bluuebunny/crossref_metadata_2025 huggingface dataset:
Mitoxantrone hydrochloride liposome injection in the treatment of recurrent/metastatic head and neck cancers: A multicenter, open-label, single-arm, phase Ⅰb study.
Authors: Yang Hang , Wang Xicheng , Zhang Hong , Peng Jiyong , Li Weidong , Liu Yanyan , Hu Jianbing , Zhou Hui , Zhang Bing , Liu Jixiang , Lin Shunhuan , Luo Hao , Hu Jie , Li Zhiming
Published: June 2022

e18028

Background: Mitoxantrone is an anthraquinone antibiotic antitumor agent, and mitoxantrone hydrochloride liposomes have been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL) in China. The current study aimed to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome in patients (pts) with recurrent/metastatic head and neck cancers. Methods: This study is a multicenter, open-label, single-arm, phase Ⅰb study. The pts with histologically confirmed diagnosis of head and neck squamous cell carcinoma (including nasopharyngeal carcinoma) were enrolled. Mitoxantrone hydrochloride liposome was administered at 20 mg/m2 by an intravenous infusion, every 21 days (q3w, 1 cycle) until disease progression, intolerable toxic reaction, death, or withdrawal by investigator or patient decision (a maximum of 8 cycles). The primary objective was to determine the safety of mitoxantrone hydrochloride liposome. Secondary objective was to assess the efficacy of mitoxantrone hydrochloride liposome in the treatment of recurrent/metastatic head and neck squamous cell carcinoma. Efficacy assessment was performed every 2 cycles after dosing as per RECIST v1.1. Results: From July 8, 2021 through November 5, 2021, 34 pts with median age of 48 years (range 20-69 years) were enrolled, including 23 with nasopharyngeal cancer and 11 with non-nasopharyngeal cancer (5 with tongue cancer, 2 with hypopharynx, 2 with tonsil cancer, and 1 each with larynx and gum cancer). The most common treatment-emergent adverse events (TEAEs) were white blood cell decreased (41.2%), anemia (41.2%) and lymphocyte count decreased (29.4%). TEAEs were generally Grade (G) 1-2; 13 pts reported G3 TEAE. The summary of all-grade TEAEs (≥ 10%) are shown in the table below. Nineteen pts had undergone at least 1 efficacy evaluation (including 18 pts with nasopharyngeal cancer and 1 with non-nasopharyngeal cancer). The overall objective response rate (ORR) was 42.1% (8/19) and disease control rate (DCR) was 78.9% (15/19). ORR for nasopharyngeal cancer was 38.9% (7/18) and DCR was 77.8% (14/18). One case of hypopharyngeal cancer was evaluated as partial remission (PR). Conclusions: The preliminary data of mitoxantrone hydrochloride liposome has showed manageable safety and evidence of efficacy in pts with recurrent/metastatic head and neck squamous cell carcinoma. An expanded sample size is still needed for further validation in the future study. Clinical trial information: NCT04902027. [Table: see text]
Survivorship profile and post-treatment quality of life of oral cancer survivors in comparison with caregivers: An analysis of a real-world cohort of a developing country.
Authors: Thaduri Abhinav , Malhotra Manu , Garg Pankaj Kumar , Singh Mahendra Pal , Poonia Dharma Ram , Sharma Pankaj , Gupta Ravi , Gupta Manoj kumar
Published: June 2022

e18036

Background: Oral cavity cancer is the second most common cancer in India; India bears the most burden of oral cancer in the world. The most effective way to study the effectiveness of treatments is in clinical trials, but the quality of life (QOL) and post-treatment effects of those treatments are seldom studied in real-world settings. Methods: All oral cancer survivors treated with curative intent at our institute from September 2019 to January 2021, who were disease-free for a minimum of six months following treatment, were included in this study. The QOL of these cancer survivors was compared with that of their caregivers using the WHOQOL BREF questionnaire. The complete survivorship profile was evaluated using a Constant shoulder score for shoulder dysfunction, clinical oral dryness score (CODS) for xerostomia, Sydney Swallow Questionnaire (SSQ) for swallowing dysfunction, Patterson scale for lymphedema, Comprehensive Score for financial Toxicity (COST)‐Functional Assessment of Chronic Illness Therapy (FACIT) questionnaire for financial toxicity, Depression, Anxiety and Stress Scale - 21 Items (DASS-21) for psychological wellbeing. Results: A total of seventy-nine survivors were included. The median age was 49 years. Though both survivors and caregivers had similar QOL scores in the physical and environmental domains, survivors had poor scores in the social (M = 58.7,SD = 21.9) and psychological domains (M = 60.4,SD = 15.6). The T stage (p = 0.06), surgery (p = 0.008), and trismus (p = 0.03) were significant factors affecting swallowing. Those patients who had undergone selective neck dissection had better shoulder scores compared to those who had modified radical neck dissection (p = 0.006). 75% of people had xerostomia and 10.9% had severe xerostomia. Internal lymphedema was seen in 30.4% of people. Depression and anxiety were recorded in 46 (58.2%) and 33 (41.8%) patients respectively. Employment status (p = 0.04) and treatment modality (p = 0.05) were significant factors affecting financial toxicity. Conclusions: Oral cancer survivors had a poor psychosocial QOL compared to their caregivers. Treatment-related functional sequelae had a significant negative impact on quality of life across all domains. Clinical trial information: CTRI/2020/07/026848.
Annual household income and its association with financial toxicity, health utility, and survival in head and neck cancer.
Authors: Noel Christopher W , Hueniken Katrina , Forner David , Goldstein David Paul , de Almeida John R
Published: June 2022

