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2. Biomarker analysis of the ASPEN study comparing zanubrutinib with ibrutinib for patients with Waldenström macroglobulinemia

Author

Tam, Constantine S., Opat, Stephen, D'Sa, Shirley, Jurczak, Wojciech, Lee, Hui-Peng, Cull, Gavin, Owen, Roger G., Marlton, Paula, Wahlin, Björn E., García-Sanz, Ramón, McCarthy, Helen, Mulligan, Stephen, Tedeschi, Alessandra, Castillo, Jorge J., Czyż, Jarosław, Fernández De Larrea, Carlos, Belada, David, Libby, Edward, Matous, Jeffrey, Motta, Marina, Siddiqi, Tanya, Tani, Monica, Trněný, Marek, Minnema, Monique C., Buske, Christian, Leblond, Véronique, Treon, Steven P., Trotman, Judith, Wu, Binghao, Yu, Yiling, Shen, Zhirong, Chan, Wai Y., Schneider, Jingjing, Allewelt, Heather, Cohen, Aileen, and Dimopoulos, Meletios A.

Published
2024
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4. Pooled safety analysis of zanubrutinib monotherapy in patients with B-cell malignancies

Author

Tam, Constantine S., Dimopoulos, Meletios, Garcia-Sanz, Ramon, Trotman, Judith, Opat, Stephen, Roberts, Andrew W., Owen, Roger, Song, Yuqin, Xu, Wei, Zhu, Jun, Li, Jianyong, Qiu, Lugui, D'Sa, Shirley, Jurczak, Wojciech, Cull, Gavin, Marlton, Paula, Gottlieb, David, Munoz, Javier, Phillips, Tycel, Du, Chenmu, Ji, Meng, Zhou, Lei, Guo, Haiyi, Zhu, Hongjie, Chan, Wai Y., Cohen, Aileen, Novotny, William, Huang, Jane, and Tedeschi, Alessandra

Published
2022
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5. Corrigendum: Genome Data Provides High Support for Generic Boundaries in Burkholderia Sensu Lato.

Author

Beukes, Chrizelle W, Palmer, Marike, Manyaka, Puseletso, Chan, Wai Y, Avontuur, Juanita R, van Zyl, Elritha, Huntemann, Marcel, Clum, Alicia, Pillay, Manoj, Palaniappan, Krishnaveni, Varghese, Neha, Mikhailova, Natalia, Stamatis, Dimitrios, Reddy, TBK, Daum, Chris, Shapiro, Nicole, Markowitz, Victor, Ivanova, Natalia, Kyrpides, Nikos, Woyke, Tanja, Blom, Jochen, Whitman, William B, Venter, Stephanus N, and Steenkamp, Emma T

Subjects
Burkholderia, Burkholderia rhizoxinica, Caballeronia, Paraburkholderia, Robbsia andropogonis, phylogenomics, Environmental Science and Management, Soil Sciences, Microbiology
Abstract

[This corrects the article on p. 1154 in vol. 8, PMID: 28694797.].

Published
2018

6. Ipatasertib plus paclitaxel versus placebo plus paclitaxel as first-line therapy for metastatic triple-negative breast cancer (LOTUS): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial

Author

Kim, Sung-Bae, Dent, Rebecca, Im, Seock-Ah, Espié, Marc, Blau, Sibel, Tan, Antoinette R, Isakoff, Steven J, Oliveira, Mafalda, Saura, Cristina, Wongchenko, Matthew J, Kapp, Amy V, Chan, Wai Y, Singel, Stina M, Maslyar, Daniel J, Baselga, José, investigators, LOTUS, Lee, Keun Seok, Wang, Hwei-Chung, Tan, Antoinette, Sohn, Joo Hyuk, De Laurentiis, Michelino, Estevez, Laura Garcia, Huang, Chiun-Sheng, Romieu, Gilles, Velez, Michel, Villanueva, Rafael, Conte, Pier Franco, Dakhil, Shaker, Debled, Marc, Martin, Antonio Gonzalez, Hurvitz, Sara, Kim, Jee Hyun, Levy, Christelle, Rovira, Pedro Sanchez, Seo, Jae Hong, Valero, Vicente, Vidal, Gregory, Wong, Andrea, Allison, Mary Ann K, Figlin, Robert, Chan, David, Chen, Shin-Cheh, Chen, Yen-Hsun, Cobleigh, Melody, De Braud, Filippo, Dirix, Luc, Hansen, Vincent, Bessard, Anne Hardy, Iannotti, Nicholas, Isakoff, Steven, Lawler, William, Montaño, Alvaro, Salkini, Mohamad, and Seigel, Leonard

Subjects
Clinical Research, Breast Cancer, Clinical Trials and Supportive Activities, Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Administration, Oral, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Confidence Intervals, Disease-Free Survival, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Humans, Maximum Tolerated Dose, Middle Aged, Neoplasm Invasiveness, Neoplasm Staging, Paclitaxel, Patient Selection, Placebos, Prognosis, Proportional Hazards Models, Proto-Oncogene Proteins c-akt, Risk Assessment, Survival Analysis, Treatment Outcome, Triple Negative Breast Neoplasms, LOTUS investigators, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

BackgroundThe oral AKT inhibitor ipatasertib is being investigated in cancers with a high prevalence of PI3K/AKT pathway activation, including triple-negative breast cancer. The LOTUS trial investigated the addition of ipatasertib to paclitaxel as first-line therapy for triple-negative breast cancer.MethodsIn this randomised, placebo-controlled, double-blind, phase 2 trial, women aged 18 years or older with measurable, inoperable, locally advanced or metastatic triple-negative breast cancer previously untreated with systemic therapy were recruited from 44 hospitals in South Korea, the USA, France, Spain, Taiwan, Singapore, Italy, and Belgium. Enrolled patients were randomly assigned (1:1) to receive intravenous paclitaxel 80 mg/m2 (days 1, 8, 15) with either ipatasertib 400 mg or placebo once per day (days 1-21) every 28 days until disease progression or unacceptable toxicity. Randomisation was by stratified permuted blocks (block size of four) using an interactive web-response system with three stratification criteria: previous (neo)adjuvant therapy, chemotherapy-free interval, and tumour PTEN status. The co-primary endpoints were progression-free survival in the intention-to-treat population and progression-free survival in the PTEN-low (by immunohistochemistry) population. This ongoing trial is registered with ClinicalTrials.gov (NCT02162719).FindingsBetween Sept 2, 2014, and Feb 4, 2016, 166 patients were assessed for eligibility and 124 patients were enrolled and randomly assigned to paclitaxel plus ipatasertib (n=62) or paclitaxel plus placebo (n=62). Median follow-up was 10·4 months (IQR 6·5-14·1) in the ipatasertib group and 10·2 months (6·0-13·6) in the placebo group. Median progression-free survival in the intention-to-treat population was 6·2 months (95% CI 3·8-9·0) with ipatasertib versus 4·9 months (3·6-5·4) with placebo (stratified hazard ratio [HR] 0·60, 95% CI 0·37-0·98; p=0·037) and in the 48 patients with PTEN-low tumours, median progression-free survival was 6·2 months (95% CI 3·6-9·1) with ipatasertib versus 3·7 months (1·9-7·3) with placebo (stratified HR 0·59, 95% CI 0·26-1·32, p=0·18). The most common grade 3 or worse adverse events were diarrhoea (14 [23%] of 61 ipatasertib-treated patients vs none of 62 placebo-treated patients), neutrophil count decreased (five [8%] vs four [6%]), and neutropenia (six [10%] vs one [2%]). No colitis, grade 4 diarrhoea, or treatment-related deaths were reported with ipatasertib. One treatment-related death occurred in the placebo group. Serious adverse events were reported in 17 (28%) of 61 patients in the ipatasertib group and nine (15%) of 62 patients in the placebo group.InterpretationProgression-free survival was longer in patients who received ipatasertib than in those who received placebo. To our knowledge, these are the first results supporting AKT-targeted therapy for triple-negative breast cancer. Ipatasertib warrants further investigation for the treatment of triple-negative breast cancer.FundingF Hoffmann-La Roche.

