Association of Circulating Tumor Cells and Tumor Molecular Profile With Clinical Outcomes in Patients With Previously Untreated Metastatic Colorectal Cancer: A Pooled Analysis of the Phase III VISNÚ-1 and Phase II VISNÚ-2 Randomized Trials
The bCTC count is a well-established prognostic biomarker in mCRC, as well as in other tumor types. The aim of this analysis was to evaluate the prognostic/predictive role of the bCTC count (≥3 vs.
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| Veröffentlicht in: | Clinical colorectal cancer 2023-06, Vol.22 (2), p.222-230 |
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| creator | Jiménez-Fonseca, P. Sastre, J. García-Alfonso, P. Gómez-España, M.A. Salud, A. Gil, S. Rivera, F. Reina, J.J. Quintero, G. Valladares-Ayerbes, M. Safont, M.J. La Casta, A. Robles-Díaz, L. García-Paredes, B. López López, R. Guillot, M. Gallego, J. Alonso-Orduña, V. Diaz-Rubio, E. Aranda, E. |
| description | The bCTC count is a well-established prognostic biomarker in mCRC, as well as in other tumor types. The aim of this analysis was to evaluate the prognostic/predictive role of the bCTC count (≥3 vs. |
| doi_str_mv | 10.1016/j.clcc.2023.02.004 |
| format | Article |
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The study involved 589 untreated mCRC patients included in the intention-to-treat population of 2 randomized clinical trials (phase III VISNU-1 [NCT01640405] and phase II VISNU-2 [NCT01640444] studies).
Of the 589 patients, 349 (59.2%) had bCTC≥3 and 240 (40.7%) had bCTC<3. Multivariate analysis showed that the bCTC count is an independent prognostic factor for overall survival (OS) (HR 0.59, 95% CI 0.48-0.72; P = 0.000) and potential for progression-free survival (PFS) (P = 0.0549). Median OS was 32.9 and 19.5 months in patients with bCTC<3 and bCTC≥3 (P <0.001), respectively. This effect was also observed comparing OS in RASwt patients from both studies. Other prognostic factors were: ECOG-PS, primary tumor site, number of metastatic sites and surgery of the primary tumor. Median OS was lower for patients treated with anti-VEGF versus anti-EGFR (22.3 vs. 33.3 months, P <0.0001) while there were no significant differences in PFS according to the targeted treatment received.
This post-hoc analysis of 2 randomized studies confirms the poor prognosis of patients with bCTC≥3 but this is not associated with other adverse independent prognostic factors such as RAS/BRAF mutations.
Baseline circulating tumor cell (bCTC ) enumeration is an established biomarker in metastatic colorectal cancer (mCRC). A total of 589 untreated mCRC patients from 2 randomized clinical trials were included for evaluation of the prognostic/predictive role of the bCTC count (≥3 vs. <3). Our results confirm the poor prognosis of patients with bCTC≥3 but this is not associated with other adverse prognostic factors such as RAS/BRAF mutations.]]></description><identifier>ISSN: 1533-0028</identifier><identifier>ISSN: 1938-0674</identifier><identifier>EISSN: 1938-0674</identifier><identifier>DOI: 10.1016/j.clcc.2023.02.004</identifier><identifier>PMID: 36944559</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Bevacizumab ; BRAF ; Clinical Trials, Phase II as Topic ; Colonic Neoplasms - drug therapy ; Colorectal Neoplasms - drug therapy ; Colorectal Neoplasms - genetics ; Humans ; Metastatic colorectal cancer ; Neoplastic Cells, Circulating ; Prognosis ; Prognostic factors ; Randomized Controlled Trials as Topic ; RAS ; Rectal Neoplasms - drug therapy</subject><ispartof>Clinical colorectal cancer, 2023-06, Vol.22 (2), p.222-230</ispartof><rights>2023 Elsevier Inc.</rights><rights>Copyright © 2023 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c356t-fab2dce3f2eec2e70ddd11233fed79e9c439ce3ad5c8ba5e2955e5e0688cae053</citedby><cites>FETCH-LOGICAL-c356t-fab2dce3f2eec2e70ddd11233fed79e9c439ce3ad5c8ba5e2955e5e0688cae053</cites><orcidid>0000-0003-4592-3813</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.clcc.2023.02.004$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36944559$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Jiménez-Fonseca, P.