bluuebunny/crossref_metadata_2025 huggingface dataset:
Barriers to offering female fertility preservation to pediatric and young adult oncology patients: A national survey of pediatric hematology oncology providers in the United States and Canada.
Authors: Walker Amanda , Baskir Elan , Matthes Geoffrey , Pentakota Sri Ram , Bhatla Teena , Batra Surabhi
Published: June 2023

e24088

Background: The American Society of Clinical Oncology (ASCO) recently updated its guidelines on fertility preservation based on similar rates of pregnancy from oocyte and embryo preservation. However, fertility preservation in female pediatric and young adults undergoing cancer treatment remains a challenge due to barriers in communication, lack of awareness and resources. Methods: A survey created using SurveyMonkey was sent electronically to all physicians who were Children’s Oncology Group (COG) members (2190), weekly for 4 weeks. Results: 304 physicians (13.8%) responded to the survey. While most providers discuss the possibility of infertility with all female patients (83%), only 43% offer fertility preservation irrespective of age. Cancer diagnosis is a key factor in the decision to offer fertility preservation to patients (63%). Ewing sarcoma (75%), osteosarcoma (69%), and bone marrow transplant candidacy (70%) are the most common diagnoses associated with physician offering of fertility preservation. It is typically offered prior to the first round of chemotherapy (53%). Seventy-five percent of providers report that insufficient time before starting chemotherapy is a major barrier to offering fertility preservation. Severity of patient illness (58%), insurance issues and high cost (19%), provider belief that it is not necessary in every patient (25%), and lack of data supporting female fertility preservation and experimental methods (16%) are other barriers which impact the decision to offer fertility preservation. Ovarian suppression (77%), cryopreservation (egg freezing) (85%), and ovarian tissue freezing (66%) are the most discussed fertility preservation options with only one out of four providers discussing freezing embryos. Only one out of five providers check Anti-Mullerian hormone (AMH) levels prior to starting cancer treatment; however, two out of five check AMH levels after completion of therapy. Most providers do not check AMH levels. Conclusions: Despite high risk for infertility among female cancer patients due to treatment and several advances that have been made in the field, the practice of offering fertility preservation is not universal due to various barriers at the physician and institutional level. Physician education and familiarity with ASCO’s newer guidelines is one way to promote a healthier dialogue and informed decision making. We also conclude that detailed guidelines and monitoring practices for diminished ovarian reserve are lacking and need further thought.[Table: see text]
Risk and protective factors for dementia in cancer survivors vary by cancer type.
Authors: Neth Bryan , Graff-Radford Jonathan , Alden Eva , Botha Hugo , Raghunathan Aditya , Johnson Derek R. , Lachance Daniel Honore , Petersen Ronald C. , Jack Clifford R. , Vemuri Prashanthi , Cerhan James Robert , Knopman David S.
Published: June 2023

e24089

Background: Little is known about risk and protective factors for dementia in cancer survivors. With increasing longevity due to improved cancer therapy, it’s prudent to study factors contributing to cognitive impairment in this patient population. Methods: We performed multivariable cox regression analyses to assess established risk factors for all-cause dementia (age, education, APOE4-status, social and physical activity engagement) in breast and prostate cancer survivors. Patients 50+ years old with pathology-confirmed cancer diagnosis at Mayo Clinic were identified from a longitudinal, population-based cohort – Mayo Clinic Study of Aging. Analyses were controlled for age, APOE4-status, education, and cancer treatment. Results: We included a total of 209 patients with breast cancer (mean age 75.4 years, 24% APOE4-positive, median follow-up 6.8 years) and 352 with prostate cancer (mean age 77 years, 26% APOE4-positive, median follow-up 6.4 years). 31 patients with breast cancer (15%) and 66 patients with prostate cancer (20%) were diagnosed with dementia at last follow-up. Older age was associated with increased risk for dementia (5-year increase – breast: hazard ratio (HR) 1.9 [95%CI 1.3-2.7, p = 0.001]; prostate: HR 2.4 [95%CI 1.8-3.2, p < 0.0001]). APOE4-positivity was associated with increased dementia risk in breast (HR 3.6 [95%CI 1.6-7.8, p < 0.002]), but not prostate cancer (HR 1.2 [95%CI 0.7-2.0, p = 0.5]). More education was associated with lower dementia risk in prostate cancer (education year: HR 0.91 [95%CI 0.84-0.98, p < 0.02]; education years > 12: HR 0.26 [95%CI 0.1-0.6, p < 0.001]). Physical activity engagement in mid-life was associated with lower dementia risk (prostate: HR 0.56 [95%CI 0.4-0.8, p < 0.005]; breast: HR 0.48 [95%CI 0.3-0.9, p < 0.02]). Conclusions: In this longitudinal, population-based study we found that some risk and protective factors for dementia in cancer survivors vary by cancer type. While advanced age is an expected dementia risk factor, there were mixed results for APOE4-positivity (increased risk only in breast cancer) and education (only protective in prostate cancer). Our results support further study into factors influencing dementia risk by cancer type in hopes of identifying preventative strategies.
Delayed immune toxicities in patients with breast cancer receiving immune checkpoint inhibitors.
Authors: Jacob Saya , Quandt Zoe , Melisko Michelle E. , Majure Melanie , Chien Amy Jo , Blaes Anne Hudson , Heditsian Diane , Esserman Laura , Rugo Hope S.
Published: June 2023

