Journal ArticleDOI
Dual-targeted therapy with trastuzumab and lapatinib in treatment-refractory, KRAS codon 12/13 wild-type, HER2-positive metastatic colorectal cancer (HERACLES): A proof-of-concept, multicentre, open-label, phase 2 trial
Andrea Sartore-Bianchi,Livio Trusolino,Cosimo Martino,Katia Bencardino,Sara Lonardi,Francesca Bergamo,Vittorina Zagonel,Francesco Leone,Ilaria Depetris,Erika Martinelli,Teresa Troiani,Fortunato Ciardiello,Patrizia Racca,Andrea Bertotti,Giulia Siravegna,Valter Torri,Alessio Amatu,Silvia Ghezzi,Giovanna Marrapese,Laura Palmeri,Emanuele Valtorta,Andrea Cassingena,Calogero Lauricella,Angelo Vanzulli,Daniele Regge,Silvio Veronese,Paolo M. Comoglio,Alberto Bardelli,Silvia Marsoni,Salvatore Siena +29 more
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TLDR
The combination of trastuzumab and lapatinib is active and well tolerated in treatment-refractory patients with HER2-positive metastatic colorectal cancer.Abstract:
Summary Background We previously found that dual HER2 blockade with trastuzumab and lapatinib led to inhibition of tumour growth in patient-derived xenografts of HER2 -amplified metastatic colorectal cancer. In this study, we aimed to assess the antitumour activity of trastuzumab and lapatinib in patients with HER2-positive colorectal cancer. Methods HERACLES was a proof-of-concept, multicentre, open-label, phase 2 trial done at four Italian academic cancer centres. We enrolled adult patients with KRAS exon 2 (codons 12 and 13) wild-type and HER2-positive metastatic colorectal cancer refractory to standard of care (including cetuximab or panitumumab), an Eastern Cooperative Oncology Group performance status of 0 or 1, and at least one measurable lesion. We defined HER2 positivity in tumour samples by use of immunohistochemistry and fluorescence in-situ hybridisation in accordance with our previously validated colorectal cancer-specific diagnostic criteria. Eligible patients received intravenous trastuzumab at 4 mg/kg loading dose followed by 2 mg/kg once per week, and oral lapatinib at 1000 mg per day until evidence of disease progression. The primary endpoint was the proportion of patients achieving an objective response (defined as complete response or partial response), which was assessed by independent central review in the intention-to-treat population. This trial is registered with EudraCT, number 2012-002128-33. Findings Between Aug 27, 2012, and May 15, 2015, we screened 914 patients with KRAS exon 2 (codons 12 and 13) wild-type metastatic colorectal cancer and identified 48 (5%) patients with HER2-positive tumours, although two died before enrolment. Of these patients, 27 were eligible for the trial. All were evaluable for response. At the time of data cutoff on Oct 15, 2015, with a median follow-up of 94 weeks (IQR 51–127), eight (30%, 95% CI 14–50) of 27 patients had achieved an objective response, with one patient (4%, 95% CI −3 to 11) achieving a complete response, and seven (26%, 95% CI 9–43) achieving partial responses; 12 (44%, 95% CI 25–63) patients had stable disease. Six (22%) of 27 patients had grade 3 adverse events, which consisted of fatigue in four patients, skin rash in one patient, and increased bilirubin concentration in one patient. No grade 4 or 5 adverse events were reported. We detected no drug-related serious adverse events. Interpretation The combination of trastuzumab and lapatinib is active and well tolerated in treatment-refractory patients with HER2-positive metastatic colorectal cancer. Funding Associazione Italiana Ricerca Cancro (AIRC), Fondazione Oncologia Niguarda Onlus, and Roche.read more
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Colon Cancer, Version 1.2017, NCCN Clinical Practice Guidelines in Oncology
Al B. Benson,Alan P. Venook,Lynette Cederquist,Emily Chan,Yi-Jen Chen,Harry S. Cooper,Dustin A. Deming,Paul F. Engstrom,Peter C. Enzinger,Alessandro Fichera,Jean L. Grem,Axel Grothey,Howard S. Hochster,Sarah E. Hoffe,Steven C. Hunt,Ahmed Kamel,Natalie Kirilcuk,Smitha S. Krishnamurthi,Wells A. Messersmith,Mary F. Mulcahy,James D. Murphy,Steven J. Nurkin,Leonard B. Saltz,Sunil Sharma,David Shibata,John M. Skibber,Constantinos T. Sofocleous,Elena M. Stoffel,Eden Stotsky-Himelfarb,Christopher G. Willett,Christina Wu,Kristina M. Gregory,Deborah A. Freedman-Cass +32 more
TL;DR: This portion of the NCCN Guidelines for Colon Cancer focuses on the use of systemic therapy in metastatic disease and considers treatment history, extent of disease, goals of treatment, the efficacy and toxicity profiles of the regimens, KRAS/NRAS mutational status, and patient comorbidities and preferences.
