tbuckley/cabot-search huggingface dataset:
987P A phase Ib study of the PD-1 antagonist CS1003 plus lenvatinib (LEN) in Chinese patients (pts) with the first-line (1L) unresectable hepatocellular carcinoma (uHCC)
Authors: L. Shen, Y. Zhang, Y. Guo, W. Li, J.F. Gong, Z. Ma, W. Peng, N. Wang, J. Ni, Q. Qi, Y. Ma, Z. Qin, A. Tse
Journal: Annals of Oncology (2020)

CS1003 is a novel humanized IgG4 anti-PD-1 monoclonal antibody. LEN, a multi-kinase inhibitor of VEGFR 1-3, FGFR 1-4, PDGFRα, RET, and KIT, is approved for the treatment of 1L uHCC in multiple countries. Here we report the preliminary efficacy and safety from a phase Ib trial of CS1003 + LEN in 1L uHCC. In this open-label phase Ib study, pts with 1L uHCC, BCLC stage B or C, Child-Pugh class A, and ECOG PS ≤ 1 received 200 mg CS1003 intravenously once every 3 weeks and LEN orally (body weight ≥ 60 kg: 12 mg/day; < 60 kg: 8 mg/day) daily. Dose-limiting toxicity (DLT) was monitored during the first cycle in Part 1. Additional pts were enrolled in Part 2 for efficacy expansion. The primary endpoint was objective response rate (ORR) assessed by investigators per RECIST v1.1. Secondary endpoints included safety and other efficacy parameters. As of 21 Mar 2020, no DLTs were reported in Part 1. A total of 19 pts were treated (Part 1, n=8; Part 2, n=11) and 17 remained on study treatment. The median treatment duration of CS1003/LEN was 15.0 (range: 0.7-27.4) weeks. Among the 16 efficacy-evaluable pts, ORR was 37.5% with 6 pts achieving partial response (3 confirmed); duration of response (DoR) ranged from 0.03+ to 4.17+ months, and median DoR was not reached. Tumor shrinkage was observed in 6 of the 7 pts with stable disease. Treatment-related adverse events (TRAEs) occurred in 16 pts (84.2%). The most common TRAEs were hypothyroidism (n=5), platelet count decreased (n=5) and protein urine present (n=5). CTCAE Grade (G) ≥3 TRAEs occurred in 3 pts (15.8%). One pt had a G3 bilirubin conjugated increased that was attributed to both CS1003 and LEN. The other two pts had a G3 diarrhoea and a G3 hypophosphataemia, respectively, that were only related to LEN. No new safety signals were identified. The CS1003 + LEN combination shows promising antitumor activity and an acceptable safety profile in Chinese pts with 1L uHCC. A multi-regional, double-blinded, randomized phase III trial of LEN with or without CS1003 in 1L uHCC is underway.
