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51. 548P Molecular pre-screening using comprehensive gene panels offered by clinical trials (CT)

Author

Ruiz, I. Victoria, primary, Moreno, D., additional, Sole, P., additional, Gonzalez, B. Mellado, additional, Pineda, E., additional, Gaba, L., additional, Sauri, T., additional, Mileo, L. Ferrer, additional, Orrillo, M., additional, Maurel, J., additional, Oliveres, H., additional, Munoz-Mateu, M., additional, Losada, M.J. Vidal, additional, Saez, O. Martinez, additional, Chic, N., additional, Baste, N., additional, Segarra, N. Vinolas, additional, Reyes, R., additional, Prat, A., additional, and Garcia-Corbacho, J., additional

Published
2020
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52. 474P Prognostic and predictive role of Consensus Molecular Subtypes (CMS) determined by immunohistochemistry in metastatic colorectal cancer (mCRC)

Author

Gomez, O. Higuera, primary, Soto, V. Heredia, additional, Machado, I., additional, Mendez, M.C., additional, Cuatrecasas, M., additional, Horndler, C., additional, Vermeulen, L., additional, Hoorn, S. Ten, additional, Mendiola, M., additional, Martín-Richard, M., additional, Ruiz-Casado, A., additional, Galvez, E., additional, Aparicio, J., additional, García, I. Sevilla, additional, Leno, R., additional, Fernández-Martos, C., additional, Alonso-Orduna, V., additional, Montes, A. Fernandez, additional, Maurel, J., additional, and Feliu, J., additional

Published
2020
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53. 471P Identification and validation of a new prognostic score in metastatic colorectal cancer (mCRC): GEMCAD score

Author

Seguí, E., primary, Alonso-Orduna, V., additional, Sesma, A., additional, Martin-Richard, M., additional, Salud, A., additional, Fernández-Montes, A., additional, Fernández-Martos, C., additional, Ruiz-Casado, A., additional, Gallego, J., additional, Aparicio, J., additional, Gálvez, E., additional, Manzano, H., additional, Alcaide-Garcia, J., additional, Gallego, R., additional, Falco, E., additional, Esposito, F., additional, Oliveres, H., additional, Torres, F., additional, Feliu, J., additional, and Maurel, J., additional

Published
2020
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54. 109P Subpopulations of peripheral blood lymphocytes and response to immunotherapy across cancer-types

Author

Garcia-Corbacho, J., primary, Gonzalez-Navarro, E.A., additional, Victoria Ruiz, I., additional, Arrufat, A., additional, Moreno Fernández, D., additional, Heredia, L., additional, Ortiz de Landázuri, I., additional, Segarra, N. Vinolas, additional, Mellado, B., additional, Sauri, T., additional, Maurel, J., additional, Gaba, L., additional, Pare, L., additional, Sanfeliu, E., additional, Baste, N., additional, Vidal Losada, M.J., additional, Arance Fernandez, A.M., additional, Reguart, N., additional, Prat, A., additional, and Juan, M., additional

Published
2020
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55. 476P Mutational profiling allows the stratification of metastatic colorectal cancer patients with poor prognosis

Author

Hernandez, A. Rodriguez, primary, LaHoz, S., additional, Laia, F.M., additional, Puga, T. Gorría, additional, Moreno, R., additional, Esposito, F., additional, Oliveres, H., additional, Rodriguez, S. Albiol, additional, Sauri, T., additional, Cuatrecasas, M., additional, Jares, P., additional, Pedrosa, L., additional, Pineda, E., additional, Castells, A., additional, Prat, A., additional, Camps, J., additional, and Maurel, J., additional

Published
2020
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60. Consensus meeting for the management of gastrointestinal stromal tumors Report of the GIST Consensus Conference of 20–21 March 2004, under the auspices of ESMO

Author

Blay, J.-Y., Bonvalot, S., Casali, P., Choi, H., Debiec-Richter, M., Dei Tos, A.P., Emile, J.-F., Gronchi, A., Hogendoorn, P.C.W., Joensuu, H., Le Cesne, A., Mac Clure, J., Maurel, J., Nupponen, N., Ray-Coquard, I., Reichardt, P., Sciot, R., Stroobants, S., van Glabbeke, M., van Oosterom, A., and Demetri, G.D.

