bluuebunny/crossref_metadata_2025 huggingface dataset:
Young adults with squamous cell head and neck cancer: Ten years of a single institution’s experience (1999-2008).
Authors: Alves Marcos Pantarotto , Martins Ferreira Castro Ana Filipa , Lombo Liliana , Rodrigues Helena , Silva Jose D. , Azevedo Isabel
Published: March 2020

5567

Background: Head and neck cancer of squamous cell type (SCHNC) is characterised by its aggressiveness and strong relationship with smoking and drinking habits. It is generally diagnosed in locally advanced stages, mainly in middle-aged men. People younger than 35yo are rarely affected by this disease, and little is known about its behaviour among young Portuguese adults. Our aim was to describe the clinical and epidemiological features of young adults with diagnosis of SCHNC in a single oncological centre in Portugal. Methods: Retrospective cohort including clinical registries’ databases for patients (pts) with diagnosis of SCHNC, with 3391 eligible pts from 1999 to 2008. Pts aged ≧18yo and ≤35yo at diagnosis with histopathological diagnosis in our Institution were included. Pts admitted to radiation therapy with no follow-up information were excluded. 39 pts fulfilled the criteria described, comprising the study population. Statistical analysis was carried out using SPSS v19.0 for Mac (IBM, 2010, EUA), with values of p<0,05 considered significant. Results: Male sex predominance (82%) was observed. The median age of presentation was 33 yo [22; 35], with 90% smokers with a median of 18,5 package-years [1; 48]. Alcohol consumption was mild to moderate (n=9; 23%) or heavy (n=15; 38%). The median of follow-up time was of 24 months [1;151]. Locally advanced diseased was present at diagnosis in 24 pts, where localised disease was commonest among women (57%) than in men (29%). Median overall survival (OS) was not reached on this population, although K-M graphs seems to show a significant difference in survival between sexes. Alcohol consumption was the most significant variable to influence the survival (p<0,01). Conclusions: SCHNC in young people is a rare condition, with distinct epidemiological and clinical features. Women seems to have greater survival rates, which may be explained by other risk factors already reported for this gender, namely HPV infection. The finding of an apparent relationship between alcohol consumption and OS, and the high prevalence of alcoholic intake habits on this parcel of the population, urge the need of development of public health programs addressed to this specific age group.
Impact of p16 status on the QOL effects of chemoradiation for locally advanced oropharynx cancer: Results of TROG 02.02.
Authors: Ringash Jolie , Fisher Richard , Peters Lester J. , O'Sullivan Brian , Trotti Andy , Kenny Lizbeth M. , Young Richard J. , Rischin Danny
Published: March 2020

5571

Background: We report the impact of p16 status on quality of life (QOL) for patients with stage III or IV (excluding T1-2N1 and M1) squamous cell carcinoma of the oropharynx (OPC) treated with concurrent chemoradiotherapy in a large international phase III trial (TROG 02.02/HeadSTART). Methods: The 861 patients accrued received definitive radiotherapy (RT) (70 Gy/7 weeks) concurrently with 3 cycles of either cisplatin (100mg/m2) or cisplatin (75 mg/m2) plus tirapazamine (290 mg/m2/day) by random assignment, as previously described. QOL was measured with the FACT-H&N at baseline, 2,6,12, 23 and 38 months. No significant difference in overall or subscale QOL score change from baseline was observed between arms at any subsequent time point; results for the oropharynx subgroup by p16 status are reported for both treatment arms combined. Results: Of 853 eligible participants, 465 had OPC, for whom p16 status could be determined in 206. Of 179 who received adequate RT (≥ 60 Gy, no major deviations) and completed baseline QOL, 104 were p16+ and 79 were p16-. p16+ patients had better baseline ECOG PS, lower T-category, higher N-category, were younger and were less likely to be current smokers. Baseline mean FACT-H&N score was statistically and clinically significantly better in p16+ patients (111 vs. 102, p=0.001). The drop in QOL from baseline to 2 months was more severe in p16+ cases (-20.4 vs -9.1, p=0.001), resulting in an equalization of 2 month scores (p16+: 90.6, p16-: 93.6, p=0.16). At 6 and 12 months post-treatment, no difference in score changes from baseline by p16 status was seen (6 mo, p16+: -6.2, p16 -:-1.2, p=0.22; 12 mo, p16 +: -0.3, p16 -: +2.0, p=0.82). Conclusions: p16 associated oropharyngeal cancer has been shown to be a distinct entity with different demographic features. In our study, such patients exhibited better baseline QOL and a more severe drop immediately after treatment, but did not differ in long-term QOL response to the effects of aggressive concurrent chemoradiation. Given the favorable prognosis of p16-associated oropharyngeal cancer, efforts to reduce the QOL burden of treatment are warranted.
Importance of HPV involvement and FOXP3+ T-cell status as prognostic factors in tonsilar squamous cell carcinoma.
Authors: Park Kwonoh , Cho Kyung-Ja , Yoon Dok Hyun , KIM Jiyoun , Kim Sang Yoon , Nam Soon Yuhl , Choi Seung-Ho , Han Myung Woul , Lee Sang-wook , Song Si Yeol , Kim Sung-Bae
Published: March 2020

