A phase II trial of proton radiotherapy for medulloblastoma: Preliminary results.

2010 ◽  
Vol 28 (18_suppl) ◽  
pp. CRA9507-CRA9507 ◽  
Author(s):  
T. I. Yock ◽  
B. Y. Yeap ◽  
D. Ebb ◽  
S. M. MacDonald ◽  
M. B. Pulsifer ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Late Effects ◽  
Prospective Trial ◽  
Hormone Deficiency ◽  
Entire Group ◽  
Proton Radiotherapy ◽  
Early Results ◽  
Pediatric Medulloblastoma ◽  
Platinum Based Chemotherapy

CRA9507 Background: Pediatric medulloblastoma (MB) is commonly cured with surgery, chemotherapy and radiation. However, the late effects of radiotherapy can be disabling. Proton radiotherapy irradiates less normal tissue, which should result in fewer late side effects of treatment. The purpose of this study was to describe the clinical outcomes of proton radiotherapy. Methods: All patients had surgery of the primary tumor followed by proton radiotherapy with or without concurrent chemotherapy and adjuvant platinum based chemotherapy. CSI doses ranged from 18-36 GyE, median dose 23.4 GyE. The tumor bed or posterior fossa was brought to 54 GyE. Concurrent enrollment in COG or other protocols was allowed. All pathology and imaging was reviewed at MGH to confirm the diagnosis. Results: 60 patients with MB were prospectively enrolled from May 2003 to December 2009 and 59 were evaluable for this analysis. Median age 6.6 yrs, range 3.5 - 22 years; M/F ratio 1.3; standard risk (SR, 45) or high risk (HR, 14). The median follow-up is 16 months. Two-year overall survival (OS) and progression-free survival (PFS) for the entire group is 91% and 87%. Two-year OS for SR MB and HR MB is 92% and 87%. 54 pts have baseline (BL) neurocognitive testing and 19 pts (14 SR, 5 HR) have follow-up (FU) evaluations including FSIQ spanning at an average of 2 years. Mean FSIQ at BL and FU are 107 and 102 (paired t-test: 0.046). Endocrine late effects include 4 patients with growth hormone deficiency, 1 patient with central hypothyroidism and 2 other endocrinopathies. Audiology information will be presented. Conclusions: Early results of this prospective trial are promising for improving clinical outcomes in patients with medulloblastoma. [Table: see text]

Proton radiotherapy for rhabomyosarcoma: Preliminary results from a multicenter prospective study.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9585-9585
Author(s):  
Torunn I. Yock ◽  
Jackie Szymonifka ◽  
Alison M. Friedmann ◽  
Anita Mahajan ◽  
Beow Yong Yeap ◽  
...  
Keyword(s):  
Late Effects ◽  
Prospective Trial ◽  
Progression Free Survival ◽  
Stage I ◽  
Entire Group ◽  
Early Results ◽  
Group I ◽  
Oral Pain ◽  
Grade 3

9585 Background: Pediatric rhabdomyosarcoma (RMS) is commonly cured with chemotherapy and radiation. However, late effects of radiotherapy (RT) can be disabling. Proton RT irradiates less normal tissue, which should result in fewer late side effects of treatment. The purpose of this study was to describe the disease control and side effect profile of proton RT in RMS patients (pts). Methods: Eligible pts included those with localized disease and metastatic embryonal RMS if age 2-10. All pts were treated with VAC (vincristine, actinomycin, cyclophosphamide) based chemotherapy and proton RT, median dose 50.4 Gy (36-50.4 GyRBE). Concurrent enrollment in COG protocols was allowed. All pathology/imaging was reviewed at the treating institution. Results: 47 pts with RMS were prospectively enrolled from January 2005 to June 2011 and evaluable for analysis. Median age was 3.1 yrs, (range 0.6-15.6 years; M/F ratio 23:24). There were 1, 7, 37, and 2 Group I, II, III and IV and 14, 12, 19 and 2, Stage I-IV pts respectively, and 33 with embryonal 14 with alveolar/other. Most common sites included PM (48.9%), orbital (23.4%) bladder/prostate (6.4%), H&N non-PM (6.4%), extremities (4.3%), trunk/abdomen 2.1%), perineal/anal region (2.1%) and other (6.4%). Median follow-up is 15.2 months. One/two-year overall survival (OS) and progression-free survival (PFS) for the entire group is 94/81% (OS) and 79/73% (PFS). 2-year OS for stage I,II/III,IV pts is 91/66% (OS, p=0.114) and two-year PFS for these pts is 86/57%, respectively, (p=0.083. 16 (34%) had grade 3/4 acute toxicities attributable to the radiation during treatment, the most common of which was mucositis/oral pain (12.8%), anorexia (4.3%), and erythema (4.3%). Among the 24 pts analyzable for late toxicities with at least 2 yrs of follow up, there were no grade 3 or 4 late toxicities attributable to radiation. Conclusions: Early results of this prospective trial demonstrate comparable disease outcomes and thus far limited late effects in a young pediatric RMS population. However, additional follow up is needed to determine if protons truly reduce rates and severity of late effects compared with photon cohorts published in the literature.

