Postoperative Cancer Patients Research Articles

Acupuncture Effect on Digestion in Critically Ill Post-Operative Oral and Hypo-pharyngeal Cancer Patients

Acupuncture Effect on Digestion in Critically Ill Post-Operative Oral and Hypo-pharyngeal Cancer Patients

Effects of a mouth-opening intervention with remote support on adherence, the maximum interincisal opening, and mandibular function of postoperative oral cancer patients: A randomized clinical trial.

The purpose of the study was to investigate the effects of a mouth-opening intervention for postoperative trismus and remote support provided via telephone following hospital discharge for intervention adherence in patients with oral cancer. The study is a parallel randomized trial. Patients admitted at a general hospital for oral cancer surgery were recruited and randomly assigned to either the experimental or the active control group. Both groups underwent a 12-week intervention program, including warm compress, masticatory muscle massage, and jaw exercise. Subjects in the experimental group received additional support via telephone following hospital discharge. Data on intervention adherence maximum interincisal opening and mandibular function impairment were collected at baseline, week 4, and week 12. Sixty subjects (30 in each group) that completed the study were included in the analysis. At week 12, the intervention practice time in the experimental group was 299.67 min (95% CI: 223.44-357.89) more than that of the active control group. From baseline to week 12, the change in maximum interincisal opening was 10.30 mm (95% CI: 8.22-12.37) greater in the experimental than in the active control group. The change in mandibular function impairment score was -0.36 (95% CI: -0.44 to -0.28) greater in the experimental than in the active control group. The study results support the effect of remote support via telephone for enhancing adherence to the intervention protocol, and the effect of the intervention program for alleviating trismus and mandibular function impairments in patients who receive curative surgery for oral cancer.

A dosimetric study of automated intensity-modulated radiotherapy planning for rectal cancer patients based on Pinnacle3 system

Objective To compare the dosimetric differences of the targets and the OARs in rectal cancer patients between Auto-planning and intensity-modulated radiotherapy (IMRT) , and explore the advantages of Auto-planning (AP). Methods A total of 10 postoperative radiotherapy rectal cancer patients were selected, whose CT images were used to create AP plan and IMRT plan respectively using Pinnacle3 9.10 treatment planning system. Through comparing the dose-volume histograms of the two plan types, the differences of the homogeneity index, conformity index and the doses to organs at risk (OARs) were analyzed. Results The AP plans were significantly better (t= -1.36, -3.03, 0.37, P 0.05). In the AP plan, the HI values of the target area were significantly reduced, and the CI values were significantly increased (t=1.24, 0.10, P 0.05). Conclusions Compare with IMRT plans, the AP plans for rectal cancer can achieve better homogeneity index, effectively reduce the maximum dose, increase the minimum dose, reduce hot and cold volumes in the target area. Meanwhile, AP plans can also protect the normal tissues better by reducing the dose to the OARs. Key words: Rectal cancer; Auto-planning; Intensity-modulated radiotherapy

Research of obtaining pseudo-CT images based on ultrasound deformation fields in radiotherapy

Objective An improved method for obtaining pseudo-computed tomography (CTps) based on ultrasound deformation field. Methods The three-dimensional image data of computed tomography and ultrasound for three postoperative cervical cancer patients were selected, including the CT (CTsim) and ultrasound (USsim) images obtained during the simulated positioning stage, and the cone beam CT (CBCT) and ultrasound images obtained during the positioning verification stage of the treatment one week later. Binary masks of the OROI and OROW were created and applied in ultrasound image registration; thus, the deformation field was obtained. The deformation field was applied to CTsim images and different pseudo-CT images were obtained. Similarities between these pseudo-CT images and those of CBCT were compared, and registration accuracies between pseudo-CT images under different binary masks and CTsim were discussed. Results The averages of the correlation coefficient between pseudo-CT based on OROI, OROW, no binary mask and CBCT were 0.95, 0.82 and 0.64 respectively. The average of the normalized mean square Error were 0.12, 0.42 and 0.57 respectively. Conclusion The pseudo-CT based on OROI binary mask matches the best with CTsim and achieves the highest similarity with CBCT. Key words: Tomography, X-ray computed; Three-dimensional ultrasound image; Pseudo-CT imagingimage guided radiation therapy

EP-2189 Compare OARs dose in postoperative high-risk prostate cancer patients using IMRT and VMAC technique

EP-2189 Compare OARs dose in postoperative high-risk prostate cancer patients using IMRT and VMAC technique

A clinical trial of somatic and germline analyses for healthy longevity in a postoperative cancer patient.

