RESUMEN
PURPOSE OF REVIEW: There is still a need of biomarkers in the induction and neoadjuvant settings for squamous cell carcinoma of the head and neck (SCCHN). The objective of this concise review article is to give an overview on both predictive and prognostic biomarkers potentially useful for the management of SCCHN. RECENT FINDINGS: Human papilloma virus (HPV) positivity translated by the presence of the protein indicator p16 is synonymous of favorable prognosis SCCHN. However, there is some disparity for disease evolution among p16 positive SCCHN. A lack of correlation between immunohistochemistry (IHC) and precise quantification of active epidermal growth factor receptors (EGFRs) may explain the absence of link between EGFR expression performed by IHC and response to EGFR targeting therapies reported in SCCHN. Circulating tumor cells (CTCs) have the property to share the main somatic mutations and genetic rearrangements with the primary tumors. A particular potential interest lies on the possibility to predict patient outcome based on a single-CTC analysis. SUMMARY: This short review indicates that key biological marker reflecting disease outcome is not yet emerging for a clinical use in SCCHN. Hopes can be put into the so-called liquid biopsies incorporating circulating tumor cells and circulating tumor DNA.
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Carcinoma de Células Escamosas , Neoplasias de Cabeza y Cuello , Células Neoplásicas Circulantes , Humanos , Neoplasias de Cabeza y Cuello/genética , Carcinoma de Células Escamosas de Cabeza y Cuello , Carcinoma de Células Escamosas/patología , Biomarcadores , Receptores ErbB/genética , Receptores ErbB/metabolismo , Biomarcadores de Tumor/metabolismoRESUMEN
PURPOSE OF REVIEW: Recent recommendations on cachexia highlight, in head and neck cancers, the heterogeneity of studies, focusing on weight loss and sequelae including swallowing disorders. The current national guidelines emphasize that, in cases of concurrent chemoradiotherapy (cCRT) involving the oral cavity and oropharynx, prophylactic gastrostomy placement should be carried out systematically. We review why this technique is particularly relevant in this specific location for the feasibility of cCRT. RECENT FINDINGS: A randomized trial is underway on swallowing disorders and the quality of life of patients after prophylactic vs. reactive gastrostomy in advanced oropharyngeal cancer patients treated with CRT. Concurrently, recent literature reviews emphasize the importance of the cumulative dose of chemotherapy for local control and survival. In cases of cCRT involving the oral cavity or the oropharynx, nutritional support could have a beneficial or detrimental impact on chemotherapy. SUMMARY: Specifically for patients treated with cCRT involving the oral cavity and oropharynx, prophylactic gastrostomy would be able to fulfill the three objectives of local control, survival, and quality of life, minimizing complications related to nutritional support. Studies need to be more homogeneous. In clinical practice, nutrition should primarily assist in carrying out cancer treatment when survival is the main goal.
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Trastornos de Deglución , Neoplasias de Cabeza y Cuello , Humanos , Quimioradioterapia , Trastornos de Deglución/etiología , Trastornos de Deglución/prevención & control , Gastrostomía , Neoplasias de Cabeza y Cuello/tratamiento farmacológico , Neoplasias de Cabeza y Cuello/radioterapia , Boca , Orofaringe , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
PURPOSE: To investigate the role of photobiomodulation (PBM) in patients undergoing head and neck cancer (HNC) treatment. We focused on the consequences of the main complications, such as quality of life (QoL), analgesia, functional impairment, and nutritional status, as well as on the impact on survival/ recurrences, radiotherapy (RT) interruption, adherence, cost-effectiveness, safety, feasibility, and tolerability. METHODS: An electronic search in PubMed and Scopus databases was performed. Full texts were carefully assessed, and data were assimilated into a tabular form for discussion and consensus among the expert panel. RESULTS: A total of 22 papers were included. Overall, a beneficial effect of PBM was evidenced in the amelioration of QoL, nutritional status, the reduction of pain, and functional impairment. Preventive PBM may reduce the incidence and duration of RT interruptions, potentially contributing to improved cancer treatment outcomes. PBM treatments are safe and recommended for routine use, with the caveat of avoiding direct tumor exposures where feasible. However, it does not appear to impact cancer survivorship/recurrences directly. Despite additional clinical efforts involving routine PBM use, the individual and public health benefits will positively impact oncology care. CONCLUSIONS: Quality of life, pain and functional impairment, nutritional status, and survival may be effectively improved with PBM. Given its established efficacy also in reducing RT interruptions and its safety, feasibility, and tolerability, PBM should be included in the field of supportive cancer care in HNC patients. Improved understanding of PBM mechanisms and precise dose parameters is enabling the generation of more robust, safe, and reproducible protocols; thus, it is imperative to support further clinical implementation as well as both applied and basic science research in this novel field.
