Mini-review Should involved-field radiation therapy be used as an adjunct to lymphoma autotransplantation?

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1 (2002) 29, Nature Publishing Group All rights reserved /02 $ Mini-review Should involved-field radiation therapy be used as an adjunct to lymphoma autotransplantation? P Wadhwa 1, DC Shina 2, D Schenkein 3,4 and HM Lazarus 1 1 Department of Medicine, Comprehensive Cancer Center of the University Hospitals of Cleveland/Case Western Reserve University, Cleveland, OH, USA; 2 Department of Radiation Therapy, Comprehensive Cancer Center of the University Hospitals of Cleveland/Case Western Reserve University, Cleveland, OH, USA; and 3 New England Medical Center, Boston, MA, USA Summary: Relapse at sites of prior disease involvement accounts for the majority of treatment failures following highdose therapy and autologous transplantation for both Hodgkin s disease and non-hodgkin s lymphoma. Several studies have demonstrated the utility of involvedfield radiation as a treatment modality in this setting to minimize disease bulk prior to transplants, to reduce relapse rates at sites of prior disease involvement and to improve local control for disease resistant to highdose therapy. Other studies recommend caution due to potential toxicities including radiation-induced pneumonitis and secondary myelodysplasia. Further investigations are needed to better define the optimal extent, dose and timing of radiation in the setting of transplantation, as well as to identify those subsets of patients likely to be at a higher risk of radiation-induced morbidity. (2002) 29, DOI: /sj/bmt/ Keywords: involved field radiation therapy; autotransplantation; lymphoma Even when detected at an early stage, intermediate and high-grade non-hodgkin s lymphomas (NHL) are thought to represent systemic disease and the standard of care has been combination chemotherapy. For patients with advanced-stage intermediate and high-grade NHL, longterm disease-free survival is attained with combination chemotherapy in 40 50% of patients. 1 High-dose chemotherapy and autologous stem cell transplantation has emerged as a valuable treatment option for those patients with relapsed or primary refractory disease. Despite the observation that 40 50% of patients who have chemotherapy-sensitive relapse 2 and about 30% of patients with primary refractory disease 3 achieve prolonged, disease-free survival using high-dose chemotherapy and autologous Correspondence: Dr HM Lazarus, Department of Medicine, University Hospitals of Cleveland, Euclid Avenue, Cleveland, OH 44106, USA 4 Current address: Millenium Pharmaceuticals, Cambridge, MA, USA stem cell transplantation, a high relapse rate accounts for the majority of deaths in autotransplant patients, with most relapses occurring at sites of prior disease involvement. 4 Similarly, approximately 80% of Hodgkin s disease (HD) patients in early stage given conventional chemotherapy with or without radiotherapy attain a cure and about 50% of advanced disease patients achieve long-term disease-free survival. 5 Very few patients who relapse or fail to achieve a remission with primary induction regimens achieve a long-term cure with conventional salvage chemotherapy. 6 According to the Autologous Blood and Marrow Transplant Registry data reported by Lazarus and associates, the 3- year DFS for HD patients undergoing autotransplantation is 46% for those transplanted in first relapse, 64% for those transplanted in second remission, 7 and 38% for those with primary refractory disease. 8 Once again, the majority of treatment failures following high-dose chemotherapy and stem cell transplantation for Hodgkin s disease stem from relapses at prior disease sites. 9 These observations have prompted an interest in the use of involved-field radiation therapy (IFRT) as an adjunct to autotransplants in an attempt to improve patient outcome by reducing the relapse rate. While multiple reports describe the use of adjuvant IFRT, such analyses are retrospective in nature and no randomized studies have been performed. Furthermore, contemporary practice, in general, reflects institutional preferences and there is controversy regarding the optimal dose, timing and extent of IFRT. This review addresses the rationale for using IFRT in the autologous hematopoietic stem cell transplant setting, and discusses the efficacy as well as potential toxicity and concerns regarding this treatment modality. IFRT as an adjunct to conventional chemotherapy IFRT has been validated in the conventional dose setting as therapy for HD and NHL by both non-randomized and randomized studies (Table 1). In localized, early stage NHL, IFRT used in conjunction with chemotherapy has been shown to improve both event-free survival (EFS) and overall survival (OS). Longo and colleagues 10 treated 47 stage I/IE aggressive NHL patients using four cycles of ProMACE-MOPP (cyclophosphamide, etoposide, doxorubicin, nitrogen mustard, procarbazine, vincristine and high-