Published
2005
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65. Prospective Biomarker Study in Advanced RAS Wild-Type Colorectal Cancer: POSIBA Trial (GEMCAD 10-02)

Author

García-Albéniz X, Alonso V, Escudero P, Méndez M, Gallego J, Rodríguez JR, Salud A, Fernández-Plana J, Manzano H, Zanui M, Falcó E, Feliu J, Gil M, Fernández-Martos C, Bohn U, Alonso C, Calderero V, Rojo F, Cuatrecasas M, and Maurel J

Subjects
Clinical score, Cetuximab, neoplasms, Colorectal cancer, Biomarkers
Abstract

Background RAS testing is used to select patients with anti-epidermal growth factor receptor (EGFR) therapies sensitivity in metastatic colorectal cancer (mCRC). However, other biomarkers such as BRAF, PIK3CA/PTEN, and p-IGF-1R+/MMP7+ (double positive [DP] phenotype) have not been prospectively assessed to predict anti-EGFR resistance. Materials and Methods We designed a multicenter prospective trial (NCT01276379) to evaluate whether the biomarkers BRAF mutation, PIK3CA mutation/PTEN loss, and DP phenotype can improve the prediction for 12-months progression-free survival (PFS) over the use of clinical variables exclusively in patients with RAS wild-type (WT) mCRC treated with standard chemotherapy plus biweekly cetuximab as first-line therapy. The planned sample size was 170 RAS WT patients to detect a 20% difference in 12-month PFS based on the analysis of clinical and selected biomarkers (alpha = .05, beta = .2). The discriminatory capacity of the biomarkers was evaluated using receiver operating characteristic curves. Results We included 181 RAS WT patients. The biomarker distribution was as follows: BRAF mutant, 20 patients (11%); PIK3CA mutated/PTEN loss, 98 patients (58%); DP, 23 patients (12.7%). The clinical variables in the clinical score were progression status >0, left-sided tumor, and resectable liver metastasis as the only metastatic site. The area under the curve (AUC) of the score containing the clinical variables was 0.67 (95% confidence interval [CI], 0.60-0.75). The AUC of the score with clinical variables and BRAF mutational status was 0.68 (0.61-0.75, p = .37). The AUC of the score with clinical variables and PI3KCA mutation/PTEN status was 0.69 (0.61-0.76, p = .32). The AUC of the score with clinical variables and DP phenotype was 0.66 (0.58-0.73, p = .09). Conclusion The addition of BRAF, PIK3CA/PTEN, and DP to a clinical score does not improve the discrimination of 12-month PFS. Implications for Practice This prospective biomarker design study has important clinical implications because many prospective clinical trials are designed with the hypothesis that BRAF mutation per se and MEK and PIK3CA downstream pathways are critical for colorectal tumor survival. The results lead to the question of whether these pathways should be considered as passengers instead of drivers.

Published
2019

74. Phase II trial of ifosfamide in combination with the VEGFR inhibitor sorafenib in advanced soft tissue sarcoma: a Spanish group for research on sarcomas (GEIS) study

Author

del Muro X, Maurel J, Trufero J, Lavernia J, Pousa A, de las Penas R, Cubedo R, Berros J, Herraez A, de Juan A, and Broto J

