Pick Topic
Review Topic
List Experts
Examine Expert
Save Expert
  Site Guide ··   
Pancreatic Neoplasms: HELP
Articles by Joan Maurel
Based on 14 articles published since 2008
||||

Between 2008 and 2019, J. Maurel wrote the following 14 articles about Pancreatic Neoplasms.
 
+ Citations + Abstracts
1 Guideline [Recommendations for the diagnosis, staging and treatment of pre-malignant lesions and pancreatic adenocarcinoma]. 2016

Martin-Richard, Marta / Ginès, Angels / Ayuso, Juan Ramón / Sabater, Luis / Fabregat, Joan / Mendez, Ramiro / Fernández-Esparrach, Glòria / Molero, Xavier / Vaquero, Eva C / Cuatrecasas, Miriam / Ferrández, Antonio / Maurel, Joan / Anonymous3560884. ·Servicio de Oncología Médica, Hospital Sant Pau, Barcelona, España. Electronic address: mmartinri@santpau.cat. · Servicio de Gastroenterología, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Hospital Clínic de Barcelona, Barcelona, España. · Servicio de Radiología, Hospital Clínic de Barcelona, Barcelona, España. · Servicio de Cirugía, Hospital Clínico Universitario de Valencia, Valencia, España. · Servicio de Cirugía, Hospital de Bellvitge, Barcelona, España. · Servicio de Radiología, Hospital Clínico San Carlos, Madrid, España. · Servicio de Gastroenterología, Hospital Vall d'Hebron, Barcelona, España. · Servicio de Anatomía Patológica, Hospital Clínic de Barcelona, Barcelona, España. · Servicio de Anatomía Patológica, Hospital Clínico Universitario de Valencia, Valencia, España. · Servicio de Oncología Médica, Translational Genomics and Targeted Therapeutics in Solid Tumors Group, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Barcelona, España; Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Hospital Clínic, Barcelona, España. ·Med Clin (Barc) · Pubmed #27726847.

ABSTRACT: BACKGROUND AND OBJECTIVE: Clinical management of adenocarcinoma of the pancreas is complex, and requires a multidisciplinary approach. The same applies for the premalignant lesions that are increasingly being diagnosed. The current document is an update on the diagnosis and management of premalignant lesions and adenocarcinoma of the pancreas. PATIENTS AND METHODS: A conference to establish the basis of the literature review and manuscript redaction was organized by the Grupo Español Multidisciplinar en Cáncer Digestivo. Experts in the field from different specialties (Gastroenterology, Surgery, Radiology, Pathology, Medical Oncology and Radiation Oncology) met to prepare the present document. RESULTS: The current literature was reviewed and discussed, with subsequent deliberation on the evidence. CONCLUSIONS: Final recommendations were established in view of all the above.

2 Guideline [Recommendations for diagnosis, staging and treatment of pancreatic cancer (Part II)]. 2010

Navarro, Salvador / Vaquero, Eva / Maurel, Joan / Bombí, Josep Antoni / De Juan, Carmen / Feliu, Jaime / Fernández Cruz, Laureano / Ginés, Angels / Girela, Enrique / Rodríguez, Ricardo / Sabater, Luis / Anonymous1440657 / Anonymous1450657 / Anonymous1460657 / Anonymous1470657 / Anonymous1480657 / Anonymous1490657. ·Servicio de Gastroenterología, CIBERehd, IDIBAPS, Hospital Clínic, Universitat de Barcelona, Barcelona, España. snavarro@clinic.ub.es ·Med Clin (Barc) · Pubmed #20356609.

ABSTRACT: -- No abstract --

3 Guideline [Recommendations for diagnosis, staging and treatment of pancreatic cancer (Part I). Grupo Español de Consenso en Cáncer de Páncreas]. 2010

Navarro, Salvador / Vaquero, Eva / Maurel, Joan / Bombí, Josep Antoni / De Juan, Carmen / Feliu, Jaime / Fernández Cruz, Laureano / Ginés, Angels / Girela, Enrique / Rodríguez, Ricardo / Sabater, Luis / Anonymous44180656 / Anonymous44190656 / Anonymous44200656 / Anonymous44210656 / Anonymous44220656 / Anonymous44230656. ·Servicio de Gastroenterología, CIBERehd, IDIBAPS, Hospital Clínic, Universitat de Barcelona, Barcelona, España. snavarro@clinic.ub.es ·Med Clin (Barc) · Pubmed #20346471.