e24091

Background: Immune checkpoint inhibitors (ICI) have improved outcomes in patients with breast cancer, however management of immune-related adverse events (irAE) remains a challenge. Delayed irAE after cessation of ICI have been observed. We sought to characterize delayed irAE occurring at our center. Methods: We identified patients with breast cancer who received ICI at UCSF using ICD codes specific to ICI administration between 2012-2018. After IRB approval, charts were reviewed for delayed irAE. Delayed irAE were defined as occurring >60 days after the last ICI dose; events were counted as irAE if provider notes indicated that the toxicity was/possibly was related to ICI. Data were securely stored using RedCap. Results: We reviewed 100 consecutive patients who underwent ICI (56 metastatic, 44 localized) of which 11 (2 (4%) with metastatic disease, 9 (20.5%) with localized disease) developed delayed irAE. Median age was 42. 3 patients had HR+ disease, 8 patients had triple negative disease. 10 patients received ICI on a clinical trial, including 9 on the neoadjuvant ISPY2 trial. 10 patients received pembrolizumab; 1 received durvalumab. Median number of ICI doses was 4, median follow-up time after last ICI infusion was 46 months. 14 incidences of delayed irAEs were identified (Table). 9 patients experienced both delayed and early irAE. 7 patients experienced 2 irAEs: 1) three dermatitis & delayed hypophysitis/adrenal insufficiency (AI) 2) one AI & delayed thyroiditis 3) one dermatitis and delayed colitis 4) one elevated transaminases & delayed colitis 5) one delayed elevated transaminases and delayed thyroiditis. One patient had 3 irAEs (thyroiditis, delayed AI & delayed arthralgia) and one patient had 4 irAE (colitis, dermatitis, delayed elevated transaminases & delayed neutropenia). Of the 9 patients with > 1 irAE, 3 experienced > 1 delayed irAE (thyroiditis + elevated transaminases; arthralgia + AI; elevated transaminases + neutropenia). All irAE either self-resolved, resolved with systemic steroids or indefinite hormone replacement. 6 irAEs required systemic steroids, not including hydrocortisone replacement for AI. Conclusions: Delayed irAE may occur months after ICI cessation and require awareness for identification. Patients who experience irAE may be more likely to develop additional irAE at either a delayed or earlier time point. Most patients with delayed irAE experienced an irAE at an early time point. Future directions include identifying risk factors for early and delayed irAEs to inform treatment decisions. [Table: see text]
Toxicities associated with sacituzumab govitecan: Data from clinical trials and real-word pharmacovigilance database.
Authors: Mei Xiangping , Tan Qiaoyun , Yao Jing
Published: June 2023

e24093

Background: This study aimed to analyze the adverse effect of sacituzumab govitecan (SG) with multiple source data, to provide reference for clinical medication safety management. Methods: Clinical trials of SG with available safety data were searched and included in the pooled analysis (up to January 5th, 2023). The adverse drug reaction (ADR) signals of SG were collected from the FDA Adverse Event Reporting System (FAERS) database up to January 1st, 2023. The ADR signals were presented and sorted by incidence frequency and reporting odds ratio (ROR) strength, respectively. We also searched and summarized drug interactions with SG in DDInter database. Results: A total of 6 clinical trials enrolled 1737 patients were included in pooled analysis, the most common adverse events of ≥3 grade were neutropenia (51.55%), leukopenia (14.50%), anemia (10.69%), diarrhea (7.30%), fatigue and asthenia (4.23%). In pharmacovigilance study, 1024 AE reports were extracted, the most common toxicities of SG are hematologic and gastrointestinal. AEs not included in the instructions also showed high signals, such as meningitis, colitis and lymphedema. A total of 40 drugs identified can induce drug-drug interaction when concomitant administration with SG. Conclusions: This study provides a comprehensive profile of SG based on clinical trial, FRAES and DDInter database, attention should be paid not only to the common ADRs, but also to the ADRs not reported in the drug instructions and potential drugs that induce drug-drug interactions. [Table: see text]
Non-hematopoietic cell transplant-related veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) in solid tumor and hematologic malignancies: A systematic review.
Authors: Stewart Fiona , Ruiz Kimberly , Gill Malia , Devani Darsh , Fusco Nicole , Fan Lin , Amber Vian , Hanvesakul Raj , Gangi Alexandra
Published: June 2023

