System for remote assessment of clinical response and dynamic optimization of chemotherapies in oncology

Abstract

A system for remote assessment of clinical response and dynamic optimization of the chemotherapy regimen in oncology, consisting of: a device for clinical assessment of patient response, designed as a physical machine structure with a housing for use on the body or at the bedside; a housing-mounted physiological sensor unit configured to record continuous or periodic measurements of heart rate, heart rate variability, respiratory rate, peripheral oxygen saturation, body temperature, physical activity and sleep-related parameters of an oncology patient during chemotherapy; a biochemical sensor unit integrated into the housing, configured to detect biochemical indicators related to response to chemotherapy and toxicity, including inflammatory markers, metabolic indicators, hematological trends or drug-related metabolites; a patient interaction unit configured to receive symptom data reported by the patient, corresponding to treatment tolerability and functional status; an embedded processing unit that is operationally connected to the physiological sensor unit, the biochemical sensor unit, and the patient interaction unit, and is configured to perform signal conditioning, temporal alignment, data integrity verification, and encryption of the acquired patient data; a communication unit that is operationally connected to the embedded processing unit and configured to transmit the processed patient data to a remote processing infrastructure using secure communication protocols; a remote processing system comprising at least one processing unit and a storage unit for storing executable instructions, wherein the processing unit is configured to aggregate longitudinal patient data across chemotherapy cycles, analyze correlations between recorded physiological data, biochemical indicators, patient-reported outcomes, and parameters of chemotherapy administration, and calculate a clinical assessment of response; and A system for interacting with physicians, configured to display the results of the clinical response assessment and generate recommendations for optimizing the chemotherapy regimen, which are subject to review and approval by the physician.

Description

Technical field of the invention

[0001] This disclosure relates to the field of oncological treatment management and digital health technologies. In particular, it relates to a system and an associated device configured as a machine or apparatus for remotely assessing the clinical response of cancer patients undergoing chemotherapy and for dynamically optimizing chemotherapy regimens based on continuously acquired multiparametric clinical data. This enables adaptive, patient-specific cancer treatment under medical supervision. Background of the invention

[0002] Chemotherapy remains a cornerstone of cancer treatment for a wide range of solid and hematological malignancies. Conventional chemotherapy regimens are generally based on standardized dosing schedules and the results of clinical trials in patient groups. In routine clinical practice, therapy adjustments are typically made at predefined intervals, relying on regular assessments such as laboratory values, radiological imaging, and personal clinical evaluations. This approach often fails to capture physiological fluctuations between cycles, early-onset toxicities, developing treatment resistance, or transient side effects that may occur between hospital visits.Consequently, patients may be exposed to suboptimal dosing, avoidable toxicities, or delayed therapy adjustments, which can lead to reduced therapeutic efficacy and a reduced quality of life.

[0003] Existing tele-oncology and digital monitoring solutions primarily enable remote consultations, symptom tracking, and electronic health records. These systems typically lack the integrated capability for objective, continuous measurement of clinical response combined with computer-aided optimization of chemotherapy regimens. Furthermore, most existing solutions lack a dedicated device capable of securely acquiring, processing, and transmitting highly accurate physiological, biochemical, and behavioral data suitable for therapy-based adjustment. Therefore, there is a significant need for an integrated system that extends oncological care beyond routine clinical practice, enabling dynamic, data-driven optimization of chemotherapy while ensuring physician oversight and regulatory compliance.

[0004] Chemotherapy remains one of the most frequently used therapies in oncology, particularly for solid tumors and hematological malignancies when surgery or local radiation therapy alone is insufficient. Chemotherapy regimens are traditionally developed through large-scale clinical trials and standardized treatment guidelines. These define drug combinations, dosage intensity, and cycle intervals based on population-level efficacy and toxicity profiles. Although these protocols have significantly improved survival rates in recent decades, their application in clinical practice is largely static and selective, with limited responsiveness to dynamic, patient-specific physiological and pathological changes during the course of therapy.

[0005] In current oncological practice, the assessment of response to chemotherapy and its toxicity is predominantly performed during routine hospital visits. These assessments are based on individual laboratory tests such as complete blood counts, liver and kidney function profiles, imaging procedures such as computed tomography (CT) or positron emission tomography (PET), and clinical symptom assessment. Such examinations are typically conducted at intervals of several weeks, corresponding to the chemotherapy cycles. As a result, clinically relevant events such as acute toxicity, incipient organ dysfunction, developing intolerances, or resistance can occur and progress between visits without being detected in a timely manner. This temporal discrepancy in assessment leads to a significant gap between the patient's actual physiological state and the information relevant to the physician.

