bluuebunny/crossref_metadata_2025 huggingface dataset:
Termination of intraperitoneal chemotherapy is driven by treatment toxicity rather than catheter dysfunction
Authors: Edwards R. P. , Richard S. D. , Krivak T. C. , Zorn K. K. , Sukumvanich P. , Kelley J. L.
Published: March 2020

16054

Background: Three separate studies have shown increased survival for women with epithelial ovarian carcinoma treated with intraperitoneal (IP) chemotherapy. Barriers to its use have included toxicity concerns. We compared the morbidity associated with IP cisplatin- based chemotherapy and IP immunologic therapies. Methods: A retrospective cohort analysis of patients diagnosed with epithelial ovarian carcinoma treated with IP chemotherapy at a single institution from 1996–2006 was performed. Patients were separated into those who received IP Interleukin-2 or Interleukin-12 and those who received cisplatin-based IP chemotherapy. Primary endpoint was completion of the intended treatments. Complications arising from the placement or use of the catheter were deemed catheter-related and included obstruction of flow or catheter site infection. Those felt to be caused by treatment toxicity (e.g. nausea, pain, fever) or progression of disease were deemed treatment-related. Chi square test was used for all univariate analysis. Results: Seventy-five patients were identified. Thirty-five (46.6%) received IL-2 or IL-12, while 40 (53.4%) received cisplatin-based chemotherapy. There were 16 complications that led to treatment termination (21.3%). Immunologic therapy had an increased frequency of early termination (n=13, 37.1%) compared to cisplatin-based therapy (n=3, 7.5%) (p=0.002). There were 3 (8.6%) catheter-related complications in the immunologic group and 2 (5%) in the cisplatin-based group (p=0.54). Reasons for termination of therapy in the immunologic therapy group were progression of disease (n=5), catheter site infection (n=3), grade 3/4 nausea (n=3), and grade 3/4 abdominal pain (n=2). In the cisplatin therapy group, reasons for termination included catheter site infection (n=1), catheter site leak (n=1), and progression of disease (n=1). Conclusion: Local-regional immunotherapy produces significantly more complications and local symptoms than cisplatin-based regimens. Catheter complications were not significantly different between the two groups, and accounted for a small percentage of the treatment terminations in this series.

No significant financial relationships to disclose.
The target genes research for diagnosis, therapy and prognosis in cases with ovarian cancer
Authors: Bakhidze E. V. , Malek A. V. , Belyaeva A. V.
Published: March 2020

16060

Background: Epithelial ovarian cancer has one of the worst prognoses among gynecologic malignancies. Molecular genetic analyses of ovarian cancers have uncovered genetic alterations of several genes. Normal tissues were readily distinguished from tumor tissues. These studies identified several genes, such as High mobility group A2 (HMG A2) proteins. The expression of HMG A2 gene is detected in foetal stage of human development and stopped in normal adult tissues. Elevation of the HMG A2 gene expression was shown for several human malignant tumours. Targeted supression of HMG A2 protein synthesis can be one of important directions for anti-tumour therapy in cases of ovarian cancer Methods: The HMG A2 gene expression was searched in 48 flash-frozen samples of ovarian serous papillary adenocarcinoma and 12 samples of normal ovarian tissue. The HMG A2 gene expression was investigated by RNA in situ hybridisation. Results: High and middle level of HMG A2 gene expression was shown in 37 from 48 (77%) ovarian cancer samples. HMG A2 mRNA was not detected in normal ovarian surface epithelium. Low grade tumour differentiation (G3) was detected in 24 cases from 37 (64,9%), middle differentiation (G2) was detected in 12 cases (32,4%) and high grade differentiation (G1) was detected in 1 case (2,7%). Conclusions: HMG A2 high expression is a typical and important feature of serouse type of ovarian carcinoma. High level of HMG A2 gene expression correlate with low grade tumour differentiation.

No significant financial relationships to disclose.
Phase II pilot study of biweekly cisplatin and gemcitabine in multi-refractory ovarian cancer
Authors: Sutton G. , Fisher W. , Rivers S.
Published: March 2020

16065

Background: Preclinical data suggest the combination of cisplatin and gemcitabine may have synergy in inhibiting ovarian cancer growth in vitro. Clinical trials in breast cancer support the use of biweekly gemcitabine. A pilot trial of biweekly cisplatin and gemcitabine in multi-refractory ovarian cancer was undertaken. Methods: This was a single-stage phase II pilot trial. Eligible patients had platinum-resistant, multidrug-refractory epithelial ovarian cancer with CA125 levels exceeding 90 units/ml and acceptable renal, hepatic, and bone marrow function. Cisplatin 30 mg/m2 IV and gemcitabine 800–1000 mg/m2 IV were given biweekly (d1, 15) and CA125 levles monitored. Toxicity was monitored before each course and graded by NCI-CTC. Responses were measured using Rustin's criteria (JCO 15:172,1997). Treatment was continued until disease progression or prohibitive toxicity supervened. Results: Eleven patients aged 30–71 years (median 58 years) with advanced ovarian cancer received cisplatin and gemcitabine. They had been treated with from 1 to 7 (mean 3.9) previous chemotherapy regimens. A total of 85 course (mean 7.7 courses/patient) were administered, Toxicity included CTC grade 2 anemia in 3 patients and one case each of grade 2 and grade 4 neutropenia without fever. No patients experienced exacerbation of pre-existing peripheral neuropathy. Two patients had stable disease of 3 months or greater duration, four (36%) had complete responses (CA125 decrease > or = to 75% baseline), and the remainder had progressive disease. Conclusions: Biweekly cisplatin and gemcitabine is an active combination in patients with refractory ovarian cancer. Limited toxicity and ease of administration suggest a role for this combination in consolidation therapy.