886MO Health-related quality of life (HRQoL) from KEYNOTE-204: A phase III, randomized, open-label study of pembrolizumab (pembro) vs brentuximab vedotin (BV) in relapsed or refractory classical Hodgkin lymphoma (R/R cHL)
Authors: P.L. Zinzani, R. Ramchandren, A. Santoro, E. Paszkiewicz-Kozik, R. Gasiorowski, N.A. Johnson, J.S.R. de Oliveira, V. Buccheri, G.F. Perini, M. Dickinson, A. McDonald, M. Ozcan, N. Sekiguchi, M. Raut, Y. Zhu, A. Nahar, P. Marinello, J. Kuruvilla
Journal: Annals of Oncology (2020)
228P Pathologic response to neoadjuvant antiher2 therapy in HER2 equivocal overexpression with FISH amplification
Authors: S. Morales, A. Gasol Cudos, A. Rodriguez Galindo, A. Serrate Lopez, A. Velasco Sanchez, J. Melé Olivé, C. Canosa Morales
Journal: Annals of Oncology (2020)
437P Designing clinical profiles that influence the discordance of RAS mutations in blood and tissue: Sidedness and anatomical metastasis as factors of disagreement
Authors: E. Brozos-Vázquez, R. Lago-Lestón, M. Covela-Rúa, J. De la Cámara-Gómez, A. Fernandez Montes, S. Candamio-Folgar, L. Muinelo-Romay, Y. Vidal-Insua, F. Vázquez-Rivera, R. López-Rodríguez, C. Blanco-Freire, I. Ferreirós-Vidal, R. Lopez Lopez
Journal: Annals of Oncology (2020)
1728P Evaluation of medical practices in oncology in a context of COVID-19 pandemic in France: Point of view of physicians, PRATICOVID study
Authors: C. Helissey, A. Cessot, L. Boudin, E. Romeo, C. Prieux, D. Ghebriou, A. Schernberg, N. Grellier, C. Joly, O. Bauduceau, C. Thibault, E. Mamou, G. Raynal, S. Setey Eiffel, H. Le Floch, D. Ricard, L. Brureau
Journal: Annals of Oncology (2020)
296P Tumour mutational burden and clinical outcomes with first-line atezolizumab and nab-paclitaxel in triple-negative breast cancer: Exploratory analysis of the phase III IMpassion130 trial
Authors: L.A. Emens, L. Molinero, S. Adams, H.S. Rugo, A. Schneeweiss, V. Diéras, H. Iwata, C.H. Barrios, M. Nechaeva, E.P. Winer, C.W. Chang, S.Y. Chui, P. Schmid, S. Loi
Journal: Annals of Oncology (2020)
1542P Untargeted metabolomics to identify novel biomarkers of pancreatic cancer
Authors: O. Caba, C. Jimenez-Luna, A. Martin-Blazquez, J. Martinez-Galan, J. Perez Del Palacio, C. Melguizo, C. Diaz, C. Dieguez, F. Vicente, O. Genilloud, J.L. Martin-Ruiz, J. Prados
Journal: Annals of Oncology (2020)
The role of Frailty on Adverse Outcomes Among Older Patients with COVID-19
Authors: Harun Kundi, Elif Hande Özcan Çetin, Uğur Canpolat, Sevgi Aras, Osman Celik, Naim Ata, Suayip Birinci, Serkan Çay, Özcan Özeke, Ibrahim Halil Tanboğa, Serkan Topaloğlu
Journal: Journal of Infection (2020)
GraphAligner: rapid and versatile sequence-to-graph alignment
Authors: Mikko Rautiainen, Tobias Marschall
Journal: Genome biology (2020)

Abstract Genome graphs can represent genetic variation and sequence uncertainty. Aligning sequences to genome graphs is key to many applications, including error correction, genome assembly, and genotyping of variants in a pangenome graph. Yet, so far, this step is often prohibitively slow. We present GraphAligner, a tool for aligning long reads to genome graphs. Compared to the state-of-the-art tools, GraphAligner is 13x faster and uses 3x less memory. When employing GraphAligner for error correction, we find it to be more than twice as accurate and over 12x faster than extant tools.Availability: Package manager: https://anaconda.org/bioconda/graphaligner and source code: https://github.com/maickrau/GraphAligner
Seymour Schwartz: surgeon, editor, cartographer, and historian
Authors: John Illman
Journal: BMJ (2020)

schwartz220920.f1 

Credit: Carlos Ortiz/Democrat and Chronicle

The name Seymour Schwartz became synonymous with surgery after his five fellow editors of Principles of Surgery , published by McGraw Hill in 1969, voted him editor in chief. Schwartz edited the next seven editions of the seminal textbook, later re-named Schwartz’s Principles of Surgery . The first edition ran to 1850 pages and 52 chapters.

The 11th edition was published last year, when Schwartz was in his 90s. In a characteristic visionary foreword, Schwartz noted, “The ‘science of surgery’ has gained dominance over the ‘art of surgery.’ Diverse technologies have been incorporated to expedite diagnosis and improve surgical excision or repair. It is as if today’s surgeons have adopted a new language, new rules, new protocols—and anticipate new outcomes.”