</creatorcontrib><creatorcontrib>Sastre, J.</creatorcontrib><creatorcontrib>García-Alfonso, P.</creatorcontrib><creatorcontrib>Gómez-España, M.A.</creatorcontrib><creatorcontrib>Salud, A.</creatorcontrib><creatorcontrib>Gil, S.</creatorcontrib><creatorcontrib>Rivera, F.</creatorcontrib><creatorcontrib>Reina, J.J.</creatorcontrib><creatorcontrib>Quintero, G.</creatorcontrib><creatorcontrib>Valladares-Ayerbes, M.</creatorcontrib><creatorcontrib>Safont, M.J.</creatorcontrib><creatorcontrib>La Casta, A.</creatorcontrib><creatorcontrib>Robles-Díaz, L.</creatorcontrib><creatorcontrib>García-Paredes, B.</creatorcontrib><creatorcontrib>López López, R.</creatorcontrib><creatorcontrib>Guillot, M.</creatorcontrib><creatorcontrib>Gallego, J.</creatorcontrib><creatorcontrib>Alonso-Orduña, V.</creatorcontrib><creatorcontrib>Diaz-Rubio, E.</creatorcontrib><creatorcontrib>Aranda, E.</creatorcontrib><creatorcontrib>Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD)</creatorcontrib><title>Association of Circulating Tumor Cells and Tumor Molecular Profile With Clinical Outcomes in Patients With Previously Untreated Metastatic Colorectal Cancer: A Pooled Analysis of the Phase III VISNÚ-1 and Phase II VISNÚ-2 Randomized Trials</title><title>Clinical colorectal cancer</title><addtitle>Clin Colorectal Cancer</addtitle><description><![CDATA[The bCTC count is a well-established prognostic biomarker in mCRC, as well as in other tumor types. The aim of this analysis was to evaluate the prognostic/predictive role of the bCTC count (≥3 vs. <3) in previously untreated mCRC.
The study involved 589 untreated mCRC patients included in the intention-to-treat population of 2 randomized clinical trials (phase III VISNU-1 [NCT01640405] and phase II VISNU-2 [NCT01640444] studies).
Of the 589 patients, 349 (59.2%) had bCTC≥3 and 240 (40.7%) had bCTC<3. Multivariate analysis showed that the bCTC count is an independent prognostic factor for overall survival (OS) (HR 0.59, 95% CI 0.48-0.72; P = 0.000) and potential for progression-free survival (PFS) (P = 0.0549). Median OS was 32.9 and 19.5 months in patients with bCTC<3 and bCTC≥3 (P <0.001), respectively. This effect was also observed comparing OS in RASwt patients from both studies. Other prognostic factors were: ECOG-PS, primary tumor site, number of metastatic sites and surgery of the primary tumor. Median OS was lower for patients treated with anti-VEGF versus anti-EGFR (22.3 vs. 33.3 months, P <0.0001) while there were no significant differences in PFS according to the targeted treatment received.
This post-hoc analysis of 2 randomized studies confirms the poor prognosis of patients with bCTC≥3 but this is not associated with other adverse independent prognostic factors such as RAS/BRAF mutations.
Baseline circulating tumor cell (bCTC ) enumeration is an established biomarker in metastatic colorectal cancer (mCRC). A total of 589 untreated mCRC patients from 2 randomized clinical trials were included for evaluation of the prognostic/predictive role of the bCTC count (≥3 vs. <3). Our results confirm the poor prognosis of patients with bCTC≥3 but this is not associated with other adverse prognostic factors such as RAS/BRAF mutations.]]></description><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Bevacizumab</subject><subject>BRAF</subject><subject>Clinical Trials, Phase II as Topic</subject><subject>Colonic Neoplasms - drug therapy</subject><subject>Colorectal Neoplasms - drug therapy</subject><subject>Colorectal Neoplasms - genetics</subject><subject>Humans</subject><subject>Metastatic colorectal cancer</subject><subject>Neoplastic Cells, Circulating</subject><subject>Prognosis</subject><subject>Prognostic factors</subject><subject>Randomized Controlled Trials as Topic</subject><subject>RAS</subject><subject>Rectal Neoplasms - drug