The cancer-related 5-year survival was 80% in 79 patients with penile cancer treated at the Norwegian Radium Hospital from 1974 to 1985 (N0 = 61, N1-2 = 12, N3 = 6). Sentinel node biopsy (SLN) of the inguinal lymph nodes medial to the... more
The cancer-related 5-year survival was 80% in 79 patients with penile cancer treated at the Norwegian Radium Hospital from 1974 to 1985 (N0 = 61, N1-2 = 12, N3 = 6). Sentinel node biopsy (SLN) of the inguinal lymph nodes medial to the saphenous vein helps to identify patients with early regional spread. The survival for these N+ patients is favourable if radical lymph node dissection is performed immediately. A tumour-negative SLN biopsy does, however, not exclude the subsequent development of inguinal lymph node metastases. These were found equally often during follow-up in patients with or without primary performance of SLN biopsy. Five of 6 patients, relapsing with groin metastases, were cured by secondary lymph node dissection. Most of the small primary tumours (T1/T2) can be treated radically by primary radiotherapy, but frequent follow-up is necessary to detect surgically curable penile recurrences (3 of 11 patients). Combination treatment of chemotherapy, radiotherapy and surgery represents a good palliation treatment in advanced cases.
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Kaplan-Meier estimates of recurrence-free survival of patients with KIT exon 11 substitution mutation (A) and patients with KIT exon 9 mutation (B). The 5-year and 10-year survival rates are shown. Censored patients are indicated with a bar
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Aim To evaluate the activity and safety of the PD-1 antibody pembrolizumab in adult patients with advanced osteosarcoma. Material and methods The study was a single-arm, open-label, phase 2 trial in patients with unresectable, relapsed... more
Aim To evaluate the activity and safety of the PD-1 antibody pembrolizumab in adult patients with advanced osteosarcoma. Material and methods The study was a single-arm, open-label, phase 2 trial in patients with unresectable, relapsed osteosarcoma. The primary endpoint was clinical benefit rate (CBR) at 18 weeks of treatment, defined as complete response, partial response, or stable disease using RECIST v1.1. The trial had a Simon´s two-stage design, and ≥ 3 of 12 patients with clinical benefit in stage 1 were required to proceed to stage 2. The trial is registered with ClinicalTrials.gov, number NCT03013127. NanoString analysis was performed to explore tumor gene expression signatures and pathways. Results Twelve patients were enrolled and received study treatment. No patients had clinical benefit at 18 weeks of treatment, and patient enrollment was stopped after completion of stage 1. Estimated median progression-free survival was 1.7 months (95% CI 1.2–2.2). At time of data cut-...
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Research Interests: Surgery, Medicine, Clinical Practice, Mutations, GIST, and 4 moreRandomized Trial, Kit, Iv, and Phase II Trial
Epithelioid sarcoma (ES) is an exceedingly rare malignant neoplasm with distinctive pathologic, molecular, and clinical features as well as the potential to respond to new targeted drugs. Little is known on the activity of... more
Epithelioid sarcoma (ES) is an exceedingly rare malignant neoplasm with distinctive pathologic, molecular, and clinical features as well as the potential to respond to new targeted drugs. Little is known on the activity of anthracycline-based regimens, gemcitabine-based regimens, and pazopanib in this disease. To report on the activity of anthracycline-based regimens, gemcitabine-based regimens, and pazopanib in patients with advanced ES. Seventeen sarcoma reference centers in Europe, the United States, and Japan contributed data to this retrospective analysis of patients with locally advanced/metastatic ES diagnosed between 1990 and 2016. Local pathological review was performed in all cases to confirm diagnosis according to most recent criteria. All patients included in the study received anthracycline-based regimens, gemcitabine-based regimens, or pazopanib. Response was assessed by RECIST. Progression-free survival (PFS) and overall survival (OS) were computed by Kaplan-Meier met...
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Despite of multitude investigations no reliable prognostic immunohistochemical biomarkers in GIST have been established so far with added value to predict the recurrence risk of high risk GIST besides mitotic count, primary location and... more
Despite of multitude investigations no reliable prognostic immunohistochemical biomarkers in GIST have been established so far with added value to predict the recurrence risk of high risk GIST besides mitotic count, primary location and size. In this study, we analyzed the prognostic relevance of eight cell cycle and apoptosis modulators and of TP53 mutations for prognosis in GIST with high risk of recurrence prior to adjuvant treatment with imatinib. In total, 400 patients with high risk for GIST recurrence were randomly assigned for adjuvant imatinib either for one or for three years following laparotomy. 320 primary tumor samples with available tumor tissue were immunohistochemically analyzed prior to treatment for the expression of cell cycle regulators and apoptosis modulators cyclin D1, p21, p16, CDK4, E2F1, MDM2, p53 and p-RB1. TP53 mutational analysis was possible in 245 cases. A high expression of CDK4 was observed in 32.8% of all cases and was associated with a favorable r...
