European Cooperative Groups Research Articles

The EHA Research Roadmap: Malignant Lymphoid Diseases.

The EHA Research Roadmap: Malignant Lymphoid Diseases.

Alveolar rhabdomyosarcoma with regional nodal involvement: Results of a combined analysis from two cooperative groups

Treatment of children and adolescents with alveolar rhabdomyosarcoma (ARMS) and regional nodal involvement (N1) have been approached differently by North American and European cooperative groups. In order to define a better therapeutic strategy, we analyzed two studies conducted between 2005 and 2016 by the European paediatric Soft tissue sarcoma Study Group (EpSSG) and Children's Oncology Group (COG). We retrospectively identified patients with ARMS N1 enrolled in either EpSSG RMS2005 or in COG ARST0531. Chemotherapy in RMS2005 comprised ifosfamide + vincristine + dactinomycin + doxorubicin (IVADo), IVA and maintenance (vinorelbine, cyclophosphamide); in ARST0531, it consisted of either vincristine+dactinomycin+cyclophosphamide (VAC) or VAC alternating with vincristine+irinotecan (VI). Local treatment was similar in both protocols. The analysis of the clinical characteristics of 239 patients showed some differences between study groups: in RMS2005, advanced Intergroup Rhabdomyosarcoma Study Group (IRS) and large tumors predominated. There were no differences in outcomes between the two groups: 5-year event-free survival (EFS), 49% (95% confidence interval [CI]: 39-59) and 44% (95% CI: 30-58), and overall survival (OS), 51% (95% CI: 41-61) and 53.6% (95% CI: 40-68) in RMS2005 and ARST0531, respectively. In RMS2005, EFS of patients with FOXO1-positive tumors was significantly inferior to those with FOXO1-negative (49.3% vs 73%, P=.034). In contrast, in ARST0531, EFS of patients with FOXO1-positive tumors was 45% compared with 43.8% for those with FOXO1-negative. The outcome of patients with ARMS N1 was similar in both protocols. However, patients with FOXO1 fusion-negative tumors enrolled in RMS2005 showed a significantly better outcome, suggesting that different strategies of chemotherapy may have an impact in the outcome of this subgroup of patients.

Current models, challenges and best practices for work conducted between European academic cooperative groups and industry

BackgroundThe academia-industry interface is important, and, despite challenges that inevitably occur, bears the potential for positive synergies to emerge. Perceived barriers to wider collaboration in academia-industry oncology research in Europe need to be addressed, current academic cooperative group and industry models for collaboration need to be discussed, and a common terminology to facilitate understanding of both sectors’ concerns needs to be established with an eye towards improving academia-industry partnerships on clinical trials for the benefit of patients with cancer.MethodologyCAREFOR (Clinical Academic Cancer Research Forum), a multi-stakeholder platform formed to improve the direction for academic clinical trials in the field of oncology in Europe, formed the CAREFOR-Industry Working Group comprised of experienced professionals from European academic cooperative groups joined by industry representatives selected based on their activities in the area of medical oncology. They jointly discussed academic cooperative groups, clinical trials conducted between academic cooperative groups and industry, examples of successful collaborative models, common legal negotiation points in clinical trial contracts, data access, and principles of interaction.ResultsFour principles of interaction between the academia and industry are proposed: (1) clarify the roles and responsibilities of all partners involved in the study, (2) involve legal teams from an early stage; (3) acknowledge that data is an important output of the study, (4) agree on the intent of the trial prior to its start.ConclusionsThe CAREFOR-Industry Working Group describes current models, challenges, and effective strategies for academia-industry research in Europe with an eye towards improving academia-industry partnerships on clinical trials for patients with cancer. Current perceived challenges are explained, and future opportunities/recommendations for improvement are described for the areas of most significant impact. Challenges are addressed from both the academic and industry perspectives, and principles of interaction for the optimal alignment between academia and industry in selected areas are proposed.