2 184 Table 1 Randomized studies addressing the impact of IFRT on event-free and overall survival in conventional therapy for NHL Ref. Tumor No. Design No. patients EFS OS Comments patients given (median) (median) IFRT Glick et al 11 Stage 345 CHOP vs CHOP vs 58% at 6 84 vs 70% at 6 Survival benefit for I, II NHL IFRT years years bulky disease P 0.03 P 0.01 Miller et al 12 Stage I, II NHL 401 CHOP vs CHOP vs 64% at 5 82 vs 72% at 5 Survival benefit for IFRT years years bulky disease P 0.03 P 0.02 Aviles et al 13 Stage IV NHL 88 CEOP-Bleo/DA vs 35% at 5 81 vs 55% at 5 Survival benefit for with bulky C vs CEOP- years years bulky disease disease Bleo/DA C P 0.01 P 0.01 IFRT NHL non-hodgkin s lymphoma; HD Hodgkin s disease; IFRT involved-field radiation therapy; EFS event-free survival; OS overall survival; CHOP cyclophosphamide, adriamycin, vincristine, prednisone; CEOP-Bleo/DAC cyclophosphamide, epirubicin, vincristine, prednisone, bleomycin alternating with dexamethasone, cytosine arabinoside and cisplatin. dose methotrexate) followed by 4000 cgy IFRT. They reported an impressive 96% complete remission (CR) rate using this combined approach. Furthermore, no relapses were detected at a median follow-up of 42 months. The Eastern Cooperative Oncology Group (ECOG) 11 treated 345 intermediate-grade, early-stage NHL patients using eight cycles of CHOP (cyclophosphamide, vincristine, adriamycin and prednisone) chemotherapy. Patients who attained a partial remission (PR) received 4000 cgy IFRT. As a result, 28% percent of these patients subsequently attained a CR. Sixty-one percent of all patients achieved a CR after receiving combination chemotherapy alone and were randomized either to receive 3000 cgy as consolidation IFRT to pre-treatment lymphomatous sites, or were assigned no further treatment. The combination IFRT chemotherapy arm attained a significantly improved 6-year DFS (73 vs 58%; P 0.03) and OS (84 vs 70%; P 0.06). Similarly, a Southwest Oncology Group (SWOG) study 12 randomized 401 stage I/II intermediate/high-grade NHL patients to receive either eight cycles of CHOP chemotherapy vs three cycles of CHOP plus IFRT ( cgy). Patients assigned to the combination arm had a significantly improved PFS (77 vs 64%; P 0.03) and OS (87 vs 72%; P 0.02) compared to those treated with CHOP chemotherapy alone. Additionally, Aviles et al 13 treated 218 stage IV, intermediate-grade NHL patients using CEOP-bleo (cyclophosphamide, epirubicin, vincristine, prednisone, bleomycin) alternating with DAC (dexamethasone, cytosine arabinoside and cisplatin). Of the complete responders, 88 patients had originally presented with bulky disease ( 10 cm), and these were randomized to receive either adjuvant IFRT ( cgy) or no further treatment. At a median follow-up of 5 years, the DFS was 72% in the combination chemotherapy IFRT arm compared to 35% in the group who did not receive radiation (P 0.01), while the projected 5-year OS was superior in the combination arm (81 vs 55%; P 0.01). These studies demonstrate that IFRT in combination with systemic chemotherapy confers a significant survival advantage over combination chemotherapy alone in the setting of earlystage aggressive NHL; additional studies are probably warranted to confirm this survival advantage over chemotherapy alone in patients with advanced-stage disease. Use of IFRT in the transplant setting Although multiple studies that have demonstrated a survival benefit for transplanting NHL patients in the setting of primary high-risk patients, 14 chemosensitive relapse 2 or primary refractory disease, 3 relapses at sites of prior disease involvement continue to be the major cause of transplant failures. Philip et al 4 reported 100 adult patients with intermediate/high-grade NHL in the relapsed/refractory setting, who underwent high-dose chemotherapy and autologous stem cell transplantation. While 39 patients underwent TBI-containing regimens, none received IFRT. Seventy-six percent of episodes of progression following transplant were isolated, and occurred in sites of involvement prior to salvage therapy, indicating that local control is a significant issue. Takvorian