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18F-FDG-PET/CT as an imaging biomarker for regorafenib efficacy in metastatic colorectal cancer (JACCRO CC-12)

18F-FDG-PET/CT as an imaging biomarker for regorafenib efficacy in metastatic colorectal cancer... IntroductionRegorafenib is a multikinase inhibitor approved for the treatment of metastatic colorectal cancer (mCRC). Despite providing a statistically significant survival benefit, a substantial number of patients fail to respond to or continue with treatment, which has resulted in an unmet clinical need for a biomarker of regorafenib efficacy.MethodsThe JACCRO CC-12 study was a prospective, multicenter, single-arm phase II trial designed to evaluate the usefulness of [18F]fluorodeoxyglucose positron emission tomography (FDG-PET) as an imaging biomarker of regorafenib in patients with mCRC that progressed after standard chemotherapies. FDG-PET and contrast-enhanced computed tomography (CT) were performed before and after treatment with regorafenib 160 mg once daily 3 weeks on/1 week off. The primary end point was the change in the maximum standardized uptake value in the lesion with the highest uptake at pre-treatment FDG-PET. The secondary end points included overall survival (OS), progression-free survival (PFS), the objective response rate (ORR), safety, and the correlation between FDG-PET and CT.ResultsTwenty patients were enrolled from November 2014 to March 2016, 17 of whom were evaluated for metabolic and morphological changes. Metabolic response with FDG-PET was partial response (PR) in one case (5.9%), stable disease (SD) in four (23.5%), and progressive disease (PD) in 12 (70.6%). The metabolic response rate was 5.9%. On CT imaging, no complete response or PR was observed, and the ORR was 0%. Median PFS and OS were 1.7 and 9.8 months, respectively. The median PFS of patients who achieved PR or SD by FDG-PET was 3.7 months, whereas that of those assessed as PD was 1 month (p = 0.13). The median OS of patients who achieved PR or SD by FDG-PET was 13.0 months, whereas that of patients assessed as PD was 10.6 months (p = 0.43). Frequent adverse events were palmar–plantar erythrodysesthesia syndrome, hypertension, loss of appetite, and fatigue.ConclusionsIn this study, FDG-PET failed to demonstrate usefulness as an early imaging biomarker of regorafenib in patients with mCRC. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Oncology and Therapy Springer Journals

18F-FDG-PET/CT as an imaging biomarker for regorafenib efficacy in metastatic colorectal cancer (JACCRO CC-12)

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Publisher
Springer Journals
Copyright
Copyright © The Author(s) 2021
ISSN
2366-1070
eISSN
2366-1089
DOI
10.1007/s40487-021-00173-1
Publisher site
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Abstract

IntroductionRegorafenib is a multikinase inhibitor approved for the treatment of metastatic colorectal cancer (mCRC). Despite providing a statistically significant survival benefit, a substantial number of patients fail to respond to or continue with treatment, which has resulted in an unmet clinical need for a biomarker of regorafenib efficacy.MethodsThe JACCRO CC-12 study was a prospective, multicenter, single-arm phase II trial designed to evaluate the usefulness of [18F]fluorodeoxyglucose positron emission tomography (FDG-PET) as an imaging biomarker of regorafenib in patients with mCRC that progressed after standard chemotherapies. FDG-PET and contrast-enhanced computed tomography (CT) were performed before and after treatment with regorafenib 160 mg once daily 3 weeks on/1 week off. The primary end point was the change in the maximum standardized uptake value in the lesion with the highest uptake at pre-treatment FDG-PET. The secondary end points included overall survival (OS), progression-free survival (PFS), the objective response rate (ORR), safety, and the correlation between FDG-PET and CT.ResultsTwenty patients were enrolled from November 2014 to March 2016, 17 of whom were evaluated for metabolic and morphological changes. Metabolic response with FDG-PET was partial response (PR) in one case (5.9%), stable disease (SD) in four (23.5%), and progressive disease (PD) in 12 (70.6%). The metabolic response rate was 5.9%. On CT imaging, no complete response or PR was observed, and the ORR was 0%. Median PFS and OS were 1.7 and 9.8 months, respectively. The median PFS of patients who achieved PR or SD by FDG-PET was 3.7 months, whereas that of those assessed as PD was 1 month (p = 0.13). The median OS of patients who achieved PR or SD by FDG-PET was 13.0 months, whereas that of patients assessed as PD was 10.6 months (p = 0.43). Frequent adverse events were palmar–plantar erythrodysesthesia syndrome, hypertension, loss of appetite, and fatigue.ConclusionsIn this study, FDG-PET failed to demonstrate usefulness as an early imaging biomarker of regorafenib in patients with mCRC.

