ACTR-02. NRG ONCOLOGY/RTOG 0424: LONG-TERM RESULTS OF A PHASE II STUDY OF TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH-RISK LOW-GRADE GLIOMAS

13007 Background: Radioimmunotherapy has been shown to be effective in CD20 + B-cell lymphomas. Both non-myeloablative as well as myeloablative regimens have been employed for low grade and high grade lymphomas with impressive response rates and remission durations. Recently, the Press group and our group published data on myeloablative 131-I-anti-CD20 RAIT with high response rates and favourable long term survival especially in follicular lymphomas and transformed FL. Therefore, a phase II study is currently being done within the German Radioimmunotherapy Group, interim analysis data are presented. Methods: Patients were to receive R-Dexa-BEAM, followed by BEAM and HD-RAIT 2–6 months after BEAM. 131-I-Rituximab was administered with a maximum kidney and lung dose of 25 Gy. Sample size was calculated to be 16 to evaluate toxicity and feasibility of the tandem approach as primary endpoint. Results: 16 pts with relapsed (14) or primary refractory (2) B-cell lymphomas (FLI,II: 4pts; DLBCL: 4pts (all early relapses); transformed FL: 6 pts; MCL:1 pt, marginal zone lymphoma: 1 pt) were treated with 1 (15 pts) or 2 cycles (1 pt) of R-Dexa-BEAM. 13/16 pts achieving PR (5) or CRu (8) were treated with BEAM, 2 pts with PD and 1 with subdural hematoma were drop outs. After BEAM, 9/13 pts were in CR, 3/13 PR, 1/13 PD. Of 12 responding pts, 6 received HD-RAIT (1 pancytopenia, 1 hepatic, 2 pulmonary toxicity, 3 too early). After HD RAIT, 5/6 pts were in CR, 1 in PR. 4/6 pts (3 CR, 1 PR) are alive for 22–31 months, 2 pts died in CR, 1 of interstitial lung disease 2 months after HD-RAIT, 1 pt of pneumonia 8 months after HD-RAIT. Conclusions: Myeloablative RAIT is a feasible and effective treatment modality for relapsed poor prognosis CD20+ B-NHL not having severe toxicity due to the salvage regimen and HD-chemotherapy. HD RAIT offers the potential for long term relapse free survival. Final analysis of toxicity and outcome of this phase II study will be presented at the meeting. No significant financial relationships to disclose.

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Temozolomide-based chemoradiation in naïve pure and mixed anaplastic astrocytoma: Long term results of a phase II study.

Journal of Clinical Oncology ◽

10.1200/jco.2011.29.15_suppl.2057 ◽

2011 ◽

Vol 29 (15_suppl) ◽

pp. 2057-2057

Author(s):

S. Chiesa ◽

G. Chiloiro ◽

S. Manfrida ◽

A. Mangiola ◽

G. R. D'Agostino ◽

...

Keyword(s):

Phase Ii ◽

Anaplastic Astrocytoma ◽

Phase Ii Study ◽

Long Term Results

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Repeated anti-CEA-radioimmunotherapy (RAIT) with 131iodine-labetuzumab after resection of colorectal liver metastases (CLM): Long-term results of a prospective phase II study.

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.3_suppl.719 ◽

2015 ◽

Vol 33 (3_suppl) ◽

pp. 719-719

Author(s):

Kia Homayounfar ◽

Carsten O. Sahlmann ◽

Martin Niessner ◽

Johannes Meller ◽

Lena-Christin Conradi ◽

...

Keyword(s):

Phase Ii ◽

Phase Ii Study ◽

Long Term Results ◽

Hematological Toxicity ◽

R0 Resection ◽

Term Survival ◽

Salvage Resection ◽

Metastatic Relapse ◽

Experienced Grade

719 Background: Previously, single anti-CEA-radioimmunotherapy (RAIT) with 131iodine(I)-labetuzumab after complete (R0) resection of CEA-positive CLM was well tolerated and improved overall survival (OS) compared to a control group without RAIT. In this phase II study, we examined safety, feasibility, and long-term efficacy of repeated RAIT in the same setting. Methods: After R0-resection of CEA-positive CLM, 63 pts (42 m, 21 f; median age, 64.5 yrs) with synchronous (n=33) or metachronous (n=30) CLM received RAIT with 40-50 mCi/m2 per dose. 45 pts were intermediate/high risk for early metastatic relapse according to the Fong score. Restaging with CT/MRI and FDG-PET was performed prior to each RAIT. Pts with persistent elevated serum CEA-levels or inconclusive lesions during post-operative restaging received RAIT, but were classified as “non-adjuvant.” Toxicity was classified according to NCI-CTC v2.0. Time to progression (TTP), OS and cancer-specific survival (CSS) were calculated. The median follow-up was 54 (range 6-127) mos. Results: After the first cycle of RAIT 14 of 63 pts experienced grade 4 hematological toxicity. Nineteen pts did not receive the second cycle of RAIT due to prolonged toxicity, impaired performance status (n=6), or metastatic relapse (n=13). The latter were further treated by resection (n=3) or systemic chemotherapy (n=10). Forty-four pts received the planned second cycle of RAIT. Of these, 4 pts newly experienced grade 4 hematological toxicity. For all 63 pts, the median TTP, OS and CSS were 13, 57 and 92 months, respectively. The truly “adjuvant” pts (n=39) had a an improved median TTP (26 vs. 6.6 mos, p<0.0001), OS (76 vs. 42 mos, p=0.03) and CSS (not reached vs. 42 mos, p=0.003) in comparison to “non-adjuvant” pts (n=24). Conclusions: Repeated anti-CEA-RAIT with 131I-labetuzumab is safe, feasible, and well-tolerated (100% compliance), with expected hematological toxicity. The long-term survival after RAIT is very encouraging, in particular for pts deemed truly “adjuvant” post-salvage resection of CLM at restaging prior to RAIT.

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