Abstract 1614

Background:

Registries can be invaluable for describing patterns of care for a population of patients. COMPLETE is a registry of peripheral T-cell lymphoma (PTCL) patients designed to identify the lymphoma-directed treatments and supportive care measures that PTCL patients receive. We report here the first detailed findings of initial therapy.

Methods:

This is a prospective, longitudinal, observational registry that is led by a global steering committee. Patients with newly diagnosed PTCL and providing written informed consent are eligible. Patients are entered into the registry from time of initial diagnosis and followed for up to 5 years. Only locked records are reported.

Results:

As of July 2012, 330 patients have been enrolled from the United States. The first patient was enrolled in February 2010. Locked baseline and treatment records are available for 124 and 81 patients, respectively. Of the 124 patients with locked baseline records, 67 patients (54%) were male, the mean age was 59 (range: 19–89), and race/ethnicity was recorded as: White (87 patients; 70%), Black (19; 15%), Asian (5; 4%) and other/unknown (13; 11%). Histology was reported as follows: PTCL-not otherwise specified (27%), anaplastic large cell lymphoma-primary systemic type (18%), angioimmunoblastic T-cell lymphoma (17%), transformed mycosis fungoides (7%), T/NK-cell lymphoma-nasal and nasal type (6%), adult T-cell leukemia/lymphoma, HTLV 1+ (6%) and other (19%). 25 patients (20%) had received another diagnosis, including B-cell lymphoma, Hodgkin's disease and other T-cell lymphomas, prior to their current diagnosis of PTCL. 49 patients (40%) had B symptoms, 102 patients (82%) had an Ann Arbor stage of III/IV, 116 patients (94%) had ECOG performance status of 0–1, and international prognostic index (IPI) score was distributed as follows: IPI 0 (7% of patients), 1 (15%), 2 (43%), 3 (26%), and 4 (9%). Of the 81 patients with locked treatment records, details on initial treatment can be found in table below.

Initial TreatmentN=81
Induction chemotherapy alone 56 69% 
Induction chemotherapy + transplant 7% 
Induction chemotherapy + local radiotherapy 6% 
Observation only/best supportive care 5% 
Induction chemotherapy + CNS prophylaxis 4% 
Other 9% 
Primary Intent of Initial Treatment N=81  
Cure 62 76% 
Palliation 19 24% 
Chemotherapy Regimens N=69  
CHOP* or CHOP-like regimen 20 29% 
Cyclophosphamide, doxorubicin, vincristine (± rituximab or denileukin diftitox) 10% 
EPOCH** 7% 
Cyclophosphamide (± prednisone or dexamethasone) 7% 
Anthracycline-based regimen (other than CHOP) 6% 
Steroid (prednisone or dexamethasone) alone 6% 
Doxorubicin alone 4% 
Gemcitabine-based regimen 4% 
Etoposide-ifosfamide based regimen 3% 
Platinum-based regimen 3% 
Vincristine alone 3% 
Single-agent chemotherapy, other 7% 
Other 13% 
Number of Cycles Given N=69  
Mean 
Median 
Range 1-14 
Best Response to Initial Treatment N=50  
Complete response 20 40% 
Partial response 10 20% 
No response/stable disease 4% 
Progressive disease 12% 
Not evaluable 12 24% 
Vital Status at End of Initial Treatment N=50  
Alive 39 78% 
Dead 11 22% 
Cause of Death N=11  
Disease related 73% 
Other 27% 
Initial TreatmentN=81
Induction chemotherapy alone 56 69% 
Induction chemotherapy + transplant 7% 
Induction chemotherapy + local radiotherapy 6% 
Observation only/best supportive care 5% 
Induction chemotherapy + CNS prophylaxis 4% 
Other 9% 
Primary Intent of Initial Treatment N=81  
Cure 62 76% 
Palliation 19 24% 
Chemotherapy Regimens N=69  
CHOP* or CHOP-like regimen 20 29% 
Cyclophosphamide, doxorubicin, vincristine (± rituximab or denileukin diftitox) 10% 
EPOCH** 7% 
Cyclophosphamide (± prednisone or dexamethasone) 7% 
Anthracycline-based regimen (other than CHOP) 6% 
Steroid (prednisone or dexamethasone) alone 6% 
Doxorubicin alone 4% 
Gemcitabine-based regimen 4% 
Etoposide-ifosfamide based regimen 3% 
Platinum-based regimen 3% 
Vincristine alone 3% 
Single-agent chemotherapy, other 7% 
Other 13% 
Number of Cycles Given N=69  
Mean 
Median 
Range 1-14 
Best Response to Initial Treatment N=50  
Complete response 20 40% 
Partial response 10 20% 
No response/stable disease 4% 
Progressive disease 12% 
Not evaluable 12 24% 
Vital Status at End of Initial Treatment N=50  
Alive 39 78% 
Dead 11 22% 
Cause of Death N=11  
Disease related 73% 
Other 27% 
*

CHOP=cyclophosphamide, doxorubicin, prednisone, and vincristine

**

EPOCH=cyclophosphamide, doxorubicin, prednisone, vincristine and etoposide

The most important reasons cited for choice of initial treatment were sub-type of PTCL (23% of reasons), clinical data from the literature (16%), patient age (13%), presence of disseminated disease (12%), patient co-morbidities (10%) and patient performance status (10%) and other (16%).

Conclusions:

This first detailed analysis of primary treatment of PTCL indicates that this disease is still largely being treated with regimens derived primarily from studies of B-cell lymphomas and that a single standard of care does not exist. The fact that a meaningful proportion of patients were initially diagnosed with something other than their current diagnosis of PTCL points out the challenges of diagnosing the disease. While the intent of initial treatment for most patients is to affect a cure, more than 20% of patients were noted as deceased at the end of initial treatment, underscoring the need for more effective, disease-specific therapy.

Disclosures:

Foss:Merck: Study Grant, Study Grant Other; Celgene: Study Grant, Study Grant Other; Eisai: Consultancy; Seattle Genetics: Consultancy; Celgene: Consultancy; Allos: Consultancy. Carson:Allos: Consultancy, Speakers Bureau; Celgene: Consultancy, Speakers Bureau. Pinter-Brown:Allos: Consultancy, Membership on an entity's Board of Directors or advisory committees. Horwitz:Allos: Consultancy, Research Funding. Rosen:Allos: Consultancy, Honoraria. Pro:Celgene: Honoraria, Research Funding; Spectrum: Honoraria; Allos: Honoraria; Seattle Genetics: Research Funding. Gisselbrecht:Allos: Consultancy, Membership on an entity's Board of Directors or advisory committees. Hsi:Allos: Research Funding; Eli Lilly: Research Funding; Abbott: Research Funding; Cellerant Therapeutics: Research Funding; BD Biosciences: Research Funding; Millenium: Research Funding.

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