Olaparib as maintenance therapy in patients with BRCA 1–2 mutated recurrent platinum sensitive ovarian cancer: Real world data and post progression outcome

Sabrina Chiara Cecere, Gaia Giannone, Vanda Salutari, Laura Arenare, Domenica Lorusso, Graziana Ronzino, Rossella Lauria, Gennaro Cormio, Claudia Carella, Paolo Scollo, Viola Ghizzoni, Francesco Raspagliesi, Marilena Di Napoli, Enrica Mazzoni, Claudia Marchetti, Alice Bergamini, Michele Orditura, Giorgio Valabrega, Giovanni Scambia, Giuseppa MalteseElisabetta De Matteis, Cinzia Cardalesi, Vera Loizzi, Serena Boccia, Emanuele Naglieri, Giuseppa Scandurra, Sandro Pignata

Research output: Contribution to journalArticle

Abstract

Objectives: Olaparib is approved as maintenance therapy in patients with BRCA mutated platinum sensitive (PS) recurrent ovarian cancer (OC) after response to last platinum based therapy. Few data are available regarding the use out of the registration trials and on response to further treatments after progression. Materials ad methods: In this non interventional, retrospective study, patients treated with olaparib in 13 centers, according to the label, have been collected and analyzed. Primary objectives of the study are to describe effectiveness and safety of olaparib in a real world setting with a focus on post progression treatments and response. Results: 234 patients were analyzed. All patients were BRCA mutated and most of them had germline mutations. Around 50% of the patients received olaparib after 3 or more lines of platinum based chemotherapy achieving a radiologic complete (CR) or partial response. 12.4% patients with stable disease were also included. Median PFS was 14.7 months (95% CI:12.6–18), with statistically longer PFS in patients with normal serum Ca125 at baseline, a CR after last platinum based therapy and that received olaparib after second platinum based therapy. Median OS was not reached. Most frequent G3-G4 toxicity was anaemia (6%) with dose discontinuation and dose reduction in 11 (4.7%) and 49 (20.9%) of cases, respectively. Among 66 patients receiving further treatment after olaparib progression and evaluable for response, ORR was 22.2, 11.1% and 9.5% in patients with Platinum Free interval (PFI) of more than 12 months, between 6 and 12 months and less than 6 months, respectively. Conclusions: Olaparib is effective and safe in real world setting. Data on post-progression treatments seem to suggest cross resistance with chemotherapy and need to be confirmed in larger studies because of the potential importance in clinical practice decisions.

Original languageEnglish
JournalGynecologic Oncology
DOIs
Publication statusAccepted/In press - Jan 1 2019

Fingerprint

Platinum
Ovarian Neoplasms
Therapeutics
olaparib
Drug Therapy
Germ-Line Mutation
Anemia
Retrospective Studies
Safety
Serum

Keywords

  • Maintenance
  • Olaparib
  • Ovarian cancer
  • Post progression
  • Real world

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynaecology

Cite this

Olaparib as maintenance therapy in patients with BRCA 1–2 mutated recurrent platinum sensitive ovarian cancer : Real world data and post progression outcome. / Cecere, Sabrina Chiara; Giannone, Gaia; Salutari, Vanda; Arenare, Laura; Lorusso, Domenica; Ronzino, Graziana; Lauria, Rossella; Cormio, Gennaro; Carella, Claudia; Scollo, Paolo; Ghizzoni, Viola; Raspagliesi, Francesco; Di Napoli, Marilena; Mazzoni, Enrica; Marchetti, Claudia; Bergamini, Alice; Orditura, Michele; Valabrega, Giorgio; Scambia, Giovanni; Maltese, Giuseppa; De Matteis, Elisabetta; Cardalesi, Cinzia; Loizzi, Vera; Boccia, Serena; Naglieri, Emanuele; Scandurra, Giuseppa; Pignata, Sandro.

In: Gynecologic Oncology, 01.01.2019.