[0006] Existing solutions attempt to address some of these limitations through telemedicine and remote patient monitoring platforms. Tele-oncology systems primarily focus on enabling virtual consultations, appointment scheduling, and electronic communication between patients and healthcare professionals. While these platforms improve access to care and reduce travel, they rely largely on subjective symptom reports and lack objective, high-resolution physiological or biochemical monitoring. Consequently, their usefulness for precisely adjusting chemotherapy doses or optimizing treatment regimens remains limited.

[0007] Technologies for remote patient monitoring, including wearables and mobile health apps, have been introduced to capture parameters such as heart rate, activity levels, and sleep patterns. However, these solutions are typically designed for general health monitoring or the management of chronic diseases, rather than for oncology-specific applications. Most commercially available wearables are unable to measure chemotherapy-relevant biomarkers, indicators of drug toxicity, or metrics of treatment response. Furthermore, the data generated by such devices are rarely integrated into oncology treatment workflows in a way that supports real-time clinical decision-making or systematic regimen adjustments.

[0008] Another category of existing solutions comprises electronic patient-reported outcome (PROM) systems. Here, patients regularly report symptoms such as nausea, fatigue, pain, or neuropathy using digital questionnaires. While PROMs provide valuable insights into the subjective tolerability of treatment, they are inherently influenced by patient adherence, memory biases, and differing interpretations of symptoms. These systems also lack objective validation and are insufficient on their own to detect subclinical toxicity, early organ dysfunction, or biochemical changes that precede the onset of overt symptoms. Therefore, relying solely on PROMs can delay necessary treatment.

[0009] Clinical decision support systems have also been developed to assist oncologists in treatment planning and protocol selection. These systems typically utilize clinical guidelines, rule-based logic, or retrospective outcome data to recommend chemotherapy regimens at the time of treatment initiation. However, most existing decision support systems are static and not designed to continuously adapt treatment plans based on longitudinal patient data collected during therapy. Once a regimen is selected, subsequent adjustments are largely manual and dependent on clinical judgment at follow-up visits, limiting the potential for detailed, data-driven optimization.

[0010] More advanced computational approaches, including artificial intelligence and machine learning models, have been investigated for predicting chemotherapy response and toxicity. These models often rely on historical datasets from clinical trials or institutional records. While such approaches hold promise for patient stratification or predicting treatment outcomes at the start of therapy, they are rarely integrated into real-time clinical workflows. Furthermore, many of these models require high-quality, centralized datasets and are not designed to process continuous, patient-specific data streams generated outside of clinical settings. This discrepancy limits their applicability for continuous, adaptive therapy management.

[0011] Imaging-based assessment of treatment response remains a cornerstone of chemotherapy evaluation. Radiological imaging provides crucial information about tumor size, metabolic activity, and disease progression. However, imaging procedures are expensive, resource-intensive, and, due to costs, radiation exposure, and logistical limitations, are generally performed infrequently. Furthermore, imaging alone does not detect systemic toxicity or functional impairments, which may necessitate treatment adjustments even in the absence of radiological disease progression. Therefore, relying solely on imaging as the primary tool for assessing treatment response limits the sensitivity and accuracy of chemotherapy optimization.

[0012] Hospital-centric oncology care models exacerbate these limitations by concentrating assessment and decision-making within clinical settings. Patients undergoing chemotherapy often experience side effects at home, such as dehydration, infections, cardiovascular strain, or neurotoxicity, which often only require immediate medical attention when symptoms become severe. Existing systems lack a reliable mechanism for the continuous monitoring of patients in their daily lives and the proactive escalation of clinical interventions. This reactive approach contributes to emergency room admissions, treatment interruptions, and increased healthcare costs.

[0013] Another significant drawback of existing solutions is the lack of a unified device architecture specifically designed for oncological monitoring. Current approaches often rely on fragmented instruments such as standalone wearables, mobile applications, laboratory systems, and imaging platforms that operate in isolation. The absence of a dedicated device capable of securely aggregating physiological, biochemical, behavioral, and therapy-adherence-related data limits the feasibility of a closed-loop control system for chemotherapy optimization. Without this integration, clinicians must manually interpret disparate data sources, increasing cognitive load and raising the risk of delayed or suboptimal decisions.