Recent developments in molecular-targeted therapies have improved the clinical outcome of cancer patients; however, the issue of adverse effects due to treatments has often gone unconsidered. We herein report the results of a clinical trial of dual genomic analyses for healthy longevity in a postoperative cancer patient. We performed dual genomic analyses for a representative 79-year-old rectal cancer patient who relapsed with liver metastasis. First, we determined single-nucleotide polymorphisms according to the constitution and disease risk in the genomic DNA from the patient's saliva by referring to the data of 10,000 Japanese patients obtained from Yahoo Japan Corporation. Second, we conducted whole-exome sequencing to detect druggable mutations in the primary tumour. Forty of 59 determinable characters related to the constitution were consistent with the clinical phenotype. Several diseases classified as 'high risk' diseases actually occurred during the patient's clinical course. Of the 129 significant mutations, we identified somatic mutations in BRAF, PIK3CA, and SMAD4 as targets. The dual genomic examination will improve the follow-up observation system to support primary care doctors in the social community for taking care of postoperative cancer patients.

Loneliness in Pre and Post-operative Cancer Patients: A Mini Review

This review explored the experience of hospitalization and the experience of cancer patients who were undergoing Ear Nose and Throat [ENT] surgery. Hospitals, which were designed with treatment and healing in mind, are known to be the source of uncontrollable noise, physicians who talk in a language that patients do not understand. Entering the hospital as a patient, one becomes part of that very complex system, which may include being treated as a ‘nonperson,’ not getting enough information, and losing control of daily activities. Hospitalized patients’ social contact is limited to interaction with the medical staff which thus become a key factor in determining the quality of care, and whether the patients can successfully cope with the stress of their hospitalization experience.Loneliness was found to be associated with a range of negative physical health outcomes such as dementia, increased blood pressure, suicidal thinking and unhealthy and damaging behaviors such as smoking, excess alcohol consumption and lack of exercise leading and contributing to increased mortality. Being, both, hospitalized and in the midst of a frightening illness they experience loneliness and isolation.

Effects of transitional care on urinary control function and quality of life among prostatic cancer patients with postoperative urinary incontinence

Objective To explore the effects of transitional care on postoperative urinary control function and quality of life among prostatic cancer patients so as to provide a basis for improving patients' quality of life after discharge. Methods From January 2013 to December 2014, we selected 120 prostatic cancer patients with postoperative urinary incontinence of the First Affiliated Hospital of Wenzhou Medical University as subjects. All of the patients were divided into observation group and control group with the method of random number table. Patients of control group received routine nursing instruction after discharge. On the basis of routine nursing, patients of observation group were treated with transitional care after discharge. The urinary control function and quality of life of patients between two groups were compared six months after discharge. Results The total compliance rate of functional exercise for pelvic mucles in observation group was 91.7% statistically higher than that (71.7%) of control group (χ2=8.015, P<0.01) ; the scores of self-care, self-responsibility, self-concept and health knowledge of observation group were statistically higher than those of control group (t=4.536, 11.425, 9.674, 2.942; P<0.01) . The recovery time of urinary control function of observation group was (1.21±0.72) months lower than that (3.03±0.84) months of control group (t=12.742, P<0.01) ; the total score of quality of life was (77.13±12.42) in observation group higher than that (59.76±13.21) in control group (t=6.574, P<0.01) ; the differences were all statistical. Conclusions The application of transitional care in postoperative prostatic cancer patients after discharge can improve patient compliance as well as self-care ability, shorten postoperative recovery time of urinary control function and improve patients' quality of life. Key words: Prostatic neoplasms; Prostatectomy; Urinary incontinence; Quality of life; Transitional care; Urinary control function

Using novel real-time tracking to monitor postoperative recovery in a comprehensive cancer center.