5586

Background: Human papillomavirus (HPV) status is a strong and independent favorable prognostic factor for survival in tonsilar squamous cell cancer (TSCC). The reason for the improved survival in HPV associated TSCC is unclear. Recently, activation of immune surveillance mechanism against non-self Ag is postulated to one of reasonable causes as favorable prognosis of HPV associated with TSCC. Methods: We reviewed the medical records of histologically confirmed locally advanced TSCC patients, curatively treated in Asan Medical Center from January 2000 to December 2008. The immunohistochemistry (IHC) assays for p16 and FOXP3 were done in TSCC pafaffin-embedded samples. Results: We identified 79 patients who met the inclusion criteria. The median age was 54 years (range 32-76) and 16 (20%) patients were stage III and the others were all stage IV. With the median follow up of 62.9 months (95% CI, 59.2 - 66.7), sixty three (80%) were HPV-positive with p16 overexpression, and 38 (48%) were Treg-positive with FOXP3. Treg involvement was significantly related to HPV positive status (P=0.011). The result was the same after adjustment of age, T & N stage, smoking exposure and alcohol consumption. (Odd ratio = 6.54, 95% CI 1.58-27.1, P=0.01) Five-year overall survival (OS) rate in HPV-positive group was significantly higher than that of HPV-negative group (78% and 63%, Hazard Ratio (HR)=0.347, 95% CI 0.14-0.87, P=0.025), and 5-year OS of Treg-positive group was also higher than that of Treg-negative group (89% and 61%, HR=0.158, 95% CI 0.05-0.53, P=0.003). In multivariate analysis, the Treg status was an independent prognostic factor (HR=0.11, 95% CI 0.03-0.40, P=0.001), as well as HPV status. (HR=0.28, 95% CI 0.10 - 0.78, P=0.016). Conclusions: HPV positivity was associated with Treg positivity in TSCC and both were found to be favourable prognostic factors for survival.
Pretreatment neurocognitive function (NCF) status in head and neck cancer (HNC) patients (pts) with comparison to control cohort.
Authors: Abdul Razak Albiruni Ryan , Gan Hui Kong , Pond Gregory Russell , Tirona Kattleya M , Chen Eric Xueyu , Chan Kelvin , Hope Andrew J. , Kim Joon-Hyung J. , Siu Lillian L. , Bernstein Lori J
Published: March 2020

5587

Background: There is increasing evidence that NCF abnormalities may occur in cancer pts. Data on pre-treatment NCF in HNC pts are lacking. This study reports NCF in pts with newly diagnosed, curable HNC compared to controls. Methods: HNC pts underwent a 2-hour battery of NCF tests prior to radio +/-chemo(bio)therapy. Domains tested were intelligence (IQ), memory, language, attention, processing speed, executive function and manual dexterity. Test performances were transformed into Z-scores using normative data (score < -1 signified deficit). Pts also had self-reported assessments for NCF, quality of life (QOL), fatigue and affect. Data obtained were compared to non-cancer controls who underwent the same tests. Results: Eighty HNC and 30 control subjects were assessed. Objective NCF testing demonstrated that HNC and control cohorts were similar across all domains, except for IQ, with pts having higher scores (mean 0.55 vs 0.12, p=0.03). However, individual analysis showed that 39% of HNC and 43% of control subjects had abnormal Z-scores in ≥ 2 domains. Multivariable analysis of factors associated with ≥ 2 abnormal NCF domains included: low education level, significant smoking history (≥ 10 pack year), previous mild brain injury, gender, and group (pt vs control). Amongst pts, HPV -ve status and non-oropharyngeal tumors were also associated with decreased NCF. Pts reported statistically worse subjective baseline symptoms compared to controls: NCF (mean FACT-COG 33.7 vs 18.2, p=0.002), QOL (FACT H&N 33.8 vs 14.9), fatigue (FACT-F 35.1 vs 15.1), anxiety (HADS 7.0 vs 3.1) and depression (HADS 3.9 vs 1.2), p<0.01 for all five parameters. Conclusions: Objectively assessed NCF was similar between HNC pts and controls, but a proportion of participants in both cohorts have multi-domain abnormal Z-scores. Several patient demographics and disease characteristics were associated with abnormal NCFs. Subjectively, pts reported worse NCF, QOL, fatigue and affect. These data suggest that participant and disease characteristics may play a larger role in determining NCF than previously shown. Whether such characteristics impact subsequent NCF is under investigation in a longitudinal study.
Long-term survival after distant metastasis in oropharyngeal carcinoma.
Authors: McBride Sean M , Busse Paul M. , Clark John Ross , Parambi Ron J. , Wirth Lori J. , Chan Annie W
Published: March 2020

5594

Background: The possibility of cure after distant metastases (DM) in oropharyngeal carcinoma (OPC) is uncertain. We conducted a retrospective cohort study to determine outcome and factors predictive of survival after metastasis in patients with OPC. Methods: From 2003-2010, 24 patients definitively treated (96% with concurrent chemo-radiation) at the Massachusetts General Hospital for OPC subsequently developed DM. At initial diagnosis, HPV status was available in 13 patients, 12 of whom were positive; six patients had T4 and 12 N2c-3 disease. Imaging studies pertinent to the diagnosis of DM were re-reviewed; 83% of patients had DM pathologically confirmed. Overall survival (OS) was defined from 1st radiographic evidence of DM to either death or last follow-up. Cox regression was used to evaluate factors predictive of OS after DM. Results: Median time to DM after initial treatment was 8.25 months (range, 1.6-24). Twenty (83%) patients had isolated distant failure; of these, 6 had limited (1 lesion or 2 adjacent lesions) single-organ disease. Eighteen (75%) had treatment after DM (83% had chemotherapy, 61% radiation, and 33% surgery). Median survival after distant metastasis was 19.2 months. Median follow-up for survivors was 23.5 months (range, 7.9-60.3). In multivariate analysis, limited single-organ disease (HR=0.14, p=0.01, 95% CI 0.031, 0.67) was predictive of improved survival after DM; T4 disease at initial diagnosis predicted for decreased OS after DM (HR=3.9, p=0.01, 95% CI 1.31, 11.89). For patients with limited single-organ disease, the 2-year OS was 82% compared to 32% with extensive metastases (p = 0.006). Of the 6 patients with limited, single-organ metastatic disease, two remained alive at 59.4 and 60.5 months without evidence of disease; both had HPV-positive tumors. One patient had a solitary hepatic failure and received neoadjuvant chemotherapy followed by partial hepatectomy; the other had a solitary lung metastasis and received wedge resection followed by radiation. Conclusions: Limited, single-organ metastatic disease predicts improved survival after DM in OPC. Cure is possible in this group. Patients with limited, single-organ distant disease should be considered for aggressive, local salvage treatment.
Assessment of the prognostic and predictive utility of the breast cancer index (BCI): An NCIC CTG MA.14 study.
Authors: Sgroi Dennis , Goss Paul Edward , Chapman Judy-Anne W. , Richardson E. , Binns Shemeica N. , Zhang Yi , Schnabel Catherine A. , Erlander Mark G. , Pritchard Kathleen I. , Han Lei , Shepherd Lois E. , Pollak Michael N.
Published: March 2020

