Mobile-health tool for timely management of cancer treatment toxicity.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 321-321
Author(s):  
Amit Sanyal ◽  
Sara Mistretta ◽  
Morgan Fulton ◽  
Clemens walter Janssen
Keyword(s):  
Cancer Treatment ◽  
Patient Experience ◽  
Mobile Health ◽  
B Cell Lymphoma ◽  
Cost Of Care ◽  
Phase Iii ◽  
Free Text ◽  
Common Symptom ◽  
Patient Reported

321 Background: Treatment related side effects after chemotherapy are common, with significant toxicities seen in 78.2% to 98.3% of patients allocated to two study arms of a lymphoma trial [1]. While most oncology clinics provide patient education before treatment, onetime delivery of large amounts of information without reiteration of crucial facts results in information gaps, delay in seeking care, culminating in potentially avoidable ED visits and hospitalizations. Technology based symptom monitoring can facilitate early detection of complications, reduce symptom burden and cost of care. Here we update our study [2] of utility of a mobile-health tool for timely management of cancer treatment related toxicities in a community-based oncology practice. Methods: A web-based mobile application consisting of a patient interface, a provider interface and an embedded analytic platform was developed. Patient ‘check-ins’ incorporating a brief introduction and chemotherapy toxicity questionnaires are delivered through automated text or email. Toxicity questionnaires are based on the NCI-PRO-CTCAE ITEMS-ENGLISH form builder. The provider interface incorporates a ‘patient records summary’ page and a ‘tracker’ page, allowing the oncology care team to monitor responses in real-time. Responses exceeding pre-specified thresholds generate a color-coded ‘flag’ and are marked for follow up. Flags result in a phone call followed by in-person evaluation if necessary. All interventions are time stamped. Patient experience is measured concurrently using a Likert-scale as well as free-text response box. Results: 310 patients were enrolled as of January 21, 2021. Median age was 64 years. There were 49% females.8916 check-ins were sent out and 2963 responses recorded for an overall response rate of 33.23%. 531 responses provided by 109 unique patients were flagged for follow up, amounting to 6% of all responses. Fatigue was the most common symptom flagged for follow-up (454), followed by nausea/vomiting or diarrhea (167), abdominal pain (140), cough/dyspnea (140) and numbness/tingling (138). Follow up was prompt, with 60% of patient symptoms followed up on the same day and of these, 84% followed-up within 4 hours of patient reported symptom. Patient experience was consistently favorable. 72% of patients reported an experience score of ≥ 4 (1-5 scale, 5 being the most favorable). Conclusions: Electronic capture of symptoms using connected technology is feasible and can be used for timely management of treatment related complications. References: Bartlett, N.L., et al., Dose-Adjusted EPOCH-R Compared With R-CHOP as Frontline Therapy for Diffuse Large B-Cell Lymphoma: Clinical Outcomes of the Phase III Intergroup Trial Alliance/CALGB 50303. J Clin Oncol, 2019. 37(21): p. 1790-1799. Sanyal, A. Mobile health tool for monitoring cancer treatment complications. 2020. ASCO Quality Care Symposium: American Society of Clinical Oncology.

Mobile health tool for monitoring cancer treatment complications.

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 297-297
Author(s):  
Amit Sanyal ◽  
James M. Heun ◽  
Clemens walter Janssen ◽  
Jessica Sweeney
Keyword(s):  
Cancer Treatment ◽  
Cancer Patients ◽  
Mobile Health ◽  
Care Delivery ◽  
Symptom Burden ◽  
Cost Of Care ◽  
Phase Iii ◽  
Screening Methods ◽  
Distress Screening

