Impact of interim PET on Hodgkin lymphoma treatment outcome and survival in clinical practice.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e20017-e20017
Author(s):  
Serena Zheng ◽  
Kanika Gupta ◽  
Piyush Goyal ◽  
Reiko Nakajima ◽  
Laure Michaud ◽  
...  
Keyword(s):  
Overall Survival ◽  
Clinical Practice ◽  
Hodgkin Lymphoma ◽  
Cancer Center ◽  
Inclusion Criteria ◽  
Eligibility Criteria ◽  
Interim Pet ◽  
Lymphoma Treatment ◽  
Selection Of

e20017 Background: FDG avidity above liver on interim PET (PET2) during frontline ABVD is considered a marker of impending treatment failure and an indication to switch to an intensified regimen. However, in clinical practice the utility of PET2 for treatment decisions is less clear. We describe outcomes of patients with positive PET2 who continued treatment with ABVD in the clinical setting. Methods: A retrospective study of all patients with newly diagnosed advanced-stage Hodgkin lymphoma treated with frontline ABVD at Memorial Sloan Kettering Cancer Center between 2008-2017. Eligibility criteria were set to correspond with the RATHL inclusion criteria (stage IIB - IV, or IIA bulky or ≥ 3 involved sites). We identified all PET2 reports indicating suspected residual uptake. All positive PET2 images were then reviewed by a single study radiologist. To increase reproducibility and avoid selection of borderline cases, we defined as PET2 positive only those cases with a lesion-to-liver (mean) SUV ratio ≥ 1.3. We also used a recently published stringent criterion of lesion-to-liver (max) ratio ≥ 1.4 (mPET2+). Progression-free and overall survival (PFS, OS) were calculated from the date of initial treatment until progression or death of any cause. Consolidative radiation was not considered a PFS event, and all progressions were verified by biopsy. Results: We identified 227 patients fitting RATHL inclusion criteria treated with ABVD. Median age was 34, with 25% (58) ≥ 45 years, 12% (26) had an IPS ≥ 4; 28% (64) stage II (5% II-X) and 38% (87) with extranodal involvement. 57 (25%) patients had a PET2 report indicating suspected residual lymphoma (PET2+), however, only 32 (14%) met the more stringent mPET2+ criterion. Most patients with PET2+ continued ABVD (84%, 48), and 9 switched to escBEACOPP (this subset of patients had substantially worse disease and are not the focus of this analysis). 21 (9%) patients received consolidative radiation. With a median follow-up of 47 months (42-54m), PET2+ patients who continued ABVD had a 3yPFS of 70% (58-85%, n = 48); mPET+ had a 3yPFS of 71% (55-92%, n = 24). Overall survival was excellent regardless of PET2 status (5yOS 97%). Conclusions: The outcome of PET2+ patients in this analysis was better than previously reported and the continuation of ABVD was appropriate for most patients. Use of a confirmatory biopsy is important for identifying true progressions. Patients with PET2+ had an excellent OS. Evaluation of the superiority of alternative regimens in PET2+ patients requires an ABVD comparator arm.

scholarly journals Active surveillance for nodular lymphocyte-predominant Hodgkin lymphoma

Blood ◽  
2019 ◽  
Vol 133 (20) ◽  
pp. 2121-2129 ◽  
Author(s):  
Sven Borchmann ◽  
Erel Joffe ◽  
Craig H. Moskowitz ◽  
Andrew D. Zelenetz ◽  
Ariela Noy ◽  
...  
Keyword(s):  
Overall Survival ◽  
Hodgkin Lymphoma ◽  
Active Surveillance ◽  
Management Strategy ◽  
Progression Free Survival ◽  
Cancer Center ◽  
Initial Management ◽  
Free Survival ◽  
Radiotherapy Alone