561

Background: Breast Cancer Index (BCI), a continuous risk index, combines the ratio of HOXB13 to IL17BR (H/I) and the molecular grade index (MGI) (Jerevall et al., British J Cancer, 2011). Here, the prognostic and predictive performance of BCI for BC relapse in MA.14 trial was examined. Methods: MA.14 randomly assigned 667 hormone receptor positive (HR+) women to 5 years of tamoxifen (TAM) +/- 2 years of octreotide LAR (TAM-OCT). A representative subgroup of 299 patients was profiled by RT-PCR for BCI. The primary objective was to determine the prognostic performance of BCI based on relapse-free survival (RFS) with median 9.8 years follow-up. Association of BCI was assessed with step-wise forward stratified Cox regression. Pre-defined categories of low (L), intermediate (I) and high (H) BCI risk groups were used to provide adjusted 5- and 10-year RFS. Results: 292 of 299 patient samples passed internal analytical quality control. The 292 patients contained 49% LN+ patients and had 19.9% BC relapses. Both continuous and pre-specified BCI risk groups were significant multivariate factors (p<0.0001; p=0.007) with higher BCI associated with shorter RFS. Adjusted univariate hazard ratios and 95% CI were 2.53 (1.36 – 4.71) for BCI-H vs -L and 1.28 (0.65 – 2.52) for BCI-I vs -L. With both LN- and LN+ included, BCI-L had 5- and 10-year RFS of 94.0% and 87.5%; -I, 91.8% and 83.9%; and -H, 81.5% and 74.7%. No significant difference in BCI’s ability to stratify patients into 3 risk groups was observed between LN-/no chemotherapy subgroup vs balance of MA.14 patients (p=0.26). Higher pathologic T-stage was multivariately associated with shorter RFS (p=0.01). Interactions between trial therapy and BCI was not significant (p=0.40). Conclusions: This study confirmed the strong prognostic effect of BCI on breast cancer recurrence. BCI was prognostic in both LN- and LN+ patients. The lower 10-year RFS in the BCI-L group than in our previous studies reflected the mixed LN-/LN+ population examined. Like the parent MA.14 trial, BCI did not predict benefit of adding OCT to TAM therapy (Pritchard et al., J Clin Oncol, 2011). This retrospective study is an independent validation of the prognostic performance of BCI within a prospective trial.
Fertility preservation options and the young breast cancer patient: A survey.
Authors: Junqueira Manuela Jacobsen , Goldfarb Shari Beth , Oppong Bridget A. , Patil Sujata , Eaton Anne , Olcese Cristina , Morgan Jessica , Kelvin Joanne Frankel , Dickler Maura N. , Gemignani Mary
Published: March 2020

575

Background: Approximately 15% of breast cancers (BC) are diagnosed in reproductive aged women. Management of the disease in this age group frequently includes chemotherapy and hormonal therapy, which can both affect fertility. Considering that age at first delivery has been steadily increasing, young women may face BC before completion of childbearing. Methods: In this prospective study, women referred to our institution for surgical treatment of BC were asked, before their first visit, to fill out a questionnaire regarding their reproductive history and fertility preservation knowledge. Eligible patients included women between the ages of 18 and 45, with a newly diagnosed BC, who had not yet started treatment. Results: Sixty women were eligible with a median age of 40 (range 20-45). 98% of responders (59 out of 60) had been diagnosed within the previous 2 months. 78% (47/60) had a college or post-graduate degree. 80% (48/60) had been pregnant before, while 86.5% (45/52) reported having had children. 81% (47/58) were premenopausal, and only 3 patients reported not having had periods for more than 1 year. 50% of responders (30/60) declared no interest in future childbearing, 25% were definitely interested, and 25% were undecided. However, only 9% (5/57) reported having received information on fertility preservation options before the survey. Women who have been pregnant were significantly less likely to consider fertility preservation options prior to treatment (egg/embryo/ovarian tissue cryopreservation [6% vs. 50%, p=0.001]), or after treatment (egg/embryo donation, surrogacy or adoption [6% vs. 58%, p<0.0001]). Conclusions: This pilot study was designed to gather information on reproductive health of newly diagnosed young BC patients and to assess their willingness to consider various fertility preservation options before or after treatment. Our study population consisted of mostly women who had been pregnant and had children. We found that 50% of the women were unsure or wanted future children. Yet, only 9% had received information on fertility options at diagnosis. This pilot study highlights the need for education and/or intervention in fertility preservation options for young women with breast cancer.
A multicenter phase II trial of the LH-RH analogue and an aromatase inhibitor combination in premenopausal patients with advanced or recurrent breast cancer refractory to an LH-RH analogue with tamoxifen: JMTO BC08-01.
Authors: Nishimura Reiki , Anan Keisei , Yamamoto Yutaka , Higaki Kenji , Tanaka Maki , Shibuta Kenji , Sagara Yasuaki , Ohno Shinji , Tsuyuki Shigeru , Mase Takahiro , Teramukai Satoshi
Published: March 2020

