Phase 2 trial of rituximab plus hyper-CVAD alternating with rituximab plus methotrexate-cytarabine for relapsed or refractory aggressive mantle cell lymphoma.
BACKGROUND
Relapsed or refractory mantle cell lymphoma has a very poor prognosis. The authors evaluated the response rates and survival times of patients treated with an intense regimen known to be effective against untreated aggressive mantle cell lymphoma: rituximab plus hyper-CVAD (cyclophosphamide, vincristine, doxorubicin, and dexamethasone) alternating with rituximab plus methotrexate-cytarabine.


METHODS
In this prospective, open-label, phase 2 study, patients received this combination for 6 to 8 cycles. Twenty-nine patients were evaluable for response.


RESULTS
The median number of cycles received was 5 (range, 1-7 cycles), and the overall response rate was 93% (45% complete response [CR] or CR unconfirmed [CRu] and 48% partial response [PR]). All 5 patients previously resistant to treatment had a response (1 CR, 4 PR), and both patients whose disease did not change in response to prior therapy had PRs. Toxic events occurring in response to the 104 cycles given included neutropenic fever (11%), grade 3 or 4 neutropenia (74%), and grade 3 or 4 thrombocytopenia (63%). There were no deaths from toxicity. At a median follow-up of 40 months (range, 5-48 months), the median failure-free survival time was 11 months with no plateau in the survival curve.


CONCLUSIONS
This combination chemotherapy was effective for refractory/relapsed mantle cell lymphoma.
Wang
Michael
M
Department of Lymphoma & Myeloma, The University of Texas M. D. Anderson Cancer Center, Houston, Texas, USA.
Fayad
Luis
L
Cabanillas
Fernando
F
Hagemeister
Fredrick
F
McLaughlin
Peter
P
Rodriguez
Maria A
MA
Kwak
Larry W
LW
Zhou
Yuhong
Y
Kantarjian
Hagop
H
Romaguera
Jorge
J
D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D058846:Antibodies, Monoclonal, Murine-Derived; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D003561:Cytarabine / Q000008:administration & dosage / Q000009:adverse effects; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D020522:Lymphoma, Mantle-Cell / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality; D012008:Recurrence; D000069283:Rituximab; D016879:Salvage Therapy; D014750:Vincristine / Q000008:administration & dosage / Q000009:adverse effects
D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D003561:Cytarabine; D000069283:Rituximab; D014750:Vincristine; D003907:Dexamethasone; D004317:Doxorubicin; D003520:Cyclophosphamide; D008727:Methotrexate