ABSTRACT: -- No abstract --

4 Clinical Trial A phase I, dose-finding study of sorafenib in combination with gemcitabine and radiation therapy in patients with unresectable pancreatic adenocarcinoma: a Grupo Español Multidisciplinario en Cáncer Digestivo (GEMCAD) study. 2014

Aparicio, Jorge / García-Mora, Carmen / Martín, Marta / Petriz, Ma Lourdes / Feliu, Jaime / Sánchez-Santos, Ma Elena / Ayuso, Juan Ramón / Fuster, David / Conill, Carlos / Maurel, Joan. ·Department of Medical Oncology, Hospital Universitario y Politécnico La Fe, Valencia, Spain. · Department of Radiation Oncology, Hospital Universitario y Politécnico La Fe, Valencia, Spain. · Department of Medical Oncology, Hospital de Sant Pau, Barcelona, Spain. · Department of Radiation Oncology, Hospital de Sant Pau, Barcelona, Spain. · Department of Medical Oncology, Hospital Universitario La Paz, Madrid, Spain. · Department of Radiation Oncology, Hospital Universitario La Paz, Madrid, Spain. · Department of Radiology, Hospital Clínic, Barcelona, Spain. · Department of Nuclear Medicine, Hospital Clínic, Barcelona, Spain. · Department of Radiation Oncology, Hospital Clínic, Barcelona, Spain. · Department of Medical Oncology, Hospital Clínic, Barcelona, Spain. ·PLoS One · Pubmed #24416138.

ABSTRACT: PURPOSE: Sorafenib, an oral inhibitor of B-raf, VEGFR2, and PDGFR2-beta, acts against pancreatic cancer in preclinical models. Due to the radio-sensitization activity of both sorafenib and gemcitabine, we designed a multicenter, phase I trial to evaluate the safety profile and the recommended dose of this combination used with concomitant radiation therapy. METHODS: Patients with biopsy-proven, unresectable pancreatic adenocarcinoma (based on vascular invasion detected by computed tomography) were treated with gemcitabine (300 mg/m2 i.v. weekly ×5 weeks) concurrently with radiation therapy (45 Gy in 25 fractions) and sorafenib (escalated doses in a 3+3 design, from 200 to 800 mg/day). Radiation portals included the primary tumor but not the regional lymph nodes. Patients with planning target volumes (PTV) over 500 cc were excluded. Cases not progressing during chemoradiation were allowed to continue with sorafenib until disease progression. RESULTS: Twelve patients were included. Three patients received 200 mg/day, 6 received 400 mg/day, and 3 received 800 mg/day; PTVs ranged from 105 to 500 cc. No dose-limiting toxicities occurred. The most common grade 2 toxicities were fatigue, neutropenia, nausea, and raised serum transaminases. Treatment was discontinued in one patient because of a reversible posterior leukoencephalopathy. There were no treatment-related deaths. CONCLUSION: The addition of sorafenib to concurrent gemcitabine and radiation therapy showed a favorable safety profile in unresectable pancreatic adenocarcinoma. A dose of 800 mg/day is recommended for phase II evaluation. TRIAL REGISTRATION: EudraCT 2007-003211-31 ClinicalTrials.gov 00789763.

5 Clinical Trial CA 19-9 as a biomarker in advanced pancreatic cancer patients randomised to gemcitabine plus axitinib or gemcitabine alone. 2009

Wasan, H S / Springett, G M / Chodkiewicz, C / Wong, R / Maurel, J / Barone, C / Rosbrook, B / Ricart, A D / Kim, S / Spano, J-P. ·Department of Cancer Medicine, Hammersmith Hospital, Du Cane Road, London W12 0HS, UK. ·Br J Cancer · Pubmed #19724276.

