bluuebunny/crossref_metadata_2025_split huggingface dataset:
The impact of chronic hepatitis C virus infection on survival in oropharyngeal cancer patients.
Authors: Economides Minas P. , Sturgis Erich M. , Amit Moran , Hosry Jeff , Mahale Parag , Jiang Ying , Torres Harrys A. 
Published: September 2018

e17556 Background: An association between Hepatitis C virus (HCV) infection and oropharyngeal cancers (OPCs) has been reported; however, the clinical significance of this epidemiological finding remains unknown. We therefore analyzed the oncologic outcomes of HCV-infected patients (pts) with OPCs. Methods: In this retrospective cohort study, all pts with OPCs seen at MD Anderson (1/2004-12/2015) were reviewed. HCV infection was defined as detectable HCV RNA in serum. Risk of 5-year (yr) overall survival (OS) and progression-free survival (PFS) was compared between HCV-infected (HCV+) and uninfected (HCV-) pts. OPCs that were positive for p16 by immunohistochemistry were considered HPV-related. Antiviral therapy (AVT) included either interferon (IFN)-based or IFN-free regimens. Multivariate cox proportional hazards model was used to identify independent predictors of mortality. Results: We studied 161 pts. Most of the pts were white (141; 88%), male (132; 82%) and had tumor stage 3 or 4 (147; 92%). The OPC involved tonsils (83; 52%), base of tongue (67; 42%) or soft palate (11; 7%). The median follow-up time after OPC diagnosis was 3 yrs (range: 1-13 yrs). HCV+ (n = 25) and HCV- pts (n = 136) were comparable in regards to smoking and alcohol status. In univariate analysis, HCV+ pts had more OPC progression after 1stline cancer treatment (48% vs 20.6% in HCV-, P = .0009) and were more likely to relapse (26% vs 5% in HCV-, P = .02). In multivariate analysis, HCV was associated with increased all-cause mortality [hazard ratio (HR): 2.15, 95% confidence intervals (CI): 1.08-6.85; P = .02] and risk of OPC progression [HR: 5.42, 95% CI: 2.64-11.14; P = .0008] independent of age and cirrhosis status. In HPV+ OPCs (n = 86), HCV + and HCV- pts did not have significant difference in mortality [HR: 2.03, 95% CI: 0.82-4.98; P = .12]. AVT was administered after OPC diagnosis in 8 of the 25 HCV+ pts (32%), with 6 of them receiving IFN-free AVT. HCV+ pts that received AVT had better 5 yr OS (median of 5.2 vs 2.3 yrs, P = .005) and PFS (median of 3.1 vs 0.7 yrs, P = .007) than the ones who did not. Conclusions: HCV seems to affect the oncologic outcomes of pts with OPCs and treating this infection might be beneficial. HCV screening and treatment should be considered in such pts.
Clinical experiences of gene therapy.
Authors: Li Longjiang 
Published: September 2018

e17561 Background: Based on the theoretic and clinical development of modern medicine, gene therapy has been a promising treatment strategy for cancer and other patients. Methods: In the present paper, we reviewed the history and clinical experiences of gene therapy from the aspects of treatment protocol, administration cycle, dosage calculation and evaluation of therapeutic effects, in order to provide more information for the further development of this promising treatment. Results: Although the development of gene therapy has not gone smoothly since the beginning of the clinical trials, the results showed that this was a promising treatment for the cancer patients. There are still a lot of researches needed to be done to further solve the theoretic and clinical issues, and to improve the therapeutic effects. Conclusions: : In conclusion, although the development of gene therapy has not gone smoothly since the beginning of the clinical trials, the results showed that this was a promising treatment for the cancer patients. There are still a lot of researches needed to be done to further solve the theoretic and clinical issues, and to improve the therapeutic effects. But the future of the gene therapy will be bright, and it will become a new basic strategy to help more patients.
Is there a role for adjuvant radiation in T1N0 squamous cell carcinoma tongue with adverse pathological features? Factors affecting local control and the development of a scoring system.
Authors: Srinivasalu Vijay Kumar , Subramaniam Narayana , Balasubramanian Deepak , Low Hubert , Anand Adharsh , Thankappan Krishnakumar , Philip Arun , Iyer Subramania , Pavithran Keechilat 
Published: September 2018