et al 15 transplanted 49 patients with relapsed/refractory NHL using cyclophosphamide and TBI conditioning followed by infusion of B lymphocyte-purged autologous bone marrow. Of the 13 patients who relapsed following transplant, 11 were at sites of prior bulk disease. The findings from these and other early studies have prompted investigators to use IFRT as an adjunct to autotransplants in order to provide better local control of lymphoma since 70 90% of relapses after autotransplant occur in sites of previous disease. The optimal radiation field, timing and dose of IFRT in the transplant setting remain to be determined and continue to be a subject of debate. Proponents of pre-transplant IFRT make their case on the basis of the ability to minimize disease bulk at the time of transplant (an independent prognostic variable in multiple studies), to treat symptomatic bulky disease and also minimize the exposure of re-infused stem cells to potentially myelosuppressive and leukemogenic therapy. Advocates of the post-transplant IFRT strategy believe they can tailor the dose of post-transplant radiation based on residual disease volume, possibly allowing for the use of lower doses of IFRT. Additionally, some of the pulmonary and hematol-

3 Table 2 Advantages and disadvantages of differing timing of IFRT in association with autotransplant Pre-transplant: Ability to minimize bulk disease before transplant Treatment of symptomatic disease Avoids exposing re-infused stem cells to myelosuppressive and potentially leukemogenic therapy May increase incidence of interstitial pneumonitis/veno-occlusive disease Patients may relapse outside the radiation field prior to transplant Post-transplant: Avoids delaying transplant in patients with rapidly progressive disease Allows tailoring radiation dose based on residual disease volume May allow for use of lower doses of IFRT ogical complications associated with pre-transplant IFRT could be avoided. The advantages and potential drawbacks of these different strategies are summarized in Table 2. Table 3 depicts the impact of IFRT on event-free and overall survival in lymphoma autotransplant patients. Investigators at the University of Rochester 16 provided autografts to 136 relapsed/refractory NHL patients. Fiftyone patients had clinical or radiological evidence of disease after transplant and were given adjuvant IFRT. For the subset of 58 patients who had bulky disease at the time of transplant (defined as nodal or extranodal disease more than 2 cm in diameter, or involvement of 20% of marrow cellularity by lymphoma), the 3 year EFS was 35% in the 30 patients who received post-transplant IFRT compared to only 16% in the 28 patients who were not given additional treatment (P 0.04). This survival advantage observed with IFRT, however, did not extend to the group of patients with non-bulky disease at the time of transplant. Moreover, a potential bias arises from the fact that the patients who died within 50 days after transplant were included in the analysis of patients not receiving post-transplant IFRT, leading to a spuriously higher survival in the irradiated group. Mundt et al 17 transplanted 53 aggressive relapsed/refractory NHL patients. In their analysis, the use of IFRT lowered the rate of relapse in previously active lymphoma sites from 41% to 0% (P 0.04) and improved 4-year local control of persistent disease sites after transplant (100 vs 29.4%; P 0.01). The number of patients who received IFRT, however, was quite small (seven patients and 10 disease sites), making it difficult to draw firm conclusions. Vose and associates, 3 on behalf of the Autologous Blood and Marrow Transplant Registry (ABMTR), reported on 184 patients with diffuse, aggressive NHL who had primary refractory disease. After highdose chemotherapy and stem cell transplant, 44% achieved a CR, with a 5-year probability of progression-free survival (PFS) of 31% and OS 37%. In multivariate analysis, not receiving IFRT either before or after transplant was an adverse prognostic factor for OS. In this report, chemotherapy resistance, a Karnofsky performance status of 80%, age 55 years and receiving 3 prior chemotherapy regimens were also adverse prognostic factors. Not all studies have demonstrated a survival benefit or improved local control of disease for IFRT. Kewalramani and associates 18 reported that use of IFRT in 90 primary refractory disease patients did not result in improvement in either OS or PFS. Friedberg and colleagues 19 reported a single-institution experience of 552 patients transplanted 185 Table 3 Impact of IFRT