bluuebunny/crossref_metadata_2025_split huggingface dataset:
Clinical and demographical factors associated with fertility counseling in colorectal cancer.
Authors: Peng Chengwei , Masri Lena , Roman Stefanie , Sherman Scott , Becker Daniel Jacob 
Published: June 2021

e24047 Background: The incidence of colorectal cancer in patients younger than 50 has been increasing over the past 2 decades. This demographic shift has important implications for survivorship care, in particular regarding issues of future fertility especially in light of USPSTF’s recommendation for colorectal cancer screening to begin at 45. Although ASCO has longstanding recommendations for fertility counseling in patients with cancer, the rates of fertility counseling in younger patients with colorectal cancer are unknown. Methods: Records for new patient visits for colorectal cancer in patients younger than age 55 in a large academic cancer center between 2012 and 2019 were queried for patient demographics, disease characteristics, and documentation of fertility counseling. Associations between demographic/clinical characteristics and fertility counseling were explored. Univariate and multivariable logistical regression analyses were performed using SAS v9.4. Results: Among 194 patients who met inclusion criteria, 39.2% of patients were female, 10.4% were African American, 31.4% had rectal cancer, and 69.6% were treated with curative intent. Approximately 14.5% of patients had Medicaid insurance. Age ranged from 22-55. The overall rate of fertility counseling among all patients was 15.5%. Of these patients, 43.3% were male. In univariate analysis, age less than or equal to 40 (p < 0.01), female gender (p = 0.03) and curative intent therapy (p = 0.03) were associated with fertility counseling. These factors were again statistically significant in multivariate analysis: age < 40, female, and curative intent therapy (Table). Race, stage of cancer, insurance status, prior exposure to chemotherapy, year of diagnosis and colon vs rectal cancer were not associated with counseling. Conclusions: The rate of fertility counseling was very low among patients with colorectal cancer, and exceptionally low among men. Despite changes in the demographics of colorectal cancer, it does not appear that appropriate changes have been made in fertility counseling. Increases in fertility counseling were not seen in more recent years despite recognition of increasing incidence in younger patients. Additional studies to identify barriers to counseling and strategies to improve survivorship care are urgently needed.[Table: see text]
The experience of pain among cancer patients at the University of the Philippines: Philippine General Hospital Cancer Institute—A cross-sectional study.
Authors: Tan Harold Nathan C. , Velasco Rogelio Nona , Catedral Lance Isidore Garcenila , San Juan Michael Ducusin , Ngelangel Corazon , Calvo Emiliano 
Published: June 2021

e24078 Background: Pain is one of the most common and dreaded sequelae of cancer, occurring in approximately 55% of patients. The experience of pain takes a toll on the patients’ quality of life. However, many patients do not receive adequate pain management. This study aimed to determine the prevalence of pain, its severity, and the adequacy of pain management among cancer patients in the Philippines. Methods: A cross-sectional study was conducted at a representative cancer center in the Philippines, enrolling 351 cancer patients. Pain severity was assessed using the Brief Pain Inventory-Short Form (BPI-SF) Filipino. The BPI evaluates pain severity and its impact on daily functioning (pain interference). To ascertain the adequacy of pain control, the pain management index (PMI) was calculated by subtracting the subtracting the severity of pain reported by the patient from the type of analgesic treatment received. Logistic regression analysis was conducted to evaluate the factors associated with worst pain and adequacy of pain management. Data were analyzed using Stata version 16.0, with statistical significance set at p < 0.05. Results: Three hundred three cancer patients (86.3%) experienced pain. Approximately 3 out of 5 patients (n = 208) did not receive adequate pain control, and one-third of patients experienced severe pain (n = 121). Patients who reported severe pain interference (n = 110) had three times greater odds to experience severe pain (OR 3.2, 95% CI 1.82-5.61, p < 0.001). Those patients who had regular follow up were 65% less likely to experience severe pain (OR 0.35, 95% CI 0.16 – 0.78, p = 0.01). Patients who used pain medications (n = 196) were 14 times more likely to experience adequate pain management (OR 14.19, 95% CI 6.53 – 30.83, p < 0.001). Patients who were referred to pain service (n = 25) were seven times more likely to report adequate pain control (OR 6.62, 95% CI 2.50 – 17.56, p < 0.001). Conversely, those patients who reported a severe rating on total pain interference were 75% less likely to experience adequate pain management (OR 0.25, 95% CI 0.17 – 0.35, p < 0.001). Conclusions: Unexpectedly, there was a high prevalence of pain among cancer patients at a representative cancer center in the Philippines. Pain exerts a heavy toll on patients, affecting daily functioning. The undertreatment of pain discovered in this study (59% of cancer patients) is alarming. Timely pain evaluation can help identify the presence of pain and the need for appropriate use of analgesics. The assessment and management of pain is a critical component of cancer care that should not be neglected.
