Aim. The percentage of adolescents and young adults with sarcoma enrolled in multicenter clinical trials is reportedly much lower than that of younger children. We intended to determine if this remained true despite the availability of a study open to patients up to the age of 40 years. Method. Review of interim recruitment and randomization rates in a large randomized multinational trial for resectable osteosarcoma, EURAMOS-1, jointly performed by COG, COSS, EOI, and SSG, within ECT-EUROCORES. Randomization scheduled after preoperative chemotherapy and definitive surgery of the primary tumour. Results. Between Apr-2005 and Jan-2010, 1,682 patients were recruited (870 COG, 390 COSS, 338 EOI, 85 SSG). To date, 979 have been randomized. When normalizing for population-based, age-dependent osteosarcoma incidence rates according to SEER data (Mirabello et al., Cancer 2009;115:1531–43) and arbitrarily defining observed/expected recruitment at age 10-14 years as 1, there was age-appropriate recruitment at age 5-9 (1.06 patients recruited per patient expected), but under recruiting for patients aged 15 and above, particularly above the age of 19 (15-19yr: 0.88, 20-24yr: 0.52; 25-29yr: 0.17, 30-34yr: 0.09, 35-39yr: 0.22 patients recruited per patient expected) (Fig. 1). If age groups 15yr and above had recruited with the same incidence-based ratio as younger ages, up to 592 additional patients might have been recruited, an increment of 35%. Uptake of randomization was similar across all age groups. Fig. 1: EURAMOS recruitment in comparison to epidemiological data (SEER). Recruitment ratio at age 10-14 arbitrarily defined as 1. Conclusion. Recruitment and randomization into large, multinational osteosarcoma trials might be increased by approximately one third if older adolescents and young adults were recruited at similar incidence-related rates as younger pediatric patients. Supported by the European Science Foundation (ESF), under the EUROCORES Program European Clinical
The primary objective of this study was to compare the postoperative infection rate between negative pressure wound therapy (NPWT) and conventional dressings for closed incisions following soft-tissue sarcoma (STS) surgery. Secondary objectives were to compare rates of adverse wound events and functional scores. In this prospective, single-centre, randomized controlled trial (RCT), patients were randomized to either NPWT or conventional sterile occlusive dressings. A total of 17 patients, with a mean age of 54 years (21 to 81), were successfully recruited and none were lost to follow-up. Wound reviews were undertaken to identify any surgical site infection (SSI) or adverse wound events within 30 days. The Toronto Extremity Salvage Score (TESS) and Musculoskeletal Tumor Society (MSTS) score were recorded as patient-reported outcome measures (PROMs).Aims
Methods
Aneurysmal bone cysts (ABCs) are locally aggressive lesions typically found in the long bones of children and adolescents. A variety of management strategies have been reported to be effective in the treatment of these lesions. The purpose of this review was to assess the effectiveness of current strategies for the management of primary ABCs of the long bones. A systematic review of the published literature was performed to identify all articles relating to the management of primary ABCs. Studies required a minimum 12-month follow-up and case series reporting on under ten participants were not included.Aims
Methods
Limb salvage in bone tumour patients replaces the bone with massive segmental prostheses where achieving bone integration at the shoulder of the implant through extracortical bone growth has been shown to prevent loosening. This study investigates the effect of multidrug chemotherapy on extracortical bone growth and early radiological signs of aseptic loosening in patients with massive distal femoral prostheses. A retrospective radiological analysis was performed on adult patients with distal femoral arthroplasties. In all, 16 patients were included in the chemotherapy group with 18 patients in the non-chemotherapy control group. Annual radiographs were analyzed for three years postoperatively. Dimensions of the bony pedicle, osseointegration of the hydroxyapatite (HA) collar surface, bone resorption at the implant shoulder, and radiolucent line (RLL) formation around the cemented component were analyzed.Aims
Methods
A single-centre prospective randomized trial was conducted to
investigate whether a less intensive follow-up protocol would not
be inferior to a conventional follow-up protocol, in terms of overall
survival, in patients who have undergone surgery for sarcoma of
the limb. Initial short-term results were published in 2014. The primary objective was to show non-inferiority of a chest
radiograph (CXR) group compared with a CT scan group, and of a less
frequent (six-monthly) group than a more frequent (three-monthly)
group, in two-by-two comparison. The primary outcome was overall
survival and the secondary outcome was a recurrence-free survival.
Five-year survival was compared between the CXR and CT scan groups
and between the three-monthly and six-monthly groups. Of 500 patients
who were enrolled, 476 were available for follow-up. Survival analyses
were performed on a per-protocol basis (n = 412).Aims
Patients and Methods
Clinical studies of patients with bone sarcomas have been challenged
by insufficient numbers at individual centres to draw valid conclusions.
Our objective was to assess the feasibility of conducting a definitive
multi-centre randomised controlled trial (RCT) to determine whether
a five-day regimen of post-operative antibiotics, in comparison
to a
24-hour regimen, decreases surgical site infections in patients
undergoing endoprosthetic reconstruction for lower extremity primary
bone tumours. We performed a pilot international multi-centre RCT. We used
central randomisation to conceal treatment allocation and sham antibiotics
to blind participants, surgeons, and data collectors. We determined
feasibility by measuring patient enrolment, completeness of follow-up,
and protocol deviations for the antibiotic regimens. Objective
Methods
Opinion remains divided as to whether the development
of pathological fracture affects the prognosis of patients with
an osteosarcoma of the extremities. We conducted a comprehensive systematic review and meta-analysis
of papers which reported the outcomes of osteosarcoma patients with
and without a pathological fracture. There were eight eligible papers
for final analysis which reported on 1713 patients, of whom 303
(17.7%) had a pathological fracture. The mean age for 1464 patients in
six studies was 23.2 years old (2 to 82). The mean follow-up for
1481 patients in seven studies was 90.1 months (6 to 240). The pooled estimates of local recurrence rates in osteosarcoma
patients with and without pathological fractures were 14.4% (8.7
to 20.0) The development of a pathological fracture is a negative prognostic
indicator in osteosarcoma and is associated with a reduced five-year
event-free survival and a possibly higher rate of local recurrence.
Our findings suggest that there is no absolute indication for amputation,
as similar rates of local recurrence can be achieved in patients
who are carefully selected for limb salvage. Cite this article: