bluuebunny/crossref_metadata_2025 huggingface dataset:
Neuroendocrine carcinoma of the cervix: A single institution’s experience.
Authors: Preston Megan , McCann Georgia Anne-Lee , O'Malley David M. , Boutsicaris Christina , Copeland Larry J. , Cohn David E. , Fowler Jeffrey , Salani Ritu , Eisenhauer Eric Lawernce
Published: March 2020

e15585

Background: Neuroendocrine carcinomas (NEC) of the cervix comprise only 2% of all cervical cancers. As a result, prospective data is limited and treatment guidelines rely on literature from lung NEC. The objective of this study was to examine and report on our experience in the management of this rare, aggressive disease. Methods: This was an IRB-approved, single-institution, retrospective review. Study criteria included patients with cervical NEC diagnosed between 1990-2011. Demographic, treatment and survival data was collected. Progression-free survival (PFS) and overall survival (OS) was defined as the time from date of initial treatment until progression or death respectively, or date of last contact. Results: A total of 24 patients met inclusion criteria. The median age at diagnosis was 43. Median PFS was 13.6 months and median OS was 16.4 months. The majority of patients had advanced-stage disease (61% stage II-IV, 39% stage I). Of the 9 patients with stage I disease, 4 were treated with platinum + etoposide-based neoadjuvant chemotherapy and 5 were treated with initial radical surgery. Seven of the 9 patients had post-operative adjuvant therapy consisting of chemotherapy, chemo-radiation or radiation only. Seven of the 9 patients (78%) were alive at last follow-up. Of the two patients who were deceased, one had metastatic disease found at surgery and the other declined adjuvant therapy and died of recurrence. Patients with stage II-IV disease (n=15) had a median PFS and OS of 11.5 and 12.1 months, respectively. Only 2 had no evidence of disease at last encounter. The remainder died without achieving remission. Patients with metastatic disease had significantly worse survival when compared to those with loco-regional disease with a median OS of 8 vs. 28 months (p = .03), respectively. Conclusions: We report one of the largest single-institution experiences of neuroendocrine cervical cancer. Advanced-stage patients had a poor prognosis regardless of therapy. However, multi-modality therapy in early-stage disease resulted in an excellent prognosis (78% survival) for these rare, highly aggressive tumors. These findings support the goal of curative intent for early-stage disease using multi-modality therapy.
Cisplatin (CDDP) and radiation versus cetuximab (Cx) and radiation in locally advanced head and neck squamous cell cancer (SCHNC): A retrospective review.
Authors: Peddi Prakash , Shi Runhua , Panu Lori , Ampil Fred , Nathan Cherie-Ann , Armaghany Tannaz , Mills Glenn Morris , Jafri Syed Hasan Raza
Published: March 2020

e16009

Background: SCHNC is a common malignancy and approximately 60% of patients present with locally advanced disease. There is paucity of data directly comparing Cx and CDDP with concurrent radiation in locally advanced SCHNC. We retrospectively reviewed charts of patients treated with CDDP and/or Cx along with radiation in locally advanced SCHNC comparing efficacy and outcomes in an academic cancer center. Methods: Ninety-five patients with locally advanced SCHNC were treated with concurrent CDDP (100 mg/m2 day 1, 22, 43) or Cx (400mg/m2 on day -7 and 250mg/m2 weekly) at our institution between January 2006 and June 2011. Forty-four patients were treated with CDDP (group A), 24 with Cx (group B) and 27 were initially started on CDDP but were switched to Cx secondary to toxicity (group C). All patients received concurrent radiation treatments (66-70 Gy, 2.0 Gy/fraction). The selection of CDDP versus Cx was largely based on ECOG performance status (PS) and baseline renal function of the patients. Chi-square test, analysis of variance, and log-rank test was used for analysis. The three groups had similar baseline characteristics except for mean age of 61, 56 and 55 years in group A, B and C respectively; T4 tumors consisted of 44%, 75% and 41% in groups A, B and C respectively. Groups A, B and C had a combined ECOG 0 and I (PS) of 93%, 75% and 92%. Patients with ECOG III PS were excluded. Results: Oropharynx was the most common treated site (38%) followed by Larynx (35%). Complete response (CR) was seen in 77%, 17% and 67% in groups A, B and C respectively (P<0.001). Median progression free survival (PFS) was 16.6, 4.3 and 22.8 in groups A, B and C respectively (P<0.001) and median overall survival (OS) was >35, 11.6 and >32 months in groups A, B and C respectively (P<0.0001). Conclusions: Concurrent CDDP with radiation leads to better response rate PFS and OS as opposed to Cx though many patients treated with CDDP could not complete treatment due to toxicity. Randomized trial comparing the two should be considered.
A comparative study of monoclonal antibody against EGFR (nimotuzumab) used in combination with chemoradiation versus chemoradiation alone in the treatment of locally advanced inoperable squamous cell carcinoma of the head and neck.
Authors: Bhatnagar Aseem Rai , Singh Dharam Pal , Sharma Rameshwaram , Sharma Om Prakash , Sharma Shantanu , Gupta Shivani , Kumbhaj Prashant
Published: March 2020