e18040

Background: While several studies have documented a link between socioeconomic status and survival in head and neck cancer, nearly all have used ecologic, community-based measures. Studies using more granular patient level data are lacking. We sought to determine the association between baseline annual household income with financial toxicity, health utility and survival. Methods: This was a prospective cohort of adult head and neck cancer patients treated at tertiary cancer center between September 17, 2015, and December 19, 2019. Our primary exposure was annual household income at time of diagnosis. Outcomes of interest included disease-free survival, financial toxicity, measured using the FIT tool, and health utility, measured using the Health Utilities Index Mark 3. Cox proportional hazards models were used to estimate the relationship between household income and survival. Income was regressed onto log-transformed FIT scores using linear models. The association between income and health utility was explored using generalized linear models. A generalized estimating equations approach was incorporated to account for patient level clustering. Results: There were 555 patients included in this cohort. Two-year disease-free survival was worse for patients in the bottom income quartile (< $30,000 - 67% [95%CI 58-78])) compared to the top quartile (≥$90,000 - 88% [95%CI 83-93]). In risk adjusted models, patients in the bottom income quartile had inferior disease-free survival (aHR 2.13 [95%CI 1.22-3.71]) but not overall survival (aHR 2.01 [95%CI 0.94-4.29]). The average FIT score was 22.6 in the lowest income quartile vs. 11.7 in the highest quartile. In adjusted analysis, low-income patients had 12-month FIT scores that were, on average, 134% higher (worse) [95%CI 16%-253%] than high-income patients. Similarly, health utility scores were, on average, 0.106 [95%CI 0.029-0.184] points lower for low-income patients. Conclusions: Head and neck cancer patients with a household income < $30,000 experienced worse financial toxicity, health status and disease-free survival. Significant disparities exist for Ontario’s head and neck cancer patients.
Establishment of 5-hydroxymethylcytosine expression model of circulating-free DNA gene in early diagnosis of nasopharyngeal carcinoma.
Authors: Chen Bijuan
Published: June 2022

e18047

Background: Nasopharyngeal carcinoma (NPC) has no obvious symptoms in the early stage of onset, and more than 65% of patients have been diagnosed as intermediate and advanced stage. Studies have shown that early diagnosis and timely treatment of NPC play a key role in the survival of patients.5-hydroxymethylcytosine (5hmC) as an important epigenetic modification of DNA is closely related to gene regulation and NPC pathogenesis. Objective: To clarify the diagnostic value of 5hmC expression in circulating free DNA (cfDNA) gene for NPC. Methods:The expression of 5hmC in cfDNA of 166 NPC and 165 controls was detected with high-throughput technology, and the differentially expressed gene map of 5hmC was drawn. Based on the screened 5hmC Top50 differentially expressed genes, the NPC diagnosis model was established with 70% of the sample size as the training set and 30% as the verification set. The efficacy of 5hmC in distinguishing NPC from healthy controls was evaluated by drawing the receiver operating characteristic curve (ROC) and calculating the sensitivity, specificity, area under the curve (AUC) and accuracy rate (AR). Results: High throughput detection showed that there were significant differences in 5hmC expression of 194 genes between NPC and control cfDNA, of which 185 genes were up-regulated and 9 down regulated in NPC. The results of diagnostic test show that when the Youden index threshold of 0.4749 at the verification set is taken as the cut-off value, the sensitivity, specificity, AUC and AR of the training set are 0.7652, 0.7304, 0.8250 and 0.7478, while in the verification set, they are 0.6863, 0.7400, 0.7388 and 0.7129 respectively. Conclusions: Our findings suggest that cell-free 5hmC signatures are valuable as potential noninvasive diagnostic biomarkers of NPC, which can be transformed into clinical application by further optimizing the diagnostic model.
Outcomes of cisplatin dosing strategies in locally advanced non-nasopharyngeal head and neck squamous cell carcinoma treated with definitive concurrent chemoradiation in a safety-net hospital.
Authors: Lee Jennifer Minkyoung , Satpathy Shuchismita Roy , Shah Farah , LaBarbera Katie , Gutierrez Eutiquio
Published: June 2022

e18064

Background: For patients with locally advanced non-nasopharyngeal head and neck squamous cell carcinoma (HNSCC) not amenable for resection, concurrent chemoradiation with cisplatin is the standard of care. Most popular dosing strategies for cisplatin include bolus dosing once every three weeks for a total of three cycles and once a week for seven cycles. Randomized studies comparing efficacy and tolerability of these dosing strategies have been conflicting. We examined how different dosing strategies affect outcomes in our institution, a safety-net hospital serving the medically underserved population in a large metropolitan area. Methods: We conducted a retrospective chart review of patients diagnosed with HNSCC from January 2015 to July 2021 in our institution. Patients with biopsy proven HNSCC with oral cavity, oropharyngeal, laryngeal, or hypopharyngeal primary tumor sites treated with definitive concurrent chemoradiation with cisplatin were included in the study. Those who received cisplatin bolus dosing were identified as Arm A and weekly dosing identified as Arm B. Primary outcome studied was 12-month event-free survival (EFS). We controlled for stage at diagnosis, age, p16 positivity, smoking status, treatment delay or premature discontinuation, and number of comorbidities. Secondary outcomes were rates of treatment delay or discontinuation, and median cisplatin dose received. To determine whether a preliminary association exists, a Pearson Chi-Square test for association of treatment type to 12-month EFS was utilized. To control for potential confounding variables the Mantel-Haenszel test was used on each confounder. Results: A total of 51 patients were included in the study, 36 (70.6%) with bolus and 15 (29.4%) with weekly cisplatin. After controlling for confounding variables listed above, there was no statistically significant association between Arm A or Arm B and 12-month EFS (p = 0.324). Delay or discontinuation rate for Arm A was 10 out of 36 patients (27.8%) and for Arm B was 5 out of 15 patients (33.3%). The difference in these rates were not statistically significant (p = 0.743). The median cisplatin dose received for Arm A was 300 mg/m2 and 280 mg/m2 for Arm B. Conclusions: In our institution, there was no difference in 12-month EFS or rates of treatment delay or discontinuation between patients who underwent definitive concurrent chemoradiation with bolus versus weekly cisplatin (p = 0.324). This has a significant impact on practical management of concurrent chemoradiation in our resource limited setting.
Anlotinib combined with induction chemotherapy followed by chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma: A phase II study.
Authors: Jiang Feng , Chen Xiaozhong , Liu Tongxin , Qin WeiFeng , Huang Shuang , Cao Caineng , Jin Ting , Jin Qifeng
Published: June 2022