297 Background: Side effects after cancer treatment are ubiquitous, seen in up to 98.3% of patients in one Phase III lymphoma trial. Additionally, cancer patients are at a greater risk of mortality from infections such as coronavirus disease 2019 (COVID-19), prompting recommendations for routine screening. Current care delivery model, reliant on self- triaging of symptoms by patients results in delayed management and avoidable emergency room visits and hospitalizations. Technology based symptom monitoring allows early identification of complications, reduces symptom burden, cost of care and enables early detection of relapse. We studied utility of a mobile-health tool for toxicity monitoring and COVID-19 screening. Methods: We developed an application that periodically delivers disease specific toxicity questionnaires to patients following cancer treatment. Based on NCI- PRO-CTCAE form builder, the questions are delivered through SMS or e-mail. Responses crossing pre-specified thresholds are flagged for manual care team follow-up. Patient and staff experience as well as medical interventions are captured. Results: Currently, 68 patients with different malignancies are enrolled. Median age 60 years (range 24-85), 35 males, 31 females. 72.35% patients rated user experience at 4 or higher (1-5 scale, 5 highest). Aggregate provider rating was 3.25 (1-5 scale, 5 highest). Of 639 captured responses, 157 reported fatigue, 145 no symptoms, 57 nausea/vomiting or diarrhea, 52 numbness/tingling and 48 shortness of breath. 76 responses were flagged for nurse follow-up calls. These resulted in 72 successful outpatient symptom management, 2 hospitalizations for neutropenic fever, 1 MRI diagnosis of radiation necrosis and 1 diagnosis of lymphoma progression. 92% of patients received a follow up within one business day. Median time between response recorded and follow up completed was 55 minutes. Of 1299 responses recorded by COVID-19 screening, 1175 reported no symptoms. All positive responses (47 cough, 52 diarrhea, 5 fever and 20 dyspnea) were false positives. Study is ongoing with recent implementation of a distress screening and survivorship modules. Conclusions: Electronic capture of symptoms using connected technology is feasible and can be used to screen cancer patients for treatment related complications as well as pandemic related illnesses.

Survivorship: The UHealth patient experience.

2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 183-183 ◽  
Author(s):  
Adrienne Marie Vazquez ◽  
Chinny Trivedi ◽  
Annette Amoros
Keyword(s):  
Cancer Treatment ◽  
Patient Experience ◽  
Exercise Physiology ◽  
Clinic Visit ◽  
Free Text ◽  
Survivorship Care ◽  
Cancer Society ◽  
Care Plans ◽  
Accredited Institutions

183 Background: The University of Miami has a formal Survivorship Program based on the Commission on Cancer (CoC) requirements. CoC requires accredited institutions to deliver survivorship care plans (SCP) to patients who fit analytic criteria. There is a lack of research on the patient experience as it pertains to survivorship care. Methods: Using a Likert-type scale, dual language survey (English and Spanish), patients were asked 6 questions about the Survivorship Clinic visit ranging from scheduling feasibility to information received during the visit and any opinions to improve the visit for future patients. Patients were given two weeks to complete the survey through a secure, HIPAA compliant online source (REDCap). Those who did not reply were called on the phone by a registered nurse to obtain a statistically significant sample size. Results: Of the 236 patients that were contacted, 45 responded (Breast 38.3%, Gastrointestinal 12.8%, Prostate 10.6%, Gynecologic 8.5%, Lymphoma 6.4%, Lung 6.4%, Sarcoma 4.3%, Other 12.8%). Our results found that 95.7% of patients would recommend this visit to anyone who has completed cancer treatment. Also, 59.6% of patients found the SCP to be most helpful, followed by Survivorship Provider input (38.3%) and then American Cancer Society Healthy living tips (36.2%). As a note, it was mentioned in free text that 11.1% would have preferred a similar visit at the beginning of treatment, at the completion of treatment and/or incremental follow up. Of those surveyed, 88.9% were referred to nutrition, 44.4% to exercise physiology and 27.8% to psychology/psychiatry. Conclusions: Of the patients surveyed 95.7% were satisfied with the survivorship visit. Our conclusion based on survey results shows that institutions should continue to provide formal survivorship care as per CoC requirements. Future directions should look at expanding services to patients at diagnosis and throughout the continuum of treatment and follow up. As survivorship programs grow, practices should consider increasing resources to accommodate the identified needs of patients at the beginning and end of cancer treatment.

