Here's the Zevalin abstract NOT highlighted by Spectrum probably because it came from the EU. This abstract was actually posted several weeks ago.
1806 90Yttrium-Ibritumomab Tiuxetan as First Line Treatment for Follicular Non-Hodgkin Lymphoma. 5 Year Results from an International Multicenter Phase II Clinical Trial
Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies
Program: Oral and Poster Abstracts
Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster I
Saturday, December 3, 2016, 5:30 PM-7:30 PM
Hall GH (San Diego Convention Center)
Kristina Lerch1*, Corinna Leng1*, Antonello Pinto2*, Werner Linkesch3, Heinz Sill3, Ola Linden4*, Andreas Viardot5, Ulrich Keller6*, Georg Hess, MD7*, Secondo Lastoria2*, Ferdinando Frigeri2*, Nicole Neik1*, Christiane Pott8*, Christian W. Scholz9 and Antonio Pezzutto, MD, PhD10*
1Charité University School of Medicine, Berlin, Germany
2Istituto Nazionale Tumori, Fondazione 'G. Pascale', Naples, Italy
3Medical University of Graz, Graz, Austria
4University Hospital Lund, Lund, Sweden
5University Hospital of Ulm, Ulm, Germany
6Technische Universität München, Munich, Germany
7IIIrd Dept. of Medicine, Johannes Gutenberg-University Medical Center, Mainz, Germany
8University Hospital Schleswig-Holstein, Kiel, Germany
9Vivantes Klinikum Am Urban, Berlin, Germany
10Department of Hematology, Oncology and Tumorimmunology, Charité University School of Medicine, Berlin, Germany
Purpose
Updated 5 year results are presented from the multicenter phase II trial of 90Yttrium-Ibritumomab-Tiuxetan (90YIT) as first line stand-alone therapy for patients with follicular lymphoma (FL).
Patients and Methods
59 patients with CD20-positive FL grade 1 to 3a in stages II with bulky disease (n=12), III (n= 26), or IV (n=21), and in need for therapy, were enrolled between 05/2007 and 06/2010. They received 90YIT according to standard procedure (rituximab 250 mg/m2 days -7 and 0, then 90YIT 15 MBq/kg (0.4mCi/kg) day 0; patients with platelet counts below 150.000/ul but above 100.000/ul received only 11 MBq/kg). Primary end point was the clinical and molecular remission rate. Secondary end points were time to progression, safety, and tolerability. Results at 5 years after therapy with 90YIT are presented.
Results
Clinical remission rate (CR, Cru) 6 months after treatment with 90YIT was 56% (33 patients), while 31% had achieved a PR (18 patients). Median follow-up was 5 years with 8 patients lost to follow-up. Progression free survival was 2.6 years. Of the 26 patients who were in CR 12 months after 90YIT 57% were still without progress after 5 years, PFS after 90YIT was not reached versus 1.13 years for patients without CR 12 months after treatment (P =0.025, HR 2.474). Elevated LDH predicted a shorter PFS (4.0 years vs. 1.3 years, P=0.056). Some of the patients had extensive disease at time of treatment. Ann Arbor stadium did not differ significantly in response rate and 5 year PFS (II with bulky disease 50%, III 42.3%, IV 33.3%, P=0.12). Median time to next treatment (TTNT) for the whole population was 3.95 years (5-year TTNT-free, 50%). 5 year overall survival since treatment with 90YIT was 80%. Cause of Death was progressive disease (1 patient), secondary malignancy (3 patients) and others (6 patients).
As previously reported, most common toxicities were transient thrombo- and leukocytopenia. Non-hematologic toxicities never exceeded grade II (CTCAEv2.0). No unexpected toxicities emerged during 5 year follow-up. Secondary malignancies occurred in 5 patients within 5 years after treatment with 90YIT (8%, oropharyngeal cancer, pancreatic cancer, lung carcinoma, cerebellar tumor, adenocarcinoma of the colon). All these cases had occurred shortly after therapy, suggesting pre-existing morbidity (retrospectively confirmed in 2 cases) or chance association (3 cases). Cases of acute myeloid leukemia were not reported. Transformation occurred in 8 patients (14%) with an annual transformation rate of 2.7%.
Conclusion
90YIT is well tolerated and achieves a 5 year PFS of 40%. Considering that this treatment is a very short procedure (two outpatient drug applications one week apart) this appears remarkable. While patients with elevated LDH tend to relapse early, individuals who continue to be in CR 1 year after 90YIT achieve significantly long responses with a 5 year PFS of 59%. Secondary malignancies and transformation rate were not elevated after 5 years of follow up. 90YIT can be considered for the initial treatment of FL in patients who are unable or unwilling to tolerate standard therapy.
