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Proffered paper session - Gastrointestinal tumours, colorectal

5040 - TRIBE2: a phase III, randomized strategy study by GONO in the 1st- and 2nd-line treatment of unresectable metastatic colorectal cancer (mCRC) patients (pts).


22 Oct 2018


Proffered paper session - Gastrointestinal tumours, colorectal


Cytotoxic Therapy

Tumour Site

Colon and Rectal Cancer


Chiara Cremolini


C. Cremolini1, C. Antoniotti1, S. Lonardi2, D. Rossini1, F. Pietrantonio3, S.S. Cordio4, S. Murgioni5, F. Marmorino1, E. Maiello6, A. Passardi7, G. Masi1, E. Tamburini8, D. Santini9, R. Grande10, A. Zaniboni11, C. Granetto12, F. Loupakis2, L. Delliponti1, L. Boni13, A. Falcone1

Author affiliations

  • 1 Department Of Translational Research And New Technologies In Medicine And Surgery, University of Pisa, 56100 - Pisa/IT
  • 2 Dip. Oncologia Clinica E Sperimentale, Istituto Oncologico Veneto IRCCS, 35128 - Padova/IT
  • 3 Medical Oncology Department, Istituto Nazionale dei Tumori di Milano - Fondazione IRCCS, 20133 - Milan/IT
  • 4 Oncologia Medica, Azienda Ospedaliera ARNAS Garibaldi, 95100 - Catania/IT
  • 5 Medical Oncology 1, Department Of Clinical And Experimental Oncology, Istituto Oncologico Veneto IRCCS, 35128 - Padova/IT
  • 6 Oncology, Hospital Casa Sollievo della Sofferenza-IRCCS, san giovanni rotondo/IT
  • 7 Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, 47014 - Meldola/IT
  • 8 Oncologia Medica, Ospedale Infermi, 47900 - Rimini/IT
  • 9 Oncology, Campus Bio-Medico di Roma, 128 - Rome/IT
  • 10 Oncologia Medica, Ospedale Fabrizio Spaziani-ASL Frosinone, 3100 - Frosinone/IT
  • 11 Medical Oncology, Casa di Cura Poliambulanza, 25124 - Brescia/IT
  • 12 Oncologia Medica, Azienda Sanitaria Ospedaliera Santa Croce e Carle, 12100 - Cuneo/IT
  • 13 Istituto Toscano Tumori, clinical trial coordinating center, AOU careggi ,, firenze/IT


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Abstract 5040


TRIBE2 aimed at comparing two strategies of 1st and 2nd line treatment of mCRC with different chemotherapy intensity and a prolonged angiogenesis inhibition


TRIBE2 (NCT02339116) was a phase 3 trial in which previously untreated pts with unresectable mCRC were randomized 1:1 to FOLFOX/bev followed by FOLFIRI/bev after disease progression (PD) (arm A) or FOLFOXIRI/bev followed by the reintroduction of the same regimen after PD (arm B). Combination treatments were administered up to 8 cycles, followed by 5-FU/bev until PD. The primary endpoint was Progression Free Survival 2 (PFS2), defined as the time from randomization to PD on any treatment given after first PD or death. Estimating a median PFS2 in arm A of 15 months, 466 events and 654 pts were required to detect a HR of 0.77 in favor of arm B, with overall 2-sided-α and β errors of 0.05 and 0.20, respectively. An interim analysis at 2/3 of events (303) was planned. According to the O’Brien Fleming spending rule, 2-sided-α levels of 0.0131 and 0.0455 were defined for the interim and final analysis


From February 2015 to May 2017, 679 pts (arm A/B: 342/337) were enrolled in 58 Italian sites. Main patients’ characteristics were (arm A/B): median age 61/60 yrs, ECOG PS 0 86%/87%, right-sided primary 38%/38%, liver-only disease 29%/32%, RAS mutant 65%/63%, BRAF mutant 10%/10%. At a median follow-up of 22.8 mos, 547 (arm A/B 286/261) patients progressed and 423 (arm A/B 235/188) events of PFS2 were reported. As compared with FOLFOX/bev, upfront FOLFOXIRI/bev significantly improved PFS1 (median 9.9 vs 12.0 mos, HR 0.73 [95%CI: 0.62-0.87], p<0.001) and RECIST response rate (61% vs 50%, OR 1.55 [95%CI: 1.14-2.10], p=0.005). 247 (86%) and 197 (75%) patients received a treatment after PD in arm A and B, respectively. Patients in arm B reported significantly longer PFS2 than in arm A (median PFS2 18.9 vs 16.2 mos, HR 0.69 [95%CI: 0.57-0.83], p<0.001)


The primary endpoint was met at the interim analysis: 4-months induction with FOLFOXIRI/bev followed by maintenance and reintroduction improves mCRC patients’ outcome as compared with a sequential strategy of oxaliplatin- and irinotecan-based doublets.

Clinical trial identification


Editorial Acknowledgement

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