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Treatments (tx) after progression to first-line FOLFOXIRI + bevacizumab (bev) in metastatic colorectal cancer (mCRC) patients (pts): A pooled analysis of TRIBE and TRIBE-2 studies by GONO.

Date

29 Sep 2019

Session

Poster Display session 2

Presenters

Daniele Rossini

Citation

Annals of Oncology (2019) 30 (suppl_5): v198-v252. 10.1093/annonc/mdz246

Authors

D. Rossini1, S. Lonardi2, C. Antoniotti1, D. Santini3, G. Tomasello4, G. Aprile5, R. Moretto1, A.A. Prete2, C. Granetto6, F. Urbano7, B. Borelli1, A. Zaniboni8, G. Randon9, A. Buonadonna10, G. Ritorto11, C. Barbara12, T.P. Latiano13, R. Bordonaro14, A. Falcone1, C. Cremolini1

Author affiliations

  • 1 Department Of Translational Research And New Technologies In Medicine And Surgery, Unit of Medical Oncology 2, Azienda Ospedaliera Universitaria Pisana, 56126 - Pisa/IT
  • 2 Unit Of Medical Oncology 1, Department Of Clinical And Experimental Oncology, Veneto Institute Of Oncology, IOV - IRCSS, 35128 - Padova/IT
  • 3 Department Of Medical Oncology, Campus Bio-Medico - University of Rome, 00128 - Rome/IT
  • 4 Oncology Unit, Oncology Department, ASST of Cremona, Cremona/IT
  • 5 Unit Of Medical Oncology, ULSS 8 Berica - Vicenza-Ospedale Civile "San Bortolo", 36100 - Vicenza/IT
  • 6 Oncologia Medica, Azienda Sanitaria Ospedaliera Santa Croce e Carle, 12100 - Cuneo/IT
  • 7 Department Of Radiological Science, Oncology And Patology, Policlinico Umberto I, "Sapienza" University of Rome, Rome/IT
  • 8 Medical Oncology Unit, Poliambulanza Foundation, 25124 - Brescia/IT
  • 9 Medical Oncology Department, Fondazione IRCSS - Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 10 Department Of Clinical Oncology, Centro di Riferimento Oncologico(CRO) IRCCS, 33081 - Aviano/IT
  • 11 Ssd Colorectal Cancer Unit Dipartimento Di Oncologia, AOU Città della Salute e della Scienza di Torino, Turin/IT
  • 12 Uoc Di Oncologia Medica, Ospedale di Livorno - Azienda USL Toscana Nord Ovest, Livorno/IT
  • 13 Oncology Unit, IRCCS Casa Sollievo della Sofferenza, 71013 - San Giovanni Rotondo/IT
  • 14 Oncologia Medica, Azienda Ospedaliera ARNAS Garibaldi, 95100 - Catania/IT
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Background

FOLFOXIRI + bev is regarded as a valuable option in the first-line tx of mCRC pts. A possible concern for the adoption is the feasibility and efficacy of tx after progression, and especially the reintroduction of the same agents used upfront. The aim of the study was to evaluate the efficacy of tx after progression among pts treated with first-line FOLFOXIRI + bev in the phase III TRIBE (NCT00719797) and TRIBE2 (NCT02339116) studies. The impact of the oxaliplatin and irinotecan free interval (OIFI), defined as the time from the last administration of oxaliplatin and irinotecan to disease progression, on the efficacy of tx after progression was also investigated.

Methods

Data about tx received after progression including 2ndPFS (i.e. the time from 2nd line tx start to disease progression or death) were collected. The efficacy of tx after progression according to the duration of the OIFI was explored. A cut-off value of 4 months was adopted.

Results

Out of 586 pts treated with upfront FOLFOXIRI + bev, 520 progressed. Among 409 (79%) pts who received a tx after progression, 168 (41%) received FOLFOXIRI ± bev (Group A) and 241 (59%) received other tx (Group B), including FOLFOX or FOLFIRI ± bev or other agents not used in first line in 124 and 117 cases, respectively. Anti-EGFR moAbs were administered in 68 cases.

Pts in Group A experienced significantly longer 2nd PFS than pts in Group B (median 2nd PFS: 6.1 vs 4.2, HR 0.76, 95%CI 0.62-0.94; p = 0.012). Pts with an OIFI ≥ 4 mos (n = 279) had longer 2nd PFS than those with an OIFI < 4 mos (n = 130) independently of the second-line tx (6.1 vs 3.7 mos: HR 0.54, 95%CI 0.42-0.69; p < 0.001). In the subgroup of pts with an OIFI ≥ 4 mos FOLFOXIRI ± bev (n = 125) was associated with longer 2nd PFS compared to other tx (n = 154) (7.2 vs 5.5 mos; HR 0.75, 95% CI 0.58-0.97; p = 0.029). Conversely, in pts with an OIFI < 4 mos no significant difference was shown between Group A (n = 43) and B (n = 87) (4.4 vs 3.2; HR 0.94, 95%CI 0.65-1.36; p = 0.75).

Conclusions

Tx after progression to first-line FOLFOXIRI + bev were feasible. Pts with longer OIFI showed better 2nd PFS and seemed to derive more benefit from the reintroduction of the triplet.

Clinical trial identification

TRIBE NCT00719797 TRIBE2 NCT02339116.

Editorial acknowledgement

Legal entity responsible for the study

G.O.N.O.: Gruppo Oncologico Nord Ovest.

Funding

Has not received any funding.

Disclosure

S. Lonardi: Advisory / Consultancy, Research grant / Funding (institution): Amgen; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Merck Serono; Advisory / Consultancy, Speaker Bureau / Expert testimony: Lilly; Speaker Bureau / Expert testimony: Roche; Speaker Bureau / Expert testimony: Bristol-Myers Squibb; Speaker Bureau / Expert testimony: Servier. D. Santini: Advisory / Consultancy: Amgen; Advisory / Consultancy: Novartis; Advisory / Consultancy: Roche; Advisory / Consultancy: MSD; Advisory / Consultancy: Eisai; Advisory / Consultancy: Sanofi; Advisory / Consultancy: Ipsen; Advisory / Consultancy: Janssen; Advisory / Consultancy: Merck. A. Falcone: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Amgen; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Bayer; Advisory / Consultancy: Bristol-Myers Squibb; Honoraria (institution), Advisory / Consultancy: Lilly; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Merck; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Servier. C. Cremolini: Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Travel / Accommodation / Expenses: Bayer; Advisory / Consultancy: Amgen; Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Servier. All other authors have declared no conflicts of interest.

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