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; Anke Reinacher-Schick; Giampaolo Tortora; H. Algül; E. M. O'Reilly; D. McGuinness; K. Y. Cui; S. Joo; H. K. Yoo; N. Patel; T. Golan; Lorraine 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; Thomas Ettrich; Ulrich Thorsten Hacker; Elke Hennes; Lutz Jacobasch; Stephan Kanzler; Ursula Pession; 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; David Ryan; Tara Seery; Somasundaram Subramaniam; David Van Echo; Andrea Wang-Gillam; Colin Weekes; Stephen Welch

doi:10.1093/annonc/mdz406

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, Anke 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, Thomas Ettrich, Ulrich Thorsten Hacker, Elke Hennes, Lutz Jacobasch, Stephan Kanzler, Ursula Pession, 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, David Ryan, Tara Seery, Somasundaram Subramaniam, David Van Echo, Andrea Wang-Gillam, Colin Weekes, Stephen Welch

^*Corresponding author for this work

Oncology

Research output: Contribution to journal › Article › peer-review

32 Scopus citations

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 language	English
Pages (from-to)	1959-1968
Number of pages	10
Journal	Annals of Oncology
Volume	30
Issue number	12
DOIs	https://doi.org/10.1093/annonc/mdz406
State	Published - 1 Dec 2019

Funding

Funders	Funder number
Mudskipper Business Ltd
National Institutes of Health
National Cancer Institute	P30CA008748
National Cancer Institute
AstraZeneca
Meso Scale Diagnostics
Merck Sharp and Dohme

Keywords

BRCA
health-related quality of life
metastatic
olaparib
pancreatic cancer

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1093/annonc/mdz406

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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

@article{adcd7d5d273a4389a5750baa5fd9db99,

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

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.",

keywords = "BRCA, health-related quality of life, metastatic, olaparib, pancreatic cancer",

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

note = "Publisher Copyright: {\textcopyright} 2019 The Author(s) 2019. Published by Oxford University Press on behalf of the European Society for Medical Oncology.",

year = "2019",

month = dec,

day = "1",

doi = "10.1093/annonc/mdz406",

language = "אנגלית",

volume = "30",

pages = "1959--1968",

journal = "Annals of Oncology",

issn = "0923-7534",

publisher = "Elsevier Ltd.",

number = "12",

}

Hammel, P, Kindler, HL, Reni, M, Van Cutsem, E, MacArulla, T, Hall, MJ, Park, JO, Hochhauser, D, Arnold, D, Oh, DY, Reinacher-Schick, A, Tortora, G, Algül, H, O'Reilly, EM, McGuinness, D, Cui, KY, Joo, S, Yoo, HK, Patel, N, Golan, T, Chantrill, L, Goldstein, D, Joubert, W, Pavlakis, N, Tognela, A, Van Cutsem, E, Van Fraeyenhove, F, Van Laethem, JL, Peeters, M, Dhani, N, Kavan, P, Lemay, F, Adenis, A, Artru, P, Baba-Hamed, N, Belletier, C, Ben Abdelghani, M, Blanc, JF, Borg, C, Coriat, R, Deplanque, G, Faroux, R, Follana, P, Guimbaud, R, El Hajbi, F, Hammel, P, Hautefeuille, V, Malka, D, Metges, JP, Tougeron, D, Walter, T, Ettrich, T, Hacker, UT, 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, Golan, T, 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, JW, Kim, JW, Oh, DY, Oh Park, J, Wilmink, H, Gallego, RA, Ogalla, GD, Velasco, AG, Cabanas, EG, Gomez Martin, C, Ponce, CG, Saez, BL, Lopez, R, MacArulla, T, Martin, AM, Pazo, R, Pijaume, CP, Rodriguez, J, Yaya-Tur, R, Arora, A, Anthoney, DA, Jeffrey Evans, TR, Harrison, M, Hochhauser, D, 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, Ryan, D, Seery, T, Subramaniam, S, Van Echo, D, Wang-Gillam, A, Weekes, C & 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, vol. 30, no. 12, pp. 1959-1968. https://doi.org/10.1093/annonc/mdz406

TY - JOUR

T1 - Health-related quality of life in patients with a germline BRCA mutation and metastatic pancreatic cancer receiving maintenance olaparib

AU - Hammel, P.

AU - Kindler, H. L.

AU - Reni, M.

AU - Van Cutsem, E.

AU - MacArulla, T.

AU - Hall, M. J.

AU - Park, J. O.

AU - Hochhauser, D.

AU - Arnold, D.

AU - Oh, D. Y.

AU - Reinacher-Schick, Anke

AU - Tortora, Giampaolo

AU - Algül, H.

AU - O'Reilly, E. M.

AU - McGuinness, D.

AU - Cui, K. Y.

AU - Joo, S.

AU - Yoo, H. K.

AU - Patel, N.

AU - Golan, T.