ABSTRACT: BACKGROUND: Response assessment in advanced pancreatic cancer (APC) is difficult and predictive markers are needed. There are insufficient data on the value of carbohydrate antigen 19-9 (CA 19-9) and cytostatic-targeted therapies. Axitinib, a selective vascular endothelial growth factor (VEGF) receptors 1, 2, 3 inhibitor, may increase overall survival (OS) in APC. METHODS: We assessed serum CA 19-9, clinical outcomes and diastolic blood pressure (dBP) in APC patients receiving gemcitabine plus axitinib (Gem+A) or gemcitabine alone. RESULTS: In the total population (N=95), median OS was significantly longer in patients with baseline CA 19-9 values at or below the median than in those with values above it (12.2 months [95% confidence interval (CI), 8.6-16.6%] vs 5.0 months [95% CI, 3.9-5.7%]; P<0.0001). This also reached significance in the Gem+A arm (median OS, 12.5 months [95% CI, 8.6-16.6%] vs 4.9 months [95% CI, 3.6-5.6%]; P<0.0001). Patients with any dBP>90 mmHg had significantly longer OS than those who did not. However, there was no predictive significance of CA 19-9. CONCLUSION: Baseline CA 19-9 levels had prognostic value for OS, but caution is advised in interpreting CA 19-9 as a predictive biomarker for novel cytostatic agents such as VEGF-targeted therapies in phase II studies.

6 Article Endoscopic ultrasonography can avoid unnecessary laparotomies in patients with pancreatic adenocarcinoma and undetected peritoneal carcinomatosis. 2017

Alberghina, Nadia / Sánchez-Montes, Cristina / Tuñón, Carlos / Maurel, Joan / Araujo, Isis K / Ferrer, Joana / Sendino, Oriol / Córdova, Henry / Vaquero, Eva C / González-Suárez, Begoña / Martínez-Palli, Graciela / Ginès, Àngels / Fernández-Esparrach, Glòria. ·Endoscopy Unit, Gastroenterology Department, ICMDiM, IDIBAPS, CIBEREHD, Hospital Clínic, Universitat de Barcelona, Barcelona, Catalunya, Spain. · Oncology Department, Hospital Clínic, Universitat de Barcelona, Barcelona, Catalunya, Spain. · Surgical Department, ICMDiM, Hospital Clínic, Universitat de Barcelona, Barcelona, Catalunya, Spain. · Gastroenterology Department, ICMDiM, IDIBAPS, CIBEREHD, Hospital Clínic, Universitat de Barcelona, Barcelona, Catalunya, Spain. · Anesthesiology Department, ICMDiM, Hospital Clínic, Universitat de Barcelona, Barcelona, Catalunya, Spain. · Endoscopy Unit, Gastroenterology Department, ICMDiM, IDIBAPS, CIBEREHD, Hospital Clínic, Universitat de Barcelona, Barcelona, Catalunya, Spain. Electronic address: mgfernan@clinic.ub.es. ·Pancreatology · Pubmed #28844696.

ABSTRACT: BACKGROUND/OBJECTIVE: To assess the relationship between the presence of ascites detected by endoscopic ultrasonography (EUS) and peritoneal carcinomatosis (PC) in patients with pancreatic adenocarcinoma. METHODS: Consecutive patients who underwent a EUS for preoperative staging of a pancreatic adenocarcinoma between 1998 and 2014 were retrospectively reviewed. The diagnosis of PC was confirmed by histopathology or peritoneal fluid cytology. The main outcome of the study was the relationship of ascites at EUS and PC in patients with pancreatic cancer. Secondarily, to evaluate the relationship between this finding and survival as well as the development of PC during follow-up. RESULTS: A total of 136 patients were included: 30 patients with local unresectable tumor or metastatic disease and 106 potentially-resectable candidates based on CT staging. EUS showed ascites in 27 (20%) patients, of whom 8 (29.6%) had PC. The sensitivity, specificity, PPV, NPV and accuracy of ascites by EUS in the detection of PC in this group of patients were 67%, 85%, 30%, 96% and 83%, respectively. Ascites detected by EUS was the only independent predictive factor of PC with an OR of 11 (CI 95%: 3-40). The detection of ascites by EUS was associated with a shorter survival (median survival time 7,3 months; range 0-60 vs 14.2 months; range 0-140) (p = 0.018) and earlier development of PC during follow-up (median 3.2 months, range 1.4-18.1 vs 12.7 months, range 5.4-54.8; p = 0.003). CONCLUSION: The finding of ascites at EUS in patients with pancreatic adenocarcinoma is highly associated with PC and a poor outcome.