scholarly journals Pedicle subtraction osteotomy: a comprehensive analysis in 104 patients. Does the cause of deformity influence the outcome?

2017 ◽  
Vol 27 (1) ◽  
pp. 56-62 ◽  
Author(s):  
Karin Eskilsson ◽  
Deep Sharma ◽  
Christer Johansson ◽  
Rune Hedlund
Keyword(s):  
Clinical Outcomes ◽  
Sagittal Plane ◽  
Lumbar Fusion ◽  
Adult Spinal Deformity ◽  
Surgical Site Infections ◽  
Pedicle Subtraction Osteotomy ◽  
Entire Group ◽  
Sagittal Vertical Axis ◽  
Suboptimal Outcome

OBJECTIVEThe clinical outcomes and complications of patients who underwent pedicle subtraction osteotomy (PSO) for various diagnoses were compared. More specifically, the purpose was to identify if outcomes differed between patients with flat-back syndrome after lumbar fusion (FBS-LF) versus patients who underwent surgery for adult spinal deformity (ASD).METHODSA retrospective analysis of 104 patients who underwent a PSO for sagittal plane imbalance was performed. There were 28 patients with FBS-LF and 76 patients with various forms of ASD. Outcome was measured using visual analog scale (VAS)-back, VAS-leg, Oswestry Disability Index (ODI) (range 0–100 for all scales), and EQ-5D scores (range 0–1). Patients also rated their global outcomes as much better, better, unchanged, or worse at follow-up. The minimum follow-up was 1 year (range 1–4 years). Clinical outcomes and complications were compared between the 2 groups of patients.RESULTSThe most common level of PSO was L-3 and L-2; 100 single and 4 double PSOs were performed. The average local correction by PSO itself was 27.2°. The sagittal vertical axis (SVA) improved from a mean preoperative value of 74 ± 23 mm to 49 ± 20 mm at the final follow-up. The VAS-back, ODI, and EQ-5D scores improved significantly for the entire group by 33, 16, and 0.31 points, respectively. In total, 57% of patients reported that they were “much better” or “better” than before surgery. Preoperatively, as well as postoperatively, the FBS-LF patients reported significantly worse VAS scores. According to VAS-back results, the ASD group improved by 34 points compared with 29 points in FBS-LF patients. ODI scores were similar between the 2 groups preoperatively but improved significantly more in the ASD group (18 points) compared with the FBS-LF group (13 points). The EQ-5D scores improved from 0.07 to 0.35 in FBS-LF patients, and from 0.21 to 0.56 on average in ASD patients. Similarly, a “much better” or “better” outcome compared with before surgery was reported by 72% of patients in the ASD group compared with 24% of patients in the FBS-LF group (p < 0.001). The overall reoperation rate was 31%: 46% of patients in the FBS-LF group compared with 25% of patients in the ASD group. There were 19 (18%) dural tears, 14 (13.5%) surgical site infections, 12 (11.5%) instances of pseudarthrosis, 15 (14%) proximal junctional failures, and 2 distal junctional failures. The 12 (11%) neurological complications were dominated by partial weakness of hip flexion and knee extension, and all but 2 of these were temporary.CONCLUSIONSPSO is a safe and effective method for correcting sagittal plane imbalance due to multiple etiologies. The authors found patient satisfaction to be high, and health-related quality of life was greatly improved by the procedure in patients with ASD. In contrast, in FBS-LF patients, a suboptimal outcome was observed and the cautious use of PSO seems warranted in this subset of patients.