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Neoplasias de Cabeza y Cuello , Terapia por Luz de Baja Intensidad , Humanos , Calidad de Vida , Recurrencia Local de Neoplasia , Neoplasias de Cabeza y Cuello/radioterapia , Resultado del Tratamiento , Terapia por Luz de Baja Intensidad/métodosRESUMEN
PURPOSE: The study aims to assess the feasibility, safety, and tolerability of CareMin650, a new photobiomodulation device, in patients treated by radiotherapy (RT) and to collect preliminary data on efficacy for prevention and treatment of oral mucositis (OM) and radiation dermatitis (RD). METHODS: Safe PBM is a French, multicentric, prospective, non-comparative study which include patients with head and neck cancer (H&NC, cohort A) or breast cancer (BC, cohort B) treated in prophylactic (cohorts A1 and B1) or curative setting (cohort A2 and B2). Prophylactic treatment was administered from D1 to end of RT, at a dose of 3 J/cm2. Curative treatment started when a grade 1 to grade 3 lesion had occurred and was pursued until end of RT. Primary endpoint was incidence of device-related adverse events (AEs). OM and RD lesions were graded according to CTCAE V3. RESULTS: Overall, 72 patients were included (22, 9, 23, and 18 in cohorts A1, A2, B1, and B2, respectively). No device-related AE was reported after 1312 CareMin650 sessions. In cohorts A1 and B1, median time to first OM or RD lesion was 20 days. One BC patient developed G3 RD after completion of RT and discontinuation of CareMin650. Four H&NC patients developed G3 OM. In cohorts A2 and B2, lesions improved or stabilized in 71% of patients. Rates of satisfaction were high among patients and users. CONCLUSION: CareMin650 is feasible, safe, and well tolerated for preventive or curative treatment of OM and RD in cancer patients treated with RT. Preliminary efficacy results are promising.
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Neoplasias de Cabeza y Cuello , Terapia por Luz de Baja Intensidad , Radiodermatitis , Estomatitis , Neoplasias de Cabeza y Cuello/radioterapia , Humanos , Estudios Prospectivos , Radiodermatitis/etiología , Radiodermatitis/prevención & control , Estomatitis/etiología , Estomatitis/prevención & controlRESUMEN
Photobiomodulation-based (PBM-based) therapies show promising results in mucositis and dermatitis treatment by stimulating wound healing mechanisms such as cell proliferation and migration. The aim of the present study is to investigate the in vitro effects of CareMin650 on the proliferation and migration of two different types of cells, namely cancer and non-cancer cells, with or without X-ray radiation. Study design used PBM through a combination of 0-3-6 J/cm2 doses-with or without X-ray radiation-on the proliferation and migration capabilities of a keratinocyte cell line (HaCaT) and a squamous cell carcinoma line (SCC61). PBM is delivered by a new woven optical fiber device, namely CareMin650 prototype (light emission by LEDs (light-emitting diodes), peak at 660 nm, irradiance of 21.6 mW/cm2). The effectiveness of PBM to increase HaCaT proliferation and migration (with or without X-ray radiation) supports the capability of PBM to favor wound healing. It also highlights that PBM does not provide any anti-radiation effect to previously X-rays radiated SCC (p < 0.001). Such data supports the beneficial effect of PBM delivered by an optical fiber device to heal wounds, without promoting cancer development.
