INTRODUCTION: Formal geriatric assessment is now recommended for all older (65+) adults with cancer who are receiving systemic therapy (Dale, JCO, 2023). While many tools have been validated in cancer populations, the association of geriatrics-driven frailty assessment tools with long-term survival for older adults with hematologic malignancies has yet to be characterized. METHODS: The Older Adult Hematologic Malignancy (OHM) Program at Dana-Farber Cancer Institute aims to assess the utility of three widely-studied frailty assessment tools-deficit accumulation method, phenotypic model and 4-meter gait speed (4MGS)-for older adults with blood cancers. From February 2015 to July 2024, we approached patients aged ≥ 73 years presenting for an initial consultation for MDS/leukemia, myeloma, or lymphoma at our institution. A trained research assistant conducted a frailty assessment consisting of 42 patient-reported and objective measures, spanning domains of comorbidity, functional status (e.g., instrumental activities of daily living, IADLs), physical performance (e.g., 4MGS and grip strength), and cognition (e.g., delayed recall). The majority of assessments were performed in-person, with a portion conducted virtually (DuMontier, Blood Advances, 2022). The deficit accumulation method (Rockwood, Journals of Gerontology, 2007) counts aging-related health deficits across multiple domains to compute a frailty index (FI) as the proportion of deficits present out of the total number of possible deficits measured. Patients were classified as robust if the FI was less than 0.2, pre-frail if between 0.2 and 0.35, and frail if greater than 0.35. The phenotypic model (Fried, Journals of Gerontology, 2001) uses five criteria to define a frailty syndrome (slow gait speed, weakness measured by grip strength, self-reported exhaustion, low physical activity, and weight loss). Patients were classified as robust if they had no deficits, pre-frail if they had one or two deficits, and frail if they had 3 or more deficits. For gait speed, patient's normal 4MGS was analyzed as a categorical variable (>0.8, >0.6 to 0.8, < 0.6) consistent with a priori cutoffs from the literature. Patients were followed from the time of initial consultation through the date of death or last follow-up, after which they were censored. Demographic and clinical variables were descriptively summarized, and multivariable Cox proportional hazards regression was used to estimate hazard ratios for the frailty assessment tools adjusted for age and gender. RESULTS: As of July 18, 2024, frailty was assessed for 1271 patients; all three measures of interest-deficit accumulation method, phenotypic model and 4MGS-were available for 945 patients. Among these, median age was 78 years (IQR, 76 to 82) and 36% were female. 32% had MDS/AML, 34% lymphoma, and 34% myeloma. Median follow-up was 30 months (IQR, 10 to 59) among all patients and 44 months (IQR, 0.03 to 110) among 490 patients alive at last follow-up. Median survival was 56 months and 5-year overall survival was 48% (95% CI 45%, 52%). According to the deficit accumulation method, 34% were pre-frail and 8% were frail. According to the phenotypic model, 61% were pre-frail and 6% were frail. In terms of 4MGS, 33% were >0.6 to 0.8 m/s and 14% were < 0.6 m/s. Over half (52%) reported weak grip strength, 31% unintentional loss of at least 10 pounds within the past year, and 10% “exhaustion.” All three frailty assessment tools were associated with mortality, independent of age and gender (deficit accumulation method: robust ref; pre-frail HR 1.90 [95% CI 1.55, 2.32]; frail HR 2.46 [1.83, 3.31]; phenotypic model: robust ref; pre-frail HR 2.07 [1.64, 2.62], frail HR 3.19, [2.19, 4.66]); 4MGS: >0.8 m/s ref; >0.6 to 0.8 HR 1.47 [1.19, 1.81], ≤ 0.6 HR 2.13 [1.63, 2.78]). CONCLUSIONS: In this large cohort of older adults with blood cancers and long-term follow-up, pre-frail and frail states were prevalent as measured with gold standard geriatric tools. Impaired mobility, weakness, and weight loss were more prevalent than in general populations of community-dwelling adults (e.g., 31% of OHM patients reported weight loss, while this has been found to be only 6% in a general population; Fried, Journals of Gerontology, 2001). All three tools showed dose-response relationships with survival. These data underscore the importance of measuring and addressing frailty in older adults undergoing treatment for blood cancer.
