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Clinical Applications of Metronomic Chemotherapy
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Clinical Applications of Metronomic Chemotherapy

A special issue of Journal of Clinical Medicine (ISSN 2077-0383). This special issue belongs to the section "Oncology".

Deadline for manuscript submissions: closed (25 April 2022) | Viewed by 22147

Printed Edition Available!
A printed edition of this Special Issue is available here.

Special Issue Editors

Dr. Guido Bocci

E-Mail Website
Guest Editor
Department of Clinical and Experimental Medicine, School of Medicine, University of Pisa, 56126 Pisa, Italy
Interests: metronomic chemotherapy; pharmacokinetics; pharmacodynamics; clinical trials
Special Issues, Collections and Topics in MDPI journals
Dr. Giulio Francia

E-Mail Website
Co-Guest Editor
Border Biomedical Research Center, University of Texas at El Paso, El Paso, TX, USA
Interests: chemotherapy; cancer biology; metronomic chemotherapy; metastasis; immunotherapy
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Metronomic chemotherapy has finally arrived in clinical use. After 20 years of preclinical development and clinical trials, the emerging data will be of paramount importance in allowing us to assess the impact of metronomic chemotherapy on different tumor types. Indeed, it is likely that the next decade will see a major reassessment of the possible applications of metronomic chemotherapy, alone and in combination with new therapeutic approaches such as immunotherapies, for the management of cancer. Moreover, the clinical trial results will likely profoundly affect the direction of the laboratory efforts that are going on in parallel, aimed at improving personalization of this therapeutic strategy. This Special Issue is our attempt to cover the past and present clinical results that have brought us to this pivotal moment and build the bases for future clinical developments. Scientists and clinicians caring for cancer patients are well aware of the challenges in dealing with this particular therapeutic approach, such as to obtain an improvement of patient survival without an important toxicity. The expectation today is that this different approach to clinical research on chemotherapy will translate into genuine progress in routine therapy. With this Special Issue, we hope to encourage submissions that discuss the current state-of-the-art, address ongoing knowledge gaps, and focus on ongoing controversies related to metronomic chemotherapy.

Dr. Guido Bocci
Prof. Giulio Francia
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Journal of Clinical Medicine is an international peer-reviewed open access semimonthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2600 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • Metronomic chemotherapy
  • Lymphoma
  • Gastrointestinal cancers
  • Breast cancer
  • Lung cancer
  • Prostate cancer
  • Pediatric tumors

Published Papers (10 papers)