e18071

Background: Necrotic lesion is a negative prognostic factor for nasopharyngeal carcinoma (NPC) while there are few treatment options for it. This study investigated the efficacy and safety of anlotinib (a multi-target tyrosine kinase inhibitor) in combination with induction chemotherapy (IC) followed by concurrent chemoradiotherapy (CCRT) in treatment of liquefactive necrosis of NPC. Methods: This is an open-label, single-arm, phase II trial (NCT05232552). Patients with histologically confirmed stage T3-4N2/T1-4N3M0 NPC (AJCC 8th) who had measurable lesions per RECISTv1.1 and received no previous treatment for cancer were enrolled. Other inclusion criteria included 18-70 years old and ZPS 0-2. All patients received docetaxel (75 mg/m², iv, d1), cisplatin (75 mg/m², iv, d1) and anlotinib (12mg, oral, qd, d1-14) every 3 weeks for 3 cycles before CCRT. Chemoradiotherapy was 2 cycles of cisplatin (100 mg/m², iv, d1) and anlotinib (12mg, oral, qd, d1-14) every 3 weeks, concurrently with intensity-modulated radiotherapy (GTV > 66Gy). The primary endpoint was progression-free survival rate at 3 years. Here we report the results of a preliminary analysis. Results: Between January 2021 and September 2021, 34 patients (28 males and 6 females) were enrolled, and the median age was 54 years old. At the data cutoff date on January 24, 2022, all patients were eligible for the evaluation of tumor response with primary and lymph node lesions. 79.4% of the patients (27 of 34) had a response each for primary and lymph node lesions after IC, while 70.6% (20 of 34) achieved complete response in lymph node lesions compared with 29.4% (10 of 34) in primary lesions. At 6 weeks after CCRT, 100.0% of the patients (34 of 34) had a response in primary lesions and 97.1% (33 of 34) in lymph node lesions. The incidence of liquefactive necrosis was 58.8% (20 of 34) and there were 51 necrotic lesions in all. Among those necrotic lesions, 56.9% (29 of 51) and 80.4% (41 of 51) had complete response after IC and CCRT. The average area shrinkage of necrotic lesion after IC and CCRT was 84.5%±0.25, 97.7%±0.06, respectively. The most common adverse events of grade 3 was leucopenia (17.6%) and mucositis (17.6%), and there was 1 patient (2.9%) occurred neutropenia of grade 4. Conclusions: This preliminary analysis indicated that anlotinib combined with IC and CCRT had promising efficacy and favorable tolerance as treatment of liquefactive necrosis of locoregionally advanced NPC.
Anlotinib in radioactive iodine-refractory differentiated thyroid cancer and the usefulness of SUVmax as an prognostic indicator.
Authors: Zhu Zongping , Liu Jianyu , Ding Yueyun , Shi Dedao , Zheng Feibo
Published: June 2022

e18077

Background: Radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC) is characterized by poor therapeutic effect on radioactive iodine with poor prognosis. Therefore, a variety of molecularly targeted drugs are used in the treatment of RAIR-DTC. However, sorafenib and lenvatinib are not “broad-spectrum” anti-cancer drugs for RAIR-DTC. The efficacy and safety of Anlotinib in the treatment of RAIR-DTC need to be studied. Methods: From September 2020 to September 2021, 9 patients with RAIR-DTC were included. Follow-up continued until disease progression or intolerable adverse events occurred. Efficacy was evaluated by serum triglycerides (Tg) and imaging (RECIST1.1). Adverse events were also recorded. Gender, age, maximum standard unit value (SUVmax), tumor metabolic volume (MTV), total glycolysis (TLG), pathological type and tumor stage were included in the univariate analysis. Results: 8 patients reached the standard of “partial biochemical remission”. The average Tg level of these 8 patients decreased by 74.8% after Anlotinib treatment. 15 target lesions (TLs) were found in 6 patients. The average reduction ratio of TLs in these 6 patients was 28.7%. Furthermore, we observed three (50%) PR, three (50%) SD, with an ORR of 50% and a DCR of 100% in these 6 patients. The severity of AEs in all 9 patients did not exceed Grade 2. The most common AEs were hand-foot skin reactions, diarrhea, and hypertension, which accounted for 5/9, 3/9, and 3/9, respectively. Serious drug-related AEs did not occur. The average decrease in Tg after 3 courses was significantly greater in the high metabolism group (TL SUVmax 27.9) compared with the average decrease in the low metabolism group (TL SUVmax < 7.9), with 83.25% and 16.11% respectively (p = 0.027). There was no correlation between age, gender, pathological type, staging, other metabolic indexes of PET/CT and the ratio of patients' Tg reduction. Conclusions: Anlotinib can be used for the treatment of RAIR-DTC. This study confirmed the efficacy of Anlotinib with a high disease control rate. SUVmax can be used as an indicator to predict the therapeutic effect of Anlotinib in RAIR-DTC patients.
Significance of induction chemotherapy combined with cetuximab in laryngeal preservation rate of locally advanced hypopharyngeal cancer.
Authors: Xu Xia , Liu Xiong , Tian Wendong , Chen Huanhong , Li Gang , Li Xiangping , Lu Juan , Peng Xiaohong , Yu Bolong
Published: June 2022

