Preliminary Effectiveness of an In-Hospital Peer Support Program, Adolescent and Young Adult Hiroba, on Anxiety in Adolescent and Young Adult Patients with Cancer.

Purpose: Adolescent and young adult (AYA) patients with cancer have few opportunities to connect with patients of the same generation while hospitalized. Although anxiety is frequently reported by them, there are no reports on the psychological effectiveness of an in-hospital patient support program based on peer support. This study aimed to evaluate the effectiveness of a program, termed Adolescent and Young Adult Hiroba (AYA Hiroba), for anxiety in AYA patients with cancer. Methods: This single-center, prospective, observational study in 24 AYA patients with cancer was conducted at the National Cancer Center Hospital in Japan. The Hospital Anxiety and Depression Scale-Anxiety (HADS-A) was used to evaluate the primary outcome, anxiety. The Distress Thermometer (DT) was used to evaluate the secondary outcome, distress. The two outcomes were assessed before and after participation in AYA Hiroba. The Net Promoter Score (NPS) was used to evaluate satisfaction after participation in AYA Hiroba. Participants' free-text descriptions of the program were categorized according to similarities and differences. Results: The HADS-A and DT scores were significantly lower after the program than before (p < 0.001), as was the percentage of AYA patients with cancer with high distress (p = 0.04). The NPS was 27, which was lower than the value of 52 obtained in our previous study. Requests and suggestions to improve the program were grouped into three categories: content, facilitation, and online connection environment. Conclusion: This study suggests the preliminary effectiveness of the in-hospital peer support program for anxiety in AYA patients with cancer. The Clinical Trial Registration number: UMIN000045779.

Feasibility of an Electronic Patient-Reported Outcome Tool for Screening Distress and Supportive Care Needs of Adolescents and Young Adults with Cancer.

Purpose: Although adolescent and young adult (AYA) cancer patients are digital natives and have high digital communication needs, previous studies of screening tools for AYAs have primarily used paper when measuring patient-reported outcomes (PROs). There are no reports on using an electronic PRO (ePRO) screening tool with AYAs. This study evaluated the feasibility of such a tool in clinical settings, and assessed the prevalence of AYAs' distress and supportive care needs. Methods: An ePRO tool based on the Distress Thermometer and Problem List (DTPL)-Japanese (DTPL-J) version for AYAs was implemented in a clinical setting for 3 months. To determine the prevalence of distress and need for supportive care, descriptive statistics were calculated for participant characteristics, selected items, and Distress Thermometer (DT) scores. Response rates, referral rates to an attending physician and other experts, and time required to complete PRO tools were assessed to evaluate feasibility. Results: From February to April 2022, 244 (93.8%) of 260 AYAs completed the ePRO tool based on the DTPL-J for AYAs. Based on a DT cutoff of ≥5, 65 of 244 patients (26.6%) had high distress. Worry (n = 81, 33.2%) was the most frequently selected item. Primary nurses referred 85 (32.7%) patients to an attending physician or other experts. The referral rate resulting from ePRO screening was significantly higher than that after PRO screening (χ2(1) = 17.99, p < 0.001). The average response time did not differ significantly between ePRO and PRO screening (p = 0.252). Conclusion: This study suggests the feasibility of an ePRO tool based on the DTPL-J for AYAs.

Predicting Trabectedin Efficacy in Soft Tissue Sarcoma: Inflammatory Biomarker Analysis.

BACKGROUND/AIM: Trabectedin is used as a treatment for advanced-stage soft tissue sarcomas (STSs), particularly liposarcoma and leiomyosarcoma. Aside from its direct effect on tumor cells, trabectedin can affect the immune system in the tumor microenvironment. This study aimed to evaluate whether inflammatory biomarkers predict trabectedin efficacy in STSs. PATIENTS AND METHODS: We retrospectively reviewed the clinical features and outcomes of patients with STS treated with trabectedin at our institution between 2016 and 2020. The neutrophil-to-lymphocyte ratio (NLR), lymphocyte-to-monocyte ratio (LMR), platelet-to-lymphocyte ratio (PLR), and systemic inflammation response index (SIRI=neutrophil × monocyte/lymphocyte) were calculated based on the blood samples obtained prior to trabectedin treatment initiation. Analyses of overall survival (OS) and progression-free survival (PFS) were performed according to various factors. RESULTS: Of the 101 patients identified, 54 had L-sarcoma (leiomyosarcoma: 30; liposarcoma: 24), and 47 had other types of STSs. Elevated SIRI, NLR, PLR, LMR, and C-reactive protein (CRP) were associated with worse PFS (p<0.001, p=0.008, p=0.027, p=0.013, and p<0.001, respectively) according to the results of the univariate analysis. Multivariate analysis showed that elevated SIRI, other histology, and CRP were associated with poor PFS (p=0.007, p=0.008, and p=0.029, respectively). In addition, the multivariate analysis of OS showed that SIRI was an independent prognostic factor (hazard ratio=2.16, p=0.006). CONCLUSION: Pretreatment SIRI can be considered a biomarker for the prognostic prediction of patients with STS treated with trabectedin.