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Carcinoma de Células Escamosas , Terapia por Luz de Baja Intensidad , Carcinoma de Células Escamosas/radioterapia , Proliferación Celular , Humanos , Queratinocitos , Fibras Ópticas , Rayos XRESUMEN
BACKGROUND: Oral mucositis (OM) is a severe complication cancer patients undergo when treated with chemoradiotherapy. Photobiomodulation (PBM) therapy also known as low-level laser therapy has been increasingly used for the treatment of such oral toxicity. The aim of this review is to discuss the mechanisms of photobiomodulation (PBM) regarding OM prevention and treatment, and more precisely to focus on the effect of PBM on tumor and healthy cells. METHODS: MEDLINE/PubMed, and google scholar were searched electronically. Selected studies were focusing on PBM effects on tumor and healthy cells. RESULTS: PBM interactions with the tissue and additional mechanism in OM therapy were detailed in this review. Moreover, this review highlighted a controversy about the carcinogenic effect of PBM. Indeed, Many studies reported that PBM could enhance malignant cell proliferation; suggesting that PBM would have no protective effect. In addition to acting on cancer cells, PBM may damage healthy cells. CONCLUSION: More prospective studies are needed to assess the effect of PBM on cancer cells in order to improve its use for OM prevention and treatment.
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Terapia por Luz de Baja Intensidad , Neoplasias , Estomatitis , Quimioradioterapia , Humanos , Estudios Prospectivos , Estomatitis/etiología , Estomatitis/prevención & controlRESUMEN
Answer questions and earn CME/CNE Oral complications resulting from cancer and cancer therapies cause acute and late toxicities that may be underreported, underrecognized, and undertreated. Recent advances in cancer treatment have led to changes in the incidence, nature, and severity of oral complications. As the number of survivors increases, it is becoming increasingly recognized that the aggressive management of oral toxicities is needed to ensure optimal long-term oral health and general well-being. Advances in care have had an impact on previously recognized oral complications and are leading to newly recognized adverse effects. Here, the authors briefly review advances in cancer therapy, including recent advances in surgery, oral care, radiation therapy, hematopoietic cell transplantation, and medical oncology; describe how these advances affect oral health; and discuss the frequent and/or severe oral health complications associated with cancer and cancer treatment and their effect upon long-term health. Although some of the acute oral toxicities of cancer therapies may be reduced, they remain essentially unavoidable. The significant impact of long-term complications requires increased awareness and recognition to promote prevention and appropriate intervention. It is therefore important for the primary oncologist to be aware of these complications so that appropriate measures can be implemented in a timely manner. Prevention and management is best provided via multidisciplinary health care teams, which must be integrated and communicate effectively in order to provide the best patient care in a coordinated manner at the appropriate time.
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Antineoplásicos/efectos adversos , Neoplasias de Cabeza y Cuello/terapia , Radioterapia/efectos adversos , Candidiasis Bucal/etiología , Candidiasis Bucal/terapia , Caries Dental/etiología , Caries Dental/prevención & control , Relación Dosis-Respuesta a Droga , Dolor Facial/etiología , Dolor Facial/terapia , Humanos , Recurrencia Local de Neoplasia , Neoplasias Primarias Secundarias , Trastornos del Olfato/etiología , Trastornos del Olfato/terapia , Salud Bucal , Úlceras Bucales/etiología , Úlceras Bucales/terapia , Osteorradionecrosis/etiología , Osteorradionecrosis/terapia , Periodontitis/etiología , Calidad de Vida , Factores de Riesgo , Índice de Severidad de la Enfermedad , Sialorrea/etiología , Sialorrea/terapia , Estomatitis/etiología , Estomatitis/terapia , Trastornos del Gusto/etiología , Trastornos del Gusto/terapia , Desmineralización Dental/etiología , Desmineralización Dental/prevención & control , Trismo/etiología , Trismo/terapia , Virosis/etiología , Virosis/terapiaRESUMEN
PURPOSE: To systematically review the literature and update the evidence-based clinical practice guidelines for the use of photobiomodulation (PBM), such as laser and other light therapies, for the prevention and/or treatment of oral mucositis (OM). METHODS: A systematic review was conducted by the Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society for Oral Oncology (MASCC/ISOO) using PubMed and Web of Science. We followed the MASCC methods for systematic review and guidelines development. The rigorously evaluated evidence for each intervention, in each cancer treatment setting, was assigned a level-of-evidence (LoE). Based on the LoE, one of the following guidelines was determined: Recommendation, Suggestion, or No Guideline Possible. RESULTS: Recommendations are made for the prevention of OM and related pain with PBM therapy in cancer patients treated with one of the following modalities: hematopoietic stem cell transplantation, head and neck (H&N) radiotherapy (without chemotherapy), and H&N radiotherapy with chemotherapy. For each of these modalities, we recommend 1-2 clinically effective protocols; the clinician should adhere to all parameters of the protocol selected. Due to inadequate evidence, currently, No Guideline Possible for treatment of established OM or for management of chemotherapy-related OM. The reported clinical settings were extremely variable, limiting data integration. CONCLUSIONS: The evidence supports the use of specific settings of PBM therapy for the prevention of OM in specific patient populations. Under these circumstances, PBM is recommended for the prevention of OM. The guidelines are subject to continuous update based on new published data.
