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Phase II Trial of Short-Course CHOP-R Followed by ⁹⁰Y-ibritumomab Tiuxetan and Extended Rituximab in Previously Untreated Follicular Lymphoma

Authors' Affiliations: Departments of ¹ Medicine, ² Pathology, and ³ Radiology, ⁴ Clinical Research Services, University of Pittsburgh Medical Center Cancer Centers, ⁵ Department of Biostatistics, Graduate School of Public Health, NSABP and University of Pittsburgh Cancer Institute, and ⁶ Oncology-Hematology Associates, Pittsburgh, Pennsylvania

Requests for reprints: Samuel A. Jacobs, Department of Medicine, University of Pittsburgh Medical Center Cancer Centers, 5150 Centre Avenue, Suite 510, University of Pittsburgh Medical Center Cancer Pavilion, Pittsburgh, PA 15232. Phone: 412-235-1278; Fax: 412-623-4655; E-mail: jacobssa{at}upmc.edu.

Purpose: Radioimmunotherapy has been approved for relapsed follicular lymphoma (FL), including rituximab-refractory FL. This study was designed to determine the CR rate with short-course chemoimmunotherapy with cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (CHOP-R) followed by 90-Y ibritumomab tiuxetan (RIT) with extended rituximab as first-line treatment.

Experimental Design: Between March 2004 and February 2007, 60 patients with stage II to IV symptomatic or bulky FL from a single institution supported by a large community network entered this phase II trial. Patients received CHOP-R for three treatment cycles before RIT followed by four additional weekly treatments with rituximab. Response was determined using fusion [¹⁸ F] fluorodeoxyglucose-positron emission tomography (PET)-computed tomography (CT) imaging.

Results: Of the 60 patients entering this trial, 55 patients completed all protocol therapy. The median follow up was 19.7 months (range, 0.26-35.9 months). For intent-to-treat analysis, the complete response (CR) rate after CHOP-R, as assessed by CT and PET imaging, was 40% and 46%, respectively. After RIT, the CR rate improved, as assessed by CT and PET imaging, to 82% and 89%, respectively. Ten patients have progressed, including eight from best response of CR. Seven of 18 patients who were PET positive after CHOP-R progressed compared with 3 of 37 patients who were PET negative (P = 0.010).

Conclusions: In patients with previously untreated, symptomatic or bulky FL, short-course chemoimmunotherapy and consolidation RIT and extended rituximab resulted in a high CR rate. Failure to achieve an early PET CR after CHOP-R indicated high risk of relapse.

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