e24094

Background: VOD/SOS is a serious liver injury caused by toxic damage to sinusoidal endothelial cells. It has been linked to conditioning regimens preceding hematopoietic cell transplant (HCT) but little is known about its epidemiology and characteristics outside the HCT setting. We conducted a systematic review to examine the incidence, burden of illness, and management of non-HCT VOD/SOS. Methods: We searched MEDLINE, Embase (2002–2022), and relevant congress proceedings (2019–2022) for studies reporting incidence, diagnosis, clinical and patient characteristics, humanistic and economic burden, and treatments in non-HCT VOD/SOS. All study designs were eligible except case series of < 5 patients. Pyrrolizidine alkaloid-induced VOD/SOS was excluded. Results: We identified 3,544 records and included 80 studies; 58% were retrospective cohort studies. Sample sizes ranged from 5 to 12,941; 38% of the studies included > 100 patients. The highest incidences of non-HCT VOD/SOS were in patients with colorectal liver metastases (CLM) (median 41%) and Wilms tumor (median 14%) (table). Diagnostic criteria were heterogenous. Rubbia-Brandt histological criteria were used in CLM. In other disease settings, diagnosis varied and was based on clinical criteria (eg, McDonald, Seattle, or Baltimore). Management of VOD/SOS included defibrotide, supportive therapy (eg, fluid restriction, blood products) and switching/pausing chemotherapy. No usable data were found on humanistic/economic burden. Conclusions: Non-HCT VOD/SOS occurs in diverse disease areas, including hematologic and solid tumor cancers. Lack of consensus regarding diagnosis of non-HCT VOD/SOS may indicate underdiagnosis. Clinicians should be vigilant for VOD/SOS even in non-HCT patients. Defibrotide is approved for post-HCT VOD/SOS but there is no approved therapy for non-HCT VOD/SOS; future trials should focus on diagnosis and treatment outside the HCT setting, which represents a significant unmet need. A limitation of the current work is the suboptimal reporting and low methodological quality in some primary studies.[Table: see text]
Trends and factors related to pregnancy after breast cancer treatment in young patients.
Authors: Lee Young-Jin , Lee Young Joo , Yoo Tae-Kyung , Lee Sae Byul , Kim Jisun , Chung Il Yong , Ko Beom Seok , Lee jong Won , Sohn Byung Ho , Kim hee Jeong
Published: June 2023

e24095

Background: In women of reproductive age who have been treated for breast cancer (BC), interest in fertility preservation (FP) is as important as treatment. Although methods for FP are already well known, sufficient information is not provided about the pregnancy results at specified BC stage or treatment. This study was designed to retrospectively analyze and provide information on fertility preservation attempts and actual pregnancy in women of childbearing age who had been diagnosed with BC for the past 10 years. Methods: We retrospectively reviewed women of childbearing age (18-40 years) with treated at single tertiary medical center from December 2010 to September 2020. The relationship between the tumor characteristics and treatments and actual pregnancy was analyzed. Time from diagnosis to pregnancy was analyzed according to tumor characteristics and treatments. During the period, intensive education on FP was offered to the patients from 2014, and whether there were any changes in the results before and after this was also analyzed. Results: A total of 1033 patients were included, representing 115 patients who were pregnant during the observation period. Overall, 519 (50.2%) patients were offered fertility counseling, 81 (7.8%) patients get oocytes or embryos preservation and 456 (44.1%) patients underwent Gonadotrophin hormone receptor analogue (GnRHa) for FP. Our analysis showed differences in pregnancy rates for age at diagnosis ( P= .002), HR (Hormone receptor) status ( P=.015), and hormonal therapy ( P= .004), among them, there was a significant difference in pregnancy timing only for HR (2.53 vs 3.42 years, P= .009) and hormonal therapy (2.39 vs 3.56 years, P<.001). There were 93 patients who stopped taking tamoxifen for preparing pregnancy, and 53 patients succeeded in becoming pregnant. In this cohort there were no significant difference in pregnancy rate for age, tumor characteristics, stage and treatments. Conclusions: Tumor characteristics which required endocrine therapy was related to the pregnancy rate and time to conception. However, more than half of the women who actively consulted with their doctor for pregnancy and interrupted endocrine therapy within first five years had a successful pregnancy and also were not inferior in disease free survival. Most of FP was still predominantly underwent with concurrent GnRHa use. In young women who want to preserve fertility, it is important to provide such information and make mutual decisions for active FP.[Table: see text]
Quality of life in patients diagnosed and treated for breast cancer in Uruguay.
Authors: Camejo Natalia , Amarillo Dahiana , Castillo Cecilia , Guerrina Maria , Savio Florencia , Carrasco Mariana , Strazzarino Noelia , Hernandez Ana Laura , Herrera Guadalupe , Krygier Gabriel David
Published: June 2023

e24096

Background: Breast cancer (BC) and its treatment can impair patient quality of life (QoL), and those undergoing more aggressive treatments may be more severely impacted. Objective: Assess the level of perception of the QoL of patients treated for BC at the Hospital de Clínicas and the Departmental Hospital of Soriano. Methods: A questionnaire for cancer patients (EORTC, QLQ-C30) and one specific for BC (EORTC QLQ-BR23) were used. Results: A total of 158 patients who had completed chemotherapy treatment at least one year prior to the evaluation were enrolled. The average age was 61 years old. QLQ-C30 questionnaire: the global QoL score (GQOL) was high: 70.9. Patients undergoing breast-conservation surgery (BCS) had better scores in physical and emotional functioning (p < 0.005) and presented less frequently with: pain, constipation and financial difficulties (p < 0.005). Those undergoing sentinel lymph node biopsy (SLNB) had higher scores for GQOL and for physical, role and social functioning scales (p < 0.001) and had less fatigue, pain, insomnia and financial difficulties (p < 0.005). Questionnaire QLQ-BR23: sexual functioning and sexual enjoyment scales were relatively low. Patients undergoing BCS had better scores on the functional scales: body image and future outlook; and fewer breast symptoms (p < 0.005). Those undergoing SLNB also had better scores on the functional scales for body image and future outlook future and presented less frequently with symptoms (p < 0.005). Conclusions: Patients had high values on the GQOL scale, those undergoing BCS and SLNB had better scores on most functional and problem/symptom scales. The implementation of intervention strategies aimed at improving the quality of life and the physical and emotional care of patients is recommended. Uruguayan BC patients experience high values on the GQOL scale, those undergoing BCS and SLNB had better scores on most functional and problem/symptom scales. Patients undergoing BCS had better scores in physical and emotional functioning and presented less frequently with: pain, constipation and financial difficulties. With respect to the type of axillary surgery received, patients who underwent SLNB had higher scores on the GQOL scale and on the physical, role and social functional scales. The implementation of intervention strategies aimed at improving the quality of life and the physical and emotional care of patients is recommended.
Obesity and toxic habits as avoidable determinants of chronic peripheral neuropathy induced by chemotherapy (NPCIQ): NeuroPredict project.
Authors: Vargas Alicia , Contreras María José , De la Haba María , Cano Maria Teresa , Morales-Estevez Cristina , Porras Ignacio , Pulido Gema , Flores Paco Pablo , De La Haba Juan , Aranda Enrique
Published: June 2023