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Terapia por Luz de Baja Intensidad/métodos , Mucositis/terapia , Guías de Práctica Clínica como Asunto , Estomatitis/prevención & control , Estomatitis/terapia , Protocolos Clínicos , Humanos , Masculino , Neoplasias/terapiaRESUMEN
PURPOSE OR REVIEW: There is a large body of evidence supporting the efficacy of low-level laser therapy (LLLT) also known as PhotoBioModulation (PBM) when used for the prevention and/or treatment of oral mucositis in patients undergoing radiotherapy for head and neck cancer, or high-dose chemotherapy regimens. This review aims at giving the state of the art of this technique in this indication. RECENT FINDINGS: Recent advances in LLLT/PBM technology, together with a better understanding of mechanisms involved and dosimetric parameters may lead to the management of a broader range of complications associated with cancer treatment. This could enhance patient adherence to cancer therapy, and improve quality of life and treatment outcomes. SUMMARY: The article discusses LLLT/PBM mechanisms of action, dosimetry, and safety, and aims to identify some cancer treatment side-effects for which LLLT/PBM may prove to be effective (oral mucositis, radiation dermatitis, lymphedema). In addition, LLLT/PBM parameters for each of these complications are suggested and future research directions are discussed.
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Dermatitis/radioterapia , Neoplasias de Cabeza y Cuello/complicaciones , Terapia por Luz de Baja Intensidad/métodos , Linfedema/radioterapia , Mucositis/radioterapia , Dermatitis/etiología , Neoplasias de Cabeza y Cuello/tratamiento farmacológico , Neoplasias de Cabeza y Cuello/radioterapia , Humanos , Terapia por Luz de Baja Intensidad/efectos adversos , Linfedema/etiología , Mucositis/etiología , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
This commentary attempts to clarify the setting of photobiomodulation (BPM) therapy in the management of oral mucositis. The suggested dose range balances efficacy data with our current understanding about PBM safety. The literature about the molecular basis of photobiomodulation and its controversial relationship to malignant transformation is briefly presented.
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Terapia por Luz de Baja Intensidad/métodos , Estomatitis/terapia , HumanosRESUMEN
Necrosis of the oral mucosa following head and neck cancer radiation therapy presents considerable clinical management challenges. We report three cases of symptomatic persisting oral ulcerations where the addition of photobiomodulation therapy resulted in a rapid resolution of the oral lesions and in patient symptoms. These cases suggest that photobiomodulation may represent an adjunct to care of these difficult to manage complications in oncology.
