bluuebunny/crossref_metadata_2025_split huggingface dataset:
Provider feedback improves reporting on quality measures: National profile reports for adjuvant chemotherapy for stage III colon cancer
Authors: Stewart A. K. , Gay E. G. , Patel-Parekh L. , Winchester D. P. , Edge S. B. , Ko C. Y. 
Published: March 2020

6572 Background: The National Quality Forum recently announced accountability measures including use of chemotherapy (ACT) with Stage III colon cancer. This study examines the impact of performance reporting using cancer registry data to assess the quality of care for Stage III colon cancer patients using the Commission on Cancer's (CoC) Cancer Program Practice Profile Reports. Cancer registries are the primary source for measurement but adjuvant treatment may be incomplete. Methods: In January 2005 the CoC provided reports to 1,337 hospitals using registry data on over 80,000 Stage III colon cancer patients diagnosed from 1998–2003. Each hospital received a weighted performance rate (PR) and comparison to hospitals of similar types, nationally and regionally. Hospitals could review and correct missing or inaccurate data to provide an updated profile. Results: The initial overall hospital-level PR was 66.2%, hospitals in the top quartile had PRs =80.1%. After 24 months 603 hospitals had corrected data. The mean PR was 74.9%, an increase of 8.7%. The top quartile PR was =89.7%. The PRs for hospitals in the top quartile increased on average by 4.3%, and for hospitals outside this group by 22.7%. The proportion of hospitals with PRs =90% increased from 7.9% to 23.9%. Conclusions: With over two-fifths of hospitals correcting data, the concordance rate with ACT in Stage III colon cancer has significantly increased compared to initial registry data. Reporting quality data and allowing auditing and correction on key quality indicators corrects the data gap in cancer registry out-patient treatment data. Exposure to profile reports can spur local providers to promote better communication with centralized data repositories, significantly contributing to the assessment of care provided to cancer patients. No significant financial relationships to disclose.
Utility of photography to confirm skin lesion response assessed using a severity weighted assessment tool (SWAT) in cutaneous T-cell lymphoma (CTCL)
Authors: Mann B. S. , Johnson J. R. , He K. , Sridhara R. , Farrell A. T. , Dagher R. , Justice R. , Pazdur R. 
Published: March 2020

6579 Background: In Oct 2006, FDA approved vorinostat for treatment of cutaneous manifestations of CTCL–based on response rate and duration of response observed in CTCL skin lesions. Response was determined by change in SWAT score at follow up compared to the baseline score. SWAT Score: sum of % Body Surface Area weighted by factor 1, 2, or 4 for patch (no elevation from normal skin), plaque (< 5 mm elevation) and tumor (= 5 mm elevation), respectively. All responses but one were partial. A partial response required = 50% reduction in whole body SWAT score lasting = 4 weeks. FDA also reviewed serial photographs of all patients (standard whole body views and close-ups of skin lesions), submitted as supportive evidence. Methods: An expert external reviewer, blind to SWAT scores, adjudicated responses by examining photographs and response determinations by photographs and by SWAT scores were compared. Results: Based on SWAT scores, skin lesions in 18 of 61 stage = IIB CTCL patients responded to vorinostat; there were 17 partial and 1 complete responses. Blinded reviewer adjudicated 4 photographs not evaluable (reasons: blurred image, color or light problem, wrong label), easily confirmed 7 responses, and called 7 responses equivocal. Responses seemed easier to determine in skin lesions with tumors or ulcers. Predominantly patch or plaque lesions were harder to evaluate: patches due to poor color reproduction and plaques due to inability to palpate. A response from plaque to patch morphology decreases SWAT score 50%, but the change may not manifest adequately in a photograph. Small sample size did not allow a reliable statistical analysis for correlation between different lesion types and ability to confirm objective responses (based on SWAT scores) by photography. Conclusions: Photography allows a limited evaluation of skin lesions in CTCL: inability to measure lesion thickness in photographs limits direct confirmation of SWAT scores. Photography complements SWAT evaluation: in half the cases in the vorinostat pivotal trial, a response by SWAT score was easily confirmed by the reviewer blind to SWAT scores. Further experience and technological advances in photography may reduce the number of not evaluable photographs. No significant financial relationships to disclose.
Patterns of care among veterans with colon cancer: Insights from California SEER, Medicare and VA-linked data
Authors: Hynes D. M. , Tarlov E. , Perrin R. , Zhang Q. , Bennett C. , Ferreira M. , Lee T. , Benson A. 
Published: March 2020