Impact of relative dose intensity of trabectedin with pegfilgrastim support: a single-centre retrospective study.

Relative dose intensity (RDI) has been associated with improved survival in patients with advanced solid tumours. However, there is no evidence regarding RDI in patients under long-term treatment with trabectedin for adult advanced soft tissue sarcoma (STS). Pegfilgrastim use was associated with chemotherapy dose intensity maintenance in patients with various cancers. We retrospectively evaluated the RDI in patients with STS receiving trabectedin. The patients were grouped based on whether trabectedin administration was supported by pegfilgrastim. RDI was obtained for 114 of the 140 included patients. Chemotherapy cycles that included filgrastim were excluded. Patients treated with and without pegfilgrastim had similar RDI rates (77.1% ± 17.6% vs 78.8% ± 16.4%; P = 0.485). Moreover, we found no association between patients receiving ≥4 trabectedin cycles and the use of pegfilgrastim. These results suggested that trabectedin dose delays or reductions should be considered before administering prophylactic pegfilgrastim.

Clinical and biomarker factors affecting survival in patients with platinum-sensitive relapsed ovarian cancer receiving olaparib monotherapy: a multicenter retrospective study.

The standard treatment for platinum-sensitive relapsed ovarian cancer (PSROC) is platinum-based chemotherapy followed by olaparib monotherapy. A retrospective study was conducted to identify factors affecting the survival of patients with PSROC undergoing olaparib monotherapy in real-world clinical settings. The study enrolled 122 patients who received olaparib monotherapy between April 2018 and December 2020 at three national centers in Japan. The study used the Kaplan-Meier method and univariable and multivariable Cox proportional hazards models to evaluate the associations between factors and progression-free survival (PFS). Patients with BRCA1/2 mutations had a significantly longer median PFS than those without these mutations. Both the BRCA1/2 mutation-positive and mutation-negative groups exhibited a prolonged PFS when the platinum-free interval (PFI) was ≥ 12 months. Cancer antigen 125 (CA-125) level within reference values was significantly linked to prolonged PFS, while a high platelet-to-lymphocyte ratio (≥ 210) was significantly associated with poor PFS in the BRCA1/2 mutation-negative group. The study suggests that a PFI of ≥ 12 months may predict survival after olaparib monotherapy in patients with PSROC, regardless of their BRCA1/2 mutation status. Additionally, a CA-125 level within reference values may be associated with extended survival in patients without BRCA1/2 mutations. A larger prospective study should confirm these findings.

Cancer-Chemotherapy-Related Regimen Checks Performed by Pharmacists of General Hospitals Other than Cancer Treatment Collaborative Base Hospitals: A Multicenter, Prospective Survey.

Although prescription review is an important role for pharmacists in anticancer drug therapy, there are no guidelines in Japan that specify what pharmacists should check for in chemotherapy regimens. This prospective multicenter survey aimed to investigate the implementation of chemotherapy regimen checks by pharmacists in general hospitals by focusing on 19 recommended confirmation items designed to enhance chemotherapy safety. This study involved 14 hospitals within the National Hospital Organization in different regions of Japan. The top five cancers in Japan (gastric, colorectal, lung, breast, and gynecological) were targeted and specific chemotherapy regimens were analyzed. This study assessed the amount of time required for regimen checks, the number of confirmation items completed, the number and the content of inquiries raised regarding prescriptions, and the pharmacists' opinions using a questionnaire that had a maximum score of 10 points. Pharmacists checked 345 and 375 chemotherapies of patients in the control group (CG) and recommended items group (RIG), respectively. The mean time periods required for completing a chemotherapy regimen check were 4 min and 14 s (SD ±1 min and 50 s) and 6 min and 18 s (SD, ±1 min and 7 s) in the CG and RIG, respectively. The mean of the recommended items for the CG = 12.4 and for the RIG = 18.6. The items that the pharmacists did not confirm included urine protein (sixty-nine cases, 18.4%), allergy history (four cases, 1%), previous history (two cases, 0.5%), and a previous history of hepatitis B virus (sixty-nine cases, 18.4%). The number of inquiries for a doctor's prescription order was higher in the RIG than in the CG (41 vs. 27 cases). This multicenter survey demonstrated the potential effectiveness of implementing 19 recommended confirmation items in the regimen checks by pharmacists in general hospitals other than cancer treatment collaborative base hospitals.

