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Phase II study of spartalizumab (PDR001) vs chemotherapy (CT) in patients with recurrent/metastatic nasopharyngeal cancer (NPC) [Meeting Abstract]

Lim, Darren Wan-Teck; Wang, Hung-Ming; Li, Shau-Hsuan; Ngan, Roger; Dechaphunkul, Arunee; Zhang, Li; Yen, Chia Jui; Chan, Po Chung; Chakrabandhu, Somvilai; Ma, Brigette; Tanasanvimon, Suebpong; Lee, Victor; Lou, Pei-Jen; Li, Zujun; Spira, Alexander; Sukari, Ammar; Guigay, Joel; McCune, Steven; Sun, Yongjian; Szpakowski, Sebastian; Yao, Yao; Fan, Xueqiang; Manenti, Luigi; Even, Caroline
ISI:000488129900134
ISSN: 0008-5472
CID: 4135682

The development, usability, and reliability of the Electronic Patient Visit Assessment (ePVA) for head and neck cancer

Van Cleave, Janet H; Fu, Mei R; Bennett, Antonia V; Persky, Mark S; Li, Zujun; Jacobson, Adam; Hu, Kenneth S; Most, Allison; Concert, Catherine; Kamberi, Maria; Mojica, Jacqueline; Peyser, Amanda; Riccobene, Ann; Tran, Anh; Persky, Michael J; Savitski, Justin; Liang, Eva; Egleston, Brian L
Background/UNASSIGNED:Annually, over 65,000 persons are diagnosed with head and neck cancer in the United States. During treatment, up to 50% of patients become severely symptomatic with pain, fatigue, mouth sores, and inability to eat. Long term complications are lymphedema, fibrosis, dysphagia, and musculoskeletal impairment. Patients' ability to perform daily activities and to interact socially may be impaired, resulting in poor quality of life. A pragmatic, clinically useful assessment is needed to ensure early detection and intervention for patients to report symptoms and functional limitations over time. We developed the Electronic Patient Visit Assessment (ePVA) that enables patients to report 42 symptoms related to head and neck cancer and 17 limitations of functional status. This manuscript reports (I) the development of the ePVA, (II) the content validity of the ePVA, and (III) the usability and reliability of the ePVA. Methods/UNASSIGNED:Usability was evaluated using the "Think Aloud" technique to guide the iterative process to refine the ePVA based on participants' evaluations. After signing the informed consent, 30 participants with head and neck cancer completed the ePVA using digital tablet devices while thinking aloud about ease of use. All patient conversations were recorded and professionally transcribed. Reliability of the ePVA symptom and functional limitation measures was estimated using the Kuder-Richardson test. Convergent validity of the ePVA was evaluated using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 global QoL/health scale. Transcribed qualitative data were analyzed using directed content analysis approach. Quantitative analyses consisted of descriptive statistics and correlation analyses. Results/UNASSIGNED:Among participants, 90% strongly agreed or agreed that the ePVA system was easy to use and 80% were very satisfied. Only minor usability problems were reported due to formatting and software "bugs". Reporting of usability problems decreased in frequency over the study period and no usability problems were reported by the last 3 participants who completed the ePVA. Based on participants' suggestions during the iterative process, refinement of the ePVA included increased touch sensitivity of the touch screen technology and customized error messages to improve ease of use. The ePVA also recorded patient reported symptoms (mouth symptoms: 93%, fibrosis: 60%, fatigue: 60%). The ePVA demonstrated acceptable reliability (alpha =0.82-0.85) and convergent validity (ePVA total number of reported symptoms and function limitations was negatively correlated with EORTC QLQ-C30 global QOL/health scale: r=-0.55038, P<0.01). Conclusions/UNASSIGNED:The ePVA was rigorously developed, accepted by patients with satisfaction, and demonstrated acceptable reliability and convergent validity. Future research will use data generated by the ePVA to determine the impact of symptom trajectories on functional status, treatment interruptions and terminations, and health resource use in head and neck cancer.
PMCID:6691072
PMID: 31463307
ISSN: 2306-9740
CID: 4054542

A Phase I/II, open-label, two part study of GSK3359609 in combination with tremelimumab in participants with selected, advanced solid tumors [Meeting Abstract]

Hansen, Aaron; Abdul-Karim, Raghad; Rizvi, Naiyer; Rischen, Danny; Hilton, John; Li, Zujun; Ott, Patrick; Karpinich-Fedoriw, Natalie; Yadavilli, Sapna; Wang, Xiaowei; Adams, Laurel; Wyres, Melody; Ferte, Charles; Ballas, Marc; Hoos, Axel; Zandberg, Daniel
ISI:000488129900148
ISSN: 0008-5472
CID: 4135692