[0014] Data security, interoperability, and regulatory compliance pose additional challenges to existing solutions. Many remote monitoring and digital health platforms are not designed to meet the data quality, traceability, and auditability requirements of oncology. Integration with chemotherapy delivery systems, infusion devices, and electronic health records is often incomplete or inconsistent. This fragmentation hinders the development of reliable, end-to-end systems that enable physician-authorized, dynamic therapy adjustments in accordance with clinical and regulatory standards.

[0015] Given these limitations, existing solutions are insufficient to enable continuous, objective, and adaptive chemotherapy management tailored to individual patient responses. The lack of real-time, multi-parameter monitoring, the absence of device integration, limited opportunities for computer-aided optimization, and reliance on episodic clinical assessments all restrict the overall effectiveness of current oncology care models. These shortcomings underscore the need for a comprehensive system that integrates a point-of-care device, telemedicine-based assessment of clinical response, and dynamic optimization of the chemotherapy regimen within a secure, physician-supervised environment. This system is capable of transforming chemotherapy from a static, protocol-driven process into an adaptive, patient-centered treatment strategy. Summary of the invention

[0016] The present invention overcomes the limitations of existing approaches by providing a system for the telemedical assessment of clinical response and the dynamic optimization of chemotherapy regimens in oncology. The system integrates a specialized device for assessing clinical response, a secure communication infrastructure, and a computing environment for analyzing longitudinal patient data and generating adaptive optimization suggestions for the chemotherapy regimen. It enables continuous or near-continuous monitoring of treatment response, toxicity indicators, and the patient's functional status, and transforms these measurements into clinically relevant recommendations, such as dose adjustment, cycle postponement, initiation of supportive therapy, or therapy change.

[0017] In one embodiment, the invention relates to a machine-implemented system consisting of a physical device for direct application to the patient, one or more processing units for analyzing aggregated clinical data, and an interface for interaction with medical professionals. This interface enables the review, validation, and approval of changes to the chemotherapy regimen. The system is designed for use in outpatient, home, and day-clinic infusion settings, thereby reducing the reliance on frequent hospital visits while simultaneously improving personalized treatment.

[0018] The main objective of the present invention is to provide a technically advanced system for the telemedical assessment of clinical response and the dynamic optimization of chemotherapy regimens in oncology. This system enables a continuous, objective, and patient-specific evaluation of treatment efficacy and toxicity outside of conventional hospital settings. The invention aims to transform chemotherapy management from an episodic, visit-based process into a continuously adaptive clinical workflow controlled by real-time data acquisition and computer-aided analysis, while preserving physician autonomy and patient safety.

[0019] A further objective of the invention is to provide a special device or apparatus for point-of-care application that acquires multiparametric physiological, biochemical, and behavioral data on chemotherapy response and side effects. The invention aims to ensure data acquisition with sufficient temporal resolution and technical accuracy to detect early changes in the patient's condition, such as subclinical toxicity, functional impairments, or incipient therapy resistance, and thus enable timely clinical intervention.

[0020] A further objective of the invention is the dynamic optimization of chemotherapy regimens through the computer-aided correlation of longitudinal patient data with treatment parameters, toxicity thresholds, and response indicators. The invention aims to generate clinically relevant recommendations such as dose adjustment, cycle shifting, escalation of supportive therapy, or therapy substitution, which are tailored to the patient's changing physiological state and disease profile and are not based solely on static, population-based protocols.

[0021] A further objective of the invention is to provide a closed clinical decision support system in which remotely monitored patient data is continuously analyzed, optimization results are generated within predefined clinical safety limits, and final treatment changes are subject to review, approval, and documentation by a physician. The invention thus aims to improve the accuracy and responsiveness of decisions while simultaneously ensuring compliance with regulatory requirements, accountability, and ethical oversight in oncological care.

[0022] A further aim of the invention is to reduce chemotherapy-related side effects, unplanned hospital admissions, and treatment discontinuations through the early detection and proactive management of side effects. By identifying physiological stress, biochemical abnormalities, or a worsening of symptoms at an early stage, the system is intended to reduce severe toxicity and improve the tolerability of chemotherapy regimens for patients.

[0023] A further aim of the invention is to improve therapeutic efficacy through the early detection of inadequate treatment response or newly emerging resistances. The invention is intended to enable timely adjustment of the treatment regimen or a change of therapy before irreversible disease progression, thereby improving progression-free survival and overall treatment outcomes.