Survivorship care plans and adherence with surveillance schedule in patients with invasive melanoma.
Authors: Shah Hemali , Feustel Paul , Davis Lindy 
Published: June 2021

e24079 Background: Melanoma accounts for 5.5% of new cancer diagnoses in the United States, and the 5-year overall survival is 93%. Overall, 7% of patients develop a recurrence, and 4-8% develop a second primary melanoma. This study aimed to assess how the standards set by the American College of Surgeons Commission on Cancer (CoC) to provide survivorship care plans (SCP) to patients may improve adherence to surveillance visits. Methods: All patients treated for invasive melanoma at our institution between 8/2018-2/2020 were included. SCP containing stage, treatment summary, and surveillance plan were delivered in-person to patients and sent to primary providers and dermatologists as outlined by CoC Standards for Optimal Care. Psychosocial distress (PSD) screening was performed using the National Comprehensive Cancer Network Distress Thermometer, with scores > 4 requiring further evaluation by oncology social worker. SCP and PSD were provided during the initiation phase of our cancer care program, and half the patients received services. Surveillance adherence was determined from chart review. The two groups were compared by t-test for continuous or chi-square test for categorical variables. Multiple regression analysis with odds ratios were performed. Mann-Whitney analysis was performed to assess the impact of SCP on PSD. Results: Of 146 patients identified for our cohort, 73 received SCP and PSD screening. Stage IA was the most common diagnosis (44%), followed by IB (13%) and IIIC (9%). Ninety-eight patients (67%) were adherent to all surveillance visits, and 55 of these received SCPs. Most patients noted low distress without the need for further support (79%), and 12 (21%) scored ≥4, benefiting from emotional and financial support and appointment and health insurance navigation. High PSD score did not correlate with advanced stage. Reception of SCP (p = 0.036) and close distance to treating facility (p = 0.016) improved adherence to surveillance visits. For patients who did not receive SCP, likelihood to follow up decreased by a factor of 0.469 (95% CI 0.231 - 0.952). Sex, age, PSD score, and stage did not affect surveillance adherence (p = NS). There were 6 recurrences, of which 4 were physician-detected during surveillance, and 8 patients developed second primary melanomas, all physician-detected. Conclusions: Delivery of SCP, a component of which includes counseling regarding signs and symptoms of recurrence or possibility of second primary melanoma, leads to significantly higher rates of surveillance adherence. This was shown for all stages. Melanoma survivors require close clinical follow-up, as demonstrated by our study finding that even with patient education, most recurrences and all new primary melanomas were physician-detected. PSD among melanoma patients is common, and all patients regardless of stage should undergo screening, as even early-stage patients exhibited distress.
Pan-cancer analysis of fear of cancer recurrence in cancer survivors.