In 2018 he told the Rochester Democrat and Chronicle newspaper, “I was happiest in the operating room. I prepared for every operation. I have an ego. And I felt I could operate as well, if not better than, most of the surgeons I was around.”

But Schwartz was much more than a leading surgeon, once described as “sharp as a tack.” He was also a …
1753P Coronavirus or cancer: What are oncological patients most afraid of?
Authors: D.S. Sigorski, P. Sobczuk, K. Kuć, M. Osmola, A. Walerzak, T. Ciszewski, S. Kopeć, K. Hryń, P. Rutkowski, R. Stec, L. Bodnar
Journal: Annals of Oncology (2020)
350TiP A phase III trial of capivasertib and fulvestrant versus placebo and fulvestrant in patients with HR+/HER2− breast cancer (CAPItello-291)
Authors: N. Turner, S. Howell, K. Jhaveri, H. Gomez, M. Toi, X. Hu, S. Loibl, H.S. Rugo, P. Ni, E. De Bruin, C.M.A.A. Orbegoso, G. Schiavon, A. Foxley, M. Oliveira
Journal: Annals of Oncology (2020)
1838P Do irinotecan (IRI) dose reductions driven by UGT1A1*28 genotyping prevent IRI-related severe neutropenia? A real-world study
Authors: N. Personeni, R. Mineri, A. D'Alessio, A. Cammarota, A. Michelini, S. Bozzarelli, V. Smiroldo, T. Pressiani, L. Giordano, M.T. Sandri, A. Santoro, L. Rimassa
Journal: Annals of Oncology (2020)
1686P The impact of the COVID-19 crisis on perceived changes in care and wellbeing of cancer patients and norm participants: Results of the PROFILES registry
Authors: L.V. Van De Poll-franse, B. de Rooij, N. Horevoorts, A.M. May, G. Vink, M. Koopman, H.W.M. van Laarhoven, M. Besselink, S. Oerlemans, O. Husson, S. Beijer, N. Ezendam, N. Raijmakers, B. Wollersheim, M. Hoedjes, S. Siesling, M. van Eenbergen, F. Mols
Journal: Annals of Oncology (2020)
1283P Tepotinib in patients (pts) with advanced NSCLC with MET exon 14 (METex14) skipping: Overall efficacy results from VISION cohort A
Authors: J. Mazieres, P.K. Paik, E. Felip, R. Veillon, H. Sakai, A.B. Cortot, S. Viteri, M.C. Garassino, J.P. Van Meerbeeck, J. Raskin, M. Thomas, M. Morise, B.C. Cho, P. Conte, R. Bruns, T. Demuth, K.M. Schumacher, X. Le
Journal: Annals of Oncology (2020)
837P Phase II trial of oncolytic vaccinia virus primed immunochemotherapy in platinum-resistant/refractory ovarian cancer (PRROC) (NCT02759588)
Authors: R.W. Holloway, A.A. Mendivil, J.E. Kendrick, L.N. Abaid, J.V. Brown, C.K. Fitzsimmons, J.A. Kennard, M. King, J. LeBlanc, K. Lopez, M. Manyam, N.D. McKenzie, K.M. Mori, A.J. Stephens, S. Ahmad
Journal: Annals of Oncology (2020)
526O High activity of nivolumab in patients with pathogenic exonucleasic domain POLE (edPOLE) mutated Mismatch Repair proficient (MMRp) advanced tumours
Authors: B.J-C. Rousseau, I. Bieche, E. Pasmant, V. Simmet, N. Hamzaoui, J. Masliah-Planchon, D. Pouessel, A. Bruyas, P. Augereau, J-J. Grob, F. Rolland, E. Saada-Bouzid, R. Cohen, O. Bouche, N. Hoog-Labouret, F. Legrand, C. Simon, A. Lamrani-Ghaouti, S. Chevret, A. Marabelle
Journal: Annals of Oncology (2020)
835P Clinical outcomes of advanced/ recurrent ovarian clear cell carcinoma in a multi-ethnic Asian cohort following bevacizumab and immune checkpoint inhibitor therapy