Published
2017

7. Genome Data Provides High Support for Generic Boundaries in Burkholderia Sensu Lato

Author

Beukes, Chrizelle W, Palmer, Marike, Manyaka, Puseletso, Chan, Wai Y, Avontuur, Juanita R, van Zyl, Elritha, Huntemann, Marcel, Clum, Alicia, Pillay, Manoj, Palaniappan, Krishnaveni, Varghese, Neha, Mikhailova, Natalia, Stamatis, Dimitrios, Reddy, TBK, Daum, Chris, Shapiro, Nicole, Markowitz, Victor, Ivanova, Natalia, Kyrpides, Nikos, Woyke, Tanja, Blom, Jochen, Whitman, William B, Venter, Stephanus N, and Steenkamp, Emma T

Subjects
Microbiology, Biological Sciences, Evolutionary Biology, Genetics, Burkholderia, Paraburkholderia, Caballeronia, phylogenomics, Robbsia andropogonis, Burkholderia rhizoxinica, Environmental Science and Management, Soil Sciences, Medical microbiology
Abstract

Although the taxonomy of Burkholderia has been extensively scrutinized, significant uncertainty remains regarding the generic boundaries and composition of this large and heterogeneous taxon. Here we used the amino acid and nucleotide sequences of 106 conserved proteins from 92 species to infer robust maximum likelihood phylogenies with which to investigate the generic structure of Burkholderia sensu lato. These data unambiguously supported five distinct lineages, of which four correspond to Burkholderia sensu stricto and the newly introduced genera Paraburkholderia, Caballeronia, and Robbsia. The fifth lineage was represented by P. rhizoxinica. Based on these findings, we propose 13 new combinations for those species previously described as members of Burkholderia but that form part of Caballeronia. These findings also suggest revision of the taxonomic status of P. rhizoxinica as it is does not form part of any of the genera currently recognized in Burkholderia sensu lato. From a phylogenetic point of view, Burkholderia sensu stricto has a sister relationship with the Caballeronia+Paraburkholderia clade. Also, the lineages represented by P. rhizoxinica and R. andropogonis, respectively, emerged prior to the radiation of the Burkholderia sensu stricto+Caballeronia+Paraburkholderia clade. Our findings therefore constitute a solid framework, not only for supporting current and future taxonomic decisions, but also for studying the evolution of this assemblage of medically, industrially and agriculturally important species.

Published
2017

8. Zanubrutinib for the treatment of MYD88 wild-type Waldenström macroglobulinemia: a substudy of the phase 3 ASPEN trial

Author

Dimopoulos, Meletios, Sanz, Ramon Garcia, Lee, Hui-Peng, Trneny, Marek, Varettoni, Marzia, Opat, Stephen, D'Sa, Shirley, Owen, Roger G., Cull, Gavin, Mulligan, Stephen, Czyz, Jaroslaw, Castillo, Jorge J., Motta, Marina, Siddiqi, Tanya, Gironella Mesa, Mercedes, Granell Gorrochategui, Miquel, Talaulikar, Dipti, Zinzani, Pier Luigi, Askari, Elham, Grosicki, Sebastian, Oriol, Albert, Rule, Simon, Kloczko, Janusz, Tedeschi, Alessandra, Buske, Christian, Leblond, Veronique, Trotman, Judith, Chan, Wai Y., Michel, Jan, Schneider, Jingjing, Tan, Ziwen, Cohen, Aileen, Huang, Jane, and Tam, Constantine S.

Published
2020
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9. IBCL-117 ASPEN: Long-Term Follow-Up Results of a Phase 3 Randomized Trial of Zanubrutinib vs Ibrutinib in Patients With Waldenström Macroglobulinemia

Author

Castillo, Jorge J., Tam, Constantine S., Garcia-Sanz, Ramon, Opat, Stephen, D'Sa, Shirley, Jurczak, Wojciech, Lee, Hui-Peng, Cull, Gavin, Owen, Roger G., Marlton, Paula, Wahlin, Bjorn E., Tedeschi, Alessandra, Siddiqi, Tanya, Buske, Christian, Leblond, Veronique, Chan, Wai Y., Schneider, Jingjing, Cohen, Aileen, and Dimopoulos, Meletios

Published
2022
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10. Zanubrutinib Versus Ibrutinib in Symptomatic Waldenström Macroglobulinemia: Final Analysis From the Randomized Phase III ASPEN Study

Author

Dimopoulos, Meletios A., primary, Opat, Stephen, additional, D'Sa, Shirley, additional, Jurczak, Wojciech, additional, Lee, Hui-Peng, additional, Cull, Gavin, additional, Owen, Roger G., additional, Marlton, Paula, additional, Wahlin, Björn E., additional, Garcia-Sanz, Ramon, additional, McCarthy, Helen, additional, Mulligan, Stephen, additional, Tedeschi, Alessandra, additional, Castillo, Jorge J., additional, Czyz, Jaroslaw, additional, Fernández de Larrea, Carlos, additional, Belada, David, additional, Libby, Edward, additional, Matous, Jeffrey, additional, Motta, Marina, additional, Siddiqi, Tanya, additional, Tani, Monica, additional, Trněný, Marek, additional, Minnema, Monique C., additional, Buske, Christian, additional, Leblond, Veronique, additional, Treon, Steven P., additional, Trotman, Judith, additional, Chan, Wai Y., additional, Schneider, Jingjing, additional, Allewelt, Heather, additional, Patel, Sheel, additional, Cohen, Aileen, additional, and Tam, Constantine S., additional

Published
2023
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11. Data from A First-in-Human Phase I Study of the ATP-Competitive AKT Inhibitor Ipatasertib Demonstrates Robust and Safe Targeting of AKT in Patients with Solid Tumors

Author

Saura, Cristina, primary, Roda, Desamparados, primary, Roselló, Susana, primary, Oliveira, Mafalda, primary, Macarulla, Teresa, primary, Pérez-Fidalgo, José Alejandro, primary, Morales-Barrera, Rafael, primary, Sanchis-García, Juan Manuel, primary, Musib, Luna, primary, Budha, Nageshwar, primary, Zhu, Jin, primary, Nannini, Michelle, primary, Chan, Wai Y., primary, Sanabria Bohórquez, Sandra M., primary, Meng, Raymond D., primary, Lin, Kui, primary, Yan, Yibing, primary, Patel, Premal, primary, Baselga, José, primary, Tabernero, Josep, primary, and Cervantes, Andrés, primary