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Research

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13 pages, 2394 KiB  
Article
Vinorelbine and Intermittent Cyclophosphamide Sensitize an Aggressive Myc-Driven B-Cell Lymphoma to Anti-PD-1 by an Immunological Memory Effective against Tumor Re-Challenge
by Stefania Orecchioni, Paolo Falvo, Giovanna Talarico, Giulia Mitola, Giulia Bravetti, Patrizia Mancuso, Paola Nicoli and Francesco Bertolini
J. Clin. Med. 2023, 12(7), 2535; https://doi.org/10.3390/jcm12072535 - 27 Mar 2023
Cited by 2 | Viewed by 1610
Abstract
We have previously shown in triple-negative breast cancer (TNBC) models that a triple therapy (TT) including intermittent cyclophosphamide (C), vinorelbine (V), and anti-PD-1 activates antigen-presenting cells (APC) and generates stem like-T cells able to control local and metastatic tumor progression. In the present [...] Read more.
We have previously shown in triple-negative breast cancer (TNBC) models that a triple therapy (TT) including intermittent cyclophosphamide (C), vinorelbine (V), and anti-PD-1 activates antigen-presenting cells (APC) and generates stem like-T cells able to control local and metastatic tumor progression. In the present manuscript, we report the generation of a highly aggressive, anti-PD-1 resistant model of a high-grade, Myc-driven B-cell non-Hodgkin’s lymphoma (NHL) that can be controlled in vivo by TT but not by other chemotherapeutic agents, including cytarabine (AraC), platinum (P), and doxorubicin (D). The immunological memory elicited in tumor-bearing mice by TT (but not by other treatments) can effectively control NHL re-challenge even at very high inoculum doses. TT re-shaped the landscape of circulating innate NK cells and adaptive immune cells, including B and T cells, and significantly reduced exhausted CD4+ and CD8+ TIM3+PD-1+ T cells in the spleens of treated mice. Full article
(This article belongs to the Special Issue Clinical Applications of Metronomic Chemotherapy)
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13 pages, 1528 KiB  
Article
Retrospective National “Real Life” Experience of the SFCE with the Metronomic MEMMAT and MEMMAT-like Protocol
by Camille Winnicki, Pierre Leblond, Franck Bourdeaut, Anne Pagnier, Gilles Paluenzela, Pascal Chastagner, Gwenaelle Duhil-De Benaze, Victoria Min, Hélène Sudour-Bonnange, Catherine Piette, Natacha Entz-Werle, Sylvie Chabaud and Nicolas André
J. Clin. Med. 2023, 12(4), 1415; https://doi.org/10.3390/jcm12041415 - 10 Feb 2023
Cited by 5 | Viewed by 1699
Abstract
Background: Relapses in pediatric high-risk brain tumors remain unmet medical needs. Over the last 15 years, metronomic chemotherapy has gradually emerged as an alternative therapeutic approach. Patients and Methods: This is a national retrospective study of patients with relapsing pediatric brain tumors treated [...] Read more.
Background: Relapses in pediatric high-risk brain tumors remain unmet medical needs. Over the last 15 years, metronomic chemotherapy has gradually emerged as an alternative therapeutic approach. Patients and Methods: This is a national retrospective study of patients with relapsing pediatric brain tumors treated according to the MEMMAT or MEMMAT-like regimen from 2010 to 2022. Treatment consisted of daily oral thalidomide, fenofibrate, and celecoxib, and alternating 21-day cycles of metronomic etoposide and cyclophosphamide associated with bevacizumab and intraventricular chemotherapy. Results: Forty-one patients were included. The most frequent malignancies were medulloblastoma (22) and ATRT (8). Overall, the best responses were CR in eight patients (20%), PR in three patients (7%), and SD in three patients (7%), for a clinical benefit rate of 34%. The median overall survival was 26 months (IC95% = 12.4–42.7), and median EFS was 9.7 months (IC95% = 6.0–18.6). The most frequent grade ¾ toxicities were hematological. Dose had to be adjusted in 27% of the cases. There was no statistical difference in outcome between full or modified MEMMAT. The best setting seems to be when MEMMAT is used as a maintenance and at first relapse. Conclusions: The metronomic MEMMAT combination can lead to sustained control of relapsed high-risk pediatric brain tumors. Full article
(This article belongs to the Special Issue Clinical Applications of Metronomic Chemotherapy)
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11 pages, 2086 KiB  
Article
Metronomic Chemo-Endocrine Therapy (FulVEC) as a Salvage Treatment for Patients with Advanced, Treatment-Refractory ER+/HER2-Breast Cancer—A Retrospective Analysis of Consecutive Patients Data
by Anna Buda-Nowak, Łukasz Kwinta, Paweł Potocki, Anna Michałowska-Kaczmarczyk, Agnieszka Słowik, Kamil Konopka, Joanna Streb, Maciej Koniewski and Piotr J. Wysocki
J. Clin. Med. 2023, 12(4), 1350; https://doi.org/10.3390/jcm12041350 - 08 Feb 2023
Cited by 5 | Viewed by 1618
Abstract