250 Background: Early mobilization is thought to be a key component of postoperative care following surgery. However, the benefit of early ambulation is not well studied. Normal and abnormal ambulatory patterns for postoperative cancer patients remains unknown. The aim of the current study is to characterize the postoperative movement patterns of the patients recovering from surgery at Comprehensive Cancer Center using an objective novel real-time location system (RTLS). Methods: In this retrospective cohort study, patient ambulatory movements were captured using RTLS. Clinical data was extracted from the medical record. A custom algorithm was created to measure postoperative ambulation and an ambulatory mobility event was defined as movement in and out of the patient’s room on the postoperative ward lasting from three to 60 minutes. Mobility data was analyzed to determine predictors of postoperative ambulation. Results: 358 postoperative patients (39.7% female, median age 62) were identified for inclusion in this study. 272 (76.0%) patients had a postoperative mobility event. Median number of walks 1.2 (IQR 0.7-2.2) per day was 6.7 (IQR) with median duration of 6.7 (IQR4.6-10.8) minutes. Time to first ambulatory event after surgery was 1.2 (IQR 0.9-2.0) days. Time to first ambulatory events varied by surgical service with Thoracic Surgery having the most patients ambulating on postoperative day zero (43.3%). In univariate analysis, young age, shorter operation length, and surgical service were predictors of early first ambulatory event (all p &lt; 0.05). In multiple variable analysis, young age and surgical service were predictors of early first ambulatory event (all p &lt; 0.05). Conclusions: The current study demonstrates the feasible application of RTLS to passively monitor the recovery of postoperative cancer patients In addition, this technology provides a novel opportunity to correlating patient movement with clinical outcomes, such as morbidity, mortality, and length of stay.

Three Biomarkers Predict Gastric Cancer Patients' Susceptibility To Fluorouracil-based Chemotherapy.

Background: Fluorouracil-based chemotherapy is recommended by the main clinical guidelines for post-operative gastric cancer (GC) patient's chemotherapy treatment, this study aim to establish relate model to predict patients' susceptibility to fluorouracil-based chemotherapy to prevent patients' unnecessary exposure to chemotherapy treatments and improve patients' treatment.Methods: Data from Gene Expression Omnibus (GEO) database, Cancer Cell Line Encyclopedia (CCLE) database, Cancer Therapeutics Response Portal (CTRP) and The Cancer Genome Atlas (TCGA) were used. A predictive model was built based on univariate and multivariate Cox analysis and visualized by nomogram. Survival analysis was performed using Kaplan-Meier and log-rank test.Results: A total of 514 differentially expressed genes (DEGs) were identified between fluorouracil-resistant cell lines and fluorouracil-sensitive cell lines based on CCLE database. A total of 300 patients who had radical gastrectomy were recruited, of which 144 received fluorouracil-based chemotherapy and 156 were untreated. Three biomarkers (CTF1, BTN3A3, ADAD2) were finally selected by univariate and multivariate Cox regression analysis to establish the predictive models visualized by nomogram. This model could precisely predict both the Disease free survival (DFS) and Overall survival (OS) of patients treated with fluorouracil-based chemotherapy after surgery compared to untreated GC patients validated by both GEO database and TCGA database.Conclusion: Our data established three genes-based predictive model which might predict GC patients' susceptibility to fluorouracil and help clinicians develop personalized treatment.

Speech Rehabilitation with Palatal Augmentation Prosthesis in Postoperative Oral Cancer Patients

Speech Rehabilitation with Palatal Augmentation Prosthesis in Postoperative Oral Cancer Patients

Behavioural Response Alteration in Caenorhabditis elegans to Urine After Surgical Removal of Cancer: Nematode-NOSE (N-NOSE) for Postoperative Evaluation.