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LBA1 Background: Adjuvant IM administered for 12 months (mos) after surgery improves recurrence-free survival (RFS) of patients (pts) diagnosed with operable GIST. We compared 12 vs 36 mos of adjuvant IM as treatment of pts with a high... more
LBA1 Background: Adjuvant IM administered for 12 months (mos) after surgery improves recurrence-free survival (RFS) of patients (pts) diagnosed with operable GIST. We compared 12 vs 36 mos of adjuvant IM as treatment of pts with a high risk for GIST recurrence after surgery. Methods: Pts with histologically diagnosed KIT-positive GIST were entered to this prospective, open-label, multicenter, randomized Phase III study (identifier NCT00116935 ). The risk of recurrence was estimated according to the modified Consensus Criteria. The primary objective was RFS. The secondary objectives included survival (OS) and treatment safety. The key exclusion criteria were ECOG PS >2, metastatic or inoperable GIST, and >12 wks from surgery to the study entry. IM was administered orally 400 mg/d. The sample size (n =200 in each group to obtain ≥110 events) was estimated by simulating log-rank tests assuming an overall hazard ratio (HR) of 0.44, a 20% drop-out rate, 2-sided type-I error rate of .05 and power 0.80. Analysis was based on the intention-to-treat population (ITT). Tumor histology was centrally reviewed. Results: 400 pts were entered to the study from Feb 2004 to Sep 2008. Three pts were excluded due to lack of consent from the ITT, which includes 15 pts who did not have GIST at a central review. The median FU time was 54 mos. RFS was longer in the 36-mo group compared to the 12-mo group (HR 0.46, 95% CI 0.32-0.65; p <.0001; 5-y RFS 65.6% vs 47.9%, respectively). Pts assigned to 36-mo of IM had longer OS (HR 0.45, 0.22-0.89; p =.019; 5-y OS 92.0% vs 81.7%). IM was generally well tolerated. The proportion of pts who discontinued IM during the assigned treatment period for reasons other than GIST recurrence was 25.8% in the 36-mo group and 12.6% in the 12-mo group. Exploratory efficacy subgroup analyses including KIT and PDGFRA mutation analysis data from 366 tumors will be presented. Conclusions: IM administered for 36 mos improves RFS and OS compared to 12 mos of administration as adjuvant treatment of GIST pts who have a high estimated risk of recurrence after surgery.
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Denosumab is a relatively new treatment option for patients with giant-cell tumor of bone (GCTB). The purpose of this study was to report the results for patients treated in Norway. Patients treated with denosumab for GCTB were identified... more
Denosumab is a relatively new treatment option for patients with giant-cell tumor of bone (GCTB). The purpose of this study was to report the results for patients treated in Norway. Patients treated with denosumab for GCTB were identified from the clinical databases at the Norwegian sarcoma reference centers. Data were retrieved from the clinical databases and supplemented by retrospective review of patient records. Denosumab was given as a subcutaneous injection every 4 weeks with loading doses on day 8 and 15 in cycle 1. Eighteen patients treated with denosumab for GCTB were identified. Denosumab was given for recurrent disease in seven cases and as first-line treatment in 11 patients, of which 6 received therapy as part of a neoadjuvant/adjuvant strategy and 5 for surgically unsalvageable primary tumor. Ten of 12 patients with unresectable disease are still on denosumab without progression with median treatment duration of 41 months (range 18-60). Two patients discontinued treatm...
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The SLUG transcription factor has been linked with the KIT signalling pathway that is important for gastrointestinal stromal tumour (GIST) tumourigenesis. Its clinical significance in GIST is unknown. Influence of SLUG expression on cell... more
The SLUG transcription factor has been linked with the KIT signalling pathway that is important for gastrointestinal stromal tumour (GIST) tumourigenesis. Its clinical significance in GIST is unknown. Influence of SLUG expression on cell proliferation and viability were investigated in GIST48 and GIST882 cell lines. The association between tumour SLUG expression in immunohistochemistry and recurrence-free survival (RFS) was studied in two clinical GIST series, one with 187 patients treated with surgery alone, and another one with 313 patients treated with surgery and adjuvant imatinib. SLUG downregulation inhibited cell proliferation, induced cell death in both cell lines, and sensitised GIST882 cells to lower imatinib concentrations. SLUG was expressed in 125 (25.0%) of the 500 clinical GISTs evaluated, and expression was associated with several factors linked with unfavourable prognosis. SLUG expression was associated with unfavourable RFS both when patients were treated with surg...