Factors Affecting Workload of Cancer Clinical Trials: Results of a Multicenter Study of the National Cancer Institute of Canada Clinical Trials Group

2002 ◽  
Vol 20 (2) ◽  
pp. 545-556 ◽  
Author(s):  
Kathyrn Roche ◽  
Nancy Paul ◽  
Bobbi Smuck ◽  
Marlo Whitehead ◽  
Benny Zee ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Data Collection ◽  
Cancer Treatment ◽  
Multicenter Study ◽  
National Cancer Institute ◽  
Phase Iii ◽  
Study Phase ◽  
Factors Affecting ◽  
Clinical Research Associates

PURPOSE: Increasingly, cancer treatment centers need to be able to estimate specific costs and resources associated with clinical trials. Because the time requirements of trial coordination and data collection are not well known, the Clinical Research Associates (CRA) Committee of the National Cancer Institute of Canada Clinical Trials Group carried out a multicenter study to measure trials’ task times and evaluate the effects of certain factors. METHODS: A data collection instrument was designed and validated before its implementation in the study. Eighty-three CRAs from 24 cancer treatment institutions across Canada collected timing observations of 41 tasks (156 subtasks). Information from all stages of trials activity (protocol management, eligibility and entry, treatment, and follow-up and final stage) was obtained, from initial negotiations to follow-up after study closure. RESULTS: After controlling for stage, phase and sponsor were found to be significant independent factors. Analysis within the stages showed similar patterns. New drug inclusion as a factor was confounded with phase. Industry-sponsored studies had significantly higher overall mean times than did local and cooperative group studies. Early-phase studies required more time than did phase III trials. External sponsorship of any kind increased CRA time more than that necessary for locally coordinated studies, except during the protocol management stage. The burden of a phase I study increased to greater than average once underway and accruing patients. CONCLUSION: Our data demonstrated that sponsor and study phase are important factors to be taken into consideration when estimating clinical trial costs and resource use.

Comparison of hypofractionated high-dose intensity-modulated radiotherapy schedules for prostate cancer: Results from the phase III randomized CHHiP trial (CRUK/06/016).

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 2-2 ◽  
Author(s):  
David P. Dearnaley ◽  
Isabel Syndikus ◽  
Helen Mossop ◽  
Alison J. Birtle ◽  
DJ Bloomfield ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Intensity Modulated Radiotherapy ◽  
Dose Intensity ◽  
Late Toxicity ◽  
Phase Iii ◽  
High Dose ◽  
Significant Difference ◽  
Patient Reported ◽  
Free Rate

2 Background: We aimed to explore the dose response relationship for two 3 Gray (Gy) hypofractionated radiotherapy (hRT) schedules for localised prostate cancer (PCa). Methods: hRT schedules of 60Gy/20 fractions (f) and 57Gy/19f were compared with conventional RT (cRT) 74Gy/37f; iso-effective for alpha-beta ratios of 2.5Gy and 1.5Gy respectively. The trial was powered to demonstrate non-inferiority between each hRT schedule and cRT, with 3,213 patients (pt) needed to rule out 5% inferiority (80% power, 1-sided alpha 5%) assuming 70% event-free rate in cRT, corresponding to a critical hazard ratio (HR) of 1.21. The trial was not formally powered to directly compare the two hRT schedules. Pt with N0 T1b-T3a localised PCa were randomized (1:1:1 ratio). The primary endpoint was PCa progression (freedom from biochemical failure by Phoenix consensus guidelines or PCa recurrence). Acute toxicity was assessed up to 18 weeks post treatment and late side effects to 5 years (yr) by RTOG, LENT-SOM and patient reported outcomes (PROs). Results: 3,216 pts were randomized between 2002 and 2011; 1,065 (74Gy), 1,074 (60Gy), 1,077 (57Gy). Baseline characteristics were well balanced across groups: median age 69 yr; NCCN risk group 15% low, 73% intermediate, 12% high. With median follow up 5.2yr, 5yr progression-free rate (95% CI) was 74Gy: 88.3% (86.0%, 90.2%); 60Gy: 90.6% (88.5%, 92.3%), 57Gy: 85.9 (83.4, 88.0); HR60/74: 0.83, 90% CI (0.68, 1.03), HR57/74: 1.20, 90% CI (0.99, 1.45). Significantly more events were observed with 57Gy compared to 60Gy; HR57/60: 1.44, 90% CI (1.18, 1.75), log-rank p=0.003. No significant difference in acute RTOG bladder or bowel toxicity was observed between hRT schedules. Late toxicity profile was favorable; with grade 2+ RTOG bladder (60Gy: 16/960 (1.7%); 57Gy: 11/962 (1.1%), p=0.34) and bowel (60Gy: 28/960 (2.9%); 57Gy: 17/962 (1.8%), p=0.10) toxicity at 2yr. Analysis of LENT-SOM and PROs supported these results. Conclusions: With 5 yr follow-up treatment with a 3Gy schedule of 60Gy/20f shows improved treatment efficacy compared to 57Gy/19f and is non-inferior to 74Gy/37f with a similar low level of acute and late normal tissue damage. Clinical trial information: ISRCTN97182923.