Subjects
Soft tissue sarcoma, GEIS, Ifosfamide, Sorafenib
Abstract

Background Sorafenib is a potent targeted-therapy that blockades angiogenesis and has demonstrated activity against some sarcoma subtypes. Preclinical studies suggested that treatment with sorafenib plus cytotoxic agents could result in additive efficacy. Methods Patients with advanced soft tissue sarcoma, with or without anthracycline pretreatment were included. Patients received oral sorafenib 400 mg twice daily starting on Day +2, ifosfamide 2.0 g/m2 iv infusion lasting 4 h on days 1. 2 and 3 with concurrent mesna 400 mg/m(2) every three weeks until disease progression or unacceptable toxicity or up to a maximum of 6 cycles of ifosfamide (sorafenib could be continued until progressive disease or unacceptable toxicity). Primary objective was progression-free rate (PFR) at 3 and 6 months; secondary objectives were overall response rate (ORR), Progression-free survival (PFS), Overall survival (OS) and safety. This article reports the phase II part of a phase I/II clinical trial. Results Thirty-five patients were enrolled. PFR at 3 and 6 months was 66% (95% CI 48-81) and 37% (95% CI 22-55). Six patients (17%) achieved partial response and 17 (49%) stable disease. Median PFS was 4.8 months (CI 95% 1.94-6.36) and overall survival 16.2 months (95% CI 8.75-NA). Conclusion Treatment with sorafenib plus ifosfamide achieved a significant clinical benefit with an acceptable safety profile in patients with advanced soft tissue sarcoma resistant to anthracyclines, which warrants a more detailed study in randomized clinical trials.

Published
2018

76. Immune signatures identify three immune clusters in mCRC, with potential clinical implications

Author

Pedrosa, L., primary, Moreno, R., additional, Esposito, F., additional, Jares, P., additional, Cuatrecasas, M., additional, Pineda, E., additional, Español, M., additional, Paré, L., additional, De la Iglesia, N., additional, Benitez, D., additional, Camps, J., additional, Church, S., additional, Cascante, M., additional, Thomson, T., additional, Prat, A., additional, and Maurel, J., additional

Published
2019
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77. Ibrutinib in combination with nab-paclitaxel and gemcitabine as first-line treatment for patients with metastatic pancreatic adenocarcinoma: results from the phase 3 RESOLVE study

Author

Tempero, M., primary, Oh, D., additional, Macarulla, T., additional, Reni, M., additional, Van Cutsem, E., additional, Hendifar, A., additional, Waldschmidt, D., additional, Starling, N., additional, Bachet, J., additional, Chang, H., additional, Maurel, J., additional, Lonardi, S., additional, Coussens, L., additional, Fong, L., additional, Tsao, L., additional, Cole, G., additional, James, D., additional, and Tabernero, J., additional

Published
2019
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79. Randomized phase II clinical trial to evaluate the efficacy of second-line FOLFIRI-panitumumab in patients with RAS wild-type metastatic colorectal cancer who have received FOLFOX-panitumumab in first-line (BEYOND)

Author

Aparicio, J., primary, Virgili, A., additional, Capdevila, J., additional, Muñoz Boza, F., additional, Álvarez, R., additional, Bosch, C., additional, Cámara, J., additional, Fernandez-Martos, C., additional, Fernandez-Plana, J., additional, Gallego, J., additional, Gallego, R., additional, Hernández-Yagüe, X., additional, Macías Declara, I., additional, Rodríguez-Salas, N., additional, Vera, R., additional, Taberner, M., additional, and Maurel, J., additional

Published
2019
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80. Do we need adjuvant therapy in patients with rectal cancer and pathologic complete response, after conventional preoperative chemoradiation and laparoscopic (LapTME) or Transanal total mesorectal excision (TaTME)?

Author

Reyes, R., primary, Ayuso, J., additional, Pagés, M., additional, Conill, C., additional, Darnell, A., additional, Pineda, E., additional, Gines, A., additional, Fernández-Esparrach, M., additional, Cuatrecasas, M., additional, Moreno, R., additional, Lacy, A., additional, Pellisé, M., additional, and Maurel, J., additional

Published
2019
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82. Surrogate endpoints in advanced sarcoma trials: a meta-analysis

