bluuebunny/crossref_metadata_2025_split huggingface dataset:
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]