e24097

Background: Anti-tumor therapy is the most frequent cause of toxic neuropathy in the Western population. Unlike its acute presentation (AN), chronic neuropathy appears during treatment and persists for more than six months after the end of chemotherapy, significantly limiting the quality of life of many patients. Although it is a drug-dependent toxicity, there is scarce evidence about its frequency and the factors that are determinant in its development. The main objetive is to know the incidence of NPCIQ as well as to identify factors that predispose to its appearance. Methods: We retrospectively selected 98 patients treated with adjuvant chemotherapy with paclitaxel (P) (80mg/m2/weekly) or oxaliplatin (O) (130 mg/m2/every 3 weeks), establishing three groups: Group A and B: Patients treated with P or O and who have developed NPCIQ and Group C patients treated with P or O and who have not developed NPCIQ.Group A P+ NPCIQ: 34 (33,3 %), Group B O+NPCIQ: 27 (26,5 %) and Group C non-NPCIQ: 37 (36,2%). Results: Of the 79 patients who developed AN, 61 (77,2%) developed NPCIQ, of these 34 due to paclitaxel and 27 due to oxaliplatin. Those patients with a body mass index > 30 or toxic habits developed NPCIQ more frequently: 24% vs 36% and 24% vs 42% (p: 0.054) respectively (Table 1).The obesity impact on NPCIQ is statistically significative for paclitaxel group (p: 0,027). Conclusions: NPCIQ is a frequent toxicity, there are avoidable factors such as obesity, smoking and alcohol that can influence its development. Recommendations aimed at avoiding overweight or the consumption of alcohol and tobacco may be useful to reduce the incidence of NPCIQ. [Table: see text]
Relative and functioning sleep disturbance and fatigue: Impact on patients with ovarian cancer.
Authors: Andac-Jones Elif , Newell Abigail , Szamreta Elizabeth A. , Gonzalo Maria Belen , Hoffman Juliette , Monberg Matthew
Published: June 2023

e24102

Background: Sleep disturbance and fatigue are prevalent among ovarian cancer patients and are associated with poor mental health and Health-related quality of life (HRQoL) outcomes; while this has been well-documented, we know less about the factors that may contribute, what cancer patients perceive as contributing to their issues, and how they describe and manage these issues across their treatment trajectory. Methods: In this qualitative study, data were collected via semi-structured interviews with 20 stage III/IV ovarian cancer patients diagnosed within three years with varied treatment trajectory, race/ethnicity, and location. A screener included PROMIS Sleep Disturbance and Fatigue measures, sociodemographics, and cancer history. Transcripts were analyzed using deductive codes of sleep and fatigue and inductive codes based on emergent themes. We identify two novel concepts of patients’ sleep and fatigue experiences: relative and functioning. Relative fatigue and sleep issues capture how patients self-report relative to different points in their treatment. Functioning concept shows how patients reinterpret and self-censor the severity and impact of their sleep and fatigue by emphasizing their ability to overcome exhaustion or insomnia. Results: All twenty patients reported persistent, debilitating fatigue, difficulty falling and staying asleep through the course of their disease, which negatively impacted their HRQoL and activities of daily living. The majority of patients struggled to complete daily chores (17/20), keep up with paid work (9/10), and maintain relationships(16/20). Although patients experience fatigue across their trajectories, the majority of patients described their fatigue as more intense during chemotherapy than maintenance therapy. Patients struggled to evaluate their current fatigue and sleep without reflecting on previous treatment experiences (relative), and continuously reinterpreted their levels of fatigue and sleep based on how much of their daily functions they could complete (functioning). Patients self-censor in reporting to meet their perceived expectations of their care provider/data collector . Although fatigue and sleep disturbance significantly impaired their HRQoL, patients framed their experiences positively and minimized their struggles. Conclusions: We conclude that PROMIS measures are important in evaluating baseline sleep disturbance and fatigue in patients with ovarian cancer. However, patients’ reporting is informed by their previous treatment experiences, subject to continued reinterpretation. Therefore 1) more nuanced and repeated measures including patients’ narratives are needed to understand the complexity of patients’ experiences; and 2) Patients’ self-censorship and filtering need to be considered. Future research will test these new concepts with a 200 patient survey.
Hypertriglyceridemia associated with the use of capecitabine in a Mexican cohort.
Authors: Luna Palencia Rosa Luz Luna , Macedo Perez Eleazar Omar
Published: June 2023

