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

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

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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 (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 of maintenance olaparib in patients with a gBRCAm and metastatic pancreatic cancer. ClincalTrials.gov number: NCT02184195.

Original languageEnglish (US)
Pages (from-to)1959-1968
Number of pages10
JournalAnnals of Oncology
Volume30
Issue number12
DOIs
StatePublished - Dec 1 2019

Keywords

  • BRCA
  • health-related quality of life
  • metastatic
  • olaparib
  • pancreatic cancer

ASJC Scopus subject areas

  • Hematology
  • Oncology

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    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., Algül, H., O'Reilly, E. M., McGuinness, D., Cui, K. Y., Joo, S., Yoo, H. K., Patel, N., ... Welch, S. (2019). Health-related quality of life in patients with a germline BRCA mutation and metastatic pancreatic cancer receiving maintenance olaparib. Annals of Oncology, 30(12), 1959-1968. https://doi.org/10.1093/annonc/mdz406