e16012

Background: To determine the efficacy, safety and tolerability of concurrent Nimotuzumab (monoclonal antibody against epidermal growth factor receptor) used in combination with chemoradiation versus chemoradiation (CRT) alone in advanced inoperable squamous cell carcinoma of the head and neck (SCCHN). Methods: 56 patients were randomly assigned to either of the two treatment arms, nimotuzumab + CRT arm and CRT alone arm. Both arms received concurrent cisplatin 30 mg/m2 repeated weekly for 6-7 cycles along with external beam radiotherapy 64-70 Gy (200cGy/day for 5 days a week for 6-7 weeks). Nimotuzumab arm additionally received nimotuzumab 200 mg weekly for 6-7 cycles. The patients were followed for 6 months after completion of CRT. The study end points were tumor response evaluation according to the RECIST Criteria version 1.1 and safety analysis using RTOG Acute Radiation Morbidity Scoring Criteria. Patients were evaluated weekly with hematologic tests and for adverse events like mucositis and dermatitis during the CRT. Tumor assessment was performed with clinical and endoscopic methods regularly during the CRT and then at 1 month, 3 month and 6 month interval after CRT. One MR imaging was done before starting the CRT to evaluate the baseline tumor characteristics and another was done after the completion of CRT either at 3 months or 6 months or at both the intervals. Results: 25 patients each were evaluable in both the arms who completed the 6 months study. The overall response rate (complete response + partial response) was 96% in Nimotuzumab + CRT arm whereas it was only 72% in CRT alone arm after 6 months of completion of CRT, which is statistically significant (p-value = 0.0206 by chi square test). Additionally, nimotuzumab did not potentiate toxicities of CRT and there was no significant difference in the acute radiation mucositis, dermatitis or hematological toxicities in both the groups (p-value>>0.05). Conclusions: Nimotuzumab can be safely added to the standard CRT treatment for advanced inoperable SCCHN, to achieve better tumor response without potentiating toxicity.
A French national network for rare head and neck cancers (REFCOR).
Authors: Baujat Bertrand , Baglin Anne Catherine , Chabolle Frederic , Costes Martineau Valerie , Janot Francois , Testelin Sylvie , Thariat Juliette , Reyt Emile ,   REFCOR Collaborative Group
Published: March 2020

e16013

Background: Squamous cell carcinomas of upper aerodigestive tract and endemic undifferenciated nasopharyngeal carcinomas are the most frequent head and neck (H&N) cancers. Apart from these two entities, malignant H&N tumors are uncommon due to their location and/or their histological type. They account for 10% of H&N cancers (around 2,000 new cases/year in France). The rarity of these cancers limits the progress in all aspects. Treatments are based on low level scientific proofs. In most histological types, chemotherapy is uneffective. Prognosis is usually threatening. It was necessary to federate medical centers at a national level to enhance epidemiological knowledge, quality of patient management and to promote research projects. Methods: Structuration of the network included: 2008-2009: 4 working groups to edit recommandations of good practice in diagnosis and treatment of sinus cancers, salivary glands cancers, ear cancers, upper aerodigestive tract non squamous cell carcinoma cancers; 2009: A national database including sociodemographical, clinical, epidemiological, histological and follow-up data; 2009: Organization of biorepositories; 2010: A national group of expert pathologists for diagnosis advice (telepathology); 2011: Specialized multidisciplinary clinics at regional and national levels. Results: To date, 783 patients were included in the database by 29 centers. Tumor sites were sinus/nasal fossa (53%), Salivary glands (28%), Upper aerodigestive tract (18%), ear (1%). Stage at diagnosis repartition was 15% stage I, 24% stage II, 17% stage III, 44% stage IV. Main histological types are adenocarcinoma (17%), Adenoid Cystic carcinoma (9%), mucoepidermoid carcinoma (5%), muquous melanoma (5%). 337 biospecimens are referenced. Conclusions: The majority of french centers involved in H&N cancers treatment contribute to this project. This network is a unique tool for improving the knowledge of rare H&N tumors. Ongoing epidemiological studies will shortly be published. Translational studies based on biospecimens will follow. Collaboration with other networks such as the Salivary Gland Tumors Biorepository could be useful in the next future. Funding source: French National Institute of Cancer (INCa).
LIHNCS trial: Lugol's iodine in head and neck cancer surgery.
Authors: Dunn Janet A , Kulkarni Raghav , Gouldesbrough David , Mehanna Hisham , McMahon Jeremy McMahon , Shaw Richard , McCaul James Anthony
Published: March 2020

e16042

Background: Residual dysplasia at margins of mucosal tumour resection is a cause of disease failure. While risk of transformation of dysplasia is difficult to assess, malignant cells within a field of dysplastic change indicate high transformation potential of this dysplastic field. Lugol's iodine assists in the assessment of surgical margins at tumour resection to ensure removal of margin dysplasia where present and resectable using the surrogate biomarker of glycogen storage. This multicenter RCT assesses efficacy of this technique in head and neck cancer surgery and is recruiting over the next two years. Methods: Patients undergoing primary surgery for oral cavity and oropharynx squamous carcinoma are randomised to gold standard surgical resection or to resection guided by Lugol's iodine application. Mucosal surfaces are irrigated with saline, carbocisteine solution applied to remove surface mucus and then irrigated with Lugol's iodine solution. Where present, adjacent visible surface dyplasia is resected with the tumour specimen. Histopathologists are blinded to the technique used. Histopathology is repeated centrally for quality control. Margin status is assessed for involved, close and clear for carcinoma and for presence of dysplasia at margins. Quality of life data are collected at baseline, six weeks, six, twelve and 24 months. Results: Our cohort study of 100 cases showed a reduction in margin dyplasia from 32% to 4% p<0.001. A feasibility pilot trial recruited 98 patients with 100% consent and data collection rates. Recruitment is progressing on schedule and at time of writing two sites are open. Forty six patients have consented in four sites and are included in the trial to date. A further 12 sites are in the trial set up process. We will report our interim data regarding sites open, screened and consented rates and outcomes so far. Conclusions: To date recruitment is on schedule. We have demonstrated the acceptability of the trial and techniques therein to both patients and surgeons. This is a promising technique which may modify head and neck cancer surgery by targeting dysplasia for inclusion at time of resection of primary cancer. Thus locoregional recurrence may be reduced in a proportion of patients undergoing curative surgical resection.
Induction gemcitabine and cisplatin followed by radiation therapy in advanced loco-regional head and neck cancer.
Authors: Jamshed Arif , Iqbal Hassan , Hussain Raza , Mehmood Tahir , Saeed Kamran , Sadaf Tabinda , Loya Asif , Masood Asif , Shah Mazhar Ali
Published: March 2020