7 Article SEOM Clinical Guideline for the treatment of pancreatic cancer (2016). 2016

Vera, R / Dotor, E / Feliu, J / González, E / Laquente, B / Macarulla, T / Martínez, E / Maurel, J / Salgado, M / Manzano, J L. ·Department of Medical Oncology, Complejo Hospitalario de Navarra, c/Irunlarrea-3, 31008, Pamplona, Spain. rveragar@cfnavarra.es. · Consorcio Sanitario de Terrassa, Barcelona, Spain. · Hospital Universitario la Paz, Madrid, Spain. · Complejo Hospitalario Universitario de Granada Virgen de las Nieves, Granada, Spain. · ICO-Hospitalet de LLobregat, Hospital Duran i Reynals, Hospitalet de Llobregat, Spain. · Hospital Vall`Hebron, Barcelona, Spain. · Hospital Universitario Marqués de Valdecilla, Santander, Spain. · Hospital Clínic i Provincial de Barcelona, Barcelona, Spain. · Complexo Hospitalario de Orense (CHUO), Ourense, Spain. · ICO-Badalona, Hospital Germans Trias i Pujol, Barcelona, Spain. ·Clin Transl Oncol · Pubmed #27896637.

ABSTRACT: Pancreatic cancer remains an aggressive disease with a 5 year survival rate of 5%. Only 15% of patients with pancreatic cancer are eligible for radical surgery. Evidence suggests a benefit on survival with adjuvant chemotherapy (gemcitabine o fluourouracil) after R1/R0 resection. Adjuvant chemoradiotherapy is also a valid option in patients with positive margins. Borderline resectable pancreatic cancer is defined as the involvement of the mesenteric vasculature with a limited extension. These tumors are technically resectable, but with a high risk of positive margins. Neoadjuvant treatment represents the best option for achieving an R0 resection. In advanced disease, two new chemotherapy treatment schemes (Folfirinox or Gemcitabine plus nab-paclitaxel) have showed improvements in overall survival compared with gemcitabine alone. Progress in pancreatic cancer treatment will require a better knowledge of the molecular biology of this disease, focusing on personalized cancer therapies in the near future.

8 Article Characterization of human pancreatic orthotopic tumor xenografts suitable for drug screening. 2011

Pérez-Torras, Sandra / Vidal-Pla, Anna / Miquel, Rosa / Almendro, Vanessa / Fernández-Cruz, Laureano / Navarro, Salvador / Maurel, Joan / Carbó, Neus / Gascón, Pere / Mazo, Adela. ·Departament de Bioquímica i Biologia Molecular, Institut de Biomedicina, Universitat de Barcelona, Spain. ·Cell Oncol (Dordr) · Pubmed #21681527.

ABSTRACT: BACKGROUND: Efforts to identify novel therapeutic options for human pancreatic ductal adenocarcinoma (PDAC) have failed to result in a clear improvement in patient survival to date. Pancreatic cancer requires efficient therapies that must be designed and assayed in preclinical models with improved predictor ability. Among the available preclinical models, the orthotopic approach fits with this expectation, but its use is still occasional. METHODS: An in vivo platform of 11 orthotopic tumor xenografts has been generated by direct implantation of fresh surgical material. In addition, a frozen tumorgraft bank has been created, ensuring future model recovery and tumor tissue availability. RESULTS: Tissue microarray studies allow showing a high degree of original histology preservation and maintenance of protein expression patterns through passages. The models display stable growth kinetics and characteristic metastatic behavior. Moreover, the molecular diversity may facilitate the identification of tumor subtypes and comparison of drug responses that complement or confirm information obtained with other preclinical models. CONCLUSIONS: This panel represents a useful preclinical tool for testing new agents and treatment protocols and for further exploration of the biological basis of drug responses.

9 Article [Malignancy predictive factors in pancreatic intraductal papillary mucinous neoplasm]. 2011

Adet Caldelari, Ana Celia / Miquel, Rosa / Bombi, Josep Antoni / Ginés, Angels / Fernández-Esparrach, Gloria / Ayuso, Juan Ramón / Maurel, Joan / Feu, Faust / Castells, Antoni / Fernández-Cruz, Laureano / Navarro, Salvador. ·Servicio de Gastroenterología, Institut de Malalties Digestives i Metabòliques, IDIBAPS, CIBERehd, Barcelona, Spain. ·Med Clin (Barc) · Pubmed #21414642.

