Background: In the phase III OlympiAD trial, olaparib significantly increased progression-free survival (PFS) compared with chemotherapy of physician's choice in patients with germline BRCA-mutated (gBRCAm), human epidermal growth factor 2 (HER2)-negative metastatic breast cancer (mBC). The phase IIIb LUCY trial assessed the clinical effectiveness of olaparib in similar patients, in a setting reflecting clinical practice. Methods: This open-label, single-arm trial of olaparib (300 mg, twice daily) enrolled patients with BRCAm, HER2-negative mBC who had received taxane and/or anthracycline in the (neo)adjuvant/metastatic setting and not more than two lines of prior chemotherapy for mBC. Patients with hormone receptor-positive mBC had progressed on at least one line of endocrine therapy in an adjuvant/metastatic setting and were unsuitable for further endocrine treatment. This interim analysis was planned after 160 PFS events. Results: Of 563 patients screened, 252 patients with gBRCAm were enrolled and received at least one dose of olaparib. The median investigator-assessed PFS was 8.11 months (95% confidence interval [CI], 6.93-8.67; 166/252 events [65.9% maturity]). The investigator-assessed clinical response rate was 48.6%, and median time to first subsequent treatment or death was 9.66 months (95% CI, 8.67-11.14). The most common treatment-emergent adverse events (TEAEs; >20% patients) were nausea, anaemia, asthenia, vomiting and fatigue. Eleven patients (4.4%) discontinued treatment because of a TEAE. Grade 3 or higher TEAEs occurred in 64 patients (25.4%), including anaemia (33 patients; 13.1%). Conclusion: Olaparib was clinically effective in patients with gBRCAm, HER2-negative mBC with safety outcomes consistent with previous findings. ClinicalTrials.gov identifier: NCT03286842.
Clinical effectiveness of olaparib monotherapy in germline BRCA-mutated, HER2-negative metastatic breast cancer in a real-world setting: phase IIIb LUCY interim analysis / Gelmon, K. A.; Fasching, P. A.; Couch, F. J.; Balmana, J.; Delaloge, S.; Labidi-Galy, I.; Bennett, J.; Mccutcheon, S.; Walker, G.; O'Shaughnessy, J.; Timcheva, C.; Tomova, A.; Eisen, A.; Lemieux, J.; Bazan, F.; Bourgeois, H.; Chakiba, C.; Chehimi, M.; Dalenc, F.; De La Motte Rouge, T.; Frenel, J. -S.; Goncalves, A.; Hardy-Bessard, A. C.; Lamy, R.; Levy, C.; Lortholary, A.; Mailliez, A.; Medioni, J.; Patsouris, A.; Spaeth, D.; Teixeira, L.; Tennevet, I.; Villanueva, C.; You, B.; Ettl, J.; Gerber, B.; Hoffmann, O.; Park-Simon, T. -W.; Reinisch, M.; Tio, J.; Wimberger, P.; Boer, K.; Ballestrero, A.; Bianchini, G.; Biganzoli, L.; Bordonaro, R.; Cognetti, F.; De Laurentiis, M.; De Placido, S.; Guarneri, V.; Montemurro, F.; Naso, G.; Santoro, A.; Zamagni, C.; Kim, S. -J.; Nakamura, S.; Chae, Y. S.; Cho, E. K.; Hyun, K. J.; Im, S. -A.; Lee, K. S.; Park, Y. H.; Sohn, J. H.; Byrski, T.; Huzarski, T.; Kukielka-Budny, B.; Nowecki, Z.; Szoszkiewicz, R.; Tarnawski, R.; Dvornichenko, V.; Moiseenko, F.; Mukhametshina, G.; Poddubskaya, E.; Popova, E.; Tarasova, A.; Vats, A.; Adamo, B.; Conejero, R. A.; Torres, A. A.; Gelpi, J. B.; Fernandez, N. D.; Gonzalez, A. F.; Garcia, J.; Lorenzo-Lorenzo, I.; Anton, F. M.; Santisteban, M.; Stradella, A.; Huang, C. -S.; Aksoy, S.; Arslan, C.; Artac, M.; Aydiner, A.; Ozyilkan, O.; Sezer, E.; Armstrong, A.; Barrett, S.; Borley, A.; Kemp, Z.; Michie, C.; Mukesh, M.; Perren, T.; Swampillai, A.; Young, T.. - In: EUROPEAN JOURNAL OF CANCER. - ISSN 1879-0852. - 152:(2021), pp. 68-77. [10.1016/j.ejca.2021.03.029]
Clinical effectiveness of olaparib monotherapy in germline BRCA-mutated, HER2-negative metastatic breast cancer in a real-world setting: phase IIIb LUCY interim analysis
De Laurentiis M.;De Placido S.;Montemurro F.;Naso G.;Garcia J.;
2021
Abstract
Background: In the phase III OlympiAD trial, olaparib significantly increased progression-free survival (PFS) compared with chemotherapy of physician's choice in patients with germline BRCA-mutated (gBRCAm), human epidermal growth factor 2 (HER2)-negative metastatic breast cancer (mBC). The phase IIIb LUCY trial assessed the clinical effectiveness of olaparib in similar patients, in a setting reflecting clinical practice. Methods: This open-label, single-arm trial of olaparib (300 mg, twice daily) enrolled patients with BRCAm, HER2-negative mBC who had received taxane and/or anthracycline in the (neo)adjuvant/metastatic setting and not more than two lines of prior chemotherapy for mBC. Patients with hormone receptor-positive mBC had progressed on at least one line of endocrine therapy in an adjuvant/metastatic setting and were unsuitable for further endocrine treatment. This interim analysis was planned after 160 PFS events. Results: Of 563 patients screened, 252 patients with gBRCAm were enrolled and received at least one dose of olaparib. The median investigator-assessed PFS was 8.11 months (95% confidence interval [CI], 6.93-8.67; 166/252 events [65.9% maturity]). The investigator-assessed clinical response rate was 48.6%, and median time to first subsequent treatment or death was 9.66 months (95% CI, 8.67-11.14). The most common treatment-emergent adverse events (TEAEs; >20% patients) were nausea, anaemia, asthenia, vomiting and fatigue. Eleven patients (4.4%) discontinued treatment because of a TEAE. Grade 3 or higher TEAEs occurred in 64 patients (25.4%), including anaemia (33 patients; 13.1%). Conclusion: Olaparib was clinically effective in patients with gBRCAm, HER2-negative mBC with safety outcomes consistent with previous findings. ClinicalTrials.gov identifier: NCT03286842.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