e16043

Background: This retrospective study was performed to evaluate the efficacy and toxicity of induction chemotherapy with gemcitabine and cisplatin (GC) followed by radiation / concomitant chemoradiation (RT/CRT) in advanced loco-regional head and neck cancer (LRHANC). Methods: Between 2005 - 2009, 446 newly diagnosed advanced LRHANC patients were treated with induction GC followed by RT/CRT in our institution. M 69%: F 31%. Median age 50 years (range 18 – 81 years). Site; oral cavity 232 (52%), hypopharynx 45 (10%), nasopharynx 63 (14%), larynx 46 (10%), oropharynx 14 (3%), paranasal sinuses 33 (8%) and others 13 (3%). Histology; squamous cell carcinoma 373 (84%), undifferentiated carcinoma 53 (12%), others 20 (4%). Pre treatment AJCC stage (6th edition); T1-3 N0/N+ 139 (31%), T4 N0/N+ 307 (69%). Induction chemotherapy consisted of cisplatin 75 mg / m2 day 1 and gemcitabine 1 gm / m2 day 1 and 8 every 3 weeks. 383 (86%) patients received 2 cycles of induction GC. CRT with 3 weekly cisplatin 75mg/ m2 was given in 299 (67%) and RT alone in 147 (33%) patients. Radiation doses ranged from 55Gy - 70 Gy in 20 - 35 fractions. Results: Minimum follow-up was 2 years. Response to induction chemotherapy; complete response (CR) 58 (13%), partial response (PR) 315 (71%), stable disease (SD) 55 (12%) and progressive disease (PD) 18 (4%). Response to RT/CRT; CR 293 (66%) and persistent disease at 3 months post radiation in 153 (34%) patients. G3/G4 toxicity on induction GC was anemia 2%/0%, neutropenia 17%/4%, thrombocytopenia 2%/1%, vomiting 5%/1% and diarrhea 5%/1%. G1 transient elevation of ALT/ AST was 17% /11%. G3/4 elevation of creatinine was 2 %/1%. Nine patients (2%) had toxicity related hospital admissions during RT/CRT. The 5-year actuarial overall survival and relapse free survival were 67% and 44% respectively. Local control, regional control and distant control rates were 62%, 50% and 49% respectively. Conclusions: Induction GC followed by RT/CRT is a safe and effective approach in untreated head and neck cancer and merits further evaluation in controlled clinical trials.
Retrospective review of patients treated with intensity modulated radiation therapy (IMRT) with or without concurrent chemotherapy for locally advanced thyroid cancer: The Dana-Farber experience.
Authors: Kodali Swati , Limaye Sewanti Atul , Shreenivas Aditya V. , Zhao Dave , Lorch Jochen H. , Tishler Roy B. , Margalit Danielle Nina , Posner Marshall R. , Haddad Robert I.
Published: March 2020

e16060

Background: Chemotherapy has been used concurrently with radiation for local control as adjuvant treatment or for locally recurrent thyroid cancer. We present our experience using IMRT with or without sensitizing concurrent chemotherapy in this setting. Methods: All patients with thyroid carcinoma with or without minimal metastatic disease treated since 2005 at DFCI were reviewed. We collected data and analyzed the outcomes of patients treated with IMRT with or without concurrent chemotherapy for local control. Results: Twenty-two patients were identified: 13 Males, 9 Female, Median age 60 years There were 11 papillary, 6 medullary, 4 anaplastic, and1 follicular. Thirteen patients were treated adjuvantly, seven for locally recurrent disease and two definitively for unresectable disease. All patients with papillary and follicular thyroid cancer had prior surgery and radioactive iodine therapy. Patients with medullary carcinoma had surgery alone. Two patients with anaplastic carcinoma had surgery and two were found to be unresectable.. Seventeen patients received concurrent weekly carboplatin AUC1.5 and paclitaxel 30mg/m2 with radiation. Five patients did not receive any concurrent chemotherapy and were treated with radiotherapy alone. Radiation fields encompassed the thyroid bed, bilateral neck and in some cases the mediastinum. The radiation dose ranged from 5600cGy to 6600cGy. Mean follow up was 42 months. The overall survival at 36 months was 89.5% (95% CI, 76.7-100). Two patients with unresectable anaplastic thyroid cancer died from progressive disease. Loco-regional control rate at 36 months was 78.9% (95% CI, 62.6-99.6). No grade 3 or 4 toxicities were reported during treatment. Conclusions: IMRT with or without concurrent chemotherapy provided excellent loco regional control and might have contributed to improved overall survival in patients with locally advanced thyroid cancer.
A phase I study of everolimus in combination with cetuximab and cisplatin as first-line therapy inrecurrent and metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
Authors: Chung Christine H. , Wang Hao , Tsottles Nancy , Gourin Christine Gail , Agrawal Nishant , Molinolo Alfredo , Gutkind Silvio , Forastiere Arlene A. , Marur Shanthi
Published: March 2020