Journal

Oncology and Therapy – Springer Journals

Published: Dec 1, 2021

Keywords: Colorectal cancer; Regorafenib; FDG-PET; Metabolic response; Biomarker

References

  • A phase I dose-escalation study of regorafenib (BAY 73–4506), an inhibitor of oncogenic, angiogenic, and stromal kinases, in patients with advanced solid tumors
    Mross, K; Frost, A; Steinbild, S
  • Regorafenib (BAY 73–4506) in advanced colorectal cancer: a phase I study
    Strumberg, D; Scheulen, ME; Schultheis, B
  • Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial
    Grothey, A; Van Cutsem, E; Sobrero, A
  • Regorafenib plus best supportive care versus placebo plus best supportive care in Asian patients with previously treated metastatic colorectal cancer (CONCUR): a randomised, double-blind, placebo-controlled, phase 3 trial
    Li, J; Qin, S; Xu, R
  • Radiological imaging markers predicting clinical outcome in patients with metastatic colorectal carcinoma treated with regorafenib: post hoc analysis of the CORRECT phase III trial (RadioCORRECT study)
    Ricotta, R; Verrioli, A; Ghezzi, S
  • Evaluating tumor response with FDG PET: updates on PERCIST, comparison with EORTC criteria and clues to future developments
    Pinker, K; Riedl, C; Weber, WA
  • (18)F-FDG PET/CT Is an early predictor of pathologic tumor response and survival after preoperative radiochemotherapy with bevacizumab in high-risk locally advanced rectal cancer
    Avallone, A; Aloj, L; Pecori, B
  • Immediate postablation 18 F-FDG injection and corresponding SUV are surrogate biomarkers of local tumor progression after thermal ablation of colorectal carcinoma liver metastases
    Cornelis, FH; Petre, EN; Vakiani, E
  • 18F-FDG PET/CT Is an immediate imaging biomarker of treatment success after liver metastasis ablation
    Cornelis, F; Sotirchos, V; Violari, E
  • Measurement of clinical and subclinical tumour response using [18F]-fluorodeoxyglucose and positron emission tomography: review and 1999 EORTC recommendations. European organization for research and treatment of cancer (EORTC) PET study group
    Young, H; Baum, R; Cremerius, U
  • From RECIST to PERCIST: evolving considerations for PET response criteria in solid tumors
    Wahl, RL; Jacene, H; Kasamon, Y
  • New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1)
    Eisenhauer, EA; Therasse, P; Bogaerts, J; Schwartz, LH; Sargent, D; Ford, R; Dancey, J; Arbuck, S; Gwyther, S; Mooney, M; Rubinstein, L; Shankar, L; Dodd, L; Kaplan, R; Lacombe, D; Verweij, J
  • Clinical features of regorafenib-induced liver injury in Japanese patients from postmarketing experience
    Uetake, H; Sugihara, K; Muro, K
  • Regorafenib dose-optimisation in patients with refractory metastatic colorectal cancer (ReDOS): a randomised, multicentre, open-label, phase 2 study
    Bekaii-Saab, TS; Ou, FS; Ahn, DH
  • Regorafenib vs trifluridine/tipiracil for metastatic colorectal cancer refractory to standard chemotherapies: a multicenter retrospective comparison study in Japan
    Ogata, M; Kotaka, M; Ogata, T
  • Tumor treatment response based on visual and quantitative changes in global tumor glycolysis using PET-FDG imaging: the visual response score and the change in total lesion glycolysis
    Larson, SM; Erdi, Y; Akhurst, T
  • Prognostic significance of volume-based PET parameters in cancer patients
    Moon, SH; Hyun, SH; Choi, JY
  • Evaluation of response to neoadjuvant therapy by quantitative 2-deoxy-2-[18F]fluoro-D-glucose with positron emission tomography in patients with esophageal cancer
    Arslan, N; Miller, TR; Dehdashti, F; Battafarano, RJ; Siegel, BA
  • Recent trends in PET image interpretations using volumetric and texture-based quantification methods in nuclear oncology
    Rahim, MK; Kim, SE; So, H