bluuebunny/crossref_metadata_2025 huggingface dataset:
Decreased survival in cervical cancer patients with thromboembolic events
Authors: Jacobson G. M. , Goodheart M. , Smith B. , Lammli J.
Published: March 2020

16034

Background: We have previously reported on the incidence of thromboembolic events (TE) in cervical cancer patients treated with definitive chemoradiation.Patients with TE seemed to have decreased survival compared to those without TE. We reviewed a larger cohort to compare the survival of cervical cancer patients with and without TE. Materials and Methods: We performed a retrospective chart review of cervical cancer patients diagnosed and treated at the University for Iowa from January 1997 until December 2003. Data sources included the University of Iowa Tumor Registry, the Gynecologic Oncology Tumor Data Base, and the relevant ICD-9 codes to identify cervical carcinoma and types of TE in both inpatients and outpatients. Statistical analysis included the Pearson chi-squared test for categorical variable, and the two-sample t-test for continuous factors. Log-rank tests were used for survival analysis along with the generation of Kaplan-Meier survival curves. Multivariate analysis was performed with Cox proportional hazards regression. All tests are two sided and carried out at the 5% level of significance. Results: Three hundred and fifty nine (359) patients were treated with surgery or chemoradiation; thirty-six patients (10%) developed TE. There were significant associations between thromboembolic status and pelvic irradiation (p=0.0493), chemotherapy (p=0.0118), and stage (p=0.0197). Survival could not be estimated for patients not experiencing a thromboembolism; survival did not drop below 50% by the end of follow-up. Median survival time for patients with thromboembolism was 4.5 years. According to log-rank test, this difference was significant (p-value<0.0001). Conclusion: The incidence of thromboembolic events in this cohort of cervical cancer patients was 10%. TE was associated with a significant decrease in survival.

No significant financial relationships to disclose.
Improved survival for ovarian cancer patients stage IIIC treated at the Norwegian Radium Hospital between 1984 - 2001
Authors: Trope C. , Oksefjell H. , Sandstad B.
Published: March 2020

16044

Background: The aim of this study was to evaluate the treatment of FIGO stage IIIC patients who were primarily treated completely or partially at the Norwegian Radium Hospital (NRH) during a 15-year period in order to discover possibilities for improvement of prognosis of advanced ovarian cancer. Methods: A retrospective study based on record information from all patients with epithelial ovarian cancer stage IIIC treated at NRH 1985 - 2000, in total 776 patients. Results: We found age, amount of residual tumour after surgery for primary treatment and type of chemotherapy to be the most significant prognostic factors for overall survival. During the last 5-year period primary surgery was increasingly centralised, surgery was improved with lymph node staging and paclitaxel was used. Survival was significantly best during the last 5-year period and after macroscopically radical surgery. Also progression-free survival was best with no macroscopic tumour left. Conclusions: Improved survival during the last 5-year period is partly attributed to improved surgery, partly to the addition of paclitaxel. We believe that a further centralisation of primary surgery for advanced ovarian cancer can contribute towards a better prognosis.

No significant financial relationships to disclose.
Overexpression of the osteopontin correlates with the aggressiveness of endometrial cancer
Authors: Cho C. , Cha S. , Kwon S. , Kwon Y. , Kang S. , Lee J. , Kim K. , Yea J.
Published: March 2020

16048

Background: To test the hypothesis that expression of osteopontin (OPN), an integrin-binding glycoprotein, can independently predict the potential aggressiveness of endometrial cancer. Methods: The status of OPN expression in benign and malignant endometrial cancer cell lines and tissues was analyzed by real time PCR, Western blot, and immunohistochemistry. Nonparametric Spearman's correlation coefficient method was used to assess the statistical significance of the correlation between clinicopathologic characteristics of tumor and OPN expression. Results: An increased expression of OPN was observed in the endometrial cancer compared to normal endometrial tissue samples. When the level of OPN in normal tissue was set at 1, its level in benign endometrial hyperplasia was slightly increased at 1.2, whereas the OPN level in the highly malignant endometrial carcinoma tissue was greatly increased by nearly 3–5 folds. Amongst the 160 cases examined immunohistochemically, of the 43 grade 1 endometrial carcinomas, 31 were unstained and 12 stained weakly positive (+). For the 41 grade 3 or serous type endometrial carcinomas analyzed, 25 (60%) stained strongly positive (+++), 8 (19%) stained moderately positive (++) and 4 (9%) stained weakly positive (+). These results showed that the level of OPN expressed between grade 1 and grade 3 or more was significantly different (Spearman's correlation coefficient method, p = 0.001). However, Kaplan-Meier survival analysis showed that the increased level of OPN expression was not significantly associated with reduced survival time of the patients. Conclusion: The results suggest that the increased OPN level may be involved in the malignant transformation of endometrial adenocarcinoma cells.

