bluuebunny/crossref_metadata_2025 huggingface dataset:
A retrospective analysis of tislelizumab and GP regimen neoadjuvant therapy followed by concurrent chemoradiotherapy plus nimotuzumab in patients with high-risk nasopharyngeal carcinoma.
Authors: Zhang Qinhua , Lai Mingfen , Li Fangming , Chen Jiarong , Chang Mingzhang , Yang Peixin , Chen Guojian
Published: June 2023

e18060

Background: Efficacy of nasopharyngeal carcinoma (NPC) with T4 or N3 remains unsatisfactory due to high-risk of distant metastasis or recurrence, indicating the need of more comprehensive treatment. We aim to analysis the efficacy and safety of tislelizumab and GP regimen in combination with neoadjuvant therapy and concurrent chemoradiotherapy (CCRT) plus nimotuzumab in patients with high-risk NPC. Methods: Our team conducted a retrospective analysis of 44 adult patients with high-risk locally advanced (T4 or N3; M0) nasopharyngeal carcinoma between March 2021 and January 2022, the median follow-up time was 599 days. The patients had received neoadjuvant chemotherapy (gemcitabine,1000 mg/m2, days 1 and 8, cisplatin,80 mg/m2, day 1), and tislelizumab (200mg) on day 1 every 3 weeks for 4 cycles followed by chemoradiotherapy including intensity modulated radiotherapy (IMRT), lobaplatin and nimotuzumab. Lobaplatin was intravenously administered at a dose of 30 mg/m2 on days 1 and 22. Nimotuzumab was intravenously administered at a dose of 200 mg on day 1 every week for 6 weeks. All patients underwent response assessments during neoadjuvant therapy, chemoradiotherapy and follow-up at regular intervals. Results: 44 patients were identified with the median age being 50y(24y-70y). At neoadjuvant treatment period, 44 patients completed 170 cycles of the combination of tislelizumab and GP regimen. During concurrent chemo-radiotherapy period, 42 (95.45%) of 44 patients completed 6 weeks of nimotuzumab treatment and 41 (93.18%) of 44 patients completed 2 cycles of lobaplatin treatment. Overall, 20 patients (45.5%) had a complete response, and 24 (54.5%) had a partial response after neoadjuvant therapy before the start of chemoradiotherapy. At 3 months and 6 months after radiotherapy, 90.9% (40 of 44) and 97.7% (43 of 44) of the patients had a complete response. 42 of the 44 patients were alive (95.5%). 3 events of recurrence(1) or death(2) were recorded. 19 (43.2%) of 44 patients had grade 3-4 treatment-related adverse events, and grade 3-4 immune-related adverse events(irAE) was recorded in 3 patients (6.8%) in the entire treatment. Grade 3-4 irAEs were rash(2) and hypothyroidism(1). Conclusions: Neoadjuvant therapy with tislelizumab and GP regimen followed by concurrent chemoradiotherapy plus nimotuzumab seems to have promising efficacy, lower toxic effects and better treatment compliance, which is a new treatment strategy for high-risk NPC.
The association of body mass index with overall survival, progression free survival and locoregional control in head and neck cancer treated with curative-intent definitive chemoradiation.
Authors: Chatterjee Udit , Ma Sung Jun , Khan Michael , Santhosh Sharon , Hashmi Mahnoor , Gill Jasmin , Yu Brian , Iovoli Austin , Farrugia Mark , Yu Han , Singh Anurag K.
Published: June 2023

e18062

Background: The prevalence of obesity is anticipated to increase with nearly 1 in 2 adults having obesity by 2030. Previous meta-analysis and prospective studies showed that both obesity and overweight BMI were associated with worse all-cause mortality, cancer-related mortality, and the incidence of multiple types of cancer. Combined modality therapy, such as chemoradiation, often results in significant morbidity among patients with head and neck cancer (HNC). The association of BMI with treatment response, tumor recurrence, and survival outcomes among HNC patients remains unclear. Methods: Our study included a total of 445 patients with non-metastatic head and neck cancer who underwent curative-intent definitive chemoradiation at the Roswell Park Comprehensive Cancer Center from 01/2005 to 01/2021. We evaluated overall survival (OS), progression-free survival (PFS), locoregional failure (LRF), and distant failure (DF). BMI was stratified by normal weight (18.5-24.9 kg/m2), overweight (25.0-29.9 kg/m2), and obese (30 kg/m2 or higher). Evaluation was performed using Kaplan-Meier method, log-rank tests, Cox proportional hazard multivariable (MVA) analyses. Results: A total of 445 patients (373 male [83.8%], median [interquartile range] age, 61 [55-66] years; n = 107 with normal, n = 179 with overweight, and n = 159 with obese) were included for analysis. Median follow up was 48.1 months (interquartile range 24.7-74.9). On Cox MVA, only overweight was associated with improved OS (adjusted hazards ratio [aHR] 0.59, 95% confidence interval [CI] 0.39-0.91, p = 0.02) and PFS (aHR 0.51, 95% CI 0.34-0.75, p < 0.001). On logistic MVA, overweight (adjusted odds ratio [aOR] 0.86, 95% CI 0.80-0.93, p < 0.001) and obese (aOR 0.89, 95% CI 0.81-0.96, p = 0.005) were associated with complete metabolic response on follow-up PET-CT after treatments. On Fine-Gray MVA overweight was associated with reduction in LRF (aHR 0.30, 95% CI 0.12-0.71, p = 0.007), but not DF (aHR 0.92, 95% CI 0.47-1.77, p = 0.79). Being obese was not associated with both LRF (aHR0.63, 95% CI 0.29-1.37, p = 0.24) and DF (aHR 0.70, 95% CI 0.35-1.38, p = 0.30). Conclusions: When compared to normal BMI, overweight BMI was an independent, favorable prognostic factor for complete response after treatments, OS, PFS and a reduction in LRF. Further investigations are warranted to improve our understanding on the role of BMI among patients with HNC.
Antitumor regimens with gemcitabine are safe for tumor patients with COVID-19.
Authors: Wu Yuanqiang , Quan Weini , Ma Jinan , Li Zhenjiang
Published: June 2023