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Neoplasias de Cabeza y Cuello/radioterapia , Terapia por Luz de Baja Intensidad/métodos , Úlceras Bucales/radioterapia , Traumatismos por Radiación/radioterapia , Humanos , Masculino , Persona de Mediana Edad , Mucosa Bucal/patología , Mucosa Bucal/efectos de la radiación , Necrosis , Úlceras Bucales/etiología , Orofaringe/patología , Orofaringe/efectos de la radiación , Traumatismos por Radiación/etiologíaRESUMEN
PURPOSE: Medical doctors' (MDs), but not patients', perception of supportive care in cancer (SCC) in France has been previously assessed in a national survey. This study evaluated MDs and patients' perceptions of the SCC organization and implementation in France. METHODS: The French SCC Association conducted two observational studies: study 1 (S1), containing a 30-point questionnaire sent to 2263 MDs, and study 2 (S2), containing a 40-point questionnaire sent to 2000 patients. RESULTS: Overall, 711 MDs completed S1 and 1562 patients completed S2. In S1, 81% of MDs reported relying on a SCC organization and 76% attended SCC multidisciplinary discussions. MDs considered palliative (98%), psychological (98%), and social care (98%) as the top 3 SCC areas of importance for patients. In contrast, patients' priorities were psychology (61%), nutrition (55%) and organization of intake consultations (55%). The concept of SCC was familiar to 34% of patients; according to MDs, this concept was introduced mainly by MDs (78%) and admission nurses (41%). Outpatients identified as professional resources for SCC information general practitioners (84%), nurses (58%), and pharmacists (52%). Patients reported supportive treatment being prescribed in 63% of cases, with 64% receiving information on the negative side-effects. Among MDs, 87% reported proposing palliative and 41% adjuvant SCC treatment. Furthermore, 72% of MDs recommended SCC treatment at the metastatic stage, and 36% immediately following diagnosis. DISCUSSION: Oncologists play a vital role in enhancing SCC efficacy. This can be increased by implementing a multidisciplinary integrated approach or by assuring the availability of patient information.
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Neoplasias/psicología , Derivación y Consulta/normas , Apoyo Social , Femenino , Francia , Humanos , Masculino , Cuidados Paliativos/psicología , Encuestas y CuestionariosRESUMEN
BACKGROUND: Radioresistant glioblastoma stem cells (GSCs) contribute to tumor recurrence and identification of the molecular targets involved in radioresistance mechanisms is likely to enhance therapeutic efficacy. This study analyzed the DNA damage response following ionizing radiation (IR) in 10 GSC lines derived from patients. METHODS: DNA damage was quantified by Comet assay and DNA repair effectors were assessed by Low Density Array. The effect of RAD51 inhibitor, RI-1, was evaluated by comet and annexin V assays. RESULTS: While all GSC lines displayed efficient DNA repair machinery following ionizing radiation, our results demonstrated heterogeneous responses within two distinct groups showing different intrinsic radioresistance, up to 4Gy for group 1 and up to 8Gy for group 2. Radioresistant cell group 2 (comprising 5 out of 10 GSCs) showed significantly higher RAD51 expression after IR. In these cells, inhibition of RAD51 prevented DNA repair up to 180 min after IR and induced apoptosis. In addition, RAD51 protein expression in glioblastoma seems to be associated with poor progression-free survival. CONCLUSION: These results underscore the importance of RAD51 in radioresistance of GSCs. RAD51 inhibition could be a therapeutic strategy helping to treat a significant number of glioblastoma, in combination with radiotherapy.
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Glioblastoma/metabolismo , Células Madre Neoplásicas/metabolismo , Recombinasa Rad51/metabolismo , Tolerancia a Radiación/fisiología , Western Blotting , Línea Celular Tumoral , Ensayo Cometa , Daño del ADN/efectos de la radiación , Citometría de Flujo , Humanos , Inmunohistoquímica , Células Madre Neoplásicas/efectos de la radiación , Análisis de Matrices TisularesRESUMEN
PURPOSE: There is a large body of evidence supporting the efficacy of low level laser therapy (LLLT), more recently termed photobiomodulation (PBM), for the management of oral mucositis (OM) in patients undergoing radiotherapy for head and neck cancer (HNC). Recent advances in PBM technology, together with a better understanding of mechanisms involved, may expand the applications for PBM in the management of other complications associated with HNC treatment. This article (part 1) describes PBM mechanisms of action, dosimetry, and safety aspects and, in doing so, provides a basis for a companion paper (part 2) which describes the potential breadth of potential applications of PBM in the management of side-effects of (chemo)radiation therapy in patients being treated for HNC and proposes PBM parameters. METHODS: This study is a narrative non-systematic review. RESULTS: We review PBM mechanisms of action and dosimetric considerations. Virtually, all conditions modulated by PBM (e.g., ulceration, inflammation, lymphedema, pain, fibrosis, neurological and muscular injury) are thought to be involved in the pathogenesis of (chemo)radiation therapy-induced complications in patients treated for HNC. The impact of PBM on tumor behavior and tumor response to treatment has been insufficiently studied. In vitro studies assessing the effect of PBM on tumor cells report conflicting results, perhaps attributable to inconsistencies of PBM power and dose. Nonetheless, the biological bases for the broad clinical activities ascribed to PBM have also been noted to be similar to those activities and pathways associated with negative tumor behaviors and impeded response to treatment. While there are no anecdotal descriptions of poor tumor outcomes in patients treated with PBM, confirming its neutrality with respect to cancer responsiveness is a critical priority. CONCLUSION: Based on its therapeutic effects, PBM may have utility in a broad range of oral, oropharyngeal, facial, and neck complications of HNC treatment. Although evidence suggests that PBM using LLLT is safe in HNC patients, more research is imperative and vigilance remains warranted to detect any potential adverse effects of PBM on cancer treatment outcomes and survival.
