Clinical trial enrollment and follow-up visit rates among survivors of childhood cancer.

2017 ◽  
Vol 35 (5_suppl) ◽  
pp. 22-22
Author(s):  
Kelley Kennedy Hutchins ◽  
Sureyya Savasan ◽  
Ronald Thomas ◽  
Laura Strathdee ◽  
Jeffrey Warren Taub

22 Background: Childhood cancer treatment outcomes have improved substantially with five-year overall survival rates reaching greater than 80%. However, survivors are at increased risk of long-term complications, and long-term follow-up (LTFU) is critical. Distance from a cancer treatment center and increased time from completion of therapy have been associated with decreased LTFU rates. We studied whether lack of enrollment in a therapeutic clinical trial may be an additional barrier to receiving LTFU care. Methods: We conducted a retrospective review of 353 patient records at the Children’s Hospital of Michigan enrolled in our Children’s Oncology Group (COG) registry between 1/1/05-12/31/10. All patients were ≤ 25 years of age at diagnosis.Sixty-seven patients were excluded (died prior to follow-up, n = 61; still on therapy, n = 5; insufficient information, n = 1). A total of 286 patient charts were available for analysis after exclusion. One hundred sixty-two (57%) patients were enrolled in a therapeutic clinical trial, and 124 (43%) were enrolled in a biology study alone due to lack of an open therapeutic clinical trial at the time of diagnosis. One hundred eighty-six (65%) patients were < 10 years of age at diagnosis. Results: Follow-up rates at one-, two- and five-years following completion of therapy for patients enrolled in a therapeutic clinical trial were 94.5%, 91.9% and 74%, respectively, compared to 82.9% (p = 0.002), 74% (p < 0.001) and 66% (p = 0.029) for patients not enrolled. The follow-up rate at five-years for patients who were < 10 years of age was 77.5% compared to 70.7% (p = 0.007) for patients > 10 years. There was no significant difference at one- or two-years based on age at diagnosis. Conclusions: Our findings demonstrate that patients enrolled in a therapeutic clinical trial have significantly superior LTFU rates compared to patients enrolled in biology studies alone. Younger age at diagnosis demonstrated a superior rate at five-years of follow-up. Our findings suggest that additional resources/strategies must be utilized to ensure better LTFU for patients not enrolled in therapeutic clinical trials.

2021 ◽  
Vol 10 (7) ◽  
pp. 1336
Author(s):  
Toshifumi Takahashi ◽  
Shinya Somiya ◽  
Katsuhiro Ito ◽  
Toru Kanno ◽  
Yoshihito Higashi ◽  
...  

Introduction: Cystine stone development is relatively uncommon among patients with urolithiasis, and most studies have reported only on small sample sizes and short follow-up periods. We evaluated clinical courses and treatment outcomes of patients with cystine stones with long-term follow-up at our center. Methods: We retrospectively analyzed 22 patients diagnosed with cystine stones between January 1989 and May 2019. Results: The median follow-up was 160 (range 6–340) months, and the median patient age at diagnosis was 46 (range 12–82) years. All patients underwent surgical interventions at the first visit (4 extracorporeal shockwave lithotripsy, 5 ureteroscopy, and 13 percutaneous nephrolithotripsy). The median number of stone events and surgical interventions per year was 0.45 (range 0–2.6) and 0.19 (range 0–1.3) after initial surgical intervention. The median time to stone events and surgical intervention was 2 years and 3.25 years, respectively. There was a significant difference in time to stone events and second surgical intervention when patients were divided at 50 years of age at diagnosis (p = 0.02, 0.04, respectively). Conclusions: Only age at a diagnosis under 50 was significantly associated with recurrent stone events and intervention. Adequate follow-up and treatment are needed to manage patients with cystine stones safely.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Leah B Kosyakovsky ◽  
Federico Angriman ◽  
Emma Katz ◽  
Neill Adhikari ◽  
Lucas C Godoy ◽  
...  

