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1. Nomogram for Estimating Overall Survival in Patients With Metastatic Pancreatic Cancer

Author

Michele Reni, David Goldstein, Chrystal U. Louis, Josep Tabernero, Marc F. Botteman, Abdalla Aly, Chee Khoon Lee, Daniel D. Von Hoff, Sandra Margunato-Debay, Desmond McGovern, Brian Lu, E. Gabriela Chiorean, Ramesh K. Ramanathan, Institut Català de la Salut, [Goldstein D] Department of Medical Oncology, Prince of Wales Hospital, Randwick. Prince of Wales Clinical School, University of New South Wales, New South Wales, Australia. [Von Hoff DD] Division of Molecular Medicine, Translational Genomics Research Institute, Phoenix, AZ. HonorHealth, Scottsdale, AZ. [Chiorean EG] Department of Medicine and Oncology, University of Washington, Fred Hutchinson Cancer Research Center, Seattle, WA. [Reni M] Department of Oncology, San Raffaele Scientific Institute, Milan, Italy. [Tabernero J] Servei d’Oncologia Mèdica, Vall d'Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. UVic-UCC, IOB-Quiron, CIBERONC, Barcelona, Spain. [Ramanathan RK] Department of Hematology and Oncology, Mayo Clinic, Scottsdale, AZ, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Male, Oncology, Nomografia (Matemàtica), Endocrinology, Diabetes and Metabolism, Kaplan-Meier Estimate, Deoxycytidine, 0302 clinical medicine, Endocrinology, metastatic pancreatic cancer, Antineoplastic Combined Chemotherapy Protocols, Outcome Assessment, Health Care, Medicine, Investigative Techniques::Epidemiologic Methods::Statistics as Topic::Models, Statistical::Investigative Techniques::Nomograms [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], nab-paclitaxel plus gemcitabine, neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias pancreáticas [ENFERMEDADES], Liver Neoplasms, Prognosis, 030220 oncology & carcinogenesis, ComputingMethodologies_DOCUMENTANDTEXTPROCESSING, Female, 030211 gastroenterology & hepatology, medicine.drug, medicine.medical_specialty, Paclitaxel, Adenocarcinoma, técnicas de investigación::métodos epidemiológicos::estadística como asunto::modelos estadísticos::técnicas de investigación::nomogramas [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], nomogram, 03 medical and health sciences, Internal medicine, Metastatic pancreatic cancer, Internal Medicine, Overall survival, Humans, Clinical significance, Proportional Hazards Models, Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Pancreatic Neoplasms [DISEASES], Pàncrees - Càncer, Hepatology, business.industry, Reproducibility of Results, Original Articles, Metastatic Pancreatic Adenocarcinoma, Nomogram, Gemcitabine, Confidence interval, clinical variables, Pancreatic Neoplasms, Clinical trial, Nomograms, Multivariate Analysis, business
Abstract

Supplemental digital content is available in the text., Objectives This analysis investigated nomogram use to evaluate metastatic pancreatic cancer prognosis. Methods Thirty-four baseline factors were examined in the Metastatic Pancreatic Adenocarcinoma Clinical Trial (MPACT) (nab-paclitaxel plus gemcitabine vs gemcitabine) data set. Factors significantly (P < 0.1) associated with overall survival (OS) in a univariable model or with known clinical relevance were tested further. In a multivariable model, factors associated with OS (P < 0.1) were selected to generate the primary nomogram, which was internally validated using bootstrapping, a concordance index, and calibration plots. Results Using data from 861 patients, 6 factors were retained (multivariable analysis): neutrophil-lymphocyte ratio, albumin level, Karnofsky performance status, sum of longest diameter of target lesions, presence of liver metastases, and previous Whipple procedure. The nomogram distinguished low-, medium-, and high-risk groups (concordance index, 0.67; 95% confidence interval, 0.65–0.69; median OS, 11.7, 8.0, and 3.3 months, respectively). Conclusions This nomogram may guide estimates of the range of OS outcomes and contribute to patient stratification in future prospective metastatic pancreatic cancer trials; however, external validation is required to improve estimate reliability and applicability to a general patient population. Caution should be exercised in interpreting these results for treatment decisions: patient characteristics could differ from those included in the nomogram development.