[0024] A further aim of the invention is to improve patients' quality of life and therapy adherence by minimizing unnecessary hospital visits, reducing uncertainties related to symptom control, and ensuring continuous clinical monitoring in the home environment or in outpatient care. The invention aims to empower patients through structured interaction with the device while simultaneously reducing the physical and psychological burden of frequent in-person checkups.

[0025] A further objective of the invention is to provide a scalable and interoperable system architecture that can be integrated into existing oncology infrastructures, including electronic health records, infusion systems, laboratory databases, and imaging platforms. The invention aims to ensure seamless data exchange and uninterrupted workflows in both inpatient facilities and home care settings, without disrupting established clinical procedures.

[0026] A further objective of the invention is to improve the efficiency and consistency of oncological care by standardizing the assessment of therapy response and optimizing treatment regimens using data-driven analyses. The invention aims to reduce variability among treating physicians, support evidence-based decisions, and improve the overall utilization of healthcare resources.

[0027] A further objective of the invention is to provide a technically robust, safe, and compliant system suitable for use in various oncology settings, including outpatient clinics, home infusion programs, and resource-constrained environments. The invention is intended to support long-term, longitudinal cancer treatment by enabling continuous monitoring, adaptive therapy optimization, and improved coordination between patients and oncology treatment teams. BRIEF DESCRIPTION OF THE IMAGE

[0028] These and other features, aspects and advantages of the present invention will be better understood if the following detailed description is read with reference to the accompanying drawing, in which the same symbols represent the same parts: Fig. Figure 1 shows a block diagram of a system for the telemedicine assessment of clinical response and for the dynamic optimization of the chemotherapy regimen in oncology.

[0029] Furthermore, those skilled in the art will recognize that the elements in the drawing are shown for the sake of simplicity and may not be drawn to scale. Moreover, with regard to the design of the device, one or more components of the device may have been represented in the drawing by conventional symbols, and the drawing may show only those specific details relevant to understanding the embodiments of the present disclosure, so as not to obscure the drawing with details that would be obvious to a person skilled in the art after reading the description contained herein. Detailed description of the invention

[0030] To facilitate understanding of the principles of the invention, reference is made below to the embodiment shown in the drawing, which is described using specific terms. It is understood, however, that this does not limit the scope of protection of the invention. Rather, modifications and further developments of the depicted system, as well as further applications of the inventive principles shown therein, are conceivable, insofar as they would normally occur to a person skilled in the art in the field of the invention.

[0031] It will be clear to those skilled in the art that the foregoing general description and the following detailed description are exemplary and explanatory of the invention and are not to be understood as a limitation thereof.

[0032] References to “an aspect”, “another aspect”, or similar phrases in this description mean that a particular feature, structure, or property described in connection with the embodiment is included in at least one embodiment of the present disclosure. Therefore, phrases such as “in one embodiment”, “in another embodiment”, and similar expressions in this description may, but do not necessarily, all refer to the same embodiment.

[0033] Likewise, the specification of one or more devices, subsystems, elements, structures or components with the addition "includes...a" without further restrictions does not exclude the existence of other devices, other subsystems, other elements, other structures, other components, additional devices, additional subsystems, additional elements, additional structures or additional components.

[0034] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as generally known to those skilled in the art in the field to which this invention belongs. The system and the examples contained herein serve only for illustration and are not to be construed as a limitation.

[0035] Embodiments of the present disclosure are described in detail below with reference to the attached drawing.

[0036] Fig.Figure 1 shows a block diagram of a system for the telemedicine assessment of clinical response and the dynamic optimization of the chemotherapy regimen in oncology. The system 100 comprises: a patient-side device (102) for assessing clinical response, designed as a physical machine structure with a housing for use on the body or at the bedside; a housing-integrated physiological sensor unit (104) for the continuous or periodic measurement of heart rate, heart rate variability, respiratory rate, peripheral oxygen saturation, body temperature, physical activity, and sleep-related parameters of an oncology patient undergoing chemotherapy;A housing-integrated biochemical sensor unit (106) for recording biochemical indicators related to response to chemotherapy and its toxicity, including inflammatory markers, metabolic indicators, hematological trends, or drug-related metabolites; a patient interaction unit (108) for recording patient-reported symptom data related to treatment tolerability and functional status; an embedded processing unit (110) operationally linked to the physiological sensor unit, the biochemical sensor unit, and the patient interaction unit, configured for signal conditioning, temporal alignment, data integrity checks, and encryption of the recorded patient data;a communication unit (112) that is operationally connected to the embedded processing unit and is configured to transmit the processed patient data to a remote processing infrastructure using secure communication protocols; a remote processing system (114) consisting of at least one processing unit and a storage unit for storing executable instructions, wherein the processing unit is configured to aggregate longitudinal patient data across chemotherapy cycles, analyze correlations between recorded physiological data, biochemical indicators, patient-reported outcomes and parameters of chemotherapy administration and calculate a clinical response assessment;and a system for interaction with the physician (116) configured to display the clinical response assessment and to generate recommendations for optimizing the chemotherapy regimen, subject to review and approval by the physician.