e24107

Background: Capecitabine is a prodrug activated to its cytotoxic form 5-fluorouracil by thymidine phosphorylase whose active metabolites inhibit DNA synthesis by reducing thymidine production and also inhibits RNA and protein synthesis by competing with uridine triphosphate. Capecitabine is used in many types of tumors and its main reported side effects are diarrhea, hand-foot syndrome and hematologic toxicity. Methods: Retrospective analysis of a cohort of patients visited in a private hospital in Mexico City, that has a basal triglyceride profile and at least two determinations during treatment with capecitabine with or without oxaliplatin. Results: We analyzed 14 patients with a mean age of 55 years (IQR 40-73), 12 patients with colorectal cancer, 78.5% in the adjuvant setting, a half of patients with capecitabine monotherapy and the other half in combination with oxaliplatin. Comorbidities as overweight/obesity were seen in a half of the patients, diabetes in 21.4% and hypertriglyceridemia at baseline in 57.1% of patients all of them G1. The mean baseline glucose was 99.5 mg/dl (IQR 74-174), the mean baseline cholesterol was 180.8 mg/dl (IQR 85-243), the mean baseline triglycerides was 153.3 mg/dl (IQR 85-243). During capecitabine treatment a total of 85.7% of patients developed hypertriglyceridemia: G3/4 of 21.4%, G2 of 28.5%, G1 of 35.7%. No patient developed a serious complication associated with hypertriglyceridemia such as pancreatitis. There was no association between monotherapy or combination treatment with oxaliplatin, of patients with grade ≥2 hypertriglyceridemia, five received capecitabine monotherapy and two in combination with oxaliplatin. Also, no association was found among the highest levels of cholesterol, glucose, disease stage, age or body mass index. All of the 6 patients with normal baseline triglycerides developed hypertriglyceridemia 66.6% G1 and 33.3% G2. All the patients who present with hypertriglyceridemia G3/4 had baseline hypertriglyceridemia and 66.6% also diabetes. Conclusions: This analysis shows the high prevalence of hypertriglyceridemia associated with the use of capecitabine as monotherapy or combined with oxaliplatin in a Mexican cohort, with an incidence of 21.4% of hypertriglyceridemia G3/4 having the pre-existing hypertriglyceridemia and diabetes as risk factors. The cause of the worsening of the lipid profile requires more research but justify lipid profile at baseline and during the treatment with capecitabine. Due to the small size of the sample, the findings need to be confirmed with a prospective study with a larger number of patients.
Randomized double-blind, placebo-controlled multicenter phase III study of prevention of irinotecan-induced diarrhea by a probiotic mixture containing Bifidobacterium, BB-12 and Lactobacillus rhamnosus, LGG in colorectal cancer patients: The Probio SK 006-Slovak cooperative oncology group trial.
Authors: Mego Michal , Danis Radoslav , Chovanec Jozef , Jurisova Silvia , Bystricky Branislav , Porsok Stefan , Konkolovsky Peter , Vaclav Vladimir , Wagnerova Maria , Stresko Marian , Brezinova Bibiana , Reckova Maria , Sutekova Dagmar , Pazderova Natalia , Novisedlakova Maria , Zomborska Eva , Ciernikova Sona , Svetlovska Daniela , Drgona Lubos
Published: June 2023

e24109

Background: The incidence of irinotecan-induced diarrhea varies between 60-90%, by which the incidence of severe diarrhea is 20-40%. The objective of this phase III trial was to determine the effectiveness of the probiotic mixture containing Bifidobacterium, BB-12 and Lactobacillus rhamnosus, LGG in the prophylaxis of irinotecan-induced diarrhea in metastatic colorectal cancer patients due to a reduction in the activity of intestinal beta-D-glucuronidase. Methods: From March 2016 to May 2022, a total of 242 patients with colorectal cancer starting a new line of irinotecan-based therapy were registered to the study in 11 cancer centers in Slovakia. Patients were randomized in a ratio 1:1 to probiotic formula vs. placebo that was administered for 6 weeks. Each capsule of Probio-Tec BG-Vcap-6.5 contained 2.7x109colony-forming units (CFU) of 2 lyophilized probiotic strains Bifidobacterium, BB-12 (50%) and Lactobacillus rhamnosus GG, LGG (50%). Results: Administration of probiotics compared to placebo was not associated with a significant reduction of grade 3/4 diarrhea (placebo arm 11.8% vs. probiotic arm 7.9%, p = 0.38). Neither the overall incidence of diarrhea (46.2% vs. 41.2%, p = 0.51) nor the incidence of enterocolitis (3.4% vs. 0.9%, p = 0.37) was different in the placebo vs. probiotic arm. Subgroup analysis revealed that patients with colostomy had higher incidence of any diarrhea and grade 3/4 diarrhea in the placebo arm compared to the probiotic arm (48.5% vs. 22.2%, p = 0.06 and 15.2% vs. 0%, p = 0.06, respectively). Moreover,patients on probiotic arm had significantly better diarrhea-free survival (HR = 0.41, 95%CI 0.18 – 0.95, p = 0.05) and needed less loperamide (p = 0.01) compared to patients on placebo arm. We did not observe any infection caused by probiotic strains used in this study. Conclusions: This study failed to achieve its primary endpoint, and results suggest a lack of benefit of administered probiotic formula for the prevention of irinotecan-induced diarrhea. However, subgroup analysis suggests a possible benefit in patients with colostomy. Clinical trial information: NCT02819960 .
Clinical research policy for oral mucositis associated with cancer treatment (J-SUPPORT).
Authors: Yokota Tomoya , Ueno Takao , Soga Yoshihiko , Ishiki Hiroto , Uezono Yasuhito , Mori Takehiko , Zenda Sadamoto
Published: June 2023

