scholarly journals Patient preference for IUD follow up

Author(s):  
Lauren E. Abern ◽  
Kristen A. Kiely ◽  
Glendell S. de Guzman ◽  
Karla E. Maguire
Keyword(s):  
2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9576-9576
Author(s):  
Kevin Lynch ◽  
Yinin Hu ◽  
Norma Farrow ◽  
Yun Song ◽  
Max Meneveau ◽  
...  

9576 Background: While management of the nodal basin for melanoma has largely moved to observation for microscopic sentinel lymph node (SLN) metastasis, complete lymph node dissection (CLND) remains the current standard of care for melanoma patients with macroscopic, clinically detectable lymph node metastases (cLN). As CLND is associated with high surgical morbidity, we sought to study whether cLN may be safely managed by excision of only clinically abnormal nodes (precision lymph node dissection, PLND). Currently, a small subset of patients with cLN do not undergo CLND because of frailty or patient preference. We hypothesized that in these selected patients, PLND would provide acceptable regional control rates. Methods: Retrospective chart review was conducted at four academic tertiary care hospitals to identify melanoma patients who underwent PLND for cLN. cLN were defined as palpable or radiographically abnormal nodes. Recurrences were categorized as local/in-transit, same-basin lymph node, or distal lymph node/visceral. The primary outcome was isolated same-basin recurrence after PLND. Results: Twenty-one patients underwent PLND for cLN without synchronous distant metastases (characteristics of primary lesions summarized in Table). Reasons for forgoing CLND included patient preference (n=8), imaging indeterminate for distant metastases (n=2), comorbidities (n=4), loss to follow up (n=1), partial response to checkpoint blockade (n=1), or not reported (n=5). The inguinal node basin was the most common site (n=10), followed by the axillary (n=8) and cervical basins (n=3). A median of 2 nodes were resected at PLND, and 68% of resected nodes were positive for melanoma (median: 1, range: 1-3 nodes). Median follow-up was 23 months from PLND, and recurrence was observed in 28.6% of patients overall. Only 1 patient (4.8%) developed an isolated same-basin recurrence. The 3-year cumulative incidence of isolated same-basin recurrence was 5.3%, while risk of isolated local/in-transit recurrence or distant basin/visceral metastasis were 19.8% and 33.3%, respectively. Complications from PLND were reported in 1 patient (4.8%) and were limited to post-operative seroma and lymphedema. Conclusions: These pilot data suggest that PLND may offer acceptable regional disease control for cLN. Post-operative morbidity from PLND was also low, raising the possibility that PLND may provide adequate regional disease control without the morbidity associated with CLND. These data justify additional, prospective evaluation of PLND in selected patients.[Table: see text]


Radiology ◽  
2004 ◽  
Vol 233 (2) ◽  
pp. 328-337 ◽  
Author(s):  
Rogier E. van Gelder ◽  
Erwin Birnie ◽  
Jasper Florie ◽  
Michiel P. Schutter ◽  
Joep F. Bartelsman ◽  
...  

2006 ◽  
Vol 101 (1) ◽  
pp. 4-11 ◽  
Author(s):  
Cheryl Palmer ◽  
Jennie Pratt ◽  
Bristi Basu ◽  
Helena Earl

1992 ◽  
Vol 19 (10) ◽  
pp. 788-793 ◽  
Author(s):  
Kenneth L. Kalkwarf ◽  
Wayne B. Kaldahl ◽  
Kashinath D. Patil

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 4396-4396
Author(s):  
Mazyar Shadman ◽  
Ajay K Gopal ◽  
Oliver Press ◽  
David G. Maloney ◽  
Raya Mawad ◽  
...  