Background: Breast cancer, with 2.3 million new cases and 0.7 million deaths every year, represents a great medical challenge worldwide. These numbers confirm that approx. 30% of BC patients will develop an incurable disease requiring life-long, palliative systemic treatment. Endocrine treatment and chemotherapy [...] Read more.
Background: Breast cancer, with 2.3 million new cases and 0.7 million deaths every year, represents a great medical challenge worldwide. These numbers confirm that approx. 30% of BC patients will develop an incurable disease requiring life-long, palliative systemic treatment. Endocrine treatment and chemotherapy administered in a sequential fashion are the basic treatment options in advanced ER+/HER2- BC, which is the most common BC type. The palliative, long-term treatment of advanced BC should not only be highly active but also minimally toxic to allow long-term survival with the optimal quality of life. A combination of metronomic chemotherapy (MC) with endocrine treatment (ET) in patients who failed earlier lines of ET represents an interesting and promising option. Methods: The methodology includes retrospective data analyses of pretreated, metastatic ER+/HER2- BC (mBC) patients who were treated with the FulVEC regimen combining fulvestrant and MC (cyclophosphamide, vinorelbine, and capecitabine). Results: Thirty-nine previously treated (median 2 lines 1–9) mBC patients received FulVEC. The median PFS and OS were 8.4 and 21.5 months, respectively. Biochemical responses (CA-15.3 serum marker decline ≥50%) were observed in 48.7%, and any increase in CA-15.3 was observed in 23.1% of patients. The activity of FulVEC was independent of previous treatments with fulvestrant of cytotoxic components of the FulVEC regimen. The treatment was safe and well tolerated. Conclusions: Metronomic chemo-endocrine therapy with FulVEC regimen represents an interesting option and compares favorably with other approaches in patients’ refractory to endocrine treatments. A phase II randomized trial is warranted. Full article
(This article belongs to the Special Issue Clinical Applications of Metronomic Chemotherapy)
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13 pages, 1395 KiB  
Article
Remarkable Remission Rate and Long-Term Efficacy of Upfront Metronomic Chemotherapy in Elderly and Frail Patients, with Diffuse Large B-Cell Lymphoma
by Guido Bocci, Sabrina Pelliccia, Paola Orlandi, Matteo Caridi, Marta Banchi, Gerardo Musuraca, Arianna Di Napoli, Maria Paola Bianchi, Caterina Patti, Paola Anticoli-Borza, Roberta Battistini, Ivana Casaroli, Tiziana Lanzolla, Agostino Tafuri and Maria Christina Cox
J. Clin. Med. 2022, 11(23), 7162; https://doi.org/10.3390/jcm11237162 - 01 Dec 2022
Cited by 6 | Viewed by 1423 | Correction
Abstract
The upfront treatment of very elderly and frail patients with diffuse large B-cell lymphoma (DLBCL) is still a matter of debate. Herein, we report results of the metronomic all-oral DEVEC [prednisolone/deltacortene®, vinorelbine (VNR), etoposide (ETO), cyclophosphamide] combined with i.v. rituximab (R). [...] Read more.
The upfront treatment of very elderly and frail patients with diffuse large B-cell lymphoma (DLBCL) is still a matter of debate. Herein, we report results of the metronomic all-oral DEVEC [prednisolone/deltacortene®, vinorelbine (VNR), etoposide (ETO), cyclophosphamide] combined with i.v. rituximab (R). This schedule was administered as a first line therapy in 22 elderly/frail DLBCL subjects (median age = 84.5 years). In 17/22 (77%) patients, the Elderly-IPI-score was high. After a median follow-up of 24 months, 15 patients had died: seven (50%) for causes unrelated to DLBCL or its treatment, six (40%) for progression, and two (13%) for multiorgan failure. Six treatment-pertinent serious-adverse-events occurred. At the end of induction, 14/22 (64%) achieved complete remission; overall survival and event-free survival at 24 months were both 54% (95% CI = 32–72%), while the disease-free survival was 74% (95% CI = 48–88%). Furthermore, antiproliferative and proapoptotic assays were performed on DLBCL/OCI-LY3 cell-line using metronomic VNR and ETO and their combination. Both metronomic VNR and ETO had concentration-dependent antiproliferative (IC50 = 0.036 ± 0.01 nM and 7.9 ± 3.6 nM, respectively), and proapoptotic activities in DLBCL cells. Co-administration of the two drugs showed a strong synergism (combination index < 1 and dose reduction index > 1) against cell proliferation and survival. This low-dose schedule seems to compare favourably with intravenous-CHEMO protocols used in the same subset. Indeed, the high synergism shown by metronomic VRN+ETO in in vitro studies, explains the remarkable clinical responses and it allows significant dose reductions. Full article
(This article belongs to the Special Issue Clinical Applications of Metronomic Chemotherapy)
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Review