Validation and Improvement Opportunities of the Revised International Staging System for Multiple Myeloma: An Analysis on Mature Data from European Clinical Trials within the Harmony Big Data Platform

Validation and Improvement Opportunities of the Revised International Staging System for Multiple Myeloma: An Analysis on Mature Data from European Clinical Trials within the Harmony Big Data Platform

Niveau, a Phase 3 Study for Pts with B- or T-Cell Aggressive Non-Hodgkin Lymphoma in First Relapse or Progression Not Eligible for High-Dose Chemotherapy (HDT), Testing Nivolumab in Combination with Gemcitabine, Oxaliplatin (GemOx), Plus Rituximab (R) in Case of B-Cell Lymphoma

Niveau, a Phase 3 Study for Pts with B- or T-Cell Aggressive Non-Hodgkin Lymphoma in First Relapse or Progression Not Eligible for High-Dose Chemotherapy (HDT), Testing Nivolumab in Combination with Gemcitabine, Oxaliplatin (GemOx), Plus Rituximab (R) in Case of B-Cell Lymphoma

Clinical pathways of recovery after surgery for advanced ovarian/tubal/peritoneal cancer: an NSGO-MaNGO international survey in collaboration with AGO-a focus on surgical aspects.

This survey assessed the implementation of enhanced recovery after surgery (ERAS) for patients undergoing surgery for advanced ovarian cancer in three European cooperative study groups in Scandinavia, Italy, and Austria. The aim was to evaluate the landscape for future trials on ERAS pathways in ovarian cancer, because high-level evidence for such interventions is lacking. In July 2017, a web-based questionnaire (SurveyMonkey Inc, Palo Alto, CA, USA) was sent to centers conducting surgery for advanced ovarian cancer within the Nordic Society of Gynecologic Oncology (NSGO), Mario Negri Gynecologic Oncology Group (MaNGO) and other Italian institutions, and the Association for Gynecologic Oncology Austria (AGO Austria) (n = 100). The survey covered all aspects of an ERAS pathway including surgery, nursing, and anesthesia. We herein report on the survey findings relating to surgery, including nursing care issues; however, anesthesiologic issues will be discussed in a separate report. The overall response rate was 62%. Only a third of the centers in Italy and Austria follow a written ERAS protocol compared with 60% of the Scandinavian centers. Only a minority of centers have completely abandoned bowel preparation, with the highest proportion in Scandinavia (36%). Two hours of fasting for fluids before surgery is routinely practiced in Scandinavia and Austria (67-57%, respectively), but not in Italy (5%). Carbohydrate loading is routinely administered only in Scandinavia (67%). Peritoneal drainage is used by 22% routinely and by 61% in cases of bowel resection/lymphadenectomy/peritonectomy. Early feeding with a light diet on day 0 or 1 is the standard of care in Scandinavia and Austria, but not in Italy. The degree of implementation of ERAS protocols varies across and within cooperative groups. The centralization of ovarian cancer care seems to facilitate standardization of peri-operative protocols. Currently, the high heterogeneity in patterns of care may challenge an international approach to a clinical trial.

Demographic and Treatment Variables Influencing Outcome for Localized Paratesticular Rhabdomyosarcoma: Results From a Pooled Analysis of North American and European Cooperative Groups.

Treatment recommendations for localized paratesticular rhabdomyosarcoma (PT RMS) differ in North America and Europe. We conducted a pooled analysis to identify demographic features and treatment choices that affect outcome. We retrospectively analyzed the effect of nine demographic variables and four treatment choices on event-free survival (EFS) and overall survival (OS) from 12 studies conducted by five cooperative groups. Eight hundred forty-two patients with localized PT RMS who enrolled from 1988 to 2013 were included. Patients age ≥ 10 years were more likely than younger patients to have tumors that were > 5 cm, enlarged nodes (N1), or pathologically involved nodes ( P ≤ .05 each). With a median follow-up of 7.5 years, Kaplan-Meier estimates for 5-year EFS and OS were 87.7% and 94.8%, respectively. Of demographic variables, cooperative group, era of enrollment, age category, tumor size, Intergroup Rhabdomyosarcoma Study group, and T stage affected EFS ( P ≤ .05 each). Surgical assessment of regional nodes, which was performed in 23.5% of patients-usually in those age ≥ 10 years or with suspicious or N1 nodes-was the only treatment variable associated with EFS by univariable and multivariable analyses ( P ≤ .05 each) in patients age ≥ 1 year. A variable selection procedure on a proportional hazards regression model selected era of enrollment, age, tumor size, and surgical assessment of regional nodes as significant ( P ≤ .05 each) in the EFS model, and era of enrollment, age, tumor size, and histology ( P ≤ .05 each) in the OS model. Localized PT RMS has a favorable prognosis. Age ≥ 10 years at diagnosis and tumor size larger than 5 cm are unfavorable prognostic features. Surgical assessment of regional nodes is important in patients age ≥ 10 years and in those with N1 nodes as it affects EFS.