6586 Background: U.S. veterans have been shown to be a vulnerable population with high cancer rates, yet practice pattern information is lacking. Linkage of cancer registry, Medicare, and VA data provides a more complete view of health status and healthcare received among veterans with cancer. Methods: As part of a national study, a retrospective cohort of incident colon cancer patients from the California Cancer Registry data, who were = 66 years old and eligible to use VA and Medicare between 1999 and 2001, were followed for three years through 2004. We examined practice patterns for stages I-IV colon cancer, specifically, surgery and use of chemotherapy, and trends in one-year mortality using descriptive and multivariate regression models. Results: Among 633 veterans with colon cancer, 93% were male; 16% were African American; 28% were diagnosed at a VA facility compared to 72% at a Medicare facility, and 553 (87%) had colectomy. One year mortality rate was 29%. Among the 553 colectomy patients, prevalence of chemotherapy use, according to stage was 8%, 27%, 61% and 52% for stages I-IV, respectively (p-value <0.0001). Regression analyses of factors affecting whether chemotherapy was received revealed that Stage III patients were most likely to receive adjuvant chemotherapy (Odds Ratio (OR) 19.80, 95% Confidence Interval (CI): 9.68–40.50). However stage II and stage IV patients were also highly likely to receive chemotherapy following surgery (OR: 4.41 CI: 2.18–8.91 and OR: 13.21; CI: 6.01–29, respectively). Patients =76 years and those =86 years were less likely to receive chemotherapy following surgery (OR: 0.61, CI: 0.40–0.94 and OR: 0.25, CI: 0.094–0.64, respectively) compared to patients 66–75 years. Patients with Charlson Comorbidity Score of 2 or greater were less likely to receive chemotherapy (OR: 0.49; CI: 0.29–0.84). Treating facility (VA or Medicare), did not affect chemotherapy use. Conclusions: Among veterans with colon cancer in California, older patients were less likely to receive chemotherapy even when stage and comorbidity status were considered. Efforts focused on improving guideline consistent adjuvant chemotherapy use among older veterans with stage III colon cancer across treating facilities may yield the greatest benefit. No significant financial relationships to disclose.
Ethnic neutropenia among women of European, African, and Caribbean backgrounds
Authors: Grann V. R. , Bowman N. , Wei Y. , Horwitz M. , Joseph C. , Abdul K. , Abdul K. , Barlatier H. , Sandoval R. , Jacobson J. , Hershman D. 
Published: March 2020

6587 Background: Black women are less likely than white women to receive complete chemotherapy for cancer. One reason for interruption of chemotherapy may be a patient's low white blood count (WBC) or absolute neutrophil count (ANC). In studies of white blood cell count (WBC) and race, white individuals’ WBC has been considered the standard, and 25–40% of non-Hispanic black individuals have been described as having “benign ethnic neutropenia.”. We therefore studied the prevalence and severity of ethnic neutropenia among women in six ethnic groups and of the association between neutropenia and serum cytokine and C-reactive protein (CRP) levels and neutrophil elastase (ELA2) polymorphisms. Methods: Following IRB approval, each participant provided a blood sample that was tested for WBC with differentials, cytokines and CRP levels, and ELA2 polymorphisms. We compared median WBC and ANC using Kruskal-Wallis tests. We used Fisher's exact tests to analyze association of severe neutropenia with ethnicity, cytokine and CRP levels, and ELA2 polymorphisms. Results: We enrolled 263 women 20–70 years old who had no cancer diagnosis.. As the table shows, median WBC and ANC differed by group; Dominicans had significantly higher median WBCs and ANCs than all other groups. Of 12 women with severe neutropenia (ANC = 1,500), none was Dominican or European-American. Subjects with a common upregulating ELA2 promoter polymorphism (C-199A) had lower ANC counts than other subjects. No associations were found between ANC counts and either cytokines or CRP levels. Conclusions: Median WBC and ANC and severe neutropenia were associated with ethnicity. Mild neutropenia is considered clinically benign, but because severe neutropenia may result in decreased doses or delays in chemotherapeutic treatment for malignancies, ethnic neutropenia and its role in treatment decisions requires further investigation. No significant financial relationships to disclose. [Table: see text]
Influence of health insurance status on breast cancer diagnosis and treatment delay: A safety net hospital's experience
Authors: Vakkalanka B. K. , Ruda K. , O'Brien T. 
Published: March 2020