Author

Savina, M., Litiere, S., Italiano, A., Burzykowski, T., Bonnetain, F., Gourgou, S., Rondeau, V., Blay, J.Y., Cousin, S., Duffaud, F., Gelderblom, H., Gronchi, A., Judson, I., Cesne, A. Le, Lorigan, P., Maurel, J., Graaf, W.T.A. van der, Verweij, J., Mathoulin-Pelissier, S., Bellera, C., Savina, M., Litiere, S., Italiano, A., Burzykowski, T., Bonnetain, F., Gourgou, S., Rondeau, V., Blay, J.Y., Cousin, S., Duffaud, F., Gelderblom, H., Gronchi, A., Judson, I., Cesne, A. Le, Lorigan, P., Maurel, J., Graaf, W.T.A. van der, Verweij, J., Mathoulin-Pelissier, S., and Bellera, C.

Abstract

Contains fulltext : 200421.pdf (publisher's version ) (Open Access), Background: Alternative endpoints to overall survival (OS) are frequently used to assess treatment efficacy in randomized controlled trials (RCT). Their properties in terms of surrogate outcomes for OS need to be assessed. We evaluated the surrogate properties of progression-free survival (PFS), time-to-progression (TTP) and time-to-treatment failure (TTF) in advanced soft tissue sarcomas (STS). Results: A total of 21 trials originally met the selection criteria and 14 RCTs (N = 2846) were included in the analysis. Individual-level associations were moderate (highest for 12-month PFS: Spearman's rho = 0.66; 95% CI [0.63; 0.68]). Trial-level associations were ranked as low for the three endpoints as per the IQWiG criterion. Materials and Methods: We performed a meta-analysis using individual-patient data (IPD). Phase II/III RCTs evaluating therapies for adults with advanced STS were eligible. We estimated the individual- and the trial-level associations between then candidate surrogates and OS. Statistical methods included weighted linear regression and the two-stage model introduced by Buyse and Burzykowski. The strength of the trial-level association was ranked according to the German Institute for Quality and Efficiency in Health Care (IQWiG) guidelines. Conclusions: Our results do not support strong surrogate properties of PFS, TTP and TTF for OS in advanced STS.

Published
2018

83. Surrogate endpoints in advanced sarcoma trials: A meta-analysis

Author

Savina, M. (Marion), Litière, S. (Saskia), Italiano, A., Burzykowski, T. (Tomasz), Bonnetain, F., Gourgou, S. (Sophie), Rondeau, V. (Virginie), Blay, J.Y. (Jean Yves), Cousin, S. (S.), Duffaud, F. (Florence), Gelderblom, H. (Hans), Gronchi, A. (Alessandro), Judson, I.R. (Ian), Cesne, A. (Axel) le, Lorigan, P.C. (P.), Maurel, J. (Joan), Graaf, W.T.A. (Winette) van der, Verweij, J. (Jaap), Mathoulin-Pélissier, S., Bellera, C.A. (Carine A.), Savina, M. (Marion), Litière, S. (Saskia), Italiano, A., Burzykowski, T. (Tomasz), Bonnetain, F., Gourgou, S. (Sophie), Rondeau, V. (Virginie), Blay, J.Y. (Jean Yves), Cousin, S. (S.), Duffaud, F. (Florence), Gelderblom, H. (Hans), Gronchi, A. (Alessandro), Judson, I.R. (Ian), Cesne, A. (Axel) le, Lorigan, P.C. (P.), Maurel, J. (Joan), Graaf, W.T.A. (Winette) van der, Verweij, J. (Jaap), Mathoulin-Pélissier, S., and Bellera, C.A. (Carine A.)