SC23.01 Cooperative Groups in Latin America

SC23.01 Cooperative Groups in Latin America

Cooperative versus Conventional (Joint-Stock) Banking In Europe: Comparative Resistance And Resilience During The Recent Financial Crisis

During the banking crisis of the 1990s, French cooperative banks emerged as more resistant and efficient than joint-stock banks, which enabled them to improve their market share and increase their reserve capital. This subsequently became the keystone of the external restructuring that led to the transformation of cooperative banks into large universal banking groups. At the time, their competitive advantage relied mainly on a different approach to risk-taking, which was associated with their cooperative legal form and their specific governance model.However, the same features have clearly not prevailed during the financial phase of the most recent crisis. Whereas governance models in the banking sector have been deeply questioned, the original cooperative model has evolved differently within European countries, with a high level of hybridization in some and a very diffuse cooperative network in others. Some European cooperative groups have been damaged by the crisis, mainly because of the corporate and investment banking that formed part of their activity.Yet the recent crisis has revealed the importance of a resistant and resilient worldwide banking system and the diversity of legal forms and organizations could contribute to achieving this goal. In this paper, we assess the resistance and resilience of major joint-stock banks during the crisis and compare them to cooperative banks in different European countries and Canada. We conduct our analysis at an aggregated/consolidated level for these two categories of banks. Using different indicators (e.g., z-score, loans to the economy, return on equity) as dependent variables, we verify whether the cooperative form is synonymous with greater resistance or resilience, and whether the results may be explained by different organizational schemes in cooperative banking.

Critères de qualité en radiothérapie des cancers de la tête et du cou sous l’égide de l’Intergroupe ORL

The aim of radiotherapy is to deliver enough radiation to the tumor in order to achieve maximum tumour control in the irradiated volume with as few serious complications as possible with an irradiation dose as low as possible to normal tissue. The quality of radiotherapy is essential for optimal treatment and quality control is to reduce the bias in clinical trials avoiding possible major deviations. The assurance and quality control programs have been developed in large european (EORTC, GORTEC) and american cooperative groups (RTOG) of radiation oncology since the 1980s. We insist here on the importance of quality assurance in radiotherapy and the current status in this domain and the criteria for quality control especially for current clinical trials within GORTEC are discussed here.

Parameningeal rhabdomyosarcoma in pediatric age: results of a pooled analysis from North American and European cooperative groups

Parameningeal (PM) site is a well-known adverse prognostic factor in children with localized rhabdomyosarcoma (RMS). To identify risk factors associated with outcome at this site, we pooled data from 1105 patients treated in 10 studies conducted by European and North American cooperative groups between 1984 and 2004. Clinical factors including age, histology, size, invasiveness, nodal involvement, Intergroup Rhabdomyosarcoma Study (IRS) clinical group, site, risk factors for meningeal involvement (MI), study group, and application of radiotherapy (RT) were studied for their impact on event-free and overall survival (EFS and OS). Ten-year EFS and OS were 62.6 and 66.1% for the whole group. Patients without initial RT showed worse survival (10-year OS 40.8% versus 68.5% for RT treated patients). Multivariate analysis focusing on 862 patients who received RT as part of their initial treatment revealed four unfavorable prognostic factors: age <3 or >10 years, signs of MI, unfavorable site, and tumor size. Utilizing these prognostic factors, patients could be classified into different risk groups with 10-year OS ranging between 51.1 and 80.9%. While, in general, PM localization is regarded as an adverse prognostic factor, the current analysis differentiates those with good prognosis (36% patients with 0-1 risk factor: 10-year OS 80.9%) from high-risk PM patients (28% with 3-4 factors: 10-year OS 51.1%). Furthermore, this analysis reinforces the necessity for RT in PM RMS.

Expanding Clinical Trial Networks in Pediatric Acute Lymphoblastic Leukemia

Expanding Clinical Trial Networks in Pediatric Acute Lymphoblastic Leukemia

Double Vs Single Autologous Stem Cell Transplantation After Bortezomib-Based Induction Regimens For Multiple Myeloma: An Integrated Analysis Of Patient-Level Data From Phase European III Studies

Double Vs Single Autologous Stem Cell Transplantation After Bortezomib-Based Induction Regimens For Multiple Myeloma: An Integrated Analysis Of Patient-Level Data From Phase European III Studies

Paediatric and adolescent alveolar soft part sarcoma: A joint series from European cooperative groups