Abstract Nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) is a rare subtype of lymphoma that, like other Hodgkin lymphomas, has historically been treated aggressively. However, in most cases, NLPHL has an indolent course, which raises the question of to what extent these patients require aggressive upfront treatment. We describe the management and outcomes of consecutive NLPHL patients diagnosed at Memorial Sloan Kettering Cancer Center (MSK), with a focus on evaluating active surveillance. All patients aged 16 years or older diagnosed and followed at MSK between 1974 and 2016 were included. Treatment outcomes were compared between management with active surveillance and other strategies. We identified 163 consecutive patients who were treated with radiotherapy alone (46%), active surveillance (23%), chemotherapy (16%), combined modality (12%), or rituximab monotherapy (4%). Median follow-up was 69 months. Five-year progression-free survival (PFS), second PFS (PFS2), and overall survival (OS) estimates were 85% (95% confidence interval [CI], 78-90), 97% (95% CI, 92-99), and 99% (95% CI, 95-100), respectively. Only 1 of 7 deaths was lymphoma related. Patients managed with active surveillance had slightly shorter PFS than those receiving any active treatment, with 5-year PFS of 77% (95% CI, 56-89) vs 87% (95% CI, 79-92; P = .017). This difference did not translate into better PFS2 or OS. Only 10 patients managed with active surveillance (27%) eventually required treatment, after a median of 61 months, and none died. NLPHL has an excellent prognosis. Within the limitations of a retrospective analysis, active surveillance is a viable initial management strategy for selected NLPHL patients.

Questions Collaborative Dexamethasone Trial

PEDIATRICS ◽  
1992 ◽  
Vol 89 (6) ◽  
pp. 1266-1266
Author(s):  
ROSAMOND JONES ◽  
ADRIAN GRANT ◽  
Keyword(s):  
Clinical Practice ◽  
Random Sample ◽  
Human Beings ◽  
Eligibility Criteria ◽  
Clinical Uncertainty ◽  
Trial Entry ◽  
Selection Of

In Reply.— We are glad to respond to Dr MacMahon's letter about the generalizability of the results of our trial. Basing trial entry on `clinical uncertainty' is actually one of the strengths of this trial.1 No trial can ever include a random sample of all human beings who meet the eligibility criteria; there is always selection of subjects (whatever the entry criteria). Inevitably, therefore, at some point there has to be a leap of faith from the evidence to clinical practice.2

Positron Emission Tomography–Driven Strategy in Advanced Hodgkin Lymphoma: Prolonged Follow-Up of the AHL2011 Phase III Lymphoma Study Association Study

2022 ◽  
Author(s):  
René-Olivier Casasnovas ◽  
Reda Bouabdallah ◽  
Pauline Brice ◽  
Julien Lazarovici ◽  
Hervé Ghesquieres ◽  
...  
Keyword(s):  
Positron Emission Tomography ◽  
Hodgkin Lymphoma ◽  
Emission Tomography ◽  
Phase Iii ◽  
Second Primary ◽  
Second Primary Malignancy ◽  
Interim Pet ◽  
Positron Emission ◽  
Study Results

PURPOSE The AHL2011 study (ClinicalTrials.gov identifier: NCT01358747 ) demonstrated that a positron emission tomography (PET)-driven de-escalation strategy after two cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP) provides similar progression-free survival (PFS) and overall survival (OS) and reduces early toxicity compared with a nonmonitored standard treatment. Here, we report, with a prolonged follow-up, the final study results. METHODS Patients with advanced Hodgkin lymphoma (stage III, IV, or IIB with mediastinum/thorax ratio > 0.33 or extranodal involvement) age 16-60 years were prospectively randomly assigned between 6 × BEACOPP and a PET-driven arm after 2 × BEACOPP delivering 4 × ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) in PET2– and 4 × BEACOPP in PET2+ patients. PET performed after four cycles of chemotherapy had to be negative to complete the planned treatment. RESULTS In total, 823 patients were enrolled including 413 in the standard arm and 410 in the PET-driven arm. With a 67.2-month median follow-up, 5-year PFS (87.5% v 86.7%; hazard ratio [HR] = 1.07; 95% CI, 0.74 to 1.57; P = .67) and OS (97.7% in both arms; HR = 1.012; 95% CI, 0.50 to 2.10; P = .53) were similar in both randomization arms. In the whole cohort, full interim PET assessment predicted patients' 5-year PFS (92.3% in PET2–/PET4–, 75.4% [HR = 3.26; 95% CI, 18.3 to 5.77] in PET2+/PET4– and 46.5% [HR = 12.4; 95% CI, 7.31 to 19.51] in PET4+ patients, respectively; P < .0001) independent of international prognosis score. Five-year OS was also affected by interim PET results, and PET2+/PET4– patients (93.5%; HR = 3.3; 95% CI, 1.07 to 10.1; P = .036) and PET4+ patients (91.9%; HR = 3.756; 95% CI, 1.07 to 13.18; P = .038) had a significant lower OS than PET2–/PET4– patients (98.2%). Twenty-two patients (2.7%) developed a second primary malignancy, 13 (3.2%) and 9 (2.2%) in the standard and experimental arms, respectively. CONCLUSION The extended follow-up confirms the continued efficacy and favorable safety of AHL2011 PET-driven strategy, which is noninferior to standard six cycles of BEACOPP. PET4 provides additional prognostic information to PET2 and allows identifying patients with particularly poor prognosis.

