Predicting Risk of Severe Toxicity and Early Death in Older Adult Patients Treated with Chemotherapy.

BACKGROUND: Determining the risk of grade 3-5 toxicity and early death (ED) is important to plan chemotherapy in older adult patients with cancer. Our objective was to identify factors predicting these complications at the time of treatment initiation. METHODS: 234 patients aged ≥70 were subjected to a geriatric assessment and variables related to the tumor and the treatment were also collected. Logistic regression multivariable analysis was used to relate these factors with the appearance of grade 3-5 toxicity and ED. Predictive scores for both toxicity and ED were then developed. RESULTS: Factors related to grade 3-5 toxicity were hemoglobin, MAX2 index, ADL, and the CONUT score. Factors related to ED were tumor stage and the GNRI score. Two predictive scores were developed using these variables. ROC curves for the prediction of toxicity and ED were 0.71 (95% CI: 0.64-0.78) and 0.73 (95% CI: 0.68-0.79), respectively. CONCLUSIONS: Two simple and reliable scores were developed to predict grade 3-5 toxicity and ED in older adult patients with cancer. This may be helpful in treatment planning.

miR-124 as a Liquid Biopsy Prognostic Biomarker in Small Extracellular Vesicles from NSCLC Patients.

Despite advances in non-small cell lung cancer (NSCLC) research, this is still the most common cancer type that has been diagnosed up to date. microRNAs have emerged as useful clinical biomarkers in both tissue and liquid biopsy. However, there are no reliable predictive biomarkers for clinical use. We evaluated the preclinical use of seven candidate miRNAs previously identified by our group. We collected a total of 120 prospective samples from 88 NSCLC patients. miRNA levels were analyzed via qRT-PCR from tissue and blood samples. miR-124 gene target prediction was performed using RNA sequencing data from our group and interrogating data from 2952 NSCLC patients from two public databases. We found higher levels of all seven miRNAs in tissue compared to plasma samples, except for miR-124. Our findings indicate that levels of miR-124, both free-circulating and within exosomes, are increased throughout the progression of the disease, suggesting its potential as a marker of disease progression in both advanced and early stages. Our bioinformatics approach identified KPNA4 and SPOCK1 as potential miR-124 targets in NSCLC. miR-124 levels can be used to identify early-stage NSCLC patients at higher risk of relapse.

Prognostic Impact of Dihydropyrimidine Dehydrogenase Germline Variants in Unresectable Non-Small Cell Lung Cancer Patients Treated with Platin-Based Chemotherapy.

Platin-based chemotherapy is the standard treatment for patients with non-small cell lung cancer (NSCLC). However, resistance to this therapy is a major obstacle in successful treatment. In this study, we aimed to investigate the impact of several pharmacogenetic variants in patients with unresectable NSCLC treated with platin-based chemotherapy. Our results showed that DPYD variant carriers had significantly shorter progression-free survival and overall survival compared to DPYD wild-type patients, whereas DPD deficiency was not associated with a higher incidence of high-grade toxicity. For the first time, our study provides evidence that DPYD gene variants are associated with resistance to platin-based chemotherapy in NSCLC patients. Although further studies are needed to confirm these findings and explore the underlying mechanisms of this association, our results suggest that genetic testing of DPYD variants may be useful for identifying patients at a higher risk of platin-based chemotherapy resistance and might be helpful in guiding future personalized treatment strategies in NSCLC patients.

High tumor burden in patients with non-small-cell lung cancer: a Delphi survey among Spanish oncologists.

Aim: To define high tumor burden (HTB) in non-small-cell lung cancer. Methods: A total of five oncologists initiated the project, selecting 66 participants, and elaborated a questionnaire with 26 statements using the Delphi method with a 9-point Likert scale of agreement. Results: Factors with moderate strength of consensus were identified, including a sum of the longest diameter of lesions ≥10 cm, elevated Lactate dehydrogenase, hepatic involvement, lymphangitis carcinomatosis, brain involvement unapproachable with local techniques and pericardial effusion. There was a consensus against increases in tumor markers and asymptomatic brain involvement being related to HTB. HTB was considered a relevant factor for treatment selection supporting the choice of combination regimens versus immunotherapy only. Conclusion: In this Delphi study, experts defined several factors associated with HTB in non-small cell lung cancer.