The technique used for cancer monitoring is essential for effective cancer therapy. Currently, several methods such as diagnostic imaging and biochemical markers have been used for cancer monitoring, but these are invasive and show low sensitivity. A previous study reported that Caenorhabditis elegans sensitively discriminated patients with cancer from healthy subjects, based on the smell of a urine sample. However, whether C. elegans olfaction can detect the removal of cancerous tumours remains unknown. This study was conducted to examine C. elegans olfactory behaviour to urine samples collected from 78 patients before and after surgery. The diagnostic ability of the technique termed Nematode-NOSE (N-NOSE) was evaluated by receiver operating characteristic (ROC) analysis. The ROC curve of N-NOSE was higher than those of classic tumour markers. Furthermore, we examined the change in C. elegans olfactory behaviour following exposure to preoperative and postoperative samples. The results suggest that a reduction in attraction indicates the removal of the cancerous tumour. This study may lead to the development of a noninvasive and highly sensitive tool for evaluating postoperative cancer patients.

A multi-institutional observational study on the effects of three-dimensional radiotherapy and weekly 40-mg/m2 cisplatin on postoperative uterine cervical cancer patients with high-risk prognostic factors

BackgroundThe aim of this study was to evaluate the effects of treatment with both three-dimensional radiotherapy (3DRT) and weekly 40-mg/m2 cisplatin on postoperative uterine cervical cancer patients with high-risk prognostic factors.MethodsWe conducted a retrospective multi-institutional chart review of postoperative uterine cervical cancer patients with high-risk prognostic factors who had been treated with both 3DRT and weekly 40-mg/m2 cisplatin from 2007 to 2012. Each participating hospital provided detailed information regarding patient characteristics, treatment outcomes, and treatment complications.ResultsThe eligible 96 patients were analyzed. The median follow-up period was 61 months. The 3-year relapse-free survival, overall survival (OS), and locoregional relapse-free survival (LRFS) rates were 76%, 90%, and 88%, respectively. In multivariate analysis, the histological finding of either adenocarcinoma or adenosquamous carcinoma was a significant risk factor for both OS and LRFS. The percentage of patients with grade ≥ 3 acute hematologic toxicity, acute lower gastrointestinal toxicity (GIT), and late lower GIT were 45%, 19%, and 17%, respectively.ConclusionsThe outcomes of concurrent chemoradiotherapy (CCRT) using weekly 40-mg/m2 cisplatin are similar to those in the previous studies that used several chemotherapy regimens. However, postoperative CCRT using 3DRT had a high level of late GIT.

A Prospective Study of IMRT Versus 3D-CRT for Post-Operative Cervical Cancer Patients.

The use of intensity-modulated radiation therapy (IMRT) in postoperative cervical cancer is on the rise, yet there is still some controversy to adopt adjuvant IMRT as standard practice. The purpose of this study is to compare the difference between IMRT and three dimensional conformal radiation therapy (3D-CRT) especially in quality of life for pelvic radiation of postoperative treatment with cervical cancer. A total of 398 patients were enrolled from Oct 2015 to Oct 2017. They were selected randomly into two groups: IMRT group (n=190) and 3D-CRT group (n=208). Each patient received a prescribed dose of 45Gy/25F. Radiation dosimetry, the grade 2-4 in GI and GU; the score from functional assessment of cancer therapy scale-cervix (FACT-CX) scale and expanded prostate cancer index composite for clinical practice (EPIC-CP) scale were compared. (1) There was no significant difference on age, culture level, family economic condition and ratio of radiochemotherapy in two groups (P>0.05). (2) Dosimetric comparison: IMRT plans had a significant better conformity index (CI) of PTV compared with 3D-CRT (P<0.05). Compared with 3D-CRT plans , V40 of the small bowel, rectum, bladder, V20 and V10 of bone marrow were all significantly reduced (P<0.05). (3) The incidence of acute grade 2-3 gastriontestinal reaction was significantly high for 3D-CRT group versus the IMRT group(24.0%,15.8%; P=0.04). The incidence of acute grade 2-3 urinary toxicity was high for 3D-CRT group versus the IMRT group(25.5%,17.9%),but has no statistically difference P=0.07). (4) Quality of life scale: FACT-Cx score were 84.8±16.3 and 71.2±17.9 before and after radiation therapy in 3D-CRT group, 81.8±15.5 and 76.4±14.4 in IMRT group. FACT-Cx score was decreased significantly from beginning of radiation in 3D-CRT group ,it was reached 12.3±4.5,but it was only 5.1±2.3 in IMRT group(t=15.530, P=0.000). EPIC-CP scale score: EPIC-CP score were 15.4 ± 6.2 and 21.7±7.1 before and after radiation therapy in 3D-CRT group, 15.6 ± 6.9 and 18.4±7.2 in IMRT group. EPIC-CP score was increased significantly from beginning of radiation in 3D-CRT group ,it was reached 6.6±4.1,but it was only 3.1±4.2 in IMRT group(t=5.500, P=0.000). IMRT has shown a dosimetric advantage and also provided good quality of life for the postoperative patients with cervical cancer compared to 3D-CRT. Long term follow up will be needed to determine late toxicity and DFS/OS.