Significant association between hand-foot syndrome and efficacy of capecitabine in patients with metastatic breast cancer.

Capecitabine, an oral prodrug of 5-fluorouracil (5-FU), is a promising treatment for colorectal, breast and gastric cancers, but often causes hand-foot syndrome (HFS), the most common dose-limiting toxicity. The current study was conducted to investigate the relationship between HFS and efficacy of capecitabine in 98 patients with metastatic breast cancer. Possible associations between HFS and efficacy endpoints, including time-to-treatment failure (TTF), tumor response in metastatic lesions and changes in tumor markers, were investigated retrospectively using electronic medical records. The TTF of group with HFS of grade 1 and ≥2 was significantly longer than that of group with no HFS, respectively (hazard ratio (HR), 0.39; 95% confidence interval (CI), 0.18-0.87 for group with grade 1; HR, 0.42, 95% CI, 0.19-0.90 for group with grade ≥2). Significantly higher disease control rates for the liver metastasis were observed in patients with HFS (grade 1 and greater) than in those without HFS (92.9 vs. 42.9%, p=0.009). Furthermore, prevention of increases in tumor marker levels (carcinoembryonic antigen (CEA), carbohydrate antigen 15-3 (CA15-3) and National Cancer Center-Stomach-439 (NCC-ST439)) was evident in patients with HFS. This study clearly showed a significant correlation between HFS and some efficacy markers of capecitabine therapy in patients with metastatic breast cancer, and suggests that early dose adjustment based on severity of HFS might improve efficacy. Studies are needed to explore predictive biomarkers for HFS/efficacy, so that capecitabine therapy can be further tailored to patient response.

A Hospital-Based Online Patients Support Program, Online Adolescent and Young Adult Hiroba, for Adolescent and Young Adult Cancer Patients at a Designated Cancer Center in Japan.

Adolescent and young adult (AYA) patients with cancer have few opportunities to interact with peers in their lives. To meet peers safely during the coronavirus disease 2019 (COVID-19) pandemic, a hospital-based online patients support program called Online AYA Hiroba was launched for AYA patients with cancer and held regularly by the National Cancer Center Hospital in Japan. This retrospective study suggested the degree of satisfaction with this program and issues about facilitating the sessions that are unique to the online environment. Our findings potentially contribute to the establishment of a hospital-based online patients support program for AYA patients with cancer at other hospitals.

A Questionnaire Survey on Adolescent and Young Adult Hiroba, a Peer Support System for Adolescent and Young Adult Cancer Patients at a Designated Cancer Center in Japan.

Adolescent and young adult (AYA) cancer patients have few opportunities to interact with peers in the hospital. AYA Hiroba, a peer support system for AYA cancer patients, was launched and held regularly at the National Cancer Center Hospital in Japan. This questionnaire survey was conducted to investigate the degree of satisfaction and opinions of AYA cancer patients regarding this program. Participants reported that the content was satisfying and useful. Their impressions suggested that AYA Hiroba is potentially effective for promoting interaction with the same generation, change in mood, and acquisition of information.

Patient-associated risk factors for severe anemia in patients with advanced ovarian or breast cancer receiving olaparib monotherapy: A multicenter retrospective study.