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34 pages, 1215 KiB  
Review
Metronomic Chemotherapy in Pediatric Oncology: From Preclinical Evidence to Clinical Studies
by Marta Banchi, Elisabetta Fini, Stefania Crucitta and Guido Bocci
J. Clin. Med. 2022, 11(21), 6254; https://doi.org/10.3390/jcm11216254 - 24 Oct 2022
Cited by 2 | Viewed by 2362
Abstract
Metronomic chemotherapy (MC) is the frequent, regular administration of drug doses designed to maintain a low, but active, range of concentrations of chemotherapeutic drugs, during prolonged periods of time without inducing excessive toxicities. To date, more than 400,000 children and adolescents under the [...] Read more.
Metronomic chemotherapy (MC) is the frequent, regular administration of drug doses designed to maintain a low, but active, range of concentrations of chemotherapeutic drugs, during prolonged periods of time without inducing excessive toxicities. To date, more than 400,000 children and adolescents under the age of 20 are diagnosed with cancer, per year, with 80% survival in most high-income countries, but less than 30% in low- and middle-income ones. In this review, we summarized the principal preclinical and clinical studies involving the use of MC in the most common pediatric tumors, with an overview of efficacy, toxicity, pharmacokinetic profile, and biomarkers. The best advantages of MC are low toxicity, oral administration and, thus, the feasibility of a more comfortable, home-based treatment, therefore improving the quality of life of the children themselves and of their parents and caregivers. Moreover, MC could represent a valid method to reduce the economic burden of anticancer therapy in the pediatric setting. Full article
(This article belongs to the Special Issue Clinical Applications of Metronomic Chemotherapy)
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18 pages, 1005 KiB  
Review
Metronomic Chemotherapy for Metastatic Breast Cancer Treatment: Clinical and Preclinical Data between Lights and Shadows
by Marina Elena Cazzaniga, Serena Capici, Nicoletta Cordani, Viola Cogliati, Francesca Fulvia Pepe, Francesca Riva and Maria Grazia Cerrito
J. Clin. Med. 2022, 11(16), 4710; https://doi.org/10.3390/jcm11164710 - 12 Aug 2022
Cited by 10 | Viewed by 2730
Abstract
Metronomic chemotherapy (mCHT), defined as continuous administration of low-dose chemotherapeutic agents with no or short regular treatment-free intervals, was first introduced to the clinic in international guidelines in 2017, and, since then, has become one of the available strategies for the treatment of [...] Read more.
Metronomic chemotherapy (mCHT), defined as continuous administration of low-dose chemotherapeutic agents with no or short regular treatment-free intervals, was first introduced to the clinic in international guidelines in 2017, and, since then, has become one of the available strategies for the treatment of advanced breast cancer (ABC). Despite recent successes, many unsolved practical and theoretical issues remain to be addressed. The present review aims to identify the “lights and shadows” of mCHT in preclinical and clinical settings. In the preclinical setting, several findings indicate that one of the most noticeable effects of mCHT is on the tumor microenvironment, which, over the last twenty years, has been demonstrated to be pivotal in supporting tumor cell survival and proliferation. On the other hand, the direct effects on tumor cells have been less well-defined. In addition, critical items to be addressed are the lack of definition of an optimal biological dose (OBD), the method of administration of metronomic schedules, and the recognition and validation of predictive biomarkers. In the clinical context—where mCHT has mainly been used in a metastatic setting—low toxicity is the most well-recognised light of mCHT, whereas the type of study design, the absence of randomised trials and uncertainty in terms of doses and drugs remain among the shadows. In conclusion, growing evidence indicates that mCHT is a suitable treatment option for selected metastatic breast cancer (MBC) patients. Moreover, given its multimodal mechanisms of action, its addition to immunological and targeted therapies might represent a promising new approach to the treatment of MBC. More preclinical data are needed in this regard, which can only be obtained through support for translational research as the key link between basic science and patient care. Full article