Research output: Contribution to journalArticle

Cecere, SC, Giannone, G, Salutari, V, Arenare, L, Lorusso, D, Ronzino, G, Lauria, R, Cormio, G, Carella, C, Scollo, P, Ghizzoni, V, Raspagliesi, F, Di Napoli, M, Mazzoni, E, Marchetti, C, Bergamini, A, Orditura, M, Valabrega, G, Scambia, G, Maltese, G, De Matteis, E, Cardalesi, C, Loizzi, V, Boccia, S, Naglieri, E, Scandurra, G & Pignata, S 2019, 'Olaparib as maintenance therapy in patients with BRCA 1–2 mutated recurrent platinum sensitive ovarian cancer: Real world data and post progression outcome', Gynecologic Oncology. https://doi.org/10.1016/j.ygyno.2019.10.023
Cecere, Sabrina Chiara ; Giannone, Gaia ; Salutari, Vanda ; Arenare, Laura ; Lorusso, Domenica ; Ronzino, Graziana ; Lauria, Rossella ; Cormio, Gennaro ; Carella, Claudia ; Scollo, Paolo ; Ghizzoni, Viola ; Raspagliesi, Francesco ; Di Napoli, Marilena ; Mazzoni, Enrica ; Marchetti, Claudia ; Bergamini, Alice ; Orditura, Michele ; Valabrega, Giorgio ; Scambia, Giovanni ; Maltese, Giuseppa ; De Matteis, Elisabetta ; Cardalesi, Cinzia ; Loizzi, Vera ; Boccia, Serena ; Naglieri, Emanuele ; Scandurra, Giuseppa ; Pignata, Sandro. / Olaparib as maintenance therapy in patients with BRCA 1–2 mutated recurrent platinum sensitive ovarian cancer : Real world data and post progression outcome. In: Gynecologic Oncology. 2019.
@article{c1b1d5a57f454f698fae4813ab7cab05,
title = "Olaparib as maintenance therapy in patients with BRCA 1–2 mutated recurrent platinum sensitive ovarian cancer: Real world data and post progression outcome",
abstract = "Objectives: Olaparib is approved as maintenance therapy in patients with BRCA mutated platinum sensitive (PS) recurrent ovarian cancer (OC) after response to last platinum based therapy. Few data are available regarding the use out of the registration trials and on response to further treatments after progression. Materials ad methods: In this non interventional, retrospective study, patients treated with olaparib in 13 centers, according to the label, have been collected and analyzed. Primary objectives of the study are to describe effectiveness and safety of olaparib in a real world setting with a focus on post progression treatments and response. Results: 234 patients were analyzed. All patients were BRCA mutated and most of them had germline mutations. Around 50{\%} of the patients received olaparib after 3 or more lines of platinum based chemotherapy achieving a radiologic complete (CR) or partial response. 12.4{\%} patients with stable disease were also included. Median PFS was 14.7 months (95{\%} CI:12.6–18), with statistically longer PFS in patients with normal serum Ca125 at baseline, a CR after last platinum based therapy and that received olaparib after second platinum based therapy. Median OS was not reached. Most frequent G3-G4 toxicity was anaemia (6{\%}) with dose discontinuation and dose reduction in 11 (4.7{\%}) and 49 (20.9{\%}) of cases, respectively. Among 66 patients receiving further treatment after olaparib progression and evaluable for response, ORR was 22.2, 11.1{\%} and 9.5{\%} in patients with Platinum Free interval (PFI) of more than 12 months, between 6 and 12 months and less than 6 months, respectively. Conclusions: Olaparib is effective and safe in real world setting. Data on post-progression treatments seem to suggest cross resistance with chemotherapy and need to be confirmed in larger studies because of the potential importance in clinical practice decisions.",
keywords = "Maintenance, Olaparib, Ovarian cancer, Post progression, Real world",
author = "Cecere, {Sabrina Chiara} and Gaia Giannone and Vanda Salutari and Laura Arenare and Domenica Lorusso and Graziana Ronzino and Rossella Lauria and Gennaro Cormio and Claudia Carella and Paolo Scollo and Viola Ghizzoni and Francesco Raspagliesi and {Di Napoli}, Marilena and Enrica Mazzoni and Claudia Marchetti and Alice Bergamini and Michele Orditura and Giorgio Valabrega and Giovanni Scambia and Giuseppa Maltese and {De Matteis}, Elisabetta and Cinzia Cardalesi and Vera Loizzi and Serena Boccia and Emanuele Naglieri and Giuseppa Scandurra and Sandro Pignata",
year = "2019",
month = "1",
day = "1",
doi = "10.1016/j.ygyno.2019.10.023",
language = "English",
journal = "Gynecologic Oncology",
issn = "0090-8258",
publisher = "Academic Press Inc.",

}

TY - JOUR

T1 - Olaparib as maintenance therapy in patients with BRCA 1–2 mutated recurrent platinum sensitive ovarian cancer

