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Survival analyses of the ZeOxaNMulti trial: Follow-up randomized, double-blinded, placebo-controlled trial of oral PMA-zeolite to prevent chemotherapy-induced side effects, especially peripheral neuropathy

Affiliation
Medical Oncology Unit ,University Hospital of Modena ,Modena ,Italy
Vitale, Maria Giuseppa;
Affiliation
Epidemiology and Biostatistics Unit ,Istituto Nazionale Tumori-IRCCS “Fondazione G. Pascale” ,Naples ,Italy
Crispo, Anna;
Affiliation
Medical Oncology Unit ,AORN Antonio Cardarelli ,Naples ,Italy
Arundine, Dario;
Affiliation
Medical Oncology Unit ,AORN Antonio Cardarelli ,Naples ,Italy
Ronga, Riccardo;
Affiliation
Medical Oncology Unit ,AORN Antonio Cardarelli ,Naples ,Italy
Barbato, Carmela;
Affiliation
Epidemiology and Biostatistics Unit ,Istituto Nazionale Tumori-IRCCS “Fondazione G. Pascale” ,Naples ,Italy
Luongo, Assunta;
Affiliation
UOC Neurofisiopatologia AORN Cardarelli ,Naples ,Italy
Habetswallner, Francesco;
Affiliation
UOC Neurofisiopatologia AORN Cardarelli ,Naples ,Italy
De Martino, Bernardo Maria;
Affiliation
Medical Oncology Unit ,AORN Antonio Cardarelli ,Naples ,Italy
Maione, Angela;
Affiliation
Panaceo International GmbH ,Villach ,Austria
Eisenwagen, Sandra;
Affiliation
School of Medicine and Surgery ,University of Campania Luigi Vanvitelli ,Caserta ,Italy
Vitale, Giovanna;
Affiliation
Medical Oncology Unit ,AORN Antonio Cardarelli ,Naples ,Italy
Riccardi, Ferdinando

Following the previously published results of the clinical randomized ZeOxaNMulti trial, we evaluated the potential of the tested product PMA-ZEO (Multizeo Med) in the prevention of chemotherapy-induced side effects (especially peripheral neuropathy) within a 30-month follow-up analysis. The aim was to determine the disease-free survival (DFS), progression-free survival (PFS), and overall survival (OS) in a study-population suffering from colorectal cancer that was previously enrolled in the ZeOxaNMulti trial from April 2015 to October 2018. The participants of the study were randomized to receive either PMA-ZEO or placebo while undergoing oxaliplatin-based chemotherapy. A total of 104 patients (pts) (51% of participants randomized to the PMA-ZEO group and 49% to the placebo group), out of a total of 120 pts included in the ZeOxaNMulti trial in 2015, were followed up until March 2021 and were included in the follow-up analysis. According to the chemotherapy line, 44.2% of patients received chemotherapy in an adjuvant setting, and 55.8% of patients received chemotherapy as first-line treatment. The statistical analysis for DFS, PFS, and OS was performed by comparison of the end results with data from the PMA-ZEO/placebo-intervention start point. The analysis of OS did not show statistically significant differences in the first-line chemotherapy patients randomized to PMA-ZEO than among the placebo group ( p = 0.1) over the whole period of follow-up (30 months). However, focusing on the PMA-ZEO supplementation time point (7 months), a positive and statistically significant trend ( p = 0.004) was documented in the OS analysis for the first-line chemotherapy patients with increasing months of PMA-ZEO treatment compared to the placebo group. Furthermore, borderline statistical significance was reached for PFS at the PMA-ZEO supplementation time point (7 months) in the first-line chemotherapy patients ( p = 0.05) for cancer progression events. After stratification of the first-line chemotherapy patients, statistically relevant trends for OS for age, comorbidities, and oxaliplatin dosage (cycles) were also determined. The overall results for DFS (adjuvant patients), PFS (first-line chemotherapy patients), and OS (adjuvant and first-line chemotherapy patients) were generally slightly better in the PMA-ZEO group than in the placebo group, even though no statistically significant results were obtained between the groups within the follow-up period until 2021 (30 months). Based on this follow-up analysis, protective effects of PMA-zeolite supplementation can be deduced. A positive trend and more importantly, significant results in PFS and OS for specific patient groups during and/or after PMA-ZEO treatment were determined, which supports the use of PMA-ZEO as an oncological supportive therapy.

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License Holder: Copyright © 2022 Vitale, Crispo, Arundine, Ronga, Barbato, Luongo, Habetswallner, De Martino, Maione, Eisenwagen, Vitale and Riccardi.

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