e17565 Background: The patterns of recurrence and the prognostic factors of early tongue lesions have been previously described in literature, often grouping T1 and T2N0 tongue lesions together. Adverse pathological features (APFs) have been used to predict nodal spread, but the prognostic factors predicting local recurrences in T1N0 tongue have seldom been described. We aim to evaluate the APFs associated with poor local control and the possible need for escalation of therapy. Methods: A retrospective analysis of 144 patients of pT1N0 squamous cell carcinoma tongue, extracted from our database of 598 patients of oral cavity who underwent wide local excision with neck dissection in a single institution between 2006-2014 were included in our study. Patients who received any adjuvant therapy were excluded. Results: APFs associated with local control were least margin 5 mm (p=0.004), infiltrative margin (p=0.403), depth ≥ 4mm (p=0.136), lymphovascular invasion (p=0.301) and perineural invasion (p=0.342). We derived a scoring system assigning a score to each of these factors out of a total 10 points, based on the hazard ratio for local failure. Patients with a score ≥ 5 points had a 5-year local control rate of ≤ 60%. Conclusions: Having least margin of 5 mm was the greatest predictor of local failure. This would suggest that all patients having a margin of 5 mm need revision, however if they do not have additional APF (score ≤ 4 points), they still have good local control rates (5-year local control rate of 88%) and may be observed. Those who have margins over 5 mm with a total score ≥ 5 may still benefit from adjuvant therapy for local control. Those with margins over 5mm have improved local control rates (p=0.029). [Table: see text]
Long-term result of out-patient intra-arterial chemotherapy in patients with stage II and III oral cancer.
Authors: Ohmae Masatoshi , Kato Itsuro , Fujita Yusei , Tkaoka Hiroo , Meshii Noritoshi , Takasu Ayako , Nakazawa Mitsuhiro 
Published: September 2018

e17569 Background: We have developed a superselective intra-arterial chemotherapy (iaCT) approach for oral cancer, in which intra-arterial catheter is retrogradely inserted via the superficial temporal artery and/or occipital artery. The extra-arterial portion of catheter is connected to an infusion reservoir implanted subcutaneously around the mastoid process through the subcutaneous tunnel. The catheter and reservoir are completely placed under the skin, so there is little possibility of catheter-related issues such as infection and displacement. Hence, out-patient iaCT (op-iaCT) can be performed. This method has improved ADL of patients without any loss of curative effect and oral function. We reported the usefulness of op-iaCT at the ASCO annual meeting in 2013. We assessed the long-term outcome and survival rate of patients with stage II and III oral cancer who received op-iaCT and survived for at least 5 years. Methods: We have used op-iaCT for 46 patients who had oral cancer, out of which we selected 14 patients with stage II and III oral cancer, and monitored them for more than 5 years. Results: Two patients died owing to distant metastasis, to the brain and liver, and 12 patients were cancer-free. Neck metastases were detected after primary treatment and op-iaCT in 3 patients, who were salvaged by neck dissection. The 5-year survival rate was 86%. Conclusions: Distant and/or regional lymph node metastases were observed in 5 out of 14 patients. The op-iaCT improves quality of life of patients with stage II and III oral cancer, but the metastasis rate is somewhat high. Close observation, intravenous chemotherapy, and /or prophylactic neck dissection should be employed in the op-iaCT approach for oral cancer.
Outcomes in patients with head and neck squamous cell carcinoma (HNSCC) requiring salvage resection after definitive therapy.
Authors: Haque Sulsal , Riaz Muhammad Kashif , Hassan Sarah , Karivedu Vidhya , Ying Jun , Takiar Vinita , Wise-Draper Trisha Michel 
Published: September 2018