AU - Chantrill, Lorraine

AU - Goldstein, David

AU - Joubert, Warren

AU - Pavlakis, Nick

AU - Tognela, Annette

AU - Van Cutsem, Eric

AU - Van Fraeyenhove, Frank

AU - Van Laethem, Jean Luc

AU - Peeters, Marc

AU - Dhani, Neesha

AU - Kavan, Petr

AU - Lemay, Frederic

AU - Adenis, Antoine

AU - Artru, Pascal

AU - Baba-Hamed, Nabil

AU - Belletier, Christine

AU - Ben Abdelghani, Meher

AU - Blanc, Jean Frederic

AU - Borg, Christophe

AU - Coriat, Romain

AU - Deplanque, Gael

AU - Faroux, Roger

AU - Follana, Philippe

AU - Guimbaud, Rosine

AU - El Hajbi, Farid

AU - Hammel, Pascal

AU - Hautefeuille, Vincent

AU - Malka, David

AU - Metges, Jean Philippe

AU - Tougeron, David

AU - Walter, Thomas

AU - Ettrich, Thomas

AU - Hacker, Ulrich Thorsten

AU - Hennes, Elke

AU - Jacobasch, Lutz

AU - Kanzler, Stephan

AU - Pession, Ursula

AU - Scholz, Christian

AU - Sinn, Marianne

AU - Stein, Alexander

AU - Strassburg, Christian

AU - Vogel, Arndt

AU - Ben-Shahar, Menachem

AU - Brenner, Ronen

AU - Epelbaum, Ron

AU - Geva, Ravit

AU - Gluzman, Alexander

AU - Golan, Talia

AU - Idelevich, Efraim

AU - Kolin, Maya

AU - Semenisty, Valeriya

AU - Shai, Ayelet

AU - Stemmer, Salomon

AU - Yarom, Nirit

AU - Celio, Luigi

AU - Conte, Pierfranco

AU - Garufi, Carlo

AU - Gianni, Luca

AU - Leonardi, Francesco

AU - Maiello, Evaristo

AU - Di Marco, Mariacristina

AU - Milella, Michele

AU - Pinto, Carmine

AU - Santini, Daniele

AU - Scartozzi, Mario

AU - Vaccaro, Vanja

AU - Vasile, Enrico

AU - Kim, Ji Won

AU - Kim, Jin Won

AU - Oh, Do Youn

AU - Oh Park, Joon

AU - Wilmink, Hanneke

AU - Gallego, Rafael Alvarez

AU - Ogalla, Gema Duran

AU - Velasco, Adelaida Garcia

AU - Cabanas, Elena Garralda

AU - Gomez Martin, Carlos

AU - Ponce, Carmen Guillén

AU - Saez, Berta Laquente

AU - Lopez, Rafael

AU - MacArulla, Teresa

AU - Martin, Andres Munoz

AU - Pazo, Roberto

AU - Pijaume, Carles Pericay

AU - Rodriguez, Javier

AU - Yaya-Tur, Ricardo

AU - Arora, Arvind

AU - Anthoney, David Alan

AU - Jeffrey Evans, T. R.

AU - Harrison, Mark

AU - Hochhauser, Daniel

AU - Palmer, Daniel

AU - Sarker, Debashis

AU - Starling, Naureen

AU - Valle, Juan

AU - Wall, Lucy

AU - Agajanian, Richy

AU - Bearden, James

AU - Bekaii-Saab, Tanios

AU - Carter, Corey

AU - Cohen, Deirdre

AU - Distefano, Alfred

AU - Dragovich, Tomislav

AU - Ejadi, Samuel

AU - Ford, James

AU - Grabelsky, Stephen

AU - Hall, Michael

AU - Hochster, Howard

AU - Hosein, Peter

AU - Javle, Milind

AU - Kindler, Hedy

AU - Lacy, Jill

AU - Laheru, Daniel

AU - Leong, Stephen

AU - Lowery, Maeve

AU - Marsh, Robert

AU - Noonan, Anne

AU - Oberstein, Paul

AU - Ocean, Allyson

AU - Ryan, David

AU - Seery, Tara

AU - Subramaniam, Somasundaram

AU - Van Echo, David

AU - Wang-Gillam, Andrea

AU - Weekes, Colin

AU - Welch, Stephen

PY - 2019/12/1

Y1 - 2019/12/1

N2 - 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.

AB - 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.

KW - BRCA

KW - health-related quality of life

KW - metastatic

KW - olaparib

KW - pancreatic cancer

UR - http://www.scopus.com/inward/record.url?scp=85077402748&partnerID=8YFLogxK

U2 - 10.1093/annonc/mdz406

DO - 10.1093/annonc/mdz406

M3 - ???researchoutput.researchoutputtypes.contributiontojournal.article???

C2 - 31562758

AN - SCOPUS:85077402748

SN - 0923-7534

VL - 30

SP - 1959

EP - 1968

JO - Annals of Oncology

JF - Annals of Oncology

IS - 12

ER -

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

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