Alveolar soft part sarcomas (ASPS) are generally chemo- and radio-resistant mesenchymal tumours, with no standardized treatment guidelines. We describe the clinical behaviour of paediatric ASPS and compare these features to previously reported adult series. The clinical data of 51 children and adolescents with ASPS, prospectively enrolled in or treated according to seven European Paediatric trials were analysed. Median age was 13 years [range: 2-21]. Primary sites included mostly limbs (63%). IRS post-surgical staging was: IRS-I (complete resection) 35%, II (microscopic residual disease) 20%, III (gross residual disease) 18% and IV (metastases) 27%. Only 3 of the 18 evaluable patients (17%) obtained a response to conventional chemotherapy. After a median follow-up of 126 months (range: 9-240), 14/18 patients with IRS-I tumour, 10/10 IRS-II, 7/9 IRS-III and 2/14 IRS-IV were alive in remission. Sunitinib treatment achieved two very good partial responses in four patients. Ten-year overall survival (OS) and event free survival (EFS) was 78.0 ± 7% and 62.8 ± 7% respectively. Stage IV, size >5 cm and T2 tumours had a poorer outcome, but only IRS staging was an independent prognostic factor. ASPS is a very rare tumour frequently arising in adolescents and in the extremities, and chemo resistant. Local surgical control is critical. ASPS is a poorly chemo sensitive tumour. For IRS-III/IV tumours, delayed radical local therapies including surgery are essential. Metastatic patients had a poor prognosis but targeted therapies showed promising results.

Improving acute promyelocytic leukemia (APL) outcome in developing countries through networking, results of the International Consortium on APL

AbstractThanks to modern treatment with all-trans retinoic acid and chemotherapy, acute promyelocytic leukemia (APL) is now the most curable type of leukemia. However, this progress has not yielded equivalent benefit in developing countries. The International Consortium on Acute Promyelocytic Leukemia (IC-APL) was established to create a network of institutions in developing countries that would exchange experience and data and receive support from well-established US and European cooperative groups. The IC-APL formulated expeditious diagnostic, treatment, and supportive guidelines that were adapted to local circumstances. APL was chosen as a model disease because of the potential impact on improved diagnosis and treatment. The project included 4 national coordinators and reference laboratories, common clinical record forms, 5 subcommittees, and laboratory and data management training programs. In addition, participating institutions held regular virtual and face-to-face meetings. Complete hematological remission was achieved in 153/180 (85%) patients and 27 (15%) died during induction. After a median follow-up of 28 months, the 2-year cumulative incidence of relapse, overall survival (OS), and disease-free survival (DFS) were 4.5%, 80%, and 91%, respectively. The establishment of the IC-APL network resulted in a decrease of almost 50% in early mortality and an improvement in OS of almost 30% compared with historical controls, resulting in OS and DFS similar to those reported in developed countries.

Impact of Bortezomib Incorporated Into Autotransplantation On Outcomes of Myeloma Patients with High-Risk Cytogenetics: An Integrated Analysis of 1894 Patients Enrolled in Four European Phase 3 Studies

Abstract 749 We performed an integrated analysis of four phase 3 studies independently conducted by HOVON/GMMG, IFM, PETHEMA/GEM and GIMEMA European cooperative groups. These studies were designed to compare standard-dose bortezomib-based (V-b) induction regimens (VD or VTD or PAD) vs non bortezomib-based (NV-b) treatments (VAD or TD) before single or double autotransplantation (ASCT) for newly diagnosed myeloma (MM) patients (pts). In three trials bortezomib was also planned as (part of) post-ASCT consolidation or maintenance therapy. Aim of this analysis was to evaluate efficacy results of bortezomib incorporated into ASCT (V-b ASCT) vs ASCT not including bortezomib, particularly in pts with high-risk cytogenetics (HR-cyto) defined by t(4;14) and/or del(17p). A total of 2169 pts were enrolled and were followed for a median of 37 months (mos). Data on cytogenetics were available in 1894 pts. In the overall population, V-b regimens significantly increased the post-induction rate of CR (14.5% vs 4%, p Disclosures: Cavo:Janssen, Celgene, Millennium: Honoraria, Membership on an entity9s Board of Directors or advisory committees; Novartis: Honoraria. Sonneveld:Janssen, Celgene, Onyx: Honoraria, Research Funding. Moreau:Janssen, Millennium, Onyx: Membership on an entity9s Board of Directors or advisory committees. Blade:Janssen, Celgene: Honoraria, Membership on an entity9s Board of Directors or advisory committees. Goldschmidt:Celgene, Janssen: Membership on an entity9s Board of Directors or advisory committees. San Miguel:Janssen, Celgene, Novartis, Millennium, BMS: Membership on an entity9s Board of Directors or advisory committees. Attal:Celgene, Janssen: Membership on an entity9s Board of Directors or advisory committees. Facon:Onyx, Celgene, Janssen, Millennium: Membership on an entity9s Board of Directors or advisory committees. Lahuerta:Celgene, Janssen: Honoraria. Lokhorst:Celgene: Honoraria. Palumbo:Celgene, Janssen: Membership on an entity9s Board of Directors or advisory committees; Celgene, Janssen, Merck, Amgen: Honoraria. Petrucci:Janssen, Celgene: Honoraria. Rosinol:Janssen, Celgene: Honoraria, Membership on an entity9s Board of Directors or advisory committees. Salwender:Celgene, Janssen: Honoraria, Membership on an entity9s Board of Directors or advisory committees.

