Transcript Diapositiva 1 - GOTEL: GRUPO LINFOMAS

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Consolidation treatment with
Ibritumomab Tiuxetan after R-CHOP induction in high-risk patients with
Follicular Lymphoma (FL) (GOTEL-FL1LC): a multicentric, prospective study
M Provencio ; MA Cruz, J Gómez-Codina, C Quero Blanco; M Llanos, FR García Arroyo, L de la Cruz, J Gumá, JR Delgado, R Alvarez , A Rueda. On behalf of the
GOTEL (Spanish Lymphoma Oncology Group). Corresponding mail: [email protected]
Patients and methods
This study was registered with ClinicalTrials.gov Identifier NCT 00722930,
and European EudraCT number 2007-00391-19 and was conducted within the
GOTEL, a cooperative group set up by a network of Medical Oncology
Services in Spain.(www.grupolinfomas.es).
30 patients were included from April 2008 and April 2010.
Patient eligibility:
Inclusion criteria: Patients over 18 years old with biopsy-proven, untreated,
stage II, III or stage IV follicular non-Hodgkin Lymphoma CD20+, grade I, II,
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or III, PS 0-1. All patients required absolute granulocyte count ≥1500 x 10 /L
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and a platelet count ≥100,000 x 10 /L prior to each cycle.
Exclusion criteria: HIV positive, central nervous system involvement, history
of prior chemotherapy, radiotherapy or immunotherapy, coexistent serious
cardiac disease or a prior malignancy.
Treatment plan:
Patients were treated with standard CHOP-R every 21 days for 4 cycles.
Response assessments was evaluated 4 to 8 weeks after completion of the
fourth cycle. Patients achieving at least an unconfirmed partial response were
eligible for being treated with two cycles with CHOP (without rituximab) and
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RIT. Dose Y -Ibritumomab: 0.4 mCi/Kg if granulocyte was ≥1500 x 10 /L and
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platelet >150000 x 10 /L, and < 25% bone marrow involvement or 0.3 mCi/Kg
if platelet were more than 100000 x 106/L but less than 150000 x 106/L, (max.
32 mCi)
Overall and progression-free survival curves were plotted by the method of
Kaplan and Meier and logrank test.
An independent data monitoring committee reviewed safety and efficacy data.
Patients characteristics
Clinical Outcomes
Characteristic
Nº
%
Gender
Male
Female
17
13
56.7
43.3
Histologic grade
1
2
3
9
13
8
31.0
44.8
24.2
FLIPI risk
Low
Intermediate
High
2
15
13
6.7
50
43.3
FLIPI factors
>60 years
10
LDH elevated
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Hb <12 g/dL
9
Stage III-IV
27
>4 affected regions 21
33.3
30.0
30.0
90.0
70.0
• The objective rate of clinical response was 92.1% (CI
95%: 83-100%).
•Of the 18 patients who presented partial remission to
induction treatment, 11 (61.1%) had complete response after
consolidation treatment. There was only one exitus due to
H1N1 viral pneumonia.
•The most important G3/4 toxicity was hematological, with
46% thrombopenia and 56% neutropenia.
•None of the patients in the trial died because of FL.
•With median follow-up of 26 months (13-40), the mean for
disease-free survival or overall survival were not reached.
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Graphical Results
Probability
Relapse is the main cause of therapeutic failure in follicular lymphoma (FL).
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We set out to evaluate the role of consolidation with Y -Ibritumomab Tiutexan
(RIT) in high risk FL patients. We designed a phase II study with RIT after
four cycles of CHOP-R and two CHOP, but without Rituximab.
Probabilidad
1073P
Tiempo (meses)
Conclusions
Progression Free Survival
Overall Survival
•The optimal treatment of advanced/high risk FL remains to be determined.
•With the addition of immunotherapy and radioimmunotherapy, the overall and
complete response rates have improved.
•In our study, with median follow-up of 26 months, we have good results but much
longer follow-up will be necessary to determine the durability of these responses