This prospective study compared 177 Lu-ethylene diamine tetramethylene phosphonate (EDTMP) with 153 Sm-EDTMP for painful skeletal metastases. Methods: Half of the 32 patients were treated with 177 Lu-EDTMP and half with 153 Sm-EDTMP, at 37 MBq/kg of body weight. Analgesic, pain, and quality-of-life scores (EORTC, Karnofsky, ECOG) and bone proliferation marker were used to examine efficacy. Hematologic toxicity was evaluated using NCI-CTCAE and compared between groups at baseline and each month till 3 mo after therapy. Pain relief was categorized as complete, partial, minimal, or none. Results: Pain relief with 177 Lu-EDTMP was 80%: 50% complete, 41.67% partial, and 8.33% minimal. Pain relief with 153 Sm-EDTMP was 75%: 33.33% complete, 58.33% partial, and 8.33% minimal. The difference was not significant (P 5 1.000). Quality of life at 3 mo after therapy improved significantly in both groups as per ECOG score (P 5 0.014 and 0.005 for 177 Lu-EDTMP and 153 Sm-EDTMP, respectively), Karnofsky index (P 5 0.007 and 0.023 for 177 Lu-EDTMP and 153 Sm-EDTMP, respectively), and EORTC score (P 5 0.004 and , 0.001 for 177 Lu-EDTMP and 153 Sm-EDTMP, respectively). Bone proliferation marker in responders of both groups dropped significantly (P 5 0.008 for 177 Lu-EDTMP and P 5 0.019 for 153 Sm-EDTMP), parallel to clinical response. For 177 Lu-EDTMP, anemia, leukopenia, and thrombocytopenia were nonserious (grade I/II) in 46.67%, 46.67%, and 20%, respectively, and serious (grade III/IV) in 20%, 6.67%, and 0%, respectively. For 153 Sm-EDTMP, anemia, leukopenia, and thrombocytopenia were nonserious (grade I/II) in 62.5%, 31.25%, and 18.75%, respectively, and serious (grade III/IV) in 18.75%, 0%, and 6.25%, respectively. One patient treated with 153 Sm-EDTMP had grade IV thrombocytopenia but required no blood transfusion. Differences between groups were not significant for either nonserious or serious toxicity. For 177 Lu-EDTMP, 3 of 12 responders experienced the flare phenomenon on the third day after therapy and one on the fifth day, showing no response to therapy. For 153 Sm-EDTMP, 2 of 12 responders experienced the flare phenomenon, both on the third day after therapy. Conclusion: 177 Lu-EDTMP has pain response efficacy similar to that of 153 Sm-EDTMP and is a feasible and safe alternative, especially in centers with no nearby access to 153 Sm-EDTMP.
Nodal marginal zone B-cell lymphoma (NMZL) is a rare subtype of non-Hodgkin lymphoma, usually presented at advanced stage. The treatment for NMZL is currently consistent with follicular lymphoma which includes observation for asymptomatic patients to cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or CHOP plus rituximab regimen, fludarabine or bendamustine and rituximab (B-R) for advanced, symptomatic patients. The B-R regimen is effective and could be evaluated further as the first-line therapy.
Cost containment through indigenous production of radioimmunotherapy agents for non-Hodgkin lymphoma (NHL) would be a pivotal step toward wider clinical availability, especially in developing countries. We examined the biodistribution and dosimetry of indigenously developed and radiolabeled 131 I-rituximab, using the monoclonal antibody of chimeric origin, in patients with B-cell lymphoma for potential use in radioimmunotherapy. Methods: This prospective study included 13 patients with Bcell NHL who underwent low-dose diagnostic scanning for dosimetric and biodistribution studies. Soon after rituximab infusion, a diagnostic dose of radioiodinated rituximab was administered. Serial planar whole-body γ-camera images were taken soon afterward and on days 1, 2, 4, and 6. A source of 131 I with known activity was used as a reference standard for dosimetry calculations. Results: The patient-specific administered dose that would give a whole-body absorbed radiation dose of 75 cGy, calculated by the MIRD schema, ranged from 3,095.42 to 6,330.33 MBq (83.66-171.09 mCi), with a mean of 3,986.01 ± 863.95 MBq (107.73 ± 23.35 mCi) and a median of 3,697.41 MBq (99.93 mCi). The mean residence time was 69.54 h. Within the first 48 h at least 50% of the injected activity was cleared, and by 144 h at least 80% was cleared. The patient-specific administered dose that would give a whole-body absorbed radiation dose of 75 cGy, calculated by mean residence time and activity-hours, ranged from 2,654.75 to 6,210.45 MBq (71.75-167.85 mCi), with a mean of 3,576.42 ± 927.59 MBq (96.66 ± 25.07 mCi) and a median of 3,421.02 MBq (92.46 mCi). With respect to organ-specific dosimetry, the mean absorbed doses to organs (apart from blood pool [3.77 Gy] and spleen [4.02 Gy]) were 0.97 Gy to the lungs, 0.69 Gy to the liver, and 0.7 Gy to the kidneys. Conclusion: The indigenous product had kinetics similar to commercial radiopharmaceuticals, with the advantage of a lower human antimouse antibody response because of the pharmaceutical's being a chimeric antibody rather than a murine antibody. Hence, clinical administration was safe. In none of the organs did dose-limiting radiation exposure occur at the proposed therapeutic dose.
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