scholarly journals Cost of Treating Pediatric Cancer at the Butaro Cancer Center of Excellence in Rwanda

2018 ◽  
pp. 1-7
Author(s):  
Claire Neal ◽  
Christian Rusangwa ◽  
Ryan Borg ◽  
Jean Claude Mugunga ◽  
Stephanie Kennell-Heiling ◽  
...  
Keyword(s):  
Social Support ◽  
Hodgkin Lymphoma ◽  
Survival Rates ◽  
Treatment Protocol ◽  
Fiscal Year ◽  
Cancer Center ◽  
Labor Costs ◽  
Center Of Excellence ◽  
The Cost

Purpose Improvements in childhood survival rates have been achieved in low- and middle- income countries that have made a commitment to improve access to cancer care. Accurate data on the costs of delivering cancer treatment in these settings will allow ministries of health and donors to accurately assess and plan for expansions of access to care. This study assessed the financial cost of treating two common pediatric cancers, nephroblastoma and Hodgkin lymphoma, at the Butaro Cancer Center of Excellence in rural Rwanda. Methods A microcosting approach was used to calculate the per-patient cost for Hodgkin lymphoma and nephroblastoma diagnosis and treatment. Costs were analyzed retrospectively from the provider perspective for the 2014 fiscal year. The cost per patient was determined using an idealized patient receiving a full course of treatment, follow-up, and recommended social support in accordance with the national treatment protocol for each cancer. Results The cost for a full course of treatment, follow-up, and social support was determined to be between $1,490 and $2,093 for a patient with nephroblastoma and between $1,140 and $1,793 for a pediatric patient with Hodgkin lymphoma. Conclusion Task shifting, reduced labor costs, and locally adapted protocols contributed to significantly lower costs than those seen in middle- or high-income countries.

PET-CT Adapted Therapy After 3 Cycles of ABVD for All Stages of Hodgkin Lymphoma. Interim Analysis in 173 Patients

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 1772-1772
Author(s):  
Santiago Pavlovsky ◽  
Astrid Pavlovsky ◽  
Isolda Fernandez ◽  
Miguel Pavlovsky ◽  
Virginia Prates ◽  
...  
Keyword(s):  
Overall Survival ◽  
Hodgkin Lymphoma ◽  
Progressive Disease ◽  
Cell Transplant ◽  
Advanced Stage ◽  
Event Free Survival ◽  
Bulky Disease ◽  
Free Survival ◽  
Pet Ct