e16061

Background: The AKT/mTOR pathway emerged as a promising therapeutic target and as a potential mechanism of EGFR inhibitors in HNSCC. To assess the prevalence of AKT/mTOR pathway activation, HNSCC tumors were stained with phospho-specific AKT (pAKT) antibody. To test a hypothesis that resistance to an EGFR inhibitor, cetuximab, can be overcome by mTOR inhibition, we conducted a phase I clinical trial combining everolimus, cetuximab and cisplatin in R/M HNSCC. Methods: A TMA of 153 cores from 51 HNSCC was stained with a pAKT antibody (Ser473), and digitally quantified with TMAJ software. For the trial, patients with ECOG PS 0-2 with no prior systemic therapy for R/M HNSCC were enrolled and escalating doses of everolimus (2.5, 5, or 10mg) were administered daily, cetuximab 250mg/m2 weekly, and cisplatin 40mg/m2 days 1 and 8. Each cycle was 28 days. Response was evaluated with CT/MRI and PET scans after every 2 cycles. Biospecimens to analyze the EGFR and AKT/mTOR pathways were collected. Results: pAKT staining data were evaluable in 123 cores from 45 tumors. Nine patients were accrued before the study was terminated. Five evaluable patients progressed rapidly within 12 weeks after enrolling in the study (median PFS=2.8 months, 95% CI [1.6, 13.9]). Two patients received everolimus at 5mg, and both patients were dose reduced to 2.5mg for grade 3 hypophosphatemia, infection and mucositis. Among the 7 patients enrolled to receive 2.5mg, 3 patients received the treatment until progression of disease, 2 patients were taken off the study due to grade 4 infusion reaction to the first dose of cetuximab and non-adherence to everolimus, and 2 patients withdrew consent. The 5 evaluable patients had a PET response after 2 cycles. The proposed biomarker results will be available at the time of presentation. Conclusions: While AKT/mTOR is a promising therapeutic target, a combination of everolimus, cetuximab and cisplatin was poorly tolerated even at the lowest dose level of 2.5mg daily with unexpected toxicities suggesting that this combination should be studied with a caution in patients with R/M HNSCC.
Quality of life in cancer survivors compared with the general population.
Authors: Blaes Anne Hudson , Baker Kevin Scott , Benson Brad , Bliss Robin L. , Lee Jill Lunsford , Neglia Joseph Philip , Mulrooney Daniel A.
Published: March 2020

e16502

Background: Assessments of quality of life (QOL) among cancer survivors have had mixed results. Literature suggests that those treated with cranial irradiation (CNS) or stem cell transplantation (SCT) have a poorer quality of life. Methods: 309 cancer survivors (37 adult and 241 childhood malignancies, 31 SCT survivors) completed the Medical Outcomes Study 36-Item Short Form Healthy Survey (MOS SF-36). Demographic, disease and treatment characteristics were assessed and inter-group heterogeneity tested across three survivor groups (F-test for age; chi-square for disease and treatment characteristics). Aggregate data analysis for SF-36 composite and norm-based scoring measures was undertaken by using the mixed effect model with unequal random effect variances across studies. Treatment characteristics included age at diagnosis, current age, site of disease [cranial (y/n)], chemotherapy (y/n), radiation therapy (y/n), SCT with/without total body irradiation (TBI). All statistical tests were two-sided, P-values < 0.05 considered statistically significant. Results: The mean age at assessment was 33.4 years. 255 (83.9%) received chemotherapy, 187 (60.7%) radiation, 49 (15.9%) underwent SCT. Among those irradiated, 28 (9.1%) had TBI and 62 (20.1%) had CNS irradiation. The MOS SF-36 physical composite score was 50.5 (9.5-73.3) and mental health composite score was 50.2 (9.2-55.9). Pooled results for the MOS SF-36 included: bodily pain 51.9 (19.9-62.1), general health perceptions 46.7 18.6-63.9), mental health 50.6 (16.2-64.1, physical functioning 51.0 (14.9-57.0), role emotion 50.2 (9.2-55.9), role physical 50.2 (17.7-56.9), social functioning 49.5 (13.2-56.9) and vitality 51.9 (20.9-70.8). No significant variation from the general population median normative values (50.0) was identified, including those treated with CNS and SCT. There was no difference in QOL amongst those treated as children, young adults (ages 15-30 years) or adults. Role physical declined significantly with advancing age (p=0.02). Conclusions: In spite of the chronic conditions prevalent among cancer survivors, the overall QOL of most cancer survivors, including those who have received CNS or SCT, is comparable to that of the general population.
Racial disparities in survival of adult T-cell leukemia/lymphoma patients in the United States: A SEER database analysis.
Authors: Raj Renju V. , Basu Sanjib , Boggio Lisa N , Fung Henry C. , Gregory Stephanie A. , Venugopal Parameswaran , Rich Elizabeth Shima
Published: March 2020