on event-free and overall survival in autotransplant patients Ref. Tumor No. Design No. patients EFS OS Comments patients IFRT (median) (median) Rapoport et al 16 NHL 58 IFRT to bulky vs 16% at 3 NR Survival benefit only in disease post years bulky disease transplant P 0.04 Mundt et al 17 NHL 53 IFRT Pre/post 7 NR NR Improved 4-year local transplant control of irradiated sites Friedberg et al 19 NHL 552 IFRT pretransplant vs vs 121 Increased TRM and months months MDS in IFRT arm P 0.78 P 0.02 Toren et al 24 NHL and 93 IFRT 93 NR NR Increased grade 4 solid tumors post transplant cytopenias in NHL compared to solid tumors Poen et al 20 HD 100 IFRT pre- or post vs 55% at 3 70 vs 61% Survival benefit only in transplant years at 3 years stage I III disease P 0.59 P 0.41 Mundt et al 21 HD 54 IFRT pre- and post 20 NR NR Improved 5-year local transplant control of all sites Lancet et al 22 HD 70 IFRT post transplant vs 26% NR Improved 5-year DFS P Tsang et al 23 HD 59 IFRT pre- or post 37 NR NR Increased TRM with transplant IFRT NHL non-hodgkin s lymphoma; HD Hodgkin s disease; IFRT involved-field radiation therapy; EFS event-free survival; OS overall survival; TRM transplant-related mortality; MDS myelodysplasia; TRM transplant-related mortality; NR not reported.

4 186 over a 14-year period, of whom 152 patients received pretransplant IFRT. While the median DFS was equivalent in the two groups (60 months for the IFRT group compared to 57 months for the 400 patients not receiving IFRT; P 0.78), the median OS was actually lower in the IFRT group (94 months vs 121 months; P 0.09), accounted for by the increased deaths (49% vs 37%) in the IFRT cohort, especially from secondary myelodysplasia and pulmonary complications. IFRT for Hodgkin s disease The data supporting the use of IFRT for treatment of relapsed Hodgkin s disease in the transplant setting are comparable to those for relapsed NHL. Some of the larger studies are discussed. Poen et al 20 report the Stanford experience in which 100 consecutive relapsed and refractory HD patients underwent autotransplant using a conditioning regimen consisting of etoposide, cyclophosphamide and either TBI or BCNU (carmustine). Twenty-four patients received IFRT to bulky ( 5 cm diameter at diagnosis) or active (persistent following salvage chemotherapy) disease sites as cytoreductive therapy prior to transplant (n 18) or consolidation therapy to persistent disease sites post-transplant (n 6). Use of IFRT was associated with statistically significant improved freedom-fromrelapse (FFR) and OS in two subsets of patients: those who had never received prior radiation therapy and those with stage I III disease. For the entire group of patients, IFRT was associated with a non-significant trend towards improved 3-year FFR (75 vs 64%) and OS (70 vs 61%). Mundt and co-workers 21 treated 54 relapsed and refractory HD patients with high-dose chemotherapy and stem cell transplantation, of whom 20 subjects received additional treatment using IFRT. Relapses occurred in 25 of the 54 patients; 17 (68%) of these were in previous sites of disease, while eight (32%) were observed in new sites. IFRT appeared to reduce relapse in prior sites of disease (26.3% vs 42.8%; P 0.05). For patients with disease persistence after transplant, a significantly better PFS (40% vs 12.1%) was seen in those who received IFRT. The addition of IFRT improved 5-year local control of all sites (P 0.008), nodal sites (P 0.01), and sites of persistent disease (P ). Lancet et al 22 reported data describing 70 patients transplanted for relapsed and refractory HD, 27 of whom received IFRT. While the administration of post-transplant IFRT improved 5-year EFS (44 vs 26%; P ), the most significant factor predictive of improved EFS was the presence of minimal ( 2 cm at any site) or no disease at the time of transplant. Toxicity of IFRT While most studies demonstrate that IFRT is well tolerated, some studies demonstrate increased morbidity and mortality, chiefly arising from pulmonary or hematological toxicities. The University of Toronto investigators report their experience on 50 relapsed and refractory HD patients conditioned with high-dose melphalan and etoposide followed by an autotransplant. 