Abstract Abstract 1772 Background: Hodgkin Lymphoma (HL) is the most curable type of Lymphoma with an overall survival at 5 years of 80%. ABVD can be considered as gold standard for first line treatment for all stages of HL. Dividing patients (pts.) in different prognostic groups has aimed to reduce chemo and radio toxicity in those patients with good prognosis. A negative PET-CT, either early during treatment of ABVD or after completion of it, has shown to be a powerful prognostic tool (Hutchings: Blood 2006; Gallamini: Haematologica 2006). Our cooperative group has an experience with 584 patients with HL in early or advanced stage treated with 3 or 6 cycles of ABVD plus involved field radiotherapy with a complete remission (CR) of 91% and an event free survival (EFS) and overall survival (OS) at 60 months of 79% and 95%.(S Pavlovsky, Clin Lymp My & Leuk, 2010). Aims: Test the efficacy of treatment to all stages of HL adjusted to PET-CT results after 3 cycles of ABVD. Evaluate the outcome of pts. who have a negative PET-CT after 3 cycles of ABVD and receive no further treatment. Intensify therapy only in pts. who have persistent hyper metabolic lesions in PET-CT after 3 cycles of ABVD. Method: Since October 2005, 198 newly diagnosed pts. with HL have been included in a prospective multicenter trial. Initially all patients received 3 cycles of ABVD. After the third cycle, pts. were evaluated with a PET-CT. Those pts. who achieved CR with a negative PET-CT, received no further treatment. Those with more than 50% of anatomic reduction of initial masses but persistent hyper metabolic lesions by PET-TC after 3 ABVD were considered in partial remission (PR) and completed 6 cycles of ABVD and radiotherapy (RT) on PET-CT positive areas. Those patients with less than PR after 3 cycles of ABVD received ESHAP and if CR, high doses of chemotherapy and an autologous stem cell transplant (ASCT). All patients were re-evaluated at the end of treatment. The median follow up is of 30 months (3-62). Results: One hundred and seventy three patients completed three cycles of ABVD followed by a PET-CT. The median age at diagnosis was 29 years. One hundred and thirty-six (79%) had localized stage (I-II) at diagnosis and 37 (21%) presented with advanced stage (III-IV). Of 155 pts. 77 (50%) pts had IPS 0–1, 66 (43%) had IPS 2–3 and 12 (8%) had IPS 4–5. Twenty six (17%) pts. had bulky disease at diagnosis. One hundred and thirty-seven (79%) pts. achieved CR with negative PET-CT after 3 cycles of ABVD. Thirty-six (21%) were PET-CT positive, of them 32 pts achieved PR and completed a total of 6 cycles of ABVD plus RT in hyper metabolic lesions. Twenty five achieved CR (72%), 5 persisted with PR and 2 died of progressive disease. Four pts showed progressive disease (PD) after 3 ABVD and received ESHAP and ASCT, 2 achieved and remained in CR, 1 is in PR and 1 died of progressive disease. Of 173 pts who completed treatment with ABVD × 3 cycles, ABVD × 6 cycles plus RT on PET-TC positive areas or ESHAP plus ASCT, 164 pts (95%) achieved CR. Of these 164 pts., 14 pts (8%) relapsed. The EFS and OS at 36 months is 83% and 97% respectively. Patients with early negative PET-TC have an event-free survival of 87% compared to 62% (P=0,001) for pts with early positive PET CT. The OS at 36 months was 100% versus 86% respectively (<0.001). Conclusion: Treating patients with ABVD, evaluating response after 3 cycles with PET-CT, and adapting further therapy, leads to a high rate of CR avoiding more aggressive chemotherapy and radiotherapy. Three courses of ABVD without RT are adequate in patients with early CR defined by negative PET-CT. In early positive PET-CT it is possible to intensify therapy improving the otherwise bad prognosis; more aggressive treatment might also be suitable. These results need to be confirmed by a larger group of patients and a longer follow-up. Disclosures: No relevant conflicts of interest to declare.

Cost-Effectiveness of Interim PET Response Adapted Therapy In ABVD-Treated, Advanced-Stage Hodgkin Lymphoma

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 1563-1563 ◽  
Author(s):  
Andrea Gallamini ◽  
Monia Marchetti ◽  
Anna Borra ◽  
Roberto Sorasio ◽  
Francesca Fiore
Keyword(s):  
Quality Of Life ◽  
Health Care ◽  
Sensitivity Analysis ◽  
Cost Saving ◽  
Disease Control ◽  
Hodgkin Lymphoma ◽  
Advanced Stage ◽  
Interim Pet