Neurotoxicity From Oxaliplatin Combined With Weekly Bolus Fluorouracil and Leucovorin As Surgical Adjuvant Chemotherapy for Stage II and III Colon Cancer: NSABP C-07

2007 ◽  
Vol 25 (16) ◽  
pp. 2205-2211 ◽  
Author(s):  
Stephanie R. Land ◽  
Jacek A. Kopec ◽  
Reena S. Cecchini ◽  
Patricia A. Ganz ◽  
H. Samuel Wieand ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Disease Free Survival ◽  
Adverse Event Reporting ◽  
Stage Ii ◽  
Phase Iii ◽  
Low Grade ◽  
Group V ◽  
Patient Reported ◽  
Assessment Time

Purpose The randomized, multicenter, phase III protocol C-07 compared the efficacy of adjuvant bolus fluorouracil and leucovorin (FULV) versus FULV with oxaliplatin (FLOX) in stage II or III colon cancer. Definitive analysis revealed an increase in 4-year disease-free survival from 67.0% to 73.2% in favor of FLOX. This study compares neurotoxicity between the treatments. Patients and Methods Neurotoxicity was recorded for all patients using standard adverse event reporting. Patients at select institutions completed a neurotoxicity questionnaire through 18 months of follow-up. Results A total of 2,492 patients enrolled onto C-07 and 400 patients enrolled onto the patient-reported substudy. Mean patient-reported neurotoxicity was higher with oxaliplatin throughout the 18 months of study (P < .0001). During therapy, patients receiving oxaliplatin experienced significantly more hand/foot toxicity (eg, “quite a bit” of cold-induced hand/foot pain 26% FLOX v 2.6% FULV) and overall weakness (eg, moderate weakness in 27.4% FLOX v 16.2% FULV). At 18 months, hand neuropathy had diminished, but patients who received oxaliplatin experienced continued foot discomfort (eg, moderate foot numbness and tingling for 22.1% FLOX v 4.6% FULV). Observer-reported neurotoxicity was low grade and primarily neurosensory rather than neuromotor. Sixty-eight percent in the FLOX group v 8% in the FULV group had neurotoxicity at their first on-treatment assessment. Time to resolution was significantly longer for those receiving oxaliplatin, and continued beyond 2 years for more than 10% in the oxaliplatin group. Conclusion Oxaliplatin causes significant neurotoxicity. It is experienced primarily in the hands during therapy and in the feet during follow-up. In a minority of patients the neurotoxicity is long lasting.

scholarly journals Phase III Comparison of Tamoxifen Versus Tamoxifen Plus Ovarian Function Suppression in Premenopausal Women With Node-Negative, Hormone Receptor–Positive Breast Cancer (E-3193, INT-0142): A Trial of the Eastern Cooperative Oncology Group

2014 ◽  
Vol 32 (35) ◽  
pp. 3948-3958 ◽  
Author(s):  
Amye J. Tevaarwerk ◽  
Molin Wang ◽  
Fengmin Zhao ◽  
John H. Fetting ◽  
David Cella ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Premenopausal Women ◽  
Menopausal Symptoms ◽  
Phase Iii ◽  
Health Related Quality ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related

