Cited by 710Colorectal Cancer Treatments and StudiesColorectal Cancer Surgical TreatmentsGenetic factors in colorectal cancer

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Prognostic and Predictive Relevance of Primary Tumor Location in Patients With RAS Wild-Type Metastatic Colorectal Cancer: Retrospective Analyses of the CRYSTAL and FIRE-3 Trials

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Tejpar, Sabine, Stintzing, Sebastian, Ciardiello, Fortunato, Tabernero, Josep, Van Cutsem, Eric, Beier, Frank, Esser, Regina, Lenz, Heinz-Josef, Heinemann, Volker·2017·JAMA Oncology

DOI 10.1001/jamaoncol.2016.3797PMC PMC7505121

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Abstract

IMPORTANCE: Metastatic colorectal cancer (mCRC) is heterogeneous, and primary tumors arising from different regions of the colon are clinically and molecularly distinct. OBJECTIVE: To examine the prognostic and predictive value of primary tumor location in patients with RAS wild-type (wt) mCRC treated with first-line fluorouracil, leucovorin, and irinotecan (FOLFIRI) plus cetuximab in the Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL) trial and FOLFIRI Plus Cetuximab Versus FOLFIRI Plus Bevacizumab as First-Line Treatment For Patients With Metastatic Colorectal Cancer (FIRE-3) trial. DESIGN, SETTING, AND PARTICIPANTS: In this retrospective analysis patients with RAS wt metastatic colorectal cancer from the CRYSTAL and FIRE-3 trials were classified as having left-sided or right-sided mCRC, defined, respectively, as patients whose tumors originated in the splenic flexure, descending colon, sigmoid colon, or rectum vs appendix, cecum, ascending colon, hepatic flexure, or transverse colon. MAIN OUTCOMES AND MEASURES: Progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) were assessed according to tumor location and treatment arm. RESULTS: In the RAS wt populations of the CRYSTAL and FIRE-3 trials, patients with left-sided tumors (n = 142 and n = 157, respectively) had markedly superior PFS, OS, and ORR compared with patients with right-sided tumors (n = 33 and n = 38, respectively). Among CRYSTAL and FIRE-3 study patients with RAS wt left-sided tumors, FOLFIRI plus cetuximab significantly improved OS relative to the respective comparators (FOLFIRI and FOLFIRI plus bevacizumab); in contrast, in RAS wt patients with poor-prognosis right-sided tumors, limited efficacy benefits were observed upon the addition of cetuximab to FOLFIRI in CRYSTAL, and comparable outcomes were observed between the FOLFIRI plus cetuximab and FOLFIRI plus bevacizumab arms of FIRE-3. A significant interaction was observed between primary tumor location and treatment for OS (CRYSTAL: hazard ratio [HR], 1.95; 95% CI, 1.09-3.48 and FIRE-3: HR, 0.40; 95% CI, 0.23-0.70) within the RAS wt populations of both studies in multivariable models that also included sex, prior adjuvant therapy, and BRAF mutational status. CONCLUSIONS AND RELEVANCE: In the RAS wt populations of CRYSTAL and FIRE-3, patients with left-sided tumors had a markedly better prognosis than those with right-sided tumors. First-line FOLFIRI plus cetuximab clearly benefitted patients with left-sided tumors (vs FOLFIRI or FOLFIRI plus bevacizumab, respectively), whereas patients with right-sided tumors derived limited benefit from standard treatments. TRIAL REGISTRATION: clinicaltrials.gov Identifiers: CRYSTAL, NCT00154102, and FIRE-3, NCT00433927.