e16503

Background: Adult T cell Leukemia/Lymphoma (ATL) is an aggressive lymphoproliferative disorder etiologically linked to Human T cell Lymphotropic Virus -1 (HTLV-1). HTLV-1 infection is endemic in areas of Japan, the Caribbean, South America, and Africa. ATL runs a very aggressive clinical course. It is a rare malignancy in the United States (US), and epidemiologic data are limited. We undertook a Surveillance Epidemiology and End Results (SEER) based database analysis to identify survival data of ATL patients (pts) with emphasis on race and ethnicity. Methods: We used the SEER 17 Registry data (1973-2008) for pts with a confirmed diagnosis of ATL. ICD-O-3 code 9827/3 was used to identify pts with ATL. The following exclusion criteria were used: diagnosis at death certificate or autopsy, no follow-up records, diagnosis of second malignancies or lack of documentation of sex or age at diagnosis. The Kaplan Meier method was used to evaluate survival in different races. Statistical tests were done utilizing R statistical software. Results: 272 patients were included in the final analysis (126 females; 146 males). Pts were stratified by race: White (155), Black (80), Other (33), Unknown (4). Median age (yr) of diagnosis in Blacks (51.5) was lower than in Whites (65) and other races (65). Average age of diagnosis in Blacks was significantly lower compared to Whites (p=0.002) and non-Blacks (p=0.0008). Survival analysis of the study group showed a median overall survival (OS) of 13 mo (95%CI 10-16). Whites had a higher median OS (21 mo) compared to blacks (5 mo); the difference in survival was strongly significant (Log-rank p-value < 0.001). Differences in survival between blacks or whites compared to other ethnic and unknown racial groups (n=37) were not statistically significant. Conclusions: ATL is a rare malignancy with poor prognosis in the US. Epidemiologic data on survival are limited. Blacks tend to have an earlier onset of disease and a poor prognosis compared to whites. The reasons for this aggressive course and earlier age of diagnosis in blacks are unknown.
Second-year results of the first large-scale, multistate BCBS clinical oncology pathway program.
Authors: Koeller Jim M. , Kreys Eugene
Published: March 2020

e16522

Background: Clinical pathways (CP) are viewed as valuable practice tools leading to presumed cost savings, however none have been fully implemented on a state-wide scale. CareFirst BCBS partnering with P4 Pathways implemented a multi-state oncology CP program in Aug., 2008. The CP included both chemotherapy (chemo) and supportive care (SC). Our study goals were to determine year (yr) 2 physician (MD) compliance (compl) to CP, their effects on drug and hospitalization (hosp) cost, and their ability to curb projected cost increases. Methods: This study used a retrospective single-group, pretest-posttest design. Data representing pre-CP yr -1 (2007-08) and two years after CP initiation, yr +1 and +2 (08-10) were obtained from claims data. The dataset contained breast, colorectal and lung cancer. One claim from each of the 3 yrs was needed for site eligibility. First and 2nd yr compl was defined as 65% and 80%, respectively, use of chemo regimens according to CP by site. Compl for SC was defined as 80% use of agents per CP for each year. Drug and hosp (occurring within 30 days of chemo regimen) cost were calculated. Savings were determined by extrapolating results on a per patient basis and comparing them to projections cost increases for yr +2. Results: Overall, 46 sites representing 193 MD’s, 4713 pts and 110,203 claims met inclusion criteria. The uncorrected site compl rate for chemo was 83% and 54% for yrs +1 and +2 respectively, while SC site compl was 74% for both yrs. Compared to yr -1, per patient drug expenditures ↑ by 5.8% in yr +1 and 2.7% in yr +2. Per patient hosp costs ↓ by 4.2% in yr +1 and 8.3% in yr +2 compared to yr -1. Total hosp costs ↓ by 28.4% in yr +1 and 63.4% in yr +2 compared to yr -1. Using national data to project drug cost ↑ of 14.5% and hosp cost ↑ of 9.5% yearly over yrs +1 and +2, the CP provided an estimated $36 million in savings by yr +2, with $23 million due to drug and $13 million due to hosp. An absolute $7+ million savings for yr +2 would still have been seen if we assume no ↑ in drug & hosp spending over the 2 yr period. Conclusions: Reasonable MD compliance can be achieved on broad scale use of CP. CP reduce chemotherapy and hosp expenditures, although an increase use in supportive care was seen. Total costs savings can be substantial.
Readability of websites containing information about prostate cancer treatment options.
Authors: Ellimoottil Chandy , Polcari Anthony , Kadlec Adam , Gupta Gopal Nand
Published: March 2020

e16544

Background: 90 million adults have literacy skills that test below a high school reading level. Websites written above this level can pose a challenge for those seeking more information about prostate cancer treatment options. In this study, we determine the readability of selected websites, using a systematic search process and validated readability formulas. Methods: We identified the three most popular keywords (“prostate cancer,” “prostatectomy,” and “prostate cancer treatment”) from 513 terms related to prostate cancer treatment options. Three physician searchers (CE, AP, AK) systematically collected 270 websites from the top three search engines, representing 95 % of all internet searches (Google, Yahoo, and Bing). We excluded sites that were non-English, not primarily text, irrelevant and/or duplicated, and then categorized the remaining sites by source (government, academic practice, nonacademic practice, commercial, nonprofit, news, health website, other) and treatment type. We used validated readability instruments, the Flesch-Kincaid (FK) grade level and Flesch reading ease, to calculate scores for each site. We also calculated an intraclass correlation coefficient, in order to assess inter-rater agreement among our three searchers. Results: Sixty-two unique websites were available for analysis. The mean FK grade level of all sites was 11.4 (SD +/- 0.95, range 8.0-12.0), indicating that on average, passages were written at an eleventh grade reading level. The mean Flesch reading ease score on all sites was 35.6 (SD +/- 15.7, range 0.0-65.5), indicating that on average, passages were slightly easier to read than passages more suited for university graduates (0-30). Only three sites (4.8%) were written below a high school reading level (< 9.0). The intraclass correlation coefficient between the three searchers was 0.96 for grade level and 0.97 for reading ease. Conclusions: Few websites with discussions on prostate cancer treatment options are written below a high school reading level. This is problematic for patients with a low literacy level who search online for more information. Clinicans should be aware of this finding and guide patients to websites written at their patient's reading level.
Geographic disparities in care: The Maryland gynecologic oncology experience.
Authors: Fleming Saroj , Amrane Selma , Rao Gautam G. , Temkin Sarah Madhu
Published: March 2020