[0037] In one embodiment, the physiological sensor unit (104) comprises a plurality of sensor elements arranged to maintain continuous skin contact and is configured to detect deviations in autonomic regulation, cardiopulmonary stress and disturbances of the circadian rhythm that indicate chemotherapy-induced toxicity.

[0038] In one embodiment, the biochemical sensor unit (106) comprises a minimally invasive interstitial fluid sampling structure positioned within the housing and configured to periodically extract biochemical samples for electrochemical or optical analysis without requiring venous blood sampling.

[0039] In one embodiment, the biochemical sensor unit (106) is further configured to detect temporal trends in changes in biomarker concentration over several chemotherapy cycles and to link these trends with predicted treatment tolerance thresholds stored in the storage unit.

[0040] In one embodiment, the patient interaction unit (108) comprises a touch-sensitive or voice-controlled interface configured to receive structured symptom inputs corresponding to the severity of nausea, the degree of fatigue, neuropathic symptoms, pain intensity, changes in appetite, and cognitive impairment.

[0041] In one embodiment, the embedded processing unit (110) is further configured to detect sensor artifacts, remove noise caused by motion or environmental influences, and generate validated data streams suitable for clinical-quality analysis.

[0042] In one embodiment, the communication unit (112) is configured to support redundant data transmission paths and to store encrypted data locally in the housing when no network connection is available, followed by a delayed transmission after the network connection is restored.

[0043] In one embodiment, the remote processing system (114) is configured to generate a composite clinical response index derived from the weighted integration of physiological stability metrics, biochemical toxicity indicators, patient-reported outcomes, and historical treatment response data.

[0044] In one embodiment, the composite clinical response index is dynamically recalculated as new patient data is received and compared with predefined patient-specific safety thresholds and efficacy targets stored in the memory unit.

[0045] In one embodiment, the remote processing system (114) is configured to generate recommendations for optimizing the chemotherapy regimen based on the calculated clinical response assessment, including changes to the drug dose, adjustments to the administration interval, recommendations to delay the cycle, or escalation of supportive therapy.

[0046] The system for telemedicine-based clinical response assessment and dynamic chemotherapy regimen optimization is implemented as a portable patient monitoring and clinical decision support device. The patient-side device for clinical response assessment is designed as a portable or bedside electronic instrument housed in a robust enclosure that mechanically supports and protects the internal circuitry. The physiological sensor unit comprises a suite of integrated biomedical sensors, including photoplethysmography sensors for heart rate and oxygen saturation, temperature sensors for body temperature, respiratory sensors, accelerometers for activity and sleep monitoring, and skin contact electrodes for recording autonomic and cardiopulmonary parameters. All sensors are physically mounted within the enclosure to ensure continuous contact with the patient.The biochemical sensor unit is implemented as a minimally invasive cartridge for the collection of interstitial fluid. It features microneedles or microfluidic channels coupled to electrochemical or optical biosensors and an analog input circuit to periodically measure inflammatory, metabolic, and hematological biomarkers. The patient interaction unit consists of a touch-sensitive display module and / or a microphone and speaker unit for voice-based symptom input. The embedded processing unit is implemented as a microcontroller or system-on-a-chip processor with associated RAM and flash memory. It is configured for signal conditioning, artifact removal, timing alignment, encryption, and data integrity checks using digital logic and firmware stored in hardware memory.The communication unit is implemented as a wireless or wired transceiver module, such as a cellular modem, WLAN chipset, or Bluetooth radio module, connected to antenna hardware and secure communication controllers for transmitting patient data and locally storing encrypted data in case of connection loss. The remote processing system is implemented as a server computing device or cloud-based processor cluster with CPUs, GPUs, and persistent memory. It executes stored software instructions for aggregating longitudinal physiological and biochemical data, calculating a combined clinical response index, dynamically updating safety thresholds, and generating recommendations for optimizing the chemotherapy regimen.The system for interaction with the doctor is implemented as a workstation computer, tablet or medical terminal with a graphical user interface and input devices for displaying assessment results and for review and approval by the doctor.