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Additional file 7 of Primary tumor resection with or without metastasectomy for left- and right-sided stage IV colorectal cancer: an instrumental variable analysis
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Additional file 12 of Development and validation of prognostic nomograms for early-onset colon cancer in different tumor locations: a population-based study
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Additional file 11 of Development and validation of prognostic nomograms for early-onset colon cancer in different tumor locations: a population-based study
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Additional file 2 of Development and validation of prognostic nomograms for early-onset colon cancer in different tumor locations: a population-based study
Zhu, S., Tu, J., Pei, W., Zheng, Z., 毕建军, & Feng, Q. (2024) · Figshare · doi:10.6084/m9.figshare.24417621
Additional file 13 of Development and validation of prognostic nomograms for early-onset colon cancer in different tumor locations: a population-based study
Zhu, S., Tu, J., Pei, W., Zheng, Z., 毕建军, & Feng, Q. (2024) · Figshare · doi:10.6084/m9.figshare.26630302
Additional file 10 of Development and validation of prognostic nomograms for early-onset colon cancer in different tumor locations: a population-based study
Zhu, S., Tu, J., Pei, W., Zheng, Z., 毕建军, & Feng, Q. (2024) · Figshare · doi:10.6084/m9.figshare.26630293
Additional file 1 of Organoids as a biomarker for personalized treatment in metastatic colorectal cancer: drug screen optimization and correlation with patient response
Smabers, L. P., Wensink, G. E., Veríssimo, C. S., Koedoot, E., Pitsa, K.-C., Huismans, M. A., Barón, C. H., Doorn, M., Iersel, L. V., Cirkel, G. A., et al. (2024) · Figshare · doi:10.6084/m9.figshare.25302930
Additional file 6 of Development and validation of prognostic nomograms for early-onset colon cancer in different tumor locations: a population-based study
Zhu, S., Tu, J., Pei, W., Zheng, Z., 毕建军, & Feng, Q. (2024) · Figshare · doi:10.6084/m9.figshare.26630281
Additional file 3 of Development and validation of prognostic nomograms for early-onset colon cancer in different tumor locations: a population-based study
Zhu, S., Tu, J., Pei, W., Zheng, Z., 毕建军, & Feng, Q. (2024) · Figshare · doi:10.6084/m9.figshare.26630272
Additional file 9 of Development and validation of prognostic nomograms for early-onset colon cancer in different tumor locations: a population-based study
Zhu, S., Tu, J., Pei, W., Zheng, Z., 毕建军, & Feng, Q. (2024) · Figshare · doi:10.6084/m9.figshare.26630290
Additional file 3 of Primary tumor resection with or without metastasectomy for left- and right-sided stage IV colorectal cancer: an instrumental variable analysis
Yao, Y.-C., Chen, J.-Q., Yin, L., Lin, W.-H., Peng, J.-H., & Fan, W. (2022) · Figshare · doi:10.6084/m9.figshare.19335942
Additional file 5 of Development and validation of prognostic nomograms for early-onset colon cancer in different tumor locations: a population-based study
Zhu, S., Tu, J., Pei, W., Zheng, Z., 毕建军, & Feng, Q. (2024) · Figshare · doi:10.6084/m9.figshare.26630278
Additional file 6 of Primary tumor resection with or without metastasectomy for left- and right-sided stage IV colorectal cancer: an instrumental variable analysis
Yao, Y.-C., Chen, J.-Q., Yin, L., Lin, W.-H., Peng, J.-H., & Fan, W. (2022) · Figshare · doi:10.6084/m9.figshare.19335951
Additional file 8 of Development and validation of prognostic nomograms for early-onset colon cancer in different tumor locations: a population-based study
Zhu, S., Tu, J., Pei, W., Zheng, Z., 毕建军, & Feng, Q. (2024) · Figshare · doi:10.6084/m9.figshare.26630287
Additional file 1 of Primary tumor location affects recurrence-free survival for patients with colorectal liver metastases after hepatectomy: a propensity score matching analysis
Zhang, Y., Wang, Y., Yuan, Y., Qiu, J., Qiu, Y., He, W., Zheng, Y., Wang, Z., Gu, Y., ZhenHai, L., et al. (2020) · Figshare · doi:10.6084/m9.figshare.12324734
Additional file 2 of Effect of sidedness on survival among patients with early-stage colon cancer: a SEER-based propensity score matching analysis
Huang, Z.-S., Wu, J.-W., Li, Y., Lin, Y.-H., & Li, X.-Y. (2021) · Figshare · doi:10.6084/m9.figshare.14451027
Additional file 1 of Development and validation of prognostic nomograms for early-onset colon cancer in different tumor locations: a population-based study
Zhu, S., Tu, J., Pei, W., Zheng, Z., 毕建军, & Feng, Q. (2023) · Figshare · doi:10.6084/m9.figshare.24417590
Additional file 14 of Development and validation of prognostic nomograms for early-onset colon cancer in different tumor locations: a population-based study
Zhu, S., Tu, J., Pei, W., Zheng, Z., 毕建军, & Feng, Q. (2024) · Figshare · doi:10.6084/m9.figshare.26630305
Additional file 1 of Effect of sidedness on survival among patients with early-stage colon cancer: a SEER-based propensity score matching analysis
Huang, Z.-S., Wu, J.-W., Li, Y., Lin, Y.-H., & Li, X.-Y. (2021) · Figshare · doi:10.6084/m9.figshare.14451024
Additional file 2 of Primary tumor resection with or without metastasectomy for left- and right-sided stage IV colorectal cancer: an instrumental variable analysis
Yao, Y.-C., Chen, J.-Q., Yin, L., Lin, W.-H., Peng, J., & Fan, W. (2022) · Figshare · doi:10.6084/m9.figshare.19335939
The Association of KRAS Mutation and Primary Tumor Location with Recurrence in Colorectal Liver Metastases Undergoing Radiofrequency AblationPreprint
Jiang, B., Wang, J., Yan, K., Zhang, Z., Wang, S., Wu, W., Yang, W., & Chen, M. (2023) · Research Square · doi:10.21203/rs.3.rs-3584672/v1
Additional file 1 of Primary tumor resection with or without metastasectomy for left- and right-sided stage IV colorectal cancer: an instrumental variable analysis
Yao, Y.-C., Chen, J.-Q., Yin, L., Lin, W.-H., Peng, J.-H., & Fan, W. (2022) · Figshare · doi:10.6084/m9.figshare.19335936
Additional file 5 of Primary tumor resection with or without metastasectomy for left- and right-sided stage IV colorectal cancer: an instrumental variable analysis
Yao, Y.-C., Chen, J.-Q., Yin, L., Lin, W.-H., Peng, J., & Fan, W. (2022) · Figshare · doi:10.6084/m9.figshare.19335948
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Sahm, S. W., Neumann, U. P., Zahn, M., Schwittay, M., Maintz, C., Goehler, T., Rubanov, O., Hering-Schubert, C., Janssen, J., Stenzel, K. G., et al. (2026) · BMC Cancer · doi:10.1186/s12885-026-15753-5
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Tatlıdede, D., Arslan, Ç., Yıldırım, M. E., Işıkdoğan, A., Karadurmuş, N., Karabulut, B., Çubukçu, E., Çiçin, İ., Yalçın, Ş., Türk, H. M., et al. (2025) · DergiPark (Istanbul University)
From mono- to multi-cellular in vitro models: reconstructing colorectal cancer complexity for translational and personalized applications
Edwards, G. O., Causi, F. S. L., Castagnola, G., Singh, S., & Amendola, P. G. (2026) · Frontiers in Cell and Developmental Biology · doi:10.3389/fcell.2026.1777400
AGMT mCRC Registry Third-Line and Beyond: a multicentric real-world platform with integrated imaging and biosample database for later-line metastatic colorectal cancer
Huemer, F., Piringer, G., Eisterer, W., Heibl, S., Rumpold, H. F., Wöll, E., Schreil, G., Sliwa, T., Winder, T. L., Prager, G. W., et al. (2026) · Future Oncology · doi:10.1080/14796694.2026.2644463
Etude du récepteur d’endocytose LRP1 dans les adénocarcinomes coliques : caractéristiques cliniques, pathologiques et moléculaires associées et valeur pronostique
Boulagnon‐Rombi, C. (2017) · theses.fr (ABES) · doi:10.70675/c907fd83z8cf9z4eb1z904bz91bbe9f6e21f
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Prada, P. (2022) · theses.fr (ABES) · doi:10.70675/2d0d6fe6zbcbcz4886z871az36330f2d42ba
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Gotti, J., do Vale, R., Duarte, H. O., Costa, A. F., Andújar, I., Burock, R., Rapp, E., Gomes, J., Gomes, C., & Reis, C. A. (2026) · Biochimica et Biophysica Acta (BBA) - General Subjects · doi:10.1016/j.bbagen.2026.130955