(This article belongs to the Special Issue Clinical Applications of Metronomic Chemotherapy)
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14 pages, 321 KiB  
Review
Metronomic Chemotherapy in Prostate Cancer
by Piotr J. Wysocki, Maciej T. Lubas and Malgorzata L. Wysocka
J. Clin. Med. 2022, 11(10), 2853; https://doi.org/10.3390/jcm11102853 - 18 May 2022
Cited by 8 | Viewed by 2454
Abstract
Despite the significant expansion of the therapeutic armamentarium associated with the introduction of novel endocrine therapies, cytotoxic agents, radiopharmaceuticals, and PARP inhibitors, progression of metastatic castration-resistant prostate cancer (mCRPC) beyond treatment options remains the leading cause of death in advanced prostate cancer patients. [...] Read more.
Despite the significant expansion of the therapeutic armamentarium associated with the introduction of novel endocrine therapies, cytotoxic agents, radiopharmaceuticals, and PARP inhibitors, progression of metastatic castration-resistant prostate cancer (mCRPC) beyond treatment options remains the leading cause of death in advanced prostate cancer patients. Metronomic chemotherapy (MC) is an old concept of wise utilization of cytotoxic agents administered continuously and at low doses. The metronomic is unique due to its multidimensional mechanisms of action involving: (i) inhibition of cancer cell proliferation, (ii) inhibition of angiogenesis, (iii) mitigation of tumor-related immunosuppression, (iv) impairment of cancer stem cell functions, and (v) modulation of tumor and host microbiome. MC has been extensively studied in advanced prostate cancer before the advent of novel therapies, and its actual activity in contemporary, heavily pretreated mCRPC patients is unknown. We have conducted a prospective analysis of consecutive cases of mCRPC patients who failed all available standard therapies to find the optimal MC regimen for phase II studies. The metronomic combination of weekly paclitaxel 60 mg/m2 i.v. with capecitabine 1500 mg/d p.o. and cyclophosphamide 50 mg/d p.o. was selected as the preferred regimen for a planned phase II study in heavily pretreated mCRPC patients. Full article
(This article belongs to the Special Issue Clinical Applications of Metronomic Chemotherapy)
19 pages, 2672 KiB  
Review
Cyclic Metronomic Chemotherapy for Pediatric Tumors: Six Case Reports and a Review of the Literature
by Benjamin Carcamo and Giulio Francia
J. Clin. Med. 2022, 11(10), 2849; https://doi.org/10.3390/jcm11102849 - 18 May 2022
Cited by 4 | Viewed by 2325
Abstract
We report a retrospective case series of six Hispanic children with tumors treated with metronomic chemotherapy. The six cases comprised one rhabdoid tumor of the kidney, one ependymoma, two medulloblastomas, one neuroblastoma, and a type II neurocytoma of the spine. Treatment included oral [...] Read more.
We report a retrospective case series of six Hispanic children with tumors treated with metronomic chemotherapy. The six cases comprised one rhabdoid tumor of the kidney, one ependymoma, two medulloblastomas, one neuroblastoma, and a type II neurocytoma of the spine. Treatment included oral cyclophosphamide daily for 21 days alternating with oral etoposide daily for 21 days in a backbone of daily valproic acid and celecoxib. In one case, celecoxib was substituted with sulindac. Of the six patients, three showed complete responses, and all patients showed some response to metronomic therapy with only minor hematologic toxicity. One patient had hemorrhagic gastritis likely associated with NSAIDs while off prophylactic antacids. These data add to a growing body of evidence suggesting that continuous doses of valproic acid and celecoxib coupled with alternating metronomic chemotherapy of agents such as etoposide and cyclophosphamide can produce responses in pediatric tumors relapsing to conventional dose chemotherapy. Full article
(This article belongs to the Special Issue Clinical Applications of Metronomic Chemotherapy)
