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1 November 2021
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Cover Image
Cover Image
The cover shows a section of a biopsy specimen from a patient with T790M-positive EGFR-mutated NSCLC post resistance to EGFR TKI. Multiplex immunofluorescence staining shows expression of EGFR L858R mutant protein (red), with adenocarcinoma features retained as evidenced by napsin (white), and TTF1 (green) expression on background of DAPI nuclear staining (blue). In contrast, loss of adenocarcinoma lineage markers was observed in the context of T790M-negative disease. For details, see the article by Chua and colleagues on page 5939 of this issue. - PDF Icon PDF LinkTable of Contents
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ISSN 1078-0432
EISSN 1557-3265
Highlights
CCR Translations
Review
CCR Perspectives in Regulatory Science and Policy
Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples
Anup K. Amatya; Mallorie H. Fiero; Erik W. Bloomquist; Arup K. Sinha; Steven J. Lemery; Harpreet Singh; Amna Ibrahim; Martha Donoghue; Lola A. Fashoyin-Aje; R. Angelo de Claro; Nicole J. Gormley; Laleh Amiri-Kordestani; Rajeshwari Sridhara; Marc R. Theoret; Paul G. Kluetz; Richard Pazdur; Julia A. Beaver; Shenghui Tang
Special Report
Clinical Trials: Targeted Therapy
A Phase I Study of LSZ102, an Oral Selective Estrogen Receptor Degrader, with or without Ribociclib or Alpelisib, in Patients with Estrogen Receptor–Positive Breast Cancer
Komal Jhaveri; Dejan Juric; Yoon-Sim Yap; Sara Cresta; Rachel M. Layman; Francois P. Duhoux; Catherine Terret; Shunji Takahashi; Jens Huober; Nicole Kundamal; Qing Sheng; Alejandro Balbin; Yan Ji; Wei He; Adam Crystal; Serena De Vita; Giuseppe Curigliano
Pharmacokinetics, Safety, and Efficacy of Trastuzumab Deruxtecan with Concomitant Ritonavir or Itraconazole in Patients with HER2-Expressing Advanced Solid Tumors
Shunji Takahashi; Masato Karayama; Masato Takahashi; Junichiro Watanabe; Hironobu Minami; Noboru Yamamoto; Ichiro Kinoshita; Chia-Chi Lin; Young-Hyuck Im; Issei Achiwa; Emi Kamiyama; Yasuyuki Okuda; Caleb Lee; Yung-Jue Bang
Phase I Study of 2- or 3-Week Dosing of Telisotuzumab Vedotin, an Antibody–Drug Conjugate Targeting c-Met, Monotherapy in Patients with Advanced Non–Small Cell Lung Carcinoma
D. Ross Camidge; Daniel Morgensztern; Rebecca S. Heist; Minal Barve; Everett Vokes; Jonathan W. Goldman; David S. Hong; Todd M. Bauer; John H. Strickler; Eric Angevin; Monica Motwani; Apurvasena Parikh; Zhaowen Sun; Bruce Allen Bach; Jun Wu; Philip B. Komarnitsky; Karen Kelly
Single-Agent Ibrutinib for Rituximab-Refractory Waldenström Macroglobulinemia: Final Analysis of the Substudy of the Phase III InnovateTM Trial
Judith Trotman; Christian Buske; Alessandra Tedeschi; Jeffrey V. Matous; David MacDonald; Constantine S. Tam; Olivier Tournilhac; Shuo Ma; Steven P. Treon; Albert Oriol; Jerry Ping; Eva M. Briso; Israel Arango-Hisijara; Meletios A. Dimopoulos
MONARCH 2: Subgroup Analysis of Patients Receiving Abemaciclib Plus Fulvestrant as First-Line and Second-Line Therapy for HR+, HER2−-Advanced Breast Cancer
Patrick Neven; Stephen R.D. Johnston; Masakazu Toi; Joohyuk Sohn; Kenichi Inoue; Xavier Pivot; Olga Burdaeva; Meena Okera; Norikazu Masuda; Peter A. Kaufman; Han Koh; Eva-Maria Grischke; PierFranco Conte; Yi Lu; Nadine Haddad; Karla C. Hurt; Antonio Llombart-Cussac; George W. Sledge