e18078

Background: Anatomical and functional laryngeal organ preservation is critical for patients with locally advanced hypopharyngeal squamous cell carcinoma (LAHSCC). Induction chemotherapy with taxanes (T), cisplatin (P) and 5-FU (F) is a therapeutical option in patients with a strong desire to preserve the throat, whether enhanced induction chemotherapy (TPF/TP combined with cetuximab) can improve laryngeal preservation rate (LPR) and objective response rate (ORR) of LAHSCC remains controversial. Here we report the results of a retrospectively study comparing TPF/TP with TPF/TP plus cetuximab. Methods: Nanfang Hospital database was retrospectively queried for LAHSCC patients who received 2 cycle induction chemotherapy with TPF/TP (paclitaxel, cisplatin, 5-Fu) with or without concurrent use of cetuximab for ORR. Results: A total of 81 patients were identified including 36 which had concurrent use of TPF/TP and cetuximab. The overall ORR was 71.60% (58/81), patients in the TPF/TP +Cetuximab group had significantly improved ORR (83.33% (30/36) vs 62.22% (28/45) (P = 0.037) compared to TPF/TP group. After IC, 24 patients underwent laryngopharyngectomies, 6 underwent larynx-preserving surgeries, 51 underwent CCRT and 3 received salvage surgeries. In addition, the total 3-month laryngeal preservation rate (LPR) was 69.13% (56/81), the cetuximab-associated LPR benefit was observed in patients with 60.0% (27/45) in the TPF/TP group, and 80.56% (29/36) in the TPF/TP +Cetuximab group (P < 0.001). The adverse events of grade 3 or 4 were similar between the two groups except for skin rash (TPF/TP group 6.7% vs TPF/TP+Cetuximab 41.7%, P < 0.001), which gradually subsided within 2 weeks after the drug withdrawal. Conclusions: Concurrent cetuximab use with TPF/TP induction chemotherapy in LAHSCC patients was associated with improved ORR and short-term LPR, with tolerable toxicity. Further prospective evidence from larger trials is warranted.
Genetic alterations in tumor tissue and cell-free DNA in patients with papillary thyroid carcinoma at initial surgery.
Authors: Story Ellen Shannon , Yang Hsih-Te , Stewart Ashley , Farhangfar Carol J. , Neelands Brittany , Steuerwald Nury , Donahue Erin E , Symanowski James Thomas , Milas Zvonimir , Brickman Daniel , Frenkel Catherine , Sudhakar Shwetha
Published: June 2022

e18083

Background: The value of sequencing cell-free DNA (cfDNA) from patients with papillary carcinoma of the thyroid (PTC) is controversial. Studies utilizing whole-exome sequencing (WES) or single-gene detection methods have reported lower mutational yield in cfDNA in PTC compared with other cancers. Alternatively, mutational analyses of anaplastic thyroid carcinoma (ATC), which is thought to evolve from PTC, demonstrate high levels of mutated cfDNA. We report on mutations in tumor and cfDNA at initial surgery for PTC, correlate with clinicopathologic status and further characterize the mutational landscape of these tumors in tissue and blood utilizing deep-sequencing panel testing. Methods: 50 patients were enrolled 2017-2020. Tempus xT (648 genes) and xF (105 genes) panels were used to prepare next generation sequencing libraries from tissue and blood samples, respectively. Cell-free DNA (cfDNA) sequencing depth average is 20,000x (raw reads)/5,000x (unique reads). Results: More than half of the patients had pT3-T4 tumors and/or local metastases and one had distant metastasis. 47/47 (100%) of processable tissue samples and 40/49 (81.6%) of blood samples yielded at least one relevant mutation. BRAF V600E was found in 77% of tissue and 8% of cfDNA, while mutated TERT was detected in 17% of tissue and none of the blood samples. The most frequently mutated genes in cfDNA were KMT2A (18% of blood samples, 6 % tissue), ATM (12% blood, 6% tissue), and TP53 (12% blood, 2 % tissue). There was marked mutational heterogeneity among samples, and a range of alterations representing multiple oncogenic pathways. Conclusions: Patients at initial surgery demonstrated highly mutated tissue DNA, including BRAF, TERT and other mutations known to be found in PTC. The most frequent tissue mutations were found at higher rates than previously reported by WES, which may reflect the sensitivity of targeted deep sequencing versus WES, and possibly a selection bias of more advanced PTC. A high percentage of cfDNA samples yielded mutations relevant to thyroid cancer, and the absence of TERT is consistent with prior studies. Mutations and co-mutations associated with de-differentiation and worse outcomes were demonstrated in both tissue and cfDNA. Interestingly, mutations more common in ATC than PTC, such as TP53, were detected in cfDNA, often without primary tumor correlate. Since mutations associated with aggressive behavior may be found in metastatic foci while not detected in the primary tumor, we conclude that cfDNA may reveal prognostic information important for the development of surveillance strategies in selected patients with residual PTC after surgery who may be at risk for poor outcomes.
BTCRC-HN17-111, A phase 2 trial of ADT (goserelin) in combination with pembrolizumab for patients with advanced salivary gland tumors expressing androgen receptor (AR).
Authors: Patel Manish , Fujioka Naomi , Pease Daniel Fellows , Feldman Lawrence Eric , Worden Francis P. , Laux Douglas Earl , Boumber Yanis , Mehra Ranee , Racila Emilian , Cao Qing , Yang Bruce Justine Yang
Published: June 2022