Research Interests: Biology, Immunohistochemistry, Apoptosis, Medicine, Humans, and 15 moreFemale, Male, GIST, Imatinib, Aged, Carcinogenesis, Adult, Cisplatin Resistance, Cell Proliferation, Cancers, Mesylate, Gastrointestinal stromal tumour, Imatinib Mesylate, Gastrointestinal Stromal Tumors, and Disease Free Survival
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Osteosarcoma patients are commonly treated with high doses of methotrexate (MTX). MTX is an analog of folate, which is essential for DNA synthesis. Genetic polymorphism at single nucleotide can be indicative to the prognostic outcome in... more
Osteosarcoma patients are commonly treated with high doses of methotrexate (MTX). MTX is an analog of folate, which is essential for DNA synthesis. Genetic polymorphism at single nucleotide can be indicative to the prognostic outcome in patients. Germ-line variants in candidate genes, coding for enzymes active in the metabolism of MTX, were studied in 62 osteosarcoma patients. Patients harboring the GG genotype in reduced folate carrier 1 (RFC1) rs1051266 had significantly better survival in comparison with patients having the AA genotype (P=0.046). These patients also had a lower frequency of metastasis (15%, P=0.029). Also patients homozygous for the G allele of rs1053129 in the dihydrofolate reductase (DHFR) gene were more likely to have a metastasis (45%, P= 0.005), and the methylenetetetrahydrofolate reductase (MTHFR) 677C allele was associated with higher degree of liver toxicity (88%, P=0.007). The study suggests that germ-line variants in the MTX metabolic pathway are associ...
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BackgroundPost‐relapse survival (PRS) was evaluated in patients with Ewing sarcoma (EWS) enrolled in chemotherapy protocols based on the use of high‐dose chemotherapy with busulfan and melfalan (HDT) as a first‐line consolidation... more
BackgroundPost‐relapse survival (PRS) was evaluated in patients with Ewing sarcoma (EWS) enrolled in chemotherapy protocols based on the use of high‐dose chemotherapy with busulfan and melfalan (HDT) as a first‐line consolidation treatment in high‐risk patients.ProcedureEWS patients enrolled in ISG/SSG III and IV trials who relapsed after complete remission were included in the analysis. At recurrence, chemotherapy based on high‐dose ifosfamide was foreseen, and patients who responded but had not received HDT underwent consolidation therapy with HDT.ResultsData from 107 EWS patients were included in the analysis. Median time to recurrence (RFI) was 18 months, and 45 (42%) patients had multiple sites of recurrence. Patients who had previously been treated with HDT had a significantly (P = 0.02) shorter RFI and were less likely to achieve a second complete remission (CR2). CR2 status was achieved by 42 (39%) patients. Fifty patients received high‐dose IFO (20 went to consolidation HDT...
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Abdominal leiomyosarcoma arising from the mesentery is a rare malignancy. It is an aggressive entity with an overall 5 year survival rate between 20 and 30 %. Surgical resection is the cornerstone of primary treatment and may be curative... more
Abdominal leiomyosarcoma arising from the mesentery is a rare malignancy. It is an aggressive entity with an overall 5 year survival rate between 20 and 30 %. Surgical resection is the cornerstone of primary treatment and may be curative for localized disease. However, patients often develop intra-abdominal relapse and/or metastatic disease. If surgical resection is not feasible, palliative chemotherapy is the treatment of choice. However, there are no clear guidelines regarding chemotherapy; neither in the adjuvant nor advanced setting. We present a 40 year-old woman, with a mesenteric leiomyosarcoma, who underwent radical tumor resection and did not receive adjuvant oncological therapy. Three months postoperatively, she developed metastatic disease to the lungs and liver. After multidisciplinary assessment she received an unconventional histological-subtype-tailored chemotherapy comprising 3-4 regimens. Initially, there was a decrease both in number and size of metastases. Ultimat...
