Preliminary safety and efficacy of first-line pertuzumab combined with trastuzumab and taxane therapy for HER2-positive locally recurrent or metastatic breast cancer (PERUSE)

Pertuzumab combined with trastuzumab and docetaxel is the standard first-line therapy for HER2-positive metastatic breast cancer, based on results from the phase III CLEOPATRA trial. PERUSE was designed to assess the safety and efficacy of investigator-selected taxane with pertuzumab and trastuzumab...

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Bibliographic Details
Published in:	Annals of oncology Vol. 30; no. 5; pp. 766 - 773
Main Authors:	Schneeweiss, A., Puglisi, F., Peretz-Yablonski, T., Merot, J.-L., Miles, D., Coudert, Bruno, Errihani, Hassan, Dalenc, Florence, Barrett, Sophie, Beato, Carlos, Hu, Xichun, Perrin, Christophe, Ettl, Johannes, Li, Huiping, Cariello, Anna, Frassoldati, Antonio, Wronski, Andrzej, Menjón Beltrán, Salomón, Cicin, Irfan, Schmid, Peter, Juarez, Alejandro, Matos, Erika, Uslu, Ruchan, Wildiers, Hans, Bourgeois, Hugues, von Schumann, Raquel, Wojtukiewicz, Marek, Peron, Yann Izarzugaza, Wheatley, Duncan, De Boer, Richard, Jerusalem, Guy, Latini, Luciano, Barnadas Molins, Agusti, Martinez, Eduardo, Baird, Richard, McCarthy, Nicole, Greil, Richard, Juhasz-Boess, Ingolf, de la Cruz, Luis Ruiz, Del Val, Olga, Azribi, Fathi, Turner, Nicholas, Andrade, Jurandyr, Bernstein, Vanessa, Rayson, Daniel, Gennari, Alessandra, El-Saghir, Nagi, Kukulska, Monika, Pelaez, Ignacio, del Mar Gordon, Maria, Varughese, Mohini, Levitt, Nicola, Singer, Christian, Efremidou, Anna, Evron, Ella, Luigi, Cavanna, Garcia, Andres, Lopez Ceballos, Maria Helena, García, María, Arcediano, Alberto, McAdam, Karen, Humphreys, Alison, de Grève, Jacques, Joy, Anil, Sehdev, Sandeep, Kütner, Riina, Laplaige, Philippe, Christensen, Bernd, Fountzilas, Georgios, Fried, Georgeta, Giacobino, Alice, Bonetti, Andrea, Van der Velden, Annette, Vrijaldenhoven, Suzan, Andres Conejero, Raquel, Murias, Adolfo, Saura, Salvador, Poole, Christopher, Woodward, Natasha, Califaretti, Nadia, Jiang, Jun, Padrik, Peeter, Saarni, Outi, Genet, Dominique, Catala, Stéphanie, Facchini, Thomas, Repp, Roland, Schroeder, Willibald, Kahan, Zsuzsanna, Rosengarten, Ora, Alabiso, Oscar, Van de Wouw, Yes, Sousa, Gabriela, Jesús Florián Jerico, Marta Santisteban, Torrego, Juan Carlos, Rodriguez, Cesar, Llorca, Cristina, Galán, Antonio, Rodríguez, Robinson, Alonso, Isabel
Format:	Journal Article
Language:	English
Published:	England Elsevier Ltd 01-05-2019 Oxford University Press
Subjects:	Adult Aged Aged, 80 and over Antibodies, Monoclonal, Humanized - administration & dosage Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biomarkers, Tumor - metabolism Breast Neoplasms - drug therapy Breast Neoplasms - metabolism Breast Neoplasms - pathology Breast Neoplasms, Male - drug therapy Breast Neoplasms, Male - metabolism Breast Neoplasms, Male - pathology Bridged-Ring Compounds - administration & dosage dual HER2 blockade Female first line HER2-positive Humans Male metastatic breast cancer Middle Aged Neoplasm Metastasis Neoplasm Recurrence, Local - drug therapy Neoplasm Recurrence, Local - metabolism Neoplasm Recurrence, Local - pathology Neoplasm Staging paclitaxel pertuzumab Prospective Studies Receptor, ErbB-2 - metabolism Survival Rate Taxoids - administration & dosage Trastuzumab - administration & dosage Young Adult paclitaxel pertuzumab first line dual HER2 blockade HER2-positive metastatic breast cancer
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Summary:	Pertuzumab combined with trastuzumab and docetaxel is the standard first-line therapy for HER2-positive metastatic breast cancer, based on results from the phase III CLEOPATRA trial. PERUSE was designed to assess the safety and efficacy of investigator-selected taxane with pertuzumab and trastuzumab in this setting. In the ongoing multicentre single-arm phase IIIb PERUSE study, patients with inoperable HER2-positive advanced breast cancer (locally recurrent/metastatic) (LR/MBC) and no prior systemic therapy for LR/MBC (except endocrine therapy) received docetaxel, paclitaxel or nab-paclitaxel with trastuzumab [8mg/kg loading dose, then 6mg/kg every 3weeks (q3w)] and pertuzumab (840mg loading dose, then 420mg q3w) until disease progression or unacceptable toxicity. The primary end point was safety. Secondary end points included overall response rate (ORR) and progression-free survival (PFS). Overall, 1436 patients received at least one treatment dose (initially docetaxel in 775 patients, paclitaxel in 589, nab-paclitaxel in 65; 7 discontinued before starting taxane). Median age was 54years; 29% had received prior trastuzumab. Median treatment duration was 16months for pertuzumab and trastuzumab and 4months for taxane. Compared with docetaxel-containing therapy, paclitaxel-containing therapy was associated with more neuropathy (all-grade peripheral neuropathy 31% versus 16%) but less febrile neutropenia (1% versus 11%) and mucositis (14% versus 25%). At this preliminary analysis (52 months’ median follow-up), median PFS was 20.6 [95% confidence interval (CI) 18.9–22.7] months overall (19.6, 23.0 and 18.1months with docetaxel, paclitaxel and nab-paclitaxel, respectively). ORR was 80% (95% CI 78%–82%) overall (docetaxel 79%, paclitaxel 83%, nab-paclitaxel 77%). Preliminary findings from PERUSE suggest that the safety and efficacy of first-line pertuzumab, trastuzumab and taxane for HER2-positive LR/MBC are consistent with results from CLEOPATRA. Paclitaxel appears to be a valid alternative taxane backbone to docetaxel, offering similar PFS and ORR with a predictable safety profile. NCT01572038.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0923-7534 1569-8041
DOI:	10.1093/annonc/mdz061