Abstract Abstract 1563 Background: ABVD chemotherapy (AT) is the standard treatment for patients with advanced-stage Hodgkin lymphoma (HL). However, BEACOPP achieves a higher disease control at a cost of a definitely higher toxicity. Positron emission tomography (PET) after two chemotherapy cycles (PET2) is the most reliable predictor of treatment outcome in ABVD-treated patients. A PET-2 response-adapted strategy with a therapy shift from ABVD to BEACOPP in PET2 positive patients (A/B-T) was shown to increase the 2-y Failure Free Survival (FFS) in the latter from 12% to 62% by indirect retrospective comparison, and to improve the disease control in the overall patient population (Gallamini Br. J. Haematol 2011). However, PET is an expensive test which deserves a careful economic assessment before widespread adoption and reimbursement. Methods: We built a Markov decision model comparing A/B-T with AT strategies for advanced HL. The model was calibrated on the reported retrospective cohort of 154 ABVD-treated HL patients in which treatment intensification with BEACOPP was given in PET-2 positive patients. Briefly, patients were treated with standard ABVD × 2 courses and an interim-PET performed afterwards: PET-2 negative patients continued with ABVD × 4 and consolidation RxT in presence of bulky disease; PET-2 positive patients shifted to BEACOPP escalated × 4 + BEACOPP baseline × 4. Patients failing either AT or A/B-T underwent rescue treatment with IGEV × 4, followed by Autologous Stem Cell Transplantation (ASCT). In patients failing ASCT, DHAP reinduction therapy was given and allogeneic SCT (alloSCT) was performed whenever possible. The model included 12 health-states: ABVD cycles 1–2, ABVD cycles 3–6, BEACOPP escalated (4 cycles), BEACOPP baseline (4 cycles), IGEV (4 cycles), ASCT, DHAP + allogeneic SCT, follow-up (FFS patients PET2 negative), follow-up (FFS patients PET2 positive), follow-up (FFS after ASCT/CST), relapse, death. Each health state last 1 month and the overall time horizon at baseline was 5 years. We considered severe toxicity needing inpatient care and transplant-related mortality. Quality of life was reduced by 20% for chemotherapy-treated patients, 30% for transplanted ones and 40% in relapsed ones. The model assessed the following endpoints: survival, quality of life – adjusted survival (QALY) and costs (in the perspective of the health-care system) as the principal end-points. TreeAge SW (2008) was run. National charges were used as estimators of unitary costs. First and second-order sensitivity analysis was performed. Results: A/B-T reduced the overall percentage of patients failing treatment (refractory and relapsing) from 27% to 14%. This clinical advantage induced a prolongation of quality-adjusted survival from 53.20 to 55.63 quality-adjusted months, that is a gain of 0.18 QALYs (90% CI: −0.1;+1.4). The number of interim PET needed to avoid one ASCT was 8.3. The cost of universal interim PET (€1,546) was offset by the reduced number of ASCT procedures (€36,575). Consequently, health-care costs were €27,861 for A/BT versus €29,050 for AT strategy which is a €1189 (90%CI: −41,208; +13,240) saving. At sensitivity analysis we verified that the results were mildly sensitive to the costs of PET and ASCT: A/B-T was not cost saving if PET would cost more than €3,031 and ASCT less than €20,200. A/B-T would cost more than €40,000/QALY only at a PET cost higher than €16,300. The results were also sensitive to the portion of PET2 positive patients: A/B-T wouldn't turn out cost saving if the portion was higher than 22%. The results were not sensitive to the rate of severe adverse events during chemotherapy. The results were overall robust, since A/B-T cost less than €30,000/QALY in more than 80% out of 100,000 simulations (MonteCarlo analysis). Conclusions: A/B-T is more efficacious and less expensive than standard AT treatment for advanced-stage HL patients, therefore the routine use of interim-PET is warranted in treatment planning and chemosensitivity adapting in these patients. Disclosures: Off Label Use: The study includes use of Rituximab as maintenance in responding patients after first line chemoimmunotherapy.

scholarly journals Nivolumab for the Treatment of Classical Hodgkin Lymphoma

2017 ◽  
Vol 33 (6) ◽  
pp. 237-244
Author(s):  
Maryann R. Cooper ◽  
Bassem Almalki ◽  
Kristine C. Willett
Keyword(s):  
Overall Survival ◽  
Phase I ◽  
Hodgkin Lymphoma ◽  
Phase Ii ◽  
Objective Response ◽  
Immune Surveillance ◽  
Progression Free Survival ◽  
Classical Hodgkin Lymphoma ◽  
Durable Response

Objective: To review nivolumab for the treatment of classical Hodgkin lymphoma (cHL). Data Sources: Literature searches were conducted in Medline (1946 to May week 3 2017), EMBASE (1974 to 2017 week 22), and Google Scholar using the terms Hodgkin lymphoma AND nivolumab. Study Selection and Data Extraction: Two clinical trials (phase I and phase II) were identified. Data Synthesis: Nivolumab inhibits programmed death receptor-1 allowing for increased T-cell mediated immune surveillance of tumors. Nivolumab was evaluated in cHL patients after failure of autologous stem cell transplantation and brentuximab vedotin consolidation. Patients received nivolumab 3 mg/kg every 2 weeks. In the phase I trial, the objective response rate was 87% (95% confidence interval [CI] = 66-97) and the rate of progression-free survival (PFS) at 24 weeks was 86% (95% CI = 62-95). The most common adverse events (AE) included rash (22%) and decreased platelet count (17%). Following extended follow-up at a median of 86 weeks, 50% of the initial responders maintained a durable response. In the phase II clinical trial, 53 patients (66.3%, 95% CI = 54.8-76.4) achieved an objective response and PFS at 6 months was 76.9% (95% CI = 64.9-85.3). The common AE were fatigue (25%), infusion-related reactions (20%), and rash (16%). After further follow-up at a median of 15.4 months, 12-month overall survival was 94.9% (median overall survival not reached). Conclusions: Nivolumab is an effective option in treating patients with relapsed/refractory cHL with an acceptable safety profile. Further studies are needed to investigate the role of nivolumab for the treatment of cHL.