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10014 Background: Poor response to induction chemotherapy negatively affects prognosis for Ewing's sarcoma (ES) patients. To improve outcome, high-dose chemotherapy (HDCT) with stem cell rescue was added to conventional chemotherapy... more
10014 Background: Poor response to induction chemotherapy negatively affects prognosis for Ewing's sarcoma (ES) patients. To improve outcome, high-dose chemotherapy (HDCT) with stem cell rescue was added to conventional chemotherapy in patients poor responders after induction treatment. Methods: Non-metastatic ES patients aged <= 40 years were eligible. All patients received VAC (vincristin 2 mg-doxorubicin 80 mg/m2-cyclofosfamide 1,200 mg/m2) weeks 0 and 6, IVAc (ifosfamide 9g/m2-vincristin 2 mg-actinomycin 2 mg) week 3 and IE (ifosfamide 9g/m2-etoposide 450 mg/m2) week 9 as induction therapy. Poor response was histologically defined as persistence of microfoci of viable tumor cells and radiologically as persistence of soft tissue mass. As maintenance treatment good responders (GR) received three cycles of VAC-IVAc-IE. Poor responders (PR) received VAC (weeks 13,19), IE (week 22), CE (mobilizing cycle, cyclophoshamide 4g/m2, etoposide 600 mg/m2, week 16) and HDCT with BuMel (busulfan 4 mg/kg × 4 days orally and melphalan 140 mg/m2 with stem cell support week 25). Results: Starting from 1999, 296 patients were enrolled with a median age of 15 years (3–40). 54 % of the tumors were located to the extremities and 46% in the axial skeleton. 274 patients underwent local treatment: surgery in 222 (81%) patients (with post operative Rxt in 70), RxT alone in 52 (19%). 10 patients progressed during treatment. No toxic deaths were recorded. Response evalutation was available for 262 patients: 135 (52%) were PR. 116 of them completed protocol treatment and 19 did not receive HDCT (5 poor harvest, 5 medical contraindication, 9 refusal).With a median follow-up of 37 months (1–89) 5-year overall and event-free survival were 74 % and 65.5% respectively. 5-year event-free survival was 71% (95% CI 62–81%) for GR, 68% (95% CI 58–78%) for PR treated with HDCT and 35% (95% CI 10–60%) for PR who did not receive HDCT. Conclusions: The preliminary survival data show for PR similar outcome as for GR. The treatment including HDCT is feasible with no toxic death recorded. Longer follow-up will confirm its efficacy. No significant financial relationships to disclose.
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Contains fulltext : 139108.pdf (publisher's version ) (Closed access
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Biological, physical and clinical aspects of cancer treatment with ionising radiatio
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10516 Background: EUROpean Bone Over 40 Sarcoma Study (EURO-B.O.S.S.) is the first prospective multicenter international study for patients 41 - 65 years old with high-grade bone sarcoma. Methods: Patients with HG Osteosarcoma (OS), HG... more
10516 Background: EUROpean Bone Over 40 Sarcoma Study (EURO-B.O.S.S.) is the first prospective multicenter international study for patients 41 - 65 years old with high-grade bone sarcoma. Methods: Patients with HG Osteosarcoma (OS), HG sarcoma NOS (S), Fibrosarcoma, MFH, Leiomyosarcoma, Dedifferentiated Chondrosarcoma (DCh) were included. Chemotherapy: Combinations of cisplatin/doxorubicin (CDP 100mg/m2/ADM 60mg/m2), ifosfamide/CDP(IFO 6g/m2/CDP 100mg/m2) and IFO/ADM (IFO 6g/m2/ADM 60mg/m2) were repeated three times (9 cycles). Surgery was planned after 3 cycles. Methotrexate (8g/m2) was postoperatively added in poor responders. Immediate surgery was allowed and 9 cycles with CDP, ADM, IFO were postoperatively given. Results: In December 2007, 140 patients were registered (median age 51 years). OS (51%), S (16%), and DCh (11%) were the more frequent histotypes. Synchronous metastases in 30 (21%) patients, central location of tumor in 45 (32%). Surgical complete remission (SCR) was a...