e24110

Background: Oral mucositis is one of the main areas of research in supportive and palliative care of cancer patients. However, the methodology of prospective clinical trials on oral mucositis has not been established, despite its uniqueness. Here, we propose a novel research policy on oral mucositis, including an implementable set of recommendations for researchers conducting clinical trials. Methods: The first draft was developed by an expert panel of six specialists from the Japanese Supportive, Palliative, and Psychosocial Care Study Group. A provisional draft was developed after review by the following medical societies: the Japanese Association of Supportive Care in Cancer, the Japanese Association of Oral Supportive Care in Cancer, the Japanese Cancer Association, and the receipt of public comments. Results: The research policy on oral mucositis mainly consists of the following components: (i) definition of oral mucositis; (ii) characteristics of oral mucositis; (iii) characteristics of oral mucositis research; (iv) target population for oral mucositis research; (v) endpoints and assessment measures in oral mucositis; (vi) eligibility criteria; (vii) research design; and (viii) minimally recommended intervention in oral mucositis research as a supplement. The final policy (Ver1.0) was completed on August 16, 2021. Conclusions: This policy may serve as a significant reference for planning and conducting clinical trials for the management of oral mucositis.
Morbidity of single-fraction spine radiosurgery for metastatic disease.
Authors: Gardner Ulysses Grant , McClelland Shearwood
Published: June 2023

e24116

Background: The optimal management of metastatic spine disease involves radiation therapy, with stereotactic radiosurgery (SRS) utilization having increased in adoption while proving to be efficacious and safe. Spine SRS morbidity (fatigue, dermatitis, nausea and esophagitis) is generally mild and depends on the spinal vertebral level(s) treated. More severe adverse events such as vertebral compression fracture (VCF), radiation-induced myelopathy, and tracheoesophageal (TE) fistula have been documented. The potential benefits of single-fraction SRS (sfSRS) over multi-fraction SRS include increased patient convenience, decreased financial toxicity, and increased treatment completion rates. These benefits may potentially be overshadowed by the morbidity of sfSRS versus multifraction SRS. In this analysis, we perform the first comprehensive examination of sfSRS morbidity in the treatment of spinal lesions. Methods: An extensive search of the PubMed database was undertaken through 2/2/23 to find studies examining spinal sfSRS. Search parameters included the terms “single-fraction, spine, radiation SRS OR SBRT” Articles including multi-fractionated regimens only, reviewed sites outside of the spine, or did not report on clinical outcomes/toxicities were excluded. Results: 17 articles met initial inclusion criteria; 9 were added from references for a total of 26 articles comprising at least 2,699 patients (one study reported the number of tumors, not patients). Dose ranges for single-fraction SRS were 8-26 Gy. Commonly noted toxicities were fatigue, nausea/vomiting, and dermatitis which were no worse than moderate/minimal, not requiring invasive intervention. The overall rate of VCF was 16.2%, with an increased propensity at >20 Gy. The proportion of reported segments requiring surgical intervention (operative stabilization, vertebroplasty/kyphoplasty) for VCF after single-fraction SRS was 20.2% (33/163). The rate of TE fistula at 25 Gy was 8.3%, with an overall rate (dose range = 10-28 Gy) of 1.3% with up to 12-years of follow-up. In patients receiving median dose of 24 Gy, the rate of severe esophagitis was 6.8%, myositis was 1.3% (at 1-year) and 8.3% (at 5-years). The rate of peripheral nervous system injury was 2.5% (at 18-26 Gy) and pain flare was 8% (at 16-24 Gy). The rate of ureteral and esophageal stricture was 1.9% each in patients receiving 12-24 Gy. Conclusions: VCF is the most commonly reported severe adverse events with single-fraction spine SRS, particularly for doses > 20 Gy. 80% of VCFs can be successfully managed without invasive intervention. Other severe adverse events are rare – particularly for < 20 Gy – but require post-SRS monitoring to expediently and efficiently intervene if necessary. These findings indicate that single-fraction spine SRS to < 20 Gy is safe with minimal morbidity. Further study regarding the efficacy of such dosing is being evaluated in ongoing clinical trials.
A pilot study to determine the effects of early palliative care integration on patients with newly diagnosed multiple myeloma.
Authors: Samala Renato Verayo , Valent Jason Neil , Wei Wei , Crook Jasmine , Fada Sherry
Published: June 2023

