bluuebunny/crossref_metadata_2025_split huggingface dataset:
Comparison of serum CYFRA 21-1 and ROMA in distinguishing ovarian cancer from benign pelvic masses.
Authors: Li Zhong-Qian , Smalley Robert J , Glover Curtis L , Raju Savitha , Falcone Katherine , Fegely Maryellen , He Kuanglin , Radwan Rachel R , Kettlety Timothy R 
Published: March 2020

e15565 Background: CYFRA 21-1 is a known lung cancer biomarker. In subjects with ovarian cancer (OC) versus those with benign gynecological diseases, serum CYFRA 21-1 was reported sensitivities (SN) of 44% and 41% at specificity (SP) of 95% for OC detection using an ELISA assay by Hasholzner U (1994) and Tempfer C (1998), respectively. Nolen B (2010) reported a SN of 84.1% and 85.8% and a SP of 85% and 79.3% with a combination of CYFRA 21-1, CA 125 and HE4 using a multiplex bead-based immunoassay in a training and validation set, respectively. We carried out a cohort study to evaluate the serum CYFRA 21-1 as an ovarian cancer biomarker and compared it with ROMA (Risk of Ovarian Malignancy Algorithm), an FDA-cleared ovarian cancer algorithm. Methods: ARCHITECT CYFRA 21-1 assay was used to measure the levels of serum CYFRA 21-1. Single point serum samples from 170 female subjects with a pelvic mass were randomly selected from an archive cohort of female subjects. Among the 170 subjects, 47 had OC (42 with epithelial OC and 5 with low malignant potential tumor) and 123 with benign gynecological diseases. ROMA values were obtained with HE4 EIA and ARCHITECT CA 125 II. Results: For ARCHITECT CYFRA 21-1, the ROC-AUC, cut-off, SN, SP, PPV and NPV were 86%, 1.8 ng/mL, 70.2% (95% CI: 55.1% to 82.7%), 95.1% (95% CI: 89.7% to 98.2%), 84.6% and 89.3%, repectively. For ROMA algorithm, the ROC-AUC, cut-off, SN, SP, PPV and NPV were 92%, 2.44, 89.4% (95% CI: 76.9% to 96.5%), 84.6% (95% CI: 76.9% to 90.4%), 68.9% and 95.4%, repectively. Chi-square test showed an SN for ROMA was significantly higher than that of ARCHITECT CYFRA 21-1 (p < 0.05), and SP for ARCHITECT CYFRA 21-1 was significantly higher than that of ROMA (p < 0.01). Conclusions: In distinguishing OC from benign gynecological diseases, ROMA algorithm appears to be more sensitive than serum ARCHITECT CYFRA 21-1 (p < 0.05), and serum ARCHITECT CYFRA 21-1 appears to be more specific than (p < 0.01) in this cohort study.
Neoadjuvant chemotherapy for locally advanced cervical cancer: Experience at the Instituto Oncologico Nacional SOLCA Guayaquil.