ABSTRACT: BACKGROUND AND OBJECTIVE: Intraductal papillary mucinous neoplasm (IPMN) is a premalignant lesion of the pancreas. Its natural history is not well known. We evaluated the characteristics and predictor factors of malignancy of IPMN. PATIENTS AND METHOD: A retrospective analysis was performed in 88 patients diagnosed with IPMN between January 1997 and December 2008. The diagnosis was done by abdominal computed tomography (CT), pancreatic-magnetic resonance imaging (MRI) and/or endoscopic ultrasound (EUS). Gender, age, symptoms, origin, location, CA 19.9 serum levels, size of tumours and nodules by imaging techniques, type of surgery, malignancy and survival were evaluated. Nine pre-surgical variables were selected, and univariate and multivariate analysis to identify independent prognostic factors of malignancy were performed. RESULTS: The mean age was 64 years and 53% were men. 39% of tumours were incidental. 50% had their origin on the main pancreatic duct, 37% on collateral branchs and 13% were multifocal. 68% patients were operated: 42% had malignant neoplasms (32% carcinoma in situ and 68% invasive). Twelve patients died (1 benign, 1 in situ and 10 invasive). Univariate and multivariate analysis identified the symptoms and the tumour size (≥ 22 mm [median of our serie] and ≥ 30 mm [size accepted in literature]) as independent predictor factors of malignancy. CONCLUSIONS: Many IPMN are incidental findings. The presence of symptoms and size of the tumour are independent prognostic factors of malignancy and they should be considered to decide therapeutic actions.

10 Article [Incidence and characteristics of pancreatic cystic neoplasms]. 2010

Adet, Ana / Miquel, Rosa / Bombi, Josep A / Gines, Angels / Fernández-Esparrach, Gloria / De Juan, Carmen / Ayuso, Juan R / Maurel, Joan / Castells, Antoni / Fernández-Cruz, Laureano / Navarro, Salvador. ·Servicio de Gastroenterología, IDIBAPS, CIBERehd, Institut Malalties Digestives i Metabòliques, Hospital Clinic de Barcelona, Universidad de Barcelona, Barcelona, España. ·Gastroenterol Hepatol · Pubmed #20850905.

ABSTRACT: INTRODUCTION: Cystic neoplasms (CN) of the pancreas represent 10% of cystic lesions and 1% of pancreatic tumors. Mucinous cystic neoplasm (MCN), serous cystadenoma (SC) and intraductal papillary mucinous neoplasm (IPMN) are cystic neoplasms and represent more than 90% of these types of lesion. Few series have been published on these lesions, especially in Spain. AIM: To evaluate the incidence, characteristics and survival of patients with cystic neoplasms attended in our hospital in the last 12 years. PATIENTS AND METHOD: A retrospective analysis was carried out in all patients diagnosed with CN between January 1997 and December 2008. Diagnosis was made by abdominal computed tomography, pancreatic-magnetic resonance imaging and/or endoscopic ultrasonography. Sex, age, year of diagnosis, symptoms, tumoral location and size, type of surgery, pathology, and survival were evaluated. RESULTS: A total of 117 patients were analyzed. The mean age was 63±14 years and 56% were women. Eighty-eight patients had IPMN, 21 had SC and eight had MCN. Fifty-six per cent were diagnosed in the last 4 years, 42.7% were diagnosed as an incidental finding and 19% had a history of acute pancreatitis. The most frequent location was the pancreatic head (53%). The mean imaging size was 32mm. Surgical resection was performed in 69.2% of the patients. Twenty-three percent of the tumors were malignant, 30% were carcinoma in situ and 70% were invasive. Thirteen percent of the patients died; of these 93.3% had invasive carcinoma. Five-year survival was 94.7% in SC, 76% in IPMN and 60% in MCN. CONCLUSIONS: CN were mainly identified as incidental findings, although acute pancreatitis is another possible cause. The most frequent tumor in our environment is IPMN. Surgical treatment of IPMN and MCN, at the right moment, may be useful to prevent the development of pancreatic carcinoma.

11 Article Pancreatic cancer: incidence, treatment and survival trends--1175 cases in Calvados (France) from 1978 to 2002. 2009

Lefebvre, A-C / Maurel, J / Boutreux, S / Bouvier, V / Reimund, J-M / Launoy, G / Arsene, D. ·Service d'hépato-gastro-entérologie et nutrition, pôle rein-digestif-nutrition, hôpital Côte-de-Nacre, CHU de Caen, 14033 Caen cedex, France. ·Gastroenterol Clin Biol · Pubmed #19773140.