[Table: see text]
The impact of optimal (<1cm) surgical debulking on survival at the time of recurrence in patients with uterine leiomyosarcoma (LMS)
Authors: Martino M. A. , Patrick K. , Wenham R. , Palmer J. , Cantor A. , Twitty P. , Rajaram L. , Lancaster J. , Hoffman M. S.
Published: March 2020

16067

Objective: Uterine leiomyosarcoma (LMS) is an uncommon female malignancy with limited treatment options. To evaluate whether there exists a role for surgery at the time of recurrence, we performed an outcomes analysis from over 25 years of treating LMS at a single institution. Methods: Patients with uterine leiomyosarcoma who presented for treatment at the H. Lee Moffitt Cancer Center from 1981–2005 were identified from the cancer registry database. Patients who underwent surgery (with or without adjuvant treatment) at the time of first recurrence were compared to those patients who did not undergo surgery and were managed medically. Cox regression analysis (multivariate) was used to evaluate whether demographic or pathologic characteristics were associated with survival. Survival curves were estimated using the Kaplan-Meier method and p-values with 95% confidence intervals were generated using the log rank test. Results: Forty-six charts were reviewed to identify forty-one patients with leiomyosarcomas arising from the uterus and treated during 1981–2005. Of the forty-one patients identified, only 7% (N=3) are currently in remission, with a mean follow-up of 40 months from the time of first recurrence. Sixteen patients underwent surgery at the time of first recurrence, with 60% (N=10) of these patients having an optimal cytoreduction (<1cm). On multivariate analysis, post-menopausal status (p=0.011), the presence of tumor necrosis (p=0.038) and high pathologic grade (p=0.056) were significant variables associated with decreased survival. Median survival for optimally cytoreduced patients compared to patients medically managed patients was 55.5 months and 20 months, respectively. A trend towards improved survival in the optimally cytoreduced group was suggested but was not statistically significant (P=0.26) Conclusions: Uterine leiomyosarcoma is a disease with a poor prognosis and a high likelihood of recurrence. We have identified post-menopausal status, tumor necrosis, and pathologic grade as significant predictors of survival. Given the limited treatment options available and with a suggested trend toward improved survival, cytoreductive surgery at the time of recurrence may be worthy of future investigation.

No significant financial relationships to disclose.
The expression of P-gp, Bcl-2 and VEGF in epithelial ovarian carcinoma and their significance
Authors: Gang W. , Luo F. , Li G. L. , Cheng J. , Shi X.
Published: March 2020

16075

Background: To investigate the expression of P - gp,Bcl-2 and VEGF in epithelial ovarian carcinoma as well as their significance. Methods: Expression of P- gp,Bcl-2 and VEGF were examined in 72 epithelial ovarian carcinoma by immunohistochemisty (method of S - P) . Results: The positive expressions of P - gp,Bcl-2 and VEGF in patients with ovarian carcinoma were 51.4%,54.2%,56.9% respectively .Compared with those in ovarian benign tumors and normal controls, such expression level were significantly higher ( P < 0.05). The expression of P - gp was positively correlated with the expression of VEGF( P <0. 05) while the expression of VEGF was positively correlated with the expression of Bcl-2 ( P <0. 05). Univariate analysis showed worse disease-free survival in the patients with positive expression of P-gp or VEGF than in those with negative expression of P -gp or VEGF( P < 0. 05). Multivariate analysis of clinical and pathological data by Cox-regression method showed that the expression of P - gp or VEGF and co- expression of these three indexes were correlated with poor prognosis. Conclusions: Over-expression of P - gp,Bcl-2 and VEGF is correlated with drug resistance of clinical chemotherapy and survival rate in ovarian cancer . To examine these 3 indexes in ovarian cancer is helpful to evaluate response to clinical chemotherapy as well as to predict the prognosis.

No significant financial relationships to disclose.
Concurrent platinum-based chemotherapy with intensity modulated radiation therapy (IMRT) for locally advanced squamous cell carcinoma of the head and neck (SCCHN): A retrospective single institution analysis
Authors: Saba N. F. , Gaultney J. , Edelman S. , Tighiouart M. , Davis L. W. , Khuri F. R. , Chen A. , Grist W. , Shin D. M.
Published: March 2020

16511

Background: Randomized clinical and meta-analysis data support the use of concurrent chemoradiation for treatment of locally advanced (SCCHN). IMRT is increasingly being used in treating SCCHN. We present outcome data from Emory University Winship Cancer Institute (WCI) with concurrent platinum based chemotherapy and IMRT, and analyze results according to primary site and nodal status. Methods: Between February 2003, and November 2005, 87 patients with locally advanced SCCHN underwent concurrent IMRT and platinum based chemotherapy. A total of 62 patients were treated with Cisplatin 100 mg/m2 d1,21,43, while 19 were treated with paclitaxel and carboplatin weekly for 7 weeks. Five patients were treated with other platinum based regimens. Follow up was documented in all cases with a median of 520 days (range 107 - 1269 days). Results: Patients were distributed among primary sites as follows: Hypopharynx (HP) 7 (8.0%), Larynx (L) 11(12.4%), Nasopharynx (NP) 13 (14.6%), and Oropharynx (OP) 56 (63.0%). T stage distribution was: T1: 16 patients (18.0%); lesions more advanced than T1 (>T1): 68 (76.4%). N stage distribution was, N0 :16 patients (18.0%), N1: 8 (9.0 %),nodal stage N2a or higher: 61 (68.5%). Median age was 57 years (range 32–75), and 63 patients (71.0%) were male. The median overall survival (OS) and disease-free survival (DFS) post-therapy was not reached. The 3 year OS rate for the entire cohort was 86% (L 82%, NP 89 %, OP 86 % HP 80%). The 3 year DFS rate for the entire cohort was 74%, (L 85%, NP 60%, and OP 75%, HP 76%). There was no correlation between OS and T or N stage (p=0.143 and 0.44 respectively), or between DFS and T-stage (p=0.4). A significant correlation was found between DFS and N stage (p=0.008). Conclusion: With moderate follow up, this retrospective analysis reveals an excellent outcome for patients with locally advanced SCCHN treated with chemotherapy and IMRT concurrently, supporting concurrent therapy as the current standard of care. The significant correlation of DFS and nodal status suggests a possible greater impact future approaches such as induction therapy may have on patients with advanced nodal disease.