e18064

Background: COVID-19 infection is a worldwide health threatening disease, especially for malignant tumor patients. Systemic antitumor therapies may slower the body to clear virus, which results in delayed recovery from COVID-19. Thus, present guidelines or expert consensuses recommend to postpone antictumor therapies, which would unquestionablely retard treatment cycle and reduce therapeutic effect.Gemcitabine is a nucleoside analogue, which has shown antiviral activity as well as anticancer effect. Therefore, we assume that antitumor regimens with gemcitabine are also able to control COVID-19 reproduction. Such “kill two birds with one stone” regimen aims to not delay both anticancer treatment and COVID-19 turning negative. Methods: Four newly pathologically diagnosed advanced tumor patients from Department of Oncology, Second Xiangya Hospital, Central South University were collected, including three nasopharyngeal carcinoma (NPC) patients and one non-small cell lung cancer (NSCLC) patient. All of them were asymptomaticly infected with COVID-19 recently. Anticancer regimens with gemcitabine were adopted as initial treatment for these patiens. Three patients with NPC received gemcitabine combined with cisplatin (gemcitabine 1g/㎡ on day 1 and 8, cisplatin 25mg/㎡ from day 1 to 3).The patient with NSCLC accepted gemcitabine and PD-1 inhibitor (gemcitabine 1g/㎡ on day 1 and 8,tislelizumab 100mg on day 1 and 8). Throat swabs were performed to test the COVID-19 nucleic acid on day 1, 5, 9 and 21 during treatment. Results: Four patients are all middle-aged males of 43-59 years old. Their COVID-19 nucleic acid tests were positive on day 1 before infusing any drugs.The cycle count threshold (CT) of nucleic acid did not go down but gradually went up during antitumor treatment.Patients showed no COVID-19 related symptom during the whole treatment cycle. There were no greater than or equal to grade 3 adverse evens (AEs). Treatment related AEs included one patient with grade 2 leukopenia, and one patient with grade 2 fever. All patients normally finished the first anticancer cycle and successfully went to the second cycle. Conclusions: Antitumor regimens with gemcitabine is safe for patients both with manignancy and COVID-19. Cancer patients with COVID-19 can accept gemcitabine-related therapy as soon as possible intead of waiting until COVID-19 nucleic acid becoming negative.
Characteristics of local extension based on tumor distribution in nasopharyngeal carcinoma and proposed clinical target volume delineation.
Authors: Wu Zheng , Lin fei-Fei , Zhang Lin , He Qian , Li Feiping , Wang Hui , Han Yaqian , Yin wen-Jing , Qi Bin
Published: June 2023

e18068

Background: to summarize the characteristics of local extension of the eccentric and central nasopharyngeal carcinoma (NPC) by magnetic resonance imaging (MRI) and to improve clinical target volume (CTV) delineation. Methods: MRIs of 870 newly diagnosed NPC patients were reviewed. According to the tumor distribution feature, the NPCs were divided into eccentric and central lesions. Results: All local invasions presented as continuous invasion from gross lesions and structures adjacent to the nasopharynx are more likely to be invaded. There were 240 (27.6%) and 630 (72.4%) cases with central and eccentric lesions, respectively. The spread of eccentric lesions centered on the ipsilateral Rosenmüller’s fossa; and most anatomic sites had significantly higher invasion rates in ipsilateral side than the contralateral side ( P < 0.05); however, they were at low risk of concurrent bilateral tumor invasion ( < 10%) except the prevertebral muscle (15.4%) and nasal cavity (13.8%). The extension of central NPCs centered on the nasopharyngeal superior-posterior wall and was more common in superior-posterior direction; furthermore, the bilateral tumor invasion into the anatomical sites was common. Conclusions: Local invasion of NPC was characterized by continuous invasion from proximal to distal sites. The eccentric and central lesions showed different invasion features. Individual CTV delineation should be based on the distribution characteristics of tumors. The eccentric lesion had very low probability of invasion into the contralateral tissue, thus routine prophylactic radiation of contralateral parapharyngeal space and skull base foramina may not be necessary.
Real-world survival of older adults with LA SCCHN using SEER-Medicare.
Authors: Zhou Summera Qiheng , Ng Carmen , Wang Rongrong , Gasior Greg , Schrader Dustin , Baliga Sujith , Fox David
Published: June 2023