Published
2023
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12. Supplementary Figures S1 - S4, Tables S1 - S8 from A First-in-Human Phase I Study of the ATP-Competitive AKT Inhibitor Ipatasertib Demonstrates Robust and Safe Targeting of AKT in Patients with Solid Tumors

Author

Saura, Cristina, primary, Roda, Desamparados, primary, Roselló, Susana, primary, Oliveira, Mafalda, primary, Macarulla, Teresa, primary, Pérez-Fidalgo, José Alejandro, primary, Morales-Barrera, Rafael, primary, Sanchis-García, Juan Manuel, primary, Musib, Luna, primary, Budha, Nageshwar, primary, Zhu, Jin, primary, Nannini, Michelle, primary, Chan, Wai Y., primary, Sanabria Bohórquez, Sandra M., primary, Meng, Raymond D., primary, Lin, Kui, primary, Yan, Yibing, primary, Patel, Premal, primary, Baselga, José, primary, Tabernero, Josep, primary, and Cervantes, Andrés, primary

Published
2023
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14. Contributors

Author

Arbuzova, Svetlana, primary, Bajaj, Komal, additional, Becker, Christian, additional, Bhattacharyya, Tanmoy, additional, Bian, Xiaotao, additional, Brännström, Mats, additional, Burney, Richard O., additional, Cao, Dan D., additional, Chan, Wai Y., additional, Chen, Chien-Wen, additional, Chou, Ya-Ching, additional, Conti, Marco, additional, Cope, Zebulun S., additional, Cuckle, Howard, additional, Dai, Mo-Yu, additional, De La Fuente, Rabindranath, additional, Ding, Guo-Lian, additional, Dipresa, Savina, additional, Du, Jin, additional, Eguizabal, Cristina, additional, Esencan, Ecem, additional, Ferlin, Alberto, additional, Ferreira, Jose Carlos Pinto B., additional, Fice, Heather, additional, Foresta, Carlo, additional, Gao, Qing-Qin, additional, Giordano, Jessica, additional, Giudice, Linda C., additional, Grati, Francesca Romana, additional, Gross, Susan J., additional, Handel, Mary Ann, additional, Hardy, Tristan, additional, Huang, Cheng, additional, Huang, He-Feng, additional, Izpisua Belmonte, Juan Carlos, additional, Jaillard, Sylvie, additional, Jiang, Hai-Ping, additional, Jiang, Zi-Ru, additional, Kasak, Laura, additional, Kent, Travis, additional, Khattab, Ahmed, additional, Konwar, Chaini, additional, Laan, Maris, additional, Lai, Guan-Lin, additional, LaMarre, Jonathan, additional, Lamb, Dolores J., additional, Lee, Yi-Xuan, additional, Levy, Brynn, additional, Li, Yu-Fei, additional, Liu, Ming, additional, Liu, Xin-Mei, additional, Lo, Y.M. Dennis, additional, Lu, Gang, additional, Luong, Xuan G., additional, Lye, Stephen J., additional, Ma, Xinyi, additional, Ma, Yun-Yi, additional, Maggi, Federico, additional, Miravet-Valenciano, Jose, additional, Missmer, Stacey, additional, Miu, Kai K., additional, Montgomery, Grant, additional, Montserrat, Nuria, additional, Nadeem, Lubna, additional, Narang, Kavita, additional, New, Maria, additional, Noblanc, Anaïs, additional, Norman, Robert J., additional, Normand, Elizabeth A., additional, O’Neill, Marisol, additional, Peñaherrera, Maria S., additional, Qiao, Jie, additional, Rahmawati, Endah, additional, Rahmioglu, Nilufer, additional, Rechitsky, Svetlana, additional, Robaire, Bernard, additional, Robinson, Wendy P., additional, Rogers, Peter A.W., additional, Ruiz-Alonso, María, additional, Rull, Kristiina, additional, Seli, Emre, additional, Selvaratnam, Johanna, additional, Shynlova, Oksana, additional, Simón, Carlos, additional, Simoni, Giuseppe, additional, Simpson, Joe Leigh, additional, Sinclair, Andrew H., additional, Stalker, Leanne, additional, Stosic, Melissa, additional, Teixeira, Jose M., additional, Thirumavalavan, Nannan, additional, Tsang, Jason C.H., additional, Tscherner, Allison, additional, Tucker, Elena J., additional, Tzeng, Chii-Ruey, additional, Van den Veyver, Ignatia B., additional, Viveiros, Maria M., additional, Wang, Hao, additional, Wang, Yan-Ling, additional, Wapner, Ronald, additional, White, Jeffrey T., additional, Wilson, Samantha L., additional, Yan, Liying, additional, Yuan, Victor, additional, Zhai, Fan, additional, Zhelyazkova, Boryana, additional, Zhou, Qi, additional, and Zondervan, Krina, additional

Published
2019
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15. Supplemental data from Randomized Phase II Study Evaluating Akt Blockade with Ipatasertib, in Combination with Abiraterone, in Patients with Metastatic Prostate Cancer with and without PTEN Loss

Author

de Bono, Johann S., primary, De Giorgi, Ugo, primary, Rodrigues, Daniel Nava, primary, Massard, Christophe, primary, Bracarda, Sergio, primary, Font, Albert, primary, Arranz Arija, Jose Angel, primary, Shih, Kent C., primary, Radavoi, George Daniel, primary, Xu, Na, primary, Chan, Wai Y., primary, Ma, Han, primary, Gendreau, Steven, primary, Riisnaes, Ruth, primary, Patel, Premal H., primary, Maslyar, Daniel J., primary, and Jinga, Viorel, primary

Published
2023
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17. Preliminary Safety and Efficacy of Bgb-11417, a Novel Bcl-2 Inhibitor, in Combination with Azacitidine in Patients with Acute Myeloid Leukemia (AML)

Author

Shortt, Jake, primary, Montesinos, Pau, additional, Tan, Shuh Ying, additional, Fong Ng, Teng, additional, Fong, Chun Yew, additional, Cannell, Paul, additional, Rajagopal, Rajeev, additional, Leitch, Sophia, additional, Tan, Peter T., additional, Ramanathan, Sundra, additional, Gasiorowski, Robin, additional, Lenton, Douglas Stuart, additional, Teh, Tse-Chieh, additional, Pérez-Simón, José Antonio, additional, Grove, Carolyn, additional, Huang, Xiaojun, additional, DiNardo, Courtney D., additional, Naidu, Katherine, additional, Pariseau, Joseph, additional, Cheng, Si, additional, Liu, Yu, additional, Co, Melannie, additional, Chan, Wai Y., additional, Guo, Haiyi, additional, and Wei, Andrew H., additional

Published
2022
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18. Poster: IBCL-117 ASPEN: Long-Term Follow-Up Results of a Phase 3 Randomized Trial of Zanubrutinib vs Ibrutinib in Patients With Waldenström Macroglobulinemia