No significant financial relationships to disclose.
MR-sialography as functional separate imaging of salivary gland for evaluation of radiation-induced xerostomia
Authors: Yokokawa M. , Uchida N. , Wada A. , Kawaguchi A. , Notani M. , Kitagaki H. , Uchida K. , Hara S.
Published: March 2020

16522

Background: For head and neck cancer (HNC) patients who receive curative irradiation (RT), RT-induced xerostomia is a frequent and troublesome adverse event diminishing quality of life. In this prospectve study, morphological changes in salivary glands were evaluated by means of MR volume calculation and examination of the functional changes in MR-sialography as compared with subjective symptoms. Materials and Methods: Sixteen HNC patients (15 squamous cell carcinomas and 1 lymphoma) scheduled to receive more than 44 Gy to the primary tumor were registered (median dose to salivary glands: 60 Gy). MRI was performed prior to start of RT (pre-RT), as well as 2–4 weeks after completion of RT (post-RT). Evaluations were undertaken as follows: 1) Subjective symptoms of oral dry sensation were scaled by visual analogue scale (pre-RT VAS, post-RT VAS); 2) Changes in depictions of MR-sialography (heavy T2WI) following tartaric acid stimulation were graded into three categories (good,fair, poor); and, 3) Changes in salivary gland volume were measured as reduction ratio(%) = (pre-RT volume - post -RT volume) / pre-RT volume × 100. Results: Post-RT VAS of oral dry sensation was greater than that of pre-RT (p=0.001). Clinical symptoms (changes in VAS) did not correlate with salivary gland reduction ratio nor radiation dosage for either the parotid (PG) or submandibular glands (SG). RT dosage and reduction ratio correlated well (r=0.62). Reactivity of MR-sialography stimulated by tartaric acid became poor after RT. The mean RT dosages to PG and SG of the poor group were higher than those of the good group (p<0.05). Conclusions: MR-sialography after RT showed a poor response to secretion stimulation, which correlated with RT dosage. Moreover, MR- sialography with secretion stimulation may have the potential to be a non-invasive and sensitive method by which to assess the severity of xerostomia of each gland separately as ‘functional MR - sialography‘. More cases and longer follow up, and dose-volume histogram evaluation of each salivary gland are required to confirm the results.

No significant financial relationships to disclose.
Pilot phase I study of gefitinib (GEF) in combination with paclitaxel (PAC) and radiation therapy (RT) in patients with locally advanced head and neck squamous cell carcinoma (HNSCC) and effects on epidermal growth factor receptor (EGFR) signaling pathway
Authors: Morris J. C. , Allen C. , Citrin D. , Gius D. , Chen Z. , Colevas A. D. , Harold N. , Rudy S. , Singh A. K. , VanWaes C.
Published: March 2020

16526

Background: The over expression of EGFR in HNSCC stimulates tumor cell proliferation, inhibits apoptosis, and increases resistance to chemotherapy and radiation. We examined the toxicity and maximum tolerated dose (MTD), and the downstream signaling and cellular effects in tumor biopsies in locally advanced HNSCC patients (Pts.) treated with GEF+PAC and RT. Methods: Pilot phase I dose escalation study initiated at GEF 250 mg/d + PAC 45 mg/m2 weekly x 6 with concurrent RT to 72 Gy. Eligibility: Stage III-IVB HNSCC, age=18 years, no prior RT or chemotherapy, ECOG =2, adequate organ function and informed consent. Endpoints: MTD determination, analysis of tumor biopsies for treatment effect on phospho-EGFR, Akt, Erk1/2, STAT3, NF-κB p65, Ki67 expression, TUNEL assay, serial measurement of serum IL-6, IL-8, VEGF, HGF and GROa. Results: 10 Pts., median age 60.7 yrs. (range, 41–83), 7 men and 3 women were treated. The MTD was GEF 250 mg/d + PAC 36 mg/m2 weekly x 6 with concurrent RT. Grade 3/4 toxicities included prolonged (>8 wk duration) mucositis in 7 Pts., infection (1) and interstitial pneumonitis (1). Two Pts. experienced protracted painful oral dysesthesia. There were 5 CR's and 1 PR. Of 7 Pts. undergoing serial biopsy, 1 Pt. showed a significant decrease in phosphorylated-EGFR expression, decreased downstream phosphoprotein signaling and cellular proliferation within 8 days of initiating GEF. Conclusions: Severe and prolonged mucositis was dose-limiting for this schedule of GEF+PAC and RT in locally advanced HNSCC. Inhibition of EGFR activation and downstream signaling by GEF was observed in a minority of Pts. on serial tumor biopsy specimens obtained during treatment.