Dual modality imaging of positron emission tomography-computed tomography (PET-CT) in evaluation of postoperative renal cancer patients

ObjectiveThe aim of our study was to determine the role of PET-CT in detection of recurrence and metastasis of renal cell carcinoma. Patients and methodsOur study included twenty patients with renal cell carcinoma. All patients were from those attending to radio-diagnosis department in Sharq El Madina Hospital in Alexandria referred for PET/CT study. The following were done for all patients: Careful history taking, clinical examination, ultrasound, enhanced CT and PET/CT. ResultsOne patient (5%) had positive PET/CT findings at different bone sites with high metabolic activity however these lesions were negative at CECT without any anatomical changes neither lytic nor sclerotic changes could be detected at these bone sites, with sensitivity, specificity and accuracy of PET/CT were 100%, 83% and 95% respectively. ConclusionPET/CT had advantage to PET and CT alone, making it an appropriate imaging technique in recurrence detection, therapeutic assessment and follow up of patients with renal cell carcinoma.

Association between chronological depressive changes and physical symptoms in postoperative pancreatic cancer patients

BackgroundPancreatic cancer (PC) has poorer prognosis and higher surgical invasiveness than many other cancers, with associated psychiatric symptoms including depression and anxiety. Perioperative depression has not been investigated in PC patients regarding surgical stress and relevant interventions.MethodsWe evaluated chronological depressive changes and subjective physical symptoms in surgically treated PC patients preoperatively and at 3 and 6 months postoperatively.Enrolled patients undergoing pancreatic tumor surgery completed questionnaires based on the Self-Rating Depression Scale (SDS) and Functional Assessment of Cancer Therapy for Patients with Hepatobiliary Cancer (FACT-Hep) preoperatively, and at 3 and 6 months postoperatively. Responses were analyzed with JMP® Pro using one-way and two-way ANOVA, Spearman’s rank correlation coefficient, and multiple regression analysis.ResultsMalignancy was diagnosed in 73 of 101 patients postoperatively; SDS score was significantly higher in these patients than in those with benign tumors at all timepoints: malignant/benign, 41.8/37.9 preoperatively (p = 0.004); 43.5/37.8 3 months postoperatively (p = 0.006); and 42.9/37.7 6 months postoperatively (p = 0.020). SDS scores were significantly higher in patients < 65 years old with malignancy at 3 months than at 6 months postoperatively (44.6/42.5, p = 0.046) and in patients with malignancy who underwent pancreaticoduodenectomy at 3 months postoperatively than preoperatively (43.4/41.1; p = 0.028). SDS scores moderately correlated with 8 physical symptom-related FACT-Hep items 3 months postoperatively (p < 0.05), showing low-to-moderate correlation with 16 physical symptom-related FACT-Hep items at 6 months postoperatively (p < 0.05). Multiple regression analysis of FACT-Hep symptoms significantly correlated with SDS scores revealed the following significant variables: “lack of energy” (p < 0.000) and “pain” (p = 0.018) preoperatively (R2 = 0.43); “able to perform usual activities” (p = 0.031) and “lack of energy” (p < 0.000) at 3 months postoperatively (R2 = 0.51); and “stomach swelling or cramps” (p = 0.034) and “bowel control” (p = 0.049) at 6 months postoperatively (R2 = 0.52).ConclusionsPC patients experience persistently high levels of depression preoperatively through 6 months postoperatively, with associated subjective symptoms including pain and gastrointestinal symptoms.Trial registrationUMIN Clinical Trials Registry 000009592, Registered 20 December 2012.