Neoadjuvant chemotherapy in local-regionally advanced nasopharyngeal carcinoma: A National Cancer Database analysis

Tam, Moses; Lee, Anna; Wu, S Peter; Gerber, Naamit K; Li, Zujun; Givi, Babak; Hu, Kenneth; Schreiber, David
OBJECTIVES/HYPOTHESIS/OBJECTIVE:To assess patterns of care and outcomes with the use of neoadjuvant chemotherapy followed by definitive radiation in local-regionally advanced nasopharyngeal carcinoma. STUDY DESIGN/METHODS:Retrospective database analysis. METHODS:We queried the National Cancer Database for patients with T3-4N2 or T1-4N3 nasopharyngeal carcinoma who received concurrent chemoradiotherapy or neoadjuvant chemotherapy followed by radiation. Overall survival (OS) was analyzed using the Kaplan-Meier method, propensity-score matching, and a Cox proportional hazards model adjusting for demographic and disease-specific prognostic factors. RESULTS:P = .001). At a median follow-up of 36.6 months, patients had 3-year OS of 66% in the neoadjuvant group compared with 70% in those who received concurrent chemoradiotherapy (log rank P = .29). On subgroup analysis by histology, T stage, and N stage, there remained no differences in OS between the two groups. On multivariable analysis, there was no significant survival difference associated with neoadjuvant chemotherapy (adjusted hazard ratio [HR]: 1.05, 95% confidence interval [CI]: 0.89-1.25, P = .54). In a propensity score-matched population of 1,008 patients (504 with neoadjuvant therapy and 504 without), there was no significant survival difference associated with neoadjuvant chemotherapy (H: 1.13, 95% CI: 0.93-1.38, P = .22). CONCLUSIONS:Neoadjuvant chemotherapy was used in over 25% of patients, and its use is increasing. However, neoadjuvant chemotherapy was not associated with any differences in survival compared to concurrent chemoradiotherapy. LEVEL OF EVIDENCE/METHODS:4 Laryngoscope, 2018.
PMID: 30133799
ISSN: 1531-4995
CID: 3246422

Patterns of Care and Outcomes of Neoadjuvant Chemotherapy in Locally Advanced HPV Positive Oropharyngeal Carcinoma: A National Cancer Database Analysis [Meeting Abstract]

Tam, M.; Wu, S. P. P.; Lee, A.; Gerber, N. K.; Givi, B.; Li, Z.; Schreiber, D.; Hu, K. S.
ISI:000447811601113
ISSN: 0360-3016
CID: 3493482

Utilization of Immunotherapy in Head and Neck Cancers Pre-Food and Drug Administration Approval of Immune Checkpoint Inhibitors [Meeting Abstract]

Wu, S. P. P.; Tam, M.; Gerber, N. K.; Li, Z.; Schmidt, B.; Persky, M.; Sanfilippo, N. J.; Tran, T.; Jacobson, A.; DeLacure, M.; Hu, K. S.; Persky, M.; Schreiber, D. P.; Givi, B.
ISI:000428145600179
ISSN: 0360-3016
CID: 3035562

Functional Swallowing Outcomes Using FEES Evaluation After Swallowing-Sparing IMRT in Unilateral Versus Bilateral Neck Radiation [Meeting Abstract]

Tam, M.; Mojica, J.; Kim, N. S.; No, D.; Li, Z.; Tran, T.; DeLacure, M.; Givi, B.; Jacobson, A.; Persky, M.; Hu, K. S.
ISI:000428145600250
ISSN: 0360-3016
CID: 3035552

Low rates of contralateral neck failure in unilaterally treated oropharyngeal squamous cell carcinoma with prospectively defined criteria of lateralization

Hu, Kenneth Shung; Mourad, Waleed Fouad; Gamez, Mauricio; Safdieh, Joseph; Lin, Wilson; Jacobson, Adam Saul; Persky, Mark Stephen; Urken, Mark Lawrence; Culliney, Bruce; Li, Zujun; Tran, Theresa Nguyen; Schantz, Stimson Pryor; Chadha, Juskaran; Harrison, Louis Benjamin
BACKGROUND: Unilateral radiotherapy (RT) of oropharyngeal carcinomas is accepted for patients with lateralized primary and low-volume nodal disease. Utilizing prospectively defined criteria of laterality and staging positron emission tomography (PET)/CT, we studied outcomes in patients with advanced-stage oropharyngeal cancer undergoing unilateral RT. METHODS: Thirty-seven patients with oropharyngeal tumors >1 cm from midline regardless of node status underwent unilateral RT and were followed prospectively. Patient characteristics: T1 = 11; T2 = 22; T3 = 4; N0 = 3; N1 = 9; N2a = 3; N2b = 21; and Nx = 1. Dosimetry were determined and weekly National Comprehensive Cancer Network (NCCN) distress thermometer data were collected. RESULTS: At median follow-up of 32 months, 3-year locoregional control, contralateral regional failure, distant metastasis-free survival, and disease-free survival were 96%, 0%, 7%, and 93%, respectively. CONCLUSION: Low rates of contralateral neck failure are demonstrated utilizing prospectively defined criteria for unilateral RT. The tolerances of contralateral organs are respected and patients report low to moderate levels of distress throughout treatment.
PMID: 28474380
ISSN: 1097-0347
CID: 2546872