Development and Refinement of Augmented Treatment Regimens for Pediatric High-Risk Acute Lymphoblastic Leukemia

The 5-year survival rate for children and adolescents with acute lymphoblastic leukemia (ALL) is now at least 90%. However, clinical features (age and initial white blood cell count [WBC]), early treatment response, and the presence/absence of specific sentinel genomic lesions can identify subsets of high-risk (HR) ALL patients with a much higher risk of treatment failure. Chemotherapy regimens used to treat HR ALL have been refined over the past 3 decades through randomized clinical trials conducted by the Children's Oncology Group (COG) in North America and the Berlin-Frankfurt-Muenster (BFM) group in Western Europe. Contemporary COG HR ALL treatment regimens were developed from the BFM-76 regimen, with subsequent changes that led to development and refinement of a so-called augmented BFM (ABFM) regimen used today. Although contemporary COG and BFM treatment regimens are not identical, there are many more similarities than differences. With improvements in survival, it has become clear that although the outcome of some patients with HR ALL can be improved by optimizing use of standard cytotoxic chemotherapy agents, this approach has had only limited success for other patient subsets. In contrast, introduction of the tyrosine kinase inhibitor imatinib has led to dramatic outcome improvements for children and adolescents with Philadelphia chromosome-positive ALL. Genomic studies are identifying new sentinel genomic lesions that can serve as potential therapeutic targets, which will likely lead to the testing of novel and/or targeted therapies in more children with HR ALL. Such studies will require increased collaboration between Western European and North American cooperative groups.

Parameningeal rhabdomyosarcoma: Results of a pooled analysis from U.S. and European Cooperative Groups.

9529 Background: Parameningeal (PMN) site is a well known adverse prognostic factor in children with localized rhabdomyosarcoma (RMS). To identify risk factors associated with outcome we pooled data from 1105 consecutive patients treated in ten studies conducted by European and North-American cooperative groups between 1984 and 2004. Methods: Clinical factors including age, histology, size, invasiveness, nodal involvement, IRS clinical group, site of primary, risk factors for meningeal involvement (MI), study group (Children’s Oncology Group, International Society of Pediatric Oncology, Italian Cooperative Group), type and duration of chemotherapy (CT), and application of radiotherapy (RT) were studied for their impact on event free- and overall survival (EFS and OS). Results: The five and ten year EFS and OS are 64.9 and 62.6 (EFS) and 69.5 and 66.1 (OS). By multivariate analysis OS is significantly adversely associated with 6 factors: 1. omission of RT for patients with tumors at favorable sites (i.e. m...

Hodgkin Lymphoma Patients with Stage II B or Stage II Bulky Disease Have Advanced Disease and Should Not Be Included In Limited Stage Trials