Physical Activity Among Postoperative Esophageal Cancer Patients.

Previous literature has reported that regular physical activity enhances health-related quality of life for cancer patients. However, there is a lack of studies that focus on physical activity among postoperative esophageal cancer patients. The aims of this study were to (1) describe the prevalence of physical activity among postoperative esophageal cancer patients, (2) explore variables related to physical activity (demographics, nutrition, dysphagia, and health-related qualify of life), and (3) examine potential reasons for inactivity among participants who scored low using case studies. In this cross-sectional design, physical activity was evaluated by the Japanese version of the International Physical Activity Questionnaire. Variables were analyzed using Spearman rank correlation coefficients, Mann-Whitney U tests, or Fisher exact tests. Fifty-eight patients participated in this study; 79% met the recommended physical activity guidelines. Present occupational status and past leisure-time physical activity behavior before the cancer diagnosis were related to current leisure-time physical activity and meeting the guidelines postoperatively. Participants who scored 0 (little or no activity) in the questionnaire also scored low in health-related quality of life. Participants performed especially well in physical activity related to leisure time and transportation. Positive reinforcement is needed for patients who perform adequate levels of physical activity, and reviewing the benefits of regular physical activity is encouraged for all. Occupational status and past leisure-time physical activity before diagnosis can be indicators for promoting physical activity among postoperative esophageal cancer patients. Inactive participants should be supported to promote both physical activity and health-related qualify of life.

Value of Coagulation and Fibrinolysis Biomarker in Lung Cancer Patients with Thromboembolism

背景与目的凝血与纤溶标志物能有效反映肺癌术后静脉置管患者体内止凝血各系统的功能紊乱，其水平变化与患者高凝状态密切相关。本研究旨在分析凝血与纤溶标志物在肺癌术后静脉置管患者中的变化趋势，评价其在肺癌血栓性疾病中的诊断效能，探讨其在肺癌深静脉置管患者凝血与纤溶平衡改变中的临床意义。方法收集肺癌术后静脉置管患者118例，其中肺癌血栓栓塞患者29例、对照组89例。分别检测血浆中血栓调节蛋白（thrombomodulin, TM）、凝血酶-抗凝血酶Ⅲ复合物（thrombin-antithrombin complex, TAT）、纤溶酶-α2纤溶酶抑制剂复合物（α2-plasmin inhibitor-plasmin complexes, PIC）、组织型纤溶酶原激活剂-抑制剂1复合物（tissue plasminogen activator-inhibitor complexes, t-PAIC）和凝血酶原时间（prothrombin time, PT）、活化部分凝血活酶时间（activatedpartial thrombo plastin time, APTT）、凝血酶时间（thrombin time, TT）、纤维蛋白原（fibrinogen, FIB）、抗凝血酶Ⅲ（antithrombin Ⅲ, ATIII）、纤维蛋白原降解产物（fibrinogen degradation products, FDP）以及D二聚体（D-Dimer, D-D）的水平，分析其变化及血栓发生的诊断效能。结果在肺癌术后静脉置管患者中，凝血与纤溶标志物TM、TAT、PIC、t-PAIC、D-D、FDP水平在血栓组高于非血栓组，差异均有统计学意义（P < 0.05）。诊断效能分析显示，TM、TAT、PIC、t-PAIC、D-D及FDP的曲线下面积分别为0.770、0.771、0.669、0.671、0.819和0.816，差异具有统计学意义（P < 0.05）。结论肺癌术后置管患者体内凝血和纤溶活性增强，早期监测凝血和纤溶标志物可预防血栓的发生，减少肺癌患者术后血栓并发症的发生。