No significant financial relationships to disclose.
The regulatory mechanism involved in paclitaxel-induced apoptosis: The role of ATF-3 on apoptosis in cervical cancer cell line (HeLa cell)
Authors: Kwon Y.
Published: March 2020

16052

Background: Paclitaxel, which is a potent anti-cancer drug and microtubule-binding agent, has been found to be effective against several tumors, including cervical cancer. However, the exact mechanism underlying the apoptotic effects of paclitaxel is poorly understood. Methods: We show that paclitaxel induces apoptosis, as demonstrated by DNA fragmentation, TUNEL assay, and flow cytometry analysis in cervical cancer HeLa cells, correlating with enhanced caspase-3 activation and p73 as well as p21, which are inhibited strongly by p73 siRNA. Results: The paclitaxel treatment followed by the overexpression of wild type ATF3 potentiated apoptosis is by enhancing p73 expression, but these events were attenuated in C-terminal deleted ATF3 or ATF3 siRNA-transfected cells. Interestingly, paclitaxel-induced ATF3 colocalizes with transfected GFP-p73 in nucleus, but not in p73 siRNA-transfected cells. Conversely, p73 may not affect ATF3 expression, as increase of ATF3 expression did not detect in p73-overexpressing cells. Furthermore, we observed that ATF3 binds to DNA binding domain of p73, confirmed by GST-pull down assay for ATF3. Additionally, ATF3 potentiates p21 gene, a downstream target of p73, promoter activity and p73-p21 binding activity induced by paclitaxel and also we have obtained similar data in the tissue of cervical cancer patient treated with paclitaxel. Conclusions: Collectively, these results demonstrate that overexpression of ATF3 potentiates paclitaxel-induced apoptosis in HeLa cells, at least in part, through stimulating the p73 expression and its transcriptional activity. ATF3 may function as a tumor-inhibiting factor by regulating directly p73 and may suggest a functional link between ATF3 and p73.

No significant financial relationships to disclose.
Endometrial stromal sarcomas: A retrospective analysis of 28 patients, single center experience for 20 years
Authors: Kim J. , Nam E. , Kim Y. , Kim J. , Kim S. , Kim S. , Yoon B.
Published: March 2020

16053

Background: Little is known about the pathogenesis, risk factors, optimal therapy or outcomes of endometrial stromal sarcoma (ESS). The aim of this study is to evaluate the behavior of ESS in relation to its clinical and pathogenic features and to find the better treatment strategy. Methods: A retrospective analysis was performed of 28 patients with histologically proven ESS treated at our institution between 1987 and 2006. Results: The median follow-up time was 54.7±63.1 months and 5-year survival rate was 82.0%. 16 (57.1%) patients were referred to our institution from private clinics for further treatment of the ESS. They were previously undergone either hysterectomy, myomectomy, or hysteroscopy for presumed benign gynecological conditions. 22 patients (81.5%) showed low grade and 5 patients (18.5%) showed high grade disease. A univariate analysis revealed that histologic grade according to mitotic count is associated with longer survival (p=0.004). However, among those with low grade tumor, 5/20 patients (25%) had recurrence and 2/21 (9.5%) had distant metastasis during the follow-up period. Except for 2 cases, 26 patients with ESS had hysterectomy for their primary treatment. Adjuvant treatment after surgery was performed in 14/26 cases (53.8%). Hormone therapy by progesterone, chemotherapy and/or radiotherapy individually did not influence the overall survival of the patients. However, postoperative adjuvant therapy group regardless of the treatment modality was associated with relatively increased overall survival when compared to the surgery only group (p=0.054). Conclusions: Differential diagnosis of ESS from other benign gynecologic diseases before surgery is a difficult problem. Furthermore, it is advised that postoperative adjuvant therapy should be performed after hysterectomy to prevent recurrence or distant metastasis.

No significant financial relationships to disclose.
Stromal reaction of adenomyosis protects from uterine endometrial cancer invasion to myometrium
Authors: Fujiwara H. , Nishisaka T. , Urabe T. , Miyoshi H. , Kudo Y.
Published: March 2020

16064

Background: It is unclear that stromal reaction plays role in endometrial cancer (Em Ca) invasion to uterine muscle with adenomyosis. Methods: One hundred and five patients with Em Ca (stage 0=38, 1a=18, 1b=26, 1c=10, 2b=3, 3a=4, 3c=5, 4a=1) received operative therapy with hysterectomy. Evaluation of stromal reaction using immunohistochemical method with alpha-smooth muscle actin and h-caldesmon antibody. In case of alpha-smooth muscle actin had immunoreactivity and h-caldesmon had not immunoreactivity, there was stromal reaction with myofibroblast. Evaluation of cell proliferation, using immunohistochemical method with epidermal growth factor receptor (EGFR) by global score with six degrees and MIB-1 by labeling Index (LI). Results: All cases had stromal reaction with myofibloblast in myometrial invasion area in forty nine cases with myometrial invasion equal or more than stage 1b. Em Ca invaded near to and in adenomyosis lesion in eleven cases. In stroma of adenomyosis without cancer invasion, EGFR was positive in one case (9%) and global score was two (average 0.18). In contrast, EGFR was positive in eight cases (73%) with Em Ca invasion to adenomyosis stroma and global score was from two to three (average 1.6). LI of MIB-1 was from 0 to 0.2 (average 0.05) in adenomyosis stroma without Em Ca invasion and 0.2 to 0.75 (average 0.41) with Em Ca invasion. Conclusions: When Em Ca invades to adenomyosis, myofibloblast cell proliferation in stromal reaction increases more than in adenomyosis without Em Ca invasion. Stromal reaction of adenomyosis plays role in protecting from Em Ca invasion to uterine muscle and it may contribute to being good prognosis compared with Em Ca without adenomyosis.