[0047] During operation, the patient-side device serves as the primary data acquisition device for clinical assessment of the response. Once installed, the physiological sensor unit continuously or intermittently records vital parameters such as heart rate, heart rate variability, respiratory rate, peripheral oxygen saturation, body temperature, activity level, and sleep parameters. These parameters are sampled at predefined intervals, which can be dynamically adjusted to patient stability, the phase of chemotherapy, or the monitoring intensity set by the physician. The raw sensor signals are transmitted to the integrated processing unit, where signal preprocessing takes place. This preprocessing includes motion artifact suppression, baseline deviation correction, signal normalization, and temporal synchronization of heterogeneous sensor data streams to ensure data consistency.

[0048] Simultaneously, the biochemical sensor unit captures biochemical indicators relevant to chemotherapy response and toxicity. In configurations with interstitial fluid sampling, the biochemical measurements are temporally synchronized with physiological signals to generate multimodal datasets. The integrated processing unit performs validation checks on the biochemical measurements, including range verification, trend continuity assessment, and sensor integrity confirmation, before integrating them into the patient data stream. Patient-reported symptoms captured via the patient interaction unit are time-stamped and coded into structured clinical descriptors corresponding to standardized toxicity and tolerability dimensions.

[0049] After preprocessing is complete, the embedded processing unit encrypts the validated data and transmits the data packets to the remote processing system via the communication unit. In the event of temporary connection interruptions, the embedded processing unit stores the encrypted data locally and initiates the delayed transmission as soon as the connection is restored. This ensures data continuity throughout the entire process.

[0050] In the remote processing system, the received patient data is fed into a longitudinal patient data archive within the storage unit. The processing unit performs an analysis procedure that first aggregates the incoming data over defined observation windows. These observation windows correspond to chemotherapy cycles, cycle-free periods, and acute monitoring intervals. Within each window, statistical characteristics and trend features are derived for each physiological, biochemical, and patient-reported parameter. These derived features include measures of variability, rate-of-change indicators, deviations from patient-specific baseline values, and cumulative stress indices that reflect ongoing physiological stress or biochemical abnormalities.

[0051] The processing unit then performs a correlation and weighting procedure that assigns the derived characteristics to predefined response and toxicity dimensions. This assignment is patient-specific and is initialized using baseline clinical data, treatment history, and physician-defined risk parameters stored in memory. During the course of therapy, the weighting coefficients are adaptively refined based on observed patient responses across successive chemotherapy cycles. The result of this phase is a composite clinical response index that quantitatively represents the balance between therapeutic efficacy, systemic tolerability, and functional status for the individual patient.

[0052] After calculating the clinical response, the processing unit optimizes the chemotherapy regimen. This optimization compares the clinical response with patient-specific safety thresholds, efficacy targets, and oncological guidelines. If the clinical response indicates decreasing tolerability, an increasing risk of toxicity, or an insufficient response, the optimization simulates alternative chemotherapy configurations. Dose intensity, administration intervals, or parameters of supportive therapy are adjusted within predefined limits. Each simulated configuration is evaluated using predictive models that estimate its potential impact on reducing toxicity and improving treatment efficacy.

[0053] The optimization process generates one or more prioritized recommendations for adjusting the chemotherapy regimen. Each recommendation is supplemented by supporting data that explain the physiological and biochemical basis of the proposed modification. Importantly, the process does not automatically implement treatment changes. Instead, the generated recommendations are transmitted to the system for interaction with the treating physicians and presented there along with visualizations of long-term trends, indicators of toxicity progression, and predicted outcome comparisons.

[0054] The physician interaction system allows the physician to view the underlying patient data, review the calculated clinical response index, and evaluate the proposed therapy adjustments. The physician can approve, modify, or reject any recommendation. Upon physician approval, the parameters of the approved chemotherapy are stored as active treatment instructions in the remote processing system and transmitted to the appropriate interfaces of the infusion devices or the medication administration record for implementation.

[0055] Following the implementation of an approved therapy change, the system updates its internal state to reflect the new treatment parameters. Subsequent patient data are interpreted in the context of the modified therapy. This allows the system to assess the treatment effect and further refine its weighting and predictive components. This continuous feedback loop enables gradual personalization of chemotherapy over multiple cycles while maintaining close medical supervision.