Authors: Paulson Guillermo , Garcia Katherine , Santacruz Mayra , Engracia Ruth Ginger , Mendoza Jose Francisco 
Published: March 2020

e15571 Background: Cervical cancer is the most common malignancy of women in Ecuador. The main problem of concomitant chemo-radiotherapy (CRT) is the delay in starting radiation therapy, economic and logistical problems for high demand in radiotherapy. It has been neoadjuvant chemotherapy (NACT) followed by CRT the main treatment at our center in order to find an alternative to long waits before the start of radiotherapy. The aim of this study was to determine the response to NACT followed by CRT in terms progression-free survival (PFS) and overall survival (OS). Methods: diagnosed with invasive cervical cancer locally advanced stage II-III were analyzed retrospectively reviewed clinical records of pre-existing data from 2008 to 2010. Results: after meeting the criteria of exclusion, leaving 116 cases. The median age: 49 years (range: 28-82 years). The histology was 73% (85) squamous cell carcinoma, 26% (30) adenocarcinoma and 0.9% (1) not specified. Patients with stage IIB: 81.9% (95), IIIA: 10.3% (12), IIIB: 7.8% (9). Of the 116 patients 69% (80) received NACT. The main NACT was paclitaxel 175mg/m2 + Cisplatin 75mg/m2 every 3 weeks 63.8% (74), the remaining group received another protocol, the median number of cycles of NACT was 5 (1 - 8 cycles), the start of radiotherapy since the conclusion of NACT was 53 days on average (1 to 285 days) and the main regimen of CRT concomitant was cisplatin 40mg/m2 weekly 47.5% (38). In the 49 patients who underwent NACT followed by CRT, a radiological study showed, complete response (CR) 38.8% (19), 18.4% partial response (PR) (9), disease progression (DP) 12.2% (6), stable disease (SD) 8.2% (4) and the end of treatment evaluation gynecological was performed and CR was obtained in 59.2% (29). Persistent or progressive disease after treatment was 22.4% (11), recurrence was 12.2% (6), local recurrence 2.0% (1), distant metastasis 10.2% (5). OS of NACT followed by CRT was 93.9% (46) and PFS was 65.3% (32), OS after CR was 96% (25 / 1) and then 91.7% PR (24 / 2) with p: 0.439. Conclusions: NACT followed by CRT is a valid option because it improves disease-related symptoms, but OS did not improve significantly even after CR.
Retrospective analysis of stage IC uterine cancer patients: A single center experience.
Authors: Kucukoztas Nadire , Yalcin Selim , Rahatli Samed , Ozen Ozlem , Haberal Nihan , Tarhan Cagla , Dursun Polat , Dizdar Omer , Yildiz Ferah , Altundag Ozden , Ayhan Ali 
Published: March 2020

e15573 Background: Stage IC patients are at an increased risk of recurrence and overall worse prognosis compared with stage IA and IB patients. Adjuvant chemoherapy is utilized based on specific pathologic factors. The objective of this study is to evaluate treatment outcomes at a single institution in patients with 1988 FIGO stage IC endometrial adenocarcinoma. Methods: Records of the patients with FIGO stage IB (formerly IC) endometrial cancer were retrospectively evaluated. All patients were initially treated surgically with comprehensive staging lymphadenectomy. Results: A total of 85 patients were included. Patient and tumor characteristics are shown in the table. Median age of the patients was 60 (range 27-95). Fifty-nine patients had at least one co-morbid disease. Complete surgical staging including pelvic and paraaortic lymph node dissection was performed in all the patients. Sixteen patients (19%) received adjuvant chemotherapy, including 6 patients with serous cancer and one patient with small cell cancer. Paclitaxel/carboplatin was the preferred regimen in Median follow up was 30 months (range 10-61 months). Seven patients (8%) relapsed and 4 patients (5%) died on follow up. 5 year disease free survival was 89% and overall survival was 95%. One of the 16 patients (6.2%) who received chemotherapy and 6 of the 69 patients (8.7%) who did not receive relapsed/died on follow up. Survival analysis was not performed because of the low number of events in both groups. Conclusions: We found similar rates of recurrence and death with previous studies in stage IC endometrial cancer. Complete surgical staging is the mainstay of treatment. Marginally lower recurrence rate in chemotherapy treated patients delineate the need for prospective randomized data addressing the role of adjuvant systemic therapy in early-stage patients with endometrial adenocarcinoma. [Table: see text]
Effects of weekly bevacizumab and gemcitabine/oxaliplatin with or without dasatinib on heavily pretreated patients with recurrent or persistent cervical cancer.
