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hematological malignancies
1062O A NATIONWIDE SURVEY OF ADULT T-CELL LEUKEMIA/
LYMPHOMA (ATL) NEWLY DIAGNOSED OVER THE LAST
DECADE IN JAPAN
H. Katsuya 1 , K. Ishitsuka 1 , A. Utsunomiya 2 , S. Hanada 3 , T. Eto 4 , Y. Moriuchi 5 ,
Y. Saburi 6 , T. Yamanaka 7 , J. Suzumiya 8 , K. Tamura 1
1 Department of Medicine, Division of Medical Oncology, Hematology and
Infectious Diseases, Fukuoka University, Fukuoka, JAPAN, 2 Hematology,
Imamura Bun-in Hospital, Kagoshima, JAPAN, 3 Hematology, National Hospital
Organization Kagoshima Medical Center, Kagoshima, JAPAN, 4 Hematology,
Hamanomachi Hospital, Fukuoka, JAPAN, 5 Hematology, Sasebo City General
Hospital, Sasebo, JAPAN, 6 Hematology, Oita Prefectural Hospital, Oita, JAPAN,
7 Research Center for Innovative Oncology, National Cancer Center Hospital East,
Kashiwa, JAPAN, 8 Cancer Center, Shimane University, Izumo, JAPAN
Introduction: ATL is a malignancy of mature T-lymphocytes caused by human
T-lymphotropic virus type I (HTLV-1), and it is classified into 4 clinical subtypes,
i.e. acute, lymphoma, chronic, and smoldering type according to the analysis of the
former nationwide survey performed in late 80’s. During the 2 decades after this
analsysis, treatment for ATL has improved, e.g. intensive sequential combination
chemotherapy and allogeneic hematopoietic stem cell transplantation (HSCT). We
therefore performed a nationwide survey to know the outcome of ATL patients newly
diagnosed during the last decade.
Patients and methods: The clinical data was collected retrospectively from the
medical record of patients who were diagnosed as ATL between 2000 and 2009 in
participating institutions. Approval of this study was obtained from the Ethics
Committee and Institutional Review Board of Fukuoka University where the central
office is located and at each participating center based on their institutional policies.
Results: A total of 1552 patients’ survey form was submitted from 81 institutions
across Japan. Fifty-four patients were excluded due to missing data, and the
remaining 1498 were analyzed. The median survival time (MST) of 897 for acute
type and that of 355 for lymphoma type were 8.3 and 10.6 months, and overall
survival (OS) rates at 5 years were 9% and 13%, respectively. Fifty % of patients had
received CHOP/CHOP-like regimen, 31 % had VCAP-AMP-VECP regimen, and
single agent was used in 6% of the patients. The number of patients with allogeneic
HSCT was 227 (46% from a sibling donor and 51% from an unrelated donor), a half
of them were transplanted at first remission. The MST and OS at 5 years from
transplantation were 5 months and 25%, respectively. The MST of 172 for chronic
and that of 74 for smoldering type were 30.3 and 36.7 months, respectively.
Conclusion: The prognosis of acute and lymphoma type was still poor despite the
recent progress in treatment modalities, and it is of disappointment that their
therapeutic outcome was not remarkably improved as compared to former survey. It
is also a surprise that the prognosis of smoldering type is not good as expected from
the previous survey. To note, 25% of patients who underwent transplantation
experienced a long survival, but it should be validated by the prospective study.
Disclosure: All authors have declared no conflicts of interest.
1063O SEQUENTIAL THERAPY WITH BRENTUXIMAB VEDOTIN IN
NEWLY DIAGNOSED PATIENTS WITH SYSTEMIC
ANAPLASTIC LARGE CELL LYMPHOMA
M. Fanale 1 , R. Advani 2 , N.L. Bartlett 3 , A. Davies 4 , T. Illidge 5 , D.A. Kennedy 6
,A.R. Shustov 7
1 Lymphoma/myeloma, University of Texas, MD Anderson Cancer Center,
Houston, TX, UNITED STATES OF AMERICA, 2 Medicine, Stanford University
Medical Center, Palo Alto, CA, UNITED STATES OF AMERICA, 3 Medicine,
Washington University School of Medicine, St. Louis, MO, UNITED STATES OF
AMERICA, 4 Medical Oncology, University Hospitals Southampton, Southampton,
UNITED KINGDOM, 5 Medical & Human Sciences, University of Manchester
Christie Hospital NHS, Manchester, UNITED KINGDOM, 6 Clinical Affairs, Seattle
Genetics, Inc., Bothell, WA, UNITED STATES OF AMERICA, 7 Division of
Hematology, University of Washington Medical Center, Seattle, WA, UNITED
STATES OF AMERICA
Brentuximab vedotin (ADCETRIS®) comprises an anti-CD30 antibody conjugated by
a protease-cleavable linker to a microtubule-disrupting agent, monomethyl auristatin
E (MMAE). In a pivotal phase 2 study in patients (pts) with relapsed/refractory
systemic anaplastic large cell lymphoma (sALCL), objective response rate was 86%
Annals of Oncology 23 (Supplement 9): ix348–ix360, 2012
doi:10.1093/annonc/mds403
and median duration of response was 12.6 months. A phase 1, open-label,
multicenter study was implemented to determine the safety and activity of sequential
and combination treatment approaches of brentuximab vedotin with CHOP or CH-P
chemotherapy in newly diagnosed pts with CD30-positive mature T- and NK-cell
lymphomas (ClinicalTrials.gov NCT01309789). This abstract presents data from Arm
1 of the study, which employs sequential treatment in sALCL pts. Single-agent
brentuximab vedotin (1.8 mg/kg) was administered q3 wks as a 30-minute outpatient
IV infusion for 2 cycles prior to up to 6 cycles of CHOP. Pts in complete or partial
remission (CR, PR) following CHOP were eligible to continue single-agent
brentuximab vedotin up to 16 total cycles. Investigator-evaluated response
assessments utilize the Revised Response Criteria for Malignant Lymphoma (Cheson
2007). All 13 pts in Arm 1 had sALCL; 10 had ALK- and 3 had ALK+ disease. 9
were male. Median age was 62 years (range, 23-81). The most common (≥6 pts)
AEs, regardless of severity, were nausea, peripheral sensory neuropathy, and
vomiting. The most common (>1 pt) Grade 3/4 AEs were anemia, fatigue, and
peripheral sensory neuropathy; all have improved or resolved. Thus far, no pts had a
Grade 5 AE or discontinued due to an AE. All 13 pts were evaluable at Cycle 2 and
achieved remission after single-agent brentuximab vedotin (5 CR, 8 PR). Following
CHOP, 10/12 evaluable pts maintained remission (7 CR, 3 PR). 2 pts with PR after
single-agent brentuximab vedotin experienced PD on CHOP treatment. 3 pts have
completed 16 cycles of therapy, all in CR. Sequential therapy with brentuximab
vedotin was generally well tolerated and all pts achieved remission after 2 cycles of
single-agent therapy. The level of activity observed in newly diagnosed pts with this
aggressive lymphoma is promising; a phase 3 randomized study is in development.