Author

Castillo, Jorge J., primary, Tam, Constantine S., additional, Garcia-Sanz, Ramon, additional, Opat, Stephen, additional, D'Sa, Shirley, additional, Jurczak, Wojciech, additional, Lee, Hui-Peng, additional, Cull, Gavin, additional, Owen, Roger G., additional, Marlton, Paula, additional, Wahlin, Bjorn E., additional, Tedeschi, Alessandra, additional, Siddiqi, Tanya, additional, Buske, Christian, additional, Leblond, Veronique, additional, Chan, Wai Y., additional, Schneider, Jingjing, additional, Cohen, Aileen, additional, and Dimopoulos, Meletios, additional

Published
2022
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19. Autonomous service robot for human-aware restock, straightening and disposal tasks in retail automation

Author

Garcia Ricardez, Gustavo A., primary, Uriguen Eljuri, Pedro M., additional, Kamemura, Yuta, additional, Yokota, Shiori, additional, Kugou, Noriyuki, additional, Asama, Yoshitatsu, additional, Wang, Ziyu, additional, Kumamoto, Hikaru, additional, Yoshimoto, Kotaro, additional, Chan, Wai Y., additional, Nagatani, Tomoki, additional, Tulathum, Pattaraporn, additional, Usawalertkamol, Bunyapon, additional, El Hafi, Lotfi, additional, Ikeuchi, Hiroki, additional, Yamamoto, Masaki, additional, Takamatsu, Jun, additional, Taniguchi, Tadahiro, additional, and Ogasawara, Tsukasa, additional

Published
2022
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20. ASPEN: Long-term follow-up results of a phase 3 randomized trial of zanubrutinib (ZANU) versus ibrutinib (IBR) in patients with Waldenström macroglobulinemia (WM).

Author

Tam, Constantine Si Lun, primary, Garcia-Sanz, Ramón, additional, Opat, Stephen, additional, D'Sa, Shirley, additional, Jurczak, Wojciech, additional, Lee, Hui-Peng, additional, Cull, Gavin, additional, Owen, Roger G., additional, Marlton, Paula, additional, Wahlin, Bjorn E., additional, Tedeschi, Alessandra, additional, Castillo, Jorge J., additional, Siddiqi, Tanya, additional, Buske, Christian, additional, Leblond, Veronique, additional, Chan, Wai Y., additional, Schneider, Jingjing, additional, Cohen, Aileen, additional, Huang, Jane, additional, and Dimopoulos, Meletios A., additional

Published
2022
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21. Bradyrhizobium altum sp. nov., Bradyrhizobium oropedii sp. nov. and Bradyrhizobium acaciae sp. nov. from South Africa show locally restricted and pantropical nodA phylogeographic patterns

Author

Avontuur, Juanita R., primary, Palmer, Marike, additional, Beukes, Chrizelle W., additional, Chan, Wai Y., additional, Tasiya, Taponeswa, additional, van Zyl, Elritha, additional, Coetzee, Martin P.A., additional, Stepkowski, Tomasz, additional, Venter, Stephanus N., additional, and Steenkamp, Emma T., additional

Published
2022
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22. Bradyrhizobium altum Avontuur & Palmer & Beukes & Chan & Tasiya & Zyl & Coetzee & Stepkowski & Venter & Steenkamp 2022, sp. nov

Author

Avontuur, Juanita R., Palmer, Marike, Beukes, Chrizelle W., Chan, Wai Y., Tasiya, Taponeswa, Zyl, Elritha van, Coetzee, Martin P. A., Stepkowski, Tomasz, Venter, Stephanus N., and Steenkamp, Emma T.

Subjects
Bradyrhizobium altum, Bacteria, Proteobacteria, Biodiversity, Bradyrhizobium, Rhizobiales, Bradyrhizobiaceae, Taxonomy, Alphaproteobacteria
Abstract

4.3. Description of Bradyrhizobium altum sp. nov. Bradyrhizobium altum (al’ tum. L. neut. adj. altum, high, referring to the high-altitude region where this species was isolated from). Cells are motile, Gram-negative rods and is approximately 1.29 × 0.45 μm in size. Colonies are circular, convex, opaque, cream in colour and < 1 mm in diameteron YMA after 7 daysincubation at 28 ◦ C. The pH range for growth on YMA is 5 to 10 and growth can occur between 15 and 37 ◦ Cand thesestrainscangrowinthe presenceof upto 2.0 % (w/v) NaCl. Reduction of nitrates, β- glucosidase urease, tested positive. It is also positive for the production of L-arabinose, Tween 40, Tween 80, adonitol, N-acetyl-D-glucosamine, D-cellobiose, D-arabitol, D-galactose, D- and L-fructose, m-inositol, D-mannitol, maltose, D-mannose, Draffinose, D-melibiose, L-rhamnose, D-sorbitol, sucrose, xylitol, Dtrehalose, turanose, methyl pyruvate, D-galacturonic acid, acetic acid, malonic acid, propionic acid, D-saccharic acid, quinic acid, sebacic acid, L-asparagine, D- and L-alanine, L-leucine, L-proline, L-ornithine and glycerol. Negative reactions were recorded for glucose fermentation, indole production, β- galactosidase activity and L-arginine dihydrolase. It is also negative for the assimilation of N-acetyl-glucosamine, potassium gluconate, D-maltose, adipic acid, capric acid, malic acid, phenylacetic acid, glycogen, α- cyclodextrin, L-arabinose, i-erythritol, Lthreonine, D- and L-serine, glucose-1-phosphate and glucose-6- phosphate. Strain is resistant to penicillin (10 μg/ml), ampicillin (10 μg/ml), gentamycin (10 μg/ml), chloramphenicol (30 μg/ml) and neomycin (10 μg/ml) and is susceptible to kanamycin (30 μg/ml), erythromycin (30 μg/ml), streptomycin (10 and 25 μg/ml) and tetracycline (30 μg/ml). The type strain Pear77 T (=SARCC 754 = LMG 31407), was isolated from root nodules of Pearsonia obovata collected in the Dullstroom area of the Mpumalanga Province, South Africa. This species forms effective nodules on cowpea (Vigna unguiculata) and siratro (Macroptilium atropurpureum). The DNA G + Ccontent of the type strain is 63.3 mol%. The GenBank/EMBL/DDBJ accession numbers for the genome sequence and gene sequences for this type strain are: whole genome (JACMYP000000000) and 16S rRNA (LR877298), atpD (LN650104), glnII (LN650146), dnaK (LN650125), gyrB (LN650209), rpoB (LN650188) and nodA (LN650251).

Published
2021
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23. Bradyrhizobium altum sp. nov., Bradyrhizobium oropedii sp. nov. and Bradyrhizobium acaciae sp. nov. from South Africa show locally restricted and pantropical nodA phylogeographic patterns

Author

Avontuur, Juanita R., Palmer, Marike, Beukes, Chrizelle W., Chan, Wai Y., Tasiya, Taponeswa, Zyl, Elritha van, Coetzee, Martin P.A., Stepkowski, Tomasz, Venter, Stephanus N., and Steenkamp, Emma T.