e24118

Background: While multiple studies underscore the value of early palliative care (PC) involvement in patients suffering from cancer, particularly solid tumors, the effect of early integration on the care of patients with multiple myeloma is not as widely known. This study aims to obtain preliminary data on the effects of early PC involvement on patients with newly diagnosed symptomatic multiple myeloma. Methods: This is a pilot study with a prospective cohort design and based in the outpatient setting. Patients at least 18 years of age and within eight weeks of diagnosis were included. Each participant was seen by a PC specialist monthly for 12 months for ongoing symptom management and advance care planning. Quality of life was assessed using Functional Assessment of Cancer Therapy-General (FACT-G), plus the Multiple Myeloma Subscale (FACT-MM). Hospital Anxiety and Depression Scale (HADS) was used to estimate the number of participants with self-reported symptoms of depression and anxiety. Questionnaires were administered upon enrollment and every three months for 12 months. The percentage of participants who completed the study was assessed to determine the feasibility of this approach. Results: Of the twenty participants enrolled from January 2020 to November 2022, median age was 65 (range 40, 77), 15 (75%) were female, 15 (75%) were white and 11 (55%) had an Eastern Cooperative Oncology Group Performance Status score of 1. Eighty-five percent of participants completed assessment at three months, 65% at 6 months, 65% at 9 months, and 60% at 12 months. FACT-G total score was significantly higher (increased by 15.1 points) at 12 months compared to baseline (adjusted 95% CI: 2.2-28.1, adjusted p = 0.018). Functional well-being (FWB) subscale score was significantly higher (increased by 5.0 points) at 9 months compared to baseline (adjusted 95% CI: 0.5-9.5, adjusted p = 0.025), and at 12 months compared to baseline (adjusted 95% CI: 1.1-10.9, adjusted p = 0.012). Depression and anxiety scores did not significantly change over time. Conclusions: Improvement in quality of life was seen among patients with newly diagnosed symptomatic multiple myeloma after 12 months of early PC involvement. Monthly PC visits appeared to be feasible for these patients. Clinical trial information: NCT04248244 .[Table: see text]
Availability of palliative specialty care for adults in community oncology: Results from the 2022 NCORP landscape assessment.
Authors: Statler Tiffany M. , Dressler Emily Van Meter , Kittel Carol A , Foust Melyssa , Loh Kah Poh , Weaver Kathryn E. , Klepin Heidi D. , Nightingale Chandylen L , Gabbard Jennifer
Published: June 2023

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Background: Palliative care promotes timely symptom management, and care planning and improves quality of life in oncology patients. About 60% of community oncology practices sampled in 2015 had outpatient palliative care. This study updates estimates of palliative care resources in community oncology. Methods: Questions from the 2022 Landscape Assessment of National Cancer Institute Community Oncology Research Program (NCORP) (funding provided by 2UG1CA189824) assessed the availability of specialist palliative care providers and ancillary care services, including utilization of advanced practice providers (APPs). Descriptive statistics describe availability of providers and services. Multivariable logistic regression was used to identify practice characteristics associated with palliative care specialist availability in 2022. Differences in rates of palliative care specialists, outpatient palliative care, APPs and patient portal use between 2015 and 2022 assessment results were assessed using Chi-Square tests, assuming independent time snapshots of general population characteristics. Results: Most community oncology practices sampled in 2015 had palliative care specialists (76%) and 62% of practices reported having outpatient palliative care. Of the 259 non-pediatric exclusive NCORP practice groups included in the 2022 analyses (Table 1), significantly more had palliative care specialists (86%; p = 0.003) and offered palliative care in the outpatient setting (76%; p = 0.001). Most practices utilized APPs (92%) and had a patient portal (95%), while only 41% had a survivorship clinic. Multivariable analyses demonstrated practices with more adult oncology providers (OR = 1.03, p = 0.039) and those with a designated survivorship clinic (OR = 3.16, p = 0.001), were significantly more likely to have specialty palliative care in the outpatient setting. Conclusions: More practices reported availability of palliative care specialists and outpatient services in community oncology practices in 2022 compared to 2015, with more oncology providers being associated with increased odds of having outpatient specialty palliative care in 2022. Smaller community oncology practices with fewer providers may need support to expand their capacity to provide palliative care. [Table: see text]
Sexuality as a prognostic factor: Results of an individual participant data NOGGO-meta-analysis of 1,041 recurrent ovarian cancer patients before starting chemotherapy.
Authors: Balint Nicole , Pirmorady-Sehouli Adak , Richter Rolf , Zocholl Dario , Woopen Hannah , Pietzner Klaus , Sehouli Jalid
Published: June 2023

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Background: Until now there is very little data available about sexuality in ovarian cancer patients. Aim was analyze if sexuality is associated with clinical parameters, quality of life, prior discontinuation of chemotherapy and survival in recurrent ovarian cancer patients before starting chemotherapy. Methods: Raw data including the QLQ-C30 and QLQ-OV28 EORTC questionnaire from four phase II/III trials (“Tower”, “Treosulfan”, “Hector” and “TRIAS”) conducted by the North-Eastern German Society of Gynecological Oncology (NOGGO) were synthesized for this individual participant data meta-analysis using ANOVA and cox regression analyses. All study participants were diagnosed with recurrent ovarian cancer and data for this analysis was gained before starting chemotherapy. Three patient groups were defined: (1) patients without interest in sex and not being sexually active, (2) patients with interest in sex and not being sexually active and (3) patients with interest in sex and being sexually active. Results: Data on sexuality was available from 644 patients with 437 patients without interest in sex and not being sexually active (1), 45 patients with interest in sex and not being sexually active (2) and 162 patients with interest in sex and being sexually active (3). Women of the third group were significantly younger with a median age of 57 years at randomization compared to women of group (1) with a median age of 65 years, p < 0.001. Women with interest in sex and who were sexually active showed also a significant better ECOG performance status (p < 0.001), had a lower number of recurrences (p < 0.001) and had less frequently ascites at diagnosis (p < 0.002). There were no differences regarding FIGO stage, BMI and grading between the three groups. Sexuality was associated with global quality of life (p < 0.001) and physical, psychological, social, emotional and role functionality (p < 0.001). Patients who were sexually active, reported less fatigue (p < 0.001), less pain (p < 0.001), less sleeping disorders (p = 0.004), less diarrhea (p = 0.008), less nausea and vomiting (p = 0.007) and less loss of appetite (p < 0.001). There was no association with prior discontinuation of chemotherapy. Median overall survival (OAS) was 16.7 months in platinum-resistant patients being sexually active compared to a median OAS of 8.7 months in platinum-resistant patients who are not sexually active (p = 0.016). Conclusions: Medical personnel should routinely address sexuality in ovarian cancer patients as sexuality seems to be a marker for both QoL and overall survival and warrants further investigation.
“It’s been a long journey:” A qualitative study of patient and caregiver experiences during multimodality treatment for locally advanced rectal cancer.
Authors: Lau-Min Kelsey S. , Psenka Riley , Massad Katina , El-Jawahri Areej , Temel Jennifer S. , Parikh Aparna Raj , Nipp Ryan David , Traeger Lara
Published: June 2023