e18071

Background: Squamous cell carcinomas of the head and neck (SCCHN) account for around 4% of all types of malignant neoplasms. Roughly 50-67% of patients with SCCHN present with locally advanced (LA) disease and 65% of them relapse after primary therapy. The standard of care for LA SCCHN is definitive therapy (DT), a combination of surgery and or radiation therapy (RT), with or without platinum-based chemotherapy/cetuximab (chemo), that has been shown to optimize long term disease control. Advances in surgery/RT have led to improved outcomes, but there have been no FDA approved therapeutic agents for LA SCCHN since cetuximab in 2006. Our objective was to characterize the real-world overall survival (OS) of older adults with LA SCCHN in the US. Methods: We used the Surveillance, Epidemiology, and End Results (SEER)-Medicare database, a linkage of cancer registry and claims data, to identify patients diagnosed with LA SCCHN (first and only cancer) from 2010 to 2017 who initiated a relevant treatment (treatment initiation date defined as index date) and were continuously enrolled in Medicare Parts A, B, and D from 12 months pre-index until death or 12 months post-index. We categorized DT as: no DT, non-surgical DT (concurrent chemo + RT (cCRT) or chemo followed by RT/cCRT), or surgical DT (surgery then RT/cCRT with or without prior chemo) using Medicare claims. Median OS (mOS) estimates and 95% confidence intervals (CI) were estimated using the Kaplan-Meier method starting from index date. Results: We identified 1052 older adults with LA SCCHN (median age 73 years, 37% female, and 81% non-Hispanic white). Overall, median follow up was 26.4 months and primary tumor sites were 52.6% oropharynx, 44.7% oral cavity, and 2.8% hypopharynx. LA patients overall had a mOS of 39.2 months. mOS was lowest in patients with SCCHN of the hypopharynx. Around 58% of patients received a DT regimen and mOS was lower for patients treated with non-DT vs DT regimens (21.8 vs 60.9 months, respectively). mOS differed between DT regimens (Table). Conclusions: In this descriptive analysis, we found that OS differed by site and receipt of DT and that a large proportion (42%) of patients received non-DT regimens. mOS was lower in patients who received non-DT vs DT. Despite available treatment options, there remains a need for novel therapies that can improve outcomes in LA SCCHN. Future analyses should explore differences in OS between subgroups while adjusting for patient demographic and clinical characteristics. [Table: see text]
Neoadjuvant tislelizumab combined with chemotherapy in locally advanced oral or oropharyngeal squamous cell carcinoma: A single-arm, phase II trial.
Authors: Wu Wenjie , Yao Jie , Zhang Tong , Zhang Jie
Published: June 2023

e18072

Background: Previous studies confirmed locally advanced oral or oropharyngeal squamous cell carcinoma (LA OSCC or OPSCC) patients (pts) with a pathological response had higher probability of survival in neoadjuvant settings. Several ongoing trials of neoadjuvant immunotherapy in head and neck cancer showed promising results. However, the optimal regimen remains unclear. This trial aimed to evaluate the efficacy and safety of neoadjuvant therapy with anti-programmed cell death 1 (PD-1) mAb tislelizumab and chemotherapy, followed by surgery and adjuvant radiotherapy/chemoradiotherapy in LA OSCC or OPSCC. Methods: In this phase II, single-arm study, eligible pts aged 18-80 diagnosed with stage III-IV (AJCC v8) resectable or potentially resectable LA OSCC or OPSCC received neoadjuvant therapy with tislelizumab (200 mg), albumin-bound paclitaxel (260 mg/m2), and cisplatin (60-75 mg/m2) Q3W for 2 cycles, followed by surgery and adjuvant radiotherapy or concurrent chemoradiotherapy. The primary endpoint was major pathologic response (MPR). Secondary endpoints included pathological complete response (pCR), objective response rate (ORR), event-free survival (EFS), overall survival (OS) and safety. Results: Thirty-one pts were enrolled from Mar 2022 to Nov 2022, and completed neoadjuvant therapy, with an ORR of 61.3% (19/31) and CR rate of 6.5% (2/31). Of the 31 pts, 29 pts (18 OSCC, 13 OPSCC) successfully underwent surgery with a median age of 57 (34-72) yrs, smoking history 75.9%, alcohol history 72.4% and 82.8% of male. The clinical stage III, IVA and IVB accounted for 24.1%, 48.3% and 27.6%, respectively. The MPR rate was 65.5% (19/29), of which the pCR rate was 41.4% (12/29). R0 resection rate reached 100%. For the per-protocol population, 58.6% pts (17/29) complaint of symptoms included pain, trismus, dysphagic, and speech disorders, all of them reached remission after 2 cycles of neoadjuvant therapy. No delay of surgery occurred. Grade 3-4 adverse events (AEs) occurred in 3 pts including 3.4% G3 leukopenia, 6.9% G3 anemia and 3.4% G4 thrombocytopenia and mostly chemotherapy related. Grade 1-2 AEs included 13.8% anemia, 3.4% thrombocytopenia, 17.2% leukopenia, 13.8% increased aminotransferase, 3.4% increased creatinine, 3.4% hyperglycemia, 27.6% anorexia, 3.4% vomiting, 3.4% diarrhea, 10.3% constipation, 6.9% rash, 100% alopecia and 17.2% fatigue. Conclusions: Neoadjuvant tislelizumab combined with chemotherapy yielded promising MPR and pCR rates with an acceptable safety proﬁle in LA OSCC or OPSCC. Further follow-up is needed to confirm the long-term efficacy. Clinical trial information: ChiCTR2200056354 .
Re-irradiation for recurrent head and neck cancer: Freedom from cancer recurrence rate.
Authors: Mohamad Issa , Abu Hejleh Taher , Abdelqader Sania , Wahbeh Lina , Taqash Ayat , Al-Mousa Abdelatif , Mayta Ebrahim , Al-Ibraheem Akram , Abuhijla Fawzi , Abu Hijlih Ramiz , Hussein Tariq , Al-Gargaz Wisam , Ghatasheh Hamza , Hosni Ali
Published: June 2023