Published
2020
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2. Development of a quality of life questionnaire for patients with pancreatic neuroendocrine tumours (the PANNET module)

Author

John K, Ramage, Elizabeth, Friend, Jordan, Randell, Barbara, King, Paz, Fernandez Ortega, Mairéad G, McNamara, Gregory, Kaltsas, Massimo, Falconi, Jaroslav, Cwikla, Jaume, Capdevila, Simona, Grozinsky-Glasberg, Dalvinder, Mandair, Eva, Gamper, Raj, Srirajaskanthan, Martin, O Weickert, Debra, Gray, Institut Català de la Salut, [Ramage JK, Friend E, King B] Hampshire Hospitals NHS Foundation Trust, Basingstoke, UK. [Randell J] University of Winchester, Winchester, UK. [Fernandez Ortega P] Institut Catala d’Oncologia, Barcelona, Spain. [McNamara MG] Division of Cancer Sciences, University of Manchester/The Christie NHS Foundation Trust, Manchester, UK. [Capdevila J] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall Hebron Institute of Oncology (VHIO), Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Quality of life, Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Pancreatic Neoplasms [DISEASES], Neuroendocrinologia, Pàncrees - Càncer, Manchester Cancer Research Centre, Endocrine and Autonomic Systems, ResearchInstitutes_Networks_Beacons/mcrc, Endocrinology, Diabetes and Metabolism, Neuroendocrinology, Qüestionaris, Pancreatic Neoplasms, Neuroendocrine Tumors, Cellular and Molecular Neuroscience, Endocrinology, Qualitat de vida, Surveys and Questionnaires, Quality of Life, Humans, neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias pancreáticas [ENFERMEDADES], Càncer de pàncrees, Pancreas cancer, Tumors
Abstract

Gastrinoma; Insulinoma; Pancreatic neuroendocrine tumour Gastrinoma; Insulinoma; Tumor neuroendocrino pancreático Gastrinoma; Insulinoma; Tumor neuroendocrí pancreàtic Pancreatic neuroendocrine tumours (panNET) are heterogeneous neoplasms usually characterised by slow growth and secretion of hormones, which often cause symptoms. The effect of these symptoms on quality of life (QoL) has not previously been examined in detail. EORTC (European Organisation for Research and Treatment of Cancer) guidelines were followed in phases 1–3 to produce a potential module of questions usable for trials in panNET, focusing on three common types of panNET. For two less common types, a list of symptoms was constructed. Following an extensive literature search and phase 1a interviews with patients and healthcare workers, a long list of potential issues (169) was obtained. This list was shown to 12 patients from three countries in phase 1b interviews to check that no items were missed. The list was reduced to 57 issues. The list of issues was converted to questions, mainly from existing validated questions within the EORTC item library. The list of questions was then used in a phase 3 international study in eight countries using seven languages. A provisional module of 24 items is presented for use in nonfunctioning panNET, gastrinoma and insulinoma. This module increases knowledge concerning QoL in this condition and may be a useful adjunct in clinical trials. A phase 4 trial is being considered for validation of this questionnaire.