e17572 Background: Salvage surgical resection is often offered in HNSCC patients who develop locally recurrent disease after definitive therapy. However, survival outcomes are often poor and subsequent recurrence is frequently fatal. Patients with adverse pathological features (extracapsular extension (ECE) of lymph nodes (LN), positive margins, peri-neural spread, lympovascular invasion, multiple LN metastases) after primary surgical resection have been shown to have poor outcomes. It is unclear if these same features affect outcomes in surgical salvage patients. Therefore we conducted a retrospective analysis to analyze outcomes and potential risk factors in these patients. Methods: We analyzed forty-five patients at the University of Cincinnati from 2008-2014 that underwent salvage surgery after definitive radiation with or without chemotherapy. Independent categorical variables analyzed were age, gender, alcohol, smoking, time to relapse after definitive therapy and adverse pathological features. Dependent variables were relapse free survival (RFS) and overall survival (OS) censored at time of event or last follow-up visit. Kaplan-Meier curves were used to estimate RFS and OS and Cox Proportional Hazard models were used to assess hazard ratios between groups. Results: Median age was 57 (range 41 to 86). 75.6% of patients were male. 68.9% patients had adverse pathological features. Median OS was 59 months and median RFS was 38 months from surgery. Demographics and adverse pathological features did not affect survival. However, patients who relapsed after definitive therapy within 6 months vs. after 6 months had worse OS (See Table 1). Conclusions: Although adverse pathological features correlate with poor outcome in primary surgery, these features did not impact outcomes after salvage surgery in our population. However, patients who relapsed within 6 months of definitive therapy and underwent salvage resection had significantly worse outcomes than those who developed recurrence after 6 months. [Table: see text]
Inferring the effects of concurrent chemotherapy with or without adjuvant chemotherapy versus radiotherapy alone in stage II-IVB nasopharyngeal carcinoma: Comparison of results from meta-analysis of observational studies and randomized trials.
Authors: Tan Teng Hwee , Soon Yu Yang , Cheo Timothy , Tey Jeremy Chee Seong , Tham Ivan Weng Keong 
Published: September 2018

e17573 Background: Multiple randomized trials (RCTs) reported that concurrent chemotherapy (CCT) with or without adjuvant chemotherapy (AC) improves survival in stage II-IVB nasopharyngeal carcinoma (NPC) compared to radiation therapy alone. However, it is unclear if similar benefits can be observed in routine practice as patients included in RCTs could be very different from patients in routine practice. The aim of this study is to compare the effects of CCT with or without AC as estimated from observational studies (OBS) with findings from RCTs. Methods: We searched MEDLINE for eligible studies determining the effect of addition of CCT with or without AC in stage II-IVB NPC. Outcome of interest was overall survival (OS). We performed the meta-analysis with random effects model to estimate the pooled hazard ratios (HR), confidence intervals (CI), and I squared statistic (I2) for both RCTs and OBS and compared them using Altman interaction test. Results: We found nine RCTs and 19 OBS including 6523 patients. Eight RCTs and 14 OBS had at least 75% of its patients with stage III-IVB NPC while only one RCT and five OBS had at least 75% of its patients with stage II NPC. The survival benefit associated with chemotherapy was similar in both RCTs and OBS focusing on stage III-IVB NPC (RCTs HR 0.67, 95% CI 0.56 – 0.81, I2 = 48% vs OBS HR 0.71 95% CI 0.62 – 0.82, I2 = 4%, interaction P (IP) = 0.67). Similarly, there was no significant difference in OS for RCT and OBS focusing on stage II NPC (RCTs HR 0.34, 95% CI 0.17 to 0.66, I2 = non-applicable due to single study vs OBS HR 0.61, 95% CI 0.37 to 1.02, I2 = 0%, IP = 0.17). Conclusions: Patients with stage II and stage III-IVB nasopharyngeal carcinoma treated in routine practice received similar survival benefits associated with concurrent chemotherapy with or without adjuvant chemotherapy as patients treated in randomized trials.
The Compassionate Use Advisory Committee (CompAC) for development of pre-approval access to investigational drugs.
Authors: Mitchell Edith P. , Caplan Arthur , Bateman-House Alison , Ray Amrit 
Published: September 2018