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14 pages, 3114 KiB  
Review
Metronomic Chemotherapy for Advanced Prostate Cancer: A Literature Review
by Shruti Parshad, Amanjot K. Sidhu, Nabeeha Khan, Andrew Naoum and Urban Emmenegger
J. Clin. Med. 2022, 11(10), 2783; https://doi.org/10.3390/jcm11102783 - 15 May 2022
Cited by 7 | Viewed by 1760
Abstract
Metastatic castration-resistant prostate cancer (mCRPC) is the ultimately lethal form of prostate cancer. Docetaxel chemotherapy was the first life-prolonging treatment for mCRPC; however, the standard maximally tolerated dose (MTD) docetaxel regimen is often not considered for patients with mCRPC who are older and/or [...] Read more.
Metastatic castration-resistant prostate cancer (mCRPC) is the ultimately lethal form of prostate cancer. Docetaxel chemotherapy was the first life-prolonging treatment for mCRPC; however, the standard maximally tolerated dose (MTD) docetaxel regimen is often not considered for patients with mCRPC who are older and/or frail due to its toxicity. Low-dose metronomic chemotherapy (LDMC) is the frequent administration of typically oral and off-patent chemotherapeutics at low doses, which is associated with a superior safety profile and higher tolerability than MTD chemotherapy. We conducted a systematic literature review using the PUBMED, EMBASE, and MEDLINE electronic databases to identify clinical studies that examined the impact of LDMC on patients with advanced prostate cancer. The search identified 30 reports that retrospectively or prospectively investigated LDMC, 29 of which focused on mCRPC. Cyclophosphamide was the most commonly used agent integrated into 27/30 (90%) of LDMC regimens. LDMC resulted in a clinical benefit rate of 56.8 ± 24.5% across all studies. Overall, there were only a few non-hematological grade 3 or 4 adverse events reported. As such, LDMC is a well-tolerated treatment option for patients with mCRPC, including those who are older and frail. Furthermore, LDMC is considered more affordable than conventional mCRPC therapies. However, prospective phase III trials are needed to further characterize the efficacy and safety of LDMC in mCRPC before its use in practice. Full article
(This article belongs to the Special Issue Clinical Applications of Metronomic Chemotherapy)
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11 pages, 283 KiB  
Review
Metronomic Therapy in Oral Squamous Cell Carcinoma
by Nai-Wen Su and Yu-Jen Chen
J. Clin. Med. 2021, 10(13), 2818; https://doi.org/10.3390/jcm10132818 - 26 Jun 2021
Cited by 6 | Viewed by 3141
Abstract
Metronomic therapy is characterized by drug administration in a low-dose, repeated, and regular manner without prolonged drug-free interval. The two main anticancer mechanisms of metronomic therapy are antiangiogenesis and immunomodulation, which have been demonstrated in several delicate in vitro and in vivo experiments. [...] Read more.
Metronomic therapy is characterized by drug administration in a low-dose, repeated, and regular manner without prolonged drug-free interval. The two main anticancer mechanisms of metronomic therapy are antiangiogenesis and immunomodulation, which have been demonstrated in several delicate in vitro and in vivo experiments. In contrast to the traditional maximum tolerated dose (MTD) dosing of chemotherapy, metronomic therapy possesses comparative efficacy but greatlydecreases the incidence and severity of treatment side-effects. Clinical trials of metronomic anticancer treatment have revealed promising results in a variety cancer types and specific patient populations such as the elderly and pediatric malignancies. Oral cavity squamous cell carcinoma (OCSCC) is an important health issue in many areas around the world. Long-term survival is about 50% in locally advanced disease despite having high-intensity treatment combined surgery, radiotherapy, and chemotherapy. In this article, we review and summarize the essence of metronomic therapy and focus on its applications in OCSCC treatment. Full article
(This article belongs to the Special Issue Clinical Applications of Metronomic Chemotherapy)
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