Published
2022
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3. A multilayered post-GWAS assessment on genetic susceptibility to pancreatic cancer

Author

Manuel Hidalgo, D Easton, William Greenhalf, Paige M. Bracci, Víctor Manuel Barberá, Alan A. Arslan, Enrique Dominguez-Munoz, Isabel Adoración Martín-Antoniano, Luis Arnes, L. Ilzarbe, Rita T. Lawlor, Stephen J. Chanock, Marc A. Marti-Renom, Luis Muñoz-Bellvís, LT Amundadottir, BM Wolpin, M Gunter, F.X. Real, L Beane-Freeman, Josefina Mora, Jörg Kleeff, PJ Goodman, Tatjana Crnogorac-Jurcevic, Juan Antonio Rodríguez, B Kong, K Visvanathan, Harvey A. Risch, S Gallinger, Debra T. Silverman, O Lao, Joaquim Balsells, Damian O'Driscoll, M O’Rorke, Núria Malats, D Albanes, A. Carrato, Epicuro Investigators, Eithne Costello, RZ Stolzenberg-Solomon, Esther Molina-Montes, PanGenEU Study Investigators, Xavier Molero, RE Neale, Paulina Gomez-Rubio, Thornquist, Weimin Ye, Nathanial Rothman, Xiao-Ou Shu, Laura C. Alonso, Ulrike Peters, Mirari Marquez, Wei Zheng, Aldo Scarpa, Ll Cecchini, Thomas M. Gress, Alison P. Klein, F Canzian, D Li, Adonina Tardón, A Farré, Manolis Kogevinas, M Garcia-Closas, GM Petersen, B Bueno-de-Mesquita, Mar Iglesias, MJ Sánchez, José Perea, Christoph W. Michalski, M Du, Linda Sharp, JM Gaziano, Matthias Löhr, J Yu, L LeMarchand, J Buring, E. López de Maturana, Paul Brennan, Malats, Núria [0000-0003-2538-3784], Apollo - University of Cambridge Repository, Institut Català de la Salut, [López de Maturana E, Alonso L, Molina-Montes E, Martín-Antoniano IA] Genetic and Molecular Epidemiology Group, Spanish National Cancer Research Center (CNIO), C/Melchor Fernandez Almagro 3, 28029 Madrid, Spain. CIBERONC, Madrid, Spain. [Rodríguez JA, Lao O] CNAG-CRG, Centre for Genomic Regulation (CRG), Barcelona Institute of Science and Technology (BIST), Barcelona, Spain. [Molero X, Balsells J] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain. CIBEREHD, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Genetic Phenomena::Genotype::Genetic Predisposition to Disease [PHENOMENA AND PROCESSES], Complex disease, lcsh:Medicine, Genome-wide association study, Genome, Linkage Disequilibrium, European descent, 0302 clinical medicine, Gene Regulatory Networks, neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias pancreáticas [ENFERMEDADES], Genetics (clinical), 0303 health sciences, Phenotype, 3. Good health, ddc, 030220 oncology & carcinogenesis, Molecular Medicine, Malalties congènites, Signal Transduction, Prioritization, Pancreatic cancer risk, Investigative Techniques::Epidemiologic Methods::Epidemiologic Research Design::Genome-Wide Association Study [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], lcsh:QH426-470, Systems biology, In silico, Computational biology, Biology, 03 medical and health sciences, SDG 3 - Good Health and Well-being, Cell Line, Tumor, Pancreatic cancer, Genetics, Biomarkers, Tumor, Genetic predisposition, medicine, Genetic susceptibility, Humans, Computer Simulation, Genetic Predisposition to Disease, Genome-wide association analysis, Molecular Biology, Gene, Spatial analysis, fenómenos genéticos::genotipo::predisposición genética a la enfermedad [FENÓMENOS Y PROCESOS], 030304 developmental biology, Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Pancreatic Neoplasms [DISEASES], Pàncrees - Càncer, Local indices of genome spatial autocorrelation, Genome, Human, 3D genomic structure, Research, lcsh:R, Reproducibility of Results, medicine.disease, Human genetics, Pancreatic Neoplasms, lcsh:Genetics, técnicas de investigación::métodos epidemiológicos::diseño de la investigación epidemiológica::estudio de asociación genómica completa [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Genome-Wide Association Study
Abstract

