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

التفاصيل البيبلوغرافية
العنوان:	Health-related quality of life in patients with a germline BRCA mutation and metastatic pancreatic cancer receiving maintenance olaparib
المؤلفون:	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.
المساهمون:	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.
سنة النشر:	2019
المجموعة:	IRIS Università degli Studi di Bologna (CRIS - Current Research Information System)
مصطلحات موضوعية:	BRCA, health-related quality of life, metastatic, olaparib, pancreatic cancer
الوصف:	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 <10 points in both arms and there was no significant between-group difference [-2.47; 95% confidence interval (CI) -7.27, 2.33; P = 0.31]. Analysis of physical functioning scores showed a significant between-group difference (-4.45 points; 95% CI -8.75, -0.16; P = 0.04). There was no difference in TSCMD for olaparib versus placebo for GHS [P = 0.25; hazard ratio (HR) 0.72; 95% CI 0.41, 1.27] or physical functioning (P = 0.32; HR 1.38; 95% CI 0.73, 2.63). Conclusions: HRQoL was preserved with maintenance olaparib treatment with no clinically meaningful difference compared with placebo. These results support the observed efficacy benefit ...
نوع الوثيقة:	article in journal/newspaper
وصف الملف:	ELETTRONICO
اللغة:	English
العلاقة:	info:eu-repo/semantics/altIdentifier/pmid/31562758; info:eu-repo/semantics/altIdentifier/wos/WOS:000507595800013; volume:30; issue:12; firstpage:1959; lastpage:1968; numberofpages:10; journal:ANNALS OF ONCOLOGY; http://hdl.handle.net/11585/725200Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85077402748; http://annonc.oxfordjournals.orgTest/
DOI:	10.1093/annonc/mdz406
الإتاحة:	https://doi.org/10.1093/annonc/mdz406Test http://hdl.handle.net/11585/725200Test http://annonc.oxfordjournals.orgTest/
رقم الانضمام:	edsbas.EE98EB28
قاعدة البيانات:	BASE

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الوصف
DOI:	10.1093/annonc/mdz406