High tumor burden in non-small-cell lung cancer: A review of the literature.

Background and Aim: Lung cancer is the leading cause of cancer death worldwide and the majority of the patients have advanced/metastatic disease on presentation. In clinical practice, several biomarkers and clinical factors are taken into account when choosing the best treatment option in advanced non-small-cell lung cancer (NSCLC). One potential marker may be tumor burden (TB). However, this concept is not specifically defined in NSCLC, and usually, it is used as a synonymous for aggressive disease. Methods: A non-systematic literature review was conducted. We searched for eligible randomized controlled trials from PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials with a cutoff at February 2021. The keywords included non-small-cell lung cancer, tumor burden, aggressive disease, prognosis biomarker, predictive biomarker, and immunotherapy. Results and Conclusions: This review addresses the definition of TB in advanced NSCLC, the pathophysiology of high TB lesions, and the role of TB as a prognosis biomarker. Relevance for Patients: The concept of aggressive disease, as high tumor burden definition, remains poorly defined and rarely considered in clinical research or clinical practice in oncology. The identification of this subgroup of patients could be interesting for defining and optimizing a more aggressive treatment strategy.

Stoic attitude in patients with cancer from the NEOcoping study: Cross-sectional study.

AIM: Stoicism has been applied to describe a wide range of behaviors in the face of disease and influences an individual's use of coping strategies. This study tested the relationship between stoicism and social support, optimism, psychological distress, and coping strategies in patients with cancer. METHOD: NEOcoping is a multicenter, cross-sectional study. Participants' data were collected using a standardized, self-report form and LSS, MSPSS, Mini-MAC, BSI-18, and LOT-R questionnaires. Linear regression analyses were used to assess the association between stoicism and distress scores in both genders. A total of 932 individuals with non-metastatic, resected cancer were recruited. RESULTS: Males perceived a higher risk of recurrence and toxicity with adjuvant chemotherapy and obtained higher stoic attitude scores than females. Women scored higher on somatization, depression, and anxiety. Patients with high stoicism scores were older and experienced more maladaptive coping (helplessness, anxious preoccupation), and depression, while those with lower stoicism scores had greater perceived social support, optimism, and positive attitude. In both males and females, stoicism correlated negatively with perceived social support, optimism, and positive attitude, and positively with helplessness, anxious preoccupation, and depression. In men, stoicism was directly and negatively associated with social support and optimism, and positively with anxious preoccupation. In women, stoicism was positively associated. In women, stoicism was directly and negatively associated with social support and positively with age and optimism. Stoicism was directly and positively associated with helplessness. DISCUSSION: A stoic attitude was associated with lower social support, reduced optimism, and passive coping strategies (helplessness and anxious preoccupation) in this series of patients with cancer.

Targeted therapy moves to earlier stages of non-small-cell lung cancer: emerging evidence, controversies and future challenges.

Lung cancer continues to be the leading cause of cancer mortality and a serious health problem despite the numerous advances made in the last decade and the rapid advance of research in this field. In recent years, there has been a decrease in mortality from lung cancer coinciding with the approval times of targeted therapy. To date, targeted therapy has been used in the context of advanced disease in clinical practice, with great benefits in survival and quality of life. The next step will be to incorporate targeted therapy into the treatment of earlier stages of non-small-cell lung cancer, and there is already a randomized trial showing a disease-free survival benefit. However, there are many questions that need to be resolved first. In the present review, the authors discuss the findings of published reports and ongoing clinical trials assessing the role of targeted therapies in nonmetastatic disease.

