Purpose: The utility of [18F]fluorodeoxyglucose (FDG) positron emission tomography–computed tomography (PET-CT) in assessing response at the end of induction therapy is well documented in Hodgkin's and diffuse large B-cell lymphomas, but its role in follicular lymphoma (FL) remains undetermined. We investigated the prognostic significance of PET-CT performed after first-line therapy in patients with FL treated in the prospective Primary Rituximab and Maintenance (PRIMA) study. Patients and Methods: Results of PET-CT scans performed after induction immunochemotherapy were recorded retrospectively. Patients went on to either observation or rituximab maintenance per protocol independent of the PET-CT result. Patient characteristics and outcomes were then evaluated. Results: Of 122 PET-CT scans performed at the end of the induction immunochemotherapy, 32 (26%) were reported as positive by the local investigator. Initial demographic or disease characteristics did not differ between PET-CT–positive (PET-positive) and PET-CT–negative (PET-negative) patients. PET status correlated with conventional response criteria (P < .001). Patients remaining PET positive had a significantly (P < .001) inferior progression-free survival at 42 months of 32.9% (95% CI, 17.2% to 49.5%) compared with 70.7% (95% CI, 59.3% to 79.4%) in those who became PET negative. PET status, but not conventional response (complete response or complete response unconfirmed v partial response) according to IWC 1999, was an independent predictive factor for lymphoma progression. The risk of death was also increased in PET-positive patients (hazard ratio 7.0; P = .0011). Conclusion: [18F]FDG PET-CT status at the end of immunochemotherapy induction in patients with FL is strongly predictive of outcome and should be considered a meaningful clinical end point in future studies.
Purpose: This two-stage phase IB study investigated the pharmacokinetics and safety of subcutaneous (SC) versus intravenous (IV) administration of rituximab as maintenance therapy in follicular lymphoma. Patients and Methods: In stage 1 (dose finding), 124 patients who responded to rituximab induction were randomly assigned to SC rituximab (375 mg/m 2 , 625 mg/m 2 , or an additional group at 800 mg/m 2 ) or IV rituximab (375 mg/m 2 ). The objective was to determine an SC dose that would yield a rituximab serum trough concentration (C trough ) in the same range as that of IV rituximab. In stage 2, 154 additional patients were randomly assigned (1:1) to SC rituximab (1,400 mg) or IV rituximab (375 mg/m 2 ) given at 2- or 3-month intervals. The objective was to demonstrate noninferior rituximab C trough of SC rituximab relative to IV rituximab 375 mg/m 2 . Results: Stage 1 data predicted that a fixed dose of 1,400 mg SC rituximab would result in a serum C trough in the range of that of IV rituximab. Noninferiority (ie, meeting the prespecified 90% CI lower limit of 0.8) was then confirmed in stage 2, with geometric mean C trough SC :C troughIV ratios for the 2- and 3-month regimens of 1.24 (90% CI, 1.02 to 1.51) and 1.12 (90% CI, 0.86 to 1.45), respectively. Overall safety profiles were similar between formulations (in stage 2, 79% of patients experienced one or more adverse events in each group). Local administration-related reactions (mainly mild to moderate) occurred more frequently after SC administration. Conclusion: The fixed dose of 1,400 mg SC rituximab predicted by using stage 1 results was confirmed to have noninferior C trough levels relative to IV rituximab 375 mg/m 2 dosing during maintenance, with a comparable safety profile. Additional investigation will be required to determine whether the SC route of administration for rituximab provides equivalent efficacy compared with that of IV administration.
Cancer is a chronic disease requiring long-term treatment. Exercise interventions are increasingly being recognized as an important part of treatment and supportive cancer care for patients and survivors. Previous reviews have evaluated the benefits of exercise interventions in populations of patients under supervision at a center, but none have explored the possibilities of a home-based (HB) approach in exercise during cancer rehabilitation and the period immediately following the end of cancer treatment. The aim of this descriptive systematic review was to identify the literature focusing on the health effects of HB exercise interventions in cancer survivors and to evaluate the methodological quality of the examined studies. Relevant studies were identified by a systematic search of PubMed and the Web of Science until January 2021. Nine randomized controlled trials were included. Most studies were on aerobic and resistance exercises, and the frequency, duration, intensity, and modality varied across the different interventions. Improvements in cardiorespiratory fitness (CRF), physical activity (PA) levels, fatigue, health-related quality of life (HRQOL), and body composition have been reported. However, all the studies were limited in methodology and the reporting of results. Nevertheless, the evidence in this new area, despite the methodological limitations of the studies, suggests that HB exercise interventions are feasible, and may provide physiological and psychological benefits for cancer survivors during the rehabilitation period. A methodologically rigorous design for future research is essential for making progress in this field of study.
1 October 2008 in Clinical Lymphoma Myeloma and Leukemia
I(International Extranodal Lymphoma Study Group (IELSG)
International Extranodal Lymphoma Study Group (IELSG)
+43
PURPOSE: The role of consolidation radiotherapy in patients with primary mediastinal B-cell lymphoma (PMBCL) is controversial. METHODS: The IELSG37 trial, a randomized noninferiority study, aimed to assess whether irradiation can be omitted in patients with PMBCL with complete metabolic response (CMR) after induction immunochemotherapy. The primary end point was progression-free survival (PFS) at 30 months after random assignment. Patients with CMR were randomly assigned to observation or consolidation radiotherapy (30 Gy). With a noninferiority margin of 10% (assuming a 30-month PFS of 85% in both arms), a sample size of 540 patients was planned with 376 expected to be randomly assigned. RESULTS: The observed events were considerably lower than expected; therefore, primary end point analysis was conducted when ≥95% of patients were followed for ≥30 months. Of the 545 patients enrolled, 268 were in CMR after induction and were randomly assigned to observation (n = 132) or radiotherapy (n = 136). The 30-month PFS was 96.2% in the observation arm and 98.5% in the radiotherapy arm, with a stratified hazard ratio of 1.47 (95% CI, 0.34 to 6.28) and absolute risk difference of 0.68% (95% CI, –0.97 to 7.46). The 5-year overall survival (OS) was 99% in both arms. Nonrandomized patients were managed according to local policies. Radiotherapy was the only treatment in 86% of those with Deauville score (DS) 4 and in 57% of those with DS 5. The 5-year PFS and OS of patients with DS 4 (95.8% and 97.5%, respectively) were not significantly different from those of randomly assigned patients. Patients with DS5 had significantly poorer 5-year PFS and OS (60.3% and 74.6%, respectively). CONCLUSION: This study, the largest randomized trial of radiotherapy in PMBCL, demonstrated favorable outcomes in patients achieving CMR with no survival impairment for those omitting irradiation.