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T-Cell Lymphoma: Radiotherapy Quality Assurance (QA) Review in Japan Clinical Oncology Group (JCOG) Trial 0211
I. J. Radiation Oncology d Biology d Physics
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Volume 72, Number 1, Supplement, 2008
Upfront Radiotherapy with Concurrent Chemotherapy for Localized Nasal NK/T-Cell Lymphoma: Radiotherapy Quality Assurance (QA) Review in Japan Clinical Oncology Group (JCOG) Trial 0211
M. Oguchi1, Y. Kagami2, S. Ishikura3, K. Nihei4, Y. Ito2, M. Yamaguchi5, K. Tobinai2, T. Hotta6, I. Wasada7, K. Oshimi8 1
The Japanese Fdn for Cancer Research, Cancer Institute Hospital, Tokyo, Japan, 2National Cancer Center, Tokyo, Japan, Center for Cancer Control and Information Services, National Cancer Center and Radiotherapy Support Center, Tokyo, Japan, 4 National Cancer Center Hospital East, Kashiwa, Japan, 5Mie University, Tsu, Japan, 6Nagoya National Hospital, Nagoya, Japan, 7Tokai University, Isehara, Japan, 8Juntendo University, Tokyo, Japan 3
Purpose/Objective(s): It is challenging to conduct a high quality multi-institutional clinical trial for localized nasal NK/T-cell lymphoma due to its rarity. JCOG 0211 is a multi-center phase I/II trial for this lymphoma to evaluate upfront radiotherapy (RT) with concurrent chemotherapy; a total RT dose of 50 Gy and 3 cycles of DeVIC (carboplatin, etoposide, ifosfamide, and dexamethasone). The purpose of this study is to evaluate the compliance with RT protocol guidelines in concurrent chemoradiotherapy among institutions participating in JCOG 0211. Materials/Methods: Thirty-three patients (stage I, 23; stage II, 10) were accrued in this study from 2003 to 2006 from 18 institutions. The 3-D conformal RT planning was required to cover adequately target volumes and to minimize doses to organs at risk: the eyes, the brain stem and the spinal cord. The following parameters were evaluated with RT charts and simulation/portal images by the RT-QA review board: prescribed dose, fractionation, overall treatment time, daily treatment, target delineation, target coverage, dose distributions and dose to risk organs. Results: There was no protocol violation. All cases were compliant in fractionation, daily treatment and overall treatment time. In evaluable 29 of 33 cases, all cases were protocol compliant in target coverage. Deviations were identified as follows: prescribed dose, 1/33; delineation of CTV (\ 2 cm from the edge of GTV at any direction), 2/33; and dose distribution (not covered by 90%115% isodose line), 3/33. In 11 cases, the dose to organs at risk exceeded 40 Gy mainly due to the tumor extension close to organs at risk such as the eyes. The individual case review and its feedback to participating institutions contributed to reduce protocol deviations. Conclusions: The JCOG 0211 will provide reliable results of chemoradiotherapy for localized nasal NK/T-cell lymphoma. Author Disclosure: M. Oguchi, None; Y. Kagami, None; S. Ishikura, None; K. Nihei, None; Y. Ito, None; M. Yamaguchi, None; K. Tobinai, None; T. Hotta, None; I. Wasada, None; K. Oshimi, None.