Inhibiting Fatty Acid Synthase with Omeprazole to Improve Efficacy of Neoadjuvant Chemotherapy in Patients with Operable TNBC
Sagar D. Sardesai; Alexandra Thomas; Christopher Gallagher; Filipa Lynce; Yvonne Lynn Ottaviano; Tarah Jean Ballinger; Bryan P. Schneider; Anna Maria Storniolo; Amber Bauchle; Sandra K. Althouse; Susan M. Perkins; Andrea R. Masters; Robert E. Stratford, Jr; Zizheng Dong; Jing-Yuan Liu; Jian-Ting Zhang; Kathy D. Miller
Biomarker Analysis of the Phase III NALA Study of Neratinib + Capecitabine versus Lapatinib + Capecitabine in Patients with Previously Treated Metastatic Breast Cancer
Cristina Saura; Judit Matito; Mafalda Oliveira; Hans Wildiers; Adam M. Brufksy; Simon H. Waters; Sara A. Hurvitz; Beverly Moy; Sung-Bae Kim; William J. Gradishar; Geraldo Silva Queiroz; Eduardo Cronemberger; Gerald J. Wallweber; Judith Bebchuk; Kiana Keyvanjah; Alshad S. Lalani; Richard Bryce; Ana Vivancos; Lisa D. Eli; Suzette Delaloge
Clinical Trials: Immunotherapy
Phase I Study of Entinostat and Nivolumab with or without Ipilimumab in Advanced Solid Tumors (ETCTN-9844)
Evanthia T. Roussos Torres; Christine Rafie; Chenguang Wang; David Lim; Adam Brufsky; Patricia LoRusso; Joseph Paul Eder; Vincent Chung; Melinda Downs; Molly Geare; Richard Piekarz; Howard Streicher; Leslie Anforth; Michelle A. Rudek; Qingfeng Zhu; Sepideh Besharati; Ashley Cimino-Mathews; Robert A. Anders; Vered Stearns; Elizabeth M. Jaffee; Roisin M. Connolly
Camrelizumab plus Famitinib in Patients with Advanced or Metastatic Renal Cell Carcinoma: Data from an Open-label, Multicenter Phase II Basket Study
Yuan-Yuan Qu; Hai-Liang Zhang; Hongqian Guo; Hong Luo; Qing Zou; Nianzeng Xing; Shujie Xia; Zhongquan Sun; Xuepei Zhang; Chaohong He; Jinling Cai; Xiao Zhang; Quanren Wang; Ding-Wei Ye
Nine-Year Follow-up of Patients with Relapsed Follicular Lymphoma after Nonmyeloablative Allogeneic Stem Cell Transplant and Autologous Transplant
Issa F. Khouri; Denái R. Milton; Alison M. Gulbis; Elias J. Jabbour; Loretta Nastoupil; Celina Ledesma; Paolo Anderlini; Qaiser Bashir; May Daher; Jin S. Im; Swaminathan P. Iyer; David Marin; Rohtesh S. Mehta; Amanda L. Olson; Uday R. Popat; Muzaffar Qazilbash; Neeraj Saini; Felipe Samaniego; Gabriela Rondon; L. Jeffrey Medeiros; Richard E. Champlin
Precision Medicine and Imaging
Circulating HPV DNA as a Marker for Early Detection of Relapse in Patients with Cervical Cancer
Emmanuelle Jeannot; Aurélien Latouche; Claire Bonneau; Marie-Ange Calméjane; Corine Beaufort; Kirsten Ruigrok-Ritstier; Guillaume Bataillon; Linda Larbi Chérif; Célia Dupain; Charlotte Lecerf; Marina Popovic; Anne de la Rochefordière; Fabrice Lecuru; Virginie Fourchotte; Ekaterina S. Jordanova; Heiko von der Leyen; Carine Tran-Perennou; Marie-Emmanuelle Legrier; Sylvain Dureau; Laurence Raizonville; Diana Bello Roufai; Christophe Le Tourneau; Ivan Bièche; Roman Rouzier; Els M.J.J. Berns; Maud Kamal; Suzy Scholl
Pretreatment Tissue TCR Repertoire Evenness Is Associated with Complete Pathologic Response in Patients with NSCLC Receiving Neoadjuvant Chemoimmunotherapy