Subjects
Bacteria, Proteobacteria, Biodiversity, Rhizobiales, Bradyrhizobiaceae, Taxonomy, Alphaproteobacteria
Abstract

Avontuur, Juanita R., Palmer, Marike, Beukes, Chrizelle W., Chan, Wai Y., Tasiya, Taponeswa, Zyl, Elritha van, Coetzee, Martin P.A., Stepkowski, Tomasz, Venter, Stephanus N., Steenkamp, Emma T. (2022): Bradyrhizobium altum sp. nov., Bradyrhizobium oropedii sp. nov. and Bradyrhizobium acaciae sp. nov. from South Africa show locally restricted and pantropical nodA phylogeographic patterns. Molecular Phylogenetics and Evolution (107338) 167: 1-13, DOI: 10.1016/j.ympev.2021.107338

Published
2021

24. Bradyrhizobium oropedii Avontuur & Palmer & Beukes & Chan & Tasiya & Zyl & Coetzee & Stepkowski & Venter & Steenkamp 2022, sp. nov

Author

Avontuur, Juanita R., Palmer, Marike, Beukes, Chrizelle W., Chan, Wai Y., Tasiya, Taponeswa, Zyl, Elritha van, Coetzee, Martin P. A., Stepkowski, Tomasz, Venter, Stephanus N., and Steenkamp, Emma T.

Subjects
Bacteria, Proteobacteria, Biodiversity, Bradyrhizobium, Bradyrhizobium oropedii, Rhizobiales, Bradyrhizobiaceae, Taxonomy, Alphaproteobacteria
Abstract

4.2. Description of Bradyrhizobium oropedii sp. nov. Bradyrhizobium oropedii (o.ro.pe’ di.i. Gr. neut. n. oropedion mountain plain; N.L. gen. n. oropedii, of the central Southern African plateau, from where the species was isolated). Cells are motile, Gram-negative, rod shaped and approximately 1.87 × 0.48 μm in size. Growth occurs on YMA at 28 ◦ C after 7 days and colonies are translucent to opaque, circular, convex and cream in colour. Grows at pH values ranging from 5 to 10 and at temperatures ranging from 15 to 35 ◦ C. Isolates are unable to grow in the presence of more than 0.5% NaCl (w/v). Strains tested positive for oxidase, catalase, urease and β- glucosidase activity as well as the production of Tween 40 and Tween 80. Tested positive for the following carbon sources: Dfructose, L-fructose, D-gluconic acid, D-mannitol, α and β- hydroxy butyric acid, p-hydroxy phenylacetic acid, L-alaninamide, L-lactic acid, L-leucine, D-saccharic acid, and urocanic acid. Negative reactions were recorded for indole production and the assimilation of capric acid, adipic acid, malic acid, glycogen, α- D-lactose, N-acetyl-D-galactosamine, α- cyclodextrin, Adonitol, D-cellobiose, D-raffinose, i-erythritol, maltose, lactulose, D-melibiose, sucrose, D-trehalose, turanose, xylitol, L-threonine, uridine, inosine, thymine, glucose-1-phosphate and glucose-6-phosphate, and m-inositol. Resistant to ampicillin (10 μg/ml), chloramphenicol (30 μg/ml), tetracycline (30 μg/ml), penicillin (10 μg/ ml), and susceptible to streptomycin (25 μg/ml). The type strain, Pear76 T (=SARCC 731 = LMG 31408) was isolated from root nodules of Pearsonia obovata in the Dullstroom area of the Mpumalanga Province, South Africa and forms effective nodules on cowpea (Vigna unguiculata) and siratro (Macroptilium atropurpureum). The DNA G + Ccontent of the type strain is 63.5 mol%. GenBank/ EMBL/DDBJ accession numbers for the genome sequence and the gene sequences of this type strain are: whole genome (JACMYO000000000) and 16S rRNA (LR877297), atpD (LN650103), glnII (LN650145), dnaK (LN650124), gyrB (LN650208), rpoB (LN650187) and nodA (LN650250).

Published
2021
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28. Paraburkholderia youngii sp. nov. and ‘Paraburkholderia atlantica’ – Brazilian and Mexican Mimosa-associated rhizobia that were previously known as Paraburkholderia tuberum sv. mimosae

Author

Mavima, Lazarus, primary, Beukes, Chrizelle W., additional, Palmer, Marike, additional, De Meyer, Sofie E., additional, James, Euan K., additional, Maluk, Marta, additional, Gross, Eduardo, additional, dos Reis Junior, Fabio Bueno, additional, Avontuur, Juanita R., additional, Chan, Wai Y., additional, Venter, Stephanus N., additional, and Steenkamp, Emma T., additional

Published
2021
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29. A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenström macroglobulinemia: the ASPEN study

Author

Tam, Constantine S., primary, Opat, Stephen, additional, D'Sa, Shirley, additional, Jurczak, Wojciech, additional, Lee, Hui-Peng, additional, Cull, Gavin, additional, Owen, Roger G., additional, Marlton, Paula, additional, Wahlin, Björn E., additional, Sanz, Ramón Garcia, additional, McCarthy, Helen, additional, Mulligan, Stephen, additional, Tedeschi, Alessandra, additional, Castillo, Jorge J., additional, Czyz, Jaroslaw, additional, Fernández de Larrea, Carlos, additional, Belada, David, additional, Libby, Edward, additional, Matous, Jeffrey V., additional, Motta, Marina, additional, Siddiqi, Tanya, additional, Tani, Monica, additional, Trneny, Marek, additional, Minnema, Monique C., additional, Buske, Christian, additional, Leblond, Veronique, additional, Trotman, Judith, additional, Chan, Wai Y., additional, Schneider, Jingjing, additional, Ro, Sunhee, additional, Cohen, Aileen, additional, Huang, Jane, additional, and Dimopoulos, Meletios, additional

Published
2020
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30. ASPEN: Results of a phase III randomized trial of zanubrutinib versus ibrutinib for patients with Waldenström macroglobulinemia (WM).

Author

Tam, Constantine Si Lun, primary, Opat, Stephen, additional, D'Sa, Shirley, additional, Jurczak, Wojciech, additional, Lee, Hui-Peng, additional, Cull, Gavin, additional, Owen, Roger G., additional, Marlton, Paula, additional, Wahlin, Bjorn E., additional, Tedeschi, Alessandra, additional, Castillo, Jorge J., additional, Siddiqi, Tanya, additional, Buske, Christian, additional, Leblond, Veronique, additional, Chan, Wai Y., additional, Schneider, Jingjing, additional, Ro, Sunhee K., additional, Cohen, Aileen, additional, Huang, Jane, additional, and Dimopoulos, Meletios A., additional

Published
2020
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31. Updated results of the ASPEN trial from a cohort of patients with MYD88 wild-type (MYD88WT) Waldenström macroglobulinemia (WM).

Author

Garcia-Sanz, Ramón, primary, Dimopoulos, Meletios A., additional, Lee, Hui-Peng, additional, Trneny, Marek, additional, Varettoni, Marzia, additional, Owen, Roger G., additional, Castillo, Jorge J., additional, Siddiqi, Tanya, additional, Tedeschi, Alessandra, additional, Buske, Christian, additional, Leblond, Veronique, additional, Chan, Wai Y., additional, Schneider, Jingjing, additional, Ro, Sunhee K., additional, Cohen, Aileen, additional, Huang, Jane, additional, and Tam, Constantine Si Lun, additional

Published
2020
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32. Genome-informed Bradyrhizobium taxonomy: where to from here?