Prevalence of childhood growth hormone deficiency in survivors of pediatric intracranial germ cell tumors.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e22526-e22526
Author(s):  
Diana Lone ◽  
Karim Thomas Sadak ◽  
Bradley S Miller ◽  
Michelle Roesler ◽  
Jenny N Poynter
Keyword(s):  
Growth Hormone ◽  
Germ Cell ◽  
Growth Hormone Deficiency ◽  
Late Effects ◽  
Germ Cell Tumors ◽  
Hormone Deficiency ◽  
Endocrine Disorders ◽  
Intracranial Germ Cell Tumors

e22526 Background: Survival rates for childhood cancer continue to rise, and there are now greater than 420,000 survivors in the United States. However, high cure rates come at the cost of short and long-term treatment-related toxicities. Endocrine disorders are among the most common late effects and are associated with poor health outcomes and lower quality of life. Survivors of pediatric intracranial germ cell tumors (iGCTs) are at high risk for endocrine disorders, particularly for growth hormone deficiency (GHD), due to their exposures to cranial radiation, chemotherapy, and brain surgery. To date, no long-term follow-up studies have explored the late effects experienced by survivors of iGCTs. Methods: Study participants were enrolled in the Germ Cell Tumor Epidemiology Study, which is a case-parent triad study conducted using the resources of the Children’s Oncology Group’s Childhood Cancer Research Network. Eligibility criteria included diagnosis with a germ cell tumor in any location at age 0-19 years in the years 2008-2015. The study population included 233 cases with a diagnosis of iGCT. We are currently following the cohort to evaluate outcomes and late effects of treatment, including medical record review to extract data on treatment characteristics and hormone deficiencies. This interim analysis includes chart review for 57 iGCT cases. Results: Of the 57 cases reviewed, there was a male predominance (73.7%) with the highest prevalence in non-Hispanic whites (80.4%). Cases of iGCTs can be subdivided into two main histologic subtypes, germinomas (36 cases) and non-germinomatous GCTs (NGGCT, 21 cases). The median age at diagnosis was 14.6 years for the germinomas and 10.5 years for NGGCTs. Data on growth hormone deficiency (GHD) was available for 42 of the 57 cases with a median follow-up of 7.4 years. Twenty-eight of the 42 cases (66.7%) had GHD; 19 in the germinoma group and 9 in the NGGCT group (p = 0.47). 17 of those with GHD were males (p = 0.10). There was no significant difference in prevalence of GHD by age of tumor diagnosis (p = 0.20). Conclusions: Survivors of iGCTs are at high risk for growth hormone deficiency. Identifying specific risk factors for developing GHD amongst these survivors can enhance the current guidelines for screening and management.

Mantle irradiation alone for selected patients with laparotomy-staged IA to IIA Hodgkin's disease: preliminary results of a prospective trial.

1995 ◽  
Vol 13 (4) ◽  
pp. 947-952 ◽  
Author(s):  
P M Mauch ◽  
G P Canellos ◽  
L N Shulman ◽  
B Silver ◽  
N J Tarbell ◽  
...  
Keyword(s):  
Overall Survival ◽  
Hodgkin's Disease ◽  
Hodgkin’S Disease ◽  
Prospective Trial ◽  
Results Of Treatment ◽  
Early Results ◽  
Negative Laparotomy

PURPOSE To determine the feasibility of omitting prophylactic paraaortic irradiation in selected patients with laparotomy-staged (pathologically staged [PS]) IA to IIA Hodgkin's disease. PATIENTS AND METHODS We initiated a prospective single-arm trial in October 1988 to study the role of mantle irradiation alone in selected PS IA to IIA patients with Hodgkin's disease. A total of 37 patients have been entered onto this trial. Entrance criteria included nodular sclerosis (NS) or lymphocyte predominance (LP) histology, absence of B symptoms, disease limited above the carina, and a negative laparotomy. Results of treatment of 23 patients in the prospective trial, monitored off treatment for > or = 1 year, are presented. Twenty-three additional PS IA to IIA patients, treated with mantle irradiation alone from 1970 to 1987, were analyzed as a comparison group. The median follow-up durations were 32 and 113 months, respectively, for the two groups. RESULTS The 4-year actuarial rates of freedom from relapse and overall survival are 83% and 100%, respectively, for the prospective trial. The 10-year actuarial rates of freedom from relapse and overall survival are 83% and 89%, respectively, for retrospectively studied patients. There have been five recurrences among 46 patients who received mantle irradiation alone, all with a component of relapse below the diaphragm. CONCLUSION These early results support the use of mantle irradiation alone in selected PS IA to IIA patients with NS or LP histology. Relapses, although rare, have occurred predominantly below the diaphragm. This suggests the need for continued long-term surveillance of abdominal and pelvic nodes in this group of treated patients.