Authors: Takano Masashi , Kikuchi Yoshihiro , Ikeda Yuji , Sasaki Naoki , Goto Tomoko , Kouta Hiroko , Kikuchi Ryoko , Kudoh Kazuya , Kita Tsunekazu , Furuya Kenichi 
Published: March 2020

e15579 Background: Prognoses of patients with recurrent and metastatic cervical cancer who received treatment including radiotherapy are commonly dismal. In such clinical settings effective treatment modalities are waited. Thus, we attempted to explore effects of weekly bevacizumab (B) and gemcitabine/oxaliplatin (GEMOX) with or without dasatinib (D). Methods: Ten cases with recurrent and metastatic CC after intensive treatment including radiotherapy were treated by weekly B (2mg/kg) and GEM (300mg/m2)/ OX (30mg/m2) with or without D (50mg/day) (3 weeks, one week rest) with written informed consents. The treatment was continued until development of progressive disease (PD) or unmanageable adverse effects. Adverse effects were analyzed according to NCI-CTCAE v3. The responses were evaluated by RECIST criteria. Results: In RECIST evaluation, one (10%) of 10 patients had complete remission (CR) and 4 (40%) had partial remission (PR). Overall response rate was 50%, and response was observed in four (80%) of 5 cases combined with D, and 1 (20%) of 5 patients without D. It is noteworthy that response was observed in 3 (60%) of 5 adenocarcinoma patients. Median progression-free survival (PFS) and overall survival (OS) were 6 months and 13 months, respectively. Hematological adverse effects more than grade 1 were not observed. Neurotoxicity, nasal bleeding, and general fatigue were frequently observed, but these were all grade 1. There was no toxicity-related death, and the regimen was well tolerated. Conclusions: The present preliminary study demonstrated weekly B and GEMOX with or without D was effective in heavily pretreated cervical cancer patients with tolerable toxicities, especially in patients with adenocarcinoma. These results warrant further study in such clinical settings.
Concurrent chemoradiotherapy using carboplatin/cetuximab regimen in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) not eligible for high-dose cisplatin (HD-DDP).
Authors: Saigal Kunal , Warsch Sean , Mandalia Amar , Samuels Michael , Tolba Khaled A. , Ikpeazu Chukwuemeka , Kwon Deukwoo , Santos Edgardo S. 
Published: March 2020

e16001 Background: Cetuximab (Cx) + radiation therapy (RT) is well tolerated and has improved survival in patients (pts) with LA-HNSCC. However, its efficacy when compared to HD-DDP + RT has been questioned. At our institution, low-dose weekly carboplatin (Carbo) is added to Cx + RT for pts unsuitable for HD-DDP. Methods: We reviewed records of 16 pts with LA-HNSCC treated with definitive Cx + Carbo + RT at the University of Miami from 2007-2011. Median follow-up was 9.4 months (range: 1-50 months). Results: Median age: 71.5 years (range: 57-90 years); 15 male, 1 female.ECOG PS 0=15, 1=1. TNM staging was: T1= 1, T2= 5, T3=8, T4=2; N stage: N0=8, N1=5, N2a=2, N2b=1. All pts received weekly Carbo (AUC 1.5-2), Cx given conventionally and daily conventionally-fractionated RT. Median total weeks of concurrent systemic therapy= 7 (range: 3-8 weeks). RT was delivered to a median total dose of 70 Gy (range 30-74 Gy). Of the 15 evaluable pts, there were: 12 CR, 2 PR, and 1 PD. There were 2 local in-field failures, 1 regional failure, and 3 distant failures. At last follow-up, 11/16 pts remained with NED. 3-year locoregional recurrence was 29.5% (95% CI: 5.3%-45.9%). Toxicity (NCI-CTCAE v4.0): Mean percentage of weight loss was 14% (range: 6-26%). Two pts required systemic therapy dose-reduction. Three pts experienced a treatment delay and 3 did not finish RT as planned including one pt who received only 30Gy due to death secondary to MI during treatment. Conclusions: In this small retrospective series, Carbo/Cx/RT was well-tolerated and efficacious in pts unsuitable for HD-DDP having LA-HNSCC. Acute toxicities were similar to Cx + RT, likely due to the non-overlapping toxicity profiles of the two systemic agents. We hypothesize that the addition of a well-tolerated cytotoxic chemotherapy agent may improve the therapeutic ratio of Cx + RT in pts who are poor candidates for more aggressive therapies and warrants evaluation in a prospective manner. [Table: see text]
Docetaxel (T), cisplatin (P), and TP 5-fluorouracil (F) with or without cetuximab in head and neck squamous cell carcinoma (HNSCC): Simulation of ex vivo results in the FLAVINO-assay.