Author

Avontuur, Juanita R., primary, Palmer, Marike, additional, Beukes, Chrizelle W., additional, Chan, Wai Y., additional, Coetzee, Martin P.A., additional, Blom, Jochen, additional, Stępkowski, Tomasz, additional, Kyrpides, Nikos C., additional, Woyke, Tanja, additional, Shapiro, Nicole, additional, Whitman, William B., additional, Venter, Stephanus N., additional, and Steenkamp, Emma T., additional

Published
2019
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33. Randomized Phase II Study Evaluating Akt Blockade with Ipatasertib, in Combination with Abiraterone, in Patients with Metastatic Prostate Cancer with and without PTEN Loss

Author

de Bono, Johann S., primary, De Giorgi, Ugo, additional, Rodrigues, Daniel Nava, additional, Massard, Christophe, additional, Bracarda, Sergio, additional, Font, Albert, additional, Arranz Arija, Jose Angel, additional, Shih, Kent C., additional, Radavoi, George Daniel, additional, Xu, Na, additional, Chan, Wai Y., additional, Ma, Han, additional, Gendreau, Steven, additional, Riisnaes, Ruth, additional, Patel, Premal H., additional, Maslyar, Daniel J., additional, and Jinga, Viorel, additional

Published
2019
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34. Chest Radiograph (CXR) Manifestations of the Novel Coronavirus Disease 2019 (COVID-19): A Mini-review

Author

Chan, Wai Y., Hamid, Marlina T. R., Gowdh, Nadia Fareeda Muhammad, Rahmat, Kartini, Yaakup, Nur Adura, and Chai, Chee Shee

Abstract

Background: Coronavirus disease 2019 (COVID-19) is highly contagious and has claimed more than one million lives, besides causing hardship and disruptions. The Fleischner Society has recommended chest X-ray (CXR) in detecting cases at high risk of disease progression, for triaging suspected patients with moderate-to-severe illness, and for eliminating false negatives in areas with high pre-test probability or limited resources. Although CXR is less sensitive than real-- time reverse transcription-polymerase chain reaction (RT-PCR) in detecting mild COVID-19, it is nevertheless useful because of equipment portability, low cost and practicality in serial assessments of disease progression among hospitalized patients. Objective: This study aims to review the typical and relatively atypical CXR manifestations of COVID-19 pneumonia in a tertiary care hospital. Methods: The CXRs of 136 COVID-19 patients confirmed through real-time RT-PCR from March to May 2020 were reviewed. A literature search was performed using PubMed. Results: A total of 54 patients had abnormal CXR whilst the others were normal. Typical CXR findings included pulmonary consolidation or ground-glass opacities in a multifocal, bilateral peripheral, or lower zone distribution, whereas atypical CXR features comprised cavitation and pleural effusion. Conclusion: Typical findings of COVID-19 infection in chest computed tomography studies can also be seen in CXR. The presence of atypical features associated with worse disease outcome. Recognition of these features on CXR will improve the accuracy and speed of diagnosing COVID-19 patients.

Published
2021
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35. Biomarker analysis of the ASPEN study comparing zanubrutinib to ibrutinib in patients with Waldenström macroglobulinemia

Author

Tam, Constantine S., Opat, Stephen, D'Sa, Shirley, Jurczak, Wojciech, Lee, Hui-Peng, Cull, Gavin, Owen, Roger G., Marlton, Paula, Wahlin, Bjorn E., García-Sanz, Ramón, McCarthy, Helen, Mulligan, Stephen, Tedeschi, Alessandra, Castillo, Jorge J., Czyż, Jaroslaw, De Larrea Rodriguez, Carlos Fernández, Belada, David, Libby, Edward, Matous, Jeffrey, Motta, Marina, Siddiqi, Tanya, Tani, Monica, Trněný, Marek, Minnema, Monique C., Buske, Christian, Leblond, Veronique, Treon, Steven P., Trotman, Judith, Wu, Binghao, Yu, Yiling, Shen, Zhirong, Chan, Wai Y., Schneider, Jingjing, Allewelt, Heather, Cohen, Aileen, and Dimopoulos, Meletios

Abstract

•Patients with Waldenström macroglobulinemia and mutations in CXCR4or TP53had poorer prognosis after treatment with BTK inhibitors.•Patients with CXCR4or TP53mutations had more favorable outcomes when treated with zanubrutinib versus ibrutinib.

Published
2024
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36. Abstract 2964: On-treatment changes in circulating tumor DNA (ctDNA) level as an early predictor of clinical outcome in the LOTUS randomized phase 2 trial of 1st-line ipatasertib (IPAT) + paclitaxel (PAC) for metastatic triple-negative breast cancer (mTNBC)

Author

Wongchenko, Matthew J., primary, Lipson, Doron, additional, Clark, Travis, additional, Kennedy, Mark, additional, Greene, Mandy, additional, Breese, Virginia, additional, Tsiros, Alyssa, additional, Kim, Sung-Bae, additional, Saura, Cristina, additional, Oliveira, Mafalda, additional, Baselga, Jose, additional, Kapp, Amy V., additional, Chan, Wai Y., additional, Singel, Stina M., additional, Gendreau, Steven, additional, and Dent, Rebecca, additional

Published
2018
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37. Abstract CT041: Primary results from FAIRLANE (NCT02301988), a double-blind placebo (PBO)-controlled randomized phase II trial of neoadjuvant ipatasertib (IPAT) + paclitaxel (PAC) for early triple-negative breast cancer (eTNBC)

Author

Oliveira, Mafalda, primary, Saura, Cristina, additional, Calvo, Isabel, additional, Andersen, Jay, additional, Coelho, José Luis Passos, additional, Gil, Miguel Gil, additional, Bermejo, Begoña, additional, Patt, Debra A., additional, Ciruelos, Eva, additional, Singel, Stina M., additional, Maslyar, Daniel J., additional, Wongchenko, Matthew, additional, Chan, Wai Y., additional, Kapp, Amy V., additional, Peña, Lorena de la, additional, Baselga, José, additional, and Isakoff, Steven J., additional

Published
2018
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38. Overall survival (OS) update of the double-blind placebo (PBO)-controlled randomized phase 2 LOTUS trial of first-line ipatasertib (IPAT) + paclitaxel (PAC) for locally advanced/metastatic triple-negative breast cancer (mTNBC).

Author

Dent, Rebecca, primary, Im, Seock-Ah, additional, Espie, Marc, additional, Blau, Sibel, additional, Tan, Antoinette R., additional, Isakoff, Steven J., additional, Oliveira, Mafalda, additional, Saura, Cristina, additional, Wongchenko, Matthew, additional, Kapp, Amy V., additional, Chan, Wai Y., additional, Singel, Stina M., additional, Maslyar, Daniel J., additional, Baselga, Jose, additional, and Kim, Sung-Bae, additional

Published
2018
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39. NGS, RNA-Seq, TIL, and PTEN analyses in prostate cancer specimens from patients enrolled in the study of the Akt inhibitor ipatasertib (Ipat) combined with abiraterone acetate (AA).