Lay abstract Despite major therapeutic advances over the last decade, lung cancer continues to present the highest mortality rate of all cancers. Precision and personalized therapy directed at specific alterations in the genetic material of the tumor as well as immunotherapy has significantly improved survival in metastatic non-small-cell lung cancer. The next step will be to incorporate precision medicine into the treatment of earlier stages of non-small-cell lung cancer. The recent publication of the results of the ADAURA phase III trial showing a significant improvement in disease-free survival in patients with resected EGFR-mutated non-small-cell lung cancer who received an adjuvant EGFR-directed tyrosine kinase inhibitor called osimertinib has opened the doors to the incorporation of this novel agent into routine clinical practice. However, there are many questions that need to be resolved first. In the present review, the authors discuss the findings of published reports and ongoing clinical trials assessing the role of precision medicine in nonmetastatic disease.

Neoadjuvant Chemoimmunotherapy in Patients with Resectable Non-small Cell Lung Cancer.

OPINION STATEMENT: Worldwide, lung cancer is the most common cause of cancer morbidity and mortality. Despite a trend towards an escalating diagnosis of resectable non-small cell lung cancer (NSCLC), overall survival (OS) in patients with resectable NSCLC remains poor. The incorporation of chemotherapy into the neoadjuvant setting has improved disease-free survival (DFS), time to distant recurrence, and OS. Furthermore, the incorporation of immunotherapy and the combination of chemotherapy and immunotherapy have improved pathological responses, which seems to be associated with increased survival. Therefore, immunotherapy represents a paradigm shift in treating resectable NSCLC. However, validation in large randomized trials is mandatory and a longer postoperative follow-up period is required. Additionally, neoadjuvant therapy trials offer an exceptional environment for testing predictive biomarkers. PD-L1 expression and tumor mutational burden (TMB) are the most helpful tools for predicting the likelihood of response with immunotherapy in metastatic NSCLC. However, in the neoadjuvant setting, PD-L1 expression and TMB have had opposite results until now. Recently, the immune profiling and some immune-related genes also appear to be involved in the prognosis and response to immunotherapy in NSCLC. Further prospective studies are needed to derive definitive conclusions.

Prospective Study Comparing Clinicians' and Cancer Patients' Estimates of Risk of Relapse and Toxicity with Adjuvant Chemotherapy.

The aim of this study was to compare physicians' and patients' estimates of risk of relapse and toxicity. A prospective, cross-sectional, multicenter study including 735 patients with cancer and 29 oncologists. Physicians' appraisals of risk of relapse with and without chemotherapy (27.5% and 43.1%) and risk of severe toxicity (12.2%) were more realistic than those of patients (34.6%, 78.5%, and 57.4%, respectively). The greater the risk of recurrence and risk of toxicity estimated, the less physicians expressed satisfaction with SDM. Estimations of risk of relapse and toxicity are important in diagnostic and therapeutic decision-making and can help patients face their situation.

Development and Validation of an Early Mortality Risk Score for Older Patients Treated with Chemotherapy for Cancer.

Background: Estimation of life expectancy in older patients is relevant to select the best treatment strategy. We aimed to develop and validate a score to predict early mortality in older patients with cancer. Patients and Methods: A total of 749 patients over 70 years starting new chemotherapy regimens were prospectively included. A prechemotherapy assessment that included sociodemographic variables, tumor/treatment variables, and geriatric assessment variables was performed. Association between these factors and early death was examined using multivariable logistic regression. Score points were assigned to each risk factor. External validation was performed on an independent cohort. Results: In the training cohort, the independent predictors of 6-month mortality were metastatic stage (OR 4.8, 95% CI [2.4-9.6]), ECOG-PS 2 (OR 2.3, 95% CI [1.1-5.2]), ADL ≤ 5 (OR 1.7, 95% CI [1.1-3.5]), serum albumin levels ≤ 3.5 g/dL (OR 3.4, 95% CI [1.7-6.6]), BMI < 23 kg/m2 (OR 2.5, 95% CI [1.3-4.9]), and hemoglobin levels < 11 g/dL (OR 2.4, 95% CI (1.2-4.7)). With these results, we built a prognostic score. The area under the ROC curve was 0.78 (95% CI, 0.73 to 0.84), and in the validation set, it was 0.73 (95% CI: 0.67-0.79). Conclusions: This simple and highly accurate tool can help physicians making decisions in elderly patients with cancer who are planned to initiate chemotherapy treatment.