e18077

Background: Salvage re-irradiation (rRT) for patients with locoregionally recurrent head and neck cancer (rHNC) remains challenging. Methods: A retrospective analysis was performed on patients who received rRT between 2011 and 2018. The co-primary endpoint of the study was 2-year freedom from cancer recurrence rate (FCRR) and overall survival (OS), and secondary endpoints were 2-year disease free survival (DFS), local failure (LF), regional failure (RF), distant metastases (DM), and RTOG grade 3≥ late toxicities. Results: A total of 49 cases [nasopharygeal (n = 12); laryngeal (n = 12); oral cavity (n = 11); salivary gland (n = 9); and skin (n = 5)] were identified, adjuvant or definitive rRT were delivered to 22 and 27 patients, respectively. Various rRT fractionation schedules were used and 35/49 (71%) of patients received concurrent chemotherapy. The median follow-up after rRT was 30 months. The 2-year OS, DFS, LF, RF, and DM and FCRR were 64%, 51%, 28%, 32%, 9%, and 39% respectively. MVA showed that poor performance status (PS: 1-2 vs 0) and age > 52 years were predictive of worse OS. While, poor PS (1-2 vs 0) and total dose of rRT < 60Gy were predictive of worse DFS. Late RTOG toxicity of grade 3≥ was reported in 9(18.3%) patients. Conclusions: FCRR at 2 years after salvage rRT for rHNC was higher than other traditional endpoints and could be an important new endpoint to be included in the rRT studies. rRT for rHNC at our cohort was successful; with a manageable level of late sever toxicity.
Real world outcomes of next generation sequencing (NGS) of progressive RAI resistant metastatic thyroid cancer and treatment of these patients with redifferentiation protocol.
Authors: Wheeley Jennifer , Chintapally Nikita , Kulkarni Kanchan , Nair Reshmi , Kundra Priya , Rosen Jennifer , Sharma Meeta , Wexler Jason , Burman Kenneth D , Shobab Leila , Veytsman Irina
Published: June 2023

e18088

Background: Patients with papillary and follicular thyroid cancer (PTC and FTC) who are refractory to radioactive iodine treatment (RAIR) have poor prognosis. Frequently these patients are found to have BRAF V600E and NRAS Q61R mutations, which can be targeted using BRAF and MEK inhibitors to promote redifferentiation of thyroid cancer (TC) cells to take up RAI. The aim of this study is to define clinical, pathological, and molecular characteristics associated with response to redifferentiation therapy. Methods: NGS was performed to identify targetable mutations. The protocol consisted of 6 weeks of either dual therapy Trametinib and Dabrafenib (BRAF V600E) or Trametinib alone (NRAS Q61R) followed by dosimetry and therapeutic RAI administration. Interim imaging and biochemical analysis were performed at 3 months and 6 months. Statistical analysis was performed using the Kaplan-Meier survival analysis to estimate the mean time to progression from the protocol finish date. Patients who did not progress were censored at the last date of their clinic visit or at 192 days. Exploratory analysis was conducted to look at the change in trends in thyroglobulin (TG) values. Results: 16 patients met eligibility criteria. Previous RAI dosage ranged from 83mCi to 700mCi of Iodine 131 (I-131). 5 patients were African American, and 1 was Hispanic. Upon molecular analysis, 11 patients were found to have BRAF V600E mutation, 4 patients had NRAS Q61R mutation, and 1 was not identified. All but one patient had RAI uptake and received a dosage of 140 – 357 mCi of I-131 after dosimetry scan calculation. Upon interim analysis, 3 patients progressed at 3 months and an additional 3 patients progressed at 192 days. At 192 days, the mean time to progression from protocol finish date was 170 days (SD=9.7). Interim TG level analysis and images analysis are reflected in the table. There were other mutations identified: 11 patients were PDL1 negative, 5 PDL1 positive with range of 1-50%, 8 with TERT mutation, 4 with TP53, 2 with CHEK 2, other mutations were DNMT3A, FGFR3, BLM, EGFR, GNAS, ARID1, PDGFRA, NFE2L2, ARID2, Exon 17, POT1 Exon 14, and NTRK, were only present in one patient each. Conclusions: All but one patient with RAIR TC with BRAF V600E or NRASQ61R mutation who have undergone redifferentiation protocol have increased uptake of RAI after 6 weeks of targeted therapy with excellent response on interim analysis. Our study is ongoing to further define clinical, pathological, and molecular characteristics that help select patients with advanced TC who benefit most from redifferentiation treatment. Clinical trial information: 00005381 . [Table: see text]
Risk factors predictive of cervical lymph node metastasis in papillary thyroid microcarcinoma.
Authors: Jie Liu , Meng Wang , Wei Li , Jingchao Yu , Jinle Lu , Yating Chen
Published: June 2023

e18091

Background: Papillary thyroid microcarcinoma(PTMC) is defined as a papillary thyroid carcinoma(PTC) measuring less than or equal to 10mm in its greatest diameter.It has the highest incidence among all thyroid carcinomas. However, the clinical characteristics and risk factors predictive of cervical lymph node metastasis in PTMC have not yet been fully elucidated.Our study aimed to investigate the clinicopathological characteristics for PTMC and to identify the risk factors predictive of cervical lymph node metastasis in PTMC.This study was the Medical Science Research Project of Hebei Province (NO.20210957). Methods: We retrospectively reviewed the medical records of 714 pathologically proven conventional PTMC patients who underwent lobectomy or total or near-total thyroidectomy and central neck dissection(CND),with or without lateral neck dissection(LND) in our hospital between January 2019 and December 2020.The data were analyzed in relation to age at diagnosis, gender, tumor size,capsular invasion,multifocal tumor,tumor location,and lymph node metastasis(LNM) that includes central lymph node metastasis(CLNM) and lateral lymph node metastasis(LLNM).Logistic regression model was used to investigate the risk factors for LNM in PTMC.All analyses were performed with STATA 16. Results: There were 714 patients with PTMC, consisting of 491(68.8%) women and 223 (31.2%) men.Among them,331(46.4%) were≥55 years old,and 383(53.6%) were < 55 years old. 256 patients(35.9%) with tumor diameter≤5mm,and 458 patients(64.1%) with tumor diameter > 5mm.Among all patients, 211(30.0%) had multifocal,capsular invasion,566(79.0%) had multiple lobes,and 20(2.8%) had hashimoto's thyroiditis.CLNM occurred in 438(61.3%),while LLNM was found in 219(30.6%).The univariate analysis showed that male gender,age＜55 years,tumor size＞5mmtumor location in the lower third of the thyroid,multifocal,capsular invasion and bilateralism were significantly associated with CLNM.Multivariate analysis showed that the capsular invasion,tumor size＞5mm,multifocal,tumor location in the lower third of the thyroid were independently correlated with CLNM.In addition,univariate analysis showed that tumor size＞5mm,tumor location in the superior pole of thyroid,multifocal,capsular invasion, bilateralism and CLNM were associated with LLNM.However,multivariate analysis showed that tumor location in the superior pole of thyroid,capsular invasion,tumor size＞5mm,and CLNM were independently correlated with LLNM. Conclusions: Capsular invasion,tumor size＞5mm,multifocal,and tumor location in the lower third of the thyroid predict increased CLNM in PTMC patients.The possibility of LLNM should be carefully evaluated for these patients with tumors located in the upper pole of the thyroid gland,capsular invasion,tumor size＞5mm,and CLNM. Clinical trial information: 20210957 .
Association between hyperthyroidism and thyroid cancer in the Congolese hospital setting.
Authors: Bukasa-Kakamba John , Bangolo Ayrton , Onyeka Sonia , Sagireddy Sowmya , Bangura Mary , Rathod Joshua , Gomez Eugenio L. , Naria Mansi , Erikson Conrad , Tabucanon Erwin J. , Bortely Blanka , Dongre Juilee V. , Radhakrishnan Reshma , Tirumala Aditya K.G. , Jarri Amer , Nagesh Vignesh , Chacko Angel Ann , Dey Shraboni , Proverbs-Singh Tracy Ann , Weissman Simcha
Published: June 2023