The work was partially supported by Fondo de Investigaciones Sanitarias (FIS), Instituto de Salud Carlos III, Spain (PI061614, PI11/01542, PI0902102, PI12/01635, PI12/00815, PI15/01573, PI18/01347); Red Temática de Investigación Cooperativa en Cáncer, Spain (RD12/0036/0034, RD12/0036/ 0050, RD12/0036/0073); Spanish Ministerio de Ciencia, Innovación y Universidades (BFU2017-85926-P), López de Maturana, E., Rodríguez, J.A., Alonso, L., Lao, O., Molina-Montes, E., Martín-Antoniano, I.A., Gómez-Rubio, P., Lawlor, R., Carrato, A., Hidalgo, M., Iglesias, M., Molero, X., Löhr, M., Michalski, C., Perea, J., O’Rorke, M., Barberà, V.M., Tardón, A., Farré, A., Muñoz-Bellvís, L., Crnogorac-Jurcevic, T., Domínguez-Muñoz, E., Gress, T., Greenhalf, W., Sharp, L., Arnes, L., Cecchini, L., Balsells, J., Costello, E., Ilzarbe, L., Kleeff, J., Kong, B., Márquez, M., Mora, J., O’Driscoll, D., Scarpa, A., Ye, W., Yu, J., García-Closas, M., Kogevinas, M., Rothman, N., Silverman, D.T., Albanes, D., Arslan, A.A., Beane-Freeman, L., Bracci, P.M., Brennan, P., Bueno-de-Mesquita, B., Buring, J., Canzian, F., Du, M., Gallinger, S., Gaziano, J.M., Goodman, P.J., Gunter, M., LeMarchand, L., Li, D., Neale, R.E., Peters, U., Petersen, G.M., Risch, H.A., Sánchez, M.J., Shu, X.-O., Thornquist, M.D., Visvanathan, K., Zheng, W., Chanock, S.J., Easton, D., Wolpin, B.M., Stolzenberg-Solomon, R.Z., Klein, A.P., Amundadottir, L.T., Marti-Renom, M.A., Real, F.X., Malats, N., PanGenEU Investigators, SBC/EPICURO Investigators

Published
2021
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4. Liposomal irinotecan and 5-fluorouracil/leucovorin in older patients with metastatic pancreatic cancer - A subgroup analysis of the pivotal NAPOLI-1 trial

Author

J. Chen, Floris A. de Jong, Jean-Frédéric Blanc, Teresa Macarulla, Andrea Wang-Gillam, Beloo Mirakhur, Li-Tzong Chen, Jens T. Siveke, Institut Català de la Salut, [Macarulla T] Vall d'Hebron Hospital Universitari, Barcelona, Spain. Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Blanc JF] Pôle ADEN, Hôpital Haut-Lévêque, CHU Bordeaux, Bordeaux, France. [Wang-Gillam A] Division of Oncology, Washington University in St. Louis, MO, USA. [Chen LT] National Institute of Cancer Research, National Health Research Institutes, National Cheng Kung University, Tainan, Taiwan. Department of Internal Medicine, National Cheng Kung University, Tainan, Taiwan. [Siveke JT] Division of Solid Tumor Translational Oncology, West German Cancer Center, University Hospital Essen, Essen, Germany. Cancer Consortium (DKTK, partner site Essen), German Cancer Research Center, DKFZ, Heidelberg, Germany. [Mirakhur B] Ipsen Biopharmaceuticals, Inc., Cambridge, MA, United States, Vall d'Hebron Barcelona Hospital Campus, and Hospital Universitari Vall d'Hebron

