Paclitaxel, ifosfamide & cisplatin (TIP) as second-line therapy for germ cell tumors (GCT):Long-term follow-up and expansion cohort.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 386-386
Author(s):  
Jack Patrick Gleeson ◽  
Andrea Knezevic ◽  
Maria Bromberg ◽  
Sujata Patil ◽  
Joel Sheinfeld ◽  
...  
Keyword(s):  
Risk Factors ◽  
Second Line ◽  
Inclusion Criteria ◽  
Second Line Therapy ◽  
Original Cohort ◽  
Line Therapy ◽  
Long Term Follow Up ◽  
Expansion Cohort

386 Background: TIP was established as an effective second-line regimen in a phase II study of 46 patients (pts) with relapsed GCT and favorable risk factors (Kondagunta, JCO 2005). Here, we report long-term follow up from this trial and outcomes for additional pts who subsequently received TIP off protocol. Methods: Eligiblepts included those who received TIP on the original phase II trial (original cohort) or who received TIP following study closure but would have met the trial inclusion criteria (expansion cohort). An additional exploratory cohort was comprised of pts with unfavorable risk factors who would not have met the original trial criteria. The primary endpoint was favorable response rate (FRR), which included complete responses (CR) and partial responses with negative markers (PR-). Overall survival (OS), progression free survival (PFS), and relapse rates were also evaluated. Results: Of 204 pts who received TIP for GCT at our institution from 5/1994 to 7/2019, 87 (original cohort, n=46; expansion cohort, n=41) met the inclusion criteria and were evaluable for the main analysis. An additional 17 pts were analyzed in the exploratory cohort (unfavorable risk factor: PR- lasting <6months or IR, n=13; prior adjuvant therapy, n=4). 100 pts were excluded due to participation in an ongoing clinical trial (n=17), receipt of TIP as their first regimen (n=74) or in the adjuvant (n=3) setting, or insufficient data (n=6). Baseline characteristics and efficacy data are displayed in the table below. In the main cohort, 70/87 (80%) pts achieved a favorable response. With median follow-up of 10.2 years (yrs) [original, 14.3 yrs; expansion 6.5 yrs] 26 deaths were observed. 5yr and 10yr OS rates were 72% (95% CI 63, 83) and 69% (95% CI 59, 80) respectively. 5yr and 10yr PFS were 70% (95% CI 61, 81) and 67% (95% CI 57, 78). In the exploratory cohort, there were 7 deaths at median follow-up of 6.2 yrs with 5yr OS of 56% (95% CI 35, 87) and 5yr PFS of 59% (95% CI 40, 88). Conclusions: Long-term follow-up and additional experience supports the use of TIP as second-line therapy for GCT. Similar outcomes were seen for our exploratory and main cohorts, suggesting benefit with TIP outside of those with a favorable prognosis. [Table: see text]

scholarly journals Long-Term Outcomes of Dasatinib Therapy in Patients with Imatinib-Resistant or -Intolerant Chronic Myeloid Leukemia from Physician’s and Patient’s Perspective

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 2644-2644 ◽  
Author(s):  
Tatyana I Ionova ◽  
Tatyana P Nikitina ◽  
Denis A Fedorenko ◽  
Taras A Gritsenko ◽  
Valentina L Ivanova ◽  
...  
Keyword(s):  
Research Funding ◽  
Base Line ◽  
Second Line ◽  
Second Line Therapy ◽  
Line Therapy ◽  
Patient Reported ◽  
Long Term Follow Up ◽  
Dasatinib Treatment