588

Background: The aim was to provide an endocrine therapy option against advanced (ABC) or recurrent breast cancer (RBC) in premenopausal women. We conducted an exploratory phase II trial in combination with an LH-RH analogue (LH-RHa) and an aromatase inhibitor (AI) to assess the efficacy and tolerability after failure of standard LH-RHa plus tamoxifen (TAM). Methods: Premenopausal patients (pts) with ER+ and/or PgR+ ABC or RBC refractory to LH-RHa + TAM were treated with LH-RHa (goserelin: GOS) and AI (anastrozole: ANA). The primary endpoint was an objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), clinical benefit rate (CBR) based on RECIST, and safety assessed using CTCAE ver. 3.0. Pts with only bone legions were assessed using the criteria by Japanese Breast Cancer Society (14th Ed.). Local assessment (CR, PR or long SD of 24 weeks or longer) was confirmed independently by two radiologists. Results: Between September 2008 and November 2010, 37 pts were enrolled at 10 clinical institutions in Japan. Eleven had recurrence either during, or within one year after the end of adjuvant GOS + TAM (including GOS + TAM followed by only TAM). The disease progressed in 26 women during GOS + TAM. Mean age and BMI were 43.5 years and 22.2 kg/m2, respectively. Thirty-five pts (94.6%) were ER+, and 36 pts (97.3%) were HER2- (one with unknown HER2 status). Non-endocrine treatment included chemotherapy (20 pts; 54%) and radiation therapy (13 pts; 35%). The viscera, soft tissue, and bones were treated in 17, 15 and 14 pts, respectively. Pts with both measurable lesions and bone metastasis, measurable lesions only, and only bone metastasis were 21 (57%), 15 (41%) and 1 (2%), respectively. ORR was 18.9% (95%CI: 8.0-35.2%, 1 CR and 6 PR cases), CBR 62.2% (23 pts, 95%CI: 44.8-77.5%), and median PFS was 7.2 months. Eight pts (21.6%) had adverse events, but none resulted in treatment discontinuation. GOS + ANA was well tolerated. Conclusions: LH-RHa (GOS) + ANA can be a subsequent endocrine treatment for premenopausal pts with ABC or RBC after failure of GOS + TAM.
Racial disparities in breast cancer survival.
Authors: Silber Jeffrey H. , Rosenbaum Paul R. , Clark Amy Sanders , Wang Min , Teng Yun , Ross Richard N. , Ludwig Justin , Niknam Bijan , Even-Shoshan Orit , Giantonio Bruce J. , Fox Kevin R.
Published: March 2020

6000

Background: Reducing racial disparities in breast cancer survival has been a federal priority since the early 1990’s. We present a new method to assess disparities using sequential multivariate matching. We ask if racial disparities have increased or decreased over time and if so, what were potential reasons for such changes. Methods: We studied all women over 65 years of age in the Medicare fee for service system diagnosed with breast cancer between 1991 and 2005 who were treated in one of 12 SEER sites (the sites in SEER since 1991). There were 5,251 black patients (74% early stage (I-III), 9% late stage (IV) and 17% missing stage) and 72,695 white patients (81% early stage, 5% late stage and 14% missing stage). All black cases represented the focal group for all matches. Using multivariate matching and the propensity score, white controls were matched to blacks in steps: (1) White controls matched to black cases on age and year of diagnosis; (2) Age, year of diagnosis, and stage; (3): Age, year, stage, estrogen receptor status, grade, and 30 comorbidities. We then compare 5-year survival in the Pre and Post-Taxane periods (1991-1998, 1999-2005). Results: When whites were matched to blacks on age and diagnosis year, 5-year Kaplan-Meier survival was 69.2% vs. 56.7%, P < 0.0001. Matching additionally on stage, differences = 64.1% vs. 56.7%, P < 0.0001; Matching further on tumor characteristics and 30 comorbidities, the disparity reduced to 61.6% vs. 56.7%, P < 0.0001. Comparing trends over time, white-black differences in survival matched for age and year were 67.6% vs. 55.2% (P < 0.0001) in the pre-Taxane era (difference = 12.4%) and 71.2% vs. 58.7% (P < 0.0001) in the post Taxane era (difference = 12.5%); age and year matched paired racial differences were not different across eras (P = 0.389). Conclusions: While there may have been some improvements in overall survival, racial disparities in breast cancer survival have not improved, despite important policy initiatives and treatment advances. Adjusting for presentation at diagnosis does reduce differences in survival, but even these differences remain large and significant, suggesting that differences in both presentation and treatment given presentation are contributing to this disparity.
Competing causes of mortality in long-term survivors of head and neck cancer.
Authors: Baxi Shrujal S. , Pinheiro Laura C , Patil Sujata , Pfister David G. , Oeffinger Kevin C. , Elkin Elena B.
Published: March 2020