2683
Radio-Immunotherapy (RIT): Long-term Follow-up Results with I-131 Labeled Antibody in 52 Patients with Non-Hodgkin’s Lymphoma (NHL) Refractory to Chemotherapy and Rituxan
J. B. Colenda1, R. Mark1,2, P. Anderson1, T. Neumann1, M. Nair1, R. Akins1, D. Quick1 1
Joe Arrington Cancer Center, Lubbock, TX, 2Texas Tech University, Lubbock, TX
Purpose/Objective(s): Non-Hodgkin’s Lymphoma (NHL) B-Cell subtype, is generally very sensitive to Chemotherapy and Rituxan. In patients who have developed refractory disease, the course of disease is usually rapidly fatal. Many NHL B-Cells express CD-20 Antigen. Such patients may be candidates for Radioimmunotherapy (RIT) with tositumomab murine monoclonal antibody conjugated with I-131, which can bind to CD-20 expressing cells with potentially lethal effects. We present results in 52 patients treated according to the Bexxar CP98-020 Protocol. Materials/Methods: Initially, candidates for Bexxar CP98-020 Protocol, were patients with NHL expressing CD-20 which had become refractory to Chemotherapy and Rituxan. Since 2006, four patients have received primary treatment for NHL with RIT. Eligibility criteria included Platelet count .100,000, less than 25% involved bone marrow, and no kidney dysfunction. In addition, the patients could not be pregnant or breast feeding. Between 2001 and 2008, 52 patients received I-131 labeled Antibody. The total body dose was 75 cGy for Platelet counts .150,000 and 65 cGy for Platelet 100-150,000. Activity ranged from 60 mCi to 120 mCi. Results: Median follow-up was 54 months (range, 6-84 months). The response rate was 73.0% (38/52), with complete response achieved in 26.9% (14/52) of the patients. Median progression free survival was 14 months. All four patients treated with primary RIT remain free of recurrence, with follow-up periods ranging from 12-38 months. Toxicity was moderate, with 9.6% (5/52) of patients experiencing profound (Platelets \ 10,000) thrombocytopenia, which was prolonged, lasting more than 20 weeks. There were no bleeding complications, and no patient required a transfusion. For the remaining 47 patients, Platelet counts decreased mildly for 4-6 weeks following RIT, and then returned to normal values by 10-20 weeks. Conclusions: RIT has yielded promising results in NHL patients’ refractory to Chemotherapy and Rituxan. Toxicity has been acceptable. RIT may be considered for first line treatment in some cases of NHL. Author Disclosure: J.B. Colenda, None; R. Mark, None; P. Anderson, None; T. Neumann, None; M. Nair, None; R. Akins, None; D. Quick, None.
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Palliation by Low Dose Local Radiotherapy for Indolent Non-Hodgkin’s Lymphoma
E. K. Chan1,2, R. W. Tsang Lymphoma Group1,2 1
Princess Margaret Hospital, Toronto, ON, Canada, 2University of Toronto, Toronto, ON, Canada
Purpose/Objective(s): The efficacy of local palliative radiotherapy with a 2 x 2 Gy regimen (total dose: 4 Gy) in Non-Hodgkin’s Lymphoma of indolent histology is assessed in a retrospective chart review. Materials/Methods: Between 2003 and 2005, 20 patients (10 men, 10 women, median age 71.5 years at treatment date, range, 3381) were treated with 2 x 2 Gy over two days with palliative intent. Histologies were FL in 9 patients, CLL in 9 patients, MCL in 1 patient and MALT in 1 patient. Nine patients initially presented with stage 0-2 disease, ten patients with stage 3-4 disease and one unknown. ECOG status was 0-2 in 19 patients and ECOG 3 in one patient. 17 patients had received prior chemotherapy. The
S474
2682
Volume 72, Number 1, Supplement, 2008
Upfront Radiotherapy with Concurrent Chemotherapy for Localized Nasal NK/T-Cell Lymphoma: Radiotherapy Quality Assurance (QA) Review in Japan Clinical Oncology Group (JCOG) Trial 0211
M. Oguchi1, Y. Kagami2, S. Ishikura3, K. Nihei4, Y. Ito2, M. Yamaguchi5, K. Tobinai2, T. Hotta6, I. Wasada7, K. Oshimi8 1
The Japanese Fdn for Cancer Research, Cancer Institute Hospital, Tokyo, Japan, 2National Cancer Center, Tokyo, Japan, Center for Cancer Control and Information Services, National Cancer Center and Radiotherapy Support Center, Tokyo, Japan, 4 National Cancer Center Hospital East, Kashiwa, Japan, 5Mie University, Tsu, Japan, 6Nagoya National Hospital, Nagoya, Japan, 7Tokai University, Isehara, Japan, 8Juntendo University, Tokyo, Japan 3
Purpose/Objective(s): It is challenging to conduct a high quality multi-institutional clinical trial for localized nasal NK/T-cell lymphoma due to its rarity. JCOG 0211 is a multi-center phase I/II trial for this lymphoma to evaluate upfront radiotherapy (RT) with concurrent chemotherapy; a total RT dose of 50 Gy and 3 cycles of DeVIC (carboplatin, etoposide, ifosfamide, and dexamethasone). The purpose of this study is to evaluate the compliance with RT protocol guidelines in concurrent chemoradiotherapy among institutions participating in JCOG 0211. Materials/Methods: Thirty-three patients (stage I, 23; stage II, 10) were accrued in this study from 2003 to 2006 from 18 institutions. The 3-D conformal RT planning was required to cover adequately target volumes and to minimize doses to organs at risk: the eyes, the brain stem and the spinal cord. The following parameters were evaluated with RT charts and simulation/portal images by the RT-QA review board: prescribed dose, fractionation, overall treatment time, daily treatment, target delineation, target coverage, dose distributions and dose to risk organs. Results: There was no protocol violation. All cases were compliant in fractionation, daily treatment and overall treatment time. In evaluable 29 of 33 cases, all cases were protocol compliant in target coverage. Deviations were identified as follows: prescribed dose, 1/33; delineation of CTV (\ 2 cm from the edge of GTV at any direction), 2/33; and dose distribution (not covered by 90%115% isodose line), 3/33. In 11 cases, the dose to organs at risk exceeded 40 Gy mainly due to the tumor extension close to organs at risk such as the eyes. The individual case review and its feedback to participating institutions contributed to reduce protocol deviations. Conclusions: The JCOG 0211 will provide reliable results of chemoradiotherapy for localized nasal NK/T-cell lymphoma. Author Disclosure: M. Oguchi, None; Y. Kagami, None; S. Ishikura, None; K. Nihei, None; Y. Ito, None; M. Yamaguchi, None; K. Tobinai, None; T. Hotta, None; I. Wasada, None; K. Oshimi, None.