Abstract Information about the efficacy and safety of the second-line therapy with dasatinib in patients in chronic phase chronic myeloid leukemia (CML-CP) at long-term follow-up is limited. Evaluation of benefits and risks of the treatment in a “real-world” study both from physician’s and patient’s perspective is worthwhile to better define treatment outcomes in this patients’ population. We aimed to study clinical and patient-reported outcomes as well as safety of the second-line therapy by dasatinib in CML-CP patients with imatinib resistance or intolerance treatment at long-term follow-up. 75 CML-CP patients resistant or -intolerant to imatinib were enrolled in the prospective, multicenter, non-interventional study (mean age 51.3 years old, SD 15.4; range 22–83 years; male/female – 37/38). All the patients received dasatinib as the second-line therapy (100 mg daily). Clinical and patient-reported outcomes were evaluated at base-line, 12, 18 and 24 months after treatment start. Twenty six patients were analyzed through all study time-points. For quality of life (QoL) and symptom assessment all the patients filled out the SF-36 and Comprehensive Symptom Profile in Chronic Myeloid Leukemia Patients (CSP Leuk-CML), respectively. Overall and progression-free survival rates as well as cumulative probability of achieving a complete cytogenetic response (CCgR) were calculated using Kaplan-Meier methods. To compare frequencies of CCgR χ2 criterion was applied. Comparison of QoL and symptom scores was conducted using t-test. QoL scores were analyzed using t-test, adjusting for sociodemographic and disease status. At 24 months of dasatinib treatment 94% patients achieved or maintained complete hematologic response and 69% – CCgR. The twenty four-month progression free survival rate was 79% (95% CI; 63.3–88%), overall survival rate – 93% (95% CI; 84–97%). One patient was resistant to dasatinib after 16 months of treatment. During the second year of dasatinib therapy one сase of pleural effusion (grade 3) was registered (at 18 months of treatment); other severe adverse effects (grade 4) were as follows: one patient – neutropenia (at 18 months), one patient – arthralgia/myalgia (at 18 months), one patient – memory loss (at 24 months), one patient – headache and hyperglycemia at 18 months and palpitations, alopecia, hyperglycemia at 24 months of treatment. At 24 months of dasatinib treatment improvement of QoL as compared with base-line was registered: Integral QoL index was significantly higher than at base-line (p<0.02). At 24 months follow-up the proportion of patients with no QoL impairment was 56%; 18.7% patients exhibited severe/critical QoL impairment. It was shown that 56.4% patients with no/mild QoL impairment before dasatinib treatment (favorable group) achieved CCgR as compared with 28% patients with severe/critical QoL impairment (unfavorable group). Progression-free survival rate was 87% in the favorable group vs 60% in the unfavorable group. Cumulative probability of CCgR achievement was higher in the favorable group vs the unfavorable group – 75% vs 50% (log-rank test, p<0.05). Thus, long-term outcomes of second-line therapy in CML-CP patients in a “real world” setting confirm that dasatinib treatment is effective both in terms of clinical outcomes and patient-reported outcomes, as well as exhibits good tolerability. At 24 months of treatment definite QoL improvement was registered. Patients with high QoL before second-line treatment have had better treatment outcomes at long-term follow-up. Comprehensive evaluation of the outcomes of the second-line treatment of CML-CP at long-term follow-up allows to assess the benefits and risks of therapy both from physician’s and patient’s perspective. Disclosures Ionova: BMS: Research Funding. Nikitina:BMS: Research Funding. Fedorenko:BMS: Research Funding. Gritsenko:BMS: Research Funding. Ivanova:BMS: Research Funding. Kuchma:BMS: Research Funding. Shnaider:BMS: Research Funding. Sannikova:BMS: Research Funding. Usacheva:BMS: Research Funding. Kurbatova:BMS: Research Funding.

scholarly journals Clinical Characteristics and Long Term Outcomes of Warm Type Autoimmune Hemolytic Anemia

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 4874-4874
Author(s):  
Adisak Tantiworawit ◽  
Prot Eiamprapai ◽  
Sasinee Hantrakool ◽  
Chatree Chai-adisaksopha ◽  
Ekarat Rattarittamrong ◽  
...  
Keyword(s):  
Response Rate ◽  
Good Prognosis ◽  
Line Treatment ◽  
Second Line ◽  
Long Term Outcomes ◽  
Second Line Therapy ◽  
Common Cause ◽  
Line Therapy