Women who undergo mastectomy with immediate breast reconstruction (RC) for breast cancer may receive postmastectomy radiation therapy (PMRT) to improve local control and survival. However, PMRT can negatively impact RC outcomes by increasing complications and worsening the cosmetic results. It is unclear how women prioritize these various outcomes. In the course of designing a larger trial of PMRT with a patient-centered approach, we conducted a survey study to assess patient-reported outcomes and prioritization of these outcomes by patients who had undergone immediate RC and PMRT. Sixty-two breast cancer patients who had undergone implant-based RC and completed PMRT 6-24 months prior at a single institution were approached for study participation. Twenty-nine (47%) completed interviews (by phone or in person) to evaluate opinions of the following validated quality-of-life (QOL) instruments: BREAST-Q, FACT-B, and LYMPH-ICF. These 3 instruments were selected by a group of patient advocates with the goal of capturing important outcomes while minimizing redundancy. After completing the instruments, study participants were asked to rank the relative importance of each domain of the instruments. Clinical data were abstracted from the electronic medical record, including patient age, initial tumor stage and adjuvant therapy. Linear regression modeling was performed to assess associations between patient-reported outcomes and clinical and treatment variables. The median age was 47 years (range, 26-66) and the median interval from PMRT to interview was 22 months (range, 8-27). Patients had T1-3, N0-3 disease and underwent unilateral (52%) or bilateral (48%) mastectomy. Twenty-seven (93%) received chemotherapy. The median total radiation dose was 5000 cGy (range, 4256-6400); 14 (48%) received a scar boost. The mean FACT-B total score was 112.2. Univariate predictors of higher FACT-B total scores included older age, lower N-stage and longer interval from end of PMRT to the interview. The physical well-being (PWB) subscale of the FACT-B was selected as the most important measure by 13/29 patients (45%) and was within the top 3 for 20 patients (69%). Multivariable analysis revealed that higher nodal stage (mean difference -8.1 points for N3 vs. N0; 95% CI: -15.8, -0.3) and younger age (-4.3 points for <40 vs. >40; 95% CI: -8.0, -0.7) were independently associated with a worse PWB score on the FACT-B instrument. These results indicate that among patients who agreed to participate in this study, physical well-being was valued as the most important QOL outcome after immediate implant-based reconstruction followed by PMRT. Future PMRT trials should carefully measure PWB and explore why younger patients and those with higher nodal stage may have a diminished QOL. Explicit elicitation by patients of outcomes most important to them would ensure patient-centeredness in trial design.
BACKGROUND: Most women with advanced epithelial ovarian cancer develop recurrent disease, despite maximal surgical cytoreduction and adjuvant platinum-based chemotherapy. In observational studies, secondary cytoreductive surgery has been associated with improved survival; however its use is controversial, because there are concerns that the improved outcomes may reflect selection bias rather than the superiority of secondary surgery. OBJECTIVE: To compare the overall survival of women with platinum sensitive recurrent ovarian cancer treated at National Cancer Institute designated cancer centers who receive secondary surgery vs chemotherapy. STUDY DESIGN: This retrospective cohort study included women from 6 National Cancer Institute designated cancer centers diagnosed with platinum-sensitive recurrent ovarian cancer between January 1, 2004, and December 31, 2011. The primary outcome was overall survival. Propensity score matching was used to compare similar women who received secondary surgery vs chemotherapy. Additional analyses examined how these findings may be influenced by the prevalence of unobserved confounders at the time of recurrence. RESULTS: Among 626 women, 146 (23%) received secondary surgery and 480 (77%) received chemotherapy. In adjusted analyses, patients who received secondary surgery were younger (P = 0.001), had earlier-stage disease at diagnosis (P= 0.002), and had longer disease-free intervals (P < 0.001) compared with those receiving chemotherapy. In the propensity score matched groups (n = 244 patients), the median overall survival was 54 months in patients who received secondary surgery and 33 months in those treated with chemotherapy (P < 0.001). Among patients who received secondary surgery, 102 (70%) achieved optimal secondary cytoreduction. There were no significant differences in complication rates between the 2 groups. In sensitivity analyses, the survival advantage associated with secondary surgery could be explained by the presence of more multifocal recurrences (if 4.3 times more common), ascites (if 2.7 times more common), or carcinomatosis (if 2.1 times more common) among patients who received chemotherapy instead of secondary surgery. CONCLUSION: Patients with platinum-sensitive recurrent ovarian cancer who received secondary surgery had favorable surgical characteristics and were likely to have minimal residual disease following secondary surgery. These patients had a superior median overall survival compared with patients who received chemotherapy, although unmeasured confounders may explain this observed difference.
