Abstract 1614
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.
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.
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 Treatment . | N=81 . | . |
---|---|---|
Induction chemotherapy alone | 56 | 69% |
Induction chemotherapy + transplant | 6 | 7% |
Induction chemotherapy + local radiotherapy | 5 | 6% |
Observation only/best supportive care | 4 | 5% |
Induction chemotherapy + CNS prophylaxis | 3 | 4% |
Other | 7 | 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) | 7 | 10% |
EPOCH** | 5 | 7% |
Cyclophosphamide (± prednisone or dexamethasone) | 5 | 7% |
Anthracycline-based regimen (other than CHOP) | 4 | 6% |
Steroid (prednisone or dexamethasone) alone | 4 | 6% |
Doxorubicin alone | 3 | 4% |
Gemcitabine-based regimen | 3 | 4% |
Etoposide-ifosfamide based regimen | 2 | 3% |
Platinum-based regimen | 2 | 3% |
Vincristine alone | 2 | 3% |
Single-agent chemotherapy, other | 5 | 7% |
Other | 8 | 13% |
Number of Cycles Given | N=69 | |
Mean | 4 | |
Median | 3 | |
Range | 1-14 | |
Best Response to Initial Treatment | N=50 | |
Complete response | 20 | 40% |
Partial response | 10 | 20% |
No response/stable disease | 2 | 4% |
Progressive disease | 6 | 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 | 8 | 73% |
Other | 3 | 27% |
Initial Treatment . | N=81 . | . |
---|---|---|
Induction chemotherapy alone | 56 | 69% |
Induction chemotherapy + transplant | 6 | 7% |
Induction chemotherapy + local radiotherapy | 5 | 6% |
Observation only/best supportive care | 4 | 5% |
Induction chemotherapy + CNS prophylaxis | 3 | 4% |
Other | 7 | 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) | 7 | 10% |
EPOCH** | 5 | 7% |
Cyclophosphamide (± prednisone or dexamethasone) | 5 | 7% |
Anthracycline-based regimen (other than CHOP) | 4 | 6% |
Steroid (prednisone or dexamethasone) alone | 4 | 6% |
Doxorubicin alone | 3 | 4% |
Gemcitabine-based regimen | 3 | 4% |
Etoposide-ifosfamide based regimen | 2 | 3% |
Platinum-based regimen | 2 | 3% |
Vincristine alone | 2 | 3% |
Single-agent chemotherapy, other | 5 | 7% |
Other | 8 | 13% |
Number of Cycles Given | N=69 | |
Mean | 4 | |
Median | 3 | |
Range | 1-14 | |
Best Response to Initial Treatment | N=50 | |
Complete response | 20 | 40% |
Partial response | 10 | 20% |
No response/stable disease | 2 | 4% |
Progressive disease | 6 | 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 | 8 | 73% |
Other | 3 | 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%).
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.
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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