23 Thirty-seven patients received IFRT, 33 of whom were treated prior to transplant. The use of thoracic IFRT was associated with a higher TRM secondary to radiation pneumonitis and respiratory failure (8/24 deaths compared to 2/35 deaths in those not receiving thoracic RT). Toxicity appeared to be increased, especially when radiation was administered less than 50 days prior to transplantation. Toren et al 24 reported an increased incidence of grade IV hematological toxicities in NHL patients receiving IFRT post transplant, when compared to patients with breast cancer and other solid tumors. The incidence of radiation-induced grade IV cytopenias was 28% in NHL patients compared to 4.5% in patients with solid tumors (P 0.05). In the report from Friedberg and co-workers 19 on 552 patients with relapsed NHL, an increased incidence of secondary myelodysplasia was observed in the cohort of 152 more heavily pretreated patients who also were given IFRT (12.5% vs 5.8%; P 0.01). In the same report, patients receiving radiation to the mediastinum or axilla had a significantly higher risk of late (occurring more than 3 months following transplant) respiratory death (P 0.002). In a retrospective cohort and nested case control study, Krishnan et al 25 evaluated the incidence of transplantrelated myelodysplasia and acute myelogenous leukemia (t- MDS/t-AML) in 612 patients transplanted for HD or NHL at the City of Hope Cancer Center. Twenty-two patients developed morphologic evidence of t-mds/t-aml with the estimated cumulative probability of developing morphologic t-mds/t-aml being 8.6% at 6 years. In multivariate analysis, stem cell priming with etoposide was an independent risk factor for subsequent development of t-mds/t- AML (RR 7.7), as was the use of pretransplant radiation therapy (RR 2.5). The multivariate analysis failed to reveal any association between development of t-mds/t- AML with the type of pre-transplant chemotherapy or the conditioning regimen (TBI based vs other). This study, however, does not distinguish between radiation therapy administered in the remote past vs that administered immediately prior to transplant. Similarly, Stone et al 26 describe the Dana-Farber experience on 262 NHL patients transplanted with a cyclophosphamide and TBI regimen. At a median follow-up of 31 months, the incidence of MDS was 7.6%; and in univariate analysis, pretreatment variables predictive for the development of MDS were prolonged interval between initial treatment and the transplant procedure (P 0.003), increased duration of prior exposure to alkylating agents (P 0.045), use of prior radiation therapy (P 0.032) and a history of prior pelvic irradiation (P 0.003). The median follow-up in this study was relatively short (31 months), and once again, several of these patients had received irradiation several months prior to transplant, as opposed to immediately before the transplant. Surprisingly, the medical literature has not indicated an increased incidence of gastro-intestinal complications such as typhlitis in patients receiving abdominal IFRT. Additionally, the Seattle group 27 retrospectively compared their experience on outcomes with TBI-based regimens (TBI/cyclophosphamide/etoposide) and non-tbibased conditioning regimens (busulphan/melphalan/ thiotepa) for 351 NHL patients undergoing autologous stem cell transplantation. Patients who had received prior dose-

5 limiting radiation (defined as greater than 2000 cgy to the liver or mediastinum, or 3000 cgy to the CNS) were ineligible for the TBI-based regimen. The cumulative probability of EFS, OS, and relapse at 5 years were equivalent with both regimens; additionally, the treatment-related mortality was equivalent in patients transplanted with the TBI vs non-tbi-containing regimens (8% vs 11%; P 0.9). In the busulphan/melphalan/thiotepa group (n 130), no statistically significant differences in regimen-related toxicity or mortality were noted in the groups who had (n 59) or had not (n 71) received prior dose-limiting radiation therapy, although the incidence of secondary myelodysplasia was not reported in this study. Radio-immunoconjugates An exciting alternative approach in the process of evolution is the potential to specifically target the radiotherapy to malignant cells using radio-immunoconjugated antibodies. Four radiolabeled antibody products are currently being evaluated in the clinical setting, I-tositumomab (Bexxar) and 90 Y-ibritumomab tiuxetan (Zevalin), which target the CD20 antigen, 90 Y epratuzumab (hll2) that targets CD22, and 131 I-Lym-1, which reacts with HLA-DR. Both 131 I and 90 Y kill cells primarily through emission of particles, which are believed to induce double-strand DNA breaks. Owing to the moderately long path length of these emissions (1 5 mm), both 131 I-tositumomab and 90 Y-ibritumomab can also exert some degree of bystander cytotoxicity to adjacent antigen-negative or non-targeted, antigen-positive cells. 