e18092

Background: Thyroid cancer accounts for 1% of cancers worldwide. Hyperthyroidism was long considered a protective factor against thyroid cancer. This association was rare in the literature and raised a lot of controversy in the scientific world. There are currently no studies carried out in the Congolese hospital setting to establish the association between hyperthyroidism and thyroid cancer. We hypothesize that there is an association between thyroid cancer and hyperthyroidism in the Congolese hospital setting. Methods: This is a descriptive and retrospective study, which involved 106 cases of thyroid cancer who underwent partial or total thyroidectomy and pathological examination in four laboratories in the city of Kinshasa between 2005 and 2019. These laboratories receive samples from all the medical centers in Kinshasa. Statistical analyses of the data were performed using Statistical Package for the social sciences (SPSS) for Windows version 22 software. Data were expressed as mean +/- standard deviation for metric parameters, and as absolute or relative frequencies in percentages for categorical parameters. For all tests used the p-value < 0.05 was considered as the threshold of statistical significance. This research protocol was approved by the National Health Ethics Committee of the DRC No. 197/CNES/BN/PMMF/2020. Results: Out of 106 cases of thyroid cancer, the association of hyperthyroidism and thyroid cancer was found in 5 cases (4.7%) (3.6% for women vs. 9% for men). The mean age of patients with this association was 51 ± 11 years. Papillary carcinoma (two cases), follicular carcinoma (two cases) and lymphoma (one case) were the types of cancer encountered. Etiologically, toxic multinodular goiter (four cases; 80%) and toxic adenoma (one case; 2%) were found. Conclusions: There is an association between hyperthyroidism and thyroid cancer in the Congolese hospital setting. There is a predominance of the female gender. There was an equal number of papillary and follicular carcinomas. With this study, we hope to encourage clinicians to thoroughly evaluate any suspicious nodule associated with hyperthyroidism. [Table: see text]
Factors associated with positive margins in major salivary gland cancer: An NCDB analysis.
Authors: Keirns Darby , Hsia Beau , Verplancke Kiana , Silberstein Peter T. , Wu Xinxin
Published: June 2023

e18093

Background: Major salivary gland cancer includes malignancies of the parotid, sublingual, and submandibular glands which represent a diverse spectrum of disease. Surgical resection is often the primary treatment. Positive tumor margins after resection have been associated with disease recurrence and worsened prognosis. This study investigates various factors and their influence on margin status. Methods: 41,705 patients with surgically treated major salivary gland cancer between 2004 and 2020 were identified in the National Cancer Database (NCDB). Factors including facility type, facility volume, surgical approach, primary site, Charlson-Deyo score, age, sex, race, Hispanic origin, income, and high school attainment were compared in patients based on margin status. Both macroscopic and microscopic positive margins were considered. Multivariate binary logistic regression analysis was performed in SPSS version 28 with a significance level of p < 0.05. Results: Patients treated at an Academic/Research facility were 19% less likely to have positive margins than patients treated at a Community Cancer Program. Patients treated at facilities with case volume within the top 10% were 37% less likely to have positive margins. No significant difference was found in the margin status between different surgical approaches including open, endoscopic, and robotic. Patients with non-parotid major salivary gland cancer were 15% more likely to have positive margins than parotid cancers. Patients were more likely to have positive margins with an increasing Charlson-Deyo score and an increasing age. Female and Black patients were both 9% less likely to have positive margins than their counterparts. Other racial categories, ethnicity, income, and high school attainment did not significantly impact margin status. Conclusions: Factors associated with a lower likelihood of positive margins include treatment at an Academic/Research facility, higher volume center, parotid malignancies, lower Charlson-Deyo score, younger age, female sex, and Black race. The surgical approach and other demographic factors did not demonstrate any relationship with margin status. Identifying these associations can lead to a better understanding of prognostic factors and disparities in order to improve future care. [Table: see text]
Retrospective analysis of the multikinase inhibitor (MKI) pazopanib in differentiated thyroid carcinoma (DTC) in the beyond-first-line setting.
Authors: Inampudi Jyothik Varun , Mahadevia Himil , Stone Alexandra , Toby Alana , Koshiya Hiren , Patel Jaydeepbhai , Pandav Vivek , Li Shenduo , Rao Sarika , Chindris Ana-Maria , Manochakian Rami , Lou Yanyan , Zhao Yujie
Published: June 2023