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Quimioradioterapia/efectos adversos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/terapia , Neoplasias de Cabeza y Cuello/terapia , Terapia por Luz de Baja Intensidad , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/etiología , Neoplasias de Cabeza y Cuello/tratamiento farmacológico , Neoplasias de Cabeza y Cuello/radioterapia , Humanos , Terapia por Luz de Baja Intensidad/efectos adversos , Terapia por Luz de Baja Intensidad/métodos , Terapia por Luz de Baja Intensidad/normasRESUMEN
PURPOSE: There is a large body of evidence supporting the efficacy of low-level laser therapy (LLLT), more recently termed photobiomodulation (PBM) for the management of oral mucositis (OM) in patients undergoing radiotherapy for head and neck cancer (HNC). Recent advances in PBM technology, together with a better understanding of mechanisms involved and dosimetric parameters may lead to the management of a broader range of complications associated with HNC treatment. This could enhance patient adherence to cancer therapy, and improve quality of life and treatment outcomes. The mechanisms of action, dosimetric, and safety considerations for PBM have been reviewed in part 1. Part 2 discusses the head and neck treatment side effects for which PBM may prove to be effective. In addition, PBM parameters for each of these complications are suggested and future research directions are discussed. METHODS: Narrative review and presentation of PBM parameters are based on current evidence and expert opinion. RESULTS: PBM may have potential applications in the management of a broad range of side effects of (chemo)radiation therapy (CRT) in patients being treated for HNC. For OM management, optimal PBM parameters identified were as follows: wavelength, typically between 633 and 685 nm or 780-830 nm; energy density, laser or light-emitting diode (LED) output between 10 and 150 mW; dose, 2-3 J (J/cm(2)), and no more than 6 J/cm(2) on the tissue surface treated; treatment schedule, two to three times a week up to daily; emission type, pulsed (<100 Hz); and route of delivery, intraorally and/or transcutaneously. To facilitate further studies, we propose potentially effective PBM parameters for prophylactic and therapeutic use in supportive care for dermatitis, dysphagia, dry mouth, dysgeusia, trismus, necrosis, lymphedema, and voice/speech alterations. CONCLUSION: PBM may have a role in supportive care for a broad range of complications associated with the treatment of HNC with CRT. The suggested PBM irradiation and dosimetric parameters, which are potentially effective for these complications, are intended to provide guidance for well-designed future studies. It is imperative that such studies include elucidating the effects of PBM on oncology treatment outcomes.
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Quimioradioterapia/efectos adversos , Protocolos Clínicos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/terapia , Neoplasias de Cabeza y Cuello/terapia , Terapia por Luz de Baja Intensidad/métodos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/etiología , Neoplasias de Cabeza y Cuello/tratamiento farmacológico , Neoplasias de Cabeza y Cuello/radioterapia , HumanosRESUMEN
PURPOSE: Dermatologic adverse events (dAEs) in cancer treatment are frequent with the use of targeted therapies. These dAEs have been shown to have significant impact on health-related quality of life (HRQoL). While standardized assessment tools have been developed for physicians to assess severity of dAEs, there is a discord between objective and subjective measures. The identification of patient-reported outcome (PRO) instruments useful in the context of targeted cancer therapies is therefore important in both the clinical and research settings for the overall evaluation of dAEs and their impact on HRQoL. METHODS: A comprehensive, systematic literature search of published articles was conducted by two independent reviewers in order to identify PRO instruments previously utilized in patient populations with dAEs from targeted cancer therapies. The identified PRO instruments were studied to determine which HRQoL issues relevant to dAEs were addressed, as well as the process of development and validation of these instruments. RESULTS: Thirteen articles identifying six PRO instruments met the inclusion criteria. Four instruments were general dermatology (Skindex-16©, Skindex-29©, Dermatology Life Quality Index (DLQI), and DIELH-24) and two were symptom-specific (functional assessment of cancer therapy-epidermal growth factor receptor inhibitor-18 (FACT-EGFRI-18) and hand-foot syndrome 14 (HFS-14)). CONCLUSIONS: While there are several PRO instruments that have been tested in the context of targeted cancer therapy, additional work is needed to develop new instruments and to further validate the instruments identified in this study in patients receiving targeted therapies.
