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

Cited 33 time in Web of Science Cited 34 time in Scopus
Authors

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.; Alguel, H.; O'Reilly, E. M.; McGuinness, D.; Cui, K. Y.; Joo, S.; Yoo, H. K.; Patel, N.; Golan, T.; Chantrill, Lorraine; Goldstein, David; Joubert, Warren; Pavlakis, Nick; Tognela, Annette; Van Cutsem, Eric; Van Fraeyenhove, Frank; Van Laethem, Jean-Luc; Peeters, Marc; Dhani, Neesha; Kavan, Petr; Lemay, Frederic; Adenis, Antoine; Artru, Pascal; Hamed, Nabil; Belletier, Christine; Ben Abdelghani, Meher; Blanc, Jean-Frederic; Borg, Christophe; Coriat, Romain; Deplanque, Gael; Faroux, Roger; Follana, Philippe; Guimbaud, Rosine; el Hajbi, Farid; Hammel, Pascal; Hautefeuille, Vincent; Malka, David; Metges, Jean-Philippe; Tougeron, David; Walter, Thomas; Alguel, Hana; Ettrich, Thomas; Hacker, Ulrich Thorsten; Hennes, Elke; Jacobasch, Lutz; Kanzler, Stephan; Pession, Ursula; Reinacher-Schick, Anke; Scholz, Christian; Sinn, Marianne; Stein, Alexander; Strassburg, Christian; Vogel, Arndt; Ben-Shahar, Menachem; Brenner, Ronen; Epelbaum, Ron; Geva, Ravit; Gluzman, Alexander; Golan, Talia; Idelevich, Efraim; Kolin, Maya; Semenisty, Valeriya; Shai, Ayelet; Stemmer, Salomon; Yarom, Nirit; Celio, Luigi; Conte, Pierfranco; Garufi, Carlo; Gianni, Luca; Leonardi, Francesco; Maiello, Evaristo; Di Marco, Mariacristina; Milella, Michele; Pinto, Carmine; Santini, Daniele; Scartozzi, Mario; Tortora, Giampaolo; Vaccaro, Vanja; Vasile, Enrico; Kim, Ji-Won; Kim, Jin-Won; Oh, Youn; Park, Joon Oh; Wilmink, Hanneke; Alvarez Gallego, Rafael; Duran Ogalla, Gema; Garcia Velasco, Adelaida; Garralda Cabanas, Elena; Gomez Martin, Carlos; Guillen Ponce, Carmen; Laquente Saez, Berta; Lopez, Rafael; Macarulla, Teresa; Munoz Martin, Andres; Pazo, Roberto; Pericay Pijaume, Carles; Rodriguez, Javier; Yaya-Tur, Ricardo; Arora, Arvind; Anthoney, David Alan; Evans, T. R. Jeffrey; Harrison, Mark; Hochhauser, Daniel; Palmer, Daniel; Sarker, Debashis; Starling, Naureen; Valle, Juan; Wall, Lucy; Agajanian, Richy; Bearden, James; Bekaii-Saab, Tanios; Carter, Corey; Cohen, Deirdre; DiStefano, Alfred; Dragovich, Tomislav; Ejadi, Samuel; Ford, James; Grabelsky, Stephen; Hall, Michael; Hochster, Howard; Hosein, Peter; Javle, Milind; Kindler, Hedy; Lacy, Jill; Laheru, Daniel; Leong, Stephen; Lowery, Maeve; Marsh, Robert; Noonan, Anne; Oberstein, Paul; Ocean, Allyson; O'Reilly, Eileen; Ryan, David; Seery, Tara; Subramaniam, Somasundaram; Van Echo, David; Wang-Gillam, Andrea; Weekes, Colin; Welch, Stephen

Issue Date
2019-12
Publisher
Oxford University Press
Citation
Annals of Oncology, Vol.30 No.12, pp.1959-1968
Abstract
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 (300mg 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 of maintenance olaparib in patients with a gBRCAm and metastatic pancreatic cancer.
ISSN
0923-7534
URI
https://hdl.handle.net/10371/212783
DOI
https://doi.org/10.1093/annonc/mdz406
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Research Area DNA 손상 반응 타겟 물질의 면역조절 효과, Effect of DNA damage response target substances on immunomodulatory action, Efficacy and biomarker validation studies of targeted therapeutics, Resistance mechanisms according to targeted therapeutics, 표적 항암제 내성 기전 연구, 표적 항암제의 효과 검증 및 바이오마커 규명

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