No significant financial relationships to disclose.
Correlation of serum CA125 levels with stage, grade and survival of patients with epithelial ovarian cancer
Authors: Osman N. , O'Leary N. , Higgins M. J. , Barrett N. , Wallis F. , Hickey K. , Gupta R. K.
Published: March 2020

16066

Background: Serum levels of the tumor marker CA125 and its relation to disease stage, grade, tumor volume, survival and prognosis have been studied with conflicting results. This study was conducted in a single center serving a population of 340,000. Methods: Newly diagnosed patients referred between Jan 1 2001 and Dec 31 2005 were included. Serum CA125 levels were recorded before and after optimal debulking surgery and before each cycle of chemotherapy. Patients received standard adjuvant or palliative chemotherapy. Disease was staged using the FIGO staging system. Tumors were graded by the Broders Classification. CT scan within 6 weeks of surgery was used to quantify residual disease. Disease status as of Dec 2006 was used for measurements of overall survival (OS). The relationships between preoperative CA125 and stage, grade and OS were retrospectively evaluated. Post surgical levels of CA125 were also analysed and correlated to the same parameters. The influence of age and bulk of residual disease on OS were also examined. Kaplan- Meier (univariate) analysis was applied for survival analysis and Spearman's method was used to study the correlation of CA125 and the multiple variables. Results: 91 newly diagnosed ovarian cancer referrals were received in the study period. This report is based on the 75 patients of this total group for whom full data was available. Length of follow up ranged from 2 to 71 months (median of 24, mean of 28.2 months). Preoperative CA125 level did not correlate significantly with stage, tumor grade or OS (p=0.08. p=0.113 and p=0.847 respectively). A strong correlation was seen however between postoperative CA125 level (recorded prior to commencement of chemotherapy) and stage, tumor grade and OS (p<0.0001, p<0.0001 and p<0.01respectively) OS for the total group was 37%, and OS for those with stage III and IV disease (n=43) was 17%. The mean age of the patients was 59.6 years. Older age at time of surgery (p=0.009) followed by bulk of residual disease (p=0.011) correlated strongly with shortened OS. Kaplan-Meier curves will be available for presentation. Conclusion: In our study, CA125 levels after optimal surgery correlated well with FIGO stage, tumor grade and overall survival. No correlation was seen with preoperative CA125 levels.

No significant financial relationships to disclose.
Cervical cancer patients’ preferences and use of various cancer information sources in South Korea
Authors: Noh H. , Lee M. , Yun Y. , Park S. , Bae D. , Nam J. , Park C. , Cho C. , Lee J. , Chang Y.
Published: March 2020

16073

Background: Accessing appropriate facts is important in enabling cancer patients cope with the disease. This study focused on the utilization and preferences of cancer information sources by cervical cancer patients in terms of ease in receiving and searching the available data. Methods: The study included 830 women over the age of 18 years treated for cervical cancer at six hospitals in South Korea between 1983 and 2004. All the participants provided written informed consent, and the Institutional Review Board of the National Cancer Center approved the protocol. A questionnaire addressed the patients’ use of and preferences for sources and forms of cancer information. Data were collected by mail. Results: Television and/or the radio were the the most frequently cited sources of cancer information by the middle and oldest age groups: 45–64 years (52.0%), =65 years (47.3%), while patients in the youngest age group (<45 years) used the Internet (38.8%). Booklets and/or pamphlets (24.0%) were the source of cancer information preferred by the youngest age group, while patients in the middle and oldest age groups preferred TV/radio: 45–64 years (35.7%) and =65 years (55.0%). Life notes and/or experiences (43.2%), that is, personal accounts, comprised the most easily understood form of information regardless of age group. Conclusions: Our findings indicate that cervical cancer patients’ utilization of and preferences for sources of cancer information vary according to patient age. Tailored educational materials that consider the users’ age and condition should be customized to best fit their specific preferences.

No significant financial relationships to disclose.
Phase II study of capecitabine in combination with cisplatin in advanced head and neck cancer: Preliminary results
Authors: Lorusso V. , Calvi N. , Ciccarese M. , Romano G. , Palumbo A. , Bonaduce S. , Santantonio M. , Latorre A.
Published: March 2020

16502

Background: The cisplatin-5-fluorouracil (5-FU) combination is the current standard of treatment in head and neck cancer. However, this regimen is not devoid of toxicity, and it is not confortable, because its administration requires a central vein access for the continuous infusion (c.i.) of 5-FU. Capecitabine is an oral fluoropyrimidine, whose activity, mimic of c.i. 5-FU, is well known in malignancies as colorectal cancer and breast cancer. We are investigating the efficacy and tolerability of cisplatin and capecitabine combination in advanced head and neck cancer. Methods: Patients (pts) with untreated metastatic, recurrent, or inoperable head and neck cancer were enrolled. Eligibility criteria were: squamous histology, age 18 to 75 yrs, at least one measurable lesion according to RECIST criteria, ECOG performance status </=2, normal laboratory values. Pts received capecitabine (2,000 mg/m(2)/day, days 1 to 14) and cisplatin (100 mg/m(2), day 1) every 3 weeks. Results: Since June 2004, 25 pts were enrolled: 22 were male and 3 female; median age was 56 yrs (46–79 yrs). Primitive sites of disease were: 9 pts (36%) laryngeal, 5 pts (20%) oropharyngeal, 2 pts (8%) hypopharingeal, 4 pts(16%) rhynopharingeal, and 5 pts (20%) oral cavity. Two pts with lymphonode recurrence of laryngeal carcinomas achieved a complete response (8%) and 10 pts (40%) had partial response. Stable disease was observed in 6 pts (24%), and 7 pts (28 %) had progressive disease. By the intent-to-treat analysis, the overall response rate was 48% (95% CI, 30–65). At a median follow-up of 9.5 months (4.8–26.1 months) median TTP was 3.5 months (95% CI, 1.3–5.8), and median OS was 12.4 months (95% CI, 6.3–18.5). A total of 99 cycles of chemotherapy was delivered with a median of 5 cycles per pt (range 1- 6). Grade 3 neutropenia, anemia, and thrombocytopenia, were observed in 17%, 13%, and 1% of cycles respectively. Grade 4 anemia was observed in 2 pts (8%). With regard to non hematological toxicity, grade 3–4 asthenia, nausea and vomiting, stomatitis, diarrhoea and PPD were observed in 12%, 12%, 8%, 4% and 4% of pts, respectively. Conclusions The combination regimen of capecitabine and cisplatin showed a good antitumor activity with mild toxicity in patients with advanced head and neck cancer.