Author

Zhang, Liangxuan, primary, Koeppen, Hartmut, additional, Maslyar, Daniel J., additional, Fillos, Dimitri, additional, Xu, Na, additional, Chan, Wai Y., additional, Font Pous, Albert, additional, Jinga, Viorel, additional, Massard, Christophe, additional, Bracarda, Sergio, additional, Radavoi, George Daniel, additional, De Giorgi, Ugo, additional, Arranz Arija, Jose Angel, additional, Riisnaes, Ruth, additional, Nava Rodrigues, Daniel, additional, De Bono, Johann S., additional, and Gendreau, Steven, additional

Published
2018
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40. LOTUS (NCT02162719): A double-blind placebo (PBO)-controlled randomized phase II trial of first-line ipatasertib (IPAT) + paclitaxel (P) for metastatic triple-negative breast cancer (TNBC).

Author

Dent, Rebecca Alexandra, primary, Kim, Sung-Bae, additional, Im, Seock-Ah, additional, Espie, Marc, additional, Blau, Sibel, additional, Tan, Antoinette R., additional, Isakoff, Steven, additional, Oliveira, Mafalda, additional, Saura, Cristina, additional, Wongchenko, Matthew, additional, Kapp, Amy V., additional, Chan, Wai Y., additional, Singel, Stina M., additional, Maslyar, Daniel J., additional, and Baselga, Jose, additional

Published
2017
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41. A First-in-Human Phase I Study of the ATP-Competitive AKT Inhibitor Ipatasertib Demonstrates Robust and Safe Targeting of AKT in Patients with Solid Tumors

Author

Saura, Cristina, primary, Roda, Desamparados, additional, Roselló, Susana, additional, Oliveira, Mafalda, additional, Macarulla, Teresa, additional, Pérez-Fidalgo, José Alejandro, additional, Morales-Barrera, Rafael, additional, Sanchis-García, Juan Manuel, additional, Musib, Luna, additional, Budha, Nageshwar, additional, Zhu, Jin, additional, Nannini, Michelle, additional, Chan, Wai Y., additional, Sanabria Bohórquez, Sandra M., additional, Meng, Raymond D., additional, Lin, Kui, additional, Yan, Yibing, additional, Patel, Premal, additional, Baselga, José, additional, Tabernero, Josep, additional, and Cervantes, Andrés, additional

Published
2017
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42. Randomized phase II study of AKT blockade with ipatasertib (GDC-0068) and abiraterone (Abi) vs. Abi alone in patients with metastatic castration-resistant prostate cancer (mCRPC) after docetaxel chemotherapy (A. MARTIN Study).

Author

De Bono, Johann S., primary, De Giorgi, Ugo, additional, Massard, Christophe, additional, Bracarda, Sergio, additional, Kocak, Ivo, additional, Font, Albert, additional, Arranz Arija, Jose Angel, additional, Shih, Kent C., additional, Radavoi, George Daniel, additional, Yu, Wei, additional, Chan, Wai Y., additional, Huang, Jian, additional, Musib, Luna C., additional, Gendreau, Steven, additional, Meng, Raymond D., additional, Patel, Premal H, additional, Maslyar, Daniel J., additional, and Jinga, Viorel, additional

Published
2016
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43. FAIRLANE: A phase II randomized, double-blind, study of the Akt inhibitor ipatasertib (GDC-0068) in combination with paclitaxel as neoadjuvant treatment for early stage triple-negative breast cancer.

Author

Isakoff, Steven J., primary, Saura, Cristina, additional, Calvo, Isabel, additional, Gil Gil, Miguel J., additional, Patt, Debra A., additional, Morales Murillo, Serafin, additional, Andersen, Jay C., additional, Ciruelos, EVA, additional, Fisher, Julie Gottlieb, additional, Passos-Coelho, Jose, additional, de La Pena, Lorena, additional, Kapp, Amy V., additional, Gendreau, Steven, additional, Chan, Wai Y., additional, Singel, Stina Mui, additional, Maslyar, Daniel J., additional, Baselga, Jose, additional, and Oliveira, Mafalda, additional

Published
2016
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44. JAGUAR: A randomized phase II study of the AKT inhibitor ipatasertib (GDC-0068) versus placebo in combination with mFOLFOX6 chemotherapy in patients (pts) with locally advanced or metastatic HER2-negative gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma.

Author

Bang, Yung-Jue, primary, Kang, Yoon-Koo, additional, Alsina, Maria, additional, Wainberg, Zev A., additional, Chau, Ian, additional, Zhu, Jin, additional, Chan, Wai Y., additional, Patel, Premal H., additional, Meng, Raymond D., additional, and Ajani, Jaffer A., additional

Published
2014
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45. Direct phosphorylation and regulation of poly(ADP-ribose) polymerase-1 by extracellular signal-regulated kinases ⅛.

Author

Kauppinen, Tiina M., Chan, Wai Y., Sang Won Suh, Wiggins, Amanda K., Huang, Eric J., and Swanson, Raymond A.

Subjects
BRAIN injuries, APOPTOSIS, CELL death, NEURONS, CELLS, ALKALINE phosphatase, PHOSPHATASES
Abstract

Sustained activation of poly(ADP-ribose) polymerase-1 (PARP-1) and extracellular signal-regulated kinases 1/2 (ERK1/2) both promote neuronal death. Here we identify a direct link between these two cell death pathways. In a rat model of hypoglycemic brain injury, neuronal PARP-1 activation and subsequent neuronal death were blocked by the ERK1/2 inhibitor 2-(2-amino-3-methoxyphenyl)-4H-1-benzopyran-4-one (PD98059). In neuron cultures, PARP-1-mediated neuronal death induced by N-methyi-D-aspartate, peroxynitrite, or DNA alkylation was similarly blocked by ERK1/2 pathway inhibitors. These inhibitors also blocked PARP-1 activation and PARP-1-mediated death in astrocytes, siRNA down-regulation of ERK2 expression in astrocytes also blocked PARP-1 activation and cell death. Direct effects of ERK1/2 on PARP-1 were evaluated by using isolated recombinant enzymes. The activity of recombinant human PARP-1 was reduced by incubation with alkaline phosphatase and restored by incubation with active ERK1 or ERK2. Putative ERK1/2 phosphorylation sites on PARP-1 were identified by mass spectrometry. Using site-directed mutagenesis, these sites were replaced with alanine (S372A and T373A) to block phosphorylation, or with glutamate (S372E and T373E) to mimic constitutive phosphorylation. Transfection of PARP-1 deficient mouse embryonic fibroblasts with the mutant PARP-1 species showed that the S372A and T373A mutations impaired PARP-1 activation, whereas the S372E and T373E mutations increased PARP-1 activity and eliminated the effect of ERK1/2 inhibitors on PARP-1 activation. These results suggest that PARP1 phosphorylation by ERK1/2 is required for maximal PARP-1 activation after DNA damage. [ABSTRACT FROM AUTHOR]

Published
2006
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49. Ipatasertib plus paclitaxel versus placebo plus paclitaxel as first-line therapy for metastatic triple-negative breast cancer (LOTUS): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial

Author

Sung-Bae Kim, Rebecca Dent, Seock-Ah Im, Marc Espié, Sibel Blau, Antoinette R Tan, Steven J Isakoff, Mafalda Oliveira, Cristina Saura, Matthew J Wongchenko, Amy V Kapp, Wai Y Chan, Stina M Singel, Daniel J Maslyar, José Baselga, Keun Seok Lee, Hwei-Chung Wang, Antoinette Tan, Joo Hyuk Sohn, Michelino De Laurentiis, Laura Garcia Estevez, Chiun-Sheng Huang, Gilles Romieu, Michel Velez, Rafael Villanueva, Pier Franco Conte, Shaker Dakhil, Marc Debled, Antonio Gonzalez Martin, Sara Hurvitz, Jee Hyun Kim, Christelle Levy, Pedro Sanchez Rovira, Jae Hong Seo, Vicente Valero, Gregory Vidal, Andrea Wong, Mary Ann K Allison, Robert Figlin, David Chan, Shin-Cheh Chen, Yen-Hsun Chen, Melody Cobleigh, Filippo De Braud, Luc Dirix, Vincent Hansen, Anne Hardy Bessard, Nicholas Iannotti, Steven Isakoff, William Lawler, Alvaro Montaño, Mohamad Salkini, Leonard Seigel, Kim, Sung-bae, Dent, Rebecca, Im, Seock-ah, Espié, Marc, Blau, Sibel, Tan, Antoinette R, Isakoff, Steven J, Oliveira, Mafalda, Saura, Cristina, Wongchenko, Matthew J, Kapp, Amy V, Chan, Wai Y, Singel, Stina M, Maslyar, Daniel J, Baselga, José, and De Laurentiis, Michelino

Subjects
0301 basic medicine, Administration, Oral, Triple Negative Breast Neoplasms, LOTUS investigators, law.invention, Placebos, 0302 clinical medicine, Randomized controlled trial, law, Antineoplastic Combined Chemotherapy Protocols, Cancer, education.field_of_study, Hazard ratio, Middle Aged, Prognosis, Treatment Outcome, Oncology, 030220 oncology & carcinogenesis, 6.1 Pharmaceuticals, Administration, Female, Survival Analysi, Drug, Human, Oral, Adult, medicine.medical_specialty, Paclitaxel, Maximum Tolerated Dose, Prognosi, Population, Clinical Trials and Supportive Activities, Oncology and Carcinogenesis, Placebo, Risk Assessment, Disease-Free Survival, Drug Administration Schedule, Dose-Response Relationship, 03 medical and health sciences, Breast cancer, Double-Blind Method, Clinical Research, Internal medicine, Breast Cancer, medicine, Adjuvant therapy, Confidence Intervals, Humans, Neoplasm Invasiveness, Oncology & Carcinogenesis, education, Survival analysis, Neoplasm Staging, Proportional Hazards Models, Aged, Neoplasm Invasivene, Antineoplastic Combined Chemotherapy Protocol, Dose-Response Relationship, Drug, business.industry, Patient Selection, Evaluation of treatments and therapeutic interventions, medicine.disease, Survival Analysis, Surgery, Clinical trial, 030104 developmental biology, Proportional Hazards Model, business, Confidence Interval, Proto-Oncogene Proteins c-akt
Abstract

Summary Background The oral AKT inhibitor ipatasertib is being investigated in cancers with a high prevalence of PI3K/AKT pathway activation, including triple-negative breast cancer. The LOTUS trial investigated the addition of ipatasertib to paclitaxel as first-line therapy for triple-negative breast cancer. Methods In this randomised, placebo-controlled, double-blind, phase 2 trial, women aged 18 years or older with measurable, inoperable, locally advanced or metastatic triple-negative breast cancer previously untreated with systemic therapy were recruited from 44 hospitals in South Korea, the USA, France, Spain, Taiwan, Singapore, Italy, and Belgium. Enrolled patients were randomly assigned (1:1) to receive intravenous paclitaxel 80 mg/m 2 (days 1, 8, 15) with either ipatasertib 400 mg or placebo once per day (days 1–21) every 28 days until disease progression or unacceptable toxicity. Randomisation was by stratified permuted blocks (block size of four) using an interactive web-response system with three stratification criteria: previous (neo)adjuvant therapy, chemotherapy-free interval, and tumour PTEN status. The co-primary endpoints were progression-free survival in the intention-to-treat population and progression-free survival in the PTEN-low (by immunohistochemistry) population. This ongoing trial is registered with ClinicalTrials.gov (NCT02162719). Findings Between Sept 2, 2014, and Feb 4, 2016, 166 patients were assessed for eligibility and 124 patients were enrolled and randomly assigned to paclitaxel plus ipatasertib (n=62) or paclitaxel plus placebo (n=62). Median follow-up was 10·4 months (IQR 6·5–14·1) in the ipatasertib group and 10·2 months (6·0–13·6) in the placebo group. Median progression-free survival in the intention-to-treat population was 6·2 months (95% CI 3·8–9·0) with ipatasertib versus 4·9 months (3·6–5·4) with placebo (stratified hazard ratio [HR] 0·60, 95% CI 0·37–0·98; p=0·037) and in the 48 patients with PTEN-low tumours, median progression-free survival was 6·2 months (95% CI 3·6–9·1) with ipatasertib versus 3·7 months (1·9–7·3) with placebo (stratified HR 0·59, 95% CI 0·26–1·32, p=0·18). The most common grade 3 or worse adverse events were diarrhoea (14 [23%] of 61 ipatasertib-treated patients vs none of 62 placebo-treated patients), neutrophil count decreased (five [8%] vs four [6%]), and neutropenia (six [10%] vs one [2%]). No colitis, grade 4 diarrhoea, or treatment-related deaths were reported with ipatasertib. One treatment-related death occurred in the placebo group. Serious adverse events were reported in 17 (28%) of 61 patients in the ipatasertib group and nine (15%) of 62 patients in the placebo group. Interpretation Progression-free survival was longer in patients who received ipatasertib than in those who received placebo. To our knowledge, these are the first results supporting AKT-targeted therapy for triple-negative breast cancer. Ipatasertib warrants further investigation for the treatment of triple-negative breast cancer. Funding F Hoffmann-La Roche.

Published
2017

50. Health-related quality of life in patients with Waldenström macroglobulinemia: results from the ASPEN trial.

Author

Tedeschi A, Tam CS, Owen RG, Buske C, Leblond V, Dimopoulos M, Garcia-Sanz R, Castillo JJ, Trotman J, Treon SP, Yang K, Tang B, Allewelt H, Patel S, Chan WY, Cohen A, Chen S, and Barnes G

Abstract

Aim ASPEN is a randomized, open-label, Phase III study comparing zanubrutinib and ibrutinib in patients with Waldenström macroglobulinemia (WM). Materials & methods: Patient-reported outcomes were exploratory end points assessed using the EORTC QLQ-C30 and EQ-5D-5L VAS scores. Results: Overall, 201 patients (102 zanubrutinib; 99 ibrutinib) were enrolled. Clinically meaningful differences were observed in diarrhea and nausea/vomiting in both the intent-to-treat population and in patients attaining very good partial response (VGPR) in earlier cycles of treatment, as well as in long-term physical functioning and fatigue in patients achieving VGPR. Conclusion: Treatment with zanubrutinib was associated with greater improvements in health-related quality of life compared with ibrutinib in patients with WM and MYD88 mutations. Clinical Trial Registration: NCT03053440 (ClinicalTrials.gov).

Published
2024
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