2683
Radio-Immunotherapy (RIT): Long-term Follow-up Results with I-131 Labeled Antibody in 52 Patients with Non-Hodgkin’s Lymphoma (NHL) Refractory to Chemotherapy and Rituxan
J. B. Colenda1, R. Mark1,2, P. Anderson1, T. Neumann1, M. Nair1, R. Akins1, D. Quick1 1
Joe Arrington Cancer Center, Lubbock, TX, 2Texas Tech University, Lubbock, TX
Purpose/Objective(s): Non-Hodgkin’s Lymphoma (NHL) B-Cell subtype, is generally very sensitive to Chemotherapy and Rituxan. In patients who have developed refractory disease, the course of disease is usually rapidly fatal. Many NHL B-Cells express CD-20 Antigen. Such patients may be candidates for Radioimmunotherapy (RIT) with tositumomab murine monoclonal antibody conjugated with I-131, which can bind to CD-20 expressing cells with potentially lethal effects. We present results in 52 patients treated according to the Bexxar CP98-020 Protocol. Materials/Methods: Initially, candidates for Bexxar CP98-020 Protocol, were patients with NHL expressing CD-20 which had become refractory to Chemotherapy and Rituxan. Since 2006, four patients have received primary treatment for NHL with RIT. Eligibility criteria included Platelet count .100,000, less than 25% involved bone marrow, and no kidney dysfunction. In addition, the patients could not be pregnant or breast feeding. Between 2001 and 2008, 52 patients received I-131 labeled Antibody. The total body dose was 75 cGy for Platelet counts .150,000 and 65 cGy for Platelet 100-150,000. Activity ranged from 60 mCi to 120 mCi. Results: Median follow-up was 54 months (range, 6-84 months). The response rate was 73.0% (38/52), with complete response achieved in 26.9% (14/52) of the patients. Median progression free survival was 14 months. All four patients treated with primary RIT remain free of recurrence, with follow-up periods ranging from 12-38 months. Toxicity was moderate, with 9.6% (5/52) of patients experiencing profound (Platelets \ 10,000) thrombocytopenia, which was prolonged, lasting more than 20 weeks. There were no bleeding complications, and no patient required a transfusion. For the remaining 47 patients, Platelet counts decreased mildly for 4-6 weeks following RIT, and then returned to normal values by 10-20 weeks. Conclusions: RIT has yielded promising results in NHL patients’ refractory to Chemotherapy and Rituxan. Toxicity has been acceptable. RIT may be considered for first line treatment in some cases of NHL. Author Disclosure: J.B. Colenda, None; R. Mark, None; P. Anderson, None; T. Neumann, None; M. Nair, None; R. Akins, None; D. Quick, None.
2684
Palliation by Low Dose Local Radiotherapy for Indolent Non-Hodgkin’s Lymphoma
E. K. Chan1,2, R. W. Tsang Lymphoma Group1,2 1
Princess Margaret Hospital, Toronto, ON, Canada, 2University of Toronto, Toronto, ON, Canada
Purpose/Objective(s): The efficacy of local palliative radiotherapy with a 2 x 2 Gy regimen (total dose: 4 Gy) in Non-Hodgkin’s Lymphoma of indolent histology is assessed in a retrospective chart review. Materials/Methods: Between 2003 and 2005, 20 patients (10 men, 10 women, median age 71.5 years at treatment date, range, 3381) were treated with 2 x 2 Gy over two days with palliative intent. Histologies were FL in 9 patients, CLL in 9 patients, MCL in 1 patient and MALT in 1 patient. Nine patients initially presented with stage 0-2 disease, ten patients with stage 3-4 disease and one unknown. ECOG status was 0-2 in 19 patients and ECOG 3 in one patient. 17 patients had received prior chemotherapy. The