No significant financial relationships to disclose.
Postoperative radiotherapy in head and neck squamous cell cancers: AIIMS experience
Authors: Malik M. , Puri T. , Mohanti B. K. , Rath G. K. , Julka P. K.
Published: March 2020

16514

Background: Squamous cell cancers of the head and neck are one of the most common malignancies in India. Most patients present in advanced stages of disease. Postoperative radiotherapy is generally an integral part of management in these patients. Methods: Patients of head and neck squamous cell cancers treated with surgery and postoperative radiotherapy at AIIMS between January 1999 to December 2004 were retrospectively analyzed. Results: A total of 386 patients were treated of which 281 were available for evaluation. There were 233 males and 48 females. Median age was 46 years (range 18–73). Site-wise distribution was: oral cavity- 202, larynx-55, hypopharynx-14, paranasal sinus-4, oropharynx-4, neck nodes with unknown primary-2. Post-surgical margins were adequate in 241, close in 5 (2%) and positive in 35 (12%). Pathological stage grouping was: Stage I- 11(4%), Stage II- 52 (18%), Stage III- 63(22%), Stage IV- 155 (55%). Neck node dissection was done in 245 patients and nodes were pathologically negative in 119 (42%). Extracapsular extension (ECE) was seen in 19(7%) patients. Bone/cartilage invasion was seen in 62(22%). Patients with high risk features (close/positive margins, ECE, 4/> positive nodes) were prescribed a dose of 64 Gy while the rest were planned to receive 60 Gy. 85% of patients completed the intended course of radiation. At a median follow up of 37 months, local recurrences were seen in 28 (10%), regional recurrence in 25 (9%) and distant metastasis in 10 (4%) patients. A second malignant neoplasm occurred in 6 patients (3-oropharynx, 2-oral cavity, 1-lung). Disease free survival (DFS) was 68%. ECE, post-surgical margin status and pathological lymph node status were significantly associated with DFS. Duration of postoperative radiotherapy and the surgery to radiotherapy interval did not significantly affect DFS. Conclusions: ECE, postsurgical margin status and pathological lymph node status significantly impact DFS in patients of surgically treated squamous cell cancers of head and neck. These patients require doses of adjuvant radiation >/=64 Gy.

No significant financial relationships to disclose.
Prognostic factors of concurrent chemo-radiotherapy in head and neck cancers
Authors: Thankappan K. , Rugmini S. V. , Cohen R. F. , Sunil B. , Samuel J. , Padmanabhan T. K. , Pavithran K. , Sundaram K. R. , Iyer S. , Kuriakose M. A.
Published: March 2020

16527

Background: Concurrent chemo-radiotherapy either as primary or adjuvant treatment is now the standard of care in high- risk head and neck squamous cell carcinomas. This has improved survival rates and chances of organ preservation. Advanced stage, extra- capsular extension, perineural and lympho-vascular invasion and positive surgical margins were considered as poor prognostic factors with radiotherapy alone. Herein we report the significance of these clinical and pathological factors, with concurrent chemo-radiotherapy regimens. Methods:A retrospective analysis of 54 patients with squamous cell carcinoma of head and neck who underwent either primary (21,39 %) or adjuvant (33,61%) concurrent chemoradiation at Amrita Institute of Medical Sciences, Kochi, India, during January 2004 to May 2005 and followed up to Dec 2006. 6 (11%) patients had stage III and 48 (89 %) had stage IV disease. Prognostic significance of clinical and pathological factors was evaluated. Kaplan-Meir curves for survival analysis, log rank test for univariate and Cox proportional method for multivariate analysis were employed. Results: The median follow up was 22 months. Two-year overall (OS) and disease free survival (DFS) rates were 66 % and 52 % respectively. Univariate and multivariate analysis of T stage, nodal stage, radiotherapy interruptions, completion of chemotherapy, schedule of chemotherapy (week 1,4,7 vs weekly), perineural invasion, extra-capsular extension and positive margins showed no significant difference in OS and DFS. However both univariate (p = 0.019 for OS and p = 0.012 for DFS) and multivariate analysis (p = 0.029, HR 0.16,95 %CI - 0.03 to 0.8 for OS and p = 0.017,HR 0.188,95% CI - 0.04 to 0.74 for DFS) revealed lympho-vascular invasion as a significant prognostic factor. Conclusions: Advanced stage, extra capsular invasion and positive margins were conventionally thought to be poor prognostic markers in head and neck cancer. However in our series of patients treated with concurrent chemo radiation lymphovascular invasion was the only significant poor prognostic factor. Other factors were found to be not significant.