BACKGROUND:Among patients diagnosed with stage IA non-small cell lung cancer (NSCLC), the incidence of occult brain metastasis is low, and several professional societies recommend against brain imaging for staging purposes. The goal of this study was to characterize the use of brain imaging among Medicare patients diagnosed with stage IA NSCLC. METHODS:Using data from linked SEER-Medicare claims, we identified patients diagnosed with AJCC 8th edition stage IA NSCLC in 2004 through 2013. Patients were classified as having received brain imaging if they underwent head CT or brain MRI from 1 month before to 3 months after diagnosis. We identified factors associated with receipt of brain imaging using multivariable logistic regression. RESULTS:Among 13,809 patients with stage IA NSCLC, 3,417 (25%) underwent brain imaging at time of diagnosis. The rate of brain imaging increased over time, from 23.5% in 2004 to 28.7% in 2013 (P=.0006). There was significant variation in the use of brain imaging across hospital service areas, with rates ranging from 0% to 64.0%. Factors associated with a greater likelihood of brain imaging included older age (odds ratios [ORs] of 1.16 for 70-74 years, 1.13 for 75-79 years, 1.31 for 80-84 years, and 1.46 for ≥85 years compared with 65-69 years; all P<.05), female sex (OR, 1.09; P<.05), black race (OR 1.23; P<.05), larger tumor size (ORs of 1.23 for 11-20 mm and 1.28 for 21-30 mm tumors vs 1-10 mm tumors; all P<.05), and higher modified Charlson-Deyo comorbidity score (OR, 1.28 for score >1 vs score of 0; P<.05). CONCLUSIONS:Roughly 1 in 4 patients with stage IA NSCLC received brain imaging at the time of diagnosis despite national recommendations against the practice. Although several patient factors are associated with receipt of brain imaging, there is significant geographic variation across the United States. Closer adherence to clinical guidelines is likely to result in more cost-effective care.
Women with a history of DCIS are at increased risk for developing a second breast cancer (SBC), either in the ipsilateral or contralateral breast. Treatments for DCIS currently include mastectomy or breast-conserving surgery with or without radiation therapy (RT). The addition of RT following breast-conserving surgery has been shown to decrease the risk of local recurrence, including recurrence of an invasive SBC, but has not been demonstrated to affect mortality. We seek to evaluate the impact of radiation on the characteristics of SBC and breast-cancer specific survival following SBC. We identified 5469 patients who received breast conserving surgery (+/- RT) between 2000-2013 for primary DCIS and had a SBC diagnosis (stage 0-IV) in SEER. Characteristics of SBC were described, and survival analyses were performed for the subset with stage I-III SBC (N=3487). Multivariable competing risk regression models were fit to assess the association between receipt of RT for primary DCIS and time to BC-specific death; survival time started on the date of SBC with follow-up through 2013. Interaction analyses were conducted to explore whether an association between receipt of RT for primary DCIS and BC-specific death was modified by laterality of SBC. Among 5469 patients, 2605 (48%) had ipsilateral and 2864 (52%) had contralateral SBC. Patients who developed ipsilateral (versus contralateral) SBC were younger at the time of their primary and secondary diagnoses (p<0.001), were less likely to have ER expression for both diagnoses (p<0.001), and had longer interval to SBC (p<0.001). The likelihood of SBC being invasive was 67% and 71% in the ipsilateral breast, with and without RT (p=0.04), respectively; and 64% and 68% in the contralateral breast (p=0.02). Following stage I-III SBC, 5-year cumulative incidence of BC-specific death was 8.0% with prior RT vs. 4.7% without for ipsilateral SBC; and 5.3% with prior RT vs. 4.2% without for contralateral SBC. In a multivariable competing risk analysis, prior radiotherapy was significantly associated with increased BC-specific mortality (HR 1.70; 95% CI 1.18-2.45; p = 0.005). Interaction analysis suggested that this association differed by laterality of SBC (HR 2.07 for ipsilateral vs. 1.26 for contralateral SBC), although the interaction was not statistically significant (p=0.16). Other factors independently associated with cancer-specific mortality following SBC included age at SBC diagnosis (p <0.001), and ER status (p<0.001) and stage of SBC (p <0.001). Among patients with invasive SBC after a DCIS diagnosis, prior RT was associated with increased breast cancer-specific mortality. This increase was particularly pronounced in patients with ipsilateral SBC. These findings may have implications for decision-making about treatment for DCIS and at time of SBC.