e18001 Background: In May 2015, CompAC was formed at NYU to provide guidance fairly and transparently on allocating a limited supply of , Daratumumab, to patients outside of clinical trials. Janssen, manufacturer of Daratumumab, was receiving numerous pre-approval requests for access to the drug. Daratumumab (Darzalex) was approved in the U.S. for treatment of patients with multiple myeloma who have received at least one prior therapy and approved by EMA for monotherapy. The SPR program was phased out based on country level approvals, with requests and submissions managed in a regulatory and legal environment.Methods: CompAC was 10 medical experts, bioethicists, and patient advocates; ethical and medical principles for review and process guidelines developed. Weekly meetings were held to consider SPR requests, with 3 members voting each week. After U.S. approval, requests for drug were considered only from countries where Janssen was seeking but had not gained approval. Recommendations were conveyed weekly for final decisions. Results: A total of 331 cases were received by Janssen of which 5 withdrew and 2 expired, leaving 324 cases for review. Of these, 180 were sent to CompAC and 163 were recommended by CompAC for treatment. Janssen approved all 163. CompAC recommended declining 17 of these cases; Janssen declined 15 (2 cases were approved based on additional information provided). Of the 144 patients excluded by Janssen before CompAC review, 27 were due to low benefit/risk profile, 17 provided incomplete clinical information, 42 for other variables, 46 received alternative therapies, 10 for referral to another pre-approval access channel, and 2 commercially available drug. Of the cases that CompAC recommended declining, 11 were due to low benefit/risk profile, for 3 alternative therapies available, and remaining 3 for miscellaneous reasons. Requests were received from 13 countries, the majority from outside the U.S.Conclusions: CompAC was successfully implemented and provided rapid review of SPR requests for pre-approval Daratumumab access. Janssen is extending CompAC to other relevant assets. Other companies are considering the model.
Studying chemotherapy toxicity levels in district cancer care delivery model.
Authors: Pendharkar Dinesh , Tripathi Chandramavli M. , Aagre Suhas 
Published: September 2018

e18003 Background: To increase the access to cancer care an innovative delivery model has been initiated in 77 district general hospitals of India , empowering general duty medical officers and offering 24x7 technology based backup. All the districts along with other care also offer chemotherapy services. Major concerns raised by medical community were of toxicity associated with administration of chemotherapy. Methods: Data from chemotherapy patients undergoing chemotherapy over short period of three months in one of the district hospital was collected using proforma and common terminology criteria for adverse events(CTCAE v. 4).Data was recorded in all patients by personal interview and clinical examination when patient reported for next c0urse of chemotherapy and during the administration. Results: Total number of 196 patients (136 female and 60 male) taking chemotherapy in district were evaluated. Majority of them had breast( 92), lung (24) head and neck cancer(18).A total number of 285 cycle in all lines –first, second, etc were administered. In breast cancer majority cycles were of adjuvant chemotherapy. Chemotherapy regimens in use included all standard combinations of Doxorubicin cyclophosphamide, docetaxel ,carboplatin , 5FU, paclitaxel . Commonest toxicity included nausea , vomiting, fatigue, diarrhea and anemia. Nausea was commonest (181 events)followed by vomiting (179) diarrhea (122) fatigue, anemia and neutropenia. Most toxicity was grade 1 and 2 only. Only 3 cases of febrile neutropenia were reported and there were 3 emergency admissions for vomiting ,diarrhea. No patient had to be shifted out for medical emergency to higher center. Conclusions: The level of toxicity in peripheral center matches that of standard toxicity levels reported in literature .It is feasible to safely manage chemotherapy at peripheral centers with training generalist and offering distant supervised care. For achieving universal health core goals, with extreme shortage of oncology personnel and services specially in in LMIC only such models appear to be feasible and practicable.
Time trends in the use of surgery for stage I non-small cell lung cancer (NSCLC) and the impact on population survival: Analysis from the Surveillance, Epidemiology, and End Results (SEER) Program.
Authors: Tran Krystel , Benjamin John , Woodford Katrina , Nardone Louise , Martin Catherine , Senthi Sashendra 
Published: September 2018