Effects of pain management based on active pain assessment in postoperative liver cancer patients

Objective To explore the effects of pain management based on active pain assessment in postoperative liver cancer patients. Methods From January 2015 to May 2017, we selected 88 liver cancer patients from Department of Hepatobiliary Surgery of the First Affiliated Hospital of Wenzhou Medical University by convenience sampling as subjects. All of the patients were divided into the observation group and control group with the random number table, 44 cases in each group. Patients of the control group received routinely postoperative pain management. Patients of the observation group were treated with pain management based on functional activity score. Patients were assessed with the Houston Pain Outcome Instrument (HPOI) , Pittsburgh Sleep Quality Index (PSQI) , Physical Fitness Rating Scale. And then, we compared the time of postoperative intestinal ventilation, out-of-bed activity and being hospitalized of patients in two groups. Results After intervention, there were statistical differences in the score of pain experience, emotional impact, daily life impact and satisfaction of pain education in HPOI as well as the score of PSQI and ECOG of patients in two groups (P<0.05) . The differences of patients were also significant in the time of postoperative intestinal ventilation, out-of-bed activity and being hospitalized in two groups (P<0.05) . Conclusions Pain management based on active pain assessment has good control effects by which patients' physical strength, sleep and postoperation recovery well. Key words: Liver neoplasms; Sleep; Active pain assessment

Effect of denosumab on bone mineral density in Japanese women with osteopenia treated with aromatase inhibitors for breast cancer: subgroup analyses of a Phase II study.

BackgroundThe aim of the study was to conduct subgroup analyses of therapeutic effects of 12-month denosumab therapy on the percentage change in bone mineral density (BMD) from baseline in the lumber spine and femoral neck.Materials and methodsWe prospectively evaluated the BMD of the lumbar spine and femoral neck of 100 hormone receptor-positive, clinical stage I–IIIA postoperative postmenopausal breast cancer patients, for whom treatment with aromatase inhibitors (AIs) as adjuvant endocrine therapy was scheduled. The primary endpoint was the percent change in lumbar spine BMD from baseline to 12 months. Patient subgroups were analyzed according to baseline variables that are known risk factors for bone loss, including previous AI therapy, age, time since menopause, baseline body mass index (BMI), and baseline BMD T-score.ResultsAt 12 months, lumbar spine BMD increased by 4.7%; the patients who were administered AI therapy prior to denosumab (n=70) demonstrated a 4.7% increase in BMD, and the patients who received denosumab at the start of AI therapy (n=30) demonstrated a 4.5% increase in BMD (p=0.8385). Additionally, 2.4% and 1.4% increases in BMD of the right and left femoral neck, respectively, were observed. Initiation of AI (with denosumab, before denosumab), type of AI (non-steroidal, steroidal), age (<65, ≥65 years), time since menopause (≤5, >5 years), BMI (<25, ≥25 kg/m2), and T-score (≤−1.0, >−1.0) of the right femoral neck were as follows: (2.2%, 2.5%, p=0.7773), (2.6%, 0.9%, p=0.1726), (2.5%, 2.3%, p=0.7594), (2.1%, 2.4%, p=0.2034), (2.1%, 2.9%, p=0.2034), and (2.3%, 2.7%, p=0.6823), respectively. Initiation of AI (with denosumab, before denosumab), type of AI (non-steroidal, steroidal), age (<65, ≥65 years), time since menopause (≤5, >5 years), BMI (<25, ≥25 kg/m2), and T-score (≤−1.0, >−1.0) of the left femoral neck were as follows: (1.0%, 1.5%, p=0.1972), (1.2%, 2.7%, p=0.2931), (1.4%, 1.3%, p=0.8817), (−0.1%, 1.6%, p=0.1766), (1.3%, 1.9%, p=0.6465), and (1.5%, 1.1%, p=0.6573), respectively.ConclusionTwice-yearly treatment with denosumab was associated with increased BMD among Japanese women receiving adjuvant AI therapy, regardless of the baseline characteristics or skeletal site.