e18097

Background: Sorafenib and lenvatinib are FDA-approved MKIs for locally recurrent or metastatic, progressive, DTC refractory to radioactive iodine treatment. Cabozantinib showed a survival benefit in radioiodine-refractory DTC previously treated with sorafenib and/or lenvatinib and was granted FDA approval. Our study aims to investigate the benefit of other MKIs in DTC beyond the first-line setting. Methods: DTC patients (pts) treated with multiple lines of MKIs from August 2018 to July 2022 at Mayo Clinic across all sites were identified. Electronic medical records were reviewed. 6-month, 12-month, and 18-month progression-free survival (PFS) were calculated for all lines of therapy using RECIST 1.1 criteria. Results: Among the 9 pts identified, 4 were male. The median age was 65 years (43-75). Most pts (60%) had papillary thyroid cancer. All pts received lenvatinib as first line treatment. The 6, 12 and 18-month PFS were 89%, 89%, and 55% respectively. 6 pts discontinued lenvatinib due to progression of disease (PD). 3 pts discontinued it due to adverse effects (AEs), which included hemoptysis (1 pt), severe rash (1 pt) and multiple psychiatric manifestations (1 pt). 8 pts received pazopanib, and 1 patient received cabozantinib with ipilimumab (1 dose) and nivolumab (6 months - discontinued due to myocarditis) as second-line therapy. Among them, 1 patient received pembrolizumab plus everolimus for 2 months before receiving pazopanib. The 6, 12 and 18-month PFS were 55%, 22%, and 11% respectively. All pts ceased treatment due to eventual PD, and there were no toxicity-related discontinuations. 5 pts subsequently received third-line MKIs, including cabozantinib (3 pts), pazopanib (1 pt), and lenvatinib (1 pt). The pt who received lenvatinib had discontinued it as first line therapy due to toxicity. The 2 pts treated with third-line cabozantinib and the pt rechallenged with lenvatinib showed no PD at 12-months and no toxicity related discontinuation. Conclusions: Pazopanib was associated with durable PFS and good tolerability when offered after PD or intolerance on lenvatinib in this retrospective analysis, warranting a randomized prospective study. [Table: see text]
Thyroid carcinoma showing thymus-like element: A national analysis of demographic features.
Authors: Bitar Gabriel Anthony , Hsia Beau , Wu Xinxin , Silberstein Peter T. , Keirns Darby
Published: June 2023

e18099

Background: CASTLE, or Thyroid Carcinoma Showing Thymus-Like Elements, is an indolent and uncommon cancer that is believed to originate from either ectopic thymus tissue or remnants from the branchial pouches and affects the thyroid gland. It makes up a small portion, less than 0.1 - 0.15%, of all thyroid carcinomas and tends to affect slightly more females than males. Due to the lack of literature on this malignancy, understanding the trend in its diagnoses can provide valuable information about its epidemiology. The demographic factors of patients diagnosed with CASTLE were analyzed using data from the National Cancer Database (NCDB). Methods: A study was conducted using the NCDB from 2004 – 2020 to examine patients diagnosed with CASTLE (N = 23). Demographic factors such as age, sex, race, Hispanic ethnicity, education level, insurance coverage, type of medical facility, distance from the facility, and Charleson-Deyo score were analyzed using descriptive statistics. Trends in the incidence of the disease were analyzed through regression analysis. Results: The National Cancer Database was analyzed and revealed that 23 patients were diagnosed with CASTLE between the years 2004 to 2020, with a stable incidence rate per year (R2 = 0.1). The average age of diagnosis was 61.0 years (SD = 14.3, range = 31 – 87). The average Charlson-Deyo comorbidity score was 0.5, with 0 being the most common score (69.6%). The majority of patients (87.0%) were non-Hispanic and White. Most patients were found to be in the top two income quartiles (60.8%) earning more than $57,857 per year. A larger portion of patients had private insurance coverage (60.9%) compared to those who were uninsured or covered by Medicare/Medicaid. A greater number of patients lived in metropolitan counties with a population over 1 million (47.8%) than in other metropolitan counties (43.5%). Patients were more likely to receive treatment in a non-academic program (63.6%) such as community cancer programs, comprehensive community cancer programs, or integrated network cancer programs. On average, patients lived 11.4 miles (SD = 11.1, range = 0.7 – 46.7) from the treatment facility. Conclusions: This is the first analysis of CASTLE in the National Cancer Database, filling a significant gap in knowledge on the subject, particularly regarding the socioeconomic characteristics of CASTLE patients. The average CASTLE patient is a 60-year-old White, non-Hispanic male. These patients are more likely to be upper-middle-class citizens, have private insurance, live in densely populated metropolitan areas, and receive treatment at comprehensive community cancer programs. Further investigation is necessary to explore the statistical correlation between demographic and socioeconomic variables and the diagnosis, treatment, and outcomes of CASTLE patients.
Pembrolizumab immunotherapy in advanced and recurrent/metastatic salivary gland carcinoma (R/M SGC): A systematic review and meta-analysis.
Authors: Filogonio Victor , Maia Yara Rafaela , Maia Lucas Henrique
Published: June 2023