Abstract Background: Chemoimmunotherapy regimens remain the preferred first-line treatment for most of patients with CLL/SLL. Recent studies have demonstrated the efficacy of maintenance regimens by improving progression-free survival (PFS). We studied safety and efficacy of a treatment protocol that included induction and maintenance components using vorinostat, a histone deacetylase inhibitor, in combination with FCR for induction and with rituximab for the maintenance. Methods: Previously untreated CLL/SLL patients with indication for treatment were eligible. Primary objective of the Phase I part was the maximum tolerated dose (MTD) of vorinostat that could be combined with FCR and PFS was the primary endpoint for phase II. In the induction phase, FCR (fludarabine 25 mg/m2 days 1-3, cyclophosphamide 250 mg/m2 days 1-3 and rituximab 375 mg/m2 on day 1 of cycle 1 and 500 mg/m2 on day 1 of subsequent cycles) was given every 28 days for 6 cycles. In addition to FCR, patients received vorinostat orally on days 1-5 and days 8-12 of each treatment cycle. In the dose finding phase, vorinostat was given at 3 dose levels: 200 mg, 300 mg and 400 mg PO daily. There was no dose limiting toxicity and 400 mg was chosen as the MTD for phase II. Patients who received at least 4 cycles of induction were eligible to receive maintenance beginning within 3 months of the last cycle of FCR. In the maintenance phase, given every 3 months for 8 cycles, rituximab was given at dose of 500 mg/m2 on day 1 and vorinostat was given at 400 mg PO daily on days 1-14 of each cycle. Results: 40 patients (CLL 32, SLL 8) were treated. Median age was 58 years (36-72). Median time from diagnosis to treatment was 27 months (0 -102). Rai stage at the time of treatment was I/II in 23 (60%) and III/IV in 17 (40%) patients. Cytogenetic (CG) abnormalities included del17p in 2 (5%), del11q in 2 (5%), trisomy 12 in 4 (10%), del13q in 3 (7.5%), normal CG in 14 (35%) and other abnormalities in 6 (15%) patients. Median number of induction cycles was 6 (1-6) and 33 patients (83%) patients finished at least 4 cycles of induction and were eligible for maintenance. Reasons for delivery of less than 4 induction cycles were patient preference (2), GI toxicity (1), thrombocytopenia (1), pulmonary emboli (1), progressive disease (1) and sepsis (1). Twenty-six patients (65%) received at least 1 cycle of maintenance treatment (median 8; range, 1-8) and 15 patients (40%) finished all 8 planned maintenance cycles. Eleven patients started maintenance treatment but did not receive all 8 maintenance courses due to neutropenia (3), patient preference (3), infections (1), insurance issues (1) or other reasons (3). Six patients (15%) were eligible for maintenance but did not receive it because of hematologic toxicities (3), infection (1) or patient preference (2). Overall response rate after induction was 91% with CR in 26 (74%), PR in 4 (11%), nPR in 2 (6%) and stable disease (SD) in 1 (3%). One patient (3%) had progressive disease during the induction and 1 (3%) was not evaluable. Twenty-one of 23 (88%) patients who achieved CR after induction, were tested for minimal residual disease (MRD) by flow cytometry and cytogenetics and 21 (91%) had negative MRD status. One of 2 CR patients who was MRD positive after induction converted to MRD negative after maintenance. After median follow-up of 42 months, 5-year estimate of overall survival was 90% (95% CI 75%-96%) and 5-year estimate of PFS was 72% (95% CI 51%-85%). None of the patients who achieved CR after induction (n=26; 74%) had disease progression after median 46 months of follow-up while 3 of 6 patients with PR or nPR had disease progression which occurred median of 40 months (29-51). Most common grade 3-4 toxicities were hematologic (36%), electrolyte abnormalities (9%), gastrointestinal (8%) and cardiovascular (6%). 4 patients (10%) died during the follow-up because of disease progression (1), sepsis (1), fungal infection (1) and suicide (1). Median time to death was 9.5 months (5 -20). Conclusion: Combination of vorinostat with FCR for induction and with rituximab for maintenance was feasible and effective with a high ORR and long OS and PFS with no relapses observed among patients who achieved CR after induction. Cytopenias and infections were main reasons for treatment discontinuation especially during the maintenance phase. Combination of novel agents with conventional induction and maintenance regimens is a promising strategy for treatment of CLL/SLL. Disclosures Shadman: Gilead: Honoraria, Research Funding; Emergent: Research Funding; Acerta: Research Funding; Pharmacyclics: Honoraria, Research Funding. Gopal:Paid Consultancy- Gilead, Janssen, Seattle Genetics, Spectrum, Research funding- Gilead, Janssen, Pfizer, BMS, Merck, Teva, Takeda, Spectrum, Seattle Genetics: Consultancy, Honoraria, Research Funding. Press:Roche / Genentech: Consultancy, Research Funding. Maloney:Juno Therapeutics: Research Funding; Genentech/Roche: Consultancy, Honoraria.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2814-2814
Author(s):  
Diego Villa ◽  
Laurie H Sehn ◽  
Kerry J Savage ◽  
Cynthia L Toze ◽  
Kevin Song ◽  
...  