6592 Background: Given barriers to access, uninsured women with breast cancer might experience delays in diagnosis and treatment when compared to insured women. The influence of insurance status on breast cancer outcome was addressed at a single institution whose mission statement requires that all pts be treated the same, regardless of their ability to pay Methods: Records of all pts with breast cancer seen from 1/00- 12/04 at a safety net hospital were reviewed. Insurance status was defined at the time of the first abnormal mammogram. Cases were divided into Group A (private insurance), B (medicaid or medicare) or C (uninsured). Time to diagnosis (TDx) was defined as the interval from abnormal mammogram to pathologic diagnosis of breast cancer. Time to treatment (TRx) was defined as time from pathologic diagnosis to definitive surgical therapy. Results: 560 cases were reviewed. Group A: 48%, B: 33%, C: 19%. Median age= 57 (GrpA=53, B= 67, C= 55). Race Caucasian 59%; AA 34%; other 7%. Stage (0, I, II, III and IV, in %, respectively): Grp A= 14.6, 42.9, 31.5, 7.1 and 3.9; Grp B= 13.1, 46, 22.7, 12.5 and 5.7; Grp C = 13.9, 33.7, 32.7, 11.9 and 7.9. No significant diff between groups, although there was a trend towards later (III/IV) pts in grps B and C than A (18.2% and 19.8% vs 10.9%, respectively). Mean TDx: Grp A= 50.6 days, B= 68.1d and C=52.8d; p= 0.006 when Group B was compared to the other two groups but there was no difference between uninsured and private groups. Mean TRx: 43.8d, 48.6d and 47.8 days, respectively, for groups A, B and C, without any statistical difference between any of the groups. Conclusions: A 5-year review of breast cancer cases at a large safety net hospital did not reveal any difference in the time to diagnosis or initiation of treatment for insured vs. uninsured pts. Uninsured and medicaid/medicare pts tended to present with later stage disease, perhaps due to access problems. A statistically significant delay in diagnosis was noted in the medicaid/medicare group but it is unlikely that this difference (18 days) was clinically important. Because uninsured pts are provided care at greatly discounted rates at our institution, these results may differ from those at other institutions. Further studies addressing this issue are warranted. No significant financial relationships to disclose.
Solid tumor cancer patients treated with zoledronic acid experienced reduced skeletal related events as compared to untreated patients in clinical practice claims database
Authors: Hatoum H. T. , Lin S. , Smith M. R. , Barghout V. , Koukouras K. , Lipton A. 
Published: March 2020

6596 Background: Patients (pts) with bone metastasis are at high risk for skeletal related events (SREs), leading to increased morbidity, mortality, and decreased QOL. Methods: To study the impact of zoledronic acid on SRE rates, follow-up duration (from 1st bone metastasis diagnosis to last claim) in treated pts as compared to the experience of non bisphosphonate-treated pts (untreated), and to investigate relative impact of zoledronic acid (ZA) frequency of administration using data from PharMetrics integrated claims database of 80 health plans across the U.S, from Jan 02 to Oct. 05. Results: There were 1,518 ZA treated-pts and 3308 untreated-pts, who met study inclusion criteria of having breast, prostate, or lung cancers, with confirmed bone metastasis and SRE experience. At baseline, breast cancer pts (N=1,799) had lowest Charlson Co-morbidity Index (CCI); lung cancer pts (N=2,413) had highest CCI (p<0.05). Prostate cancer pts (N=622) were significantly older (p<0.05). The average monthly ZA prescription rate (Rx) was 0.73 with average total Rxs of 7.82 over the follow-up duration. ZA use reduced monthly SRE rate by 30% from 0.41 ± 0.4 in untreated pts to 0.29 ± 0.3 in treated pts (p<0.001) and prolonged follow-up durations in months from 9.4 ± 9.8 in untreated to 12.2 ± 9.0 in treated pts (p<0.001). Regression models of SRE rate or follow-up duration as the dependent variable investigating the impact of ZA prescribing patterns indicated that pts who followed ZA label dose of 4 mg every q3, q4 experienced the lowest SRE rate (p<0.001) and had longer follow-up duration (p<0.005) as compared untreated pts. ZA use almost doubled time to 1st SRE from 101±165 days in untreated pts, to 185±210 days in treated pts (p<0.0001). ZA also delayed time between 1st to 2nd SRE from 85 days in untreated to 111 days in treated pts (p<0.05). Conclusion: Zoledronic acid significantly reduced SRE rate in cancer pts with bone metastasis by 30%, increased follow-up duration by almost 3 months, doubled time to 1st SRE, delayed time to 2nd SRE, with its label dose of 4 mg every 3 to 4 weeks achieving the best outcome. No significant financial relationships to disclose.
Concordance of study objectives with efficacy findings in metastatic breast cancer (MBC) treatment trials
Authors: Frame D. , Ross S. D. 
Published: March 2020