Authors: Tejpar, S., Stintzing, S., Ciardiello, F., Tabernero, J., Van Cutsem, E., Beier, F., Esser, R., Lenz, H.-J., & Heinemann, V.
Affiliations: Universitair Ziekenhuis Leuven (BE)
Ludwig-Maximilians-Universität München (DE)
University of Campania "Luigi Vanvitelli" (IT)
Universitat Autònoma de Barcelona (ES)
Digestive Oncology, University Hospitals Leuven and KULeuven, Leuven, Belgium
Merck KGaA, Darmstadt (Germany) (DE)
University of Southern California (US)
Corresponding author: Tejpar, Sabine
ORCID: Tejpar, Sabine
Stintzing, Sebastian
Ciardiello, Fortunato
Tabernero, Josep
Beier, Frank
Esser, Regina
Lenz, Heinz-Josef
Heinemann, Volker
Venue: JAMA Oncology
Publisher: American Medical Association (AMA)
Published: 2017-02-01
Volume: 3
Issue: 2
Pages: 194
ISSN: 2374-2437 (ISSN-L)
DOI: 10.1001/jamaoncol.2016.3797
PMC: PMC7505121
OpenAlex: W2531319683
Cited by: 709
References: 24
Citations by year: 2026: 19 · 2025: 35 · 2024: 64 · 2023: 48 · 2022: 70 · 2021: 89 · 2020: 85 · 2019: 97 · 2018: 102 · 2017: 96
FWCI: 53.50
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Locations: JAMA Oncology (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
Archivio Istituzionale della Ricerca - Università degli Studi della Campania "Luigi Vanvitelli" (submittedVersion)
Funders: National Cancer Institute (P30CA014089)
Topics: Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
Health Sciences › Medicine › Oncology › Colorectal Cancer Surgical Treatments
Health Sciences › Medicine › Pathology and Forensic Medicine › Genetic factors in colorectal cancer
Keywords: metastatic colorectal cancer, RAS wild-type, primary tumor site, cetuximab, FOLFIRI, bevacizumab, first-line therapy, progression-free survival, overall survival, objective response rate, predictive biomarkers, CRYSTAL trial, FIRE-3 trial, EGFR inhibition

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Prognostic and Predictive Relevance of Primary Tumor Location in Patients With RAS Wild-Type Metastatic Colorectal Cancer: Retrospective Analyses of the CRYSTAL and FIRE-3 Trials

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