No significant financial relationships to disclose.
Role of surgery in the management of carcinoma larynx and hypopharynx
Authors: Varghese B. T.
Published: March 2020

16528

Background: With the advent of chemoradiation the role of surgery in management of cancer of larynx and hypopharynx has come down considerably. Aim: To evaluate the overall outcome of surgery for carcinoma of the larynx and hypopharynx, with a view to establish its role in management of cancer of larynx and hypopharynx. Patients and Methods: All patients who have undergone laryngectomy at the Division of Surgical Oncology RCC from June 1995 to Dec 2005 were included in the study which retrospectively recorded the age and sex distribution TNM staging, the indications and types of laryngectomy, and reconstructive options used. The influence of preoperative chemotherapy, radiotherapy, and tracheostomy, systemic illness like diabetes melletus and COPD on the surgical outcome was assessed. Results: The ages of the patient ranged from 23 years to 75 years with a mean ± s.d of 55 ± 9.5 years. Out of a total of 167 cases, 123 (74%) cases had salvage surgery for failed chemo RT/Radical RT and 44 (26%) had primary surgical treatment. Conservation surgery was undertaken in 4 cases, Near total laryngectomy/laryngopharyngectomy (NTL/NTLP) was done in 14, Total laryngopharyngo esophagectomy (TLPE) with gastric pull up was done in 5 and total laryngectomy (TL) or TL with partial or subtotal pharyngectomy was done in 142 cases. 62 (37 %) patients had postoperative leaks, 5 leaks persisted to form pharyngocutaneous fistulae. 2 were repaired and in 2 cases speech prosthesis insertion was possible due its anatomical position. 1 patient refused further surgical closure after a previously failed repair. Fifty-six (34%) patients recurred locoregionally. Four (2.3%) patients developed second primary and 5 (2.9%) had distant metastasis. Wound infection, previous radiation and diabetes melletes were the predominant predisposing factors for the leaks and wound related complications were the commonest cause for prolongation of postoperative hospital stay. Seventy-nine patients were alive at the time of study. Conclusions: Hypopharyngeal cancers warrant a closer follow up after an organ preservation protocol, to detect recurrence at the earliest and plan for an effective salvage surgery.

No significant financial relationships to disclose.
Predictors of toxicity to concurrent chemoradiation (CRT) in patients (pts) with locally advanced head and neck squamous cell cancer (HNSCC)
Authors: Yelamanchili R. , Hotte S. , Julian J. , Wright J.
Published: March 2020

16540

Background: A number of studies have evaluated the impact of prognostic factors on survival but very few have studied their role as determinants of toxicity, especially outside of the context of clinical trials. We set out to identify patient characteristics that are likely to predict toxicity to chemotherapy (CT) with daily cisplatin 6mg/m2 and radiation therapy (RT) in pts with locally advanced HNSCC. Methods: Retrospective chart review of above pts at the Juravinski Cancer Center from 2000 through 2004. A number of pt characteristics were analysed. Toxicity outcomes evaluated were completion of CT and of RT, rise in serum Cr , hematologic suppression, need for extra hydration, and need for extra antiemetics. Results: The charts of 108 pts were reviewed. Median follow-up was 36 months. Five year projected OS and PFS were 78% and 57% in our study compared to 53% and 47% in a published EORTC trial (NEJM, 2004). Median duration of PFS was 64 months in our study compared to 55 months in the EORTC trial. Median OS was not reached in our study. Nineteen percent completed CT and 81% completed RT, 17% had full course of CRT. Thirty-nine percent required extra hydration and 50% required extra antiemetics. Twenty four percent had elevated creatinine levels and 20.4% had hematologic suppression. Logistic regression was used to search for significant correlations between pt characteristics and outcomes. Pts with occasional alcohol intake were more likely to complete RT than heavy alcohol abusers (OR 8.9; P 0.04). Pts with occasional alcohol intake were more likely to get extra hydration than heavy alcohol abusers (OR 5.1; P 0.008).Hematologic suppression was more likely with increasing age (OR 1.08;P 0.015).No significant difference in toxicity outcomes was observed between males and females. Conclusions: This review demonstrated that CRT with daily cisplatin is associated with significant toxicity and most pts are unable to receive full treatment . A number of pt variables might predict increased susceptibility to toxicity. This should be validated in a prospective study. Median PFS in our series appear to be at least as good as previously published reports of CRT using daily cisplatin as well as dose schedules but toxicity does not appear greatly reduced.

No significant financial relationships to disclose.
Significance of stress myocardial perfusion scans in predicting cardiovascular events and mortality in cancer patients
Authors: Chandra S. , Tong A. T. , Wei Wei A. , Yusuf S. W. , Javaid S. , Liu D. , Durand J. , Lenihan D. J.
Published: March 2020