Purpose The effects of ovarian function suppression (OFS) on survival and patient-reported outcomes were evaluated in a phase III trial in which premenopausal women were randomly assigned to tamoxifen with or without OFS. Patients and Methods Premenopausal women with axillary node-negative, hormone receptor–positive breast cancer tumors measuring ≤ 3 cm were randomly assigned to tamoxifen alone versus tamoxifen plus OFS; adjuvant chemotherapy was not permitted. Primary end points were disease-free survival (DFS) and overall survival (OS). Secondary end points included toxicity and patient-reported outcomes. Patient-reported outcome data included health-related quality of life, menopausal symptoms, and sexual function. These were evaluated at baseline, 6 months, 12 months, and then annually for up to 5 years after registration. Results In all, 345 premenopausal women were enrolled: 171 on tamoxifen alone and 174 on tamoxifen plus OFS. With a median follow-up of 9.9 years, there was no significant difference between arms for DFS (5-year rate: 87.9% v 89.7%; log-rank P = .62) or OS (5-year rate: 95.2% v 97.6%; log-rank P = .67). Grade 3 or higher toxicity was more common in the tamoxifen plus OFS arm (22.4% v 12.3%; P = .004). Patients treated with tamoxifen plus OFS had more menopausal symptoms, lower sexual activity, and inferior health-related quality of life at 3-year follow-up (P < .01 for all). Differences diminished with further follow-up. Conclusion When added to tamoxifen, OFS results in more menopausal symptoms and sexual dysfunction, which contributes to inferior self-reported health-related quality of life. Because of early closure, this study is underpowered for drawing conclusions about the impact on survival when adding OFS to tamoxifen.

scholarly journals Understanding the impact of a new Pharmacy Sore throat Test and Treat service on patient experience: A quantitative study

2020 ◽  
Author(s):  
Efi Mantzourani ◽  
Rebecca Cannings-John ◽  
Andrew Evans ◽  
Haroon Ahmed ◽  
Alan Meudell ◽  
...  
Keyword(s):  
Sore Throat ◽  
Patient Experience ◽  
Point Of Care ◽  
Free Text ◽  
Health Seeking Behaviour ◽  
Health Seeking ◽  
Future Health ◽  
Test And Treat ◽  
Patient Reported ◽  
The Impact

Abstract Background : A pilot of the first NHS funded Sore Throat Test and Treat (STTT) service in the United Kingdom began in selected community pharmacies in Wales in November 2018. The aim of this research was to explore whether a pharmacist delivering consultation for sore throat that included clinical scoring and point-of-care testing was acceptable to patients, and how this might influence future health-seeking behaviour for subsequent sore-throats. Methods : Quantitative research was employed, with a non-experimental design using a survey research tool including a mix of closed and open questions, developed in collaboration with members of the public. The patient experience survey was distributed to all patients who had completed a consultation between November 2018 and May 2019. Data from completed surveys were entered in Jisc Online Surveys® and exported to Excel® for descriptive statistics. Free-text comments were analysed using content and inductive thematic analysis. Results : A total of 510 surveys were received from 2,839 sore throat consultations (response rate 18%). Overall, 501 patients (98%) were satisfied with the service. Patients’ confidence in managing their condition and service satisfaction was not dependent on having been supplied antibiotics. A total of 343 patients (67%) requested a GP appointment but were offered to a consultation in the pharmacy. After the service, 504 patients (99%) stated that they would return to the pharmacy for subsequent sore throat symptoms. Inductive analysis of free-text comments (n=242) revealed 3 themes: convenience and accessibility; professionalism of pharmacy team; and perceived value of the service. Conclusions : Results confirmed high levels of patient satisfaction with the new service, the way it was delivered and the increased choice of options for sore throat symptom management it offered. Whilst this research can only discuss patients’ reported future behaviour, the patient-reported stated intentions signify a potential shift in health-seeking behaviour towards a pharmacist-led service. This has important implications in supporting the long term plan of the governments in Wales and England to redirect management of uncomplicated conditions from GPs to pharmacies.

Lenalidomide Maintenance Compared With Placebo in Responding Elderly Patients With Diffuse Large B-Cell Lymphoma Treated With First-Line Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone

2017 ◽  
Vol 35 (22) ◽  
pp. 2473-2481 ◽  
Author(s):  
Catherine Thieblemont ◽  
Hervé Tilly ◽  
Maria Gomes da Silva ◽  
Rene-Olivier Casasnovas ◽  
Christophe Fruchart ◽  
...  
Keyword(s):  
Elderly Patients ◽  
B Cell ◽  
Cell Lymphoma ◽  
International Prognostic Index ◽  
B Cell Lymphoma ◽  
Hazard Ratio ◽  
Phase Iii ◽  
Large B Cell Lymphoma ◽  
Large B Cell