scholarly journals Is It Better to Start Treatment with ABVD and Continue with PET2-Adapted Approach or Should We Use 2 Cycles of Beacopp Escalated and 2 Cycles of ABVD and Irradiation in Early Unfavorable Hodgkin Lymphoma?

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4539-4539
Author(s):  
Heidi Mocikova ◽  
Jana Markova ◽  
Lubica Gaherova ◽  
Maria Maco ◽  
Alice Sykorova ◽  
...  
Keyword(s):  
Overall Survival ◽  
Board Of Directors ◽  
Hodgkin Lymphoma ◽  
Research Funding ◽  
Clinical Stage ◽  
Progression Free Survival ◽  
Current Approach ◽  
Hematological Toxicity ◽  
Advisory Committees ◽  
Interim Pet

Abstract Introduction. EORTC H10 trial confirmed better selection of patients who needed reduced or more intensive treatment using PET response after 2 cycles of ABVD in early stages of classical Hodgkin lymphoma (cHL). GHSG HD17 showed that radiotherapy can be safely omitted in PET4-negative early unfavorable HL treated with 2 cycles of BEACOPP escalated plus 2 cycles of ABVD (2+2 chemotherapy). We compared PET2-adapted approach including 30Gy involved-node radiotherapy (INRT) with 2+2 chemotherapy followed by 30 Gy INRT (or involved-field radiotherapy, IFRT) regardless of interim PET in patients with early unfavorable cHL assessed according to the GHSG risk factors. Methods. Overall 243 patients with early unfavorable cHL (aged 18-60 years) prospectively observed in the Czech Hodgkin lymphoma study group registry between 2003-2020 were analyzed. Patients in clinical stage IIB with massive mediastinal tumor and/or with extranodal disease were not included into this analysis as they were treated with BEACOPP escalated only. Chemotherapy 2+2+30 Gy INRT/IFRT received 213 patients. Overall 30 patients were treated with PET2-adapted approach: 29 PET2-negative patients received 4 cycles of ABVD and 30 Gy INRT and one PET2-positive patient was treated with 2 cycles of ABVD plus 2 cycles of BEACOPP escalated and 30 Gy INRT. Results. Median age at the time of cHL diagnosis was 32 (range 18-59) years. Median follow-up was longer in the 2+2+INRT/IFRT group (91.3, range 6.2-211.2) months when compared to the PET2-adapted approach (19.4, range 6.4-90.4) months. The estimated 2-year progression-free survival (PFS) did not differ in both groups (100% [95% CI 100-100] both), however, the estimated 5-year PFS was significantly better in the 2+2+INRT/IFRT group (99.5% [95% CI 98.5-100]) in comparison to PET2-adapted treatment (75.0% [95% CI 32.5-100]), p&lt;0.001. The estimated 5-year overall survival was comparable in both groups (2+2+INRT/IFRT: 99.5% [95% CI 98.5-100]; PET2-guided treatment: 100% [95% CI 100-100]). Hematological toxicity was reported in most of the patients in both groups. Grade 3 non-hematological toxicity occured in 3 patients in the 2+2+INRT/IFRT approach (2 infections, 1 deep vein thrombosis). Conclusion. This retrospective analysis indicates that 2+2+INRT/IFRT is more effective in the long-term disease control, but there is no difference in overall survival in both groups. The current approach includes 2+2 chemotherapy and INRT is added in PET4-positive patients. This work was supported by the Research project Q 28 Progres awarded by the Third Faculty of Medicine of Charles University in Prague in the Czech Republic. Disclosures Belada: Roche: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: travel expenses, Research Funding; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Gilead: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Travel support, Research Funding; Celgene: Research Funding; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Travel expenses, Research Funding.

scholarly journals Trial in Progress: Real-World Safety and Effectiveness of Brentuximab Vedotin in Adults with CD30+ Lymphoma in China