Five-year outcomes of an oropharynx-directed treatment approach for unknown primary of the head and neck

Hu, Kenneth Shung; Mourad, Waleed Fouad; Gamez, Mauricio E; Lin, Wilson; Jacobson, Adam Saul; Persky, Mark Stephen; Urken, Mark L; Culliney, Bruce E; Li, Zujun; Tran, Theresa Nguyen; Schantz, Stimson Pryor; Chadha, Juskaran; Harrison, Louis Benjamin
PURPOSE: Squamous cell carcinoma of unknown primary (SCCHNUP) is commonly treated with comprehensive radiation to the laryngopharynx and bilateral necks. In 1998, we established a departmental policy to treat SCCHNUP with radiation directed to the oropharynx and bilateral neck. METHODS: From 1998-2011, 60 patients were treated - N1: 18%, N2: 75% and N3: 7%. 82% underwent neck dissection. 55% received IMRT and 62% underwent concurrent chemoradiotherapy. RESULTS: At median follow-up of 54months, 5 patients failed regionally and 4 emerged with a primary (tongue base, hypopharynx and thoracic esophagus). Five-year rates of regional control, primary emergence, distant metastasis, disease-free survival and overall survival were 90%, 10%, 20%, 72% and 79%, respectively. The 5year rate of primary emergence in a non-oropharynx site was 3%. CONCLUSION: This is the first demonstration that an oropharynx-directed approach yields low rates of primary emergence in SCCHNUP with excellent oncologic outcomes.
PMID: 28622886
ISSN: 1879-0593
CID: 2595272

Variation in symptom distress in underserved Chinese American cancer patients

Dhingra, Lara K; Lam, Kin; Cheung, William; Shao, Theresa; Li, Zujun; Van de Maele, Sandra; Chang, Victor T; Chen, Jack; Ye, Huiyan; Wong, Rhoda; Lam, Wan Ling; Chan, Selina; Bookbinder, Marilyn; Dieckmann, Nathan F; Portenoy, Russell
BACKGROUND: Cancer is prevalent in the rapidly growing Chinese American community, yet little is known about the symptom experience to guide comprehensive treatment planning. This study evaluated symptom prevalence and patient subgroups with symptom distress in a large sample of Chinese American cancer patients. METHODS: Patients were consecutively recruited from 4 oncology practices, and they completed a translated cancer symptom scale. Latent class cluster analysis was used to identify subgroups of patients with distinct symptom distress profiles. RESULTS: There were 1436 patients screened; 94.4% were non-English-speaking, and 45.1% were undergoing cancer therapy. The cancers included breast (32.6%), lung (14.8%), head and neck (12.5%), and hematologic cancer (10.1%). Overall, 1289 patients (89.8%) had 1 or more symptoms, and 1129 (78.6%) had 2 or more. The most prevalent symptoms were a lack of energy (57.0%), dry mouth (55.6%), feeling sad (49.3%), worrying (47.5%), and difficulty sleeping (46.8%). Symptoms causing "quite a bit" or "very much" distress included difficulty sleeping (37.9%), a lack of appetite (37.2%), feeling nervous (35.8%), pain (35.2%), and worrying (34.0%). Four patient subgroups were identified according to the probability of reporting moderate to high symptom distress: very low physical and psychological symptom distress (49.5%), low physical symptom distress and moderate psychological symptom distress (25.2%), moderate physical and psychological symptom distress (17.4%), and high physical and psychological symptom distress (7.8%). CONCLUSIONS: Symptom prevalence is high in community-dwelling Chinese American cancer patients, and nearly half experience severe distress (rated as "quite a bit" or "very much" distressing) from physical symptoms, psychological symptoms, or both. These data have important implications for the development of effective symptom control interventions. Cancer 2015. (c) 2015 American Cancer Society. Cancer 2015;121:3352-3359. (c) 2015 American Cancer Society.
PMID: 26059972
ISSN: 1097-0142
CID: 1802262