17009

Background: Cardiac risk assessment in cancer patients has not extensively been studied. We evaluated the role of stress myocardial perfusion scan (SMPS) in predicting cardiovascular outcomes in cancer patients. Methods: A retrospective chart review was performed on 787 patients who had a SMPS from 01/2002 - 03/2003. All patients were followed for at least 1.5 years. Cox proportional hazard model was used to determine the time-to-first event [cardiac death, myocardial infarction (MI) and coronary revascularization]. Cardiac death was defined as documented cardiac death or sudden unexplained death. Results: A total of 501/787 (64%) patients had normal SMPS, whereas 286/787 (36%) had abnormal SMPS. Adenosine [430/787 (55%)] and dobutamine [144/787 (14%)] were used for chemical stress while 213/787 (23%) patients underwent exercise testing. Mean age was 66±11 years and median follow-up duration was 1.8 years. The 3- year event-free survival rate was 0.71 (0.64–0.78) for abnormal SMPS and 0.87 (0.8–0.94) for normal SMPS (p<0.0001). Of all abnormal scans (n=286), 3-year event free-survival rate based on type of vascular defects varied from 0.79(0.67–0.93) for fixed defects, 0.68 (0.58-.08) for reversible defects and 0.63 (0.5–0.8) for co-existent fixed and reversible defects (p<0.0001). Other factors adversely affecting event-free survival were male gender (p=0.025), cardiomyopathy (p=0.001), coronary artery disease (p<0.0001), previous MI (p<0.0001), congestive heart failure (p=0.001) and hypercholesterolemia (p<0.0001). When we analyzed cardiac death as a separate event, SMPS results still made a significant difference with 3-year cardiac-survival rate of 0.79 (0.69–0.91) for abnormal scan group versus 0.88 (0.81–0.95) for normal scan group (p=0.05). Furthermore, the 3-year cardiac-survival rate in patients with both fixed and reversible defects was 0.4 (0.1–1), which was much worse than those with fixed [0.87 (0.76–0.99)] or reversible [0.85 (0.74–0.99)] defects alone (p=0.028). Conclusions: SMPS is a highly useful modality for predicting cardiac events and mortality in cancer patients. The characteristics of the perfusion defect further stratifies the patients at higher risk.

No significant financial relationships to disclose.
Access to care and patient satisfaction for surgically-treated breast cancer
Authors: Porter G. A. , Murdoch J. M. , Inglis K. M. , Veugelers P. J.
Published: March 2020

17010

Background: Although recent studies have described timeliness of breast cancer (BC) care and its impact on outcomes, there is little data on patient perception of timeliness. This study examined the association between clinicodemographic factors, timeliness and patient satisfaction for surgically-treated BC patients across defined intervals of diagnosis (Dx) and treatment. Methods: All patients undergoing surgery for primary BC within a single Health District over 24 months were enrolled in a prospective consecutive cohort study. A comprehensive, standardized method of ascertaining specific time intervals, including a patient interview, was used to quantify the timeliness of presentation, Dx and treatment. A validated satisfaction questionnaire was applied to patients 2 weeks after surgery, and following chemotherapy. Multiple linear regression, using the natural logarithm of the time interval as the dependant variable, was performed to examine the association of factors and satisfaction with specific time intervals. Results: Among the 519 patients in the study, 317 (61%) were screen-detected and 202 (39%) presented symptomatically. Complete satisfaction questionnaire responses were obtained in 348 (67%). The median time intervals in days (interquartile range) were: abnormal screen to Dx - 33 (21–48); symptoms to Dx 44 (23–97); Dx to surgery - 31 (22–43); surgery to adjuvant chemotherapy 63 (49–73). On multivariate analysis, the interval from presentation (either abnormal mammogram or symptoms) to Dx was 33% longer for screen-detected patients (p<0.0001) and 38% longer for patients where more than one diagnostic test was performed (p=0.009). Moderate correlation was identified between patient satisfaction and both the intervals from presentation to Dx (r2=0.212;p<0.0001) and from Dx to surgery (r2=0.262;p<0.0001). Controlling for the length of these intervals, younger women (p=0.01) and those with a Dx made via screening (p=0.004) had significantly lower satisfaction scores. Conclusions: The timeliness of care for BC involves several defined components; variations in the relatively short interval from Dx to surgery appeared to have most impact on patient satisfaction. Younger women and those diagnosed via screening were less satisfied with their access to timely care.

No significant financial relationships to disclose.
Communication about physical activity in an underserved patient population
Authors: Carroll J. , Epstein R. , Fiscella K. , Jean-Pierre P. , Figueroa-Moseley C. , Morrow G.
Published: March 2020

17012

Background: Promoting physical activity may help reduce the incidence of several cancers. The 5A model, used to promote other patient behavior changes in clinical practice, may be applicable to physical activity. Our goal was to determine clinicians’ use of the 5A (Ask, Advise, Agree, Assist, Arrange) guidelines when communicating about physical activity and cancer risk with an underserved patient population. Methods: Analysis of 50 audiotaped transcribed office visits with adult patients and their clinicians in two community health centers in Rochester, NY. We conducted post-visit interviews to assess patient recall of communication about physical activity.We used descriptive statistics to assess patient demographics and the frequency of each of the 5As occurring in the audiotaped visits. Analysis of the transcripts of the visits explored other contextual factors related to use of the 5As for communication about physical activity and cancer risk. Results: Patients were predominantly female (70%) and were African American (50%), Caucasian (35%) and other/mixed ethnicity (15%). In the 50 office visits, there were twelve (24%) Ask, twelve (24%) Advise, three (6%) Agree, two (4%) Assist, and one (2%) Arrange statement. Physical activity communication was mostly (92%) clinician-initiated; the only discussion which included all 5As was patient-initiated. No discussion linked physical activity to cancer risk or cancer prevention. Patients recalling the most communication about physical activity with their clinician reported that it was contextualized to their specific health needs, included support and encouragement, and consisted of clear, simple advice. Conclusions: Communication about physical activity incorporating the Agree and Arrange steps of the 5As was infrequent. Cancer prevention interventions should target these steps and prompt the patient to initiate communication to improve physical activity in underserved populations. This project was supported by a grant from the National Cancer Institute, R25- CA102618.