Journal ArticleDOI
Comprehensive review of targeted therapy for colorectal cancer
TL;DR: This review provides an overview of existing CRC-targeted agents and their underlying mechanisms, as well as a discussion of their limitations and future trends.
Journal ArticleDOI
Consensus molecular subtypes and the evolution of precision medicine in colorectal cancer
Rodrigo Dienstmann,Louis Vermeulen,Justin Guinney,Scott Kopetz,Sabine Tejpar,Josep Tabernero +5 more
TL;DR: Better characterization of the transcriptomic subtypes of colorectal cancer, encompassing tumour, stromal and immune components, has revealed convergent pathway dependencies that mandate a 'multi-molecular' perspective for the development of therapies to treat this disease.
Journal ArticleDOI
Colon Cancer, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology.
Al B. Benson,Alan P. Venook,Mahmoud M. Al-Hawary,Mustafa A. Arain,Yi Jen Chen,Kristen K. Ciombor,Stacey Cohen,Harry S. Cooper,Dustin A. Deming,Linda Farkas,Ignacio Garrido-Laguna,Jean L. Grem,Andrew J. Gunn,J. Randolph Hecht,Sarah E. Hoffe,Joleen M. Hubbard,Steven C. Hunt,Kimberly L. Johung,Natalie Kirilcuk,Smitha S. Krishnamurthi,Wells A. Messersmith,Jeffrey A. Meyerhardt,Eric D. Miller,Mary F. Mulcahy,Steven J. Nurkin,Michael J. Overman,Aparna Raj Parikh,Hitendra Patel,Katrina S. Pedersen,Leonard B. Saltz,Charles Schneider,David Shibata,John M. Skibber,Constantinos T. Sofocleous,Elena M. Stoffel,Eden Stotsky-Himelfarb,Christopher G. Willett,Kristina M. Gregory,Lisa A. Gurski +38 more
TL;DR: The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Colon Cancer focuses on systemic therapy options for the treatment of metastatic colorectal cancer (mCRC), because important updates have recently been made to this section as discussed by the authors.
Journal ArticleDOI
Diagnosis and Treatment of Metastatic Colorectal Cancer: A Review.
Leah H. Biller,Deborah Schrag +1 more
TL;DR: For example, the authors found that for the 50% of patients with metastatic colorectal cancer with KRAS/NRAS/BRAF wild-type tumors, targeted combination therapy with BRAF and EGFR inhibitors extended overall survival to 9.3 months, compared to 5.9 months for those receiving standard chemotherapy.
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Journal ArticleDOI
Cancer Genome Landscapes
Bert Vogelstein,Nickolas Papadopoulos,Victor E. Velculescu,Shibin Zhou,Luis A. Diaz,Kenneth W. Kinzler +5 more
TL;DR: This work has revealed the genomic landscapes of common forms of human cancer, which consists of a small number of “mountains” (genes altered in a high percentage of tumors) and a much larger number of "hills" (Genes altered infrequently).
Journal ArticleDOI
Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial
Yung-Jue Bang,Eric Van Cutsem,A. Feyereislova,Hyun Cheol Chung,Lin Shen,Akira Sawaki,Florian Lordick,Atsushi Ohtsu,Yasushi Omuro,Taroh Satoh,G. Aprile,Evgeny Kulikov,Julie Hill,Michaela Lehle,Josef Rüschoff,Yoon-Koo Kang +15 more
TL;DR: Trastuzumab in combination with chemotherapy can be considered as a new standard option for patients with HER2-positive advanced gastric or gastro-oesophageal junction cancer.
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Alice T. Shaw,Dong Wan Kim,Kazuhiko Nakagawa,Takashi Seto,Lucio Crinò,Myung-Ju Ahn,Tommaso De Pas,Benjamin Besse,Benjamin Solomon,Fiona H Blackhall,Yi-Long Wu,Michael Thomas,Kenneth J. O'Byrne,Denis Moro-Sibilot,D. Ross Camidge,Tony Mok,Vera Hirsh,Gregory J. Riely,Shrividya Iyer,V. Tassell,Anna Polli,Keith D. Wilner,Pasi A. Jänne +22 more
TL;DR: Crizotinib is superior to standard chemotherapy in patients with previously treated, advanced non-small-cell lung cancer with ALK rearrangement and greater improvement in global quality of life with crizotinIB than with chemotherapy.
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