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Background: Locally advanced rectal cancer (LARC) is treated with multimodality therapy including chemotherapy, radiation, and surgery to maximize the potential for cure. However, this aggressive treatment approach can result in substantial toxicity for patients, including life-altering changes in bowel, urinary, and sexual function as well as decrements in quality of life. We aimed to explore the lived experiences of patients and caregivers during multimodality treatment for LARC. Methods: We conducted a qualitative study of patients ≥18 years old undergoing multimodality treatment for LARC at the Massachusetts General Hospital, as well as their designated caregivers. We used purposive sampling to maximize variation in participant age, gender, and treatment status pre- versus post-surgery. Each participant completed a one-hour individual in-depth interview using a semi-structured interview guide covering treatment experiences, coping strategies, and supportive care needs. We audio recorded, transcribed, and coded interviews using an iterative approach, after which we analyzed the data using thematic analysis and constant comparison methods. Results: We included 21 patients (median age 51 years, 11 female, 18 white, 10 post-surgical resection) and 9 caregivers (median age 49 years, 8 white, 6 married/living with patient). Patients and caregivers reported that the lengthy and complex nature of treatment for LARC made it difficult for them to fully understand and navigate their treatment trajectories. The multimodality treatment approach presented several challenges with care coordination; discordant recommendations between treatment team members; and an overarching sense of unpredictability with respect to treatment timelines, complications, and impact on patients’ personal, work, and family lives. Patients and caregivers reported wishing that they had received more detailed information about each treatment phase upfront but recognized that the initial shock of a LARC diagnosis may have impeded their ability to absorb this new information. Many resorted to their own internet searches to address their unanswered questions but often found themselves returning to their treatment teams to clarify misperceptions and manage the additional distress they experienced online. Conclusions: Patients and caregivers face critical challenges in navigating treatment for LARC due to the lengthy, complex, and unpredictable nature of this treatment approach. Many resorted to their own internet searches and reported feeling misinformed, distressed, or regretful about the information found online. Findings from this study will inform the development of interventions to enhance information delivery and processing for patients undergoing multimodality treatment for LARC.
Wireless transcutaneous electric nerve stimulation (TENS) for chemotherapy-induced peripheral neuropathy (CIPN): A proof-of-concept, placebo-controlled, randomized clinical trial (RCT).
Authors: Gewandter Jennifer S. , Culakova Eva , Davis Jenae N , Gada Umang , Guido Joseph John , Burnette Brian Leslie , Bearden James D. , O'Rourke Mark Allen , Mustian Karen Michelle , Morrow Gary R. , Sluka Kathleen A , Mohile Nimish
Published: June 2023

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Background: Chronic CIPN affects approximately 30%-60% of people who receive neurotoxic chemotherapy. CIPN is associated with impaired quality of life and function and has few effective treatments. Methods: This 6-site, subject and assessor blinded RCT was designed to assess (1) preliminary efficacy (i.e., alpha pre-specified at 0.2) of a wearable, app-controlled, TENS device for chronic CIPN and (2) feasibility of conducting a confirmatory trial within the NCI Community Oncology Research Program (NCORP) (NCT 04367480). The primary outcome was the EORTC-CIPN20. The main secondary outcomes were hot/burning pain, sharp/shooting pain, tingling, numbness, and cramping (7-day daily diary, 0 – 10 numeric rating scales). The TENS device applies stimulation for 1hr treatment sessions followed by 1 hour rest periods. The placebo TENS device is identical, except it delivers only 2.5 mins of stimulation in the treatment period. Subjects were asked to wear the device for 5 hrs/day (i.e., 3 treatment sessions) for 6 weeks. The primary analysis used an ANCOVA with the 6-week EORTC-CIPN20 score as the dependent variable, arm as fixed effect, and baseline EORTC-CIPN20 and site as covariates. Secondary analyses used similar ANCOVA models (excluding site) for each symptom on subgroups of subjects who reported at least 4 out 10 for that symptom at baseline. Results: 142 eligible subjects were randomized and received a device; 130 (91%) completed the study. Subjects were on average 63 years old, 65% female, and 85% white. The most common chemotherapies were taxanes (37%), platinums (36%), or their combination (15%). 88% of study completers received at least 3 treatment sessions on at least 70% of study days. The median time since chemotherapy was 16 months (IQR: 7, 34). See Table for efficacy results. Conclusions: A RCT of an app-controlled, wireless TENS device for chronic CIPN with excellent adherence and retention rates is feasible in NCORP. Preliminary efficacy evidence suggests that TENS is promising for pain and cramping from CIPN, but less likely to improve numbness and tingling. A confirmatory RCT of TENS for painful CIPN is highly warranted. Clinical trial information: NCT04367480 . [Table: see text]