Authors: N.Y.L. Ngoi, A. Lai, T.Z. Tan, D.G. Lim, I.S. Khan, Y.L. Thian, B.W. Ang, K.W. Tham, P.S. Tong, J. Ng, J. Low, A. Ilancheran, Y.W. Lim, S.E. Lim, D.S. Tan
Journal: Annals of Oncology (2020)
103P Chemotherapy-induced neutropaenia as a marker for overall survival (OS) in non-small cell lung cancer (NSCLC) patients undergoing gemcitabine/carboplatin (GemCarbo) chemotherapy: A 9-year real-life data
Authors: Y.F. Clark, J. Vangara, N. Wreglesworth, P. Innominato, A. Mullard, C. Bale, N. Ghosal, A. Garcia-Alonso, C. Fuller
Journal: Annals of Oncology (2020)
682P Results from ADVANCE: A phase I/II open-label non-randomised safety and efficacy study of the viral vectored ChAdOx1-MVA 5T4 (VTP-800) vaccine in combination with PD-1 checkpoint blockade in metastatic prostate cancer
Authors: M. Tuthill, F. Cappuccini, L. Carter, E. Pollock, I. Poulton, C. Verrill, T. Evans, S. Gillessen, G. Attard, A. Protheroe, F. Hamdy, A.V.S. Hill, I. Redchenko
Journal: Annals of Oncology (2020)
493P Pembrolizumab (pembro) plus mFOLFOX7 or FOLFIRI in patients (pts) with metastatic colorectal cancer (mCRC): Updated results from KEYNOTE-651 cohorts B and D
Authors: R. Kim, J. Chaves, P. Kavan, M. Fakih, J.S. Kortmansky, K. Spencer, L. Wong, M. Tehfe, J.J. Li, A.D. Eyring, C. Mayo, E.G. Chiorean
Journal: Annals of Oncology (2020)
1463P Prognostic relevance of weight loss during a perioperative chemotherapy for locally advanced gastric cancer (GC) and tumours of the gastroesophageal junction (GEJ): A retrospective analysis
Authors: A. Lorusso, A. Hoegner, M. Schmiester, D. Bichev, L. Bullinger, P.C. Thuss-Patience
Journal: Annals of Oncology (2020)
3O Efficacy of the triple combination of Estrogen Receptor, CDK4/6 and PI3K pathway inhibitors in ex-vivo models of breast cancer
Authors: A. Diana, C.M. Della Corte, F. Carlino, V. Ciaramella, E. Franzese, S. Centonze, C. Trovato, I. Vassallo, F. Iovino, E. Procaccini, F. Ciardiello, F. Morgillo, M. Orditura
Journal: Annals of Oncology (2020)
1106P International experience of ipilimumab and nivolumab in patients with advanced melanoma
Authors: P. Serra-Bellver, J.M. Versluis, H.K. Oberoi, T.D. Slattery, Y. Khan, J.R. Patrinelly, I. Pires da Silva, C. Martínez-Vila, N. Cook, D.M. Graham, C. Zhou, A. Gupta, A.M. Arance Fernandez, D.B. Johnson, G.V. Long, L. Pickering, J. Larkin, C.U. Blank, P. Lorigan
Journal: Annals of Oncology (2020)
1694P Discovery of circulating biomarkers in COVID-19 patients undergoing anti-IL6R immunotherapy
Authors: J-M. Michot, V. Dozio, F-X. Danlos, M. Vasse, J. Rohmere, M. Roumier, F. Pommeret, E. Kishazi, A. Marabelle, C. Escher, K. Kakalacheva-Beeler
Journal: Annals of Oncology (2020)
1087P Time to clinically meaningful changes in pain in patients with advanced cutaneous squamous cell carcinoma treated with cemiplimab in a phase II clinical trial
Authors: M.R. Migden, D. Rischin, S. Hudgens, C-I. Chen, C.D. Schmults, A.C. Pavlick, A. Guminski, A. Hauschild, Z. Chen, V. Mastey, D. Bury, A.L.S. Chang, G. Rabinowits, S.F. Ibrahim, M.G. Fury, S. Li, M. Sasane