No significant financial relationships to disclose.
The Oncology Symptom Control and Information Resource (OSCIR): Using information technology to improve the management of cancer treatment-related side effects
Authors: DeAngelis C. , Giotis A. , Charbonneau L. F. , Zannella S.
Published: March 2020

17031

Background: Management of treatment related side effects remains a challenge despite availability of effective therapies and management guidelines. The main reasons include ineffective assessment of the patient's experience, inability to access prevention and management guidelines in a timely manner, poor documentation and inefficient communication within the patient's care team. We postulate treatment related side effects could be more effectively managed using software designed to assist assessment and improve communication of the patient's experience. Methods: Software specifications included internet-based wireless capability, linking to existing electronic databases and facilitated data entry (drop down menus, check boxes, pop up windows, etc.). Oncology literature was reviewed to identify appropriate symptom assessment questionnaires, prevention and treatment strategies. The National Cancer Institute Common Terminology Criteria for Adverse Events v.3.0 was adapted. An iterative process was used for software development; content and functionality was discussed with programmers on an ongoing basis. This process is aimed at providing software that more completely meets the needs of users. Feedback from oncology pharmacists was sought regularly. Results: OSCIR has been developed to facilitate the assessment and management of nausea, vomiting, diarrhea, constipation, mucositis, and palmar-plantar erythrodysesthesia. Each side effect module includes onset and resolution, signs and symptoms, automated grading, non- and pharmacological management. Program features include downloading of electronic demographic information, chemotherapy regimen, laboratory results, call back roster, and communication tools. Conclusions: Using the iterative process we have created a program that addresses the needs of pharmacists involved in the assessment and management of treatment-related side effects. Further development will incorporate feedback from other members of the patient's care team and will include additional side effects and features.

No significant financial relationships to disclose.
20-year epidemiology and treatment experience with lung cancer in Manitoba, Canada
Authors: Pitz M. W. , Musto G. , Kliewer E. , Navaratnam S.
Published: March 2020

17041

Background: Surgical techniques, radiotherapeutic technology, and systemic therapies have evolved to improve the care of lung cancer patients. We sought to determine the impact of these improvements on the outcome and pattern of care for patients diagnosed with lung cancer in Manitoba. Methods: Patients diagnosed with non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) from January 1, 1986 to December 31, 2005 were identified from the Manitoba Cancer Registry (MCR). Demographic, diagnostic, treatment, and outcome data were extracted and analyzed to determine changes over time. Joinpoint Regression Program 3.0 was used for linear regression analysis. Results: 10 679 diagnoses of NSCLC (84.3%) and 1983 diagnoses of SCLC (15.7%) were identified from the MCR. The mean age at diagnosis for NSCLC was 68.7 years, with an increasing linear trend over time (slope (m) = .19, p < .001). There was a trend away from primary surgical treatment (m = -.30, p = .005) and chemotherapy and/or radiotherapy (CRT) (m = - .29, p=.015) and towards no active treatment (m = .59, p < .001). A positive linear trend in survival was seen for patients with NSCLC whose primary treatment was surgical (m = .70, p<.001). For patients treated with CRT, there was an inflection point at 1994 with no trend prior (m= .03, p = .92) and a significant positive trend after (m = .58, p = .029). Overall survival of all NSCLC patients did not follow a trend from 1986 until 1998 (m = -.01, p = 0.97), but has shown a significant linear trend after the 1998 inflection point (m = .96, p = .036). The mean age at diagnosis for SCLC was 66.7 years, with no significant change over time (m = .075, p=.088). There was no significant improvement in survival over time with CRT (m = .13, p=.25) or in the proportion treated with CRT (m = 0.20, p=.51). Conclusions: Oncologic treatment has been administered more selectively to patients with NSCLC over time. There has been improved survival of NSCLC patients treated surgically and non-surgically that has translated into an improvement in the overall survival of NSCLC patients in Manitoba. There has been little change in the treatment pattern and outcome of patients with SCLC over time.

No significant financial relationships to disclose.
A 10-year history of lung cancer practice guideline development: Process, productivity and impact
Authors: Evans W. K. , Smith C. A. , Ung Y.
Published: March 2020

17044

Background: CCO's Program in Evidence-based Care at McMaster University, has developed and disseminated clinical guidance documents through provincial DSGs for 10 years. The 37 member Lung DSG includes medical oncologists (17), radiation oncologists (11), thoracic surgeons (4), nurses (2), and a research coordinator. Pathologists (3), community/patient representatives (2), a medical resident and medical sociologist have previously been members. Methods: The LDSG has used the practice guideline (PG) development cycle described by Browman GP et al (JCO 1998; 16(3):1226–31). Results: 31 reports have been published in peer-reviewed journals, including 25 guidelines; all PGs are posted on the CCO website. Topics were initially selected on the basis of known practice variability (chemotherapy for Stage IV NSCLC) or clinical controversy (combined modality therapy for Stage III NSCLC); PGs for single chemotherapy drugs (6) or chemotherapy usage in specific situations (7) have dominated DSG activity; 5 PGs on radiotherapy alone and 3 on RT as part of CMT have been completed; recent PGs have been written for rare tumours (mesothelioma, thymoma) and diagnostic imaging (PET). Initially, PGs were based solely on published RCT evidence. Evidence from publicly accessible abstracts/meeting presentations, and Phase II trials (in the absence of higher quality evidence) is now considered. For rare tumours (thymoma), the DSG has used a Delphi consensus methodology. Knowledge transfer occurs through the DSG meeting process (twice yearly face-to-face; 2–4 teleconferences), practitioner feedback (PF), publications, presentations and web posting. PF using a standardized feedback questionnaire is generally high (59.9%) but varies by PG and discipline; PF is incorporated into final guideline documents. Guideline recommendations for the use of vinorelbine, gemcitabine, taxanes and erlotinib in NSCLC have been successful in securing government funding.