No significant financial relationships to disclose.
Combined intra-arterial cisplatin, intravenous chemotherapy, and chemoradiotherapy is an effective program for treating advanced SCC of the head and neck: An analysis of 23 patients with a median follow-up of 6.1 years
Authors: O'Connor T. P. , Batra R. R. , Mobarek D. A. , Kirkel D. M. , Schwarsin A. , Sharma A. , Bank W. O. , Wilson W. R. , Tabbara I. A. , Siegel R. S.
Published: March 2020

16535

Background: Aggressive chemotherapy combined with radiation increases organ preservation and provides locoregional control in advanced head and neck (H&N) cancer. Intra-arterial (IA) cisplatin can provide higher dose intensity but does not control distant disease. We evaluated a program that consisted of intra-arterial and intravenous chemotherapy combined with chemoradiotherapy. Methods: The course of 23 patients treated with four weekly IA doses of cisplatin (150 mg/m2) with IV sodium thiosulfate rescue, then two cycles IV paclitaxel (175 mg/m2, day 1), ifosfamide (1,000 mg/m2 and mesna 600 mg/m2, days 1–3), and cisplatin (60 mg/m2, day 1) (TIP), and followed by radiation to 70 Gy combined with weekly paclitaxel (30 mg/m2) and amifostine (740 mg/m2 TIW) was analyzed. One patient received one cycle of cisplatin/5-FU and one cycle of TIP instead of 2 cycles of TIP. Endpoints were recurrence free survival (RFS) and overall survival (OS). Results: Of twenty-three patients, 20 were men. The median age was 57 years (range 45–70) and median follow-up was 6.1 years (range 4.1–7.9). Eighteen had long smoking histories. Seventeen completed treatment (74%). Of the 6 who did not complete the program, two had resistant tumors, one had an adverse reaction to IA therapy, and three were noncompliant. Of 23 patients, 14 are alive, 13 without evidence of disease recurrence; one patient recurred and was salvaged by surgery. Five patients recurred and died of metastatic H&N cancer. One patient recurred, was salvaged with surgery and later died of lung cancer without evidence of H&N cancer. The RFS is 56.5% and the OS is 60.8%. Adverse events were infrequent and included 1 patient who had facial swelling during IA therapy and 2 patients who developed osteonecrosis of the mandible, one while continuing to smoke 6 months after therapy and the other 3 years after therapy following tooth extraction. Conclusions: A program consisting four doses of intra-arterial cisplatin followed by two cycles of IV TIP and chemoradiotherapy is effective in treating locally advanced SCC of the H&N and was generally well tolerated.

No significant financial relationships to disclose.
Phase I/II study of concurrent erlotinib and chemoradiation for post-resected locally advanced squamous head and neck cancer (HNSCC): A GICOR study
Authors: Arias de la Vega F. , Herruzo I. , de las Heras M. , de la Torre A. , del Rio L. , Contreras J. , Prieto I. , Garcia J. A. , Amador M. L. , Calvo F. A.
Published: March 2020

16544

Background: Concurrent chemoradiation is considered the optimal treatment for advanced HNSCC, including post-resected status. Erlotinib is an oral EGFR TKI, with activity in recurrent and metastatic HNSCC.The Spanish Group of Clinical Research in Radiation Oncology (GICOR) leads a phase I/II study to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of adding erlotinib (e) to chemoradiation to patients (p) with surgically resected locally advanced HNSCC Methods: p had surgically resected advanced HNSCC, with a least one of the following criteria: T3 or T4 primary lesion (except T3N0 with negative resection margins), pathologic N2-N3 disease, and poor prognostic findings (i.e. extranodal spread, positive resection margins, perineural or perivascular involvement). Additional eligibility criteria included: age 18–70 y; life expectancy = 12 w; PS 0–1; no evidence of metastasis; adequate organic function; and written informed consent. Dose-escalating phase I study consisted on 3 cohorts of 3–6 p each, with increasing doses of erlotinib (100–150 mg po qd) and cisplatin (30–40 mg/m2, iv, d 1) for 7 w. Radiotherapy was delivered as a fixed standard regimen of daily 1.8 Gy (5 fractions/w) to a total dose of 63 Gy in high risk areas along 7 w. Results: By the time of this analysis, 7 p have entered the phase I component of the study. Median age: 52 y; male 100%. Complete data for 4 pats included in cohort 1 (e 100 mg/d, c 30 mg/m2) are available. One p withdrew prematurely the study due to a grade 2 toxicity (not considered DLT) and was considered unevaluable by the Scientific Committee. Among evaluable p, 2 developed mucositis (1g.3), vomiting (g.1) and nausea (g.1). All p developed skin rash (mild in all the cases). Haematological toxicities were single cases of anaemia, leukopenia and thrombocytopenia (g.1). All 3 p completed 7 weeks of treatment and no dose reduction was required. No DLT as per protocol has been described and study went subsequently further to cohort 2. Conclusions: This study demonstrates the safe addition of erlotinib to chemoradiotherapy in the treatment of this p population. Full data from the phase I study will be presented.