Introduction: Sepsis results in dysregulated inflammation, coagulation, and metabolism, which may contribute to increased cardiovascular disease (CVD) risk. We conducted a systematic review and meta-analysis to determine the association between sepsis and subsequent long-term CVD events. Methods: MEDLINE, Embase, and the Cochrane Controlled Trials Register and Database of Systematic Reviews were searched from inception to May 2020 to identify observational studies of adult sepsis survivors (defined by diagnostic codes or consensus definitions) measuring long-term CV outcomes. The primary outcome was a composite of myocardial infarction, CV death, and stroke. Random-effects models estimated the pooled cumulative incidence and adjusted hazard ratios of CV events relative to hospital or population controls. Odds ratios were included as risk ratios assuming <10% incidence in non-septic controls, and risk ratios were taken as hazard ratios (HR) assuming no censoring. Outcomes were analyzed at maximum follow-up (primary analysis) and stratified by time (<1 year, 1-2 years, and >2 years) since sepsis. Results: Of 11,235 abstracts screened, 25 studies (22 cohort studies, 2 case-crossover studies, and 1 case-control) involving 1,949,793 sepsis survivors were included. The pooled cumulative incidence of CVD events was 9% (95% CI; 5-14%). Sepsis was associated with an increased risk (HR 1.59, 95% CI 1.37-1.86) of CVD events at maximum follow-up ( Figure ); between-study heterogeneity was substantial (I 2 =97.3%). There was no significant difference when comparing studies using population and hospital controls. Significantly elevated risk was observed up to 5 years following sepsis. Conclusions: Sepsis survivors experience an approximately 50% increased risk of CVD events, which may persist for years following the index episode. These results highlight a potential unmet need for early cardiac risk stratification and optimization in sepsis survivors.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
H J Kim ◽  
M A Kim ◽  
D I Lee ◽  
H L Kim ◽  
D J Choi ◽  
...  

Abstract Background Ischemic heart disease (IHD) is a major underlying etiology in patients with heart failure (HF). Although the impact of IHD on HF is evolving, there is a lack of understanding of how IHD affects long-term clinical outcomes and uncertainty about the role of IHD in determining the risk of clinical outcomes by gender. Purpose This study aims to evaluate the gender difference in impact of IHD on long-term clinical outcomes in patients with heart failure reduced ejection fraction (HFrEF). Methods Study data were obtained from the nationwide registry which is a prospective multicenter cohort and included patients who were hospitalized for HF composed of 3,200 patients. A total of 1,638 patients with HFrEF were classified into gender (women 704 and men 934). The primary outcome was all-cause death during follow-up and the composite clinical events of all-cause death and HF readmission during follow-up were also obtained. HF readmission was defined as re-hospitalization because of HF exacerbation. Results 133 women (18.9%) were died and 168 men (18.0%) were died during follow-up (median 489 days; inter-quartile range, 162–947 days). As underlying cause of HF, IHD did not show significant difference between genders. Women with HFrEF combined with IHD had significantly lower cumulative survival rate than women without IHD at long-term follow-up (74.8% vs. 84.9%, Log Rank p=0.001, Figure 1). However, men with HFrEF combined with IHD had no significant difference in survival rate compared with men without IHD (79.3% vs. 83.8%, Log Rank p=0.067). After adjustment for confounding factors, Cox regression analysis showed that IHD had a 1.43-fold increased risk for all-cause mortality independently only in women. (odds ratio 1.43, 95% confidence interval 1.058–1.929, p=0.020). On the contrary to the death-free survival rates, there were significant differences in composite clinical events-free survival rates between patients with HFrEF combined with IHD and HFrEF without IHD in both genders. Figure 1 Conclusions IHD as predisposing cause of HF was an important risk factor for long-term mortality in women with HFrEF. Clinician need to aware of gender-based characteristics in patients with HF and should manage and monitor them appropriately and gender-specifically. Women with HF caused by IHD also should be treated more meticulously to avoid a poor prognosis. Acknowledgement/Funding None


2019 ◽  
Vol 2019 ◽  
pp. 1-7
Author(s):  
Wei Chen ◽  
Dipesh Kumar Yadav ◽  
Xueli Bai ◽  
Jianying Lou ◽  
Risheng Que ◽  
...  

Background. In China, the cases of liver transplantation (LT) from donation after citizens’ death have rose year by year since the citizen-based voluntary organ donor system was initiated in 2010. The objective of our research was to investigate the early postoperative and late long-term outcomes of LT from donation after brain death (DBD) and donation after circulatory death (DCD) according to the current organ donation system in China. Methods. Sixty-two consecutive cases of LT from donation after citizens’ death performed in our hospital between February 2012 and June 2017 were examined retrospectively for short- and long-term outcomes. These included 35 DCD LT and 27 DBD LT. Result. Subsequent median follow-up time of 19 months and 1- and 3-year graft survival rates were comparative between the DBD group and the DCD group (81.5% and 66.7% versus 67.1% and 59.7%; P=0.550), as were patient survival rates (85.2% and 68.7% versus 72.2% and 63.9%; P=0.358). The duration of ICU stay of recipients was significantly shorter in the DBD group, in comparison with that of the DCD group (1 versus 3 days, P=0.001). Severe complication incidence (≥grade III) after transplantation was identical among the DBD and DCD groups (48.1% versus 60%, P=0.352). There was no significant difference in postoperative mortality between the DBD and DCD groups (3 of 27 cases versus 5 of 35 cases). Twenty-one grafts (33.8%) were lost and 18 recipients (29.0%) were dead till the time of follow-up. Malignancy recurrence was the most prevalent reason for patient death (38.8%). There was no significant difference in incidence of biliary stenosis between the DBD and DCD groups (5 of 27 cases versus 6 of 35 cases, P=0.846). Conclusion. Although the sample size was small to some extent, this single-center study first reported that LT from DCD donors showed similar short- and long-term outcomes with DBD donors and justified the widespread implementation of voluntary citizen-based deceased organ donation in China. However, the results should be verified with a multicenter larger study.