e18101

Background: Treatment options for advanced R/M SGC are a limited and with variable response rates due to their safety/toxicity profile and the heterogenous l histology. Recent clinical trials tested pembrolizumab (PMB), a PD-1 inhibitor, in diverse settings. Methods: We performed a systematic review and single arm meta-analysis of clinical trials of PMB monotherapy or combined therapy in advanced and R/M SGC. PubMed, Scopus, and Cochrane database were searched for clinical trials published up to January 31, 2023. Data were extracted from published reports and quality assessment was performed per Cochrane recommendations. The primary endpoints of interest were complete/partial response (CR,PR) and disease control (DC= SD or better response) per RECIST v1.1, at any period of the trial. Results: Out of 199 database results, 4 clinical trials and 180 patients were included, all were using some form of PMB therapy. Overall, PMB was associated with a CR,PR ratio of 5.6% (95% CI 0.01-0.10, I²=25%, p=0.262) and DC ratio of 58.4% (95% CI 0.50-0.66, I²=13%, p=0.326), somewhat similar to recent evidence of PD-1/CTLA-4 combined therapy (nivolumab + ipilimumab [CR,PR=6-16%) in ongoing phase II clinical trials or PD-1 monotherapy (nivolumab [CR,PR=6%; SD=50%] in a completed clinical trial. Other systemic therapies, in which the current guidelines are based, include TKI (lenvatinib + sorafenib PR=3-15%; SD=50-94%) for adenoid cystic carcinoma (ACC); NTRK (larotrectinib CR,PR=90%, entrectinib CR,PR=86%), HER2 (transtuzumab associations CR,PR=60-90%), and AR (leuprorelin + bicalutamide CR,PR=42%, enzalutamide PR=4-15%; SD=52%) in non-ACC; and cytotoxic chemotherapy associations CR,PR=16-34% in heterogeneous histology tumors. Conclusions: There are marked limitations to the applicability of these findings in clinical practice, therefore a cautionary approach to this data is recommended, given their overall low statistical power, heterogenous histology, and tolerability to adverse effects. New trials with better standardized outcomes and comparative arms for different therapy associations and populations will help clarify the effects PD-1 inhibitors in the treatment of advanced and R/M SGC. [Table: see text]
The efficacy and safety of sequential use of anlotinib and 131I for locally advanced or metastatic differentiated thyroid cancer: A single-arm phase II clinical trial.
Authors: Song Hongjun , Qiu Xian , He Ziyan , Chen Libo
Published: June 2023

e18102

Background: Locally advanced or metastatic differentiated thyroid cancer (DTC) commonly responds poorly to radioiodine (131I) treatment alone. Tyrosine kinase inhibitors, however, have exerted promising antitumor activity in multiple advanced solid tumors. This study aimed to investigate the efficacy and safety of sequential use of anlotinib and 131I for the treatment of locally advanced or metastatic DTC. Methods: This is a single-arm phase II open-label clinical trail. The key eligibility criteria included locally advanced or metastatic 131I-avid DTC, ECOG PS of 0-1, and at least one measurable lesion. Previous tyrosine kinase inhibitor was not allowed. Patients initially received anlotinib (12 mg QD, 2 weeks on/1 week off ) for 4 cycles. At the beginning of 13th week when levothyroxine had been discontinued for 4 weeks, diagnostic 131I whole body scan (Dx-WBS) was performed, and those with 131I-avid lesions were immediately identified to undergo 131I treatment. The primary endpoint was objective response rate (ORR) . The secondary endpoints included disease control rate (DCR), biochemical response rate (BRR), time-to-response (TTR), progression-free survival (PFS), and safety. Results: From June 2021 to December 2022, a total of 16 patients with locally advanced or metastatic DTC were included. At the data cut off, 8 patients (4 males and 4 females) were withdrawn from the trial due to negative Dx-WBS, and the remaining 8 patients were subsequently treated with 131I. Six patients who had completed at least one cycle of sequential treatment were eligible for data analysis. Partial response and stable disease were found in 2 (33.33%) and 3 (50%) patients, respectively. An ORR of 33.33% [95% CI, 4.33-77.72], a DCR of 83.33% [95% CI, 35.88-99.58], a BRR of 100% [95% CI, 54.07-100.00], and a TTR of 6.34 months [95% CI, 5.85-NE] were achieved. Median PFS was not reached. Grade 3 adverse events occurred in 2 (33.33%) of the 6 subjects, including pain owing to skeletal metastasis in one patient and drug-related hypertention in the other. Conclusions: This study firstly demonstrates the favorable efficacy and safety of sequential therapy with tyrosine kinase inhibitor and 131I, suggesting anlotinib as a adjuvant option for 131I treatment of locally advanced or metastatic DTC. Randomized controlled studies on sequential therapy versus 131I treatment are warranted. Clinical trial information: ChiCTR2100045178 .
Clinical outcomes in patients with radioiodine refractory thyroid carcinoma treated with dose-reduced lenvatinib.
Authors: Au Cherry , Kim Brian , Fidler Mary Jo J. , Jelinek Michael J.
Published: June 2023

e18104

Background: In recent years, well-differentiated thyroid cancer (WDTC) accounted for over 40,000 new cancer diagnoses annually. For patients with metastatic, iodine-131-refractory thyroid cancer, systemic therapy is sometimes warranted. Lenvatinib was FDA approved in this setting at a starting dose of 24 mg orally daily based on the SELECT trial. Many patients required dose reductions on this trial, and the use of full dose (24 mg) lenvatinib is often not feasible in clinical practice. This study characterizes the clinical outcomes of lenvatinib for WDTC in a real-world setting. Methods: This study is a retrospective chart review of all patients over 18 years old diagnosed with radioiodine refractory thyroid carcinoma who received lenvatinib at a large academic center between 05/01/2016 and 01/01/2022. Demographic information, clinical data, and treatment outcomes were obtained. Results of our study were compared to historical controls from the SELECT trial. Results: There were 38 patients included in this study. Twenty-six of 38 patients had a dose reduction prior to start of treatment per judgement of the treating physician. Of the 12 patients who started at 24 mg, 11 required a dose reduction. Starting doses of lenvatinib ranged from 4 mg to 24 mg. The mean starting dose was 17 mg. Median progression free survival and overall survival were 35.2 months and 56.2 months, respectively. Eighteen patients remain on therapy. Overall response rate was 39.5% compared to 64.8% in historical controls. Disease control rate was 63.2%. Any grade weight loss was higher in this cohort versus historical control – 92.1% vs 46.4%, respectively. Systolic ( > 20 mmHg) and diastolic ( > 10 mmHg) blood pressure changes occurred in 13.2% of patients. 16.7% of patients had a peak increase in creatinine > 0.2 mg/dL above their baseline. Conclusions: Many patients were deemed ineligible for full dose lenvatinib by the treating physician. Despite an apparently lower response rate, lower doses of lenvatinib can still provide adequate disease control with an acceptable rate of blood pressure and serum creatinine elevation. Weight loss was an almost universal side effect of lenvatinib in this real-world population and was seen at a higher frequency than the historical population.
Geographic distribution of clinical trials for common advanced-stage cancers in the United States.
Authors: Swenson Wade T. , Westergard Emily , Schroeder Zachary , Swenson Abigail P.
Published: June 2023