Journal: Annals of Oncology (2020)
1010P Real-world dosing of regorafenib (REG) in patients (pts) with unresectable hepatocellular carcinoma (uHCC): Interim analysis (IA) of the observational REFINE study
Authors: P. Merle, H.Y. Lim, R.S. Finn, M. Ikeda, M. Kudo, C. Frenette, G. Masi, Y.J. Kim, R. Gerolami, M. Kurosaki, K. Numata, H-J. Klümpen, H. Zebger-Gong, S. Fiala-Buskies, K. Ozgurdal, S. Qin
Journal: Annals of Oncology (2020)
789P A differential gene expression signature identifies a population of stage I testicular non-seminomatous germ cell tumours (NSGCT) at high risk of relapse
Authors: L. Galvez-Carvajal, A. Sánchez-Muñoz, M. Álvarez, E. Alba Linero, M. del Rey, A. Garrido, Á. Santoja, A. Moya, J. Montes, M.R. Chica-Parrado, M.I. Sáez, J. Aparicio, E. González-Billalabeitia, J. Terrasa Pons, M.J. Méndez, M. Luengo, J. García del Muro, J. Pascual, E. Alba
Journal: Annals of Oncology (2020)
Cystoduodenal fistula: unusual complication after acute necrotizing pancreatitis with collection
Authors: Roberto Di Mitri, Michele Amata, Daniela Scimeca, Ambra Bonaccorso, Elisabetta Conte, Michela Lo Mastro, Filippo Mocciaro
Journal: Endoscopy (2020)

A 56-year-old man was admitted to our hospital with severe acute necrotizing gallstone pancreatitis. Computed tomography showed a 15-cm infected walled-off pancreatic necrosis (WOPN) extending to the anterior pararenal space with free air bubbles inside. After multidisciplinary evaluation and according to septic status, endoscopic ultrasound-guided drainage was planned.
1740P Assessing the impact of COVID-19 outbreak on the attitudes and practice of Italian oncologists towards breast cancer care and related research activities
Authors: F. Poggio, M. Tagliamento, M. Di Maio, V. Martelli, A. De Maria, E. Barisione, M. Grosso, F. Boccardo, P. Pronzato, L. Del Mastro, M. Lambertini
Journal: Annals of Oncology (2020)
728P A phase Ib/II study of rebastinib and paclitaxel in advanced/metastatic platinum-resistant ovarian cancer
Authors: E.P. Hamilton, S. Goel, R. Arend, C. Chu, D.L. Richardson, B. Corr, V. John, F. Janku, J. Hays, M. Michenzie, W. Reichmann, H. Achour, M.L. Sherman, R. Ruiz-Soto, C. Mathews
Journal: Annals of Oncology (2021)
Surveillance of COVID-19 school outbreaks, Germany, March to August 2020
Authors: Eveline Otte im Kampe, Ann-Sophie Lehfeld, Silke Buda, Udo Buchholz, Walter Haas
Journal: Eurosurveillance (2020)

Mitigation of the coronavirus disease (COVID-19) pandemic in Germany included school closures in early March 2020. After reopening in April, preventive measures were taken in schools. We analysed national surveillance system data on COVID-19 school outbreaks during different time periods. After reopening, smaller outbreaks (average: 2.2/week) occurred despite low incidence in the general population. School closures might have a detrimental effect on children and should be applied only cautiously and in combination with other measures.