Abstract

Background: Alternative endpoints to overall survival (OS) are frequently used to assess treatment efficacy in randomized controlled trials (RCT). Their properties in terms of surrogate outcomes for OS need to be assessed. We evaluated the surrogate properties of progression-free survival (PFS), time-to-progression (TTP) and time-to-treatment failure (TTF) in advanced soft tissue sarcomas (STS). Results: A total of 21 trials originally met the selection criteria and 14 RCTs (N = 2846) were included in the analysis. Individual-level associations were moderate (highest for 12-month PFS: Spearman's rho = 0.66; 95% CI [0.63; 0.68]). Trial-level associations were ranked as low for the three endpoints as per the IQWiG criterion. Materials and Methods: We performed a meta-analysis using individual-patient data (IPD). Phase II/III RCTs evaluating therapies for adults with advanced STS were eligible. We estimated the individual-and the trial-level associations between then candidate surrogates and OS. Statistical methods included weighted linear regression and the two-stage model introduced by Buyse and Burzykowski. The strength of the trial-level association was ranked according to the German Institute for Quality and Efficiency in Health Care (IQWiG) guidelines. Conclusions: Our results do not support strong surrogate properties of PFS, TTP and TTF for OS in advanced STS.

Published
2018
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84. Surrogate endpoints in advanced sarcoma trials: a meta-analysis

Author

Savina, M, Litiere, S, Italiano, A, Burzykowski, T, Bonnetain, F, Gourgou, S, Rondeau, V, Blay, J-Y, Cousin, S, Duffaud, F, Gelderblom, H, Gronchi, A, Judson, I, le Cesne, A, Lorigan, P, Maurel, J, de Graaf, W, Verweij, Jaap, Mathoulin-Pelissier, S, Bellera, C, Savina, M, Litiere, S, Italiano, A, Burzykowski, T, Bonnetain, F, Gourgou, S, Rondeau, V, Blay, J-Y, Cousin, S, Duffaud, F, Gelderblom, H, Gronchi, A, Judson, I, le Cesne, A, Lorigan, P, Maurel, J, de Graaf, W, Verweij, Jaap, Mathoulin-Pelissier, S, and Bellera, C

Published
2018

91. Clinical impact of circulating tumor RAS and BRAF mutation dynamics in metastatic colorectal cancer patients treated with first-line chemotherapy plus anti-EGFR therapy: Combined analysis of two prospective clinical trials

Author

Montagut, C., primary, Alonso, V., additional, Escudero, P., additional, Fernández-Martos, C., additional, Salud Salvia, A., additional, Méndez, M., additional, Gallego Plazas, J., additional, Rodriguez, J.R., additional, Martín-Richard, M., additional, Fernández-Plana, J., additional, Aparicio, J., additional, Feliu Batlle, J., additional, García de Albéniz, X., additional, Rojo, F., additional, Fernández, V., additional, Claes, B., additional, Maertens, G.G., additional, Sablon, E., additional, Jacobs, B.A.W., additional, and Maurel, J., additional

Published
2018
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92. Prospective biomarker study in advanced RAS wild-type colorectal cancer: POSIBA trial

Author

García Albéniz, X., primary, Alonso, V., additional, Escudero, P., additional, Méndez, M., additional, Gallego Plazas, J., additional, Rodriguez, J.R., additional, Salud Salvia, A., additional, Fernández-Plana, J., additional, Manzano Alemany, H., additional, Zanui, M., additional, Falcó, E., additional, Feliu Batlle, J., additional, Gil-Raga, M., additional, Fernández-Martos, C., additional, Bohn Sarmiento, U., additional, Alonso López, M.C., additional, Calderero Aragón, V., additional, Rojo, F., additional, Cuatrecasas, M., additional, and Maurel, J., additional

Published
2018
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93. AVEVAC: A phase I-II trial with avelumab plus autologous dendritic cell (ADC) vaccine in pre-treated mismatch repair-proficient (MSS) metastatic colorectal cancer (mCRC) patients (GEMCAD 16-02)

Author

Español Rego, M., primary, Alonso, V., additional, Aparicio, J., additional, Elez Fernandez, E., additional, Escudero, P., additional, Fernández-Martos, C., additional, Rodríguez, N., additional, Ruiz Casado, A., additional, Cid, J., additional, Cabezón, R., additional, Lozano, M., additional, Ginés, A., additional, Bianchi, L., additional, Garcia-Corbacho, J., additional, García de Albéniz, X., additional, Maurel, J., additional, and Benitez Ribas, D., additional

Published
2018
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94. YOSEMITE: A 3 arm double-blind randomized phase 2 study of gemcitabine, paclitaxel protein-bound particles for injectable suspension, and placebo (GAP) versus gemcitabine, paclitaxel protein-bound particles for injectable suspension and either 1 or 2 truncated courses of demcizumab (GAD).