e18091

Background: Salivary gland cancers (SGC) are rare malignancies with no standard systemic therapy available for patients with recurrent or metastatic disease. Androgen receptors (AR) are expressed and functional on many SGCs. Preclinical data suggested possible synergy between ADT and immune checkpoint blockade. The Big Ten Cancer Research Consortium conducted an open label, multi-center, Simon’s two-stage, phase II trial using ADT in combination with pembrolizumab for advanced salivary gland tumors that express AR. Here, we report the preliminary results of the first stage of the trial. Methods: Patients with incurable recurrent or metastatic SGC (any histology) with at least 20% of tumor cells expressing AR by immunohistochemistry were recruited. Patients who had received prior ADT or immune checkpoint therapy were excluded. Patients were treated with subcutaneous injection of goserelin 3.6mg every 4 weeks. Pembrolizumab 200mg was administered intravenously every 3 weeks starting 14 days after initiation of goserelin. Disease assessment was performed after completion of 4 cycles of therapy. Primary endpoint was objective response rate. Key secondary endpoints included PFS, OS, and safety of the combination. Stopping rules for excess toxicity were employed. We planned enrollment of 9 patients in the initial stage, and plan to complete enrollment if we observed³ 2 objective responses. Results: Between June 2019 and June 2021, we enrolled 9 patients into the study to complete the first stage. 7/9 were men, 8/9 were white, and the median age was 67 years old. A total of 5 ductal carcinomas, 3 adenocarcinomas, and 1 adenoid cystic carcinoma patients were enrolled. Patients had a median of 1 prior line of treatment. No stopping boundaries were crossed for excess toxicity. One patient experienced Grade 4 Stevens-Johnsons syndrome requiring permanent discontinuation of pembrolizumab. Otherwise, there was no increase in immune-related toxicity from what might be expected with pembrolizumab alone. Objective responses were observed in 2/9 patients (22%). Both responses were seen in ductal carcinomas. The best response was partial response in 2/9, while 6/9 had stable disease as best response for clinical benefit rate of 88% (8/9). The 6-month PFS was 63% (CI 19-85%). Conclusions: The combination of goserelin and pembrolizumab was well-tolerated and show preliminary evidence of efficacy in the first stage of the trial. The second stage of the trial has opened to accrual with a plan to enroll 11 additional patients. Clinical trial information: NCT03942653.
Racial disparities in commercial U.S. oocyte donors.
Authors: Combs Abigail , Kimes Mariah J. , Jaslow Carolyn , Hayes Heidi , O'Leary Lindsey B. , Levy Michael J. , Kutteh William H.
Published: June 2022

e18501

Background: Patients undergoing cancer treatment are more likely to face infertility. Despite improvements in counseling and fertility preservation, some oncology patients will require the use of donor oocytes to complete their family. We investigated whether the current cohort of commercial oocyte donors reflects the racial profile of the U.S. population. We also evaluated whether there were differences in donors’ perception of pain and quality of informed consent by race to elucidate potential avenues to improve donor retention. Methods: Institutional Review Board approved, retrospective survey of commercial, U.S. oocyte donors was emailed to recent donors recruited through Donor Egg Bank USA prior to 2020. There were 246 respondents out of 503 opened emails (48.9%). Donors were recruited by twenty different clinics that are affiliated with the same donor egg bank. Results: Black and Hispanic donors were significantly underrepresented among commercial U.S. egg bank donors while Caucasian and mixed-race donors were overrepresented (Table - left). The perception of pain in donors, however, did not differ according to race (Table - right, p = 0.245). Over 80% of donors reported that they had received better than acceptable levels of preparation through the informed consent process. Respondents’ report of the quality of the informed consent process did not differ by race (p = 0.728). Conclusions: Our study represents one of the largest cohorts of recent U.S. oocyte donors. The racial composition of recruited donors overrepresents Caucasian and mixed-race donors while underrepresenting Hispanic and Black donors when compared to the racial identity self-reported in the 2020 US census. This may represent the demographics of the current recipient cohort; however, the lack of diversity is of particular concern for oncology patients seeking oocytes as their racial composition likely reflects the diversity represented in the U.S. population. Notably, there was no difference by race in the pain score of donors by race or the quality of their informed consent process suggesting that all donors were treated similarly regardless of racial identity. Donor egg banks should consider diversification of their donor profiles to provide equal access among oncology patient seeking donor oocytes.[Table: see text]
Minority Representation in studies cited as references in National Comprehensive Cancer Network (NCCN) Guidelines for Prostate Cancer.
Authors: Zheng Zhong , Qu Lang , Du Heyue , Wang Chao Y. , Cao Xi , Xiong Yujun , Yim Barbara , Gupta Shweta
Published: June 2022