e18503

Background: This study examines the geographic distribution of clinical trials for common types of metastatic cancer in the United States and the accessibility of these trials to the general population. Methods: We accessed the ClinicalTrials.gov website and conducted a search for interventional clinical trials that were actively recruiting patients for diagnoses of metastatic lung, colon, pancreas, breast, and prostate cancers on November 25, 2022. We identified unique zip codes for all the clinical trials offered and calculated the U.S. population living within 50 miles of a clinical trial site using geographic information system software based on 2020 census data. We created maps for each cancer type, demonstrating the geographic distribution of clinical trial access in the United States. Results: We found a significant number of clinical trials providing access for most Americans diagnosed with the most common types of metastatic cancer. The majority of the United States population lives within 50 miles of a clinical trial. The access varied by cancer type studied, from 75.0% of the United States population for metastatic colon cancer to 90.2% for metastatic lung and breast cancers. See table for details. Conclusions: When considering the accessibility of these trials, we found that a large proportion of the United States population lived within 50 miles of a clinical trial site. This suggests that while many clinical trials are available, they may not be evenly distributed across the country and may not be accessible to all individuals. [Table: see text]
Socioeconomic and demographic barriers associated with delays in pancreatic cancer germline genetic testing.
Authors: Zou Xianghui , Sidiqi Baho , Tortorella Brooke , Patruni Sunita , Rezak Leora , Alfano Catherine M. , Hollweg Christopher , Kauff Noah D. , King Daniel
Published: June 2023

e18506

Background: Germline genetic testing is recommended for patients with pancreatic ductal adenocarcinoma (PDAC). We identified associations between patient social profiles and delays in obtaining germline genetic testing from New York’s largest healthcare system. Methods: Patients with PDAC were identified using our EMR between Mar 2016 and Feb 2022 with an IRB-approved protocol. Median income was extrapolated using zip code. Social vulnerability index (SVI) was obtained from CDC ATSDR website. Date of diagnosis (DOD) was recorded as the date of biopsy. Delays of testing were calculated as the difference between DOD and the date of germline test. Social work needs, sources of income, and insurances were captured by EMR review of social work notes. Pearson correlation, Mann-Whitney, and Chi-square tests were used for statistical analysis. Results: We identified 104 (34%) patients with germline tests. Other than ethnicity, there was no demographic difference between patients who performed tests and patients who did not (Table). Pearson analysis between income and delays showed a negative correlation (r=-0.3033, p=0.0018). Patients who received social security and were unemployed/disabled had significant delays in testing (167d) compared to patients receiving social security and retired (30d, p=0.0318) or patients receiving salaries (13d, p=0.0002). African Americans and Hispanics, classified as underserved minority, had significant delays (92d) in testing compared to those not underserved (21d, p=0.0018). In addition, African Americans had significant delays (92d) compared to White patients (13d, p=0.0002). Patients with social work needs (12 total: 6 home care, 3 transportation, 2 financial assistance) had significant delays in testing (109d) compared to those without needs (24.5d, p=0.0028). Patients from zip codes with SVI>0.5 had non-significant delays (40.5d) compared to patients from zip codes with SVI<0.5 (26d, p=0.1817). In addition, patients with Medicare had significant delays (40d) compared to those with Medicare and supplementary insurances (15d, p=0.0205). Conclusions: PDAC patients with delays in germline testing were more likely African American and Hispanic, had lower income with social work needs, received social security, or lacked supplemental insurance. Interprofessional collaborations may be required to prompt germline tests. [Table: see text]
Community resilience and its impact on chemotherapy availability: An ecological analysis.
Authors: Shour Abdul R , Anguzu Ronald , Onitilo Adedayo A.
Published: June 2023

e18510

Background: Cancer patients' resilience influences treatment outcomes, but how community resilience at the ecological level affects hospitals that provide chemotherapy is poorly understood. Methods: Agency for Health Care Research and Quality 2019 ecological data were analyzed (N=3,232 counties). The number of hospitals with chemotherapy services (continuous) was the outcome. The exposure was community resilience- individuals who live with various risk factors (income-poverty ratio, crowding, communication barrier, household unemployment, disability, age 65+; no health insurance, vehicle access, and broadband internet access). Covariates included residential racial segregation-dissimilarity index- degree to which non-white and white residents were distributed across counties, scored 0-100 (integration-segregation) and income inequality scored 0-1 (equality-inequality), recategorized as 10th (low-risk), 11th-89th (moderate-risk), and 90th (high-risk) percentiles and rural-urban and region. Using STATA/MPv.17, descriptive, chi-square; adjusted negative binomial regression were performed adjusting for population weight. P-values ≤0.05 were considered statistically significant. Results: Chemotherapy services were available in 38.4% of counties. The adjusted model reveals that chemotherapy availability decreased in high-risk than in low-risk resilient areas (Coef.: -1.10, 95% CI: -1.34 - -0.86), but increased in rural than in urban areas (Coef.: 0.36, 95% CI: 0.61- 0.49). Conclusions: Chemotherapy services rose in rural than urban areas and services were less likely to be provided when community resilience was low. [Table: see text]