1886P Quantifying quality of informed consent (IC) in patients enrolled in phase I (ph I) oncology clinical trials with a validated instrument (QuIC Parts A, B) in a large United Kingdom phase I trials unit
Authors: A. Pal, S. Stapleton, J.E. Lai-Kwon, N. Simoes, A.R. Minchom, U. Banerji, J.S. de Bono, D. Karikios, F. Boyle, J.S. Lopez
Journal: Annals of Oncology (2020)
Development of highly functional bioengineered human liver with perfusable vasculature
Authors: Da-Hyun Kim, Jungho Ahn, Hyun Kyoung Kang, Min-Soo Kim, Nam-Gyo Kim, Myung Geun Kook, Soon Won Choi, Noo Li Jeon, Heung-Myong Woo, Kyung-Sun Kang
Journal: Biomaterials (2020)
Recurrence of Immune-Related Adverse Events After Immune Checkpoint Inhibitor Rechallenge
Authors: Shu-Yue Zheng, Hua Duan, Hui-Juan Cui
Journal: JAMA Oncology (2020)

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1284P MET inhibitor capmatinib plus EGFR tyrosine kinase inhibitor nazartinib for EGFR-mutant non-small cell lung cancer
Authors: E. Felip, V. Minotti, R. Soo, J. Wolf, B. Solomon, D.S.W. Tan, A. Ardizzoni, D.H. Lee, L.V. Sequist, F. Barlesi, L. Paz-Ares, D. Rodriguez-Abreu, M.R. Garcia Campelo, M. Sprauten, L. O’Sullivan Djentuh, R. Belli, S. Glaser, M. Zou, M. Giovannini, J.C-H. Yang
Journal: Annals of Oncology (2020)
403MO Atezolizumab in combination with bevacizumab for patients with unresectable/metastatic anal cancer
Authors: V. Morris, S. Liu, B. Johnson, S. Prasad, A. Mahvash, P. Bhosale, M.L. Rubin, N. Rothschild, A. Futreal, I.I. Wistuba, P. Hwu, J.C. Yao, C. Eng, D. Halperin
Journal: Annals of Oncology (2020)
LBA19 GEICAM/2014-12 (FLIPPER) study: First analysis from a randomized phase II trial of fulvestrant (F)/palbociclib (P) versus (vs) F/placebo (PL) as first-line therapy in postmenopausal women with HR (hormone receptor)+/HER2– endocrine sensitive advanced breast cancer (ABC)
Authors: J. Albanell, M.T.M. Martinez, M. Ramos, M.O.' Connor, L. De la Cruz-Merino, A. Santaballa Bertran, N. Martínez-Jáñez, F. Moreno, I. Fernández Pérez, J. Alarcon Company, J.A. Virizuela Echaburu, J. De la Haba Rodríguez, P. Sánchez-Rovira, L. González-Cortijo, M. Margeli Vila, A. Sánchez Munoz, I. Garau Llinas, M. Casas, S. Bezares Montes, F. Rojo Todo
Journal: Annals of Oncology (2020)
808MO Paclitaxel with or without pazopanib in ovarian cancer patients with relapse during bevacizumab maintenance therapy: The GINECO randomized phase II TAPAZ study
Authors: F. Joly Lobbedez, M. Fabbro, D. Berton, J. Lequesne, A. Anota, A. Puszkiel, A. Floquet, M. Cancel, H. Bourgeois, L. Bengrine Lefevre, B. You, F. Pommeret, A. Lortholary, D. Spaeth, J. Martin-Babau, C. Abdeddaim, M-C. Kaminsky-Forrett, D. Petran, M. Provansal Gross, P-E. Brachet
Journal: Annals of Oncology (2020)
57P Third-line chemotherapy in advanced biliary cancers (ABC): Pattern of care, treatment outcome and prognostic factors from a multicenter study
Authors: A. Rizzo, M. Salati, V. Merz, C. Messina, A.D. Ricci, A. Palloni, G. Frega, S. De Lorenzo, F. Caputo, F. Gelsomino, A. Spallanzani, V. Mollica, F. Abbati, P. Carotenuto, E. Pettorelli, S. Benatti, G. Luppi, D. Melisi, M. Dominici, G. Brandi
Journal: Annals of Oncology (2020)
1074TiP SGNTGT-001: A phase I study of SGN-TGT, an effector-function enhanced monoclonal antibody (mAb), in advanced malignancies