e18511

Background: Prostate cancer (PC) has a higher incidence, higher lifetime risk, higher risk of progression and lower overall 5-year survival in African American (AA) men compared to Caucasian men. Historically AA men have been under-represented in clinical studies that may prevent some AA men with PC to receive appropriate therapies. We aim to estimate the AA representation in studies cited in national guidelines for PC. Methods: We retrospectively reviewed all listed references in the National Comprehensive Cancer network (NCCN) Prostate cancer guidelines version 2.2021. All cited papers were reviewed for patient level data on racial or ethnic distribution in the study population. Subgroup analysis was performed by subheadings in the guidelines for Black/African American (AA) representation in each topic of discussion. Duplicate studies in the same section were excluded. Results: A total 836 references were screened of which 167 (20%) reported patient race/ethnicity distribution. Overall, 2,711,194 patients were included in reported studies of which 2,263,936 (83.5%) were Caucasian, 12.6% AA and 3.9% others. A total 26 studies reported 20% or more AA of which 14 were under 500 patients only. While 72 studies included over 1000 patients, only 9 of them had over 20% AA patients. Only 1 study (72 patients) out of 12 for systemic therapy in castration-naïve PC reported ethnicities. For Castration resistant PC, ethnicity data was available for 152 patients (3 of 10 studies), 771 patients (2 of 11 studies) and 1200 patients (1 of 4 studies) in abiraterone, enzalutamide and apalutamide studies respectively with 47.4%, 9.2% and 5.7% AA respectively. Olaparib, rucaparib, pembrolizumab and bisphosphonates studies reported 1.4%, 6.3%, 7% and 5.7% AA respectively. Further subgroup analysis is presented in Table. Conclusions: Race/ethnicity data is not reported widely in clinical studies. The overall AA representation remains very low which is also an underestimation since about 80% studies did not report patient ethnicities. Clinical investigators should be encouraged to report racial representation in studies which will help personalize cancer care for African Americans who are at high risk.[Table: see text]
The role of real-world evidence (RWE) registries using NGS testing to address cancer health disparities (CHD) in small community oncology practices.
Authors: Gor Asutosh S. , Patel Kashyap B. , Rabara Viral , Clinton Natasha
Published: June 2022

e18519

Background: CHD may result from multiple factors, including access to care, screening, and clinical trials; limited uptake of biomarker and next-generation sequencing (NGS) testing; and unfavorable social determinants of health. CHD may contribute to almost 34% of deaths among adult cancer patients and additional spending of $230 billion. Addressing CHD could result in an indirect savings of as much as $1 trillion over 3 years (AACR, CDR, 2020). Biomarker testing enables the option of targeted treatment, providing better outcomes and reduced toxicity. The NGS testing rate is very low in some regions and among minority populations, and underuse worsens disparities. Carolina Blood and Cancer Care Associates (CBCCA) has created best practices to improve biomarker testing and provide standard-of-care treatment in advanced cancer. Methods: As a part of a pledge to decrease CHD, CBCCA partnered with 2 national NGS testing vendors to create a RWE registry to identify appropriate patients and provide access to NGS biomarker tests for somatic mutations, including whole exome sequencing (WES). Liquid biopsy was made available when tissue was unavailable. Results: CBCCA has 1 suburban and 1 rural location, with an ethnically diverse population. Regular care was provided for 1466 of the 1786 unique cancer patients seen in 2021, and 442 participated in a RWE registry. Nonparticipants were survivors having routine follow-up care (n = 512), patients with early-stage or noninvasive disease (510), or patients who refused testing because they were responding to ongoing treatment or had reservations. NGS testing was obtained for 354 patients, 31% of whom were members of ethnic minority groups. Liquid biopsy was used for 133 samples, and the remaining 221 were analyzed with somatic NGS panels or WES. Of the liquid biopsies, 24 patients had actionable mutations; an additional 52 had findings of germline implications. Actionable mutations that could be treated with an FDA-approved drug were identified using tissue-based NGS testing in 38 pt. In tissue-based testing, WES detected more results with germline implications, compared to somatic testing alone. Another 64 tests found mutations treatable with an approved drug in another tumor type. The NGS and biomarker testing rate (either tissue or liquid biopsy) was 84% of eligible pt. Of the patients tested with NGS, clinically actionable variants that could be treated with an approved agent were found in 23% (same tumor type) and 28% (another tumor type). Another 40% of patients had results with germline implications, of which P53 deletion was the most common finding. Conclusions: It is feasible to increase the NGS testing rate in appropriate situations. In this study, actionable mutations impacting treatment selection were found in up to 25% of patients where targeted therapy could be offered.
Non-small cell lung cancer disparities in stage at presentation and treatment status for Asian American, Native Hawaiian, and Pacific Islander females.
Authors: Hong Ji Hyun , Lam Miranda , Dee Edward Christopher , Swami Nishwant
Published: June 2022