2015 ◽  
Vol 2 (4) ◽  
pp. 199-204 ◽  
Author(s):  
Paul D. Brown ◽  
S. Keith Anderson ◽  
Xiomara W. Carrero ◽  
Brian P. O'Neill ◽  
Caterina Giannini ◽  
...  

Abstract Background Pilocytic astrocytoma is a rare tumor in adults. This report is of a prospective clinical trial with long-term follow-up. Methods Between 1986 and 1994, 20 eligible adults with supratentorial pilocytic astrocytomas were enrolled in a prospective intergroup trial of radiotherapy (RT) after biopsy (3 patients) or observation after gross (11 patients) or subtotal (6 patients) resection. Results At the time of analysis (median follow-up, 20.8 years), 2 patients (10%) have died and 18 patients (90%) are alive. Neurologic and cognitive function were stable or improved over time for the majority of patients. No toxic effects of treatment or malignant transformations have been recorded at last follow-up. For the entire cohort the 20-year time to progression and overall survival rates are 95% and 90% respectively. The cause of death (2.2 and 16.1 years after enrollment) in both patients was unrelated to tumor although both were biopsy-only patients. One subtotally resected tumor progressed 1 month after enrollment requiring P32 injection into an enlarging cyst. Because of further progression this patient required RT 18 months later. This patient is alive without evidence of progression 18 years after RT. Conclusion The long-term follow-up results of this prospective trial confirm that adults with pilocytic astrocytomas have a favorable prognosis with regard to survival and neurologic function. Close observation is recommended for adults with pilocytic astrocytomas, reserving RT for salvage, as the majority remain stable after gross or subtotal resection and no adjuvant therapy.


1991 ◽  
Vol 75 (4) ◽  
pp. 575-582 ◽  
Author(s):  
Mark G. Belza ◽  
Sarah S. Donaldson ◽  
Gary K. Steinberg ◽  
Richard S. Cox ◽  
Philip H. Cogen

✓ Seventy-seven patients presenting with medulloblastoma between 1958 and 1986 were treated at Stanford University Medical Center and studied retrospectively. Multimodality therapy utilized surgical extirpation followed by megavoltage irradiation. In 15 cases chemotherapy was used as adjunctive treatment. The 10- and 15-year actuarial survival rates were both 41% with an 18-year maximum follow-up period (median 4.75 years). There were no treatment failures after 8 years of tumor-free survival. Gross total removal of tumor was achieved in 22 patients (32%); the surgical mortality rate was 3.9%. No significant difference was noted in the incidence of metastatic disease between shunted and nonshunted patients. The classical form of medulloblastoma was present in 67% of cases while the desmoplastic subtype was found in 16%. Survival rates were best for patients presenting after 1970, for those with desmoplastic tumors, and for patients receiving high-dose irradiation (≥ 5000 cGy) to the posterior fossa. Although early data on freedom from relapse suggested a possible beneficial effect from chemotherapy, long-term follow-up results showed no advantage from this modality of treatment. The patterns of relapse and survival were examined; 64% of relapses occurred within the central nervous system, and Collins' rule was applicable in 83% of cases beyond the period of risk. Although patients treated for recurrent disease could be palliated, none were long-term survivors. The study data indicate that freedom from relapse beyond 8 years from diagnosis can be considered as a cure in this disease. Long-term follow-up monitoring is essential to determine efficacy of treatment and to assess survival patterns accurately.


Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2024-2024
Author(s):  
Ryan D. Gentzler ◽  
Andrew M. Evens ◽  
Alfred W. Rademaker ◽  
Bharat B Mittal ◽  
Adam M. Petrich ◽  
...  