Subjects
Adult, Oncology, medicine.medical_specialty, Heterocyclic Compounds::Heterocyclic Compounds, 1-Ring::Pyrimidines::Pyrimidinones::Uracil::Fluorouracil [CHEMICALS AND DRUGS], Population, Leucovorin, Medizin, Subgroup analysis, Disease, Adenocarcinoma, Irinotecan, 03 medical and health sciences, 0302 clinical medicine, Metàstasi, Pancreatic cancer, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, 030212 general & internal medicine, education, neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias pancreáticas [ENFERMEDADES], Aged, Aged, 80 and over, Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Pancreatic Neoplasms [DISEASES], education.field_of_study, Otros calificadores::Otros calificadores::/administración & dosificación [Otros calificadores], Pàncrees - Càncer, business.industry, Age Factors, Neoplasms::Neoplastic Processes::Neoplasm Metastasis [DISEASES], Middle Aged, Metastatic Pancreatic Adenocarcinoma, medicine.disease, Gemcitabine, Pancreatic Neoplasms, compuestos heterocíclicos::compuestos heterocíclicos de 1 anillo::pirimidinas::pirimidinonas::uracilo::fluorouracilo [COMPUESTOS QUÍMICOS Y DROGAS], Fluorouracil, neoplasias::procesos neoplásicos::metástasis neoplásica [ENFERMEDADES], 030220 oncology & carcinogenesis, Liposomal Irinotecan, Other subheadings::Other subheadings::/administration & dosage [Other subheadings], Geriatrics and Gerontology, Medicaments - Administració, business, medicine.drug
Abstract

Irinotecan liposomal; Pacients grans; Càncer de pàncrees Irinotecán liposomal; Pacientes mayores; Cáncer de páncreas Liposomal irinotecan; Older patients; Pancreatic cancer Objectives Pancreatic cancer is a highly lethal disease predominantly affecting older patients. Characterization of outcomes in these patients may help optimise treatment decisions. The global, phase 3 NAPOLI-1 trial ( NCT01494506 ) demonstrated an overall survival (OS) benefit with liposomal irinotecan and 5-flurouracil/leucovorin (nal-IRI + 5-FU/LV) versus 5-FU/LV. This subgroup analysis explored impact of age on outcomes in NAPOLI-1 patients, and nal-IRI + 5-FU/LV efficacy and safety in older patients. Materials and Methods This exploratory, post-hoc analysis of the NAPOLI-1 trial included patients aged ≥eighteen years (no upper limit) with metastatic pancreatic adenocarcinoma that had progressed on gemcitabine-based therapy. Patients were stratified by age (cut-offs at 65, 70, and 75 years); OS and progression-free survival (PFS) were estimated by Kaplan-Meier analysis. Results Of 417 randomized patients, 192 (46%), 110 (26%) and 43 (10%) were aged ≥65, ≥70 and ≥ 75 years, respectively. Mortality risk and risk of disease progression were similar in older and younger patients independent of treatment (HRs for median [m]OS/mPFS comparisons were 0.88/0.95 [ .25). Reduced mortality/morbidity risk with nal-IRI + 5-FU/LV in older subgroups was in line with the wider population. No additional toxicities with nal-IRI + 5-FU/LV were observed in older patients: 86% of patients ≥75 years versus 69%

Published
2019

5. Health-related quality of life in patients with a germline BRCA mutation and metastatic pancreatic cancer receiving maintenance olaparib