Authors: E. Garralda, R.E. Sanborn, A.R. Minchom, D. Davar, G. Curigliano, V. Ribrag, A. Mehta, F. Foss, P. Garfin, S. Ansell
Journal: Annals of Oncology (2020)
1781MO IMpower133: Characterisation of long-term survivors treated first-line with chemotherapy ± atezolizumab in extensive-stage small cell lung cancer
Authors: S.V. Liu, L. Horn, T. Mok, A. Mansfield, R. De Boer, G. Losonczy, S. Sugawara, R. Dziadziuszko, M. Krzakowski, A. Smolin, M.J. Hochmair, M.C. Garassino, S. Lam, M. McCleland, A. Cardona, S. Morris, M. Reck
Journal: Annals of Oncology (2020)
LBA88 Anlotinib in locally advanced or metastatic radioiodine-refractory differentiated thyroid carcinoma: A randomized, double-blind, multicenter phase II trial
Authors: Y. Chi, M. Gao, Y. Zhang, F. Shi, Y. Cheng, Z. Guo, M. Ge, J. Qin, J. Zhang, Z. Li, X. Zhou, R. Huang, X. Chen, H. Liu, R. Cheng, Z. Xu, X. Zheng, D. Li, P. Tang
Journal: Annals of Oncology (2020)
A Prognostic Model Based on PAM50 and Clinical Variables (PAM50MET) for Metastatic Hormone Receptor–positive HER2-negative Breast Cancer
Authors: Aleix Prat, Yi-Hsuan Tsai, Tomás Pascual, Laia Paré, Barbara Adamo, Maria Vidal, Fara Brasó-Maristany, Patricia Galván, Jan Christoph Brase, Vanessa Rodrik-Outmezguine, Stephen Johnston, Eva Ciruelos, Joel S. Parker
Journal: Clinical Cancer Research (2020)

Abstract Purpose: Predicting prognosis in HR+/HER2− metastatic breast cancer (MBC) might be clinically useful; however, no validated prognostic biomarkers exist in this setting to date. Patients and Methods: In phase III, EGF30008 trial, 484 patients with HER2− MBC who received letrozole and placebo or lapatinib were selected. PAM50 data, ECOG performance status, visceral disease, number of metastasis, biopsy type, and age were evaluated. A progression-free survival (PFS) Cox model was evaluated. The final model (PAM50MET) with a prespecified cutoff was validated in patients (n = 261) with HR+/HER2− advanced breast cancer (aBC) from BOLERO-2 (phase III trial that evaluated exemestane and placebo or everolimus). Results: In EGF30008, prognostic models with PAM50 plus clinical variables yielded higher C-index values versus models with only PAM50 or clinical variables. The PAM50MET model combined 21 variables: 2 PAM50 subtypes, basal signature, 14 genes, and 4 clinical variables. In EGF30008, the optimized cutoff was associated with PFS [HR = 0.37; 95% confidence interval (CI), 0.29–0.47; P &amp;lt; 0.0001] and overall survival (OS; HR = 0.37; 95% CI, 0.27–0.51; P &amp;lt; 0.0001). The median (months; 95% CI) PFS and OS were 22.24 (19.0–24.9) and not reached in PAM50MET-low versus 9.13 (8.15–11.0) and 33.0 (28.0–40.0) in PAM50MET-high groups, respectively. In BOLERO-2, the PAM50MET-low was associated with better PFS (HR = 0.72; 95% CI, 0.53–0.96; P = 0.028) and OS (HR = 0.51; 95% CI, 0.35–0.69; P &amp;lt; 0.0001). The median (months) (95% CI) PFS and OS were 6.93 (5.57–11.0) and 36.9 (33.4–NA) in PAM50MET-low versus 5.23 (4.2–6.8) and 23.5 (20.2–28.3) in PAM50MET-high groups, respectively. Conclusions: PAM50MET is prognostic in HR+/HER2− MBC, and further evaluation might help identify candidates for endocrine therapy only or novel therapies.