Background: Olaparib-induced anemia is a frequently occurring complication in patients with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer and is associated with a marked deterioration in patients' health-related quality of life. This study aimed to clarify patient-specific risk factors for severe anemia in patients with advanced ovarian or breast cancer receiving olaparib monotherapy in a real-world setting. Methods: This multicenter, retrospective, observational study enrolled consecutively presenting patients with advanced ovarian or breast cancer who received olaparib monotherapy as maintenance or palliative treatment between April 2018 and December 2020 at three participating medical institutions in Japan. The primary endpoint was patient-associated risk factors underlying the onset of grade ≥3 anemia from olaparib treatment initiation to 90 days after treatment. Receiver operating characteristic curves were constructed and univariable and multivariable logistic regression analyses were performed to evaluate the association between patient-associated risk factors and grade ≥3 anemia. Results: Of 113 patients evaluated in this study, 32.7% (n = 37) had grade ≥3 anemia. Multivariable logistic regression analysis revealed that low baseline red blood cell (RBC) count (<3.3 × 106 cells/µL), low baseline hematocrit level (<35%), low baseline hemoglobin level (<11.6 g/dL), and breast cancer susceptibility (BRCA1/2) mutation were significantly associated with the onset of grade ≥3 anemia (adjusted odds ratio [OR], 3.39; 95% confidence interval [CI], 1.28-9.62; P = 0.017, adjusted OR, 3.63; 95% CI, 1.28-11.64; P = 0.021, adjusted OR, 3.89; 95% CI, 1.39-12.21; P = 0.014, and adjusted OR, 4.09; 95% CI, 1.55-11.67; P = 0.006, respectively). Conclusions: Our findings suggest that low baseline RBC count, low baseline hematocrit level, and low baseline hemoglobin level might be the patient-associated risk factors for severe anemia induced by olaparib monotherapy. Additionally, BRCA1/2 mutation was suggested to be a patient-related risk factor for anemia regardless of severity. Therefore, applying these patient-associated risk factors would help classify and screen patients at risk of severe anemia.

A Support System for Adolescent and Young Adult Patients with Cancer at a Comprehensive Cancer Center.

Cancer patients in adolescents and young adults (AYA) generation aged 15-39 years have various psychosocial needs during their treatment course such as school enrollment, finding employment, marriage, and fertility. It is difficult for medical professionals to gain experience related to providing medical care and consultation support to these kinds of AYA generation cancer patients. There is a need to provide information and establish both support and medical care systems that are able to meet the diverse needs unique to this generation. This review will explain how to launch an AYA support team (AST). We have worked and established the AST since 2016, which is medical care teams that provide support according to the life stage of each individual patient and build a multidisciplinary AYA generation patient support system. The team-building process consisted of two main projects: building and enlarging multidisciplinary team and establishing screening process of psychosocial needs of AYA generation patients. Multidisciplinary healthcare professionals got involved in the AST with already-existing patient support functions in our center: the patient support center, which is an outpatient department and the palliative care team, which is an inpatient interdepartmental team. The AST systematically finds patients in need of assistance and offers them support as a multidisciplinary team. The AST also established a procedure that systematically gathers information about the needs of patients by using a screening tool. In addition, the AST provides the following specialized services: reproductive medicine, supporting cancer patients with children, employment support, and peer support. The AST has been established and sophisticatedly worked. It can flexibly provide various psychosocial support services. This review will explain how to launch an AST.

Assessment of adverse events via a telephone consultation service for cancer patients receiving ambulatory chemotherapy.

BACKGROUND: An increasing number of cancer patients are receiving ambulatory chemotherapy to improve their quality of life and reduce medical expenses. During outpatient chemotherapy, adverse events (AEs) occurring at home must be carefully monitored. We investigated the use of our institution's telephone consultation service that is available to patients and their caregivers for advice on and the management of AEs and complications arising from cancer treatment. PATIENTS AND METHODS: Telephone consultants assessed and graded AEs according to the Common Terminology Criteria for Adverse Events (CTCAE). All patient characteristics, AEs, and background factors were analyzed using logistic regression analyses. RESULTS: Between August 2011 and August 2012, we included 253 patients and 344 telephone consultations regarding AEs during chemotherapy for analysis in this study. Grade 1 AEs were assessed in 223 consultations (65%); grade 2 AEs, in 90 consultations (26%); and grade 3 AEs, in 31 consultations (9%). A multivariate logistic regression analysis revealed an association between a change in patient schedules and the occurrence of grade 2 or worse AEs (Hazard ratio = 6.58, P < 0.001). Changes in planned chemotherapy occurred more often in cases involving male patients (Hazard ratio = 2.70, P = 0.02) and in cases of grade 2 or worse AEs (Hazard ratio = 6.58, P < 0.001). CONCLUSION: We found that AE assessment using CTCAE via a telephone consultation service is useful for both the triage of patients and the prediction of severe AEs that may change clinical schedules.