scholarly journals Proton Radiotherapy for Parameningeal Rhabdomyosarcoma: Clinical Outcomes and Late Effects

2012 ◽  
Vol 82 (2) ◽  
pp. 635-642 ◽  
Author(s):  
Stephanie K. Childs ◽  
Kevin R. Kozak ◽  
Alison M. Friedmann ◽  
Beow Y. Yeap ◽  
Judith Adams ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Late Effects ◽  
Proton Radiotherapy

scholarly journals Long Term Clinical Outcomes of Proton Radiotherapy for Pediatric Medulloblastoma

2020 ◽  
Vol 108 (3) ◽  
pp. S126-S127
Author(s):  
S. Baliga ◽  
B. Bajaj ◽  
S. Gallotto ◽  
J. Lewy ◽  
E.A. Weyman ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Proton Radiotherapy ◽  
Pediatric Medulloblastoma

scholarly journals New Cementless Total Hip Arthroplasty. A Multicentre Prospective Minimum 2 Year Follow-up Clinical Outcomes Study.

2021 ◽  
Vol 11 ◽  
Author(s):  
Rohit Pandey ◽  
Simon Coffey ◽  
Rami Sorial
Keyword(s):  
Clinical Outcomes ◽  
Primary Objective ◽  
Posterolateral Approach ◽  
Consecutive Series ◽  
X Rays ◽  
Early Results ◽  
Duration Of Surgery ◽  
Oxford Hip Score ◽  
Outcomes Study

Background: Cementless implants were introduced approximately three decades ago in order to address aseptic loosening of cemented hip prostheses with the aim of early mobilisation, better functional result and bone stock preservation. The primary objective of this study is to introduce a new cementless HA coated implant and report its minimum 2 year follow up results. Material & method: This is a prospective, multi-centre, consecutive series, clinical outcomes study with 75 patients. Inclusion criteria for the study were age 21- 85 years, BMI <40, osteoarthritis of the hip. Patients were operated using a standard posterolateral approach. The Paragon stem and the Global cup were implanted in a cementless method. Patients were reviewed at 6 weeks, 6 months and two years postoperative. At each visit AQoL 6D, VAS Pain, Oxford Hip Score were recorded. Post-operative X-Rays were reviewed at immediate post-operative, 6 months and two years. Results: Mean duration of surgery was 63.1 min with range of 40-120 min. AQoL over time changed from pre-op mean 50.51, at 6 weeks and at 2 years mean 35.06. Oxford hip score had upward trend from pre-op to post-op 6wks assessments and a plateau in following assessments. VAS pain trajectories, showing a clear downward trend from pre-op to post-op 6wks and a plateau in the following postoperative assessments. Discussion & conclusion: The combination of Paragon stem and Global cup incorporates proven features of successful implants. The unique feature of lateral tension grooves and progressive neck dimension with dual offset options. This combination has shown promising early results with early follow up of a minimum of 2 years, with a 100% survivorship of the stem and 98.7% survivorship overall for any reason and is a good cementless option in THA.