6001

Background: Most head and neck cancers (HNC) recur within the first 3 yrs of diagnosis. Patients who live beyond this time point continue to have an excess risk of mortality. We investigated the causes of mortality in 3-yr survivors of HNC. Methods: We completed a retrospective cohort study using the Surveillance Epidemiology and End Results (SEER) database. We identified patients with a diagnosis of non-metastatic HNC between 1992 and 2005 who survived 3 yrs from diagnosis. The primary outcome was death from all-causes, HNC, non-HNC malignancy, cardiovascular disease (CVD), and pulmonary disease (PD). We estimated the age-adjusted standardized mortality ratio (SMR; observed-to-expected (O/E)) and the absolute excess risk (AER; O-E), for all-cause and cause-specific mortality compared to US population data. Results: 31,772 long-term survivors were identified with disease arising in the larynx (40%), oral cavity (29%), oropharynx (26%), nasopharynx (3%) and hypopharynx (1%). In this cohort, 8191 (26%) were female, 3021 (10%) were black and 15,321 (48%) were younger than 60 yrs. In this cohort, 16,697 (53%) had locally-advanced disease and 8353 (26%), 8721(27%) and 13,919 (44%) received radiation alone, surgery alone or both. With a median follow-up of 6.4 years (3-17 years), there were 10,757 deaths due to: HNC (24%), non-HNC malignancy (31%), CVD (21%), PD (6%), and other causes (19%). Compared to the US population, the all-cause SMR was 5.4 (95% CI 5.3-5.6) with an AER of 336 deaths per 10,000 person-years (py). The greatest excess risk was attributable to non-HNC malignancies (956 per 10,000 py), CVD (533 per 10,000 py) and pulmonary disease (136 per 10,000 py). Conclusions: HNC survivors experience excess mortality compared to the general population. Competing causes of mortality challenge long-term survival. Additional analytic studies with detailed data on tobacco history, treatment characteristics and co-morbidities are required to further evaluate associations with specific causes of death and individualize risk in this heterogenous population of survivors.
Patient-centered medical homes may improve breast cancer surveillance among survivors.
Authors: Wheeler Stephanie B. , Kohler Racquel Elizabeth , Goyal Ravi K. , Reeder-Hayes Katherine Elizabeth , Lich Kristen Hassmiller , Smith Timothy , Melvin Cathy , Moore Alexis , Domino Marisa E
Published: March 2020

6029

Background: Community Care of North Carolina (CCNC) initiated a medical home (MH) program in the early 1990s focused on improving care in Medicaid-insured populations. CCNC has been successful in improving asthma, diabetes, and cardiovascular disease outcomes, but has not been examined in the context of cancer care. We sought to determine whether CCNC enrollment was associated with improved cancer surveillance among breast cancer survivors. Methods: Using state cancer registry records linked to Medicaid claims, we identified women ages 18-64 diagnosed with stage 0, I, or II breast cancer from 2003-2007. We included only cases insured by Medicaid for at least 12 of 15 months following the index cancer diagnosis. Reflecting ASCO guidelines for breast cancer surveillance for survivors (2006), we defined outcomes as time to first surveillance mammogram post-diagnosis and overall receipt of mammogram by 15-months post-diagnosis. Our primary independent variable was enrollment in CCNC, categorized as never enrolled, enrolled up to 6 months, and enrolled 7 months or more. We used multivariate Cox proportional hazards stratified by receipt of radiation therapy (RT) and logistic regressions. Results: 840 women were included in our sample. Approximately half were enrolled in CCNC for at least some time during the study period, 38% for more than 7 months post-diagnosis. Among women who received RT, being in a MH for at least 7 months corresponded to earlier follow-up mammogram (Hazard Ratio: 1.34; p=0.028), controlling for all other factors. Enrollment in a MH for at least 7 months post-diagnosis also was associated with overall receipt of mammogram by 15 months (p<0.01). Interaction terms indicated that women enrolled in MHs and living in a rural area had a statistically significant higher likelihood of receiving mammography. Conclusions: Results suggest that MH enrollment is associated with improved cancer surveillance among breast cancer survivors insured by Medicaid. Given the growing population of cancer survivors and increased emphasis on MHs in the Affordable Care Act, more research is needed to explore how patient-centered medical homes can be enhanced to improve the transition from cancer patient to cancer survivor.
How radiation oncologist accessibility influences treatment choice and quality in early-stage breast cancer: A SEER database analysis.
Authors: Churilla Thomas M. , Donnelly Patrick E. , Peters Christopher A.
Published: March 2020

6031

Background: Mastectomy and breast conserving therapy (BCT, partial mastectomy and adjuvant radiotherapy) are equivalent in survival for treatment of early stage breast cancer. This study evaluated the impact of radiation oncologist accessibility on choice of mastectomy versus BCT, and the receipt of radiotherapy after BCT. Methods: In the NCI SEER database, breast cancer cases from 2004-2008 were selected with the following criteria: T2N1M0 or less, lobular or ductal histology, and treatment with simple mastectomy or partial mastectomy (+/-) adjuvant radiation. The HRSA Area Resource File was combined to define average radiation oncologist density (ROD, number of radiation oncologists/100K people) by county over the same time period. Tumor characteristics, demographic information, and ROD were evaluated with respect to mastectomy rates and receipt of radiation therapy after BCT in univariate and multivariate analyses. Results: In the 118,961 cases analyzed, mastectomy was performed 33.3% of the time relative to BCT. After adjustment for demographic and tumor variables, the odds of having mastectomy versus BCT were inversely associated with ROD (OR [95% CI] = 0.94 [0.93-0.96]; p<0.001). Adjuvant radiation therapy was not administered in 23.4% of BCT cases. Likewise, the odds of having BCT without adjuvant radiation were inversely associated with ROD (0.96 [0.95-0.98]; p<0.001, table). Conclusions: There was a significant, inverse and linear relationship between ROD and mastectomy rates independent of demographic and tumor variables. An inverse trend was also observed for the omission of radiotherapy after BCT. Access to radiation oncologists was a factor in surgical choice and receiving appropriate BCT in early stage breast cancer. [Table: see text]
Unintended consequences of health information technology: Evidence from Veterans Affairs Colorectal Cancer Oncology Watch Intervention.
Authors: Bian John , Bennett Charles L. , Fisher Deborah , Ribeiro Maria Leonor , Lipscomb Joseph
Published: March 2020