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The CircSarc study aims to provide new insights into the clinical utility of liquid biopsies in sarcomas. Today, mutational profiles of solid tumors are obtained from tissue biopsies or surgical specimens. Recent advances in technology... more
The CircSarc study aims to provide new insights into the clinical utility of liquid biopsies in sarcomas. Today, mutational profiles of solid tumors are obtained from tissue biopsies or surgical specimens. Recent advances in technology now allows to use blood plasma as a “liquid biopsy,” examining circulating tumor DNA (ctDNA) shed by the tumor cells into peripheral blood. ctDNA in plasma carries tumor-specific alterations that can be used to monitor minimal residual disease, response to therapy, tumor burden and evolution throughout the course of the disease. In CircSarc, we have enrolled 30 high-grade soft-tissue sarcoma patients, with localized disease, who are being followed throughout the course of their disease. Plasma from each patient is collected longitudinally: before and after surgery, at each routine control, and before and after each treatment cycle. Patients' tumor and germline DNA were exome sequenced to identify tumor-specific mutations, and ctDNA is being sequen...
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10081 Background: EURAMOS is a transAtlantic collaboration formed to improve survival in osteosarcoma by conducting RCTs in a clinically relevant timeframe. EURAMOS-1, the largest study conducted in this rare cancer, has completed... more
10081 Background: EURAMOS is a transAtlantic collaboration formed to improve survival in osteosarcoma by conducting RCTs in a clinically relevant timeframe. EURAMOS-1, the largest study conducted in this rare cancer, has completed accrual. It includes two randomized comparisons investigating treatment optimization on the basis of histological response to neoadjuvant chemotherapy. Methods: Pts ≤40yrs with resectable, high grade extremity or axial osteosarcoma were eligible for registration. All were planned for 2 cycles of neoadjuvant methotrexate, doxorubicin, cisplatin (MAP) then surgical resection of the primary tumour. Pts with complete macroscopic resection and no disease progression were eligible for randomization: [i] “good responders”, <10% viable tumor, MAP +/- 18m maintenance pegylated interferon; [ii] “poor responders”, ≥10% viable tumor, MAP vs MAPIE (MAP + ifosfamide, etoposide). Target sample size was ~1,260 pts randomized requiring ~2000 pts registered estimating a ...
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Background The EUROpean Bone over 40 Sarcoma Study included patients with 41 to 65 years of age with primary malignant bone sarcoma treated with intensive multiagent chemotherapy. Outcome in the subgroup of high-grade osteosarcoma has... more
Background The EUROpean Bone over 40 Sarcoma Study included patients with 41 to 65 years of age with primary malignant bone sarcoma treated with intensive multiagent chemotherapy. Outcome in the subgroup of high-grade osteosarcoma has been published (Ferrari et al. 2017). This report focuses on other bone sarcomas representing the largest prospectively collected dataset based on an international consortium. Methods Chemotherapy was based on doxorubicin, cisplatin, ifosfamide, and methotrexate. Tumors registered as MFH, sarcoma NOS, spindle cell sarcoma or undifferentiated sarcoma were grouped as „undifferentiated pleomorphic sarcoma“. Further histologies included leiomyosarcoma, fibrosarcoma and angiosarcoma. Results 122 patients with other bone sarcoma were registered into EURO-B.O.S.S. and 113 considered evaluable for analysis. Their median age was 52 years (range: 40-66). Eighty-eight bone sarcomas were grouped as UPS, 20 were leiomyosarcomas, and 5 had other histologies (3 fibro...
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10512 Background: EURAMOS-1 (NCT00134030) is an international study in osteosarcoma including two Phase III randomized controlled trials that investigated postoperative treatment optimization on the basis of histological response to... more
10512 Background: EURAMOS-1 (NCT00134030) is an international study in osteosarcoma including two Phase III randomized controlled trials that investigated postoperative treatment optimization on the basis of histological response to preoperative chemotherapy (CT). One study aim was to report outcomes from diagnosis for all registered patients in this large, intergroup study. Methods: Patients (pts) were eligible for registration if: < 30 days from diagnostic biopsy; age ≤ 40yrs; with localized or primary metastatic, high-grade extremity or axial osteosarcoma; resectable disease; fit for treatment and follow-up. Treatment was preop CT with methotrexate, doxorubicin, cisplatin (MAP), surgery and then post-op MAP-based CT according to response and optional randomization. The primary outcome measure was event-free survival (EFS), defined as time from diagnostic biopsy until the earliest of: death, local recurrence, new metastatic disease, progression of metastatic disease or secondary malignancy, or date of l...