Authors: Adashek Jacob J. , Thompson Zachary , Martinez Tyson Dina , Pabbathi Smitha 
Published: June 2021

e24104 Background: Fear of cancer recurrence (FCR) in cancer survivors is an understudied phenomenon estimated to one-third to over half of all cancer survivors. FCR has been shown to contribute to treatment noncompliance and portend a decrease in overall survival (OS). The purpose of this study was to examine factors associated with needs related to FCR among patients seen at a solid tumor survivorship clinic at a National Cancer Institute designated center. Methods: Data collected as part of a patients’ needs assessment that is administered to patients (n = 657) with solid tumors such as breast, genitourinary, gastrointestinal malignancies at their initial clinic visit were analyzed. Correlations between responses were calculated and univariable and multivariable logistic regression was used to identify predictors of met or unmet needs related to FCR. Results: There were a total of 657 patients included 442 (67.3%) female and 215 (32.7%) male. The majority of patients (84.5%) were white (n = 555), followed by 9.74% black (n = 64), the remaining patients identified as ‘other’ or Asian. The patients median age was 67 years, median age of diagnosis 55 years, and median years since diagnosis 10 years. 613 patients had recorded distress scores ranging from 0 (n = 214), 1-4 (n = 255), 5-7 (n = 106), or 8-10 (n = 38). Of 647 patients, 241 (37.2%) reported FCR was not a need and 386 (59.7%) reported FCR was a met need. According to univariate logistic regression gender had no impact on FCR (p = 0.8427) nor did years since diagnosis (p = 0.1014). Results of multivariable regression indicate the odds ratio of reporting FCR as an unmet need (vs not a need) decreases by 6% (p = 0.0023) for every year increase in age. For each unit increase in distress score the odds ratio of reporting FCR as an unmet need is increased by 32% (p = 0.0007). Conclusions: Our data suggests that patients reporting higher distress scores are more likely to report FCR as an unmet need. Therefore, survivors with high distress scores reported in clinic visits should be evaluated for FCR. FCR reported as an unmet in our study is significantly less. Further stratification of FCR can be helpful for providers caring for survivors to identify and address FCR more effectively in clinical care. Further study is needed to learn how survivors have come to identify the need as being met.
Biomarker-oriented study of durvalumab in combination with olaparib and paclitaxel in gastric cancer: A phase 2 trial-in-progress.
Authors: Kim Tae Yong , Yoon Jee Sun , Nam Ah-Rong , Bang Ju-Hee , Oh Kyoung Seok , Seo Hye-Rim , Kim Jae-Min , Oh Do-Youn 
Published: June 2021

TPS4153 Background: Olaparib (PARP inhibitor) leads to DNA damage and cell death. In phase III study (GOLD), olaparib plus paclitaxel did not improve overall survival (OS) compared with paclitaxel in second-line gastric cancer (GC) patients with statistical significance, even though there was absolute increase of OS (Lancet Oncol 2017). This highlights the importance of biomarker-based patient selection. The changes of tumor microenvironment by paclitaxel/olaparib have not been explored. Besides DNA damage, olaparib induces positive or negative immune modulation by recruiting T cells, promoting type I interferon and upregulating PD-L1, which suggests anti-PD (L1) inhibitor plus olaparib could enhance anti-tumor immunity. Combination of Anti-PD-1 agents with chemotherapy showed a good clinical efficacy in first-line of GC compared with chemotherapy alone (Checkmate 649). Based on these findings, the combination of paclitaxel/olaparib/anti-PD(L1)1 inhibitor, with different mode of actions, might enhance antitumor activity. This is phase II study of paclitaxel/olaparib/durvalumab combination in second-line GC patients, to find out immune modulation effects by paclitaxel/olaparib combination, and to see the efficacy, safety, optimal biomarkers for this combination. Methods: All patients with histologically confirmed unresectable GC have failed to prior one chemotherapy and measurable lesion. Prior exposure to anti-PD(L1)1, PARP inhibitor is excluded. At 1st cycle, paclitaxel (80 mg/m2) on D1, 8 and 15 and olaparib (150 mg bid) on D1-28 is administered. Pre-treatment biopsy and after first cycle biopsy is done. From second cycle, durvalumab 1500 mg on D1 every 4 weeks is added. At the time of disease progression, tumor biopsy is mandatory. Blood samples for biomarkers should be obtained every cycles. Response evaluation is performed after first 3 cycles and repeated every 2 cycles. Primary endpoint is the disease control rate (the percentage of patients who have achieved complete or partial remission, stable disease based on RECIST v1). Key secondary endpoints are overall response rate, progression-free survival, OS, quality of life and safety. Clinical trial information: NCT03579784.
A phase 2 study of cabozantinib in combination with atezolizumab as neoadjuvant treatment for muscle-invasive bladder cancer (HCRN GU18-343) ABATE study.