therapy</subject><issn>1533-0028</issn><issn>1938-0674</issn><issn>1938-0674</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kUuOEzEQhlsIxDzgAixQLdl08CP9QmyiFo9IM0wEGVhajl1NHLnbg-0eKXMUrsOJuAFukrBkVeXyV7_L9WfZC0pmlNDy9W6mrFIzRhifETYjZP4oO6cNr3NSVvPHKS84zwlh9Vl2EcIuZSWn9Gl2xstmPi-K5jz7vQjBKSOjcQO4Dlrj1WjTcfgO67F3Hlq0NoAc9PF87SxOiIeVd52xCN9M3EJrzWCUtHAzRuV6DGAGWCUhHGI4ICuP98aNwe7hdogeZUQN1xhliIlT0DrrPKqYRFo5KPRvYAErl97TsBik3QcTphnjFmG1lQFhuVzC1-WXT79-5vTviKfyqcrgcyq73jwkjbU30oZn2ZMuBXx-jJfZ7ft36_ZjfnXzYdkurnLFizLmndwwrZB3DFExrIjWmlLGeYe6arBRc96ka6kLVW9kgawpCiyQlHWtJJKCX2avDrp33v0YMUTRm6DSMuWAaQmCVXVTUdqQKqHsgCrvQvDYiTtveun3ghIxWS12YrJaTFYLwkSyOjW9POqPmx71v5aTtwl4ewAw_fLeoBdBJTcUajNtWWhn_qf_ByDBv5A</recordid><startdate>202306</startdate><enddate>202306</enddate><creator>Jiménez-Fonseca, P.</creator><creator>Sastre, J.</creator><creator>García-Alfonso, P.</creator><creator>Gómez-España, M.A.</creator><creator>Salud, A.</creator><creator>Gil, S.</creator><creator>Rivera, F.</creator><creator>Reina, J.J.</creator><creator>Quintero, G.</creator><creator>Valladares-Ayerbes, M.</creator><creator>Safont, M.J.</creator><creator>La Casta, A.</creator><creator>Robles-Díaz, L.</creator><creator>García-Paredes, B.</creator><creator>López López, R.</creator><creator>Guillot, M.</creator><creator>Gallego, J.</creator><creator>Alonso-Orduña, V.</creator><creator>Diaz-Rubio, E.</creator><creator>Aranda, E.</creator><general>Elsevier Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-4592-3813</orcidid></search><sort><creationdate>202306</creationdate><title>Association of Circulating Tumor Cells and Tumor Molecular Profile With Clinical Outcomes in Patients With Previously Untreated Metastatic Colorectal Cancer: A Pooled Analysis of the Phase III VISNÚ-1 and Phase II VISNÚ-2 Randomized Trials</title><author>Jiménez-Fonseca, P. ; Sastre, J. ; García-Alfonso, P. ; Gómez-España, M.A. ; Salud, A. ; Gil, S. ; Rivera, F. ; Reina, J.J. ; Quintero, G. ; Valladares-Ayerbes, M. ; Safont, M.J. ; La Casta, A. ; Robles-Díaz, L. ; García-Paredes, B. ; López López, R. ; Guillot, M. ; Gallego, J. ; Alonso-Orduña, V. ; Diaz-Rubio, E. ; Aranda, E.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c356t-fab2dce3f2eec2e70ddd11233fed79e9c439ce3ad5c8ba5e2955e5e0688cae053</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Bevacizumab</topic><topic>BRAF</topic><topic>Clinical Trials, Phase II as Topic</topic><topic>Colonic Neoplasms - drug therapy</topic><topic>Colorectal Neoplasms - drug therapy</topic><topic>Colorectal Neoplasms - genetics</topic><topic>Humans</topic><topic>Metastatic colorectal cancer</topic><topic>Neoplastic Cells, Circulating</topic><topic>Prognosis</topic><topic>Prognostic factors</topic><topic>Randomized Controlled Trials as Topic</topic><topic>RAS</topic><topic>Rectal Neoplasms - drug therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Jiménez-Fonseca, P.</creatorcontrib><creatorcontrib>Sastre, J.</creatorcontrib><creatorcontrib>García-Alfonso, P.</creatorcontrib><creatorcontrib>Gómez-España, M.A.</creatorcontrib><creatorcontrib>Salud, A.</creatorcontrib><creatorcontrib>Gil, S.</creatorcontrib><creatorcontrib>Rivera, F.</creatorcontrib><creatorcontrib>Reina, J.J.</creatorcontrib><creatorcontrib>Quintero, G.</creatorcontrib><creatorcontrib>Valladares-Ayerbes, M.</creatorcontrib><creatorcontrib>Safont, M.J.</creatorcontrib><creatorcontrib>La Casta, A.</creatorcontrib><creatorcontrib>Robles-Díaz, L.</creatorcontrib><creatorcontrib>García-Paredes, B.</creatorcontrib><creatorcontrib>López López, R.</creatorcontrib><creatorcontrib>Guillot, M.</creatorcontrib><creatorcontrib>Gallego, J.</creatorcontrib><creatorcontrib>Alonso-Orduña, V.</creatorcontrib><creatorcontrib>Diaz-Rubio, E.</creatorcontrib><creatorcontrib>Aranda, E.</creatorcontrib><creatorcontrib>Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD)</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical colorectal cancer</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Jiménez-Fonseca, P.</au><au>Sastre, J.</au><au>García-Alfonso, P.</au><au>Gómez-España, M.A.</au><au>Salud, A.</au><au>Gil, S.</au><au>Rivera, F.