No significant financial relationships to disclose.
National multi-center epidemiological study on prevalence and treatment of cancer-related symptoms
Authors: Novik A. A. , Ionova T. I. , Kalyadina S. A. , Kishtovich A. V. , Fedorenko D. A. , Wang S. X. , Cleeland C. S.
Published: March 2020

17048

Background: This outcome measure of cancer-related symptoms was conducted in Russia in 2005–2006 to have a better understanding of the current status of symptom management among patients with advanced cancer. Specific aims of this study are to describe the prevalence of pain, fatigue, and other cancer-related symptoms among cancer patients being treated in multiple sites across Russia and to assess current symptom treatment and response to it across different centers. Methods: The sample size included 500 patients with advanced cancer from 10 cancer centers: male/female - 216/284, mean age 53.6. Symptom status was assessed using M.D. Anderson Symptom Inventory and Brief Pain Inventory at two time points. We used descriptive statistics to describe symptom prevalence and severity. Pain Management Index (PMI) was calculated for each patient to examine whether or not analgesics were prescribed to treat pain according to the World Health Organization's guidelines for cancer pain management. Results: The following distribution of patients according to the malignancies was observed: breast cancer (31%), hematological malignancies (30%), lung cancer (19%), gastrointestinal tumors (13%), gynecological tumors (8.4%), others (3%). As a result, the most severe symptom was fatigue (4.2) ranging from 1.5 to 5.0 across the centers. Its prevalence was 85 %. Other pronounced symptoms were pain (3.4; ranging from 0.9 to 7.0 across the centers), distress (3.0), sadness (2.9), and sleep disturbance (2.9) with their prevalence of 65.8%, 71.8%, 71.6%, and 70.0% respectively. Out of the total sample, 130 patients had only mild symptoms and 360 - at least one symptom as moderate-to-severe. Among them there were 136 patients who had 5 or more moderate- to-severe symptoms and 13 patients who had 10 or more such symptoms. Fatigue was treated only in 131 patients (26%, including blood transfusion and erythropoietin therapy); among them the decrease in fatigue level was achieved in 35% patients. Inadequate pain management was provided for 43% of patients. Conclusions: The results of this symptom outcome study provide the initial data on symptom control in Russia and allow establishing the framework for identifying the patients who experience poor symptom assessment and management.

No significant financial relationships to disclose.
Implemention of a Division of Internal and Hospital Medicine in a free-standing comprehensive cancer center
Authors: Gross R.
Published: March 2020

17070

Background: In 2004, the Moffitt Cancer Center implemented a Division of Internal and Hospital Medicine. As a free-standing Comprehensive Cancer Center, Moffitt serves complex cancer patients with a wide range of nononcologic medical needs. These co-morbidities had previously been managed through a combination of subspecialty consultations and ‘out-of-specialty‘ care by the attending oncologist or hematologist. With the rapid growth of hospital medicine as an established specialty, Moffitt recognized an opportunity to reduce fragmentation and variation in noncancer care, minimize disruptions to the focused practices of the cancer specialists, cope with resident workload constraints, and enhance efficiency of inpatient care. The institution commited to the establishment of a dedicated internal and hospital medicine program. Methods: The presentation includes a descriptive accounting of this comprehensive project, from initial planning to implementation and consolidation. Scope of services provided, staffing ratios, and unanticipated challenges and opportunities are described. A survey of stakeholder physicians was undertaken to assess perceived value for various aspects of the program. Opportunity for discussion will be provided for those considering implementation of similar services in their host institution. Results: The new program was successfully implemented and is comprised of an active inpatient service, an inpatient consultation service, a high-risk preoperative evaluation and co-management service, a 24-hour urgent care service, and a limited outpatient clinic. There are 5 physicians and 4 midlevel practitioners in the program, which is closely integrated with the internal medicine residency program of the University of South Florida. Conclusions: An Internal and Hospital Medicine program in a free-standing cancer center appears to provide perceived patient care benefits, peer satisfaction, and utilization efficiencies based on initial survey data.

No significant financial relationships to disclose.
General epidemiology and survival rate of malignant and non-malignant brain and central nervous system tumors in Nice area (France)
Authors: Chamorey E. , Lebrun C. , Fontaine D. , Vandenbos F. , Michiels J. , Paquis P. , Frenay M.
Published: March 2020

