The length of treatment of aggressive non-Hodgkin's lymphomas established according to the international prognostic index score: long-term results of the GISL LA03 study

2006 ◽  
Vol 76 (3) ◽  
pp. 217-229 ◽  
Author(s):  
Massimo Federico ◽  
Stefano Luminari ◽  
Paolo G. Gobbi ◽  
Stefano Sacchi ◽  
Nicola Renzo ◽  
...  
Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 5072-5072
Author(s):  
Michele Spina ◽  
Ulrich Jaeger ◽  
Joseph A Sparano ◽  
Renato Talamini ◽  
Giuseppe Rossi ◽  
...  

Abstract Abstract 5072 Background: The combination of Rituximab plus chemotherapy (CT) is more effective than CT alone in the treatment of high grade NHL. Objective: To report the long-term follow-up of CDE plus Rituximab in HIV-NHL. Methods: In June 1998, we started a phase II study using infusional CDE (Cyclophosphamide 187.5 mg/m2/day, Doxorubicin 12.5 mg/m2/day and Etoposide 60 mg/m2/day) administered by continuous intravenous infusion for 4 days every 4 weeks and Rituximab 375 mg/m2 i.v. on day 1. HAART was given concomitantly with CT. Results: Seventy-four patients (pts) have been enrolled. The median CD4+ cell count was 161 (range 3–691) and the median Performance Status was 1 (range 0–3). Diffuse large B-cell NHL was diagnosed in 72% of pts and Burkitt in 28%. Seventy per cent of pts had advanced stage (III-IV) disease and 57% of pts had an age-adjusted international prognostic index >2. Fifty-two out of 74 pts (70%) achieved a complete remission (CR), 4/74 (5%) had a partial remission and 18 pts progressed. With a median follow-up of 61 months, only 17% of CRs have relapsed and 41/74 pts are alive. The overall survival, disease free survival and time to treatment failure (TTF) at 5 years were 56%, 81% and 52%, respectively. Four cases of secondary tumors have been observed. No case of late pulmonary or cardiac toxicity has been reported. Conclusions: The combination of Rituximab and CDE in HIV-NHL treated concomitantly with HAART is very active. CR rate (70%) and TTF at 5 years (52%) are comparable to those observed in high grade NHL of the general population. Our data confirm that in HAART era a high proportion of HIV-NHL can be cured. Disclosures: No relevant conflicts of interest to declare.


Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 1467-1467
Author(s):  
Michele Spina ◽  
Cecilia Simonelli ◽  
Emanuela Vaccher ◽  
Ulrich Jaeger ◽  
Joseph Sparano ◽  
...  

Abstract Background: The combination of Rituximab plus chemotherapy (CT) is more effective than CT alone in the treatment of high grade NHL. Objective: To report the long-term follow-up of CDE plus Rituximab in HIV-NHL. Methods: In June 1998, we started a phase II study using infusional CDE (Cyclophosphamide 187.5 mg/m2/day, Doxorubicin 12.5 mg/m2/day and Etoposide 60 mg/m2/day) administered by continuous intravenous infusion for 4 days every 4 weeks and Rituximab 375 mg/m2 i.v. on day 1. HAART was given concomitantly with CT. Results: Seventy-four patients (pts) have been enrolled. The median CD4+ cell count was 161 (range 3–691) and the median Performance Status was 1 (range 0–3). Diffuse large B-cell NHL was diagnosed in 72% of pts and Burkitt in 28%. Seventy per cent of pts had advanced stage (III–IV) disease and 57% of pts had an age-adjusted international prognostic index ³2. Fifty-two out of 74 pts (70%) achieved a complete remission (cr), 4/74 (5%) had a partial remission and 18 pts progressed. With a median follow-up of 61 months, only 17% of CRs have relapsed and 41/74 pts are alive. The overall survival, disease free survival and time to treatment failure (TTF) at 5 years were 56%, 81% and 52%, respectively. Only one secondary tumor (acute leukemia) has been observed. No case of late pulmonary or cardiac toxicity has been reported. Conclusions: The combination of Rituximab and CDE in HIV-NHL treated concomitantly with HAART is very active. CR rate (70%) and TTF at 5 years (52%) are comparable to those observed in high grade NHL of the general population. Our data confirm that in HAART era a high proportion of HIV-NHL can be cured. This study was supported by ISS grants.


Blood ◽  
2010 ◽  
Vol 115 (2) ◽  
pp. 289-295 ◽  
Author(s):  
Pedro Farinha ◽  
Abdulwahab Al-Tourah ◽  
Karamjit Gill ◽  
Richard Klasa ◽  
Joseph M. Connors ◽  
...  

Abstract Previous studies of follicular lymphoma (FL) patients treated heterogeneously have suggested that decreased numbers of regulatory T cells correlates with improved survival. We studied advanced-stage FL patients from a single institution phase 2 trial. All patients were treated uniformly with multiagent chemotherapy and radiation. Tissue microarrays were constructed using diagnostic biopsies available in 105 patients and stained with CD4, CD8, CD25, and forkhead/winged helix transcription factor 3 (FOXP3) antibodies. Both cell content and cell distribution were evaluated. For all antibodies, there were cases with a predominant intrafollicular or perifollicular localization of cells (follicular pattern) while others displayed a diffuse pattern. The median follow-up of living patients was 17.1 years. The International Prognostic Index score predicted overall survival (OS; P = .004) but not risk of transformation (RT). Cell content did not impact survival, while immunoarchitectural patterns of CD4/CD8 were significant for progression-free survival (PFS; P = .056), CD25 for both PFS and OS (P = .002 and P = .024, respectively), and FOXP3+ predicted PFS, OS, and RT (P = .001, P < .001 and p = .002, respectively). A Cox multivariate model showed both International Prognostic Index score and FOXP3+ pattern were independent predictors of OS (P = .008 and P < .001, respectively), while only FOXP3+ pattern predicted RT (P = .004). We conclude that FOXP3+ cell distribution significantly predicts survival and RT in FL.