Nivolumab (nivo) ± ipilimumab (ipi) in advanced small-cell lung cancer (SCLC): First report of a randomized expansion cohort from CheckMate 032.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 8503-8503 ◽  
Author(s):  
Matthew David Hellmann ◽  
Patrick Alexander Ott ◽  
Jon Zugazagoitia ◽  
Neal E. Ready ◽  
Christine L. Hann ◽  
...  
Keyword(s):  
Initial Treatment ◽  
Treatment Options ◽  
Objective Response ◽  
Immune Checkpoint Blockade ◽  
First Report ◽  
Randomized Evaluation ◽  
Early Results ◽  
Platinum Based Chemotherapy ◽  
Expansion Cohort

8503 Background: Patients (pts) with advanced SCLC after first-line platinum-based chemotherapy (PLT-CT) have a poor prognosis and limited treatment options. CheckMate 032 is a phase I/II trial evaluating multiple regimens of nivo ± ipi in solid tumors, including advanced SCLC. Tolerability and efficacy of nivo ± ipi were demonstrated in early results from the initial treatment arms (Antonia, Lancet Oncol 2016), prompting long-term follow-up and the addition of a randomized expansion cohort to further evaluate nivo ± ipi in advanced SCLC. Methods: In the initial treatment arms, pts with advanced SCLC and disease progression after prior PLT-CT were assigned to nivo (3 mg/kg Q2W; n = 98) or nivo 1 + ipi 3 (1 mg/kg and 3 mg/kg Q3W x 4, then nivo 3 Q2W; n = 61); safety/efficacy was assessed with a follow-up of ~18 mo. In the subsequent SCLC expansion cohort, pts were randomized 3:2 to nivo vs nivo 1 + ipi 3 and stratified by number of prior therapies. The primary endpoint was objective response rate (ORR). Results: Updated efficacy/safety results from the initial (non-randomized) nivo and nivo 1 + ipi 3 arms are summarized in the table. Responses were durable and occurred regardless of PD-L1 expression or PLT-sensitivity; safety was consistent with prior nivo ± ipi studies. In the expansion cohort, 247 pts were randomized to nivo or nivo 1 + ipi 3. The presentation will contain the first report of efficacy/safety results and subgroup analyses from this randomized expansion cohort. Conclusions: Durable responses are observed with nivo and nivo + ipi in pts with previously treated SCLC. The expansion cohort represents the first randomized evaluation of combined immune checkpoint blockade in SCLC. Clinical trial information: NCT01928394. [Table: see text]

Transarterial embolization of peripheral arteriovenous malformations with ethylenevinyl alcohol copolymer - feasibility, technical outcomes, and clinical outcomes

VASA ◽  
2016 ◽  
Vol 45 (6) ◽  
pp. 497-504 ◽  
Author(s):  
Tom De Beule ◽  
Jan Vranckx ◽  
Peter Verhamme ◽  
Veerle Labarque ◽  
Marie-Anne Morren ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Clinical Improvement ◽  
Arteriovenous Malformations ◽  
Clinical Success ◽  
Transarterial Embolization ◽  
Recurrent Bleeding ◽  
Complete Disappearance ◽  
Ethylene Vinyl Alcohol ◽  
Initial Symptoms

Abstract. Background: The technical and clinical outcomes of catheter-directed embolization for peripheral arteriovenous malformations (AVM) using Onyx® (ethylene-vinyl alcohol copolymer) are not well documented. The purpose of this study was to retrospectively assess the safety, technical outcomes and clinical outcomes of catheter-directed Onyx® embolisation for the treatment of symptomatic peripheral AVMs. Patients and methods: Demographics, (pre-)interventional clinical and radiological data were assessed. Follow-up was based on hospital medical records and telephone calls to the patients’ general practitioners. Radiological success was defined as complete angiographic eradication of the peripheral AVM nidus. Clinical success was defined as major clinical improvement or complete disappearance of the initial symptoms. Results: 25 procedures were performed in 22 patients. The principal indications for treatment were pain (n = 10), limb swelling (n = 6), recurrent bleeding (n = 2), tinnitus (n = 3), and exertional dyspnoea (n = 1). Complete radiological success was obtained in eight patients (36 %); near-complete eradication of the nidus was achieved in the remaining 14 patients. Adjunctive embolic agents were used in nine patients (41 %). Clinical success was observed in 18 patients (82%). Major complications were reported in two patients (9 %). During follow-up, seven patients (32 %) presented with symptom recurrence, which required additional therapy in three patients. Conclusions: Catheter-directed embolisation of peripheral AVMs with Onyx® resulted in major clinical improvement or complete disappearance of symptoms in the vast majority of patients, although complete angiographic exclusion of the AVMs occurred in only a minority of patients.

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