29 Both these CD20-targeted radioimmunoconjugates appear promising in the non-transplant setting. In early phase I/II studies, the maximum-tolerated dose of 90 Y ibritumomab was shown to be 0.4 mci/kg, 30 with reversible hematological toxicity (principally thrombocytopenia) being the major side-effect. The same group has conducted a randomized trial prospectively comparing 90 Y ibritumomab (Zevalin) with rituximab, its naked chimeric monoclonal antibody counterpart, in the setting of relapsed CD20-positive NHL. In their interim analysis on 90 patients, the 90 Y ibritumomab-treated patients demonstrated a higher response rate (80% vs 44%; P 0.05), and higher CR rate (21% vs 6%; P 0.06). 31 Similarly, studies using radiolabeled 131 I-tositumomab (non-transplant setting) have been performed in relapsed, refractory NHL, as reported by Kaminski et al 32 and Vose et al. 33 Single-agent therapy was associated with response rates of 50 70% in low-grade and about 40% in intermediate-grade NHL. These encouraging results prompted an interest in the use of these radio-immunoconjugates in the transplant setting in lieu of TBI, with the premise that selectively targeting the radiotherapy to the malignant cells would minimize radiation-induced damage to normal organs and tissues. In an ongoing phase I trial, Winter and associates 34 have treated 12 relapsed/refractory NHL patients with high-dose BEAM chemotherapy (BCNU, etoposide, cytarabine and melphalan) in conjunction with 90 Y ibritumomab, administered in a dose-escalating fashion. Two of three patients treated at the highest dose (delivering 500 cgy to normal critical organs like the lung and liver) underwent a 20% decline in pulmonary function assessed by DLCO measurement; however, both these patients are asymptomatic. It is unclear whether this decline in DLCO could be attributed to the 90 Y ibritumomab or BEAM chemotherapy alone, which is known to cause a decline in post-transplant DLCO. While ongoing studies should resolve this issue, the addition of 90 Y ibritumomab did not appear to adversely affect the time to engraftment post transplant; median time to neutrophils 1000/ l was 10 days and median time to platelet recovery was 20 days. Similarly, Press and coworkers 35 conducted a phase I/II trial of 131 I-tositumomab, cyclophosphamide and etoposide conditioning followed by autologous stem cell transplantation in 52 relapsed B cell NHL patients. The MTD (maximum tolerated dose) of 131 I-tositumomab that could be combined safely with etoposide 60 mg/kg and cyclophosphamide 100 mg/kg delivered 2500 cgy to critical normal organs. The estimated OS and PFS at 2 years for all treated patients was 83% and 68%, respectively. These results compared favorably to a non-randomized control group that underwent transplantation during the same period using TBI, cyclophosphamide and etoposide (OS 53% and PFS 36%), even after adjustment for confounding factors in a multivariate analysis. While these preliminary results are promising, it must be borne in mind that the follow-up is short, it is too early to assess the risk of secondary myelodysplasia, and that this comparison was not a randomized investigation. Also, such forms of therapy would not be efficacious in HD or CD20-negative NHL. Nevertheless, this study provides evidence that targeted radioimmunotherapy ultimately may prove superior to, or at least equivalent to, non-targeted external-beam radiotherapy, and suggests that additional studies using these and other radioimmunoconjugates are warranted in the transplant setting. Conclusions IFRT has been shown to be beneficial by many investigators as an adjunct to autotransplants for both NHL and HD by decreasing relapses at sites of prior disease and improving EFS, especially in subsets of patients with bulky disease. Potential concerns regarding involved-field radiation include increased pulmonary morbidity in patients receiving thoracic radiation prior to the transplant, as well as an increased incidence of secondary myelodysplasia. No randomized trials have been performed to definitively address the role of IFRT in the setting of autotransplants. Most of the current analyses are retrospective in nature, and may, in fact, underestimate the true potential of IFRT to improve OS and EFS owing to the inherent selection bias of offering IFRT to patients with adverse features such as bulky tumor, chemo-resistant disease, or the combination. While well-designed randomized trials are warranted, the design of such trials (Table 4) is complex and challenging owing to marked heterogeneity in institutional preferences regarding the optimal extent, dose and timing of radiation. Additionally, meta-analyses and Transplant Registry data may yield important information regarding optimization of radiation schedules and identification of subsets of patients 187

