Genistein combined with FOLFOX or FOLFOX–Bevacizumab for the treatment of metastatic colorectal cancer: phase I/II pilot study

Background Epidemiologic and preclinical data suggest isoflavones have anticancer activity in colorectal malignancy prevention and treatment. This is the first clinical trial assessing safety and tolerability of Genistein in combination with chemotherapy in metastatic colorectal cancer. Methods Pati...

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Published in:Cancer chemotherapy and pharmacology Vol. 84; no. 3; pp. 591 - 598
Main Authors: Pintova, Sofya, Dharmupari, Sirish, Moshier, Erin, Zubizarreta, Nicole, Ang, Celina, Holcombe, Randall F.
Format: Journal Article
Language:English
Published: Berlin/Heidelberg Springer Berlin Heidelberg 01.09.2019
Springer Nature B.V
Subjects:
Aged
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Antitumor activity
Bevacizumab
Bevacizumab - administration & dosage
Bone Neoplasms - drug therapy
Bone Neoplasms - secondary
Cancer
Cancer Research
Chemotherapy
Clinical trials
Colorectal cancer
Colorectal carcinoma
Colorectal Neoplasms - drug therapy
Colorectal Neoplasms - pathology
Epidemiology
Female
Fluorouracil - administration & dosage
Follow-Up Studies
Genistein
Genistein - administration & dosage
Headache
Humans
Immunotherapy
Isoflavones
Leucovorin - administration & dosage
Liver Neoplasms - drug therapy
Liver Neoplasms - secondary
Lung Neoplasms - drug therapy
Lung Neoplasms - secondary
Male
Malignancy
Medicine
Medicine & Public Health
Metastases
Metastasis
Middle Aged
Monoclonal antibodies
Nausea
NCT
NCT01985763
Oncology
Oral administration
Original Article
Oxaliplatin - administration & dosage
Patients
Peritoneal Neoplasms - drug therapy
Peritoneal Neoplasms - secondary
Pharmacology/Toxicology
Pilot Projects
Prognosis
Response rates
Survival Rate
Targeted cancer therapy
Isoflavone
Metastatic
FOLFOX
Genistein
Colorectal cancer
Bevacizumab
ISSN:0344-5704, 1432-0843, 1432-0843
Online Access:Get full text
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Summary:Background Epidemiologic and preclinical data suggest isoflavones have anticancer activity in colorectal malignancy prevention and treatment. This is the first clinical trial assessing safety and tolerability of Genistein in combination with chemotherapy in metastatic colorectal cancer. Methods Patients who had histologically confirmed metastatic colorectal cancer and had not received previous treatment were eligible to enroll. Subjects were treated with FOLFOX or FOLFOX–Bevacizumab as per the investigator choice. Genistein was administered orally for 7 days every 2 weeks, beginning 4 days prior to chemotherapy and continuing through days 1–3 of infusional chemotherapy. Primary endpoint was safety and secondary endpoints included cycle 6 response rate, best overall response rate (BOR), and median progression-free survival (PFS). Results Thirteen patients received chemotherapy with Genistein in this trial. The most common adverse events related to Genistein alone were mild and included headaches, nausea, and hot flashes. One subject was observed to have grade 3 hypertension. No increase in chemotherapy-related adverse events was observed when Genistein was added. BOR and median PFS were 61.5% and 11.5 months, respectively . Conclusion We observed that adding Genistein to FOLFOX or FOLFOX–Bevacizumab was safe and tolerable. Efficacy results are notable and warrant verification in larger clinical trials. Clinical trial registration The study was registered at ClinicalTrials.gov Identifier: NCT01985763.
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ISSN:0344-5704
1432-0843
1432-0843
DOI:10.1007/s00280-019-03886-3