Palliative radiation therapy (PRT) is an effective option for relieving pain from bone metastases. Based on randomized studies suggesting equivalent pain relief from shorter courses of treatment, national guidelines advocate for shorter courses of PRT. Though these guidelines address how PRT should be given, they do not address when PRT should be considered. We sought to measure variation in the use of PRT among Medicare patients with bone metastases at diagnosis. Using data from SEER-Medicare, we identified patients over age 65 diagnosed with metastatic non-small cell lung cancer (NSCLC) from 2010-2013 who had bone metastases at diagnosis. We calculated the proportion of patients who received PRT within one year of diagnosis by Health Service Area (HSA), representing a geographic health care market. HSAs with at least 20 patients diagnosed during the study period were included in the analysis. A multivariable generalized linear mixed model with logit link was used to identify associations between patient and HSA characteristics and likelihood of receipt of PRT. Among 20,517 patients diagnosed with metastatic NSCLC, 6,681 (33%) had bone metastases at diagnosis. Of these, 51% received PRT within the first year. Among 80 HSAs with at least 20 patients in the cohort, use of PRT ranged from 30% to 82% (median 51%, 33%-66% 5%ile-95%ile). Patient factors associated with PRT use included younger age group (overall p<.01), female gender (OR 1.3, p<.01), married status (OR 1.45, p<.01), and race (white vs black vs other, OR 1.0 vs 0.76 vs 0.92, overall p<.01). HSA factors associated with PRT use included greater per capita Medicare spending (OR 1.13/$1000, p<.01), median household income (OR 1.11/$1000, p<.01), and density of hospitals with pain and/or palliative care services (fourth vs first quartile, OR 1.58, overall p<.01). We identified substantial variation in the use and intensity of PRT among lung cancer patients with bone metastases. Patient living in HSAs with higher Medicare spending and greater financial and pain/palliative care resources were more likely to receive PRT. This suggests a potential opportunity to better optimize use of PRT.
Inherited (germline) mutations in DNA repair pathway genes including BRCA2 are associated with risk of prostate cancer (PCA) and with the severity of disease. Germline mutations in genes responsible for DNA-repair processes are more frequent in men with metastatic disease. We characterized the distribution of germline exosomal mutations in BRCA2 in a large cohort of male BRCA2 carriers ascertained and followed for development of PCA. We hypothesize that if germline mutations in BRCA2 influence development of PCA, unique patterns of BRCA2 mutations by location and/or function may be found in men with (aggressive) PCA. We identified 3051 male carriers of BRCA2 enrolled in the international Consortium of Investigators of Modifiers of BRCA1/2 (CIMBA) who consented to targeted sequencing of their germline for mutations in BRCA genes, including point mutations, insertions, and deletions. BRCA2 mutations were binned based on the location of known functional domains of BRCA2; in the absence of recognized functional domains, bins were created to homogenize the number of carriers within each bin. A Cox regression analysis was used to identify associations between BRCA2 mutation location/function and the relative risk for development of PCA. Of the 3051 male carriers of BRCA2, 264 (8.7%) developed PCA. The median overall follow-up was 54 years (range 18-102). Seven bins of mutations were generated within the BRCA2 gene, each inclusive of 395-530 carriers, corresponding to nucleotides: c.1-1000 (region inclusive of PALB2 binding site), c.1001-3005, c.3006-5172 (N-terminus BRC repeats), c.5173-6255 (C-terminus BRC repeats), c.6256-7436, c.7437-8616 (DNA binding helical plasma domain, OB1, and OB2/tower domain), and c.8617+ (a region inclusive of OB3 domain and secondary RAD51 interaction site). Interestingly, germline BRCA2 mutations in men who developed PCA appeared non-randomly distributed in clusters across BRCA2 exons. Mutations across nucleotides c.1-1000 and c.7437-8616 conferred elevated relative risk of PCA, HR 1.84 (1.13-2.98, P = 0.01) and HR 1.67 (1.02-2-75, P = 0.04), respectively. Mutations in the BRC repeat regions, known binding RAD51 binding sites, did not result in increased risk of PCA. Mutations in men with high grade PCA (Gleason 8+) were concentrated within the c.1-1000 region (HR 3.146, 1.16-8.53; P = 0.02). We have identified functionally relevant patterns of mutation clustering in BRCA2 that may inform the absolute risk of (aggressive) PCA for BRCA2 carriers. Further characterization of the relationship of these mutations to cancer outcomes will help direct the future use of DNA repair directed treatments and radiation therapy in men harboring these mutations.