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Malignant peripheral nerve sheath tumor is a rare and aggressive disease with poor treatment response, mainly affecting adolescents and young adults. Few molecular biomarkers are used in the management of this cancer type, and although... more
Malignant peripheral nerve sheath tumor is a rare and aggressive disease with poor treatment response, mainly affecting adolescents and young adults. Few molecular biomarkers are used in the management of this cancer type, and although TP53 is one of few recurrently mutated genes in malignant peripheral nerve sheath tumor, the mutation prevalence and the corresponding clinical value of the TP53 network remains unsettled. We present a multi-level molecular study focused on aberrations in the TP53 network in relation to patient outcome in a series of malignant peripheral nerve sheath tumors from 100 patients and 38 neurofibromas, including TP53 sequencing, high-resolution copy number analyses of TP53 and MDM2, and gene expression profiling. Point mutations in TP53 were accompanied by loss of heterozygosity, resulting in complete loss of protein function in 8.2% of the malignant peripheral nerve sheath tumors. Another 5.5% had MDM2 amplification. TP53 mutation and MDM2 amplification we...
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9002 Background: The ISG-SSG II study was undertaken to explore the effect of adding high-dose chemotherapy (HDCT) with peripheral blood stem cells support (PBSC) to conventional chemotherapy (CT) in patients with primary metastatic... more
9002 Background: The ISG-SSG II study was undertaken to explore the effect of adding high-dose chemotherapy (HDCT) with peripheral blood stem cells support (PBSC) to conventional chemotherapy (CT) in patients with primary metastatic and/or axial localized OS. Methods: From May 1996 to Dec 2003, 57 patients, median age 17 years (range 2–38) entered the study. 46 patients had metastases at presentation, 39 with extremity localized tumors and 7 with axial tumors. All 46 had lung metastases (> 2 nodules in 31 cases), 3 additional lymph node involvement and 6 bone metastases. 11 patients had pelvic OS without metastases. Preoperative CT included two courses of Methotrexate 12 g/m2, Cisplatin 120 mg/m2 + Adriamycin 75 mg/m2 and Ifosfamide 15 g/m2. Stem cells were harvested after the first course of Ifosfamide (day 28). Post-operatively patients received 2 cycles of Adriamycin 90 mg/m2, Cyclophosphamide (CTX) 4000 mg/m2 + VP16 600 mg/m2, and 2 cycles of HDCT containing VP16 1800 mg/m2 + Carboplatin 1500 mg/m2 wi...
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Purpose - We wanted to examine the potential of the Scandinavian Sarcoma Group (SSG) Central Register, and evaluate referral and treatment practice for soft-tissue sarcomas in the extremities and trunk wall (STS) in the Nordic countries.... more
Purpose - We wanted to examine the potential of the Scandinavian Sarcoma Group (SSG) Central Register, and evaluate referral and treatment practice for soft-tissue sarcomas in the extremities and trunk wall (STS) in the Nordic countries. Background - Based on incidence rates from the literature, 8,150 (7,000-9,300) cases of STS of the extremity and trunk wall should have been diagnosed in Norway, Finland, Iceland, and Sweden from 1987 through 2011. The SSG Register has 6,027 cases registered from this period, with 5,837 having complete registration of key variables. 10 centers have been reporting to the Register. The 5 centers that consistently report treat approximately 90% of the cases in their respective regions. The remaining centers have reported all the patients who were treated during certain time periods, but not for the entire 25-year period. Results - 59% of patients were referred to a sarcoma center untouched, i.e. before any attempt at open biopsy. There was an improveme...
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LBA10504 Background: EURAMOS-1 (NCT00134030) is an international randomized controlled trial investigating treatment optimization in osteosarcoma on the basis of histologic response to preoperative chemotherapy (CT). In patients (pts)... more
LBA10504 Background: EURAMOS-1 (NCT00134030) is an international randomized controlled trial investigating treatment optimization in osteosarcoma on the basis of histologic response to preoperative chemotherapy (CT). In patients (pts) with "good response" (GR; <10% viable tumor at surgery) to induction CT, efficacy of maintenance therapy with pegylated interferon α-2b (Ifn) was investigated. Pts ≤40yrs with resectable localized or primary metastatic high-grade extremity or axial osteosarcoma were eligible for registration at diagnosis. Eligibility for randomization included: [a] receipt of two cycles pre-op methotrexate, doxorubicin, cisplatin (MAP); [b] complete macroscopic resection of primary tumor; and [c] no disease progression. GR pts were randomized (1:1) after surgery to four cycles MAP +/-Ifn. Ifn (0.5-1.0 μg/kg/wk) was given after CT until 2yr post registration. Primary endpoint: event free survival (EFS); secondary: overall survival, toxicity. The trial desig...