Author

Hammel P., Kindler H. L., Reni M., Van Cutsem E., MacArulla T., Hall M. J., Park J. O., Hochhauser D., Arnold D., Oh D. -Y., Reinacher-Schick A., Tortora G., Algul H., O'Reilly E. M., McGuinness D., Cui K. Y., Joo S., Yoo H. K., Patel N., Golan T., Chantrill L., Goldstein D., Joubert W., Pavlakis N., Tognela A., Van Fraeyenhove F., Van Laethem J. -L., Peeters M., Dhani N., Kavan P., Lemay F., Adenis A., Artru P., Baba-Hamed N., Belletier C., Ben Abdelghani M., Blanc J. -F., Borg C., Coriat R., Deplanque G., Faroux R., Follana P., Guimbaud R., El Hajbi F., Hautefeuille V., Malka D., Metges J. -P., Tougeron D., Walter T., Ettrich T., Hacker U. T., Hennes E., Jacobasch L., Kanzler S., Pession U., Scholz C., Sinn M., Stein A., Strassburg C., Vogel A., Ben-Shahar M., Brenner R., Epelbaum R., Geva R., Gluzman A., Idelevich E., Kolin M., Semenisty V., Shai A., Stemmer S., Yarom N., Celio L., Conte P., Garufi C., Gianni L., Leonardi F., Maiello E., Di Marco M., Milella M., Pinto C., Santini D., Scartozzi M., Vaccaro V., Vasile E., Kim J. -W., Oh Park J., Wilmink H., Gallego R. A., Ogalla G. D., Velasco A. G., Cabanas E. G., Gomez Martin C., Ponce C. G., Saez B. L., Lopez R., Martin A. M., Pazo R., Pijaume C. P., Rodriguez J., Yaya-Tur R., Arora A., Anthoney D. A., Jeffrey Evans T. R., Harrison M., Palmer D., Sarker D., Starling N., Valle J., Wall L., Agajanian R., Bearden J., Bekaii-Saab T., Carter C., Cohen D., Distefano A., Dragovich T., Ejadi S., Ford J., Grabelsky S., Hall M., Hochster H., Hosein P., Javle M., Kindler H., Lacy J., Laheru D., Leong S., Lowery M., Marsh R., Noonan A., Oberstein P., Ocean A., O'Reilly E., Ryan D., Seery T., Subramaniam S., Van Echo D., Wang-Gillam A., Weekes C., Welch S., Hammel P., Kindler H.L., Reni M., Van Cutsem E., MacArulla T., Hall M.J., Park J.O., Hochhauser D., Arnold D., Oh D.-Y., Reinacher-Schick A., Tortora G., Algul H., O'Reilly E.M., McGuinness D., Cui K.Y., Joo S., Yoo H.K., Patel N., Golan T., Chantrill L., Goldstein D., Joubert W., Pavlakis N., Tognela A., Van Fraeyenhove F., Van Laethem J.-L., Peeters M., Dhani N., Kavan P., Lemay F., Adenis A., Artru P., Baba-Hamed N., Belletier C., Ben Abdelghani M., Blanc J.-F., Borg C., Coriat R., Deplanque G., Faroux R., Follana P., Guimbaud R., El Hajbi F., Hautefeuille V., Malka D., Metges J.-P., Tougeron D., Walter T., Ettrich T., Hacker U.T., Hennes E., Jacobasch L., Kanzler S., Pession U., Scholz C., Sinn M., Stein A., Strassburg C., Vogel A., Ben-Shahar M., Brenner R., Epelbaum R., Geva R., Gluzman A., Idelevich E., Kolin M., Semenisty V., Shai A., Stemmer S., Yarom N., Celio L., Conte P., Garufi C., Gianni L., Leonardi F., Maiello E., Di Marco M., Milella M., Pinto C., Santini D., Scartozzi M., Vaccaro V., Vasile E., Kim J.-W., Oh Park J., Wilmink H., Gallego R.A., Ogalla G.D., Velasco A.G., Cabanas E.G., Gomez Martin C., Ponce C.G., Saez B.L., Lopez R., Martin A.M., Pazo R., Pijaume C.P., Rodriguez J., Yaya-Tur R., Arora A., Anthoney D.A., Jeffrey Evans T.R., Harrison M., Palmer D., Sarker D., Starling N., Valle J., Wall L., Agajanian R., Bearden J., Bekaii-Saab T., Carter C., Cohen D., Distefano A., Dragovich T., Ejadi S., Ford J., Grabelsky S., Hall M., Hochster H., Hosein P., Javle M., Kindler H., Lacy J., Laheru D., Leong S., Lowery M., Marsh R., Noonan A., Oberstein P., Ocean A., O'Reilly E., Ryan D., Seery T., Subramaniam S., Van Echo D., Wang-Gillam A., Weekes C., Welch S., Institut Català de la Salut, [Hammel P] Department of Digestive Oncology, Hôpital Beaujon (AP-HP), Clichy, and University Paris VII, Paris, France. [Kindler HL] Department of Medicine, Section of Hematology/Oncology, University of Chicago, Chicago, USA. [Reni M] Department of Oncology, IRCCS Ospedale San Raffaele Scientific Institute, Milan, Italy. [Van Cutsem E] Division of Digestive Oncology, University Hospitals Gasthuisberg and KU Leuven, Leuven, Belgium. [Macarulla T] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology, Barcelona, Spain. [Hall MJ] Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, USA, Vall d'Hebron Barcelona Hospital Campus, CCA - Cancer Treatment and Quality of Life, and Oncology