2009 ◽  
Vol 150 (44) ◽  
pp. 2019-2026
Author(s):  
Tamás Schneider ◽  
Zsuzsanna Molnár ◽  
Beáta Deák ◽  
Erika Várady ◽  
Erika Tóth ◽  
...  

A cyclophosphamid-doxorubicin-vincristin-prednisolon (CHOP-) kezelés több mint 20 éven át standard kezelésnek számított a diffúz nagy B-sejtes lymphomák (DLBCL) elsődleges kezelésében. A CHOP-kezelést célzott immunterápiával, rituximabbal kiegészítve (R-CHOP) jelentős javulás volt elérhető e betegcsoport kezelésében. Magyar betegcsoporton még nem ismert olyan adat, amely a kezelés túlélésre kifejtett hatását vizsgálná. A szerzők célja az R-CHOP és az R-CHOP-like kezelés hatékonyságának elemzése volt. 2002. szeptember és 2005. április között 140 újonnan diagnosztizált, kezeletlen DLBCL-es beteg R-CHOP-kezelését kezdték. A vizsgálatba beválasztás előfeltétele az előrehaladott III–IV. klinikai stádium, vagy I–II. klinikai stádium esetén nagy tumor (>7 cm), és/vagy „B” tünet, illetve extranodalis manifesztáció voltak. Az eredményeket a korábbi években CHOP- és CHOP-like kezelésben részesült 130 beteg adataival vetették össze. A terápiás eredmények minden paramétert tekintve kedvezőbbnek bizonyultak az R-CHOP-kezeltek körében. Az átlagos 44, illetve 52 hónapos követési idő során a teljes remissziós arány 73,6% volt szemben a CHOP-csoportban észlelt 47,7%-kal. Az ötéves teljes túlélés 68,6% vs. 41,0% (RR: 0,4293, CI: 0,2963–0,6221; p < 0,0001), az eseménymentes túlélés 59,8% vs. 33,5% (RR: 0,5038, CI: 0,36,6–0,7038; p < 0,0001), míg a progressziómentes túlélés 64,4% vs. 37,6% (RR: 0,4915, CI: 0,3442–0,7019; p < 0,0001) volt. Mivel a prognosztikus paraméterek az R-CHOP-csoportban valamelyest kedvezőbbek voltak, ezért a Sehn által ajánlott módosított international prognostic index score beosztása alapján képzett betegcsoportok eredményeit is összevetették. Az alcsoportelemzés itt is szignifikáns különbségeket adott. Az ötéves teljes túlélés a jó prognózisú csoportban 74,4% vs. 47,9% (RR: 0,4475, CI: 0,2418–0,8285; p = 0,0084), a rossz prognózisú csoportban 52,0% vs. 28,8% (RR: 0,4989, CI: 0,3098–0,8035; p = 0,003) volt. A nagyon jó prognózisú csoportban a két csoport között statisztikai különbség az ötéves túlélési paraméterekben a már eleve igen nagy terápiás hatás és a kicsi esetszám miatt nem észlelhető (OS és EFS: CHOP: 100% és 62,5% vs. R-CHOP: 90,9% és 87,0%; p = 0,3873 és p = 0,1702). Rituximab hozzáadása a standard CHOP-kezeléshez a terápiás eredmények jelentős javulását eredményezte prognosztikus csoportoktól függetlenül. Az eredmények a nemzetközi irodalmi adatokkal összevethetők.


Blood ◽  
2019 ◽  
Vol 134 (4) ◽  
pp. 353-362 ◽  
Author(s):  
Emanuele Zucca ◽  
Stephanie Rondeau ◽  
Anna Vanazzi ◽  
Bjørn Østenstad ◽  
Ulrich J. M. Mey ◽  
...  

Abstract The SAKK 35/10 phase 2 trial, developed by the Swiss Group for Clinical Cancer Research and the Nordic Lymphoma Group, compared the activity of rituximab vs rituximab plus lenalidomide in untreated follicular lymphoma patients in need of systemic therapy. Patients were randomized to rituximab (375 mg/m2 IV on day 1 of weeks 1-4 and repeated during weeks 12-15 in responding patients) or rituximab (same schedule) in combination with lenalidomide (15 mg orally daily for 18 weeks). Primary end point was complete response (CR)/unconfirmed CR (CRu) rate at 6 months. In total, 77 patients were allocated to rituximab monotherapy and 77 to the combination (47% poor-risk Follicular Lymphoma International Prognostic Index score in each arm). A significantly higher CR/CRu rate at 6 months was documented in the combination arm by the investigators (36%; 95% confidence interval [CI], 26%-48% vs 25%; 95% CI, 16%-36%) and confirmed by an independent response review of computed tomography scans only (61%; 95% CI, 49%-72% vs 36%; 95% CI, 26%-48%). After a median follow-up of 4 years, significantly higher 30-month CR/CRu rates and longer progression-free survival (PFS) and time to next treatment (TTNT) were observed for the combination. Overall survival (OS) rates were similar in both arms (≥90%). Toxicity grade ≥3 was more common in the combination arm (56% vs 22% of patients), mainly represented by neutropenia (23% vs 7%). Addition of lenalidomide to rituximab significantly improved CR/CRu rates, PFS, and TTNT, with expected higher, but manageable toxicity. The excellent OS in both arms suggests that chemotherapy-free strategies should be further explored. This trial was registered at www.clinicaltrials.gov as #NCT01307605.


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