6 188 Table 4 Difficulties in designing and interpreting clinical trials to assess IFRT utility Disease heterogeneity: HD vs NHL (low/intermediate/high-grade or transformed) Defining uniform criteria for offering IFRT: (1) defining a cut-off for bulk disease (2 cm vs 5cmvs other) (2) treating all sites which can be encompassed in a single port vs only those larger than a certain predefined area (extended-field vs involved-field) Defining optimal timing in relation to transplant (bulk disease prior to transplant vs persistent disease sites after transplant) Defining the optimal IFRT treatment dose Defining appropriate end points (EFS, OS, relapse-free survival, local control, treatment-related toxicity) Defining patient populations at high risk of complications secondary to IFRT Common belief among practitioners that IFRT is beneficial, hampering accrual to proposed randomized studies at increased risk for radiation-induced toxicities. In the interim period, IFRT should continue to be offered as a valuable adjunct in the setting of autologous transplantation to reduce relapses, treat symptomatic disease and improve local control for disease refractory to high-dose therapy. A reasonable approach regarding the timing and dose of IFRT, based on current institutional practices described earlier in this paper, would be to stratify patients regarding disease status at the time of transplant. IFRT could be used prior to transplant in the following settings: (1) symptomatic disease warranting immediate treatment; (2) bulky disease ( 5 cm nodal or extra-nodal disease that can be encompassed within a standard radiation field) to minimize disease volume at the time of transplantation. IFRT post-transplant could be stratified as follows, based on recommendations by Rapoport and associates at the University of Rochester: 16 (1) if the patient is in complete remission at the time of transplant, administer 2000 cgy to sites of previously relapsed disease; (2) if the patient has persistent disease at the time of transplant or after the transplant, administer 3000 cgy to the involved areas, and consider administering an additional cgy after restaging studies if the tumor mass appears to be responding. The use of PET scanning might aid decisionmaking in such situations. Additionally, it may appear prudent to avoid the use of thoracic IFRT within a month prior to transplant, in view of increased pulmonary morbidity and mortality. It is difficult to make concrete recommendations in terms of minimizing the risk of secondary myelodysplasia, because of multiple confounding factors such as the use of TBI, duration of prior alkylating agent therapy and prior use of epipodophyllotoxins administered for anti-lymphoma therapy or mobilization of hematopoietic stem cells. Ultimately, randomized trials comparing external-beam radiation to radioimmunoconjugates may help determine the optimal method of incorporating radiation therapy into the transplant setting. References 1 Fisher RI, Gaynor ER, Dahlberg S et al. Comparison of a standard regimen (CHOP) with three intensive chemotherapy regimens for advanced non-hodgkin s lymphoma. New Engl JMed1993; 328: Philip T, Guglielmi C, Hagenbeek A et al. Autologous bone marrow transplantation as compared with salvage chemotherapy in relapses of chemotherapy-sensitive non-hodgkin s lymphoma. New Engl J Med 1995; 333: Vose JM, Zhang MJ, Rowlings PA et al. Autologous transplantation for diffuse aggressive non-hodgkin s lymphoma in patients never achieving remission: a report from the Autologous Blood and Marrow Transplant Registry. J Clin Oncol 2001; 19: Philip T, Armitage JO, Spitzer G et al. High-dose therapy and autologous bone marrow transplantation after failure of conventional chemotherapy in adults with intermediate-grade or high-grade non-hodgkin s lymphoma. New Engl J Med 1987; 316: Canellos GP, Anderson JR, Propert KJ et al. Chemotherapy of advanced Hodgkin s disease with MOPP, ABVD, or MOPP alternating with ABVD. New Engl J Med 1992; 327: Longo DL, Duffey PL, Young RC et al. Conventional-dose salvage combination chemotherapy in patients relapsing with Hodgkin s disease after combination chemotherapy: the low probability for cure. J Clin Oncol 1992; 10: Lazarus HM, Loberiza FR Jr, Zhang MJ et al. 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