Cyclophosphamide, vincristine, and prednisone followed by tositumomab and iodine-131-tositumomab in patients with untreated low-grade follicular lymphoma: eight-year follow-up of a multicenter phase II study.
OBJECTIVE
The efficacy and safety of cyclophosphamide, vincristine, and prednisone (CVP) followed by tositumomab and iodine-131 ((131)I) -tositumomab therapy were evaluated in a multicenter phase II study in patients with untreated low-grade follicular lymphoma.


METHODS
Patients received six cycles of CVP followed by one cycle of tositumomab and (131)I-tositumomab (one dosimetric dose and one therapeutic dose). The treatment was evaluated for efficacy and safety.


RESULTS
All 30 patients enrolled completed CVP as well as tositumomab and (131)I-tositumomab therapy. The overall response rate after completion of therapy was 100%, with 28 patients (93%) achieving a complete response (CR) and two patients achieving a partial response. Of the 17 patients with bone marrow involvement at enrollment, 15 achieved a confirmed CR. Fourteen of 15 patients with bulky disease (> or = 5 cm) had a CR after treatment completion. After a median follow-up of 8.4 years, the median response duration had not been reached (range, 3 to 111+ months). Five-year progression-free and overall survival rates were 56% and 83%, respectively. The most common grade > or = 3 hematologic adverse events were neutropenia (87%) and thrombocytopenia (37%). Nineteen patients received growth factor support, and three required blood product transfusions. No patients developed human antimurine antibodies. Two patients developed myelodysplastic syndrome/acute myeloid leukemia.


CONCLUSIONS
These mature data demonstrate that sequential therapy with a non-anthracycline-containing regimen comprising CVP followed by one cycle of tositumomab and (131)I-tositumomab produced high response rates with adequate safety and durable remissions and that this regimen represents a highly active treatment for first-line therapy of follicular non-Hodgkin's lymphoma.
Link
Brian K
BK
University of Iowa Hospitals and Clinics, Iowa City, IA, USA.
Martin
Peter
P
Kaminski
Mark S
MS
Goldsmith
Stanley J
SJ
Coleman
Morton
M
Leonard
John P
JP
D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage; D005240:Feasibility Studies; D005500:Follow-Up Studies; D006801:Humans; D008224:Lymphoma, Follicular / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage; D016499:Radioimmunotherapy; D012074:Remission Induction; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage
D000911:Antibodies, Monoclonal; D014750:Vincristine; D003520:Cyclophosphamide; C119496:tositumomab I-131; D011241:Prednisone