</au><au>Reina, J.J.</au><au>Quintero, G.</au><au>Valladares-Ayerbes, M.</au><au>Safont, M.J.</au><au>La Casta, A.</au><au>Robles-Díaz, L.</au><au>García-Paredes, B.</au><au>López López, R.</au><au>Guillot, M.</au><au>Gallego, J.</au><au>Alonso-Orduña, V.</au><au>Diaz-Rubio, E.</au><au>Aranda, E.</au><aucorp>Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD)</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Association of Circulating Tumor Cells and Tumor Molecular Profile With Clinical Outcomes in Patients With Previously Untreated Metastatic Colorectal Cancer: A Pooled Analysis of the Phase III VISNÚ-1 and Phase II VISNÚ-2 Randomized Trials</atitle><jtitle>Clinical colorectal cancer</jtitle><addtitle>Clin Colorectal Cancer</addtitle><date>2023-06</date><risdate>2023</risdate><volume>22</volume><issue>2</issue><spage>222</spage><epage>230</epage><pages>222-230</pages><issn>1533-0028</issn><issn>1938-0674</issn><eissn>1938-0674</eissn><abstract><![CDATA[The bCTC count is a well-established prognostic biomarker in mCRC, as well as in other tumor types. The aim of this analysis was to evaluate the prognostic/predictive role of the bCTC count (≥3 vs. <3) in previously untreated mCRC.
The study involved 589 untreated mCRC patients included in the intention-to-treat population of 2 randomized clinical trials (phase III VISNU-1 [NCT01640405] and phase II VISNU-2 [NCT01640444] studies).
Of the 589 patients, 349 (59.2%) had bCTC≥3 and 240 (40.7%) had bCTC<3. Multivariate analysis showed that the bCTC count is an independent prognostic factor for overall survival (OS) (HR 0.59, 95% CI 0.48-0.72; P = 0.000) and potential for progression-free survival (PFS) (P = 0.0549). Median OS was 32.9 and 19.5 months in patients with bCTC<3 and bCTC≥3 (P <0.001), respectively. This effect was also observed comparing OS in RASwt patients from both studies. Other prognostic factors were: ECOG-PS, primary tumor site, number of metastatic sites and surgery of the primary tumor. Median OS was lower for patients treated with anti-VEGF versus anti-EGFR (22.3 vs. 33.3 months, P <0.0001) while there were no significant differences in PFS according to the targeted treatment received.
This post-hoc analysis of 2 randomized studies confirms the poor prognosis of patients with bCTC≥3 but this is not associated with other adverse independent prognostic factors such as RAS/BRAF mutations.
Baseline circulating tumor cell (bCTC ) enumeration is an established biomarker in metastatic colorectal cancer (mCRC). A total of 589 untreated mCRC patients from 2 randomized clinical trials were included for evaluation of the prognostic/predictive role of the bCTC count (≥3 vs. <3). Our results confirm the poor prognosis of patients with bCTC≥3 but this is not associated with other adverse prognostic factors such as RAS/BRAF mutations.]]></abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>36944559</pmid><doi>10.1016/j.clcc.2023.02.004</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0003-4592-3813</orcidid></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1533-0028 |
| ispartof | Clinical colorectal cancer, 2023-06, Vol.22 (2), p.222-230 |
| issn | 1533-0028 1938-0674 1938-0674 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2789711907 |
| source | MEDLINE; ScienceDirect Journals (5 years ago - present) |
| subjects | Antineoplastic Combined Chemotherapy Protocols - therapeutic use Bevacizumab BRAF Clinical Trials, Phase II as Topic Colonic Neoplasms - drug therapy Colorectal Neoplasms - drug therapy Colorectal Neoplasms - genetics Humans Metastatic colorectal cancer Neoplastic Cells, Circulating Prognosis Prognostic factors Randomized Controlled Trials as Topic RAS Rectal Neoplasms - drug therapy |
| title | Association of Circulating Tumor Cells and Tumor Molecular Profile With Clinical Outcomes in Patients With Previously Untreated Metastatic Colorectal Cancer: A Pooled Analysis of the Phase III VISNÚ-1 and Phase II VISNÚ-2 Randomized Trials |
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