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. 2019 Feb 1;10(10):1070-1084.
doi: 10.18632/oncotarget.26626.

Safety and effectiveness of FOLFOXIRI plus molecular target drug therapy for metastatic colorectal cancer: A multicenter retrospective study

Takatsugu Ogata  1 , Hironaga Satake  2 , Misato Ogata  1 , Yukimasa Hatachi  1 , Hayato Maruoka  3 , Daisuke Yamashita  4 , Hiroki Hashida  5 , Madoka Hamada  6 , Hisateru Yasui  1
Affiliations

Safety and effectiveness of FOLFOXIRI plus molecular target drug therapy for metastatic colorectal cancer: A multicenter retrospective study

Takatsugu Ogata et al. Oncotarget. .

Abstract

Introduction: FOLFOXIRI plus bevacizumab has a promising efficacy as first-line systemic chemotherapy for metastatic colorectal cancer (mCRC). This study aimed to evaluate the safety and effectiveness of FOLFOXIRI plus antibodies.

Results: Fifty-five patients were enrolled (median age: 60 years, males: 25, females: 30). Twenty-six subjects had RAS mutations and 29 had RAS wild-type. Anti-VEGF and anti-EGFR antibodies were administered to 38 and 17 patients, respectively. The most common severe adverse event was neutropenia (51%). The overall response rate (ORR) was 69% (55% with anti-VEGF antibodies and 100% with anti-EGFR antibodies; P = 0.190), and the disease control rate was 98% (stable disease: 16 patients). With a median follow-up period of 18.4 months, the median progression-free survival (mPFS) was 11.0 months and the median overall survival (mOS) was 41.9 months. The mPFS and mOS did not significantly differ between patients treated with anti-EGFR antibodies and those with anti-VEGF antibodies.

Methods: We retrospectively collected data from mCRC patients treated with FOLFOXIRI plus antibodies between March 2014 and December 2017.

Conclusions: FOLFOXIRI plus antibody therapy was effective in patients with mCRC. The response rate was higher in patients treated with anti-EGFR antibodies than in those treated with anti-VEGF antibodies.

Keywords: FOLFOXIRI therapy; anti-EGFR antibodies; anti-VEGF antibodies; metastatic colorectal cancer; triplet.

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Conflict of interest statement

CONFLICTS OF INTEREST The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1. Depth of response
Figure 2
Figure 2. Early tumor response
Figure 3
Figure 3. Progression-free survival (PFS) and overall survival (OS)
(A) PFS for all patients; (B) OS for all patients.
Figure 4
Figure 4. Progression-free survival by antibodies and tumor location
(A) Classified by antibodies; (B) Classified by sidedness; (C) Classified by antibodies and sidedness.
Figure 5
Figure 5. Overall survival by antibodies and tumor location
(A) Classified by antibodies; (B) Classified by sidedness; (C) Classified by antibodies and sidedness.
Figure 6
Figure 6. Overall survival in patients treated with conversion therapy
Figure 7
Figure 7. Changes in the neutrophil count during FOLFOXIRI plus molecular target drugs
See this image and copyright information in PMC

References

    1. Heinemann V, von Weikersthal LF, Decker T, Kiani A, Vehling-Kaiser U, Al-Batran SE, Heintges T, Lerchenmuller C, Kahl C, Seipelt G, Kullmann F, Stauch M, Scheithauer W, et al. FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer (FIRE-3): a randomised, open-label, phase 3 trial. Lancet Oncol. 2014;15:1065–75. doi: 10.1016/S1470-2045(14)70330-4. - DOI - PubMed
    1. Yamada Y, Denda T, Gamoh M, Iwanaga I, Yuki S, Shimodaira H, Nakamura M, Yamaguchi T, Ohori H, Kobayashi K, Tsuda M, Kobayashi Y, Miyamoto Y, et al. S-1 and irinotecan plus bevacizumab versus mFOLFOX6 or CapeOX plus bevacizumab as first-line treatment in patients with metastatic colorectal cancer (TRICOLORE): a randomized, open-label, phase III, noninferiority trial. Ann Oncol. 2018;29:624–31. doi: 10.1093/annonc/mdx816. - DOI - PMC - PubMed
    1. Loupakis F, Cremolini C, Masi G, Lonardi S, Zagonel V, Salvatore L, Cortesi E, Tomasello G, Ronzoni M, Spadi R, Zaniboni A, Tonini G, Buonadonna A, et al. Initial therapy with FOLFOXIRI and bevacizumab for metastatic colorectal cancer. N Engl J Med. 2014;371:1609–18. doi: 10.1056/NEJMoa1403108. - DOI - PubMed
    1. Satake H, Sunakawa Y, Miyamoto Y, Nakamura M, Nakayama H, Shiozawa M, Makiyama A, Kobayashi K, Kubota Y, Mori M, Kotaka M, Takagane A, Gotoh M, et al. A phase II trial of 1st-line modified-FOLFOXIRI plus bevacizumab treatment for metastatic colorectal cancer harboring RAS mutation: JACCRO CC-11. Oncotarget. 2018;9:18811–20. doi: 10.18632/oncotarget.24702. - DOI - PMC - PubMed
    1. Arnold D, Lueza B, Douillard JY, Peeters M, Lenz HJ, Venook A, Heinemann V, Van Cutsem E, Pignon JP, Tabernero J, Cervantes A, Ciardiello F. Prognostic and predictive value of primary tumour side in patients with RAS wild-type metastatic colorectal cancer treated with chemotherapy and EGFR directed antibodies in six randomized trials. Ann Oncol. 2017;28:1713–29. doi: 10.1093/annonc/mdx175. - DOI - PMC - PubMed

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