No significant financial relationships to disclose.
Chemotherapy for advanced and recurring basal cell carcinoma (BCC) with docetaxel and cisplatin
Authors: Buarque E. J.
Published: March 2020

16546

Background: Up to 85% of all BCC are localized in head and neck region and can usually be cured by surgery. The recurrent BCC (rBCC) may grow under normal skin and have a more agressive behaviour. Sometimes, when it is discovered could be unresectable or lead to a great deformity if removed. Methods: Between December 2000 and December 2003 we have treated 3 patients (pts), 2 male/1 female with invasive rBCC with osseous involvement in retro-orbital region, invasion of paranasal and ethmoidal sinus, nasal cavity and orbital bone. Medium size 7 cm. Two pts have already received radiotherapy (RXT) one and two years before. Therapy consisted of docetaxel 35 mg/m2 and cisplatin 25 mg/m2 D1,D8 and D15 with one or two weeks interval. Results: They achieved complete response at the 6th cycle and received more 3 cycles- total of nine cycles.The pt that not had RXT before, received 5000 cGy as consolidation. Reconstrutive surgery was not necessary and two pts recovered the vision of the affected eye. Toxicity was mild in all pts with no grade 3 or 4. All pts are in complete remission until now. Conclusions: Contrary to previous reports, advanced BCC is responsive to chemotherapy with a longlasting response even after RXT, improving the quality of life and perhaps survival of pts with rBCC.

No significant financial relationships to disclose.
Redefining evidence
Authors: Brouwers M.
Published: March 2020

17000

Background: In the last decade, the Program in Evidence-based Care (PEBC), the guideline initiative of the cancer system in Ontario, Canada, has evolved dramatically. In addition to providing recommendations to facilitate decisions of clinicians (clinical practice guidelines), PEBC reports provide recommendations to facilitate decisions regarding universal drug funding, resource allocation, models of care, and the organization of the cancer system. For many of these issues, there is little in terms of traditional evidence, regardless of study design. As such, extending and building upon traditional notions of evidence and methodologies to gather new kinds of evidence have been required. Methods and Results: The PEBC has evolved the way it which conceives of evidence, the methods used to assemble and appraise evidence, and the role of evidence in decision making. To this end, environmental scan and consensus methods, in addition to standard systematic review methodology, are employed. The environmental scan methodology we use includes systematic and transparent internet searches of, and/or direct inquires to, organizations in jurisdictions determined, a priori, to be generalizable to the Ontario experience. Here, evidence comes in the form of organizational reports, case studies and evaluation data. These methods continue to be refined and tested. The consensus methodology we use is a modified Delphi technique. To date, these methods have been applied to various topics including standards for diagnostic assessment programs, surgical oncology and systemic therapy models of care, patient education, multidisciplinary case conferences, patient safety, and treatment of rare diseases. Evaluations of these reports have been generally positive (approval rating range: 56% to 75%) but noticeably more varied than approval ratings of our clinical practice guidelines that have relied primarily on traditional systematic review methodology (approval ratings rarely below 80%). Conclusions: The PEBC's notions of evidence continue to evolve as does the refinement and testing of new methodologies. Through this evolution, we are now able to provide advice on issues we would otherwise be unable to using traditional methods only, while still remaining true to our core principles of being participatory, rigorous, systematic and transparent.

No significant financial relationships to disclose.
Performance in a Scottish cancer network (SCAN) against ASCO/NCCN clinical quality measures for breast and colorectal cancers
Authors: Dodds C. , Chetty U. , Wilson G. , Muir P. , Gregor A.
Published: March 2020

17001

Performance in a Scottish cancer network (SCAN) against ASCO/NCCN Clinical Quality Measures for breast and colorectal cancer. Background: South East Scotland Cancer Network (SCAN) aims to improve care, treatment, and equity for all cancer patients in the 1.4m population under its care ( www.scan.scot.nhs.uk ). Clinical care is delivered by multidisciplinary teams in 7 hospitals and one regional cancer centre. Key function of the network is prospective audit collecting externally validated information on evidence-based performance indicators. Method: Cohorts of 624 breast and 359 colorectal cancer patients diagnosed over a 12-month period in Lothian have been analysed against the ASCO/NCCN measures. Conclusions: SE Scotland Breast and Colorectal services compare favourably with the ASCO/NCCN standards of care on most measures. Use of radiotherapy in rectal cancer conforms to Scottish guidelines.

[Table: see text]

No significant financial relationships to disclose.
Reducing radiotherapy delays after surgery for breast cancer in five radiotherapy departments
Authors: Woynar S. P. , Burban P. , Le Prisé E. , Romestaing P. , Maylin C. , Mazeau V. , Cauterman M. , Vendrely V.
Published: March 2020

17011

Background: An interval superior to 8 weeks between surgery and radiotherapy increases the risk of recurrence for patients with early stage breast cancer treated with conservative surgery and breast irradiation and without chemotherapy. Five French radiotherapy departments launched simultaneously a quality improvement project aimed at reducing the delay to radiotherapy for all types of cancers concerned. Breast cancer radiotherapy delays were used as the principal proxy to evaluate overall progress. Methods: Teams focused their efforts on reducing the interval between the first appointment with the radio-oncologist and the start of the radiotherapy, interval on which they had control. Between May and December 2005, consultancy firms financed by the Ministry of Health, helped the teams (radio-oncologists, physicists, radiographers and nurses) to realize an organizational audit: identifying the processes of treatment, analysing the patient flow and the staff and equipment capacity. Concerning breast cancer, target intervals were set based on the 8 weeks standard. An action plan that included matching capacity and demand (better allocation of staff time during the week), standardising treatment processes and patient programming was implemented between January and December 2006. Results: The five radiotherapy departments reduced the delays to radiotherapy for breast cancers as well as for the majority of the other cancer types. Concerning breast cancer, the average of the five departments intervals between the first appointments and the start of the radiotherapy dropped from 4.9 weeks to 2.3 weeks, reducing in the same time the interval between surgery and radiotherapy. Furthermore, the teams’ cohesion, motivation and sense of responsibility increased, key elements for the sustainability of the improvements. These results were obtained without an increase of the departments resources. Conclusion: By redesigning their organisation with a patient centred goal, the five radiotherapy departments were able to meet the standards of practice. Following these results, ten new departments have joined the program financed by the Ministry of Health.