e16546

Background: Women with gynecologic malignancies require highly specialized care that is often unavailable at local centers. Prior reports have suggested that distance from residence to treatment facility is a barrier to care. We hypothesize that insurance status influences the distance women travel to receive gynecologic cancer care. Methods: Patients with incident gynecologic cancer diagnoses at a single urban, academic Institution were identified. Distance from the patients’ homes to the hospital was calculated in miles as well as time. Insurance status at diagnosis was captured as private (P), Medicaid (MA), Medicare (MC) or uninsured (UI). Results: 153 patients were identified. The median distance travelled to the hospital was 18.1 miles with a median time travel of 28 minutes. 48 (31%) of patients were insured by P, 42 (27%) by MA, 35 (23%) by MC and 28 (18%) were UI. Patients with MC were older than those with MA, P or UI (p<0.01). Patients with P were more likely to present with cancer of the uterine corpus (p<0.01). African American women were more likely to be covered by MA than other racial groups (p<0.01). Rates of medical comorbidities (obesity, diabetes and hypertension) were similar between insurance groups, although there was a trend towards higher body mass index in UI (p=0.08). Mean distance and time to the hospital by insurance category is shown in Table 1. The distances and times were different between groups (p=0.04, p=0.03 respectively). These differences remained significant when adjusted for site of primary disease and race (p<0.01). Adherence with treatment recommendations was similar regardless of insurance status or distance travelled. Conclusions: Insurance status plays a role in the distance women travel to receive gynecologic cancer care. The neediest patients may be shouldering an unfair burden in terms of access to specialty oncology treatments. [Table: see text]
Correlation between 21-gene recurrence score assay with Nottingham prognostic index (NPI) and Adjuvant! Online (AO) prognostic tools in newly diagnosed patients with early-stage breast cancer in midwestern Ireland.
Authors: Quintyne Keith Ian , Woulfe Bernie , Gupta Rajnish K.
Published: March 2020

e16551

Background: Prognostic tools such as NPI and AO have been used to help stratify early stage breast cancer patients into specific risk-related groupings. With the development of molecular biological gene expression assays, both predictive and prognostic information for patients with early stage endocrine positive breast cancer can be determined. We herein report our experience with the use of a 21-gene recurrence score (RS) assay, it’s correlation with NPI and AO, and explore the comparative outcome for patients in MWCC, Limerick, Ireland. Methods: Study period: 01/09/2008 – 31/12/2012. Data was derived from (1) MWCC Oncology database (2) MWRH pathology reports (3) MWRH patient files (4) RS assay reports. Data was collated and entered into an Access database and exported into Predictive Analytics Software for analysis. Results: Seventy-seven (77) patients with early stage endocrine positive breast cancer were analysed. Median age: 55.9 years (range: 30.6 – 72.3 years). Median follow-up: 15.4 months. NPI distribution was: excellent – 9%, good – 53%, moderate – 38% and poor – 0%, with median NPI score – 3.36. RS distribution was: low – 49%, intermediate – 43% and high – 8%, with median RS – 18. The RS correlated poorly with NPI predictions. The median AO benefit 10-year survival with no additional therapy – 81.4%, the median AO additional benefit 10-year survival of chemotherapy (CT) – 1.2% and median AO additional benefit 10-year survival of CT and hormonal therapy (HT) – 3.9%. The RS also correlated poorly with AO predictions. Conclusions: Prognostic tools are useful in evaluating and predicting the possible outcome, but they do not correlate well with this 21-gene RS molecular assay, as seen with our cohort. These tools should therefore be used in tandem, together with good clinical judgement on an individual basis when advising patients on potential treatment pathways. Further long term evaluation is required.
Early-phase (EP) clinical trials (CTs) in the community: Results from the National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP) Early-Phase Working Group (EPWG) Baseline Assessment Study (BAS).
Authors: Go Ronald S. , Zaren Howard , Nair Suresh G , Lanier Keith S. , Thompson Michael A. , Enos Rebecca A. , Zhao Jinxiu , Fleming Deborah L. , Leighton John Charles , Gribbin Thomas Edward , Bryant Donna M. , Carrigan Angela , Corpening Jennifer C. , Csapo Kimberly A. , Dimond Eileen P. , Ellison Christie , Gonzalez Maria Magdalena , Harr Jodi L. , Wilkinson Kathy , Denicoff Andrea ,   NCCCP Early-Phase Working Group
Published: March 2020

e16561

Background: The NCCCP is a network of 30 community cancer center (CCC) sites that strive to expand cancer research capacity and deliver advanced care in the community. The EPWG was formed to facilitate NCCCP site participation in EP (phase I-II) CTs, thus allowing patients (pts) to be treated within their communities. This study describes the CT infrastructure at NCCCP sites and its association with EP accrual. Methods: A BAS was conducted to obtain data on NCCCP site CT infrastructure, funding, sponsor affiliations, and barriers to EP CTs. To evaluate EP performance, EP accruals during July 2010-June 2011 were obtained. High accruing sites were those with EP accrual above the median EP accrual per 1,000 new analytical cases seen in 2009 or 2010. Results: 27 sites, caring for ~56,000 new cancer pts annually, participated in the study. Median number of accruing EP trials/site was 6 (mean 7.4). Median EP accrual/site was 14 (mean 16). Median EP accrual rate was 7/1,000. Trials with a phase I component were open at 21 sites. Most sites (24) are members of multiple CGs (median 4) and enroll pts via the CTSU (70%). The more common barriers to EP trial implementation were related to infrastructure (59%), cost (52%), and access to trials (41%). When accrual rates to NCCCP CTEP EP trials only were analyzed, we found that between high vs low accruing sites, respectively, higher accrual rates were associated with higher number of CRAs devoted to EP trials (median 3.25 vs 1; P= .05) and lower proportion of funding from industry (median 18% vs 40%; P=.02). We did not, however, find significant associations when EP trials were examined across all sponsors. Conclusions: CCCs are capable of conducting, and actively participating in, EP trials. Infrastructure and collaborations are critical components of success. Our study provides useful information for those planning to begin EP trials in the community setting. [Table: see text]
Paclitaxel-based high-dose chemotherapy (HDCT) for relapsed or refractory germ cell tumors (GCTs): Clinical outcome and quality of life (QOL) in long-term survivors.
Authors: Carmichael Courtney , Sun Virginia , Ferrell Betty R. , Frankel Paul Henry , Margolin Kim Allyson , Pal Sumanta Kumar
Published: March 2020