Authors: Dietz Andreas , Boehm Andreas , Niederwieser Dietger , Wichmann Gunnar 
Published: March 2020

e16016 Background: Individual response evaluation in head and neck squamous cell carcinomas (HNSCC) would be welcome for better biology-based decision making since therapy strategies like concurrent radio-chemo and induction-chemo (IC) compete with surgery e.g. of resectable advanced HNSCC. However, inter-individual differences in response to mixtures of chemotherapeutics and biologicals are not exactly known even in guideline-conform treatments. The purpose was to analyze combined effects of T, P, F, and cetuximab (E) on colony formation (CF) of HNSCC in the FLAVINO assay and the comparison with the clinical response to IC. Methods: Before starting IC, biopsies were taken, collagenase-digested and exposed to T and/or P at quarter, half, and exact their tolerable plasma (TPL) levels (6.6 and 0.55 µM) in presence or absence of F (1.5 µM)±E, and controls. To facilitate counting of colonies formed within 72h, epithelial cells were stained by Cy2-labeled pan-cytokeratin antibodies. The 28-d response to the first cycle of IC (reduction in surface and volume of the primary) was compared with CF. Results: Poorest response to IC was observed in patients with HNSCC unable to form epithelial colonies (13/36). Of the 63.9% ex vivo growing HNSCC, 34.8% (8/23) and 8.7% (2/27) responded to C and T in concentrations ≤TPL with completely inhibited CF. This rate was increased in presence of E. 22/23 (95.6%) HNSCC formed >4 epithelial colonies and allowed for IC50 calculation. TP+E and TPF+E proved to be more effective than binary combinations. Combined with increasing doses of P, the IC50 of T decreased and indicated superiority compared to treatment with T in binary combination with F. We found a high correlation of ex vivo and in vivo response of HNSCC. Conclusions: Complete suppression of CF and failure to form colonies ex vivo best predicted responsiveness or resistance to IC. Despite mostly additive or synergistic effects of TP and TPF ex vivo, identification of HNSCC probably failing to benefit from IC prior to starting therapy could reduce the risk of choosing inappropriate treatment modalities for HNSCC.
Distant metastasis in head and neck cancer: Baseline factors.
Authors: Krishnatry Rahul , Gupta Tejpal , Murthy Vedang , Nair Sudhir Vasudevan , Nair Deepa , Chaturvedi Pankaj , Dcruz A. K. , Prabhash Kumar , Ghosh Sarbani Laskar , Budrukkar Ashwini Narsingrao , Agarwal Jaiprakash 
Published: March 2020

e16021 Background: Loco-regional relapse is predominant pattern of failure in locally advanced head & neck squamous cell cancer (HNSCC). Distant metastasis (DM) is increasingly detected on follow-up. this study attempts to identify baseline patient, tumor & treatment characteristics which determine poor survival in radically treated HNSCC patients developing DM. Methods: Clinical outcome audit of HNSCC receiving radical treatment from 1990-2010 in a single HNCC radiotherapy (RT) clinic who developed DM, using electronic search of a prospectively maintained database. The Disease free survival (DFS) & overall survival (OS) were calculated using Kaplan Meier method. The Log rank test & Cox regression (p< 0.05 significant) were used for univariate & multivariate analysis respectively. Results: 104 HNC patients developed DM, baseline characteristics are shown in table 1. DM was detected at a median of 7(IQR 3-14) months from treatment completion & median survival after diagnosis of DM was 2.6 (0-6) months. The median DFS & OS were 19(13-26), 21.5(16-29) months respectively. On univariate analysis, factors affecting DFS & OS were advanced tumor and nodal stage, perinodal extension & treatment factors (surgery & RT gap >30 days). On multivariate analysis stage and PNE remained significant for DFS while only stage showed significance for OS. Conclusions: Locally advanced stage of presentation (stage IV, T4, N2+) is the most important baseline factor determining poor outcome in HNC patients developing DM. Trials for aggressive primary systemic treatment (chemotherapy, targeted agents) are needed. [Table: see text]
Phase I pilot study of oxaliplatin, infusional 5-FU, and cetuximab in recurrent or metastatic head and neck cancer.