Author

Lipton L., Manzano-Mozo J.L., Cubillo Gracian A., Dean A., Munoz A., Hidalgo M., Pazo-Cid R., Martin M., Macarulla Mercade T., Harris M., Goldstein D., Stagg R., Kolevska T., Zalupski M., Sohal D., Cooray P., Tebbutt N., Guillen-Ponce C., Maurel J., Lipton L., Manzano-Mozo J.L., Cubillo Gracian A., Dean A., Munoz A., Hidalgo M., Pazo-Cid R., Martin M., Macarulla Mercade T., Harris M., Goldstein D., Stagg R., Kolevska T., Zalupski M., Sohal D., Cooray P., Tebbutt N., Guillen-Ponce C., and Maurel J.

Abstract

Background: Delta-like ligand 4 (DLL4) is a ligand that activates the Notch pathway which is important for cancer stem cell (CSC) survival. Demcizumab is a humanized, anti-DLL4 antibody that has been shown using an in vivo tumorigenicity limiting dilution assay to inhibit tumor growth and decrease CSC frequency in minimally passaged human xenograft models. In addition, inhibition of DLL4 has also been shown in preclinical studies to cause dysfunctional sprouting of new vessels resulting in an antiangiogenic effect. Encouraging data from a Phase 1b study of paclitaxel protein-bound particles for injectable suspension (Abraxane), gemcitabine and demcizumab in patients with 1st line metastatic pancreatic cancer led to this double blind randomized 3 arm placebo-controlled Phase 2 study. Method(s): Patients with metastatic pancreatic cancer were randomized (1:1:1) to 1stline therapy with either Arm 1 - GAP, Arm 2 - GAD with a single 70 day truncated course of demcizumab or Arm 3 - GAD with two 70 day truncated courses of demcizumab (second course starting on Day 168). GA were given at usual dose & schedule, P/D was given IV on days 1 and 15 in cycles 1-3 & 7-9. The primary endpoint was progression-free survival and secondary endpoints included response, survival, safety, immunogenicity, pharmacokinetics, and biomarkers of Notch signaling and CSCs in blood, hair follicles and tumor cells. The primary study analyses compared GAP to the two pooled GAD arms. Result(s): 207 patients were randomized and 204 were treated. The median age was 63, the male/female ratio was 116/88, the ECOG 0 vs 1 distribution was 98/106, the median # metastatic sites was 2 and 74% had hepatic metastases. The response/clinical benefit rates were 41.2%/70.6% and 33.1%/74.3% in the GAP and pooled GAD arms, respectively. The median progression-free survival (PFS) (mPFS) was 5.5 months in the GAP and pooled GAD arms. The interimmedian overall survival (OS) for the GAP and pooled GAD arms were not reach

Published
2017

95. Le décor des chambres en EHPAD : pour une approche des détails du quotidien et des objets du passé depuis les résidents et au travers d’une démarche projet architectural

Author

Lebras , D, Maurel , J, Lenesley, Pauline, Laboratoire Coactis, COACTIS, COACTIS (COACTIS), and Université Lumière - Lyon 2 (UL2)-Université Jean Monnet [Saint-Étienne] (UJM)

Subjects
[SHS.ARCHI]Humanities and Social Sciences/Architecture, space management, [SHS] Humanities and Social Sciences, [SHS.ARCHI] Humanities and Social Sciences/Architecture, space management, ComputingMilieux_MISCELLANEOUS, [SHS]Humanities and Social Sciences
Abstract