6044

Background: Although health information technology (HIT) has been hypothesized to help achieve greater adherence to recommended clinical guidelines and increase use of preventive care, well-conducted empirical studies evaluating this hypothesis are lacking. This study evaluated the ongoing Colorectal Cancer (CRC) Oncology Watch intervention, a clinical reminder system, implemented in 8 Veterans Affairs (VA) hospitals in 2008 for improving CRC (1) screening adherence among average- or higher-risk veterans, and (2) surveillance. Methods: VA administrative data were used to construct 4 cross-sectional groups of average-risk age 50-64 veterans, one for each of 2006, 2007, 2009, and 2010. We applied a linear probability model with hospital fixed-effects for estimation, using a natural experiment in which the 8 hospitals served as the intervention and other 121 hospitals as a control and with 2006-2007 designated as the pre-intervention period and 2009-2010 as the post-intervention period. Results: The sample included 4,352,082 veteran-years in 4 years. The proportions adherent to screening were 37.6%, 31.6%, 34.4%, and 33.2% in the intervention in 2006, 2007, 2009, and 2010, respectively, and the corresponding proportions in the control were 31.0%, 30.3%, 32.3%, and 30.9%. Regression analysis showed that among those eligible for screening, the intervention was associated with a 2.2-percentage-point decrease in likelihood of adherence (P-value<0.0001). Additional analyses showed that the intervention was associated with a 5.6-percentage-point decrease in likelihood of screening by colonoscopy among the adherent, but with increased total colonoscopies (any indication) of 3.6 per 100 veterans age 50-64. Conclusions: The intervention may have slightly reduced CRC screening rates for the studied population. This consequence may have been caused by an unintentional shift of limited VA colonoscopy capacity from average-risk screening to higher-risk screening and to CRC surveillance, or by physicians’ fatigue due to the large number of clinical reminders implemented in the VA.
Positron emission tomography/computed tomography (PET/CT) for the diagnosis of recurrent cancer (PETREC): A multicenter, prospective cohort study.
Authors: You John J. , Inculet Richard I. , Dhesy-Thind Sukhbinder K. , Chan Adrien M. , Freeman Marc , Cline Kathryn J. , Pritchard Kathleen I. , Dayes Ian S. , Gu Chu-Shu , Julian Jim A , Gulenchyn Karen Y. , Evans William K. , Levine Mark Norman
Published: March 2020

6049

Background: The clinical utility of PET/CT in patients with suspected cancer recurrence remains unclear. The aim of this multi-center, prospective, comparative effectiveness study is to assess the impact of PET/CT on clinical management of patients with suspected cancer recurrence. Methods: Patients were eligible if cancer recurrence (non-small cell lung, breast, head and neck, ovarian, esophageal, Hodgkin’s or non-Hodgkin’s lymphoma) was clinically suspected, and if conventional imaging (e.g. X-ray, ultrasound, CT, or MRI) was non-diagnostic. As a pre-requisite to PET/CT booking, clinicians were asked at enrolment to indicate their planned management if PET/CT were not available. Patients then underwent 18FDG-PET/CT. Clinicians were then asked to indicate their management plan based on PET/CT findings. Patients were followed up once at 3 months. The primary outcome was change in planned management after PET/CT and was assessed independently and in duplicate by external outcome adjudicators using all available source documents. Results: 101 patients (mean age 64 y, 45% male, median 1.3 y since last treatment) were enrolled from 4 centers in Ontario, Canada between April 2009 and June 2011. Distribution of tumor types was: non-small cell lung (55%), breast (19%), ovarian (10%), esophageal (6%), lymphoma (6%), head and neck (4%). 8 patients did not complete the study (non-adherence to protocol, 2; death, 5; disease progression prior to PET/CT, 1), of whom 2 did not receive PET/CT. PET/CT changed planned management in 52 (53%) patients (Table). At 3 months, planned management was carried out in 46/52 (88%) patients. Conclusions: In patients with suspected cancer recurrence, PET/CT changes planned management from non-treatment to treatment for approximately 1 in every 3 patients (“number needed to scan” = 3) and contributes importantly to clinical management. [Table: see text]
A randomized phase III double-blinded placebo-controlled trial of first-line chemotherapy and trastuzumab with or without bevacizumab for patients with HER2/neu-overexpressing metastatic breast cancer (HER2+ MBC): A trial of the Eastern Cooperative Oncology Group (E1105).
Authors: Arteaga Carlos L. , Mayer Ingrid A. , O'Neill Anne M. , Swaby Ramona F. , Alpaugh R. Katherine , Yang Ximing J , Wagner Lynne I. , Meropol Neal J. , Saphner Thomas James , Jahanzeb Mohammad , Perez Edith A. , Lin Nancy U. , Sledge George W.
Published: March 2020

605

Background: Pre-clinical and nonrandomized clinical data support synergy of the combination of bevacizumab and trastuzumab. We conducted a randomized double-blinded phase III trial of chemotherapy/trastuzumab ± bevacizumab to evaluate efficacy (PFS after treatment initiation) of the addition of bevacizumab in first-line treatment of HER2+ MBC. Methods: Days 1, 8 and 15 paclitaxel ± carboplatin were administered with trastuzumab and either placebo or bevacizumab 10 mg/kg every 2 weeks for a total of 6 months. Antibody therapy was then continued without chemo every 3 weeks, until disease progression or unacceptable toxicity. Disease assessments were performed every 3 months. Results: Ninety-six of the planned 489 analyzable patients (pts) were accrued between 2007 and 2009, at which time the study terminated due to poor accrual. Seventy % of pts were post-menopausal, 60% had ER+/HER2+ BC. Median age was 55 years (28-80). Outcomes and toxicities are summarized on the tables below. Median follow-up was 30 months. Conclusions: The combination of chemotherapy, trastuzumab, and bevacizumab did not significantly increased toxicity, and was overall safe and well tolerated. No significant differences in clinical benefit were observed between both treatment arms. Data on CTCs and Quality of Life will be presented at the meeting. This study was conducted by the Eastern Cooperative Oncology Group (Robert L. Comis, MD, Chair) and supported in part by Public Health Service Grants CA23318, CA66636, CA21115, CA32291, CA31946, CA49957, CA27525, CA14548, CA17145, CA32102, CA25224, CA49. [Table: see text] [Table: see text]
Improving the impact of clinical research: A systematic analysis of kidney cancer trials.
Authors: Hirsch Bradford Richard , Mitchell Aaron , Cheng Steven Kunyuan , Tasneem Asba , Schulman Kevin A. , Dilts David M. , Abernethy Amy Pickar
Published: March 2020