Authors: Dalal Jay S. , Greene Joshua B. , Hofmeister Craig C. , Clark Ann Lau , Clark Joseph 
Published: March 2020

e16027 Background: Platinum-based chemotherapy including cisplatin, 5-fluorouracil (5-FU), and the EGFR-directed monoclonal antibody cetuximab, are active in the treatment of head and neck squamous cell carcinoma (HNSCC). Patients with inoperable recurrent or metastatic HNSCC have a poor prognosis and many have difficulty tolerating cisplatin-based regimens. Oxalipatin, a third-generation platinum derivative, has demonstrated antitumor activity and lacks many of the limiting side effects of cisplatin. We conducted a phase I pilot study to investigate the dose-limitation of oxaliplatin in addition to infusional 5-FU and cetuximab in patients with untreated recurrent or metastatic HNSCC. Methods: The planned dose escalation schedule included: dose level 1: oxaliplatin 100mg/m2 day 1, 5-FU CIV 750mg/m2 over 96 hours beginning day 1, and cetuximab 400mg/m2 cycle 1, day 1 (and 250mg/m2 weekly thereafter) on a 21-day cycle. Dose level 2: oxaliplatin 130mg/m2 day 1, 5-FU CIV 1000mg/m2 over 96 hours beginning day 1 and the same dose and schedule of cetuximab. Results: A total of 10 patients were accrued, consisting of 4 females and 6 males. The first seven were enrolled onto dose level 1 and the following three onto dose level 2. Dose level 1 was tolerated well with acceptable toxicity, including grade 1-2 oral mucositis, grade 1-2 fatigue, grade 1-2 acneiform rash, grade 1 nausea, grade 1-2 anemia and grade 1 transaminitis. All responses observed, (1 MR, 1 PR, 1 CR), were short-lived. Dose level 2 was more toxic than anticipated; 2 of 3 patients experienced grade 4 toxicities (mucositis, diarrhea, acute renal failure) requiring hospitalization with a treatment-related death in one of these patients. The phase I portion of the trial was therefore closed and dose level 1 is considered the maximum tolerated dose. Conclusions: The regimen of oxaliplatin 100mg/m2 day 1, infusional 5-FU 750mg/m2 over 96 hours beginning day 1, and cetuximab 400mg/m2 cycle 1, day 1 (with 250mg/m2 weekly thereafter), given on a 21-day cycle, has manageable toxicity; these doses are recommended for phase II evaluation in the treatment of unresectable or metastatic HNSCC.
Retrospective analysis of the use of cetuximab (CTX) and paclitaxel (PTX) combination in recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).