e18013 Background: Surgery is the standard of care treatment for stage I NSCLC. Improvements in surgical techiques and perioperative care over time are developed to facilitate surgery for more patients. We assessed the factors influencing the use of surgery, the interaction of these with time and the impact on population survival. Methods: Patients enrolled into SEER between 2004 and 2012, aged at least 18 years with a first malignant primary stage I NSCLC were retrospectively assessed. Patients diagnosed on the basis of autopsy or death certificate only were excluded.Time was catergorized into three periods; 2004-6, 2007-9 and 2010-12. Age, gender, marital status, race, geographic location and time were all considered exposure variables influencing surgical use and were adjusted for using logistic regression. Impact of variables with time was assessed using interaction terms between them. The impact of time on population survival was assessed using cox regression. Results: Sex, age, marital status, race, location and time all significantly influenced whether surgery was performed (all p < 0.001). The proportion undergoing sugery declined from 68.0% during 2004-6 to 62.7% during 2010-12 (adjusted HR 0.88, p < 0.001 between subsequent periods). Patients were less likely to have surgery with increasing age (adjusted HR 0.94 per year, p < 0.001) and if they were Black or Hispanic (adjusted HR 0.58, p < 0.001 and 0.87, p = 0.008 repectively) relative to Non-Hispanic Whites. There were significant differences with location. Relative to San-Fransisco-Oakland, the greatest adjusted differences were between Louisiana (HR 0.51, p < 0.001) and New Jersey (HR 1.57, p < 0.001). Age significantly interacted with time (p = 0.007). Surgical use declined from 75.5% during 2004-6 to 71.5% during 2010-12 when less than 75 years. For those older, the decline was greater, 55.3% to 46.5%. The risk of death declined with time (adjusted HR 0.94, p < 0.001 between periods). Conclusions: Since 2004, the use of surgery for stage I NSCLC has declined and done more so with increasing age. Despite this overall population survival has improved.
Predictors of survival in patients with gastrointestinal malignancies admitted to the intensive care unit.
Authors: Ko Heidi Chwan , Yan Melissa , Gupta Rohan , Song Juhee , Kebbel Kayla , Maiti Abhishek , Nates Joseph L. , Overman Michael J. 
Published: September 2018

e18050 Background: Cancer patients have a high use of healthcare utilization at the end of life which can frequently involve admissions to the intensive care unit (ICU). We sought to evaluate the predictors for outcome in gastrointestinal (GI) cancer patients admitted to the ICU for non-surgical conditions. Methods: The objective of this study was to determine the factors associated with ICU mortality, hospital mortality and overall survival (OS). A total of 200 patients with GI cancer admitted to the ICU at The University of Texas MD Anderson Cancer Center between November 2012 and February 2015 were retrospectively analyzed. Cancer characteristics, treatment characteristics, and Sequential Organ Failure Assessment (SOFA) scores defining severity based on 6 organ systems with scores ranging from 0 to 24 were analyzed for their effects on survival endpoints using multivariate logistic regression models and a multivariate Cox proportional hazards regression model. Results: The characteristics of the 200 patients were: 64.5% male, mean age of 60 years, median admission SOFA score of 6.0, and tumor types of primary intestinal (37.5%), hepatobiliary/pancreatic (36%), and gastroesophageal (GE) (24%). The ICU mortality was 26%, hospital mortality was 41%, and 6-month OS estimate was 25%. In multivariate analysis, ICU admission SOFA score > 10 (odds ratio (OR) 17.1, p < 0.0001), poorly differentiated tumor grade (OR 3.2, p = 0.02), and shorter duration of metastatic disease (OR 2.3, p = 0.07) were associated with increased odds of ICU mortality. These same variables were associated with increased odds of hospital mortality. In multivariate OS analysis, SOFA score 6-10 (hazard ratio (HR) 2.1, p = 0.0006) and SOFA score > 10 (HR 4.4, p < 0.0001), patients with GE primary (HR 2.2, p = 0.002) and patients with a poor outpatient performance status that precluded active chemotherapy (HR 2.2, p = 0.01) were associated with increased risk of death. Conclusions: The SOFA score was the most predictive factor for ICU mortality, hospital mortality, and OS for GI cancer patients admitted to the ICU. It should be utilized in all GI cancer patients upon ICU admission to improve both acute and longer-term prognostication.