AbstractAbstract 417 Background:Trials enrolling patients with limited stage Hodgkin lymphoma conducted by European cooperative groups including EORTC, GELA and the GHSG frequently include patients with stage II B or stage II bulky (≥ 10 cm) disease in either “favorable” or “unfavorable” subgroups. Similar patients are usually excluded from North American trials of limited stage disease and rather are included in trials of advanced stage lymphoma. We sought to clarify the appropriateness of these approaches. Methods:All adult (age > 15 but < 66 y) HIV antibody negative patients with stage II A bulky, II B non-bulky or II B bulky Hodgkin lymphoma treated in British Columbia since 1981, when ABVD-type chemotherapy became standard, were identified using the BC Cancer Agency Lymphoid Cancer Database. Characteristics: n=416; male 54%; age range 16–64 y (median = 30); histologic subtype nodular sclerosis 86%, mixed cellularity 5%, not subclassifiable 6%, other 3%; subdiaphragmatic 3%; stage II A bulky 32%, II B non-bulky 32%, II B bulky 36%; localized extranodal extension (E lesion) 35%; largest mass diameter non-bulky range 1–9 cm (median 6 cm), bulky range 10–25 cm (median 12 cm); IPFP prognostic score 0, 9%; 1, 33%; 2, 32%; 3, 19%; 4, 6%; 5, 1% (data missing 36%). Results:Planned treatment consisted of 6–8 cycles of ABVD-type chemotherapy followed by radiation for a persistent residual mass (only if PET positive since 2005). 50% of patients received radiation (extended field 24%, involved field 76%). Thus, patients were treated with the same approach that is used for stage III or IV. Patients with bulky disease were much more likely to receive radiation: II A bulky 72%; II B non-bulky 11%; II B bulky 65%. For all 416 patients, with a median follow-up of 8 y, 5 and 10 y progression free survivals (PFS) were 81% and 76%; time-to-progression (TTP) estimates 83% and 81% (Fig. 1); and overall survivals (OS) were 94% and 90%. Although there is some variation, survivals were very similar across the three stage groups.Stage groupnPFS%TTP%OS%5-y10-y5-y10-y5-y10-yII A bulky135858585859493II B non-bulky134807080779588II B bulky147787282799490All patients416817683819490This experience is instructive and indicates that when patients with stage II B bulky or non-bulky or stage II A bulky Hodgkin lymphoma are treated with the same approach as is used for advanced stage disease at least 20% of patients relapse. Conclusion:It is inappropriate to include patients with stage II B or stage II A bulky Hodgkin lymphoma on trials designed for limited stage disease. With an estimated relapse rate of at least 20% inclusion of these patients can grossly distort outcomes and compromise interpretation of the results of the trial since the expectation for the rest of the patients (stage I A and II A, low bulk) is that no more than 5% of patients will relapse. Patients with stage II B or stage II A bulky Hodgkin lymphoma should be included in trials for patients with advanced stage disease. [Display omitted] Disclosures:Klasa:Seattle Genetics, Inc.: Research Funding.

Prognostic factors of localized extremity rhabdomyosarcomas: The results of a pooled analysis from U.S. and European cooperative groups.

9505 Background: We present pooled data from 643 patients (pts) treated in 14 studies conducted by European and American cooperative groups. Methods: Clinical factors, including age, histology, site of primary (hand and foot vs others), size, invasiveness (T), nodal involvement (N) and post surgical group (complete R0, microscopic residue R1 or macroscopic residue / biopsy only R2), chemotherapy (CT) type and duration, radiation therapy (RT) and period of treatment (before or after 1995) were looked at for their impact on survival (OS). Results: The 5 and 10 year OS are 67% (se 1.8) and 62% (se 2) respectively. By univariate analysis, OS is adversely influenced by age > 3 years, size > 5 cm, T2 stage, N1 stage, cooperative group (Europe vs US), incomplete initial surgery and treatment before 1995. Site and alveolar histology are less significant. RT has no impact. Many of these variables are associated. Pts treated by the US group were more often operated on and had more complete surgery at diagnosis than pts treated in Europe. In multivariate analysis OS is strongly correlated to age, T stage, N stage, initial surgery, treatment period and cooperative group. The better survival rate of tumors treated by the US group is observed for grossly resected tumors (R0 or R1) only. OS survival is 86% (se 3) for US pts as compared to 68% (se 4) for European pts (p=0.004). When considering the R0 and R1 tumors separately (n=252) by univariate analysis, OS is significantly influenced by the completeness of initial surgery (R0 vs R1, p=0.05), T stage (p=0.02), and site of the tumour (p=0.02). Longer CT duration (> 27 weeks) is associated with a better OS (p=0.002). RT had no impact. In multivariate analysis, if CT duration is not considered, cooperative group (p=0.001), site (p=0.001) and T stage (p=0.05) are significant. Completeness of initial surgery has no impact. However, adding duration of chemotherapy to the model, site of the primary remains significant (p=0.006) but T status and cooperative group are no longer significant. Conclusions: This analysis confirms the role of many prognostic factors, but in grossly resected tumors it identifies that the duration of chemotherapy has an important impact. No significant financial relationships to disclose.