[0056] In one embodiment, the system comprises a device for assessing clinical response, configured as a portable, mobile, or bedside device. The device consists of a rigid or semi-rigid housing that encloses multiple sensor components and electronic subsystems. The housing is ergonomically designed to allow for extended use by the patient and may include biocompatible contact surfaces. Inside the housing is a physiological sensor unit with sensors for the continuous or periodic measurement of vital parameters such as heart rate, heart rate variability, respiratory rate, peripheral oxygen saturation, skin temperature, physical activity, posture, and sleep parameters. These physiological parameters serve as objective indicators of systemic stress, fatigue, infection risk, and the cardiopulmonary tolerability of chemotherapy.

[0057] The device further includes a biochemical monitoring interface for acquiring biochemical indicators relevant to the response to and toxicity of chemotherapy. In certain embodiments, this interface includes minimally invasive microneedle arrays for taking samples from the interstitium for the analysis of biomarkers such as inflammatory cytokines, lactate levels, metabolites, or drug metabolite concentrations. In other embodiments, the biochemical interface includes optical or electrochemical sensor elements for the non-invasive assessment of parameters such as hemoglobin levels, hydration status, or tissue perfusion.The device may also include a patient interface, such as a touch-sensitive surface or a voice-activated input unit, through which the patient can report subjective symptoms such as nausea, pain, neuropathy, changes in appetite, or cognitive impairment.

[0058] The device for assessing clinical response includes an integrated processing unit responsible for signal preprocessing, artifact removal, time stamping, and data encryption. This processing unit works in conjunction with a communication unit that transmits the processed data to a remote computing infrastructure via secure wired or wireless communication protocols. The communication unit supports cellular, WLAN, or short-range communication standards and ensures data integrity, confidentiality, and compliance with healthcare data protection regulations.

[0059] In one embodiment, the remote computing infrastructure comprises one or more server-side processing units configured to aggregate longitudinal patient data across multiple chemotherapy cycles. These processing units execute analysis routines that correlate physiological trends, biochemical markers, patient-reported outcomes, and historical treatment parameters with expected therapeutic response profiles and toxicity thresholds. The system is configured to generate a dynamic clinical response index, which represents a composite measure of treatment effectiveness, tolerability, and the patient's functional status over time.

[0060] Based on the calculated clinical response index and predefined clinical limitations, the system is configured for dynamic optimization of the chemotherapy regimen. This optimization includes adjusting the dosage intensity, modifying the administration intervals, recommending dose delays or reductions, and identifying early indicators of treatment resistance or excessive toxicity. The system also considers safety limits derived from oncology guidelines, patient-specific risk factors, and clinically defined parameters to ensure that all optimization results remain within clinically acceptable limits.

[0061] The system includes a user interface for interaction with medical professionals. This interface presents analyzed data, therapy progress, and optimization recommendations in a structured and easily understandable way. Through this interface, physicians can view the underlying data, simulate alternative treatment scenarios, confirm or override system-generated recommendations, and document clinical decisions. Confirmed therapy changes are securely transmitted back to the patient's device and integrated into subsequent monitoring cycles, thus completing the adaptive feedback loop.

[0062] In one embodiment, the system is further configured to interact with infusion devices or drug delivery records to verify adherence to approved chemotherapy regimens. The device architecture may include physical ports or communication interfaces that enable synchronization with infusion pumps or drug delivery devices, thus ensuring accurate coordination between prescribed and administered therapy.

[0063] The presented system represents a significant technological advancement by transforming chemotherapy management from a static, episodic process into a continuous, adaptive, and data-driven clinical workflow. By integrating a dedicated, machine-level device with computer-aided remote optimization and physician monitoring, the invention improves treatment personalization, early detection of side effects, reduces unnecessary hospital visits, and contributes to better clinical outcomes in oncological care.

[0064] The system enables continuous remote monitoring of chemotherapy response and toxicity, supports dynamic and patient-specific optimization of the treatment regimen, accelerates clinical decisions, reduces treatment-related complications, and improves patients' quality of life, while simultaneously ensuring physician control and regulatory compliance. The integration of a physical device with computer-aided optimization provides a scalable and technically robust solution for modern oncology.

[0065] The drawing and the preceding description contain examples of embodiments. Those skilled in the art will recognize that one or more of the described elements can be combined to form a single functional element. Alternatively, certain elements can be divided into several functional elements. Elements of one embodiment can be added to another. For example, the sequence of the processes described here can be changed and is not limited to the manner described herein. Furthermore, actions that are independent of other actions can be performed in parallel with the other actions. The scope of protection of the embodiments is in no way limited by these specific examples. Numerous variations are possible, whether explicitly listed in the description or not, such as differences in structure, dimensions, and material usage.The scope of protection of the embodiments is at least as broad as specified in the following claims.