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Antineoplásicos/efectos adversos , Neoplasias/tratamiento farmacológico , Enfermedades de la Piel/inducido químicamente , Humanos , Terapia Molecular Dirigida/efectos adversos , Evaluación del Resultado de la Atención al Paciente , Calidad de Vida , Enfermedades de la Piel/diagnóstico , Enfermedades de la Piel/psicología , Encuestas y CuestionariosRESUMEN
BACKGROUND: EORTC trial 22921 examined the addition of preoperative or postoperative chemotherapy to preoperative radiotherapy in patients with rectal cancer. After a median follow-up of 5 years, chemotherapy-irrespective of timing-significantly improved local control. Adjuvant chemotherapy did not improve survival, but the Kaplan-Meier curves diverged, suggesting possible delayed benefit. Here, we report the updated long-term results. METHODS: We randomly assigned patients with clinical stage T3 or T4 resectable rectal cancer to receive preoperative radiotherapy with or without concomitant chemotherapy before surgery followed by either adjuvant chemotherapy or surveillance. Randomisation was done using minimisation with factors of institution, sex, T stage, and distance from the tumour to the anal verge. Study coordinators, clinicians, and patients were aware of assignment. Radiotherapy consisted of 45 Gy to the posterior pelvis in 25 fractions of 1·8 Gy over 5 weeks. Each course of chemotherapy consisted of fluorouracil (350 mg/m(2) per day intravenous bolus) and folinic acid (leucovorin; 20 mg/m(2) per day intravenous bolus). For preoperative chemotherapy, two courses were given (during weeks 1 and 5 of radiotherapy). Adjuvant chemotherapy was given in four cycles, every 3 weeks. The primary endpoint was overall survival. This analysis was done by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00002523. FINDINGS: 1011 patients were randomly assigned to treatment between April, 1993, and March, 2003 (252 to preoperative radiotherapy and 253 to each of the other three groups). After a median follow-up of 10·4 years (IQR 7·8-13·1), 10-year overall survival was 49·4% (95% CI 44·6-54·1) for the preoperative radiotherapy group and 50·7% (45·9-55·2) for the preoperative radiotherapy and chemotherapy group (HR 0·99, 95% CI 0·83-1·18; p=0·91). 10-year overall survival was 51·8% (95% CI 47·0-56·4) for the adjuvant chemotherapy group and 48·4% (43·6-53·0) for the surveillance group (HR 0·91, 95% CI 0·77-1·09, p=0·32). 10-year disease-free survival was 44·2% (95% CI 39·5-48·8) for the preoperative radiotherapy group and 46·4% (41·7-50·9) for the preoperative radiotherapy and chemotherapy group (HR 0·93, 95% CI 0·79-1·10; p=0·38). 10-year disease-free survival was 47·0% (95% CI 42·2-51·6) for the adjuvant chemotherapy group and 43·7% (39·1-48·2) for the surveillance group (HR 0·91, 95% CI 0·77-1·08, p=0·29). At 10 years, cumulative incidence of local relapse was 22·4% (95% CI 17·1-27·6) with radiotherapy alone, 11·8% (7·8-15·8) with neoadjuvant radiotherapy and chemotherapy, 14·5% (10·1-18·9) with radiotherapy and adjuvant chemotherapy and 11·7% (7·7-15·6) with both adjuvant and neoadjuvant chemotherapy (p=0·0017). There was no difference in cumulative incidence of distant metastases (p=0·52). The frequency of long-term side-effects did not differ between the four groups (p=0·22). INTERPRETATION: Adjuvant fluorouracil-based chemotherapy after preoperative radiotherapy (with or without chemotherapy) does not affect disease-free survival or overall survival. Our trial does not support the current practice of adjuvant chemotherapy after preoperative radiotherapy with or without chemotherapy. New treatment strategies incorporating neoadjuvant chemotherapy are required. FUNDING: EORTC, US National Cancer Institute, Programme Hospitalier de Recherche Clinique, Ligue contre le Cancer Comité du Doubs.