Abstract Back ground Warm type autoimmune hemolytic anemia (AIHA) is the disease which antibody reacts with self-antigen on red blood cell. Due to the uncommon of this disease, there is a little data about long term outcomes and response to therapy especially second line treatment. Methods This is a retrospective single center study from 2002 to 2013. The diagnosis of AIHA was made by positive direct Coombs’ test with clinical hemolysis and confirmed by Hematologist. Clinical data and long term outcome were reviewed and analyzed. Results During that period, 101 patients were reviewed, 77% were female, median age was 43 (15-83) years. The median hemoglobin level at diagnosis was 5.4 (2-10) g/dl. Primary AIHA was found in 61%. The secondary causes were SLE (64%), solid malignancy (13%), lymphoma (10%), drug (8%) and infection (5%). The secondary cause from SLE was commonly found in female (96%) (P<0.001). There was the difference of age between secondary cause from SLE (<50 years) and malignancy (>50 years) (p=0.013). These results showed the interesting data that secondary cause of AIHA needed to be searching especially SLE in young female and secondary cancer in elderly patients. Not only cause could be identified but also the specific treatment needed to be given according to secondary cause. Interestingly, most patients (96%) were initially response to steroid which was not different between primary and secondary AIHA. Second line treatments were required in 33 patients (33%). The indications were steroid dependent (58%), relapse (30%) and others (12%). The second line treatments were including cyclophosphamide (52%), azathioprine (21%), cyclosporine (6%), splenectomy (6%), danazol (6%) and others (9%). The overall response rate for second line was 93%. SLE group received second line therapy more than non SLE group (p<0.001). In the light of data from this study showed that this disease had a good prognosis in both frontline steroid and second line treatment. Relapse was occurred in 50 patients (50%). Most relapse occurred > 3 years after diagnosis (58%) and more common in SLE group (p<0.001). These findings illustrated the importance nature of the disease that need long follow up due to high relapse rate around half of patients. At the median follow up 53 months, the overall survival (OS) and event free survival (relapse and death) were 84% and 48%, respectively. The independent factor for decreasing OS was age >50 years with HR 3.09 (95% CI 1.09-8.73, p=0.03) and malignancy with HR 4.06 (95% CI 1.18-13.97, p=0.03). The only significant factor for relapse is age >50 years with HR 2.08 (95% CI 1.21-3.57, p = 0.008). Twenty patients were death. The common cause of death was sepsis (30%) due to heavily immunosuppressive treatment. Conclusion AIHA has good prognosis and long term survival especially in young patient without secondary malignancy. The search for secondary cause especially malignancy is important. Most patients have responded initially to steroid and high response rate to second line therapy. The most common cause of death was sepsis which related to treatment side effect. Carefully adjust and rapid taper immunosuppressant is considerable to avoid serious complication. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.

Post-Operative Dysphagia in Anterior Cervical Discectomy and Fusion

2021 ◽  
pp. 000348942110155
Author(s):  
Leonard Haller ◽  
Khush Mehul Kharidia ◽  
Caitlin Bertelsen ◽  
Jeffrey Wang ◽  
Karla O’Dell
Keyword(s):  
Risk Factors ◽  
Medical Records ◽  
Assessment Tool ◽  
Demographic Data ◽  
Anterior Cervical Discectomy ◽  
Cervical Discectomy ◽  
Long Term Follow Up

Objective: We sought to identify risk factors associated with long-term dysphagia, characterize changes in dysphagia over time, and evaluate the incidence of otolaryngology referrals for patients with long-term dysphagia following anterior cervical discectomy with fusion (ACDF). Methods: About 56 patients who underwent ACDF between May 2017 to February 2019 were included in the study. All patients were assessed for dysphagia using the Eating Assessment Tool (EAT-10) survey preoperatively and late postoperatively (≥1 year). Additionally, 28 patients were assessed for dysphagia early postoperatively (2 weeks—3 months). Demographic data, medical comorbidities, intraoperative details, and post-operative otolaryngology referral rates were collected from electronic medical records. Results: Of the 56 patients enrolled, 21 patients (38%) had EAT-10 scores of 3 or more at long-term follow-up. None of the demographics, comorbidities, or surgical factors assessed were associated with long-term dysphagia. Patients who reported no long-term dysphagia had a mean EAT-10 score of 6.9 early postoperatively, while patients with long-term symptoms had a mean score of 18.1 ( P = .006). Of the 21 patients who reported persistent dysphagia symptoms, 3 (14%) received dysphagia testing or otolaryngology referrals post-operatively. Conclusion: Dysphagia is a notable side effect of ACDF surgery, but there are no significant demographics, comorbidities, or surgical risk factors that predict long-term dysphagia. Early postoperative characterization of dysphagia using the EAT-10 questionnaire can help predict long-term symptoms. There is inadequate screening and otolaryngology follow-up for patients with post-ACDF dysphagia.