Authors: Soria Rivas Ainara , Rodriguez Garrote Mercedes , Olmedo Garcia Maria Eugenia , López Maria , Garrido López Pilar , Carrato Alfredo 
Published: March 2020

e16029 Background: Combination of platinum/5-FU and cetuximab is a 1st line standard treatment approach for R/M SCCHN. Results of a phase II study (Ann Oncol Aug 23, 2011) have shown an encouraging activity and tolerability of the combination of CTX and weekly PTX in this setting suggesting an alternative for unfit patients (pts) or when platinum-based chemotherapy is contraindicated. Methods: A retrospective analysis of our database was performed to evaluate outcomes in pts with R/M SSCHN who were treated under compassionate use with weekly PTX (80 mg/m2 IV) and CTX (initially 400 mg/m2 followed by 250 mg/m2) until progression or intolerance in a single institution in Madrid (Spain) between November, 2008 and July, 2011. Results: 16 pts were included (73% male) with a mean age of 58 years. Mainly squamous carcinomas: pharynx (7), larynx (2), tonsil (2), tongue (3), paranasal sinuses (1) and cavum lymphoepithelioma (1). Twenty percent of the pts received this treatment in 1st line; 67% in 2nd line treatment and only 2 pts received it as 3rd line treatment. Out of those who received PTX-CTX as 2nd or 3rd line treatment, 40% had received CTX as part of the 1st line treatment. Pts received a median of 13.87 cycles. All pts were evaluable for response and toxicity. Disease control rate was 47% (7% CR, 27% PR and 13% SD). With a median follow up of 10.3 months the median PFS was 4.7 months. PFS was 5.2 months for 1st line and 4 months for 2nd line after CTX. Acne-like rash appeared in 100% of the pts. It was G 1-2 in 87% of the pts and G 4 only in one patient, forcing to discontinue CTX. Main related toxicities (G 2-3) were diarrhea (13.34%) and hand-foot syndrome (13.33%). Hematological toxicity was mild, more remarkable in 3rd line treatment, and being managed with dose delays and, in two cases, with a 20% reduction of the PTX dose. Conclusions: The combination of cetuximab and weekly paclitaxel was active, well tolerated and manageable. It may be a first-line option for pts with poor performance status or non eligible for platinum as well as second line treatment for those who have failed first line platinum +/- cetuximab containing chemotherapy.
Functional organ preservation in larynx cancer: Correlation with baseline clinical and pathological features.
Authors: de Miguel Luken Maria Jose , Diaz Pena Elena , Chaves-Conde Manuel , de Miguel Luken Veronica , Chinchon Espino David , Carnero Moya Amancio , Pachon Ibanez Jeronimo , Menoyo Bueno Alicia , Paz-Ares Luis 
Published: March 2020

e16037 Background: Functional organ preservation in larynx cancer has become a treatment quality aim. The goal of our study was to evaluate the potential association between clinical and pathological features and functional larynx preservation (FLP). Methods: Clinical and pathological features were registered from 43 consecutive patients who were diagnosed of squamous cell larynx cancer between Feb 2008 and Sep 2011 and were candidates to organ preservation approaches: surgery (1), radiotherapy (10), chemo/bioradiotherapy (26) or chemo/bioradiotherapy following induction chemotherapy (6). Kaplan Meier procedure was used to estimate FLP and OS. Log-rank test and Cox proportional hazards regression were performed to assess prognostic factors for FLP. Results: Median age was 62 years (23% >70 years). Former smokers 28% and alcohol consumers 70%. Most of the tumors were supraglottic (63% supraglottic/35% glottic/2% subglottic), T3 (T4 9%/T3 67%/T2 19%/T1 5%), N0 (N0 74%/N+ 26%), well/moderated differentiated histologic grade (HG) (I 23%/II 49%/III 14%) and stage III or IV (I 2%/II 16%/III 58%/IVA 23%). 33% required pretreatment tracheostomy. At the time of the analysis, with a median follow-up of 21 months, 7(16%) deaths and 18(42%) recurrences had occurred. The cumulative proportion of patients with larynx preservation at 2 years was 48%, and the median FLP survival was 21 months (CI 95%: 10.5-31.5). The most common cause of FLP failure was recurrence, that required salvage laryngectomy in 77% of cases. The following features were found to have a significant negative impact on FLP: T4 (HR: 9.04), former smoker (HR: 2.45), N+ (HR 1.36) and stage IV (HR: 2.44). Other factors such as tumor location, age, alcohol consumption, HG and pretreatment tracheostomy were not significant. Conclusions: The most relevant risk factors for FLP in our analysis were T4 stage, lymph node status, former smoker status and stage IVA. Therefore, patients presenting these features would not be optimal candidates for organ preservation approaches. Correlation of these prognostic factors with predictive biomarkers for specific treatments is warranted.