Authors: Kilari Deepak , Szabo Aniko , Bylow Kathryn A. , Alter Robert S. , Nelson Ariel Ann , Lemke Emily , Hall William Adrian , Johnson Scott , Langenstroer Peter , Jacobsohn Kenneth , Davis Nancy B. , Fung Chunkit , Milowsky Matthew I. 
Published: June 2021

TPS4591 Background: ABACUS and PURE-01 trials demonstrated the activity of single agent atezolizumab and pembrolizumab respectively as neoadjuvant therapy for muscle invasive urothelial carcinoma (MIUC). However, downstaging to non-muscle invasive disease was noted in only 50 percent of patients. Resistance to programmed death (PD)- 1/L-1 antibodies is likely to include factors such as impaired dendritic cell maturation/function, infiltration of T-Regs and myeloid derived suppressor cells, impaired T-cell priming and T-cell trafficking in tumors. Cabozantinib is a tyrosine kinase inhibitor which targets MET, AXL, MER, Tyro3 and VEGFR2. Cabozantinib has a unique immunomodulatory profile and has demonstrated clinical activity as monotherapy and in combination with PD-1/L1 antibodies in various solid tumors including UC, renal cell cancer, castrate- resistant prostate cancer, and non-small cell lung cancer. We hypothesize that the combination of cabozantinib and atezolizumab as neoadjuvant therapy for MIUC would improve rates of pathologic downstaging compared to single-agent checkpoint inhibitors. Methods: ABATE(NCT04289779) is an open-label, single arm, multi-center study to assess the efficacy and safety of cabozantinib with atezolizumab as neoadjuvant therapy for cT2-T4aN0/xM0 MIUC. An estimated 38 patients will be enrolled and receive cabozantinib 40 mg PO daily with atezolizumab 1200mg every 3 weeks for a total duration of 9 weeks followed by radical cystectomy. Adults (≥18 years) with resectable UC who are either cisplatin-ineligible or decline cisplatin are eligible. Patients are required to have an ECOG PS of 0-2 and provide tumor tissue for PD-L1 analysis. UC should be predominant component (≥ 50%). Previous systemic anticancer therapies for MIUC are not permitted. CT/MRI will be performed before investigational therapy and cystectomy. Primary endpoint is pathologic response rate defined as the absence of residual muscle-invasive cancer in the surgical specimen ( < pT2). Secondary endpoints are safety and toxicity, pathologic complete response rate and event-free survival. Exploratory end points include patient-reported outcomes and outcome associations with biomarkers. Accrual began May 2020. Clinical trial information: NCT04289779.
CYCLONE 1: A phase 2 study of abemaciclib in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with a novel hormonal agent and taxane-based chemotherapy.
Authors: Agarwal Neeraj , Oudard Stephane , Piulats Josep M. , Schweizer Michael Thomas , Flechon Aude , Alonso Gordoa Teresa , Nacerddine Karim , Lithio Andrew , Johnston Erica L. , Smith Matthew Raymond 
Published: June 2021

TPS5086 Background: In cancer cells, the cyclin-dependent kinases 4 and 6 (CDK4 & 6)/retinoblastoma protein (Rb) pathway is commonly altered, resulting in uncontrolled cell cycle entry and proliferation. CDK4 & 6 inhibitors represent a major advance in the management of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (ABC or MBC, respectively). Abemaciclib is an oral selective inhibitor of CDK4 & 6 administered on a continuous dosing schedule, approved in combination with endocrine therapy for HR+, HER2- ABC or MBC. In addition, abemaciclib is also approved by the FDA as monotherapy for HR+, HER2- ABC or MBC following endocrine therapy and prior chemotherapy in the metastatic setting. Similar to the estrogen receptor signaling pathway in breast cancer cells, there is evidence that the androgen receptor axis activates CDK4 & 6 to sustain prostate cancer cell proliferation and survival. Preclinical studies in prostate cancer cell lines and xenograft models showed that abemaciclib exhibits single agent activity by inducing cell cycle arrest and tumor growth inhibition. Clinical activity of abemaciclib in combination with abiraterone and prednisone is investigated in a randomized phase 2 study in the first-line mCRPC setting (CYCLONE 