A phase 2 trial of CHOP chemotherapy followed by tositumomab/iodine I 131 tositumomab for previously untreated follicular non-Hodgkin lymphoma: Southwest Oncology Group Protocol S9911.

Abstract

Advanced follicular lymphoma is incurable with conventional chemotherapy and radiotherapy. The Southwest Oncology Group (SWOG) conducted a phase 2 trial (S9911) of a novel regimen consisting of 6 cycles of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy followed 4 to 8 weeks later by tositumomab/iodine I 131 tositumomab (anti-CD20 antibody) in 90 eligible patients with previously untreated, advanced stage follicular lymphoma. Treatment was well tolerated. Reversible myelosuppression was the main adverse event and was more severe during CHOP chemotherapy than following radioimmunotherapy. The overall response rate to the entire treatment regimen was 90%, including 67% complete remissions (CRs plus unconfirmed CRs [CRu's]) and 23% partial remissions (PRs). Twenty-seven (57%) of the 47 fully evaluable patients who achieved less than a CR with CHOP improved their remission status after tositumomab/iodine I 131 tositumomab. With a median follow-up of 2.3 years, the 2-year progression-free survival (PFS) was estimated to be 81%, with a 2-year overall survival of 97%. This study has established the feasibility, tolerability, and efficacy of this regimen for patients with advanced follicular lymphoma. This novel treatment appears promising compared with the SWOG's historical experience using CHOP alone and is currently being compared with CHOP plus rituximab in a randomized phase 3 trial (S0016).

• Authors: Oliver W Press, Joseph M Unger, Rita M Braziel, David G Maloney, Thomas P Miller, Michael LeBlanc, Ellen R Gaynor, Saul E Rivkin, Richard I Fisher
• Journal: Blood (Blood) Vol. 102 Issue 5 Pg. 1606-12 (Sep 01 2003) ISSN: 0006-4971 [Print] United States
• PMID: 12738671 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Antibodies, Monoclonal
• Iodine Radioisotopes
• Vincristine
• Doxorubicin
• Cyclophosphamide
• tositumomab I-131
• Prednisone

Topics

• Adult
• Aged
• Antibodies, Monoclonal (administration & dosage, adverse effects)
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects)
• Cyclophosphamide (administration & dosage, adverse effects)
• Doxorubicin (administration & dosage, adverse effects)
• Female
• Humans
• Iodine Radioisotopes (administration & dosage, adverse effects)
• Lymphoma, Follicular (drug therapy, mortality)
• Lymphoma, Non-Hodgkin (drug therapy, mortality)
• Male
• Middle Aged
• Neural Tube Defects (chemically induced)
• Patient Compliance
• Prednisone (administration & dosage, adverse effects)
• Remission Induction
• Survival Rate
• Treatment Outcome
• Vincristine (administration & dosage, adverse effects)