The factors that influence utilization of reduced-intensity conditioning (RIC) allogeneic hematopoietic stem cell transplantation (HCT) among medically fit older patients with advanced myelodysplastic syndromes (MDS) are largely unknown. The MDS Transplant-Associated Outcomes (MDS-TAO) study is an ongoing prospective observational study at the Dana-Farber Cancer Institute and Massachusetts General Hospital that enrolls transplant-eligible fit patients aged 60-75 years with advanced MDS and follows them through RIC HCT vs non-HCT treatment. In this analysis of 127 patients enrolled from May 2011 to June 2014, we examined the influence of age, gender, cytogenetics, International Prognostic Scoring System (IPSS) category, performance status, distance from HCT center and baseline patient-reported quality of life (QOL) from the EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) on the likelihood of receiving RIC HCT using competing risk regression modeling. With a median follow-up of 16 months, 44 patients (35%) had undergone RIC HCT. In multivariable analyses, age (hazard ratio (HR) 0.87 per year, 95% confidence interval (CI): 0.81-0.92, P<0.001) and higher IPSS (intermediate-2/high; HR 2.29, 95% CI: 1.25-4.19, P=0.007) were significantly predictive of receipt of RIC HCT; neither global QOL score nor any QOL subscales scores were predictive. These data suggest that baseline patient-reported QOL has little influence on the decision to undergo RIC HCT for older patients with advanced MDS.
Abstract Background: Patients who complete definitive therapy for primary, stage I-III breast cancer may develop recurrent disease. However, little is known about the outcomes patients experience after recurrence when treated outside of a clinical trial because population-based datasets usually do not capture recurrence status. We describe the overall survival of patients after developing recurrent breast cancer, identify factors independently associated with improved survival, and compare survival for patients with recurrent versus de novo stage IV metastatic disease. Methods: The cancer registries from two Kaiser Permanente (KP) sites participating in the Cancer Research Network, KP Colorado and KP Northwest, provided data on adult women diagnosed 2000-2011 with primary breast cancer and followed through death, disenrollment or study end (12/31/2012). Among patients with stage I-III disease who completed definitive therapy, recurrence was captured via manual chart abstraction. Survival time was calculated from the date of recurrence or the date of de novo stage IV disease. Multivariable modeling identified factors independently associated with restricted mean survival time (RMST) through 7 years, controlling for age, race, income, co-morbidity, year of recurrence, time from primary diagnosis to recurrence, type of recurrence (local vs. regional/distant), use of chemotherapy or radiation at recurrence, and characteristics of the primary cancer that pre-dated recurrence (i.e., primary stage, grade, hormone-receptor status, and use of chemotherapy or radiation therapy for the primary diagnosis). We compared overall survival after developing recurrent versus de novo stage IV disease after matching for age, race, income, co-morbidity and year. Results: From 7,216 breast cancer diagnoses we identified 506 cases of recurrent disease and 219 cases of de novo stage IV disease (7% and 3%, respectively). Most recurrences were regional or distant (81%). From the time of recurrence, median survival was 21 months and 2-year survival was 47%. Factors significantly associated with inferior RMST included regional/distant vs. local recurrence (-35.6 months; P<.01), primary stage III vs. stage I disease (-13.6 months; P<.01), and chemotherapy for the primary diagnosis (-9.6 months; P=0.02), but not race, income, grade, or primary cancer hormone-receptor status. Patients for whom the interval from diagnosis to recurrence was >4 years vs. <1 year had a longer RMST (+18.9 months; P<.0-1). Receipt of chemotherapy at the time of recurrence was associated with inferior RMST; the magnitude of this association was higher among patients with local (-18.5 months) versus regional/distant disease (-3.2 months). Women with regional/distant recurrence had significantly worse RMST than those with de novo stage IV disease (-10.3 months; P<.01). Conclusions: Recurrent breast cancer is at least two-fold more common than de novo stage IV disease. Among patients who develop recurrence, characteristics of the primary cancer and its treatment are associated with survival after recurrence. Survival differences between patients with recurrent and de novo stage IV disease suggest that prognostic estimates and treatment paradigms should be tailored. Citation Format: Hassett MJ, Cronin AM, Carroll NM, Uno H, Hornbrook MC, Ritzwoller D. The incidence of and survival after breast cancer recurrence. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P1-07-07.