[0066] The advantages, other benefits, and problem solutions have been described above with reference to specific embodiments. However, the advantages, benefits, problem solutions, and any components that can effect or enhance an advantage, benefit, or solution are not to be construed as critical, necessary, or essential features or components of the claims. REFERENCES 100 A system for remote assessment of clinical response and dynamic optimization of chemotherapies in oncology. 102 Device for Clinical Assessment of Patient Response 104 Physiological sensor unit 106 Biochemical Sensor Unit 108 Patient Interaction Unit 110 Embedded processing unit 112 Communication unit 114 Remote processing system 116 System for Interaction Between Clinicians

Claims

[1] A system for remote assessment of clinical response and dynamic optimization of the chemotherapy regimen in oncology, consisting of: a device for clinical assessment of patient response, designed as a physical machine structure with a housing for use on the body or at the bedside; a housing-mounted physiological sensor unit configured to record continuous or periodic measurements of heart rate, heart rate variability, respiratory rate, peripheral oxygen saturation, body temperature, physical activity and sleep-related parameters of an oncology patient during chemotherapy; a biochemical sensor unit integrated into the housing, configured to detect biochemical indicators related to response to chemotherapy and toxicity, including inflammatory markers, metabolic indicators, hematological trends or drug-related metabolites; a patient interaction unit configured to receive symptom data reported by the patient, corresponding to treatment tolerability and functional status; an embedded processing unit that is operationally connected to the physiological sensor unit, the biochemical sensor unit, and the patient interaction unit, and is configured to perform signal conditioning, temporal alignment, data integrity verification, and encryption of the acquired patient data; a communication unit that is operationally connected to the embedded processing unit and configured to transmit the processed patient data to a remote processing infrastructure using secure communication protocols; a remote processing system comprising at least one processing unit and a storage unit for storing executable instructions, wherein the processing unit is configured to aggregate longitudinal patient data across chemotherapy cycles, analyze correlations between recorded physiological data, biochemical indicators, patient-reported outcomes, and parameters of chemotherapy administration, and calculate a clinical assessment of response; and A system for interacting with physicians, configured to display the results of the clinical response assessment and generate recommendations for optimizing the chemotherapy regimen, which are subject to review and approval by the physician. [2] System according to claim 1, wherein the physiological sensor unit comprises a plurality of sensor elements arranged to maintain continuous skin contact and configured to detect deviations in autonomic regulation, cardiopulmonary stress and disturbances of the circadian rhythm that indicate chemotherapy-induced toxicity. [3] System according to claim 1, wherein the biochemical sensor unit comprises a minimally invasive structure for the extraction of interstitial fluid, which is arranged within the housing and is configured to periodically extract biochemical samples for electrochemical or optical analysis without the need for venous blood sampling. [4] System according to claim 1, wherein the biochemical sensor unit is further configured to detect temporal trends in changes in biomarker concentration over several chemotherapy cycles and to link these trends with predicted treatment tolerance thresholds stored in the storage unit. [5] System according to claim 1, wherein the patient interaction unit comprises a touch-sensitive or voice-controlled interface configured to receive structured symptom inputs corresponding to the severity of nausea, the degree of fatigue, neuropathic symptoms, pain intensity, changes in appetite and cognitive impairment. [6] System according to claim 1, wherein the embedded processing unit is further configured to detect sensor artifacts, remove noise caused by motion or environmental influences, and generate validated data streams suitable for clinical-quality analysis. [7] System according to claim 1, wherein the communication unit is configured to support redundant data transmission paths and stores encrypted data locally in the housing when no network connection is available, followed by a delayed transmission after the network connection is restored. [8] System according to claim 1, wherein the remote processing system is configured to generate a composite clinical response index derived from the weighted integration of physiological stability metrics, biochemical toxicity indicators, patient-reported outcomes and historical treatment response data. [9] System according to claim 8, wherein the composite clinical response index is dynamically recalculated as new patient data is received and compared with predefined patient-specific safety thresholds and efficacy targets stored in the storage unit. [10] System according to claim 1, wherein the remote processing system is configured to generate recommendations for optimizing the chemotherapy regimen based on the calculated clinical response assessment, including changes to the drug dose, adjustments to the administration interval, recommendations to delay the cycle or escalation of supportive therapy.

Images