e16563

Background: HDCT is a viable and potentially curative approach for patients with relapsed or refractory GCTs. However, no comparative data exist to define the optimal chemotherapeutic strategy. Herein, long-term follow-up data and QOL assessments are provided for an expanded cohort of patients treated with high-dose paclitaxel, etoposide, carboplatin, and ifosfamide (TECTIC). Methods: Details of the TECTIC regimen and clinical follow-up data for an initial 33 patients have been previously reported (Margolin Biol Blood Marrow Trans 2005). Surviving patients were surveyed using a modified EORTC Quality of Life Questionairre-30 (QLQ-C30) and the Functional Assessment of Cancer Therapy-Taxane (FACT-T) questionnaire; results were compared to relevant historical cohorts using a 2-sample t-test. Cardiovascular morbidity (CM) was ascertained through queries regarding use of antihypertensive (AH) or cholesterol-lowering (CL) agents, and presence/absence of diabetes mellitus (DM). Results: Forty-six patients received protocol-based therapy. Of these, 17 patients were progression-free at a median of 112.7 mos (49.5-170.2), and 6 patients remain alive following progression with a median overall survival (OS) of 64.4 mos (43.6-147.1). Median progression-free survival (PFS) and OS were 11.8 mos (95%CI 5.8-NR) and 21.7 months (95%CI 12.7-NR), respectively. Of the 23 patients still alive, 18 patients were accessible and consented to telephonic interview. As compared to historical cohorts (Rossen J Clin Oncol 2009), survivors had a higher global health scale score (87.04 v 75.62; P=0.02) but a lower physical functioning score (68.89 v 92.66; P=0.0001) by the QLQ-C30 scale. No difference in FACT-T scores were observed as compared to historical cohorts (Cella Cancer 2003). Four patients (22%) had DM. Three patients (17%) and 4 patients (22%) reported use of AH and CL agents, respectively. Conclusions: HDCT with the TECTIC regimen produces durable remissions in patients with relapsed or refractory GCTs, with acceptable QOL and CM in long-term survivors.
Breast cancer in the elderly: An area for improvement.
Authors: Jasra Sakshi , Sharma Vipra , Cohen Alice J. , Jabel Nicole
Published: March 2020

e16565

Background: Treatment (TX) of breast cancer (BC) in elderly (E) patients (pt) can be problematic due to the increased co-morbidities (CM), multiple medications, and cognitive dysfunction related to age. Due to this many E pt are less likely to have standardized treatment (TX). This study was undertaken to assess if pt over the age of 70 diagnosed with BC received TX based on NCCN guidelines and what CM led to selection of therapies. Methods: A retrospective review at a tertiary care medical center identified 108 pt over the age of 70 with BC from 2001-2011. Clinical data was obtained regarding race, age, stage (ST) at diagnosis, TX, CM, estrogen receptor (ER), progesterone receptor (PR), and HER2neu receptor (H2N) status. Results: Of the 108 pts, 22% were Caucasians, 66% were African-American, 3% Asian, 6% Hispanic, and 2% other. The age range was 70 to 96 years, mean of 75. Staging was as follows: 23% DCIS, 24% ST I, 28% ST II, 9% ST III, and 7% ST IV. 66% were ER positive (+), 60% PR+, and 87% H2N negative. H2N status was not available on 9% of the pts. In 92% of the pt surgical intervention (SI), either lumpectomy (L) with radiation therapy (RT), or mastectomy (M) was done (see table below). 8% of pt either refused SI or were lost to follow-up. ER/PR+ pt hormone therapy (HT) was started in 95% of pt. 3% of ER/PR+ pt refused HT. In stage II and III 60% of pt had adjuvant chemotherapy (CT), only 5% refused CT. In ST IV 30% had HT alone, 50% with CT and HT, and 25% with RT to chest wall for local recurrence. Only 23% of H2N positive pt received Herceptin. 52% of the CT used in stage II and III was cyclophosphamide, methotrexate, fluorouracil (CMF). CM in the CMF pts were as follows 90% cardiovascular disease (CAD), 53% arthritis (AR), 13% history malignancy, and 13% pulmonary disease. In the pt who refused SI, and/or CT the most common CM were 70% CAD, 50% AR, and 25% dementia. Conclusions: The majority of the E BC pt in this cohort had significant CM that made TX challenging. Some pt were not offered appropriate CT (i.e., trastuzumab) due to CM. Age impacts BC TX, but should not hinder the pt receiving optimal tx. Further studies with women over the age of 70 with BC is required to determine the most appropriate TX in this subset of pts. [Table: see text]
Patient and caregiver satisfaction with ambulatory oncology care: Agreement and predictors.
Authors: Hannon Breffni , Jayasuriya Chami , Swami Nadia , Le Lisa , Zimmermann Camilla , Rodin Gary
Published: March 2020