e18526

Background: Asian Americans, Native Hawaiians, and Pacific Islanders (AANHPI) represent the fastest-growing racial group in the United States. While often described in aggregate as one of the healthiest populations, large variations in the social determinants of health and subsequent health outcomes exist within the AANHPI community. We identified differences in stage at presentation and treatment status among AANHPI women with non-small cell lung cancer. Methods: Between 2004 and 2016, a retrospective cohort study was performed using the National Cancer Database (NCDB) with 522,361 female patients with newly diagnosed non-small cell lung cancer (NSCLC). Asian subgroups were distinguished as Chinese, Japanese, Filipino, Hawaiian, Korean, Vietnamese, Laotian, Hmong, Kampuchean, Thai, Asian Indian, Pakistani, and Pacific Islander. Multivariable logistic regression models were used to define adjusted odds ratios (aORs) with 95% CI of presenting at stage IV disease and not receiving treatment. Effect measure modification (EMM) by age was also analyzed in all models. Results: Among 522,361 women, AANHPI women were more likely to present with stage IV disease at presentation when compared to White women (54.32% vs 40.28%, aOR = 1.54, 95%CI = 1.45-1.64, p < 0.001). All AANHPI subgroups also had greater odds of presenting with stage IV diseases when compared to White populations: Chinese (aOR = 1.49, 95%CI = 1.38-1.61, p < 0.001), Japanese (aOR = 1.22, 95%CI = 1.09-1.37, p < 0.001), Filipino (aOR = 1.63, 95%CI = 1.49-1.78, p < 0.001), Korean (aOR = 1.49, 95%CI = 1.30-1.70, p < 0.001), Vietnamese (aOR = 1.74, 95%CI = 1.54-1.97, p < 0.001), Laotian (aOR = 2.24, 95%CI = 1.49-3.37, p < 0.001), Kampuchean (aOR = 1.61, 95%CI = 1.06-2.46, p = 0.027), Thai (aOR = 1.64, 95%CI = 1.17-2.31, p = 0.004), Asian Indian (aOR = 1.50, 95%CI = 1.30-1.73, p < 0.001), and Pacific Islander (aOR = 1.50, 95%C = 1.20-1.88, p < 0.001). In EMM analysis, Asian women aged younger < 65 years were more likely to present with stage IV diseases (p = 0.030 for interaction). Asian women were also more likely not to receive treatment (7.01% vs. 8.80%, 95%CI = 0.84-1.09, p = 0.497). Vietnamese women (aOR = 1.30, 95%CI = 1.06-1.58, p = 0.010) showed significant differences compared to White women. Conclusions: Differences in stage at presentation and treatment status in women with NSCLC were observed among AANHPI subgroups when populations were disaggregated. Efforts are needed to elucidate the barriers these populations face that may explain the observed delays in diagnosis. Further disaggregated study of AANHPI subpopulations is needed to reduce inequities in lung cancer.
Positive impact of oncology nurse navigation based on health insurance in head and neck cancer patients.
Authors: Pallas Christopher R , Boselli Danielle , Kuch Madison , Neelands Brittany , Carrizosa Daniel R.
Published: June 2022

e18545

Background: Health disparity in squamous cell carcinoma of the head and neck (SCCHN) is well-recognized. Privately insured SCCHN patients are observed to have better outcomes, but underlying factors are poorly understood. Oncology nurse navigators (ONN) are a well-established role focused on optimizing cancer care and patient experience. The effects of ONN on bridging health disparities have not been demonstrated. We sought to characterize health and outcome disparities in patients diagnosed with oropharyngeal cancers and to assess if the implementation of ONN bridges gaps in health disparities. Methods: Patients aged >18 diagnosed with node positive, non-metastatic oropharyngeal cancers at a large hybrid academic-community cancer center between June 2018 and September 2021 were analyzed retrospectively. Baseline demographic, socioeconomic and clinicopathologic factors including the frequency and percentage of patients receiving ONN were summarized. Clinical outcomes were assessed as a function of baseline factors and ONN. Overall survival (OS) and progression free survival (PFS) were evaluated with Kaplan Meier methods. Results: 184 patients were evaluated. Median age at diagnosis 62 (range 33-91). Median follow-up 24 months. The majority were HPV+ (73%). Navigation received in 64%. More males presented with cN1+ disease than females (57% v. 37%; p = 0.053). More Black patients presented with cN1+ disease than White patients (76% v. 50%; p = 0.017). More privately insured patients (92%) went to imaging after definitive treatment versus those with Medicaid (MD)/Self-pay (SP) (78%) or Medicare (MC)/Veteran’s affairs (VA) (78%) (p = 0.043), while more navigated patients went to imaging after definitive treatment than non-navigated patients (70% v. 40%; p = 0.003). Univariate modeling indicated clinical nodal stage, HPV status, race, and insurance status were associated with OS and PFS. In multivariable modeling adjusted for age, nodal stage, and HPV status, there was a disparity in OS associated with insurance type (MD/SP v. Private: HR 9.24, 95% CI = 2.34 to 36.41 and MC/VA; p = 0.004). There was a significant interaction of navigation and insurance type (p = 0.0157). In those not navigated, a difference in hazards exists between MD/SP or MC/VA compared with private insurance. This difference was not detected in those navigated. Similar interaction of navigation and insurance was noted in the analysis of PFS. Conclusions: We observed a disparity in patients with non-private insurance having an inferior PFS, OS and reduced rates of imaging after definitive treatment. An improved rate of post-treatment imaging was significantly associated with ONN. There was a trend towards benefit in outcomes for those receiving ONN but without private insurance suggesting that ONN may help mitigate disparities in the non-private insurance groups.
Assessing baseline cancer demographics versus those that participate in cancer clinical trials over one year in Louisiana.
Authors: Pierre Aliyah , Castellano Tara , Jernigan Amelia , Chapple Andrew G , Li Tingting , Yi Yong
Published: June 2022