Psychometric Properties of the PDRQ-9 in Cancer Patients: Patient-Doctor Relationship Questionnaire.

BACKGROUND: The patient-doctor relationship is an important concept in health care. The aim of this study was to evaluate the psychometric properties, convergent validity, and factorial invariance of the Patient-Doctor Relationship Questionnaire (PDRQ-9). METHOD: Confirmatory factor analysis was conducted to explore the scale's dimensionality and test for strong measurement invariance across sex, age, and tumor site in a prospective, multicenter cohort of 560 patients who completed the PDRQ-9, Health-related Quality of Life Questionnaire (EORTC-QLQ-C30), and Brief Symptom Inventory (BSI) scales. RESULTS: The data supported a unidimensional structure. Thresholds and factor loadings could be constrained to be invariant across sex, age, and tumor site, indicating strong measurement invariance. Scores derived from the unidimensional structure exhibited satisfactory degrees of reliability and determinacy. Evidence of convergent validity was supported by modest positive correlations with functional (p<.001) and global quality-of-life (p<.001) and negative correlations with psychological distress (p<.001). Low satisfaction with the oncologist was associated with anxiety (p=.006), and depression (p=.004). CONCLUSIONS: The PDRQ-9 is a suitable, valid instrument for assessing the quality of patient-doctor relationships in cancer patients.

Prediction of Unplanned Hospitalizations in Older Patients Treated with Chemotherapy.

PURPOSE: To determine the incidence of unplanned hospitalization (UH) and to identify risk factors for UH in elderly patients with cancer who start chemotherapy. METHODS: In all, 493 patients over 70 years starting new chemotherapy regimens were prospectively included. A pre-chemotherapy geriatric assessment was performed, and tumor and treatment variables were collected. The association between these factors and UH was examined by using multivariable logistic regression. Score points were assigned to each risk factor. RESULTS: During the first 6 months of treatment, 37% of patients had at least one episode of UH. Risk factors were the use of combination chemotherapy at standard doses, a MAX2 index ≥1, a Charlson comorbidity score ≥2, albumin level <3.5 g/dL, falls in the past 6 months ≥1, and weight loss >5%. Three risk groups for UH were established according to the score in all patients: 0-1: 17.5%; 2: 34%; and 3-7: 57% (p < 0.001). The area under receiver operation characteristic (ROC) curve was 0.72 (95% CI: 0.67-0.77). CONCLUSION: This simple tool can help to reduce the incidence of UH in elderly patients with cancer who are scheduled to initiate chemotherapy treatment.

Novel SLC12A2-ROS1 Fusion in Non-Small Cell Lung Cancer with a Significant Response to Crizotinib: The Importance of Choosing the Appropriate Next-Generation Sequencing Assay.