The 21-gene recurrence score (RS) gene expression assay is widely used to assess distant recurrence risk and adjuvant chemotherapy (CT) benefit for hormone receptor-positive (HR+) breast cancer. We hypothesized that higher recurrence score is associated with increased risk of isolated local-regional recurrence (iLRR) after surgery for HR+ breast cancer. We used the national prospective Breast Cancer-Collaborative Outcomes Research Database to identify women diagnosed 2006-2012 with Stage I-II HR+ breast cancer who had mastectomy (MTX) or breast conserving surgery (BCS) and were treated at one of 8 participating centers. We included only patients (pts) who had RS testing; results were categorized using clinically established cutoffs (low <18; intermediate 18 – 30; high > 30). We excluded pts treated with neoadjuvant therapy. The main outcome was cumulative incidence of iLRR; we also calculated the cumulative incidence of distant metastatic recurrence with or without LRR (DM). Hazard ratios were estimated with Fine and Gray's competing risks models. We identified 1,758 women with stage I (1,230, 70%) and stage II (528, 30%) breast cancer who had RS results. Of these, 946 (54%) had low RS, 659 (37%) had intermediate RS, and 153 (9%) had high RS. BCS was the most common surgery for the cohort (71%) and among all RS categories: 69% for low RS; 74% for intermediate RS; 74% for high RS (P = 0.126). CT use varied by RS, with 9% of low, 44% of intermediate, and 86% of high RS pts receiving it (P < 0.0001). Postoperative radiation (RT) use did not vary by RS (P = 0.333); 13% of MTX and 96% of BCS pts received RT. At a median follow-up of 1.7 years (IQR 0.8 – 2.9) there were 9 iLRR and 15 DM events: 2 iLRR and 3 DM events among low RS pts, 7 iLRR and 6 DM events among intermediate RS pts, and 0 iLRR and 6 DM events among high RS pts. The 3-year iLRR cumulative incidence rate for the cohort was 0.7% (95% confidence interval [CI], 0.3 – 1.7%). For the low RS group it was 0.5% (95% CI, 0.1 – 1.9%) and for the intermediate RS group it was 1.3% (95% CI, 0.4 – 3.4%). Compared to women with low RS, those with intermediate RS had a 4.7 greater hazard of iLRR (95% CI, 1.0 – 22.3; P = 0.051) and those with a high RS had a 10.0 greater hazard of DM (95% CI, 2.5 – 40.7; P = 0.001). Given the low number of iLRR events, multivariable models to assess the association between RS and iLRR while adjusting for other factors were not feasible. Local-regional control from HR+ breast cancer was excellent for pts treated in the modern era. Among high RS pts, who were more likely to receive CT but not MTX, there were no iLRR events. Among pts with RS <31, intermediate RS pts may have a greater hazard of iLRR compared to low RS pts. The rarity of iLRR among pts with high RS may be due to frequent use of CT in the setting of highly chemo-sensitive disease and/or a greater propensity for spread to distant versus local-regional sites. Our findings suggest RS testing may be valuable in tailoring local-regional treatment, supporting the rationale for ongoing trials.
Episode-based payment models have been suggested as a means of controlling costs of treatment by removing incentives to provide more treatment than necessary. We sought to estimate potential effects of an episode-based model on Medicare reimbursement for radiation therapy (RT). We identified fee for service Medicare enrolled patients in SEER surveillance areas diagnosed with metastatic (M1) lung, breast, prostate, and colorectal cancers from 2007-2011 who received external beam RT through 2012. Total Medicare costs and RT-specific costs were calculated for a hypothetical one-month episode of care starting from first treatment delivery. Simulation and planning costs incurred prior to first treatment delivery were also calculated to arrive at total RT costs. Among 15,998 patients with metastatic cancer, mean total Medicare costs within one-month of first RT delivery was $11,418 and mean total RT costs from simulation through one-month following first RT delivery was $5070. Mean total RT costs ranged from $2156 to $9044 among patients treated with 1-5 vs >20 fractions (Table 1). Although both sim/planning and delivery costs were higher with greater number of fractions, total Medicare costs were lower. Patients receiving fewer fractions were more likely to be hospitalized at the start of treatment (27% vs 3% for 1-5 vs >20 fractions, P < 0.01) and incurred greater inpatient costs (mean $9464 vs $708 for 1-5 vs >20 fractions, P < 0.01). Restricting the analysis to patients surviving to the end of the episode did not substantially affect cost estimates. RT costs increase as number of fractions increases. Patients receiving shorter courses of palliative RT are more likely to be hospitalized and to have higher total Medicare costs. Payment models that incentivize fewer RT fractions may reduce palliative RT costs, but care should be taken if incorporating hospitalization rates or other medical costs into reimbursement models.Abstract 306; Table 1. Mean Total RT and Medicare Costs by Number of Fractions among Patients with Metastatic Cancer# RT fractions1-56-1011-20>20N (%)2139 (13.4)4808 (30.1)6354 (39.7)2697 (16.9)Mean total RT cost$2156$3386$5639$9044- Costs from 1st sim/plan to 1st delivery$948$984$1316$2013- Costs from 1st delivery to 1 month after$1208$2402$4323$7031Mean total Medicare cost (1st delivery to 1 month after)$14,803$11,253$10,803$10,476 Open table in a new tab