6051

Background: Clinical trials are essential to advancing cancer care, but the means to evaluate and improve the portfolio have been lacking. This study analyzes the renal cell carcinoma (RCC) trial portfolio using the database for the Aggregate Analysis of ClinicalTrials.gov. As RCC is an area of promise, what insights can an evaluation of the portfolio provide? Methods: 40,970 clinical studies registered with ClinicalTrials.gov between October 2007 and September 2010 were aggregated by specialty using MeSH terms and submitted conditions. 8,942 oncology trials were identified and categorized by cancer type. 108 trials opening in October 2007 or later were identified as evaluating treatments for RCC. Descriptive statistics were used to characterize trial design, study agent(s), accrual and sponsorship. Results: 52 trials (48%) assessed agents already recommended as 1st or 2nd-line treatments in the National Comprehensive Cancer Network (NCCN) RCC Guidelines at the time of study initiation and 19 (18%) studied other FDA-approved treatments. 37 trials (34%) included a novel (non-FDA approved) agent or vaccine. Total anticipated or actual accrual was 12,753, with 50% accrued/accruing to trials of only NCCN agents, 34% to novel agents and 16% to other FDA-approved agents. Industry was identified as a sponsor or collaborator in 48% of trials assessing only NCCN agents, 73% of novel agent trials and 53% of other FDA-approved agent trials. As shown in the table, a minority of trials were randomized, blinded or late-phase (Phase III or IV), regardless of approval status of study agent. Conclusions: The majority of new studies and accrual in RCC assess questions of treatment sequence and setting for established therapies, many of which lack rigorous design. Across the portfolio, studies are predominantly industry sponsored. Optimizing clinical research includes increasing studies of novel therapeutics and improving the comparative effectiveness research portfolio by increasing utilization of pragmatic designs, registries and late-phase programs. [Table: see text]
A brief educational intervention to increase communication about complementary and alternative medicine (CAM) in community oncology settings.
Authors: Cohen Lorenzo , Urbauer Diana , Fisch Michael , Fellman Bryan , Hough Holly , Miller Jessica , Lanzotti Victor J. , Whisnant Mindy , Weiss Matthias , Fellenz Lori , Bury Martin J. , Kokx Patricia , Finn Kathleen T. , Daily Maureen , Parker Patricia A.
Published: March 2020

6054

Background: The widespread use of CAM in academic oncology settings has been well documented. However, there is a lack of communication between patients and health care professionals on CAM that may have negative health consequences. No comprehensive study of CAM use in community oncology settings exists. We examined the benefits of a brief educational intervention on nurse discussions of CAM with patients. Methods: A multi-site, randomized trial of an educational intervention (brief video, resource list) designed to encourage oncology nurses to discuss CAM use with their patients was conducted within the MD Anderson CCOP network. Nurses (N=175) and patients (baseline N=699 and different set of patients after intervention N=650) completed questions about CAM use, communication, and knowledge. Results: Nurses were 97% female, 96% non-Hispanic white. Two months after the intervention, nurses in the intervention group reported that they were more likely to ask about CAM use than those in the control group (OR=4.2; p<.005) and asked more of their last 5 patients about CAM use (p=.003). No significant intervention effect was found for the proportion of patients in the clinic who indicated they were asked about CAM use after the intervention (OR=1.6, p>.10). Approximately 40% of patients reported using CAM following their cancer diagnosis yet the majority of nurses estimated less than 25% of their patients used CAM. Conclusions: CAM use in community-based oncology patients is high and there is an underestimation of use by the oncology nurses. This very brief intervention significantly improved how often nurses reported asking patients about their CAM use. However, the patients of the nurses did not reflect this change in communication. Additional types of interventions are needed to increase communication between patients and nurses.
Self-reported conflicts of interest (sfCOI) of authors and the interpretation of randomized phase III trials (RCT) and related editorials (REd) in cancer research.
Authors: Bariani Giovanni Mendonca , De Celis Ferrari Anezka Carvalho Rubin , Hoff Paulo Marcelo , Riechelmann Rachel
Published: March 2020