Abstract Abstract 2024 Background: For patients with relapsed or refractory HL, salvage chemotherapy followed by aHSCT is the standard of care. Our group previously reported excellent clinical outcomes with accelerated hyperfractionated TLI followed by high-dose chemotherapy and aHSCT (Ann of Oncol. 16:679, 2007). This strategy has been adopted as the standard at our institution for eligible individuals and we now report long-term outcomes of patients previously reported on the phase I/II clinical trial in addition to those who were subsequently treated as standard of care. Patients and methods: Patients with biopsy confirmed relapsed/refractory classical HL who previously received no more than 20 Gy were eligible. Salvage chemotherapy was chosen by the patient's treating physician. All patients received accelerated hyperfractionated TLI prior to transplantation administered twice daily at 150 cGy, five days/week for 10 days. The morning dose was delivered to all nodal sites including the spleen, and the afternoon dose was delivered to all sites of previous and current disease. The goal was to treat uninvolved nodal sites and spleen to 1500 cGy and sites of current and previous disease to 3000 cGy. Conditioning chemotherapy consisted of high-dose carboplatin, cyclophosphamide, and etoposide. All patients received carboplatin 450 mg/m2 by continuous intravenous infusion (CIV) on days –6 to –4 (total dose = 1350 mg/m2) and cyclophosphamide 60 mg/kg/day over 1 h on days –3 and –2 (total dose = 120 mg/kg). Patients on the phase I portion of the trial received escalating doses of etoposide by CIV from days –6 to –4. Initial dosing levels were 400 mg/m2/day, 450 mg/m2/day, 500 mg/m2/day, 600 mg/m2/day and 700 mg/m2/day. Those treated on the phase II portion of the clinical trial or subsequent to the closing of the trial were treated with etoposide 700 mg/m2/day for a total of 2100 mg/m2. Results: 52 patients with relapsed/refractory HL at Northwestern University were treated with TLI and aHSCT from 1993 to January 2011. One patient was lost to follow-up immediately post-transplant. 51 patients were included in this analysis and had a median follow-up of 47 months (range: 0.07–204 months). Thirty patients were treated on a previously reported prospective phase I/II clinical trial. Most patients had nodular sclerosis histology (n=39, 76%) and more than half had primary induction failure (PIF; n=29). Among patients who achieved a CR with induction, 62% relapsed within one year. The most common salvage regimens were ESHAP and ICE chemotherapy and most had received two lines of chemotherapy prior to aHSCT. Only 21 patients (41%) achieved a complete response (CR) with salvage therapy and in most cases (n=31, 61%), response was determined by functional imaging prior to aHSCT. The 10-year PFS and OS for all patients were 56% and 54%, respectively. Ten-year PFS and OS for patients with PIF was 53%, compared with 63% and 59%, respectively, for those with relapsed disease (p=0.13 and p=0.20, respectively). Patients who had incomplete responses to salvage therapy had a 10-year PFS and OS of 41% and 39%, respectively, compared to 76% and 81%, respectively, for those who achieved a CR (p=0.1 and p=0.056, respectively). Treatment-related mortality within the first 100 days was observed in one patient. Five patients (10%) developed secondary malignancies; three developed MDS (one who had received MOPP induction died with MDS; one had relapsed HL post-aHSCT and died of AML and one is alive with MDS 3+ yrs post-diagnosis). There was one case each of T-cell lymphoma (7 months post-aHSCT) and melanoma. Conclusions: Sequential TLI/chemotherapy conditioning for relapsed/refractory HL for patients with limited or no prior radiotherapy continues to be associated with excellent disease control and long-term survival rates including high-risk populations such as PIF and chemotherapy-resistant disease. Disclosures: No relevant conflicts of interest to declare.


2020 ◽  
Author(s):  
Yonghua Bi ◽  
Jindong Li ◽  
Liangliang Bai ◽  
Xinwei Han ◽  
Jianzhuang Ren