Incidence and risk factors for trocar site hernia following laparoscopic cholecystectomy: A long-term follow-up study

Hernia ◽  
2012 ◽  
Vol 16 (4) ◽  
pp. 431-437 ◽  
Author(s):  
E. Erdas ◽  
C. Dazzi ◽  
F. Secchi ◽  
S. Aresu ◽  
A. Pitzalis ◽  
...  
Keyword(s):  
Risk Factors ◽  
Laparoscopic Cholecystectomy ◽  
Trocar Site ◽  
Follow Up Study ◽  
Trocar Site Hernia ◽  
Long Term Follow Up

scholarly journals Long-term follow-up results of medial opening wedge high tibia osteotomy with a pre-countered non-locking steel plate

2021 ◽  
Author(s):  
Simo S. A. Miettinen ◽  
Hannu J. A. Miettinen ◽  
Jussi Jalkanen ◽  
Antti Joukainen ◽  
Heikki Kröger
Keyword(s):  
Risk Factors ◽  
Adverse Events ◽  
Mechanical Axis ◽  
Steel Plate ◽  
Cox Regression ◽  
Opening Wedge ◽  
Cumulative Survival ◽  
Long Term Follow Up

Abstract Introduction This retrospective study investigated the long-term follow-up results of medial opening wedge high tibial osteotomy (MOWHTO) with a pre-countered non-locking steel plate implant (Puddu plate = PP) used for medial knee osteoarthrosis (OA) treatment. Materials and methods Consecutive 70 MOWHTOs (66 patients) were performed between 01.01.2004 and 31.12.2008 with the mean follow-up time of 11.4 (SD 4.5; range 1.2–16.1) years. The Kaplan–Meier survival analysis was used to evaluate the cumulative survival of the implant in terms of age (< 50 years old and ≥ 50 years old) and gender. Adverse events were studied and Cox regression analysis was used to evaluate risk factors [age, gender, body mass index (BMI), preoperative mechanical axis, severity of OA, use of bone grafting or substitution and undercorrection of mechanical axis from varus to valgus] for revisions. Results The estimates for the cumulative survival with no need for TKA after MOWHTO were 86% at 5 years, 67% at 10 years and 58% at 16.1 years (SE 0.6, CI 95% 11.1–13.5). A total of 33/70 (47%) adverse events occurred and 38/70 (54%) knees required some revision surgery during the follow-up. Cox regression did not show any statistically significant risk factors for revision. Conclusions The PP has feasible MOWHTO results with a cumulative survival of 67% at 10 years with no need for conversion to TKA. Many adverse events occurred and revision rate due to any reason was high. Age or gender did not have statistically significant differences in terms of survival.

Risk of hemorrhage from de novo cerebral aneurysms

2013 ◽  
Vol 118 (1) ◽  
pp. 58-62 ◽  
Author(s):  
William J. Kemp ◽  
Daniel H. Fulkerson ◽  
Troy D. Payner ◽  
Thomas J. Leipzig ◽  
Terry G. Horner ◽  
...  
Keyword(s):  
Risk Factors ◽  
De Novo ◽  
Patient Age ◽  
Patient Âgé ◽  
Long Term Follow Up ◽  
De Novo Aneurysm ◽  
The Mean ◽  
Risk Of Hemorrhage