Subjects
Male, 0301 basic medicine, Oncology, medicine.medical_treatment, BRCA, pancreatic cancer, Disease, Other subheadings::Other subheadings::/drug therapy [Other subheadings], Piperazines, Germline, Medicaments antineoplàstics, chemistry.chemical_compound, 0302 clinical medicine, Quality of life, Neoplasm Metastasis, neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias pancreáticas [ENFERMEDADES], ambiente y salud pública::salud pública::medidas epidemiológicas::demografía::estado de salud::calidad de vida [ATENCIÓN DE SALUD], BRCA1 Protein, Neoplasms::Neoplastic Processes::Neoplasm Metastasis [DISEASES], Hematology, Middle Aged, Progression-Free Survival, humanities, 3. Good health, metastatic, health-related quality of life, 030220 oncology & carcinogenesis, Female, Adult, medicine.medical_specialty, Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], Poly(ADP-ribose) Polymerase Inhibitors, Placebo, olaparib, Olaparib, 03 medical and health sciences, Double-Blind Method, Metàstasi, Pancreatic cancer, Internal medicine, Gastrointestinal Tumors, medicine, Humans, Germ-Line Mutation, Aged, BRCA2 Protein, Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Pancreatic Neoplasms [DISEASES], Chemotherapy, Pàncrees - Càncer, business.industry, BRCA mutation, Original Articles, medicine.disease, Pancreatic Neoplasms, Environment and Public Health::Public Health::Epidemiologic Measurements::Demography::Health Status::Quality of Life [HEALTH CARE], 030104 developmental biology, chemistry, neoplasias::procesos neoplásicos::metástasis neoplásica [ENFERMEDADES], Quality of Life, Phthalazines, Neoplasm Recurrence, Local, business
Abstract

Qualitat de vida relacionada amb la salut; Olaparib; Càncer de pàncrees Calidad de vida relacionada con la salud; Olaparib, Cáncer de páncreas Health-related quality of life; Olaparib; Pancreatic cancer Background Patients with metastatic pancreatic cancer often have a detriment in health-related quality of life (HRQoL). In the randomized, double-blind, phase III POLO trial progression-free survival was significantly longer with maintenance olaparib, a poly(ADP-ribose) polymerase inhibitor, than placebo in patients with a germline BRCA1 and/or BRCA2 mutation (gBRCAm) and metastatic pancreatic cancer whose disease had not progressed during first-line platinum-based chemotherapy. The prespecified HRQoL evaluation is reported here. Patients and methods Patients were randomized to receive maintenance olaparib (300 mg b.i.d.; tablets) or placebo. HRQoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item module at baseline, every 4 weeks until disease progression, at discontinuation, and 30 days after last dose. Scores ranged from 0 to 100; a ≥10-point change or difference between arms was considered clinically meaningful. Adjusted mean change from baseline was analysed using a mixed model for repeated measures. Time to sustained clinically meaningful deterioration (TSCMD) was analysed using a log-rank test. Results Of 154 randomized patients, 89 of 92 olaparib-arm and 58 of 62 placebo-arm patients were included in HRQoL analyses. The adjusted mean change in Global Health Status (GHS) score from baseline was

Published
2019

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