Abstract Background: Endoscopic removal is the most common method for removal of tracheal stents. Few studies have reported the technique of fluoroscopy-guided stent removal for tracheal fistula and tracheal stenosis. We aimed to study the safety and efficacy of fluoroscopy-guided stent removal as well as the optimal duration for stent usage.Methods: We conducted a retrospective analysis of 152 patients who underwent fluoroscopy-guided stent removal from January 2011 to June 2017. Reasons for stent implantation were tracheal fistula in 85 patients (TF group), and tracheal stenosis in 67 patients (TS group). All patients underwent tracheal CT scans before stent removal and during follow up. The technical success rate, complications, and survival rate were compared between the two groups.Results: The technical success rate of stent removal was 98.9% and 97.4%, respectively for the TF and TS group. Removal was routine for half of patients, and in the remainder, excessive granulation tissue was the common indications for stent removal, which was found after stenting at 142.1±25.9 days in the TF group, and at 89.9±15.0 day in the TS group. The total incidence of complications was 21.1% and 22.4%, respectively, for the TF and TS groups. Perioperative death occurred in one patient in the TF group, and two patients in the TS group. Recurrence of fistula or stenosis requiring re-stenting was the most comment complication in both groups. The 0.5-, 3-, 6-year survival rates were 90.3%, 59.6%, and 36.1% for TF group, and 80.4%, 75.7%, 75.7% for TS group.Conclusions: Fluoroscopic removal of tracheal stents is safe and effective for both tracheal fistula and tracheal stenosis, with no significant difference in outcomes. Recurrence of fistula or stenosis requiring re-stenting was the most common complication.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 2018-2018
Author(s):  
E. Franceschi ◽  
A. Tosoni ◽  
M. Ermani ◽  
V. Blatt ◽  
P. Amistà ◽  
...  

2018 Background: Due to the rarity of medulloblastoma (MB) in adults, the few studies available on this condition are retrospective, and the follow-up tends to be short. Furthermore, the different therapeutic strategies used in these patients makes it difficult to assess survival rates and prognostic factors. Methods: Between January 1989 and February 2001, a prospective phase II trial was performed to evaluate the efficacy of treatment for adults with medulloblastoma. Patients were completely staged with a neuroradiological examination of the brain and neuraxis and by CSF cytology, according to Chang’s staging system. Low risk patients received radiotherapy alone, while high risk patients were given 2 cycles of upfront chemotherapy followed by radiotherapy and adjuvant chemotherapy. The results of the preliminary analysis of this study at a median follow-up of 3.7 years are reported elsewhere. The present papers reports on the long- term results of the same trial. Results: After a median follow up of 7.6 years, among a total of 36 enrolled adults with medulloblastoma, overall progression free survival (PFS) and overall survival (OS) at 5 years were 72% (range 59% to 84%) and 75% (62% to 91%), respectively. No difference was found between low and high risk patients in terms of PFS and OS at 5 years: in low-risk patients the 5-year PFS was 80% (range, 59–100%) and the 5-year OS, 80% (range, 58 - 100%); in high-risk patients the 5-year PFS was 69% (range, 54 -89%) and the 5-year OS, 73% (range, 58 - 92%). Conclusions: A long-term follow-up is essential to evaluate the real impact of treatments in adult patients with MB. Since there is no significant difference between low-risk and high-risk patients for PFS and OS, the use of chemotherapy is also questionable in low-risk patients. No significant financial relationships to disclose.


2016 ◽  
Vol 34 (3_suppl) ◽  
pp. 66-66 ◽  
Author(s):  
Melanie Keats ◽  
Kelsey Shea ◽  
Louise Parker ◽  
Samuel A. Stewart ◽  
Annette Flanders ◽  
...  

66 Background: The treatments that childhood cancer survivors (CCS) undergo can lead to an increased risk of other health problems later in life, and risk-based follow-up care is necessary throughout their lifetime. Regrettably, family physicians caring for CCS often report having no record of their patients’ past disease, treatment history, or need for follow-up. As the large majority of CCS will transition from specialized pediatric oncology care to generalized adult care in the community, detailed treatment summaries and Survivorship Care Plans (SCP) are needed to ensure that both the survivor and their care providers are adequately informed of the survivors diagnosis, treatment(s), potential risk for late effects, and long-term surveillance and healthcare needs. This qualitative study sought to explore the needs, preferences, and the perceived utility of SCP for family physicians (FP) caring for CCS. Methods: Using publically available Children’s Oncology Group guidelines, a de-identified sample SCP indicating the diagnosis, treatment(s) received, and follow-up recommendations for a common childhood cancer diagnosis was automatically generated using a newly developed algorithm and patient data from the Cancer in Young People – Canada registry. Semi-structured telephone interviews with six FP that have a known CCS in their practice were then used to gain insight into the FP perceived role in the long-term management and care of CCS, their cancer information needs, concerns with communication, their perceived utility of the SCP, and preferred format(s) for receiving the SCP. The constant comparative method was used for thematic analysis. Results: The key themes emerging from the six completed interviews include a lack of confidence among FP in their ability to care for CCS and a need for additional knowledge and resources. FP also identified psychological barriers to cancer care discussions with CCS and identified a patient need for greater psychological support. Overall, SCP were viewed as helpful. Conclusions: SCP are perceived to be of benefit to FP of CCS as they serve to increase their knowledge of patient diagnosis, treatments received, and suggested risk-based follow-up.


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