Background Mantle cell lymphoma (MCL) is an incurable B-cell non-Hodgkin lymphoma associated with poor outcomes. First-line treatment incorporates cytotoxic chemotherapy and rituximab, but there is no single standard of care regimen. In British Columbia (BC), between January 2003 and May 2013, R-CHOP was the preferred induction regimen. Based on results from the STIL-1 trial (Rummel et al, Lancet 2013) demonstrating improved CR rate and prolonged progression-free survival (PFS) of bendamustine and rituximab (BR) compared with R-CHOP, in June 2013, BR became the standard first-line therapy for all patients with MCL regardless of age. In both eras, fit patients generally ≤65 years of age responding to induction were eligible for high-dose BEAM and autologous stem cell transplantation (ASCT). Maintenance rituximab (MR) has been offered to responding patients post ASCT since 2004 and for transplant ineligible patients since 2012. The aim of this study was to assess the efficacy of BR as an induction regimen for MCL. Methods Patients with MCL treated with first-line BR were identified in the BC Cancer clinical and pathology databases as well as the Leukemia/BMT Program of BC transplant database. BR was initiated no later than December 2018. Treatment received was verified using the BC Cancer Provincial Pharmacy database, and clinical characteristics were verified using the BC Cancer Information System. Radiotherapy for localized disease, splenectomy, or a period of observation prior to systemic therapy were permitted. PFS and overall survival (OS) were calculated from the date of initiation of systemic therapy. In the subgroup of patients ≤65 years of age, results were compared to a historical cohort uniformly treated with R-CHOP. Baseline and treatment characteristics associated with PFS or OS (p<0.05) as well as the treatment variable (BR vs. R-CHOP) were included in Cox regression multivariate models using a backward likelihood ratio approach. Results A total of 190 BR-treated patients were identified. Table 1 shows clinical and treatment characteristics. Excluding 4 patients with an unknown response to BR, 101 (54%) patients achieved a complete response and 62 (33%) a partial response, for an 87% overall response rate. 23 (12%) patients progressed during or within 3 months after BR, and all had highly proliferative MCL (Ki-67 ≥30%) or blastoid/pleomorphic histology. Among the 89 BR-treated patients ≤65 years of age, 60 (67%) underwent ASCT and 29 (33%) did not (10 PD, 10 patient preference, 7 comorbidities, 2 pending). Among the 101 patients >65 years old, 9 underwent ASCT (age 66-71) and 92 did not. 63/69 patients received MR after ASCT, and 77/121 received MR after BR (without ASCT). Reasons for not receiving MR (6 after ASCT, 44 after BR) were 25 PD, 10 ASCT/BR toxicity, 7 pending, 3 patient preference, 3 early deaths, 2 physician preference. With a median follow-up of 2.4y (range 0.2 - 6.1) in living patients the 3y OS was 69.5% (95% CI 69.4-70.6) and 3y PFS 62.8% (95% CI 62.4-63.6). Baseline characteristics and outcomes were similar between patients ≤65y treated with BR vs. R-CHOP (Table 1, Figure 1A and 1B). 81/140 (58%) patients treated with R-CHOP underwent ASCT. In the subgroup of patients who underwent ASCT, outcomes calculated from the point of ASCT were not statistically different between BR vs. R-CHOP. In univariate analysis, age >65y, ECOG performance status >1, elevated LDH, blastoid/pleomorphic morphology, no ASCT, and no MR were associated with worse PFS and OS. In multivariate analysis including these variables as well as chemoimmunotherapy regimen, treatment with BR was not associated with PFS or OS. Conclusions In this population-based analysis, BR is an effective induction regimen for both transplant eligible and ineligible patients. ASCT is feasible in patients treated with BR induction. Even though BR was associated with a numerical improvement in PFS compared to R-CHOP in patients ≤65y, differences in PFS and OS were not statistically significant. Longer follow-up is necessary to fully understand the impact of BR in the frontline setting. We observed PD in 12% patients, suggesting that BR may not be an optimal induction regimen across all patients with MCL, particularly in those with aggressive or highly proliferative disease. Disclosures Villa: Roche, Abbvie, Celgene, Seattle Genetics, Lundbeck, AstraZeneca, Nanostring, Janssen, Gilead: Consultancy, Honoraria. Sehn:Morphosys: Consultancy, Honoraria; Kite Pharma: Consultancy, Honoraria; Merck: Consultancy, Honoraria; TG Therapeutics: Consultancy, Honoraria; Abbvie: Consultancy, Honoraria; Merck: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Acerta: Consultancy, Honoraria; TG Therapeutics: Consultancy, Honoraria; Apobiologix: Consultancy, Honoraria; Janssen-Ortho: Consultancy, Honoraria; Astra Zeneca: Consultancy, Honoraria; F. Hoffmann-La Roche/Genentech: Consultancy, Honoraria, Research Funding; Takeda: Consultancy, Honoraria; Verastem: Consultancy, Honoraria; Lundbeck: Consultancy, Honoraria; Kite Pharma: Consultancy, Honoraria; Abbvie: Consultancy, Honoraria; Acerta: Consultancy, Honoraria; F. Hoffmann-La Roche/Genentech: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria; Astra Zeneca: Consultancy, Honoraria; Morphosys: Consultancy, Honoraria; TEVA Pharmaceuticals Industries: Consultancy, Honoraria; TEVA Pharmaceuticals Industries: Consultancy, Honoraria; Karyopharm: Consultancy, Honoraria; Janssen-Ortho: Honoraria; Celgene: Consultancy, Honoraria; Gilead: Consultancy, Honoraria; Seattle Genetics: Consultancy, Honoraria; Seattle Genetics: Consultancy, Honoraria; Lundbeck: Consultancy, Honoraria. Savage:BMS, Merck, Novartis, Verastem, Abbvie, Servier, and Seattle Genetics: Consultancy, Honoraria; Seattle Genetics, Inc.: Consultancy, Honoraria, Research Funding. Song:Celgene: Honoraria, Research Funding; Janssen: Honoraria; Takeda: Honoraria; Amgen: Honoraria. Freeman:Seattle Genetics, Janssen, Amgen, Celgene, Abbvie: Consultancy, Honoraria. Scott:Roche/Genentech: Research Funding; Celgene: Consultancy; Janssen: Consultancy, Research Funding; NanoString: Patents & Royalties: Named inventor on a patent licensed to NanoSting [Institution], Research Funding. Gerrie:Lundbeck, Seattle Genetics: Consultancy, Honoraria.


Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 3972-3972 ◽  
Author(s):  
Mathias Rummel ◽  
Tae Min Kim ◽  
Caterina Plenteda ◽  
Enrico Capochiani ◽  
Maria Mendoza ◽  
...  

Abstract Background Rituximab in combination with chemotherapy is the standard of care for patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). To improve patient convenience and to reduce healthcare resource burden, a subcutaneous (SC) formulation of rituximab has been developed and has been shown to be clinically comparable to intravenous (IV) rituximab. The aim of this study was to evaluate patient preference for rituximab IV or SC administration. Methods Prefmab (NCT01724021) is a randomized, open-label, crossover phase IIIb study. Eligible patients were aged ≥18 to ≤80 years with previously untreated CD20+ DLBCL (IPI 1-4 or 0 with bulky disease) or FL (FLIPI grade 1-3a), at least 1 bidimensionally measureable lesion ≥1.5cm at its largest dimension by computed tomography, and an ECOG performance status ≤3; all provided written informed consent. Patients received 8 cycles of rituximab according to 2 schedules: Arm A received 1 cycle of rituximab IV (375mg/m2) and 3 cycles of rituximab SC (1400mg) then 4 cycles of rituximab IV; Arm B received 4 cycles of rituximab IV (375mg/m2) then 4 cycles of rituximab SC (1400mg). Alongside rituximab, both arms received 6-8 cycles of chemotherapy (CHOP [cyclophosphamide, doxorubicin, oncovin, prednisone], CVP [cyclophosphamide, vincristine, prednisone], or bendamustine as per standard local practice). A Patient Preference Questionnaire (PPQ) was conducted post-rituximab therapy at cycles 6 and 8. The primary endpoint was overall preference for rituximab IV or SC. The strength of patient preference was also assessed (very strong, fairly strong, or not very strong). Adverse events (AEs), including administration-related reactions, were evaluated according to NCI-CTCAE version 4.0. Results At the primary data cut-off (January 19, 2015), the intent-to-treat population comprised 743 patients (Arm A: n=372; Arm B: n=371). The majority of patients had DLBCL (63%). The median age was 60 years (range 18-80) and baseline characteristics were balanced between arms. One hundred and twenty patients discontinued immunochemotherapy treatment prematurely, primarily due to AEs (n=52), but entered follow-up. A further 108 patients (Arm A: n=48; Arm B: n=60) discontinued the study and did not complete follow-up, primarily due to death (53 patients [DLBCL: n=48; FL: n=5], 19 of whom died due to progressive disease [DLBCL: n=16; FL: n=3]), patient request/withdrawal of consent (n=23), or AEs (n=9). Rates of study discontinuation and treatment discontinuation were balanced between arms. The PPQ was completed by 620 patients at cycle 6 and 591 at cycle 8. At cycle 6, rituximab SC was preferred by 80% (n=495) of patients (Arm A: 79%; Arm B: 81%) and rituximab IV by 10% (n=62; Arm A: 11%; Arm B: 9%), while 10% (n=63) had no preference (Arm A: 10%; Arm B: 10%). At cycle 8, the respective values were 81% (n=477; Arm A: 77%; Arm B: 84%), 11% (n=66; Arm A: 13%; Arm B: 10%), and 8% (n=48; Arm A: 10%; Arm B: 6%). The strength of patient preference for rituximab SC or IV is shown in Figure 1. Of patients who preferred rituximab SC, the main reasons were 'less time in the clinic' (cycle 6: 68%; cycle 8: 69%) and 'feels more comfortable during administration' (cycle 6: 37%; cycle 8: 37%). The mean cumulative rituximab administration time (mean ± standard deviation) was 865 ± 401 min for rituximab IV compared with 37 ± 100 min for rituximab SC. AEs were generally balanced between rituximab IV and SC administration, with the exception of gastrointestinal disorders (IV: 55%; SC: 31%) in patients with FL, notably nausea (IV: 28%; SC: 11%), constipation (IV: 14%; SC: 6%), and vomiting (IV 12%; SC 2%). No new safety signals were detected. Conclusions Most previously untreated patients with CD20+ DLBCL or FL preferred SC compared with IV administration of rituximab, mainly due to reduction in the duration and discomfort of administration. Figure 1. Figure 1. Disclosures Rummel: Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Plenteda:Roche: Other: Sub-investigator. Mendoza:Roche: Employment. Smith:Roche: Employment. Osborne:Roche: Employment. Grigg:Merck: Honoraria, Membership on an entity's Board of Directors or advisory committees; Gilead: Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees; BMS: Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees.


Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Ada Keding ◽  
Helen Handoll ◽  
Stephen Brealey ◽  
Laura Jefferson ◽  
Catherine Hewitt ◽  
...  

Abstract Background Surgeon and patient treatment preferences are important threats to the internal and external validity of surgical trials such as PROFHER, which compared surgical versus non-surgical treatment for displaced fractures of the proximal humerus in adults. We explored the treatment preferences expressed by surgeons and patients in the trial and how these impacted on patient selection, trial conduct and patient outcome. Methods A series of exploratory secondary analyses of the PROFHER trial data were undertaken. We reviewed the extent of surgeon and patient treatment preferences (surgery or not surgery) at screening (n = 1250) as well as prior preference (including no preference) of randomised patients (n = 250), and assessed their impact on recruitment and adherence to follow-up and rehabilitation. Changes in treatment after 2 years’ follow-up were explored. Patient preference and characteristics associated with trial inclusion or treatment preference (t test, chi-squared test, Wilcoxon rank-sum test) were included as treatment interaction terms in the primary trial analysis of shoulder functioning (Oxford Shoulder Score, OSS). Results Surgeons excluded 17% of otherwise eligible patients based on lack of equipoise; these patients had less complex fractures (p < 0.001) and tended to be older (p = 0.062). Surgeons were more likely to recommend surgery for patients under 65 years of age (p = 0.059) and who had injured their right shoulder (p = 0.052). Over half of eligible patients (56%) did not consent to take part in the trial; these patients tended to be older (p = 0.022), with a preference for not surgery (74%; which was associated with older age, p = 0.039). There were no differential treatment effects (p value of interaction) for shoulder functioning (OSS) based on subgroups of patient preference (p = 0.751), age group (p = 0.264), fracture type (p = 0.954) and shoulder dominance (p = 0.850). Patients who were randomised to their preferred treatment had better follow-up rates (94 vs 84% at 2 years) and treatment adherence (90 vs 83% reported completing home exercises). Patients who were not randomised to their preferred treatment were more likely to change their treatment preference at 24 months (60 vs 26%). Conclusions The robustness of the PROFHER trial findings was confirmed against possible bias introduced by surgeon and patient preferences. The importance of collecting preference data is highlighted. Trial registration ISRCTN50850043. Registered on 25 March 2008.


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