T2 - Real world data and post progression outcome

AU - Cecere, Sabrina Chiara

AU - Giannone, Gaia

AU - Salutari, Vanda

AU - Arenare, Laura

AU - Lorusso, Domenica

AU - Ronzino, Graziana

AU - Lauria, Rossella

AU - Cormio, Gennaro

AU - Carella, Claudia

AU - Scollo, Paolo

AU - Ghizzoni, Viola

AU - Raspagliesi, Francesco

AU - Di Napoli, Marilena

AU - Mazzoni, Enrica

AU - Marchetti, Claudia

AU - Bergamini, Alice

AU - Orditura, Michele

AU - Valabrega, Giorgio

AU - Scambia, Giovanni

AU - Maltese, Giuseppa

AU - De Matteis, Elisabetta

AU - Cardalesi, Cinzia

AU - Loizzi, Vera

AU - Boccia, Serena

AU - Naglieri, Emanuele

AU - Scandurra, Giuseppa

AU - Pignata, Sandro

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Objectives: Olaparib is approved as maintenance therapy in patients with BRCA mutated platinum sensitive (PS) recurrent ovarian cancer (OC) after response to last platinum based therapy. Few data are available regarding the use out of the registration trials and on response to further treatments after progression. Materials ad methods: In this non interventional, retrospective study, patients treated with olaparib in 13 centers, according to the label, have been collected and analyzed. Primary objectives of the study are to describe effectiveness and safety of olaparib in a real world setting with a focus on post progression treatments and response. Results: 234 patients were analyzed. All patients were BRCA mutated and most of them had germline mutations. Around 50% of the patients received olaparib after 3 or more lines of platinum based chemotherapy achieving a radiologic complete (CR) or partial response. 12.4% patients with stable disease were also included. Median PFS was 14.7 months (95% CI:12.6–18), with statistically longer PFS in patients with normal serum Ca125 at baseline, a CR after last platinum based therapy and that received olaparib after second platinum based therapy. Median OS was not reached. Most frequent G3-G4 toxicity was anaemia (6%) with dose discontinuation and dose reduction in 11 (4.7%) and 49 (20.9%) of cases, respectively. Among 66 patients receiving further treatment after olaparib progression and evaluable for response, ORR was 22.2, 11.1% and 9.5% in patients with Platinum Free interval (PFI) of more than 12 months, between 6 and 12 months and less than 6 months, respectively. Conclusions: Olaparib is effective and safe in real world setting. Data on post-progression treatments seem to suggest cross resistance with chemotherapy and need to be confirmed in larger studies because of the potential importance in clinical practice decisions.

AB - Objectives: Olaparib is approved as maintenance therapy in patients with BRCA mutated platinum sensitive (PS) recurrent ovarian cancer (OC) after response to last platinum based therapy. Few data are available regarding the use out of the registration trials and on response to further treatments after progression. Materials ad methods: In this non interventional, retrospective study, patients treated with olaparib in 13 centers, according to the label, have been collected and analyzed. Primary objectives of the study are to describe effectiveness and safety of olaparib in a real world setting with a focus on post progression treatments and response. Results: 234 patients were analyzed. All patients were BRCA mutated and most of them had germline mutations. Around 50% of the patients received olaparib after 3 or more lines of platinum based chemotherapy achieving a radiologic complete (CR) or partial response. 12.4% patients with stable disease were also included. Median PFS was 14.7 months (95% CI:12.6–18), with statistically longer PFS in patients with normal serum Ca125 at baseline, a CR after last platinum based therapy and that received olaparib after second platinum based therapy. Median OS was not reached. Most frequent G3-G4 toxicity was anaemia (6%) with dose discontinuation and dose reduction in 11 (4.7%) and 49 (20.9%) of cases, respectively. Among 66 patients receiving further treatment after olaparib progression and evaluable for response, ORR was 22.2, 11.1% and 9.5% in patients with Platinum Free interval (PFI) of more than 12 months, between 6 and 12 months and less than 6 months, respectively. Conclusions: Olaparib is effective and safe in real world setting. Data on post-progression treatments seem to suggest cross resistance with chemotherapy and need to be confirmed in larger studies because of the potential importance in clinical practice decisions.

KW - Maintenance

KW - Olaparib

KW - Ovarian cancer

KW - Post progression

KW - Real world

UR - http://www.scopus.com/inward/record.url?scp=85074825538&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85074825538&partnerID=8YFLogxK

U2 - 10.1016/j.ygyno.2019.10.023

DO - 10.1016/j.ygyno.2019.10.023

M3 - Article

C2 - 31699415

AN - SCOPUS:85074825538

JO - Gynecologic Oncology

JF - Gynecologic Oncology

SN - 0090-8258

ER -