2, NCT03706365). Despite recent advances, management of heavily pretreated mCRPC remains a major clinical challenge. Herein, we hypothesize that mCRPC patients whose disease progressed after novel hormonal agents (NHA) and taxane therapies may derive therapeutic benefit from single agent abemaciclib. Methods: CYCLONE 1 is a phase 2, single-arm, multicenter study to assess the safety and efficacy of abemaciclib monotherapy in 40 patients with mCRPC progressing after ≥1 NHA and 2 taxane regimens. Patients will be enrolled at time of prostate specific antigen (PSA) or radiographic progression per PCWG3 criteria and have at least 1 measurable lesion per RECIST 1.1. Metastatic tumor tissue (fresh biopsy or archival material <12 weeks) is required at baseline for biomarker analysis. Patients will receive abemaciclib 200 mg twice daily until unacceptable adverse events or disease progression. The primary objective is investigator-assessed objective response rate (ORR). Key secondary objectives include safety, radiographic progression-free survival, overall survival, PSA response rate, time to PSA progression, time to symptomatic progression, Ki-67 expression, patient-reported outcomes, and pharmacokinetics. Assuming an ORR of 15%, the study has over 73% power to observe a response rate of at least 12.5%. Accrual began in January 2021. Clinical trial information: NCT04408924.
Trial in progress: A phase I/II trial of novel MDM2 inhibitor alrizomadlin (APG-115), with or without platinum chemotherapy, in patients with p53 wild-type salivary gland carcinoma.
Authors: Swiecicki Paul , Tang Yuefen , Pearson Alexander T. , Muzaffar Jameel , Fidler Mary J. , Winkler Robert , Fu Tommy , Li Mingyu , Ahmad Mohammad , Yang Dajun , Zhai Yifan 
Published: June 2021

TPS6094 Background: Salivary gland carcinoma is a rare tumor that accounts for 6% of all head and neck cancers. This histologically and anatomically heterogeneous malignant tumor type is largely resistant to platinum and other chemotherapies but commonly has wild-type TP53 based on next-generation sequencing analysis. Alrizomadlin is a novel, orally active, small molecular agent that binds to MDM2, restoring p53 tumor suppressor function and inducing apoptosis in tumor cells retaining wild-type p53. Preliminary clinical evidence suggests promising antitumor activity and a favorable safety profile for alrizomadlin in the treatment of solid tumors (Rasco 2019). Methods: This US multicenter open-label trial is evaluating alrizomadlin with or without platinum chemotherapy in adults with histologically documented wild-type TP53 salivary gland carcinoma, including primary or metastatic lesions, an ECOG performance status 0-1, and a life expectancy of at least 12 weeks. In addition, subjects need to have measurable disease by computed tomography according to RECIST v1.1, with radiographic disease progression within the prior 12 months, high-grade status with or without metastases, and/or not amenable to curative treatment. An initial randomized phase (Part 1) will be followed by a single-arm phase (Part 2). Treatment arms include a cycle length of 21 days, and the study is using a time-to-event continual reassessment method. In Part 1 (42 patient target), patients are randomly allocated (in a 1:2 ratio) to one of two arms: single-agent alrizomadlin at a starting dose of 150 mg (Arm A) or at a starting dose of 150 mg with concomitant IV carboplatin administered at starting AUC = 4.5 (Arm B). Based on overall response rate (ORR; complete or partial response after Cycle 2) and safety profile, the most promising treatment arm will be advanced to Part 2, which has a target enrollment of 20 patients. Study endpoints are (1) dose-limiting toxicity (DLT), which is defined by the rate of drug-related grade ≥ 3 adverse events (by NCI CTCAE v5.0) over the first 2 cycles (6 weeks) of study treatment; (2) maximum tolerated dose based on these DLTs; and (3) ORR by RECIST v1.1 observed at up to 12 months. As of January 27, 2021, 11 of 42 patients had been enrolled in Part 1. Internal study identifier APG-115SG101. Clinical trial registration: NCT03781986. Clinical trial information: NCT03781986.