ABSTRACT: AIM: To assess the trends in incidence, therapeutic modalities and survival of pancreatic cancer between 1978 and 2002 in a well-defined population, as recorded in the Calvados digestive cancer registry database. PATIENTS AND METHODS: All patients living in Calvados with a diagnosis of pancreatic cancer were registered. Clinical data and treatment modalities were prospectively recorded. This 25-year database was divided into five 5-year periods. Data were compared using log-rank tests and the Cox model. RESULTS: A total of 1175 cases of pancreatic cancer (617 men, 558 women) were registered. Its incidence increased with an average annual coefficient of +2.8% in men and +5.1% in women. Therapeutic modalities changed over the five time periods: surgical resection increased from 6.8 to 13.4% (median survival 15 months) while radiation therapy and/or chemotherapy also increased from 5.5 to 13.2%. Palliative surgery decreased from 54.6 to 32.0% and favored interventional endoscopic techniques. Postoperative mortality decreased significantly. Survival increased significantly over the five time periods, although the median survival time remained stable (4 months). CONCLUSION: From 1978 to 2002, pancreatic cancer incidence increased in Calvados (France). Therapeutic modalities changed, with endoscopic treatments preferred over palliative surgery. The improvement in survival could be explained by the decrease in postoperative mortality.

12 Article [Prediction of prognosis of patients with pancreatic adenocarcinoma with curative intent resection by means of histologic grade and pathologic N stage]. 2009

Soriano-Izquierdo, Antonio / Adet, Ana C / Gallego, Rosa / Miquel, Rosa / Castells, Antoni / Pellisé, María / Nadal, Cristina / López-Boado, Miguel A / Piqué, Josep M / Gascón, Pere / Conill, Carles / Bombí, Antoni / Fernández-Cruz, Laureano / Maurel, Joan / Navarro, Salvador. ·Servicio de Gastroenterología, Institut de Malalties Digestives i Metabòliques, Hospital Clínic. Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), CIBERehd. Universidad de Barcelona, Barcelona, España. ·Med Clin (Barc) · Pubmed #19211081.

ABSTRACT: BACKGROUND AND OBJECTIVE: Pancreatic cancer has the poorest prognosis of any common gastrointestinal malignancy, with a 5-year overall survival of less than 5%. A better knowledge of prognostic factors related to this neoplasia might help improve the survival of these patients. We evaluated the prognostic significance of different factors in both overall survival and tumor recurrence in patients with pancreatic adenocarcinoma who had undergone pancreatic resection with curative intent. PATIENTS AND METHOD: All patients with pancreatic adenocarcinoma submitted to surgical resection in our unit from January 1995 to February 2005 were evaluated. Twenty-three pre-surgical, therapeutic, and histopathologic variables were analyzed. Univariate (Kaplan-Meier, log-rank test) and multivariate (Cox regression) analyses were performed to select independent prognostic factors. RESULTS: Ninety-four patients were evaluated. The median age of patients was 63 years and 53% were woman. The probability of overall survival was 63% at 1 year, 18% at 3 years, and 8% at 5 years, with a median survival of 18 months. Univariate analysis identified performance of adjuvant therapy, histologic grade, percentage of involved-resected lymph nodes, pathologic N stage, and pathologic TNM stage as variables associated with overall survival. On the other hand, the probability of tumor recurrence was 52% at 1 year, 83% at 3 years, and 91% at 5 years, with a median time to tumor recurrence of 12 months. Predictive variables of tumor recurrence in the univariate analysis were preoperative N stage, preoperative TNM stage, postoperative CA 19.9 serum concentration, histological grade, percentage of involved-resected lymph nodes, pathologic N stage and pathologic TNM stage. Multivariate analysis identified histological grade and pathologic N stage as independent predictive factors of both overall survival (histologic grade: HR=2.341 [CI 95%, 1.342-4.098; p=0.003]; pathologic N stage: HR=2.242 [1.213-4.149; p=0.01]) and tumor recurrence (histological grade: HR=1.742 [CI 95%, 1.121-3.086; p=0.05]; pathologic N stage: HR=2.096 [1.089-4.032; p=0.027]). CONCLUSIONS: The histological grade and pathologic N stage predict the prognosis of patients with pancreatic adenocarcinoma after surgical resection.

