Early tumor shrinkage and depth of response predict long-term outcome in metastatic colorectal cancer patients treated with first-line chemotherapy plus bevacizumab: results from phase III TRIBE trial by the Gruppo Oncologico del Nord Ovest

Cremolini, Chiara; Loupakis, Fotios; Antoniotti, Carlotta; Lonardi, Sara; Masi, Gianluca; Salvatore, Lisa; Cortesi, Enrico; Tomasello, Gianluca; Spadi, Rosella; Zaniboni, Alberto; Tonini, Giuseppe; Barone, Carlo; Vitello, S.; Longarini, Raffaella; Bonetti, Andrea; D’Amico, Mauro; Donato, Samantha Di; Granetto, Cristina; Boni, Luca; Falcone, Alfredo

doi:10.1093/annonc/mdv112

Cited by 164 publications

(161 citation statements)

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“…These results are slightly improved compared with those of previous studies (9)(10)(11)13,22). Although there is a lack of evidence to determine what molecular mechanisms underlie the effects of rechallenge treatments, a recent clinical result suggests a rationale for this treatment approach (19,23). In the updated results of the Triplet Plus Bevacizumab study, 5-FU, oxaliplatin and irinotecan [FOLFOXIRI] with bevacizumab as a first-line treatment revealed promising efficacy compared with FOLFIRI with bevacizumab (23).…”

Section: Discussionmentioning

confidence: 87%

“…Therefore, early tumor shrinkage (ETS) and depth of response (DoR) have been developed to overcome these problems (16). ETS and DoR have been associated with prolonged PFS, post-progression survival (PPS) and OS (18,19). ETS and DoR were initially developed to predict the efficacy of targeted agents (19), but their roles in conventional chemotherapy have not yet been fully evaluated (20).…”

Section: Introductionmentioning

confidence: 99%

“…ETS and DoR have been associated with prolonged PFS, post-progression survival (PPS) and OS (18,19). ETS and DoR were initially developed to predict the efficacy of targeted agents (19), but their roles in conventional chemotherapy have not yet been fully evaluated (20). As a biomarker to predict tumor response, several single-nucleotide polymorphisms (SNPs) have been evaluated as prognostic and predictive markers for the effectiveness of chemotherapy (21)(22)(23), although genome-wide association studies are being actively studied in various tumors.…”

Section: Introductionmentioning

confidence: 99%

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Role of depth of response and MTHFR genotype as predictors of fluorouracil rechallenge therapy for refractory metastatic colorectal cancer

et al. 2017

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Abstract. There is limited data on the clinical and biological parameters that enable the prediction of the benefits derived from additional chemotherapy after disease progression compared with standard chemotherapy in patients with metastatic colorectal cancer (mCRC). The present study evaluated the role of tumor response as a clinical parameter and single nucleotide polymorphisms (SNPs) as a biomarker to predict the benefit of additional 5-fluorouracil (5-FU) rechallenge chemotherapy in patients with refractory mCRC. Tumor responses were retrospectively reviewed based on the Response Evaluation Criteria in Solid Tumors, early tumor shrinkage (ETS) and depth of response (DoR) following first-line chemotherapy in patients with stage IV CRC. Together with these parameters, SNPs known to be associated with the response to chemotherapy were analyzed with survival outcomes. In total, the tumor responses of 242 patients with mCRC were evaluated. Overall response and ETS were identified in 110 (45.4%) and 103 patients (42.6%), respectively, and the median DoR was 38.5±30.08%. ETS and DoR were significantly associated with survival outcomes, including progression-free survival, post-progression survival and overall survival. Among these patients, SNPs were analyzed in 171 patients. X-ray repair cross complementing 1 (XRCC1) (AG/AA) with a DoR >60%, good performance status and the absence of bone lesions were associated with improved overall survival. In patients receiving third-line chemotherapy with 5-FU rechallenge therapy, the methylenetretrahydrofolate reductase (MTHFR) (C677T) CC genotype and a DoR >60% were significantly associated with a good prognosis in multivariate analysis.XRCC1 (AG/AA) was also associated with a good prognosis in patients with mCRC. Patients with a DoR >60% following first-line chemotherapy and a MTHFR (C677T) CC genotype exhibited a survival benefit from 5-FU retreatment. Therefore, the DoR and MTHFR genotype are potential markers for selecting patients with refractory mCRC that would benefit from 5-FU rechallenge therapy.