The Respiratory Nurses Association of Ireland,recognised inconsistencies and regional variations in delivery of oxygen therapy. Nationally the Patient Safety First Programme set requirments for improvements in quality and safety for patients regarding oxygen therapy. Aim: A national guideline on Long Term Oxygen Therapy. Method: Between 2014 and 2015 Respiratory Nurse Specialists,Respiratory Physician and Respiratory Physiotherapist examined practice and completed a literature review.Stakeholders dealing with patients were involved; Department of Public Health,Nursing and Midwifery Planning and Development Office,Irish Thoracic Society, National Respiratory Clinical Care Programme,State Claims Agency,Society of Chartered Physiotherapists,Association of Respiratory Scientists, Health Products Regulatory Authority,Health Service procurement and the community reform progamme. Results: Currently oxygen is requested through 34 different health service centres with many not having relevant testing and no standard prescription form.A comprehensive guideline was devised and disseminated via all stakeholders.This study highlights the benefits of multidisciplinary co-ordination.Following this the National Respiratory Therapies group, 2016 researched issues in relation to respiratory therapies including oxygen therapy noting delays due to inaccurate/inappropriate prescriptions (77.27%), financial approval (50%) and delivery (50%). Conclusion: The groups work is disseminated nationally, envisioning changes in the holistic delivery system of oxygen therapy for patients will occur.Currently there is a lack of Irish research into oxygen therapy use. This study has the potential to inform our current practice.
The clinical benefit of intensity-modulated (IMRT) compared to 3D conformal radiation (3D-RT) has not been well-established for locally advanced non-small cell lung cancer (NSCLC). We evaluated trends in use of IMRT for stage III lung NSCLC and compared survival and hospitalization outcomes. Using SEER-Medicare data, we identified use of IMRT or 3D-RT among 7061 Medicare beneficiaries diagnosed with stage III NSCLC from 2002-2009. Factors associated with use of IMRT versus 3D-RT were identified using multivariable logistic regression. Overall survival and number of hospital days within 90 days of radiation were analyzed using Cox proportional hazard and negative binomial regression models, respectively. Propensity score adjustment was used to control for clinical and demographic variables. IMRT comprised an increasing proportion of conformal treatments for NSCLC, rising from 3.0% in 2002 to 26.8% in 2009. Patients treated at freestanding versus hospital-based facilities were twice as likely to receive IMRT (17.3% vs 9.5%, adj OR = 2.0, p < 0.01). IMRT use varied by region, with higher rates in the South (12.8%, adj OR = 1.13) and West (14.2%, adj OR = 1.25), compared to the Northeast (9.9%, ref) and Midwest (9.1%, adj OR = 0.88) (overall p = 0.03) and in urban versus rural areas (12.5% vs 9.9%, adj OR = 1.52, p < 0.01). Patients with more comorbidities were more likely to receive IMRT, 11.3% (ref) vs 11.7% (adj OR = 1.03) vs 14.7% (adj OR = 1.35) for modified Charlson score 0, 1, and 2+, respectively (overall p = 0.03). We did not find a difference in IMRT use between stage IIIA and stage IIIB patients (11.8% vs 12.4%, adj OR = 1.11, p = 0.19). Patients receiving chemotherapy were more likely to receive IMRT (12.8% vs 10.4%, adj OR = 1.24, p = 0.02), though there was no difference in IMRT use among patients having surgery (11.4% vs 12.2%, adj OR = 0.95, p = 0.68). With propensity score adjustment, IMRT was associated with greater overall survival (adj HR = 0.91, p = 0.03) compared to 3D-RT, though there was no difference in survival among patients receiving at least 25 fractions of radiation (adj HR = 0.99, p = 0.83). There was no significant difference in number of hospital days in the 90 days following radiation start (mean 5 days, adj HR = 1.01, p = 0.89). When radiation is used to treat locally advanced NSCLC, IMRT is increasingly preferred to 3D-RT. However, among patients receiving potentially curative radiation (≥ 25 fractions) there was no significant difference in overall survival or time spent hospitalized following treatment compared to 3D-RT.