Identifying the druggable target is crucial for patients with nonsquamous advanced non-small cell lung cancer (NSCLC). This article adds to the spectrum of ROS1 fusion cases described in NSCLC. We describe a novel SLC12A2-ROS1 rearrangement that has not been previously reported in other cancers: a fusion that has clinical and radiological sensitivity to crizotinib. Fluorescence in situ hybridization detected the SLC12A2-ROS1 fusion and it was confirmed through hybrid capture-based next-generation sequencing (NGS); however, the fusion could not be detected by amplicon-based assay. The success of implementing NGS into routine clinical practice depends on the accuracy of testing. The test's methodological features should then be considered because they significantly affect the results. Given this patient's response to crizotinib, identifying patients with undescribed ROS1 fusions has important therapeutic implications. KEY POINTS: This is the first known description of an SLC12A2-ROS1 fusion. Considering the patient's clinical features and tumor response observed after crizotinib therapy, the authors confirm that this new rearrangement has relevant clinical impact for patients with non-small cell lung cancer. The success of implementing next-generation sequencing (NGS) into routine clinical practice depends on the accuracy of the testing. Different assays and NGS platforms can achieve differing results. Each assay's limitations need to be considered to ensure the quality of precision medicine in clinical practice.

Immunotherapy combinations and chemotherapy sparing schemes in first line non-small cell lung cancer.

In recent years, studies have explored different combinations of immunotherapy and chemotherapy. The rationale behind these is the improved survival outcomes of new immunologic therapies used in first-line-treatment of advanced non-small cell lung cancer. Moreover, for the most-studied combinations of anti-programed death-1 (PD-1)/programed death ligand-1 (PD-L1) with the addition of platinum- based chemotherapy, recent research is investigating whether combining different immunologic antitumoral mechanisms of action, such as anti-PD-1/PD-L1 and anti-CTLA-4, or anti-PD-L1 and anti-TIGIT, with or without chemotherapy, can improve efficacy outcomes compared with more classical combinations, or compared with standard chemotherapy alone. Here, we present the data of the main randomized studies that have evaluated these combinations, focusing on the basic rationale behind the different combinations, and the efficacy and tolerability data available to date.

Prediction of Chemotoxicity, Unplanned Hospitalizations and Early Death in Older Patients with Colorectal Cancer Treated with Chemotherapy.

PURPOSE: To identify risk factors for toxicity, unplanned hospitalization (UH) and early death (ED) in older patients with colorectal carcinoma (CRC) initiating chemotherapy. METHODS: 215 patients over 70 years were prospectively included. Geriatric assessment was performed before treatment, and tumor and treatment variables were collected. The association between these factors and grade 3-5 toxicity, UH and ED (<6 months) was examined by using multivariable logistic regression. Score points were assigned to each risk factor. RESULTS: During the first 6 months of treatment, 33% of patients developed grade 3-5 toxicity, 31% had UH and 23% died. Risk factors were, for toxicity, instrumental activities of daily living, creatinine clearance, weight loss and MAX2 index; for UH, Charlson Comorbidity Score, creatinine clearance, weight loss, serum albumin, and metastatic disease; and for ED, basic activities in daily living, weight loss, metastatic disease, and hemoglobin levels. Predictive scores were built with these variables. The areas under receiver operation characteristic (ROC) curves for toxicity, UH and ED were 0.70 (95% CI: 0.64-0.766), 0.726 (95% IC: 0.661-0.799) and 0.74 (95% IC: 0.678-0.809), respectively. CONCLUSION: Simple scores based on geriatric, tumor and laboratory characteristics predict severe toxicity, UH and ED, and may help in treatment planning.

Undertreatment and overtreatment in older patients treated with chemotherapy.