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4552-4552
Author(s):  
Pengpeng Xu ◽  
Mingci Cai ◽  
Wendy Zhang ◽  
Wei Li Zhao
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Informed Consent ◽  
Survival Rate ◽  
Real World ◽  
Brentuximab Vedotin ◽  
Routine Clinical Practice ◽  
Inclusion Criteria ◽  
Real World Data

Abstract Background: Clinical trials have demonstrated the effectiveness of the CD30-targeted antibody-drug conjugate brentuximab vedotin (BV) for the treatment of classical Hodgkin lymphoma (HL) and non-Hodgkin lymphoma(e.g. ALCL, PTCL-NOS, AITL, CTCL and etc.). While clinical trials are critical for establishing efficacy, collection of real-world data outside of the controlled trial setting is important to evaluate how interventions are applied and assess the effectiveness of new treatments in routine clinical practice. Inclusion criteria are often rather restrictive compared with the patient populations seen by physicians in daily practice. There are limited real-world data related to treatment with BV in China. Our study aims to obtain timely real-world knowledge in terms of safety and effectiveness of BV in CD30+ lymphoma patients in China. Study Design and Methods: The study (NCT04837222) is a real-world, prospective, multicenter study to evaluate the safety and effectiveness of BV in patients with CD30+ lymphoma in China. Consecutive CD30+ lymphoma patients treated with BV as a part of standard clinical practice will be enrolled. Key inclusion criteria includes adult patients undergoing treatment with BV or to be received with BV, patient/legal guardian must be able to read, understand, and sign the Informed Consent Form, CD30+ lymphoma by INV (any CD30 expression). Exclusion criteria includes patient who currently participates in or with plan to participate in any interventional clinical trial, any other reason that, in the investigator's opinion, makes the patient unsuitable to participate in this study. As CD30+ lymphoma is not a common disease and the affordability of novel treatment is limited, 1000 patients with CD30+ lymphoma will be recruited from almost 30 hematology centers. The physician will determine the treatment regimen, as well as the frequency of laboratory and clinical assessment according to her/his routine practice. All patients will be followed up per routine clinical practice and data will be documented at baseline/3/6/9/12/18/24 months unless withdrawal of Informed Consent, death or loss of follow-up, whichever comes first. Loss to follow-up will be minimized through active contact with participating patients thereafter to ensure almost all clinically relevant outcomes will be captured. The primary endpoint is serious adverse events. Secondary endpoints include adverse events, adverse drug reaction, dose adjustment, characteristics of patients receiving BV, use of BV, number of BV cycles administered, disease characteristics, time to next treatment, overall response rate, duration of response, progression free survival rate, overall survival rate, quality of life and cost-effectiveness ratio. Descriptive analysis will be performed for data analysis. Disclosures Zhang: Takeda Pharmaceuticals: Current Employment.

scholarly journals How does PET/CT help in selecting therapy for patients with Hodgkin lymphoma?

Hematology ◽  
2012 ◽  
Vol 2012 (1) ◽  
pp. 322-327 ◽  
Author(s):  
Martin Hutchings
Keyword(s):  
Hodgkin Lymphoma ◽  
Early Response ◽  
Precise Determination ◽  
Disease Extent ◽  
Interim Pet ◽  
First Line Therapy ◽  
Positron Emission ◽  
Pet Ct ◽  
Consolidation Radiotherapy ◽  
Selection Of

Abstract Positron emission tomography/computed tomography (PET/CT) has emerged as the most accurate tool for staging, treatment monitoring, and response evaluation in Hodgkin lymphoma (HL). Accurate staging and restaging are very important for the optimal management of HL, but we are only beginning to understand how to use PET/CT to improve treatment outcome. More precise determination of disease extent may result in more precise pretreatment risk stratification, and is also essential for the minimal and highly individualized radiotherapy volumes of the present era. Several trials are currently investigating the use of PET/CT for early response-adapted therapy, with therapeutic stratification based on interim PET/CT results. Posttreatment PET/CT is a cornerstone of the revised response criteria and enables the selection of advanced-stage patients without the need for consolidation radiotherapy. Once remission is achieved after first-line therapy, PET/CT seems to have little or no role in the routine surveillance of HL patients. PET/CT looks promising for the selection of therapy in relapsed and refractory disease, but its role in this setting is still unclear.

Sign in / Sign up

Export Citation Format

Share Document