Background The purpose of clinical trials of acupuncture is to help clinicians and patients make decisions about treatment. Yet this is not straightforward: some trials report acupuncture to be superior to sham (placebo) acupuncture while others show evidence that acupuncture is superior to usual care but not sham, and still others conclude that acupuncture is no better than usual care. Meta-analyses of these trials tend to come to somewhat indeterminate conclusions. This appears to be because, until recently, acupuncture research was dominated by small trials of questionable quality. The Acupuncture Trialists' Collaboration, a group of trialists, statisticians and other researchers, was established to synthesize patient-level data from several recently published large, high-quality trials. Methods There are three distinct phases to the Acupuncture Trialists Collaboration: a systematic review to identify eligible studies; collation and harmonization of raw data; statistical analysis. To be eligible, trials must have unambiguous allocation concealment. Eligible pain conditions are osteoarthritis; chronic headache (tension or migraine headache); shoulder pain; and non-specific back or neck pain. Once received, patient-level data will undergo quality checks and the results of prior publications will be replicated. The primary analysis will be to determine the effect size of acupuncture. Each trial will be evaluated by analysis of covariance with the principal endpoint as the dependent variable and, as covariates, the baseline score for the principal endpoint and the variables used to stratify randomization. The effect size for acupuncture from each trial - that is, the coefficient and standard error from the analysis of covariance - will then be entered into a meta-analysis. We will compute effect sizes separately for comparisons of acupuncture with sham acupuncture, and acupuncture with no acupuncture control for each pain condition. Other analyses will investigate the impact of different sham techniques, styles of acupuncture or frequency and duration of treatment sessions. Discussion Individual patient data meta-analysis of high-quality trials will provide the most reliable basis for treatment decisions about acupuncture. Above all, however, we hope that our approach can serve as a model for future studies in acupuncture and other complementary therapies.
, Abstract Purpose— Prostate specific antigen (PSA) velocity has been proposed as a marker to aid detection of prostate cancer. We sought to determine whether PSA velocity could predict the results of repeat biopsy in men with persistently elevated PSA after initial negative biopsy. Materials and Methods— We identified 1,837 men who participated in the Göteborg or Rotterdam section of the European Randomized Screening study of Prostate Cancer (ERSPC), and who had one or more subsequent prostate biopsies after an initial negative finding. We evaluated whether PSA velocity improved predictive accuracy beyond that of PSA alone. Results— There were a total of 2579 repeat biopsies, of which 363 (14%) were positive for prostate cancer, and 44 (1.7%) were high grade (Gleason score ≥7). Although PSA velocity was statistically associated with cancer risk (p<0.001), it had very low predictive accuracy (area-under-the-curve [AUC] of 0.55). There was some evidence that PSA velocity improved AUC compared to PSA for high grade cancer. However, the small increase in risk associated with high PSA velocity – from 1.7 % to 2.8% as velocity increased from 0 to 1 ng / ml / year - is of questionable clinical relevance. Conclusions— Men with a prior negative biopsy have a lower risk for prostate cancer at subsequent biopsies, with high grade disease particularly rare. We found little evidence to support the use of PSA velocity to aid decisions about repeat biopsy for prostate cancer.
6048 Background: In the era of molecularly targeted agents, optimal lung cancer treatment decision making requires high quality pathology, including histologic rather than cytologic results. If there are differences in the likelihood of histologic diagnosis by race, ethnicity, or socioeconomic status (SES), it could contribute to disparities in lung cancer treatment and outcomes. Methods: We evaluated the nature of the pathologic diagnosis among 3760 lung cancer patients enrolled in CanCORS (the Cancer Care Outcomes and Research Consortium), a multi-region population- and health system-based prospective cohort study. Patients were diagnosed in 2002-2005. Patients were classified as having a histologic or a cytologic diagnosis, on the basis of procedures performed from 3 months before to 3 months after diagnosis, abstracted from medical records. A multivariable generalized logistic regression model was fitted to evaluate the association of clinical, sociodemographic, and health system factors on type of diagnosis, conditional on patients’ not having primary surgery for lung cancer. Results: Overall, 44% of patients had a procedure yielding histology (30% with primary surgery and 14% without). Race, SES, and gender were not significantly associated with having a histologic diagnosis. Older patients were significantly less likely to have histology (in reference to age < 65: odds ratio [OR] 0.70 (95% CI 0.51-0.96) for age 65-74 and OR 0.65 (95% CI 0.46, 0.91). for age 75+) In a secondary analysis substituting geographic region for data collection site, we found that patients treated in the South and Midwest (compared to the West) and those receiving care in staff model HMOs were more likely to have cytology only. Conclusions: In the first several years after the approval of targeted agents for lung cancer, the majority of patients were not receiving histologic diagnoses. We did not identify disparities in care by race or ethnicity; but other non-clinical factors including region of the country and health system characteristics appeared to play a role. Future studies should consider the quality of the pathologic information in evaluating disparities in lung cancer treatment and outcomes.