17078

Background: The aim of this cohort study was to produce descriptive epidemiological data from the Group of Neuro- Oncology of Nice (GNON) database. Data were collected from the Comprehensive Cancer Center and the University Hospital of Nice (France). Methods: All cases that have been discussed during multidisciplinary meetings of neuro-oncology were entered. Data were compared with the Central Brain Tumor Registry of the United States (CBTRUS) report taken as reference tool. Follow-up information was obtained from the patient medical chart and from the national death registry. Results: 1,395 patients (718 males, 677 females) were registered in the data base. There were 938 tumors of neuroepithelial tissue (percentage of all reported cases in our study: 67.9%, median age in our study; 58 yrs, percentage in CBTRUS report: 43.6%, median age in CBTRUS report: 53 yrs), 55 tumors of cranial and spinal nerves (4.0%, 53 yrs; 8%, 52 yrs), 270 tumors of meninges (19.5%, 59 yrs; 31.4%, 63 yrs), 54 lymphoma and hemopoietic neoplasm (3.9%, 68 yrs; 3.1%, 60 yrs), 16 germ cell tumors, cysts and heterotopias (1.2%, 17yrs; 0.6%, 16yrs), 12 craniopharyngioma (0.9%, 50 yrs; 0.7%, 48 yrs), 9 chordoma/chondrosarcoma (0.6%, 65 yrs; 0.2%, 48 yrs), 27 unclassified tumors (2.0%, 46 yrs; 6.1%, 68 yrs). The table shows the survival rates at one, three and five years respectively for some selected brain and central nervous system tumors (results from the CBTRUS report in parentheses). Conclusions: A comparison between results from the CBTRUS and GNON data base showed some similarities and didn't point out any major unexplainable discrepancy.

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No significant financial relationships to disclose.
Modelling the direct costs of chemotherapy-induced neutropenia treatment in Portuguese hospitals clinical practice
Authors: Saramago P. , Andreozzi V. , Ferreira J. M. , Félix J.
Published: March 2020

17081

Background: Neutropenia (N) and febrile neutropenia (FN) are common adverse effects of chemotherapy, resulting in increased risk of infections and hospitalizations. Both conditions account for substantial health resource utilization (HRU). The objective of this study was to evaluate HRU patterns for patients (PTS) experiencing N or FN in “real world” practice and to model the corresponding HRU cost profiles. Methods: Breast and lung cancer PTS receiving granulocyte colony stimulating factor (GCSF) to treat chemotherapy- induced neutropenia (absolute neutrophil count [ANC] =1500 cell/μL) were selected from 8 Portuguese hospitals. In the absence of a comprehensive database PTS having neutropenia were originally identified from hospital pharmacies GCSF prescription lists; afterwards, HRU frequency (hospitalization, clinical visits, complementary examinations, medication, transfusions) in relation to N or FN (ANC =1000 cell/μL and body temperature= 38.5°C over one hour) was reviewed retrospectively from clinical records. Treatment costs attributed to N/FN were calculated by multiplying HRU frequency by unit costs from the Portuguese Ministry of Health costs database. To account for the skewed nature of the data costs were modelled using generalized linear models with gamma distribution and log link. Results: The study included 50 PTS with breast cancer and 48 with lung cancer. Mean (SD) age was 60.0 (12.5) years and 61.2% were women. Mean (SD) ANC at first N was 724 (433) cell/μL. FN (mean (SD) ANC 440 (370) cell/μL) was developed by 16.5% of PTS. Mean (SD) total cost of N treatment was 922 (1162) € (28% hospitalization, 5% clinical visits, 3% complementary examinations, 54% medication, 10% transfusions). Controlling for PTS clinical and sociodemographic characteristics, total treatment cost were 3.2 (95%CI:1.9–5.2) times higher for PTS with FN (p<0.001) when compared to N PTS, 4.4% (95%CI: 0.1–7.7) greater for every 100 cell/μL decrease in ANC (p=0.03) and 2.5% (95%CI: 1.0–4.1) higher per additional year of age at N or FN diagnosis (p=0.002). Conclusions: Chemotherapy-induced neutropenia direct treatment costs were substantially incremented in febrile patients.

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A multi-center, open-label study to evaluate the safety and efficacy of pentostatin, cytoxan, and rituxan (PCR) in the treatment of previously untreated or treated, stage III or IV, low-grade CLL
Authors: Mena R. R. , Robles R. , Auerbach M. , Moezi M. , Headley D.
Published: March 2020

17508

Background: The decision to treat indolent CLL is often based on progressive bulky disease, worsening symptoms, and increasing hematological variations. When treatment is indicated, these lymphoproliferative disorders are sensitive to combination immunochemotherapies utilizing pentostatin (P), a purine analog, cyclophosphamide (C), a DNA alkylator, and rituximab (R), an anti-CD20 monoclonal antibody. PCR represents a promising new approach in the treatment of patients with low grade CLL. Methods: Eligibility criteria allow previously treated and treatment-naïve patients diagnosed with low-grade stage II/III/IV CLL (modified Rai classification). Treatment consisted of intravenous infusions of P (4 mg/m2), C (600 mg/m2), and R (375 mg/m2) on day 1 of a 21-day cycle for a total of up to 10 cycles. Clinical evaluations (including CT scan) were performed after cycles 2, 4, 6, 8, and 10 (if necessary). Results: The intent-to-treat (ITT) population consisted of 80 CLL patients (median age 64, range 35–83) who received a total of 368 cycles (median 5 per patient). ECOG status at enrollment was 0 (68.4%), 1 (27.6%) and 2 (3.9%). The overall response rate of the 59 evaluable patients was 61% (CR 6.8%, Cru 16.9%, PR 37.3%). 7 cases of grade 4 neutropenia, 2 cases of grade 4 respiratory distress, and 1 case of grade 4 anemia were reported. 5 deaths, all in elderly patients (>70 years old), have been recorded, due to acute respiratory failure, myocardial infarction, pulmonary edema, sepsis, and one unknown cause of death. Conclusions: This immunochemotherapeutic regimen is active in Grade II/III/IV CLL and the incidence of significant toxicities was low with deaths occurring only in elderly (>80 YO) patients. The presented results are preliminary and this study is currently on-going.

No significant financial relationships to disclose.