Marta Casarrubios; Alberto Cruz-Bermúdez; Ernest Nadal; Amelia Insa; María del Rosario García Campelo; Martín Lázaro; Manuel Dómine; Margarita Majem; Delvys Rodríguez-Abreu; Alex Martínez-Martí; Javier de Castro-Carpeño; Manuel Cobo; Guillermo López-Vivanco; Edel Del Barco; Reyes Bernabé Caro; Nuria Viñolas; Isidoro Barneto Aranda; Santiago Viteri; Bartomeu Massuti; Miguel Barquín; Raquel Laza-Briviesca; Belén Sierra-Rodero; Edwin R. Parra; Beatriz Sanchez-Espiridion; Pedro Rocha; Humam Kadara; Ignacio I. Wistuba; Atocha Romero; Virginia Calvo; Mariano Provencio
Genome-Derived Classification Signature for Ampullary Adenocarcinoma to Improve Clinical Cancer Care
Saptarshi Chakraborty; Brett L. Ecker; Ken Seier; Victoria G. Aveson; Vinod P. Balachandran; Jeffrey A. Drebin; Michael I. D'Angelica; T. Peter Kingham; Carlie S. Sigel; Kevin C. Soares; Efsevia Vakiani; Alice C. Wei; Rohit Chandwani; Mithat Gonen; Ronglai Shen; William R. Jarnagin
Elucidation of Tumor-Stromal Heterogeneity and the Ligand-Receptor Interactome by Single-Cell Transcriptomics in Real-world Pancreatic Cancer Biopsies
Jaewon J. Lee; Vincent Bernard; Alexander Semaan; Maria E. Monberg; Jonathan Huang; Bret M. Stephens; Daniel Lin; Kimal I. Rajapakshe; Brian R. Weston; Manoop S. Bhutani; Cara L. Haymaker; Chantale Bernatchez; Cullen M. Taniguchi; Anirban Maitra; Paola A. Guerrero
Quantification of Translocation-Specific ctDNA Provides an Integrating Parameter for Early Assessment of Treatment Response and Risk Stratification in Ewing Sarcoma
Manuela Krumbholz; Johanna Eiblwieser; Andreas Ranft; Jakob Zierk; Christian Schmidkonz; Adrian M Stütz; Peter Peneder; Eleni M. Tomazou; Abbas Agaimy; Tobias Bäuerle; Wolfgang Hartmann; Uta Dirksen; Markus Metzler
The OncoMasTR Test Predicts Distant Recurrence in Estrogen Receptor–Positive, HER2-Negative Early-Stage Breast Cancer: A Validation Study in ABCSG Trial 8
Martin Filipits; Margaretha Rudas; Verena Kainz; Christian F. Singer; Florian Fitzal; Zsuzsanna Bago-Horvath; Richard Greil; Marija Balic; Peter Regitnig; Stefan Halper; Wolfgang Hulla; Daniel Egle; Stephen Barron; Tony Loughman; Des O'Leary; William M. Gallagher; Dominik Hlauschek; Michael Gnant; Peter Dubsky
Translational Cancer Mechanisms and Therapy
Integrative Profiling of T790M-Negative EGFR-Mutated NSCLC Reveals Pervasive Lineage Transition and Therapeutic Opportunities
Khi Pin Chua; Yvonne H.F. Teng; Aaron C. Tan; Angela Takano; Jacob J.S. Alvarez; Rahul Nahar; Neha Rohatgi; Gillianne G.Y. Lai; Zaw Win Aung; Joe P.S. Yeong; Kiat Hon Lim; Marjan Mojtabavi Naeini; Irfahan Kassam; Amit Jain; Wan Ling Tan; Apoorva Gogna; Chow Wei Too; Ravindran Kanesvaran; Quan Sing Ng; Mei Kim Ang; Tanujaa Rajasekaran; Devanand Anantham; Ghee Chee Phua; Bien Soo Tan; Yin Yeng Lee; Lanying Wang; Audrey S.M. Teo; Alexis Jiaying Khng; Ming Jie Lim; Lisda Suteja; Chee Keong Toh; Wan-Teck Lim; N. Gopalakrishna Iyer; Wai Leong Tam; Eng-Huat Tan; Weiwei Zhai; Axel M. Hillmer; Anders J. Skanderup; Daniel S.W. Tan
Upregulation of C/EBPα Inhibits Suppressive Activity of Myeloid Cells and Potentiates Antitumor Response in Mice and Patients with Cancer