6600 Background: Despite ongoing development of new agents, overall survival in MBC remains discouraging. We reviewed large randomized controlled trials (RCTs) published since 2000 to compare stated objectives with efficacy endpoints. Methods: Systematic review of RCTs of systemic antineoplastic treatment in advanced / metastatic breast cancer, published 2000–2006 in English. Studies enrolling fewer than 100 patients or performed only at sites outside North America and Europe were excluded. Study success was characterized with regard to the primary endpoint as described in prospective power calculations. Results: 68 RCTs, enrolling 24,956 patients, met inclusion criteria. The 68 RCTs comprised 83 efficacy comparisons due to multiple arms and/or more than one primary endpoint. Frequency of success was similar by geographic location and presence of industry sponsorship, but higher for noninferiority comparisons ( Table 1 ). 5 of 13 non-inferiority studies reported unplanned superiority findings for the experimental arm, while 11 of 39 studies failing to meet planned superiority endpoints made statements regarding equivalence or superiority to control treatments. For 10 of 20 successful superiority studies, reported results did not match/exceed planned between-group differences, though the comparisons reached statistical significance: 4 such studies substantially exceeded planned enrollment (2 of which recalculated sample size after reviewing interim data), while reasons for attaining superiority in 6 cases were unclear. Of the remaining 10 superiority comparisons, 4 reached significance due to underperforming control arms (enabling PFS/TTP differences of <2 months to establish superiority), 2 exceeded point estimates, and 4 exceeded estimated between- group ratios. Conclusions: Slippage from prospective study goals, even in large randomized trials, may contribute to a disconnect between the profusion of research activity and disappointing efficacy gains in MBC. No significant financial relationships to disclose. [Table: see text]
Lack of effect of prophylactic hematopoeitic colony stimulating factors in cancer patients and stem cell transplant recipients on short term survival: A meta-analysis of randomized trials
Authors: Sung L. , Nathan P. C. , Alibhai S. M. , Tomlinson G. A. , Beyene J. 
Published: March 2020

6605 Background: Previous randomized trials and meta-analyses have failed to determine with certainty whether prophylactic hematopoietic colony-stimulating factors (CSFs) influence survival in adults and children receiving cancer chemotherapy or undergoing stem cell transplantation (SCT). The primary objective was to determine whether prophylactic CSFs improve short-term overall survival. Secondary objectives were to determine whether prophylactic CSFs affected infection-related mortality, documented infections, microbiologically documented infections or febrile neutropenia. Methods: We performed electronic searches of OVID Medline from 1966 to November 2006; EMBASE from 1980 to November 2006; and the Cochrane Central Register of Controlled Trials until the second quarter, 2006. We included studies if there was randomization between CSFs and placebo/no therapy; CSFs were given concurrently with or following initiation of chemotherapy in the prophylactic setting; and chemotherapy/conditioning regimen or supportive care were not planned to be systematically different between study arms. From 4,019 reviewed titles and abstracts, 145 studies were included. Independent extraction was performed by two observers using a standardized data collection sheet. Results: Prophylactic CSFs did not affect short-term overall survival, with a relative risk (RR) of 1.00 (95% confidence interval [CI] 0.99 to 1.01; P=.9). This result was consistent across different patient populations (including patient age and underlying disease) and study characteristics. The effect of prophylactic CSFs on infection-related mortality was less clear (RR 0.83, 95% CI 0.67 to 1.03; P=.09). Intervention did reduce documented infections (rate ratio 0.85, 95% CI 0.78 to 0.92; P<.00001), microbiologically documented infections (rate ratio 0.85, 95% CI 0.75 to 0.95; P=.004) and febrile neutropenia (rate ratio 0.70, 95% CI 0.62 to 0.79; P<.00001). Conclusions: Prophylactic CSFs do not improve short-term overall survival but are associated with decreased rates of infection. Decision-making around this intervention should be based upon further exploration of costs, preferences and quality of life. No significant financial relationships to disclose.
Clinical variables are associated with treatment satisfaction in patients with breast, lung, and colorectal cancer
Authors: Trask P. C. , Tellefsen C. , Espindle D. , Getter C. , Yost K. , Hsu M. 
Published: March 2020