No significant financial relationships to disclose.
Improving breast cancer screening for indigent minorities: A county hospital cancer center's experience
Authors: O'Brien T. E. , Peacock A. , Stevenson J. T.
Published: March 2020

17020

Background: Indigent, minority women with breast cancer present with later stage disease, often because of lack of access to affordable screening tests. Breast exam and mammography are effective at early detection. A screening program targeting minority women is important, especially in an area with a high poverty rate. The most effective way to reach this population, though, has not been well established. Methods: From 11/03–7/05, 4 breast cancer screenings were performed at our cancer center which targeted poor, minority populations in the Cleveland area. Despite culturally appropriate advertisements and free exams by physicians, only 42 women were screened. To improve upon this, a bilingual community breast liaison was hired. An advisory council of community representatives was established which led to collaborations with over 100 neighborhood agencies. The venue for the screenings was changed to easily accessible locations (churches, shelters) and transportation was provided. Free clinical breast exams (CBE) were performed by experienced physicians and on-site mammograms (mam) were done. From 10/05–10/06, 7 community breast screenings were held. 403 women were screened and over 2000 were educated. Results: 98% were impoverished; 94% had an annual income of <$25,000. 78% had no health insurance. Median age=46 (range 35–89). 31% Latino; 46% AA; 16% Caucasian. Many pts had not had a mam (91%) or CBE (84%) within the past year; many never had either screening test before (31% never had a mam and 17% never had a CBE). The most common reason for this was lack of insurance (60%). “Too young” was the second most common reason (7%). Most common reason for coming to screenings: free services (49%). Of 403 pts screened, 27/371 had abnormalities on CBE and 26/293 mam were abnormal. Thus far, 2 cases of breast cancer have been diagnosed (stages I and II). Conclusion: Indigent minority women do not receive adequate breast cancer screening due to many barriers, including cost. To reduce this disparity, our center targeted this population. After adjusting our approach, screening attendance markedly improved, increasing from 42 to 403 pts screened. This improvement was due to cancer center services being brought out to the community and an active engagement of community organizations.

No significant financial relationships to disclose.
Evaluation of barriers to clinical trial enrollment through a novel pharmacy quality assurance tool
Authors: Vamos D. C. , Kane M. P. , Nishioka J. , Lisi S. , Neceskas J. R. , Rubin E. H. , Aisner J. , Shih W. , Todd M. , Goodin S.
Published: March 2020

17026

Background: Clinical trials offer the best treatment for patients with cancer, yet less than 5 percent of adults and less than 60 percent of children are enrolled on clinical trials. To determine reasons for lack of enrollment on clinical trials and to assess areas for potential trial development, we designed a ‘non-protocol’ form for use at our center. Our goal was to assess deficiencies in our menu of trials, identify other barriers to enrollment, and to indirectly increase awareness of trials. Methods: Completion of a ‘non-protocol’ form was required by the pharmacy with the first set of new chemotherapy orders for all Cancer Institute of New Jersey ambulatory patients who were not enrolled on a clinical trial. The form required completion of one of three areas for lack of enrollment: trial availability, reason for ineligibility, or other reason for not enrolling the patient. Results: From June 2003 through December 2005, 474 forms were collected for patients not enrolled on a clinical trial. The median age of patients not enrolled on trial was 56 years (range 1 to 88 years) and females outnumbered males (69% vs 31%). Lack of trial availability limited enrollment for 51% of patients (n=241) while administration of standard therapy was listed for 10 patients. Of those patients where a trial was available (n=223), 65% (n=145) of patients were not eligible, most commonly due to performance status (n=55). The remaining 78 patients refused participation. To determine if implementation of this pharmacy service changed the reasons for lack of enrollment, the data was evaluated by year: Conclusion: Lack of trial availability has been a rate-limiting factor in enrollment on clinical trials at our center. The data generated from the implementation of this novel pharmacy service is of strategic importance to the center. It is reviewed with the tumor-focused groups of the cancer center to identify areas for developing clinical trials.

