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1st-line mFOLFOXIRI + Panitumumab vs FOLFOXIRI treatment of RAS wt mCRC: a randomized phase II VOLFI trial of the AIO (KRK-0109).

Date

20 Oct 2018

Session

Poster Discussion session - Gastrointestinal tumours, colorectal 1

Presenters

Michael Geissler

Citation

Annals of Oncology (2018) 29 (suppl_8): viii150-viii204. 10.1093/annonc/mdy281

Authors

M. Geissler1, T. Klingler1, J. Riera Knorrenschild2, A. Tannapfel3, J. Greeve4, T. Seufferlein5, S. Kanzler6, S. Held7, V. Heinemann8, A. Reinacher-Schick9, U.M. Martens10

Author affiliations

  • 1 Internal Medicine, Oncology/hematology, Klinikum Esslingen, 73730 - Esslingen/DE
  • 2 Oncology, Uniklinikum Giessen und Marburg, 35043 - Marburg/DE
  • 3 Pathology, Ruhr-Universität Bochum, 44801 - Bochum/DE
  • 4 Gastroenterology, St. Vincenz Krankenhaus, Paderborn/DE
  • 5 Department Of Internal Medicine I  , Ulm Medical University, 89081 - Ulm/DE
  • 6 Department Of Internal Medicine Ii, Leopoldina Krankenhaus Schweinfurt, Schweinfurt/DE
  • 7 Statistik, Clinassess, 51379 - Leverkusen/DE
  • 8  department Of Medical Oncology And Comprehensive Cancer Center, Ludwig Maximilians University - Grosshadern, 81377 - Munich/DE
  • 9 Oncology, Ruhr University Bochum Medizinische Universitätsklinik, 44892 - Bochum/DE
  • 10 Oncology, SLK-Kliniken Heilbronn GmbH, 74078 - Heilbronn/DE
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Background

This trial evaluated activity and safety of mFOLFOXIRI + panitumumab vs FOLFOXIRI in ECOG 0-1, primarily non-resectable mCRC patients.

Methods

Prospective 2:1 randomized, multi-center, phase II trial comparing mFOLFOXIRI (Ox 85, Iri 150, 5-FU 3000, LV 200) + Panitumumab 6 mg/KG (arm A) with FOLFOXIRI (Ox 85, Iri 165, 5-FU 3200 cont. 48h, LV 200; arm B). Cohort 1: irresectable mCRC; cohort 2: chance of secondary resection of metastatic lesions. Primary endpoint: ORR, secondary endpoints: secondary resection rate, DCR, PFS, OS, toxicity, QL (QLQ-C30). Financially supported by an unrestricted grant from Amgen.

Results

A total of 96 patients were randomized (63 arm A, 33 arm B). After an observation time of 29 months in both arms, final ORR results are displayed in the table. PFS in arm A reached 9.7 mo, in arm B 10.1 mo (HR 0.92, p=n.s.). PFS cohort II was 13.0 vs 9.0 mo in arm A and B, respectively (HR0.457, p = 0.068). PFS in BRAF mutated was comparable between arm A and B (6.5 vs 6.1 mo, HR 1.368, n.s.). Secondary resections were achieved in 33.3% (arm A) and 12.1% (arm B), R0 in 61.9% vs. 75.0%, respectively. In cohort 1, resections were achieved in 14% vs 0%, in cohort 2 in 75% vs 36.4%. RFS after resection of metastases was 7.9 vs 4.0 months in arm A and B, respectively (HR 0.623, p=n.s.). Treatment related adverse advents grade 3-5 occured in 81.3% and 66.7% in arms A and B, respectively (p = 0.1336). Non.haematological AEs grade 3-5 were more frequent in arm A (71.9%) than in arm B (39.4%), p = 0.0039. Nevertheless, no differences in global health status, functional scales, and symptom scales were reported.Table: 453PD

mFOLFOXIRI +PmabFOLFOXIRIp-valueOdds Ratio95%-CI
ITT, n = 9687.360.60.00414.4691.614-12.376
Cohort II, n = 31100.063.30.010524.61.1778-513.8
Left, n = 7890.668.00.02104.5181.298-15.718
Right, n = 1870.037.50.34163.8890.543-27.886
RAS/BRAF wt, n = 6086.064.70.08063.3640.902-12.549
BRAF mut, n = 1685.722.20.040621.0001.504-293.25

Conclusions

mFOLFOXIRI + Panitumumab results in significantly higher ORR compared to FOLFOXIRI. Strong effectivity was observed also in right sided and BRAF mutated CRC. High secondary resection rates could be achieved. Although toxicity (treatment related SAEs) was increased, QL reporting was similar in both arms. OS is still immature, but will be presented first time at the meeting.

Clinical trial identification

NCT01328171.

Legal entity responsible for the study

AIO Studien GmbH.

Funding

Amgen.

Editorial Acknowledgement

Disclosure

M. Geissler: Honararium, advisory boards: Amgen, Sanofi, Merck, Lilly. All other authors have declared no conflicts of interest.

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