Asunto(s)
Adenocarcinoma/terapia , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Quimioradioterapia Adyuvante , Procedimientos Quirúrgicos del Sistema Digestivo , Terapia Neoadyuvante , Neoplasias del Recto/terapia , Adenocarcinoma/mortalidad , Adenocarcinoma/patología , Adulto , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Quimioradioterapia Adyuvante/efectos adversos , Quimioradioterapia Adyuvante/mortalidad , Quimioterapia Adyuvante , Procedimientos Quirúrgicos del Sistema Digestivo/efectos adversos , Procedimientos Quirúrgicos del Sistema Digestivo/mortalidad , Progresión de la Enfermedad , Supervivencia sin Enfermedad , Europa (Continente) , Femenino , Fluorouracilo/administración & dosificación , Humanos , Análisis de Intención de Tratar , Israel , Estimación de Kaplan-Meier , Leucovorina/administración & dosificación , Masculino , Persona de Mediana Edad , Terapia Neoadyuvante/efectos adversos , Terapia Neoadyuvante/mortalidad , Estadificación de Neoplasias , Modelos de Riesgos Proporcionales , Neoplasias del Recto/mortalidad , Neoplasias del Recto/patología , Factores de Riesgo , Tasa de Supervivencia , Factores de Tiempo , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND: Assess the current and potential indications of photobiomodulation (PBM) therapy and their level of evidence in the prevention or treatment of side effects related to oncology treatments (radiation therapy, and to a minimal extent favored and hematopoietic stem cell transplants). And report on the recommended modalities (parameters and doses) of PBM therapy. MATERIALS AND METHODS: The Embase, Medline/PubMed, Cochrane, EBSCO, Scopus, and LILACS databases were systematically reviewed to include and analyze publications of clinical studies that evaluated PBM in the prevention or management side effects related to cancer treatments. The keywords used were "photobiomodulation"; "low level laser therapy"; "acute oral mucositis"; "acute dysphagia"; "acute radiation dermatitis"; "lymphedema"; "xerostomia"; "dysgeusia"; "hyposalivation"; "lockjaw"; "bone necrosis"; "osteoradionecrosis"; "radiation induced fibrosis"; "voice and speech alterations"; "palmar-plantar erythrodysesthesia"; "graft versus host disease"; "peripheral neuropathy"; "chemotherapy induced alopecia". Prospective studies were included, while retrospective cohorts and non-original articles were excluded from the analysis. RESULTS: PBM in the red or infrared spectrum has been shown to be effective in randomized controlled trials in the prevention and management of certain complications related to radiotherapy, in particular acute mucositis, epitheliitis and upper limb lymphedema. The level of evidence associated with PBM was heterogeneous, but overall remained moderate. The main limitations were the diversity and the lack of precision of the treatment protocols which could compromise the efficiency and the reproducibility of the results of the PBM. For other effects related to chemo/radiation therapy (dysgeusia, osteonecrosis, peripheral neuropathy, alopecia, palmar-plantar erythrodysaesthesia) and haematopoietic stem cell transplantation (graft versus host disease), treatment with PBM suffers from a lack of studies or limited studies at the origin of a weakened level of proof. However, based on these results, it was possible to establish safe practice parameters and doses of PBM. CONCLUSION: Published data suggest that PBM could therefore be considered as supportive care in its own right for patients treated with radiation, chemotherapy, immunotherapy, hormone therapy or targeted therapies, whether in clinical practice or clinical trials. therapies. However, until solid data have been published on its long-term safety, the use of PBM should be considered with caution and within the recommended parameters and doses, particularly when practiced in areas of known or possible tumours. In this case, the patient should be informed of the theoretical benefits and risks of PBM in order to obtain informed consent before treatment.