[Table: see text]

No significant financial relationships to disclose.
An analysis of sentinel events after the implementation of a comprehensive information technology system for a new cancer center
Authors: Manno P. J. , Vogelzang N. , Sharma S. , Pomerantz A. , Fink L. , Halterman P. , Caramico S. , Faircloth R. , Murdock S.
Published: March 2020

17047

Background: The Nevada Cancer Institute (NVCI) is the cancer center for the state of NV conducting basic and clinical research and services in medical oncology, hematology, radiation oncology, laboratory medicine, pathology, and imaging. With the national mandate for electronic medical records (EMR), we focused on selecting a comprehensive EMR/IT system during the planning of the NVCI.. The goal was to have a seamless interface between clinical services and financial management, to maintain an extensive database of pt outcomes linked to demographics for future data mining. We hypothesized that an EMR would lead to improved safety and efficiency in patient care. Methods: Pt visits began 3/05 with paper records while EMR systems were being reviewed. Ultimately, IMPAC Medical Systems, Inc was selected. After extensive testing and re-configuration of an existing IMPAC system by the IT department and extensive training sessions, a rapid transition from paper records to a complete paperless environment occurred 9/05. As of 12/31/06, we have seen 1,271 patients. Since the care plans, lab interface and drug bar coding were in place by 4/06, we reviewed the interval of 4–12/06 for efficacy of charge capture, reduction in medication errors, the tracking of patients in ancillary services, the development of a 3 tier approval system for drug orders, and the voice recognition system for its efficiency in reducing transcription costs and turnaround time. Results: In that interval, we recorded 3617 patient visits in the medical oncology infusion center and 4766 in radiation oncology. There were 0 sentinel events. Only 2 medication errors were made which were attributed to human error but not related to the software itself. Conclusions: These safety data appear superior to comparable error rates in a paper environment.We appear to have enhanced pt safety, reduced the costs of lost revenue, increased access to the patient record and created an opportunity to analyze pt data on a longitudinal basis. We are increasing our future reporting by implementing the IMPAC Quantros Safety and Risk Management System.

No significant financial relationships to disclose.
Economic impact of hyponatremia in hospitalized patients with cancer
Authors: Callahan M. A. , Do H. T. , Caplan D. W. , Yoon-Flannery K. , Seifeldin R.
Published: March 2020

17053

Background: Hyponatremia, defined as a serum sodium concentration ([Na+]) =134 mEq/L, is a common electrolyte abnormality in hospitalized cancer patients that may be caused by the primary tumor or metastasis, diagnostic or therapeutic interventions, or a secondary complication. Hospital-acquired hyponatremia is associated with higher costs of care, but many patients present with hyponatremia at admission. Methods: This retrospective case-controlled study assessed the outcomes and cost of care among patients hospitalized for neoplasm who presented with hyponatremia at admission. Laboratory and cost-accounting data from 841 adult patients admitted to an 811-bed university hospital between January 2004 and May 2005 with a principal diagnosis of neoplasm and either mild-to- moderate or moderate-to-severe hyponatremia (serum [Na+] 130–134 mEq/L or <130 mEq/L, respectively) were compared with data from control subjects with matching ICD-9 codes and normal serum [Na+] (135–145 mEq/L) at admission during the same period. Endpoints included hospital length of stay (LOS), ICU admissions, in-hospital mortality, and total costs per admission. Results: Hyponatremia was evident in 18.9% of patients admitted for neoplasm. Patients with moderate-to-severe hyponatremia (n=192) and mild-to- moderate hyponatremia (n=649) demonstrated a significantly longer hospital LOS, higher ICU admission rate, higher in-hospital mortality, and higher median costs than control subjects (n=3610) (Table). These differences among groups remained significant after adjustments were made for age, race, sex, and comorbidity score. Conclusions: Cancer patients presenting with hyponatremia at admission have a longer hospital LOS and higher risk of death and cost of care than do cancer patients presenting without hyponatremia.

[Table: see text]

No significant financial relationships to disclose.
Symptom burden and survival outcome: 3 cycles versus 6 cycles of chemotherapy in advanced NSCLC
Authors: Wang X. S. , Lu C. , Shi Q. , Fariclough D. , Mobley G. , Palos L. , Mendoza T. , Cleeland C.
Published: March 2020

17054

Background: Improving survival and quality of life is the primary treatment goal for patient with advanced NSCLC receiving palliative chemotherapy. The optimal treatment duration remains to be determined, and there are few studies that examine longitudinal symptom burden in this population. Methods: We prospectively collected self-reported symptom data from advanced stage NSCLC patients receiving chemotherapy. Symptom data was collected weekly utilizing the MD Anderson Symptom Inventory (15 symptoms) pre chemotherapy until therapy discontinuation or up to 26 weeks. Principal components analysis of symptoms measures with a Varimax rotation were used to identify symptom clusters. A piecewise linear mixed-effect regression model was used to estimate the changes over time in symptom severity, and Cox modeling was used for data analysis. Results: Data from 102 subjects were available for analysis. Chemotherapy was primarily discontinued because of tumor progression or a decline in the patient's functional status. Seventy patients received only 2 cycles of chemotherapy, while 46 and 29 patients received 4 and 6 cycles of chemotherapy, respectively. Four clusters of symptoms were identified prior to therapy, including: general symptoms (such as pain, fatigue, sleeping disturbance), GI distress (nausea, vomiting, lack of appetite & constipation), affective symptoms (sadness & distress) and specific disease related symptoms (coughing & shortness of breath). In patients who received = 3 cycles of chemotherapy, a rapid increased in symptom severity was observed, compared to those who received > 3 cycles (P<.05). Patients who received =3 cycles of chemotherapy demonstrated shorter survival compared to those who received > 3 of chemotherapy (HR=9.9, CI=4–22.7, P<.001). Conclusion: Patients with advanced NSCLC who received more than 3 cycles of chemotherapy demonstrated more stable symptom burden and longer survival compared to those who received = 3 cycles of chemotherapy.

No significant financial relationships to disclose.