 13 in the POF group and 12 in the IF group. The median patient age was 55 years (range, 36 to 67 years), 18 were males and 7 were females. No complete response was observed. The response rate was 62.5% (POF) and 33.3% (IF) respectively. At a median follow-up of 285 days, 7(POF) versus 6(IF) patients were still alive. Hematological toxicity was the most frequent toxicity in both groups. Grade 3 to 4 neutropenia were 38.5% (POF) versus 8.3% (IF). Diarrhea was found 0% and 8.3% in POF and IF group respectively. No grade 3 peripheral neurotoxicity was observed. Conclusions: Compared with IF regiment, POF could also be used as first-line treatment for AGC with acceptable safety profile, good efficacy, and more encouraging results. No significant financial relationships to disclose.

Phase II trial of fludarabine monophosphate as first-line treatment in patients with advanced follicular lymphoma: a multicenter study by the Groupe d'Etude des Lymphomes de l'Adulte.

1996 ◽  
Vol 14 (2) ◽  
pp. 514-519 ◽  
Author(s):  
P Solal-Céligny ◽  
P Brice ◽  
N Brousse ◽  
H Caspard ◽  
Y Bastion ◽  
...  
Keyword(s):  
Follicular Lymphoma ◽  
Progression Free Survival ◽  
Complete Response ◽  
Lymphocytic Leukemia ◽  
World Health ◽  
Low Grade ◽  
Line Treatment ◽  
First Line ◽  
Fludarabine Monophosphate ◽  
First Line Treatment

PURPOSE Fludarabine monophosphate (FAMP) is a major drug in the treatment of chronic lymphocytic leukemia and showed efficacy in selected groups of patients with low-grade lymphomas, most of them pretreated. The aim of this trial was to assess the efficacy and the toxicity of FAMP in untreated patients with follicular lymphoma. PATIENTS AND METHODS Fifty-four untreated patients with advanced follicular lymphoma were treated with intravenous (i.v.) fludarabine at a dose of 25 mg/m2/d during 5 days every 4 weeks, to a maximum of nine cycles. RESULTS The toxicity of the drug was mild, mainly granulocytic. Granulocytopenia > or = 3 (World Health Organization [WHO]) was observed during 48 of 328 cycles (14.6%) and in 22 of 53 (41%) patients assessable for toxicity. Fludarabine had to be stopped prematurely because of toxicity in nine patients: marrow toxicity in five, peripheral neuropathy in two, and interstitial pneumonitis and hepatitis in one patient each. Among 49 patients assessable for response, the overall response rate was 65% and the complete response (CR) rate 37%. The median progression-free survival interval for all patients was 13.6 months. CONCLUSION These results confirm that fludarabine is active when used as first-line treatment in patients with follicular lymphoma and has a low toxicity rate. It may be used as single treatment in elderly patients. Associations of fludarabine with other drugs active against follicular lymphoma need to be determined.

Long Term Follow-up of the GELF86 French and Belgian Trials: Complete Remission after First Line Treatment with Conventional Chemotherapy in Newly Diagnosed Follicular Lymphoma Patients Correlates with Prolonged Overall Survival Compared with Partial Remission

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 2590-2590 ◽  
Author(s):  
E. Bachy ◽  
P. Brice ◽  
M. Fournier ◽  
H. Tilly ◽  
C. Haioun ◽  
...  
Keyword(s):  
Overall Survival ◽  
Complete Remission ◽  
Follicular Lymphoma ◽  
Tumor Burden ◽  
Line Treatment ◽  
Newly Diagnosed ◽  
First Line ◽  
Long Term Follow Up ◽  
First Line Treatment

Abstract Purpose . Frontline treatment for newly diagnosed follicular lymphoma (FL) patients, ranging from watch and wait policy to high-dose therapy, still remains debated, even in the rituximab-based combination therapy era. Few studies have addressed the question whether complete remission (CR) translates into better survival compared to partial remission (PR). The aim of this study was to assess the potential correlation between response quality to first line treatment and overall survival in light of a long-term follow-up. Patients and methods. Data from 536 FL patients, 435 enrolled in the French and Belgian GELF86 trials and 101 additional patients treated with the same chemotherapy regimen (CHVP-IFN or CHVP regimen after the accrual stopping date with prospectively collected data), were analysed in the study. Data from the GELF86 trials have been previously reported: 193 patients had low tumor burden (LTB) (Brice et al., JCO, 1997) and 242 and the aforementioned 101 additional patients had high tumor burden (HTB) at diagnosis (Solal-Céligny et al., NEJM 1993). All patients with at least one criteria for HTB were treated as frontline therapy with an anthracycline based CHVP regimen: cyclophosphamide, doxorubicin, teniposide, and prednisone monthly for 6 months and then every 2 months for 1 more year. Patients were randomly assigned to the CHVP arm (n=153) or the CHVP-IFN arm (n=190) when they also received α-interferon three times weekly for 18 months. Patients with LTB FL were randomly assigned to one of the three arms: arm 1, no initial treatment (n=66); arm 2, prednimustine for 5 days per month for 18 months (n=64); or arm 3, IFN three times per week for 15 months (n=63). Results. Median follow-up was 14.3 years and median overall survival (OS) was 9.8 years for the whole cohort. As expected, the Follicular Lymphoma International Prognostic Index (FLIPI) was a strong prognostic factor as well as bone marrow involvement, erythrocyte sedimentation rate (ESR), and B symptoms in univariate analysis or the FLIPI, lymphocytes count, ESR and male sex in multivariate analysis, respectively. Furthermore, treated patients who achieved a CR (n=170, 40%) had a significant longer OS than those only reaching a PR (n=162, 38%) throughout treatment (10-year OS was 64% (95% CI, 57–71%) for CR patients and 46% (95% CI, 38–54%) for PR patients, logrank p=0.0002). In a subgroup analysis by tumour burden, CR remained highly predictive of a better outcome for HTB patients (logrank p=0.001) but not for LTB patients. No difference was observed between patients who went into early complete remission (≤ 6 months) versus late complete remission (&gt; 6 months). Finally, when only HTB patients receiving CHVP-IFN were compared with those receiving the same treatment in the FL2000 trial (Salles et al., Blood, in press), Cox analysis adjusted for the FLIPI indicated a better outcome for FL2000 patients (HR=0.66, 95% CI 0.44–0.99, p=0.047). Conclusion. These data provide a long follow-up of these patients’ cohorts, and indicate strong evidence that better response to first line treatment translates into a favorable outcome for patients with newly diagnosed FL, especially for HTB patients.

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