Disclosure: M. Fanale: I have acted as a consultant for and served on Advisory Board
for Seattle Genetics, Inc. I have received honoraria and travel expenses from
SeattleGenetics, Inc. Seattle Genetics, Inc. has provided research funding to my
institution.R. Advani: I have served on scientific advisory boards for Seattle Genetics,
Inc., Celgene, and Allos Therapeutics. My institution has received research funding from
Seattle Genetics, Inc., Abbott, Genentech, Pharmacyclic, and Allos Therapeutics.N.L.
Bartlett: I have acted as a consultant to Seattle Genetics, Inc., and have been reimbursed
for travel expenses by Seattle Genetics, Inc. My institution has also received research
funding from Seattle Genetics, Inc.A. Davies: I have served on a scientific advisory
board for Seattle Genetics, Inc. My institution has also received research funding from
Seattle Genetics, Inc.T. Illidge: I have acted as a consultant to Seattle Genetics, Inc. and
Millennium/Takeda. I have received honoraria from Millennium/Takeda. My institution
has received research funding from Seattle Genetics, Inc.D.A. Kennedy: I am an
employee of and have equity ownership in Seattle Genetics, Inc. A.R. Shustov: I have
acted as a consultant to Seattle Genetics, Inc. I have received honoraria from
Millennium. My institution has received research funding from Seattle Genetics, Inc.
1064O IMPACT OF NUMBER OF PREVIOUS TREATMENT LINES
AND PRE-TREATMENT WITH BORTEZOMIB OR
LENALIDOMIDE ON EFFICACY OF
BORTEZOMIB-BENDAMUSTINE-DEXAMETHASONE (BBD) IN
PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE
MYELOMA (MM)
H. Ludwig 1 , H. Kasparu 2 , C. Leitgeb 1 , R. Greil 3 , E. Rauch 1 , W. Linkesch 4 ,
N. Zojer 1 , L. Pour 5 , M. Fillitz 6 , Z. Adam 5
1 1st Department of Medicine, Wilhelminenspital, Wien, AUSTRIA, 2 Department of
Internal Medicine, Hospital Elisabethinen, Linz, AUSTRIA, 3 IIIrd Medical
Department With Hematology and Oncology, Paracelsus Medical University,
Salzburg, AUSTRIA, 4 Hematology, Medical University Graz, Graz, AUSTRIA,
5 Internal Medicine, Hematology and Oncology, University Hospital Brno, Brno,
CZECH REPUBLIC, 6 Internal Medicine III, Hanusch Hospital, Wien, AUSTRIA
Introduction: The number of previous treatment lines and pre-treatment with
Bortezomib (B) or lenalidomide (L) likely impacts the efficacy and tolerance of BBD
in r/rMM.
Patients and methods: 71 pts with r/rMM have been enrolled. Median age: 65 yrs
(range 40-86), male/female: 32/39, ISS stage I/II/III: 22, 29, and 20 pts, respectively.
ECOG status 0/I/II: 37, 31, and 3 pts, respectively. Previous treatment lines: 1-2: 44,
3-6: 27 pts, 43 pts had previously been exposed to B and 37 to L. Full data
documentation for response evaluation (≥2 cycles) is available for 65 pts.
Treatment: Benda 70 mg/m2 day 1 + 4, B 1.3 mg/m2 and Dex 20 mg on days 1, 4, 8
and 11, q 4 wks. Planned number of treatment cycles was 8, with discontinuation after 4
cycles in case of no response. K-M survival curves were compared using the log-rank test.
Results: After a median follow up of 7.1 mos, myeloma response (ORR: CR-PR) was
noted in 38 (58.5%), CR/nCR in 11 (16.9%), VGPR in 10 (15.4%), PR in 17 (26.2%),
MR in 11 (16.9%), and SD in 16 (24.6%) pts. Median time to response was 77 days.
Tab 1 shows response rates and PFS in pts in regards to number of previous
© European Society for Medical Oncology 2012. Published by Oxford University Press on behalf of the European Society for Medical Oncology.
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