BACKGROUND: Inconsistent doses and schemes are commonly used in older patients receiving cancer chemotherapy. We performed this study in patients with cancer and age ≥ 70 years to determine the frequency of undertreatment and overtreatment as well as factors influencing the decision to modify chemotherapy doses. PATIENTS AND METHODS: Patients aged ≥70 years starting new chemotherapy regimens were prospectively included in a multicentre study. The schedule and drug doses were determined by the treating oncologist. Pre-chemotherapy assessment included sociodemographics, treatment details and geriatric assessment (GA) variables. Association between these factors and undertreatment (use of less intensive cancer treatment [LICT] in a fit patient) or overtreatment (use of standard cancer treatment in an unfit older patient) were examined by multivariate logistic regression. RESULTS: Three- hundred ninety-seven patients were included, 43% of whom received LICT. If not adjusted for GA, toxicity did not differ between those receiving LICT (38%) or standard doses of chemotherapy (37%). If the dose of chemotherapy was analyzed according to the results of GA 61 (15%) patients had been undertreated and 133 (34%) had been overtreated. Undertreatment was related with increasing age and decreased renal function. Factors related with overtreatment were younger age, curative intention of treatment, prescription of G-CSF as primary prophylaxis and adequate cognitive status. Overtreated patients had more grade 3-4 toxicity than those receiving treatment adapted to fragility (42% vs 31%; p < 0.05). CONCLUSIONS: The use of chemotherapy without considering GA leads to overtreatment more commonly than undertreatment in older patients with cancer. Oncologists should take into account the results of GA to stratify patients and to avoid under or overtreatment.

Psychometric Properties of the PDRQ-9 in Cancer Patients: Patient-Doctor Relationship Questionnaire / Propiedades Psicométricas del PDRQ-9 en Pacientes con Cáncer: Cuestionario de Relación Médico-Paciente

Background: The patient-doctor relationship is an important concept in health care. The aim of this study was to evaluate the psychometric properties, convergent validity, and factorial invariance of the Patient-Doctor Relationship Questionnaire (PDRQ-9). Method: Confirmatory factor analysis was conducted to explore the scale’s dimensionality and test for strong measurement invariance across sex, age, and tumor site in a prospective, multicenter cohort of 560 patients who completed the PDRQ-9, Health-related Quality of Life Questionnaire (EORTC-QLQ-C30), and Brief Symptom Inventory (BSI) scales. Results: The data supported a unidimensional structure. Thresholds and factor loadings could be constrained to be invariant across sex, age, and tumor site, indicating strong measurement invariance. Scores derived from the unidimensional structure exhibited satisfactory degrees of reliability and determinacy. Evidence of convergent validity was supported by modest positive correlations with functional (p<.001) and global quality-of-life (p<.001) and negative correlations with psychological distress (p<.001). Low satisfaction with the oncologist was associated with anxiety (p=.006), and depression (p=.004). Conclusions: The PDRQ-9 is a suitable, valid instrument for assessing the quality of patient-doctor relationships in cancer patients. (AU)

Antecedentes: la relación médico-paciente es un concepto importante en cuidado de la salud. El objetivo de este estudio fue evaluar las propiedades psicométricas, la validez y la invariancia factorial del Cuestionario de Relación Médico-Paciente (PDRQ-9). Método: se realizó un análisis factorial confirmatorio para explorar la dimensionalidad de la escala y la invariancia de medición a través del sexo, la edad y la localización del tumor en una cohorte prospectiva multicéntrico de 560 pacientes que completaron el PDRQ-9, el Cuestionario de Calidad de Vida (EORTC-QLQ-C30) y la Inventario Breve de Síntomas (BSI-18). Resultados: los datos apoyaron una estructura unidimensional. Los umbrales y las cargas de los factores podían considerarse invariantes en función del sexo, la edad y localización de tumor (invariancia fuerte). Las puntuaciones derivadas de la estructura unidimensional mostraron grados satisfactorios de confiabilidad y determinación. La evidencia de validez convergente fue apoyada por correlaciones positivas modestas con la escala funcional (p<.001) y la calidad de vida (p<.001) y correlaciones negativas con malestar psicológico (p<.001). La baja satisfacción con el oncólogo estuvo asociada a mayor ansiedad (p =.006) y depresión (p= .004). Conclusiones: el PDRQ-9 es un instrumento válido y adecuado para evaluar la calidad en la relación médico-paciente en pacientes con cáncer. (AU)

Immunotherapy Moves to the Early-Stage Setting in Non-Small Cell Lung Cancer: Emerging Evidence and the Role of Biomarkers.