e18546

Background: To determine which barriers exist for cancer clinical trial participation in Louisiana and define areas for improvement, we report cancer demographics of all new cancer diagnoses in Louisiana in 2019 and compare those to the baseline demographics of cancer patients that enrolled on a cancer treatment trial. Methods: A retrospective study evaluating baseline cancer demographics over 2019 was performed. Our baseline population included all new cancer diagnoses in patients 18+ registered with the Louisiana Tumor Registry (LTR) between January-December 2019. Baseline demographics were compared between all patients enrolled in a cancer treatment clinical trial in 2019 through the Gulf South Clinical Trials Network (GSCTN) versus those who were not. Summary statistics were performed with regards to basic cancer and patient demographics. Results: Although patients of the highest socioeconomic group made up, n = 5,444, (21.9%) of total cancers, a larger proportion, n = 35 (32.4%), p = 0.01 ultimately enrolled in a trial. Similarly, of those living in an urban area, n = 22,258 (84.5%), a larger proportion, n = 103 (92.8%), enrolled in a trial when compared to those that were not, p = 0.02. There was a significant positive correlation (p = 0.01) between clinical trial enrollment and residency in geographic areas with higher rate of high-school graduation. Our data also demonstrated that a smaller proportion, n = 7 (6.3%), of clinical trial participants died compared to those who did not participate, n = 5176 (19.6%), p < 0.01. Urologic cancer, including both prostate and bladder cancer, was the second most-diagnosed cancer primary site in Louisiana in 2019 with, n = 5481, patients diagnosed. Although black men made up, n = 1767 (32.2%) of diagnosed urologic cancer, only, n = 9 (14.1%), were accrued to participate in a urologic cancer clinical trial, p < 0.01. White men, who made up, n = 3661 (66.8%), of diagnosed urologic cancer, had a larger proportion, n = 55 (85%), of trial participation, p < 0.01. Conclusions: Overall, lack of geographic access proves to be a barrier for recruitment in clinical cancer trials. Patients of higher SES that live in urban areas make up a larger proportion of clinical trial participants and have better survival rates than those who do not participate. For specific cancers such as urologic cancer, further investigation on the cancer-specific inclusion and exclusion criteria must be investigated to determine the effect on equitable trial entry for populations in need. In conclusion, Louisiana offers a diverse cancer population, however, further efforts must be made to improve clinical trial access to our diverse and underserved populations.
Financial distress, health literacy, numeracy, and treatment receipt by race/ethnicity amongst breast cancer survivors.
Authors: Odai-Afotey Ashley , Lederman Ruth , Ko Naomi Y , Gagnon Haley , Hershman Dawn L. , Crew Katherine D. , Keating Nancy Lynn , Gundersen Daniel A. , Revette Anna C. , Freedman Rachel A.
Published: June 2022

e18554

Background: Low-income and minority women are less likely to receive breast cancer treatments and have higher mortality rates compared with other women.We examined economic hardship, health literacy, and numeracy by race/ethnicity and whether these factors were associated with differences in receipt of recommended treatment. Methods: We conducted a telephone survey in 2018-2020 of adult women diagnosed with stage I-III breast cancer between 2013-2016 at three centers in Boston and New York. We asked women about treatment receipt and factors contributing to decision-making. We used X2 and Fischer exact tests to examine associations between economic distress, health literacy/numeracy, and treatment receipt by race/ethnicity. Results: Among 326 respondents (AAPOR cooperation rate 63-80% across sites), 55% were Non-Hispanic (NH) White, 23% were NH Black, and 14% Hispanic; 15% were Medicaid-insured. Due to item non-response, sample sizes ranged from 294-315 per question. A substantial proportion of women, and particularly Black and Hispanic women, reported economic distress, worse finances over time, and low literacy/numeracy (Table). Overall, 7% (n = 22) did not initiate at least one recommended treatment. Although we observed no differences in treatment by race/ethnicity (p = 0.70), those not initiating recommended treatment(s) reported more worry about paying large medical bills (52% vs. 27%) and covering visit costs (27 vs. 10%); p < .05 for both. Conclusions: In a diverse sample of breast cancer survivors, financial distress was common, particularly for non-White participants; non-White women also had lower literacy/numeracy. Although we observed some associations of these factors (but not race/ethnicity) with less receipt of recommended treatments, because few women declined treatments, understanding the scope of impact is limited. However, our results highlight the importance of up-front and longer-term assessments of resource needs and allocation of support for breast cancer survivors. Novelty of this work includes the granular measures on financial distress and the focus on health literacy/numeracy among a diverse population.[Table: see text]
Project facilitate: Innovation and advancement in FDA’s oncology expanded access program.
Authors: Chan Mitchell , Antony Ramya , Boehmer Jessica , Kim Tamy , Pazdur Richard
Published: June 2022

e18556

Background: FDA Oncology Center of Excellence’s (OCE) Project Facilitate (PF) was launched in June 2019 in response to perceived barriers providers face when accessing Expanded Access (EA). Since launch, PF continues to evolve and innovate to provide a comprehensive service to assist oncology healthcare providers requesting EA. An analysis of single-patient investigational new drugs (IND) was performed over 1 year to assess the growth and impact of the program. Methods: Data was extracted from Project Facilitate’s central database that yielded 640 single-patient INDs between June 1, 2020 and June 1, 2021. Data collected included IND receipt date, granting date, status, application type, indication, drug name, address of requestor, and patient demographics. Results: Of the 640 single-patient INDs extracted, there were 183 emergency INDs (eIND) and 457 non-emergency INDs (SPI). EA requests originated primarily from academic centers (81%) and community hospitals (18%) whereas Veterans Affairs and Military Treatment Facilities (0.5%) and Other (0.5%) were the least common. The 5 most common states requests originated from include New York (14%), California (13%), Texas (11%), Pennsylvania (7%), and North Carolina (4%). Although the current FDA Form 3926 does not request race and ethnicity information, this data was reported in 17 requests: White (8), Asian (3), Black/African American (3), American Indian or Alaskan Native (0), Native Hawaiian or Other Pacific Islander (0), Hispanic or Latino (3) and non-Hispanic or Latino (0). Age distribution was analyzed for pediatric (24%) and adult (76%) patients. Age distribution was further analyzed in geriatrics >75 (10%), in pediatrics < 2 (7%) and patients 2-17 years old (17%). The processing and review times for 630 applications were <1 day (96%) and > 1 day (4%). PF granted 100% of EA requests received in this time period. PF’s call center received 525 phone calls of which 499 (95%) were answered on the first call. PF also received 7843 emails during this period. Conclusions: Since 6/1/2020, PF started performing the reviews, processing and granting of CDER oncology EA requests that generally were performed by the FDA Review Divisions. By consolidating this process to PF, review times have drastically reduced to <1 day. PF has evolved since launch to promote effective and equal access to oncology expanded access.[Table: see text]