6608 Background: The association between clinical variables (e.g. disease stage/type, side effects, ECOG performance status (PS)) and patient-reported treatment satisfaction has received little attention, despite the potential implications for treatment adherence and decision-making. We examined the relation between clinical variables and treatment satisfaction in a U.S. sample of patients with breast (BC), lung (LC), or colorectal (CRC) cancer using the Cancer Treatment Satisfaction Questionnaire (CTSQ), a recently validated 16-item measure designed to assess expectations of therapy (ET), feelings about side effects (FSE), and satisfaction with therapy (SWT). Methods: Cancer stage, line of therapy, physician-reported ECOG PS, presence vs. absence of medication side effects, and perceived change in cancer over the last two weeks were obtained on patients. These clinical variables were examined in relation to the ET, FSE, and SWT scales of the CTSQ. Higher scale scores indicated better outcomes (e.g., better satisfaction). Group means were compared using one-way ANOVAs; trends of scale scores across clinical variables were also examined. Results: Participants were 349 patients with early and late stage BC (n=137), CRC (n=121), or LC (n=91) who had ≥ 1 cycles of chemo-, bio-, or hormonal therapy in the last 6 months. In all cancer types, FSE differed by presence of side effects (BC<.03; CRC<.01; LC<.02). In BC patients, FSE differed by stage, and ET differed significantly depending on ECOG PS (p<.006) and perceived change (p<.05). For CRC patients, ET significantly differed by stage (p<.05) and perceived change (p<.02); and SWT by presence of side effects (p<.01). SWT also differed by perceived change (p<.01) for LC patients. Most trends were in the expected direction. Conclusions: These results indicate that patient-reported satisfaction with therapy is correlated with clinical variables. On average, patients who perceive less improvement in their cancer, have side effects, and poorer ECOG PS are less satisfied with their current cancer therapy. Unknown is the impact of this relation on adherence and decision-making. Recent changes in healthcare suggests that treatment satisfaction may become an increasingly important measure of clinical outcome. No significant financial relationships to disclose.
Utility of the of the M. D. Anderson Symptom Assessment Inventory (MDASI) for symptom evaluation during chemoradiation (CRT) in patients with gastrointestinal malignancies
Authors: Janjan N. A. , Wang X. S. , Mendoza T. , Zhang Y. , Das P. , Crane C. , Delclos M. , Krishnan S. , Cleeland C. 
Published: March 2020

6613 Background: Symptom assessment has become an important therapeutic endpoint in clinical trials. Measures that evaluate symptoms during CRT are needed for evaluation of clinical benefit in developing therapeutics and in monitoring quality improvement in clinical practice. Methods: 330 patients with gastrointestinal malignancies (Liver/Biliary:44; Colon:45; Rectal:197; Gastric:44) were evaluated during CRT with the self-reported MDASI-GI. All patients received 45–56Gy of radiation (1.8Gy/fraction); 78% received between 45–50.4Gy. In all cases fluoropyrimidine (oral or intravenous) was given concurrently during radiation. Lowess curves were used to describe the severity and pattern of each symptom evaluated. ANOVA was used to compare the mean severity of symptoms by tumor type. Follow-up evaluations were performed with a t-test using a Bonferroni corrected level of significance [p< 0.002]. Results: Relationships among symptoms were examined using 1,020 symptom measurements (Liver/Biliary:141; Colon:132; Rectal:613; Gastric:134 observations). Lowess curves showed almost parallel steep increases in pain and poor appetite between weeks 2–4 of CRT. Fatigue was most profound in Liver/Biliary and Rectal cancers. As expected, no significant differences in dyspnea were found among these cancers. CRT for Rectal cancer produced the worst symptom burden with significantly more pain, skin pain, and diarrhea. Consistent with clinical findings, poor appetite, nausea and vomiting were statistically more common during CRT for Gastric cancer. Conclusions: The MDASI is a brief and easy to use symptom measure in the clinical setting and is sensitive to treatment-related symptom changes during CRT in abdominopelvic malignancies. [Table: see text]