Purpose The standard treatment of patients with diffuse large B-cell lymphoma (DLBCL) is rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). Lenalidomide, an immunomodulatory agent, has shown activity in DLBCL. This randomized phase III trial compared lenalidomide as maintenance therapy with placebo in elderly patients with DLBCL who achieved a complete response (CR) or partial response (PR) to R-CHOP induction. Methods Patients with previously untreated DLBCL or other aggressive B-cell lymphoma were 60 to 80 years old, had CR or PR after six or eight cycles of R-CHOP, and were randomly assigned to lenalidomide maintenance 25 mg/d or placebo for 21 days of every 28-day cycle for 24 months. The primary end point was progression-free survival (PFS). Results A total of 650 patients were randomly assigned. At the time of the primary analysis (December 2015), with a median follow-up of 39 months from random assignment, median PFS was not reached for lenalidomide maintenance versus 58.9 months for placebo (hazard ratio, 0.708; 95% CI, 0.537 to 0.933; P = .01). The result was consistent among analyzed subgroups (eg, male v female, age-adjusted International Prognostic Index 0 or 1 v 2 or 3, age younger than 70 v ≥ 70 years), response (PR v CR) after R-CHOP, and positron emission tomography status at assignment (negative v positive). With longer median follow-up of 52 months (October 2016), overall survival was similar between arms (hazard ratio, 1.218; 95% CI, 0.861 to 1.721; P = .26). Most common grade 3 or 4 adverse events associated with lenalidomide versus placebo maintenance were neutropenia (56% v 22%) and cutaneous reactions (5% v 1%), respectively. Conclusion Lenalidomide maintenance for 24 months after obtaining a CR or PR to R-CHOP significantly prolonged PFS in elderly patients with DLBCL.

Radioimmunotherapy with 131-I tositumomab enhanced survival in good prognosis relapsed and high-risk diffuse large B-cell lymphoma (DLBCL) patients receiving high-dose chemotherapy and autologous stem cell transplantation

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 8013-8013 ◽  
Author(s):  
J. Vose ◽  
P. Bierman ◽  
G. Bociek ◽  
F. Loberiza ◽  
C. Enke ◽  
...  
Keyword(s):  
Stem Cell ◽  
High Risk ◽  
Stem Cell Transplant ◽  
B Cell Lymphoma ◽  
Autologous Stem Cell Transplant ◽  
Good Prognosis ◽  
Phase Iii ◽  
Cell Transplant ◽  
Outpatient Basis

8013 Background: The 5-year overall survival (OS) for pts with relapsed chemosensitive DLBCL with standard transplantation is approximately 40–50%. We previously piloted the addition of standard outpatient radioimmunotherapy (RIT) with 131-I tositumomab to the transplant regimen for patients with relapsed chemoresistant NHL. This phase I study demonstrated a 3 yr OS of 55% in these poor prognosis patients (JCO 23: 461–467, 2005). The current study is a follow-up phase II study in good prognosis relapsed and high risk DLBCL patients using 131-I tositumomab with BEAM (BCNU, etoposide, cytarabine, and melphalan) followed by an autologous stem cell transplant. Methods: Forty patients were accrued to the study between 2000–2005. The patients had a median age of 54 yrs (26–75) and all had a diagnosis of DLBCL. The patients had a median of two prior chemotherapies before transplant and 88% had received prior Rituximab. All patients had chemotherapy sensitive disease at the time of stem cell transplant. Following stem cell collection, all patients received a stem cell preparative regimen of 75 cGy total body dose of 131-I tositumomab (dosimetric dose day -19 and therapeutic day -12) followed by a standard BEAM transplant regimen. Autologous unpurged stem cells were infused on day 0. The median time of follow-up of the survivors is 28 months (3–68). Results: Seventy eight percent of the patients had a complete remission following the transplant. The 3 year progression free survival (PFS) is 70% (95% CI - 48 - 84%) and the 3 year OS is 81% (95% CI - 61 - 91%). The entire transplant can be delivered on an outpatient basis. No increased toxicity compared to a similar cohort receiving BEAM alone could be detected. Conclusions: The addition of 131-I tositumomab to BEAM and autologous stem cell transplant for relapsed or high-risk chemosensitive DLBCL produces a 3-yr OS of 81% without excess toxicity. This compares favorably to historical controls. This regimen is currently being tested in a phase III trial in the BMT/CTN of Rituximab/BEAM vs. 131-I tositumomab/BEAM in patients with relapsed chemosensitive DLBCL. No significant financial relationships to disclose.

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