International audience

Published
2016

97. Phase II randomised trial of autologous tumour lysate dendritic cell plus best supportive care compared with best supportive care in pre-treated advanced colorectal cancer patients

Author

Caballero-Banos, M, Benitez-Ribas, D, Tabera, J, Varea, S, Vilana, R, Bianchi, L, Ayuso, JR, Pages, M, Carrera, G, Cuatrecasas, M, Martin-Richard, M, Cid, J, Lozano, M, Castells, A, Garcia-Albeniz, X, Maurel, J, and Vilella, R

Subjects
Immunotherapy, Dendritic cells, Vaccine, Colorectal, Cancer
Abstract

Background: Autologous tumour lysate dendritic cell vaccine (ADC) has T-cell stimulatory capacity and, therefore, potential antitumour activity. We designed a phase II randomised trial of ADC + best supportive care (BSC) (experimental arm [EA]) compared with BSC (control arm [CA]), in pre-treated metastatic colorectal cancer (mCRC) patients. Patients and methods: Patients with progressive mCRC, at least to two chemotherapy regimens and Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2, were randomised to EA versus CA. Stratification criteria: ECOG PS (0-1 versus 2) and lactate dehydrogenase (ULN). EA was administered subcutaneously till progressive disease. Primary end-point was progression-free survival (PFS) at 4 months. Results: Fifty-two patients were included (28 EA/24 CA). An interim analysis recommended early termination for futility. No objective radiological response was observed in EA. Median PFS in EA was 2.7 months (95% confidence interval [CI], 2.3-3.2 months) versus 2.3 months (95% CI, 2.1-2.5 months) in CA (p = 0.628). Median overall survival (OS) was 6.2 months (95% CI, 4.4-7.9 months) in EA versus 4.7 months (95% CI, 2.3-7 months) in CA (p = 0.41). No ADC-related adverse events were reported. Immunization induces tumour-specific T-cell response in 21 of 25 (84%) patients. Responder patients have an OS of 7.3 months (95% CI, 5.2-9.4 months) versus 3.8 months (95% CI, 0.6-6.9 months) in non-responders; p = 0.026). Conclusion: Our randomised clinical trial comparing ADC + BSC versus BSC in mCRC demonstrates that ADC generates a tumour-specific immune response but not benefit on PFS and OS. Our results do not support the use of ADC alone, in a phase III trial. (C) 2016 Elsevier Ltd. All rights reserved.

Published
2016

99. YOSEMITE: A 3 arm double-blind randomized phase 2 study of gemcitabine, paclitaxel protein-bound particles for injectable suspension, and placebo (GAP) versus gemcitabine, paclitaxel protein-bound particles for injectable suspension and either 1 or 2 truncated courses of demcizumab (GAD)

Author

Cubillo Gracian, A., primary, Dean, A., additional, Muñoz, A., additional, Hidalgo, M., additional, Pazo-Cid, R., additional, Martin, M., additional, Macarulla Mercade, T., additional, Lipton, L., additional, Harris, M., additional, Manzano-Mozo, J.L., additional, Maurel, J., additional, Guillen-Ponce, C., additional, Tebbutt, N., additional, Cooray, P., additional, Sohal, D., additional, Zalupski, M., additional, Kolevska, T., additional, Stagg, R., additional, and Goldstein, D., additional

Published
2017
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100. GEIS-21: a multicentric phase II study of intensive chemotherapy including gemcitabine and docetaxel for the treatment of Ewing sarcoma of children and adults: a report from the Spanish sarcoma group (GEIS)

Author

Mora, J, primary, Castañeda, A, additional, Perez-Jaume, S, additional, Lopez-Pousa, A, additional, Maradiegue, E, additional, Valverde, C, additional, Martin-Broto, J, additional, Garcia del Muro, X, additional, Cruz, O, additional, Cruz, J, additional, Martinez-Trufero, J, additional, Maurel, J, additional, Vaz, M A, additional, de Alava, E, additional, and de Torres, C, additional

Published
2017
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