e16567

Background: Little is known about the level of agreement between patient and caregiver individual reports of satisfaction with healthcare, and no such study has been conducted in the advanced cancer setting. Our aims were to assess the level of agreement in satisfaction with oncology care, between patients with advanced cancer and their caregivers, and to identify factors associated with satisfaction. Methods: Patients with advanced cancer and their caregivers were recruited from ambulatory oncology clinics. Satisfaction with care was measured using FAMCARE- patient and caregiver versions. Patients completed measures of symptom severity (ESAS) and quality of life (FACT-G, FACIT-Sp). Caregivers completed a quality of life measure (CQOL-C). Agreement between patient and caregiver satisfaction scores was assessed using ICC and weighted kappa statistics; multivariable regression was used to determine individual predictors of satisfaction. Results: For the 191 patient-caregiver pairs, caregivers were less satisfied than patients (mean FAMCARE score 67.5 vs. 65.7 out of a possible 90, p=0.02). Overall agreement between patients and caregivers was moderate (ICC = 0.59). Agreement for individual items on FAMCARE was low (kappa range = 0.11-0.37). Both patients and caregivers were least satisfied with information on managing pain and information regarding prognosis. Factors associated with patient satisfaction were lower education level, better quality of life, and less symptom severity; caregiver satisfaction was associated with lower education levels, and better quality of life. Conclusions: Despite considerable discrepancy between caregiver and patient ratings, there was agreement regarding which elements of care needed most improvement. Greater attention to pain control and communication regarding prognosis would further improve patient and caregiver satisfaction with care in advanced cancer
Patient-reported symptom burden and quality of life in advanced lung cancer.
Authors: Iyer Shrividya , Rider Alex , Taylor-Stokes Gavin , Roughley Adam
Published: March 2020

e16570

Background: The main objective of our study was to assess patient reported symptom burden and impact on quality of life in advanced non small cell lung cancer (NSCLC) patients in the United States. Methods: Patients with advanced (stage IIIB/IV) NSCLC (N=450) were recruited with informed consent in a nationwide (US) lung cancer study from Oct-Dec 2011. Patient reported symptoms were assessed using the Lung Cancer Symptom Scale (LCSS) on a 0-100 visual analogue scale and included six symptoms: fatigue, appetite loss, shortness of breath, cough, pain and blood in sputum. An average symptom burden index was calculated. Quality of life was assessed using the Functional Assessment of Cancer Therapy- Lung (FACT-L).Higher scores indicate higher symptom severity on the LCSS and better quality of life on the FACT-L. Correlation between the total FACT-L score and LCSS symptom burden index was assessed. A multivariate regression analysis was performed with FACT-L total score as the dependent variable and LCSS symptom scores as predictors controlling for age, gender, stage and performance status. Results: Majority of the patients were male (59%), Caucasian (74%), smokers/ex-smokers (78%) with an average age of 64 years. Proportion of patients reporting each lung cancer symptom was: Fatigue (100%), loss of appetite (97%), shortness of breath (95%), cough (93%), pain (92%) and blood in sputum (63%). The average (SD) symptom burden index was 42.3 (21.5).The mean± SD severity scores on symptoms were: fatigue (53.2±24.7), loss of appetite (48.1±25.8), cough (48.4±29.9), shortness of breath (44.7± 27), pain (39.7± 28.1) and blood in sputum (18.4±23.6). The average (SD) FACT-L score was 71.7 (25.3). A significant negative correlation was found between the LCSS symptom burden index and FACT-L scores (ρ= -0.82; p<0.001). Loss of appetite (β=-0.204; p<0.001), cough (β= -0.145; p<0.01), pain (β=-0.265; p<0.001), shortness of breath (β = -0.145; p<0.01), age (β= 0.217; p<0.05) and performance status (β = 0.283; p<0.001) were found to be significant predictors of quality of life. Conclusions: Cough, pain, shortness of breath and loss of appetite contribute to symptom burden and have a significant negative impact on quality of life in advanced NSCLC patients.
Daily performance status-based target physical activity of early rehabilitation for hematologic malignancy patients after allogeneic hematopoietic stem cell transplantation.
Authors: Inoue Junichiro , Ono Rei , Okamura Atsuo , Kiyota Naomi , Makiura Daisuke , Kashiwa Miyuki , Miura Yasushi , Kurosaka Masahiro , Saura Ryuichi
Published: March 2020

e17020

Background: For hematologic malignancy patients receiving allogeneic hematopoietic stem cell transplantation (allo-SCT), the maintenance and/or increase of physical activity (PA) after allo-SCT possibly lead to favorable outcomes. However, it remains to be clarified how much intensity of daily rehabilitation should be prescribed. The aim of this study was to evaluate target PA according to daily performance status (PS) in these patients. Methods: Twenty-seven allo-SCT patients were enrolled in this study (13 males, 14 females, the median age; 47 years). Written informed consent was obtained from all patients. Donor types were bone marrow (n = 12), peripheral blood stem cell (n = 6), and single-unit cord blood (n = 9). All patients received our established exercise program supervised by physical therapists just after neutrophil engraftment in a bioclean room. As an alternative value of PA, daily steps (DS) were measured by using a uniaxial pedometer (Lifecorder EX, Suzuken Co. Ltd., Nagoya, Japan), and Eastern Cooperative Oncology Group PS after allo-SCT were also assessed daily for each individual. The data were statistically analyzed by using ANOVA and Scheff 's tests. Results: A correlation between DS and PS was observed. After the early physical intervention, the mean DS of patients with PS 1, 2, or 3 in a bioclean room were 2,411 ± 1,068, 1,205 ± 572, and 597 ± 216 steps/day, respectively. DS significantly declined by about 50% according to one grade deterioration of PS. Conclusions: As the target PA correlated with PS seems to be existence, we should plan daily activity in a bioclean room to keep more than above-mentioned mean DS according to daily PS for allo-SCT patients.