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Section: Discussionmentioning

confidence: 87%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Role of depth of response and MTHFR genotype as predictors of fluorouracil rechallenge therapy for refractory metastatic colorectal cancer

et al. 2017

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“…Early-tumor shrinkage was proposed as a surrogate endpoint for predicting long-term outcome of patients on cetuximab-based systemic chemotherapy [13,14]. Yet the time to first tumor assessment, the method and the cut-off of relative changes in tumor size remain unsettled.…”

Section: Discussionmentioning

confidence: 99%

“…Retrospective analyses of randomized clinical trials have suggested a robust association between early tumor shrinkage by 20% or more and OS, independently of treatment arm [13,14]. In contrast large increases in objective "best" response rates modestly translated into OS benefits for first line chemotherapy in patients with mCRC [15,16].…”

Section: Introductionmentioning

confidence: 99%

Early tumour response as a survival predictor in previously- treated patients receiving triplet hepatic artery infusion and intravenous cetuximab for unresectable liver metastases from wild-type KRAS colorectal cancer

Bouchahda

Boige

Smith

et al. 2016

European Journal of Cancer

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2016) Early tumour response as a survival predictor in previously-treated patients receiving triplet hepatic artery infusion and intravenous cetuximab for unresectable liver metastases from wild-type KRAS colorectal cancer. European Journal of Cancer Care, 68. pp. 163-172 Permanent WRAP URL: http://wrap.warwick.ac.uk/85119 Copyright and reuse:The Warwick Research Archive Portal (WRAP) makes this work by researchers of the University of Warwick available open access under the following conditions. Copyright © and all moral rights to the version of the paper presented here belong to the individual author(s) and/or other copyright owners. To the extent reasonable and practicable the material made available in WRAP has been checked for eligibility before being made available.Copies of full items can be used for personal research or study, educational, or not-for profit purposes without prior permission or charge. Provided that the authors, title and full bibliographic details are credited, a hyperlink and/or URL is given for the original metadata page and the content is not changed in any way. Publisher's statement:"This is the peer reviewed version of the following article: Bouchahda, Mohamed, Boige, Valérie, Smith, Denis, Karaboué, Abdoulaye, Ducreux, Michel, Hebbar, Mohamed, Lepère, Céline, Focan, Christian, Guimbaud, Rosine, Innominato, Pasquale F. et al.. (2016) Early tumour response as a survival predictor in previously-treated patients receiving triplet hepatic artery infusion and intravenous cetuximab for unresectable liver metastases from wild-type KRAS colorectal cancer. European Journal of Cancer Care, 68. pp. 163-172 which has been published in final form at http://dx.doi.org/10.1016/j.ejca.2016.09.011 This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving." A note on versions:The version presented here may differ from the published version or, version of record, if you wish to cite this item you are advised to consult the publisher's version. Please see the 'permanent WRAP URL' above for details on accessing the published version and note that access may require a subscription. within a multicenter conversion-to-resection medico-surgical strategy. Confirmation is warranted for decision-making. Protocol numbersEUDRACT 2007-004632-24 NCT00852228 KEY WORDS:Early tumor response, colorectal cancer, liver metastases, hepatic artery infusion, triplet chemotherapy. ACKNOWLEDGEMENTS:We sincerely acknowledge the contribution of the patients who participated in this trial and all our colleagues and staff at the participating institutions.

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Evaluation of Continuous Tumor-Size–Based End Points as Surrogates for Overall Survival in Randomized Clinical Trials in Metastatic Colorectal Cancer

et al. 2019

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Key PointsQuestionCan end points based on the kinetics of tumor size after treatment be used as surrogates for overall survival in metastatic colorectal cancer?FindingsIn this pooled analysis of data from 20 randomized clinical trials, time to nadir and depth of nadir were modeled and assessed as potential surrogates for overall survival at the patient and trial levels. The associations found were weak or moderate; there were notable differences in tumor-size kinetics between antiangiogenic agents and anti–epidermal growth factor receptor agents.MeaningThe implications of these results for early drug development and clinical practice are unclear and warrant further studies; the findings of this study reinforce the need to develop more reliable end points that reflect tumor biology and patient benefit.

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Early tumor shrinkage and depth of response predict long-term outcome in metastatic colorectal cancer patients treated with first-line chemotherapy plus bevacizumab: results from phase III TRIBE trial by the Gruppo Oncologico del Nord Ovest

Cited by 164 publications

References 9 publications

Role of depth of response and MTHFR genotype as predictors of fluorouracil rechallenge therapy for refractory metastatic colorectal cancer

Role of depth of response and MTHFR genotype as predictors of fluorouracil rechallenge therapy for refractory metastatic colorectal cancer

Early tumour response as a survival predictor in previously- treated patients receiving triplet hepatic artery infusion and intravenous cetuximab for unresectable liver metastases from wild-type KRAS colorectal cancer

Evaluation of Continuous Tumor-Size–Based End Points as Surrogates for Overall Survival in Randomized Clinical Trials in Metastatic Colorectal Cancer

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