6055

Background: Growing participation from industry in cancer research has resulted in increased reporting of COI. We aimed to test any association between author’s conclusion and sfCOI in cancer studies. Methods: All RCT and REd published in 6 major cancer journals in a 3.5 year period were selected. Two investigators blinded to COI disclosure independently analyzed each RCT and REd, classifying authors’ conclusions as highly positive, positive, neutral, negative, and highly negative with respect to author’s opinion on the experimental therapy. The agreement rate between investigators for conclusion classification was 90% (consensus was achieved for the remaining 10%). We also collected data on study results, COI and sponsorship. COI was defined as any self-reported financial tie between author and industry except for research funds. Predictors of positive/highly positive conclusions of RCT and of REd were tested separately in logistic regression multivariable models. Results: From Jan 2008 to Oct 2011, 1,485 articles were retrieved: 150 RCT and 140 REd were eligible. Among the RCT, 82 (55%) were positive, and 78 (52%) were entirely or partially funded by industry. Any sfCOI was present in 103 (69%) RCT and in 71 (47%) REd. Conclusions of REd and RCT were: 7.3% and 11.3% highly positive, 42.7% and 57.3% positive, 8.0% and 2.0% neutral, 29.3% and 18.7% negative, and 12.7% and 10.7% highly negative, respectively. Multivariable analysis showed that RCT positive result was the only significant predictor for positive conclusion by RCT authors (OR=109, 95% CI: 21-567; p<0.001). The only factor associated with positive conclusions of REd authors was a positive conclusion by RCT author (OR=42, 95% CI: 7-244; p<0.001). While 64 (43%) RCT reported negative results, 103 (68.7%) RCT authors interpreted studies positively. Logistic regression for discordance between RCT result and RCT conclusion did not find any association with COI. Conclusions: The interpretation of RCT results by authors was not influenced by sfCOI or trial sponsorship. Authors of REd were not influenced by study results or by their sfCOI when discussing cancer RCT.
The cost-effectiveness of improving cancer screening compliance.
Authors: Broder Michael S. , Yermilov Irina , Ko Clifford Y. , Maggard Gibbons Melinda , Chang Eunice , Bentley Tanya G. , Cherepanov Dasha , Hsiao Wendy C. , Keeler Emmett B.
Published: March 2020

6057

Background: Expensive treatments and a growing number of cancer patients have resulted in increased spending on cancer care. Within a framework we developed for measuring the value of quality improvement (QI), we describe the cost-effectiveness of improving compliance with cancer screening measures compared to other quality measures. Methods: We used our framework to examine 18 Healthcare Effectiveness Data and Information Set (HEDIS) 2010 quality measures, synthesize related cost-effectiveness (CE) data and describe measure-specific QI-adjusted incremental cost-effectiveness ratios (ICERs). For each measure we: 1) quantified current compliance; 2) reviewed literature for ICERs; 3) estimated per-person steady state cost and quality-adjusted life years (QALYs); 4) estimated affected population size; 5) estimated the cost of QI; and 6) calculated QI-adjusted ICERs at full compliance, defined as 95%. We assumed per-person QI costs did not change with compliance and varied this in sensitivity analyses. We compared QI-adjusted ICERs for 3 cancer screening measures to the remaining measures. Results: Published ICERs for the cancer screening measures were $43,180/QALY (breast), $5,102/QALY (cervix) and $15,173/QALY (colon) and for other measures from $195/QALY (drug treatment) to $35,616/QALY (flu shots). Incorporating QI costs for cancer screening measures gave QI-adjusted ICERs of $64,549/QALY (breast), $15,463/QALY (cervix) and $22,991/QALY (colon), respectively. Incorporating QI costs for all 18 measures resulted in QI-adjusted ICERs from $195/QALY (drug treatment) to $9,075,868/QALY(antidepressant management), with a median of $15,463/QALY. Reaching 95% compliance with the 3 cancer measures would cost $5.1 billion and add 160,000 QALYs ($32,640/QALY) and with all 18 measures would cost $13.4 billion and add 5.8 million QALYs ($2,313/QALY). Conclusions: Improving compliance with cancer screening may be cost-effective at a threshold of $50k/QALY, although improving care on all HEDIS measures may be even more cost-effective. Accurate assessment of the cost of increasing cancer screening requires integration of both the cost-effectiveness of the screening tests and the cost of the QI programs needed to change practice.
Rural versus urban differences among patients (pts) with hormone-receptor positive (HR+) breast cancer (BC) and a 21-gene assay recurrence score (RS).
Authors: Andreason Molly , Zhang Chong , Onitilo Adedayo A. , Charlson John A. , Ledesma Wendy M. , Ridolfi Kimberly , Kim KyungMann , Wisinski Kari Braun , Champeny Torie L , Engel Jessica Marie , Millholland Robert , Dean James T , Tevaarwerk Amye
Published: March 2020

6063

Background: Differences in BC outcomes have been noted between rural and urban women. The influence of tumor biology vs treatment factors as the driver of these differences remains unclear. The Oncotype Dx 21-gene assay RS predicts distant recurrence risk for HR+BC; a RS>18 indicates possible chemotherapy benefit. We assessed rural vs urban differences in RS and therapies received (endocrine therapy; chemotherapy for RS>18). Methods: Retrospective chart review was conducted on BC pts diagnosed 2005–2010 with a 21-gene assay RS. Stage, grade, medications and receptor status were abstracted; RS information was obtained from Genomic Health. Rural-Urban Commuting Area (RUCA) codes defined rural vs urban status. Comparisons between rural vs urban pts were made using two-sample tests, chi-square or Fisher’s exact test for discrete data such as RS (≤ 18 vs > 18), stage and ER status. T- or Wilcoxon rank sum test were used for continuous data (RS 0-100 and age.) All tests were at a two-sided significance level of 0.05. Results: Of 495pts with RS, 488 had RUCA codes (91% white, 61% postmenopausal). For rural vs urban pts, mean RS was 18 vs 19, p=0.15. The table shows univariate analysis for other predictors. For treatment, 321/354 (97%) rural vs 118/134 (94%) urban pts started endocrine therapy (p=0.2). For RS>18, 17/55 (31%) rural vs 83/165 (50%) urban pts received chemotherapy (p=0.02, Chi-square test). Conclusions: Rural pts did not have significantly different RS compared with urban pts, but received significantly less chemotherapy for RS>18. This suggests that for HR+ BC, rural vs urban discrepancies may be explained in part by treatment factors. We suggest prospective comparison or confirmation in another cohort. [Table: see text]