Despite numerous advances in targeted therapy and immunotherapy in the last decade, lung cancer continues to present the highest mortality rate of all cancers. Targeted therapy based on specific genomic alterations, together with PD-1 and CTLA-4 axis blocking-based immunotherapy, have significantly improved survival in advanced non-small cell lung cancer (NSCLC) and both therapies are now well-established in this clinical setting. However, it is time for immunotherapy to be applied in patients with early-stage disease, which would be an important qualitative leap in the treatment of lung cancer patients with curative intent. Preliminary data from a multitude of studies are highly promising, but therapeutic decision-making should be guided by an understanding of the molecular features of the tumour and host. In the present review, we discuss the most recently published studies and ongoing clinical trials, controversies, future challenges and the role of biomarkers in the selection of best therapeutic options.

Predicting Chemotherapy Toxicity in Older Patients with Cancer: A Multicenter Prospective Study.

BACKGROUND: Standard oncology tools are inadequate to distinguish which older patients are at higher risk of developing chemotherapy-related complications. MATERIALS AND METHODS: Patients over 70 years of age starting new chemotherapy regimens were prospectively included in a multicenter study. A prechemotherapy assessment that included sociodemographics, tumor/treatment variables, and geriatric assessment variables was performed. Association between these factors and the development of grade 3-5 toxicity was examined by using logistic regression. RESULTS: A total of 551 patients were accrued. Chemotherapy doses (odds ratio [OR] 1.834; 95% confidence interval [CI] 1.237-2.719) and creatinine clearance (OR 0.989; 95% CI 0.981-0.997) were the only factors independently associated with toxicity. Only 19% of patients who received reduced doses of chemotherapy and had a creatinine clearance ≥40 mL/minute had grade 3-4 toxicity, compared with 38% of those who received standard doses or had a creatinine clearance <40 mL/minute (p < .0001). However, no satisfactory multivariate model was obtained using different selection approaches. CONCLUSION: Chemotherapy doses and renal function were identified as the major risk factors for developing severe toxicity in the older patient. These factors should be considered when planning to initiate a new chemotherapy regimen and should also lead to a closer follow-up in these patients. IMPLICATIONS FOR PRACTICE: Older patients are more vulnerable to chemotherapy toxicity. However, standard tools are inadequate to identify who is at higher risk of developing chemotherapy-related complications. Chemotherapy doses (standard vs. reduced) and renal function were identified as the major risk factors for developing severe toxicity in the elderly. These factors should be considered when planning to initiate a new chemotherapy regimen and should also lead to a closer follow-up.

Validity and Reliability of the Decision Regret Scale in Cancer Patients Receiving Adjuvant Chemotherapy.

OBJECTIVES: Decisional regret is an indicator of satisfaction with the treatment decision and can help to identify those patients who need more support and evaluate the efficacy of decision support interventions. The objectives of this study are, 1) to evaluate the psychometric properties of the Decision Regret Scale and 2) to analyze the moderating effect of psychological distress on functional status and regret in patients with cancer following adjuvancy. METHODS: A prospective, multicenter cohort of 403 patients who completed the Decision Regret Scale (DRS), Health-Related Quality of Life (EORTC QLQ-C30), and Brief Symptom Inventory (BSI). The evaluation was conducted six months after receiving adjuvant treatment in patients with resected cancer. RESULTS: After treatment, most participants (51.9%) experienced no decision regret; 33.7% felt mild regret, and 14.4% exhibited high levels of regret. The Spanish version of the DRS demonstrated satisfactory properties: it had a strong, clear unidimensional factorial structure with substantial loadings. Decisional regret was related with lower scores on functional, symptom, and quality of life scales, and higher levels of psychological distress (all P = 0.001). Psychological distress was found to have a moderating effect on the relationship between functional state and decision regret. CONCLUSIONS: The Spanish version of the DRS is a reliable, valid tool to evaluate regret and post-decisional quality in clinical practice and further highlights the potential clinical implications of psychological distress for the relation between physical status and regret.