13 Article Patient-reported outcomes as a component of the primary endpoint in a double-blind, placebo-controlled trial in advanced pancreatic cancer. 2009

Eckhardt, S Gail / De Porre, Peter / Smith, David / Maurel, Joan / Steward, William P / Bouche, Olivier / van de Velde, Helgi / Michiels, Bart / Bugat, Roland. ·Developmental Therapeutics and GI Malignancies, University of Colorado Health Sciences Center, Aurora, Colorado 80045, USA. Gail.Eckhardt@UCHSC.edu ·J Pain Symptom Manage · Pubmed #18723314.

ABSTRACT: In this randomized, double-blind, placebo-controlled study comparing gemcitabine+tipifarnib (G+t) or gemcitabine+placebo (G+p) in patients with pancreatic cancer, the primary endpoint of time to deterioration (TTD) was based primarily on patient-reported outcomes. Deterioration was defined as death or worsening of disease-related symptoms, based on patient-reported outcomes of pain intensity and analgesic use in a daily diary, plus investigator-rated weekly performance status. Secondary endpoints included survival and safety. Two hundred and forty-four patients were treated for a total of 4780 weeks, during which the diary was completed daily. Overall, the completion of the diary was found to be feasible: patients completed approximately 95% of scheduled diary entries. Baseline characteristics were well balanced between the two treatment arms. The primary endpoint of TTD was not significantly different between the G+t arm (69 days) and the G+p arm (91 days, P=0.40). Survival was not significantly different between the G+t arm (202 days) and the G+p arm (221 days, P=0.66). The combination of G+t had an acceptable toxicity profile, with primarily neutropenia and thrombocytopenia. Methodologically, measurement of patient-reported outcomes is feasible and useful in assessing the effect of anti-cancer therapy in pancreatic cancer if comprehensive initial and ongoing training is provided to all people involved, including not only the patients but also the study personnel.

14 Article Efficacy of gemcitabine plus axitinib compared with gemcitabine alone in patients with advanced pancreatic cancer: an open-label randomised phase II study. 2008

Spano, Jean-Philippe / Chodkiewicz, Catherine / Maurel, Joan / Wong, Ralph / Wasan, Harpreet / Barone, Carlo / Létourneau, Richard / Bajetta, Emilio / Pithavala, Yazdi / Bycott, Paul / Trask, Peter / Liau, Katherine / Ricart, Alejandro D / Kim, Sinil / Rixe, Olivier. ·Hôpital de la Pitié Salpêtrière, Paris, France. jean-philippe.spano@psl.ap-hop-paris.fr ·Lancet · Pubmed #18514303.

ABSTRACT: BACKGROUND: Axitinib (AG-013736) is a potent and selective oral inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, which have an important role in pancreatic cancer. The aim of this study was to assess the safety and efficacy of gemcitabine plus axitinib versus gemcitabine alone. METHODS: Between January and August, 2006, 103 patients with unresectable, locally advanced, or metastatic pancreatic cancer were randomly assigned in a two to one ratio to receive gemcitabine (1000 mg/m(2)) plus axitinib 5 mg twice daily (n=69) or gemcitabine (1000 mg/m(2)) alone (n=34) by a centralised registration system. The primary endpoint was overall survival. Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00219557. FINDINGS: All randomised patients were included in the efficacy analyses. Median overall survival was longer with gemcitabine plus axitinib than with gemcitabine alone (6.9 [95% CI 5.3-10.1] months vs 5.6 [3.9-8.8] months). The hazard ratio for survival with gemcitabine plus axitinib versus with gemcitabine alone, adjusted for stratification factors, was 0.71 (95% CI 0.44-1.13). The most common grade 3 or worse adverse events were fatigue (15 [22%] patients in the gemcitabine plus axitinib group vs one [3%] in the gemcitabine alone group), abdominal pain (eight [12%] vs five [16%]), and asthenia (eight [12%] vs one [3%]). INTERPRETATION: Gemcitabine plus axitinib showed a similar safety profile to gemcitabine alone; the small, non-statistically significant gain in overall survival needs to be assessed in a randomised phase III trial.