Object A small percentage of patients will develop a completely new or de novo aneurysm after discovery of an initial aneurysm. The natural history of these lesions is unknown. The authors undertook this statistical evaluation a large cohort of patients with both ruptured and unruptured de novo aneurysms with the aim of analyzing risk factors for rupture and estimating a risk of subarachnoid hemorrhage (SAH). Methods A review of a prospectively maintained database of all aneurysm patients treated by the vascular neurosurgery service of Goodman Campbell Brain and Spine from 1976–2010 was performed. Of the 4718 patients, 611 (13%) had long-term follow-up imaging. The authors identified 27 patients (4.4%) with a total of 32 unruptured de novo aneurysms from routine surveillance imaging. They identified another 10 patients who presented with a new SAH from a de novo aneurysm after treatment of their original aneurysm. The total study group was thus 37 patients with a total of 42 de novo aneurysms. The authors then compared the 27 patients with incidentally discovered aneurysms with the 10 patients with SAH. A statistical analysis was performed, comparing the 2 groups with respect to patient and aneurysm characteristics and risk factors. Results Thirty-seven patients were identified as having true de novo aneurysms. This group had a female predominance and a high percentage of smokers. These 37 patients had a total of 42 de novo aneurysms. Ten of these 42 aneurysms hemorrhaged. De novo aneurysms in both the SAH and non-SAH group were anatomically small (< 10 mm). The estimated risk of hemorrhage over 5 years was 14.5%, higher than the expected SAH risk of small, unruptured aneurysms reported in the ISUIA (International Study of Unruptured Intracranial Aneurysms) trial. There was no statistically significant correlation between hemorrhage and any of the following risk factors: hypertension, diabetes, tobacco and alcohol use, polycystic kidney disease, or previous SAH. There was a statistically significant between-groups difference with respect to patient age, with the mean patient age being significantly older in the SAH aneurysm group than in the non-SAH group (p = 0.047). This is likely reflective of longer follow-up and discovery time, as the mean length of time between initial treatment and discovery of the de novo aneurysm was longer in the SAH group (p = 0.011). Conclusions While rare, de novo aneurysms may have a risk for SAH that is comparatively higher than the risk associated with similarly sized, small, initially discovered unruptured saccular aneurysms. The authors therefore recommend long-term follow-up for all patients with aneurysms, and they consider a more aggressive treatment strategy for de novo aneurysms than for incidentally discovered initial aneurysms.

Risk Factors For Reoperation After Lumbar Total Disc Replacement at Short-, Mid-, and Long-Term Follow-Up

2021 ◽  
Author(s):  
Dean C. Perfetti ◽  
Jesse M. Galina ◽  
Peter B. Derman ◽  
Richard D. Guyer ◽  
Donna D. Ohnmeiss ◽  
...  
Keyword(s):  
Risk Factors ◽  
Total Disc Replacement ◽  
Disc Replacement ◽  
Lumbar Total Disc Replacement ◽  
Long Term Follow Up

Management of Canine Y-T Humeral Fractures Using Titanium Polyaxial Locking Plates in 17 Dogs

2022 ◽  
Vol 58 (1) ◽  
pp. 7-16
Author(s):  
Claudio Motta ◽  
Philip Witte ◽  
Andrew Craig
Keyword(s):  
Functional Impairment ◽  
Complication Rates ◽  
Load Testing ◽  
Inclusion Criteria ◽  
Long Term Outcomes ◽  
Long Term Follow Up ◽  
Mild Impairment ◽  
Condylar Fractures

ABSTRACT The objective of this study was to document the short- and medium-to-long-term outcomes and complication rates of Y-T humeral condylar fractures fixed using titanium polyaxial locking plate (T-PLP). A retrospective review was performed of the medical records and radiographs of dogs with a Y-T humeral condylar fracture treated with T-PLP at a single veterinary referral center (2012–2018). Seventeen cases met the inclusion criteria. Medium- to long-term follow-up (.6 mo) information was derived using the Liverpool Osteoarthritis in Dogs (LOAD) questionnaire. Recorded complications were catastrophic (1/17) and minor (2/17). Gait at 10–12 wk following surgery was subjectively assessed as good or excellent for 13 cases. Radiographic bone union was achieved in 7/12 cases at 4–6 wk. LOAD scores obtained a mean of 15 mo (range 6–29 mo) following surgery and indicated no or mild impairment in 15/16 and moderate functional impairment in 1. The application of T-PLP for the treatment of Y-T humeral condylar fractures resulted in adequate stabilization allowing successful fracture healing and medium- to long-term outcomes comparable to previous reports. According to results of LOAD testing, the medium- to long-term follow-up suggests that clients were aware of mild to moderate functional impairment in all cases.

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