Ayumi Hashimoto; Debashis Sarker; Vikash Reebye; Sheba Jarvis; Mikael H. Sodergren; Andrew Kossenkov; Emilio Sanseviero; Nina Raulf; Jenni Vasara; Pinelopi Andrikakou; Tim Meyer; Kai-Wen Huang; Ruth Plummer; Cheng E. Chee; Duncan Spalding; Madhava Pai; Shahid Khan; David J. Pinato; Rohini Sharma; Bristi Basu; Daniel Palmer; Yuk-Ting Ma; Jeff Evans; Robert Habib; Anna Martirosyan; Naouel Elasri; Adeline Reynaud; John J. Rossi; Mark Cobbold; Nagy A. Habib; Dmitry I. Gabrilovich
Molecular Subtyping Combined with Biological Pathway Analyses to Study Regorafenib Response in Clinically Relevant Mouse Models of Colorectal Cancer
Adam Lafferty; Alice C. O'Farrell; Giorgia Migliardi; Niraj Khemka; Andreas U. Lindner; Francesco Sassi; Eugenia R. Zanella; Manuela Salvucci; Evy Vanderheyden; Elodie Modave; Bram Boeckx; Luise Halang; Johannes Betge; Matthias P.A. Ebert; Patrick Dicker; Guillem Argilés; Josep Tabernero; Rodrigo Dienstmann; Enzo Medico; Diether Lambrechts; Andrea Bertotti; Claudio Isella; Livio Trusolino; Jochen H.M. Prehn; Annette T. Byrne
Early Use of High-Dose Glucocorticoid for the Management of irAE Is Associated with Poorer Survival in Patients with Advanced Melanoma Treated with Anti–PD-1 Monotherapy
Xue Bai; Jiani Hu; Allison Betof Warner; Henry T. Quach; Christopher G. Cann; Michael Z. Zhang; Lu Si; Bixia Tang; Chuanliang Cui; Xiaoling Yang; Xiaoting Wei; Lalit Pallan; Catriona Harvey; Michael P. Manos; Olivia Ouyang; Michelle S. Kim; Gyulnara Kasumova; Justine V. Cohen; Donald P. Lawrence; Christine Freedman; Riley M. Fadden; Krista M. Rubin; Tatyana Sharova; Dennie T. Frederick; Keith T. Flaherty; Osama E. Rahma; Georgina V. Long; Alexander M. Menzies; Jun Guo; Alexander N. Shoushtari; Douglas B. Johnson; Ryan J. Sullivan; Genevieve M. Boland
Circulating and Intratumoral Adrenal Androgens Correlate with Response to Abiraterone in Men with Castration-Resistant Prostate Cancer
Elahe A. Mostaghel; Brett T. Marck; Orpheus Kolokythas; Felix Chew; Evan Y. Yu; Michael T. Schweizer; Heather H. Cheng; Phillip W. Kantoff; Steven P. Balk; Mary-Ellen Taplin; Nima Sharifi; Alvin M. Matsumoto; Peter S. Nelson; R. Bruce Montgomery
Dual Inhibition of FLT3 and AXL by Gilteritinib Overcomes Hematopoietic Niche-Driven Resistance Mechanisms in FLT3-ITD Acute Myeloid Leukemia
Pierre-Yves Dumas; Arnaud Villacreces; Amélie V. Guitart; Ali El-habhab; Layal Massara; Olivier Mansier; Audrey Bidet; Delphine Martineau; Solene Fernandez; Thibaut Leguay; Arnaud Pigneux; Isabelle Vigon; Jean-Max Pasquet; Vanessa Desplat
Genome-Wide miRNA Expression Profiling of Molecular Subgroups of Peripheral T-cell Lymphoma
Waseem Lone; Alyssa Bouska; Sunandini Sharma; Catalina Amador; Mallick Saumyaranjan; Tyler A. Herek; Tayla B. Heavican; Jiayu Yu; Soon Thye Lim; Choon Kiat Ong; Graham W. Slack; Kerry J. Savage; Andreas Rosenwald; German Ott; James R. Cook; Andrew L. Feldman; Lisa M. Rimsza; Timothy W. McKeithan; Timothy C. Greiner; Dennis D. Weisenburger; Federica Melle; Giovanna Motta; Stefano Pileri; Julie M. Vose; Wing C. Chan; Javeed Iqbal
Allogeneic CAR Invariant Natural Killer T Cells Exert Potent Antitumor Effects through Host CD8 T-Cell Cross-Priming
Federico Simonetta; Juliane K. Lohmeyer; Toshihito Hirai; Kristina Maas-Bauer; Maite Alvarez; Arielle S. Wenokur; Jeanette Baker; Amin Aalipour; Xuhuai Ji; Samuel Haile; Crystal L. Mackall; Robert S. Negrin
Correction
Editor’s Note
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