bluuebunny/crossref_metadata_2025 huggingface dataset:
Retrospective analysis of adjuvant treatment for localized, operable uterine leiomyosarcoma.
Authors: Chantharasamee Jomjit , Wong Karlton , Potivongsajarn Pasathorn , Aqorbani Amir , Chmielowski Bartosz , Cohen Joshua Garrett , Nelson Scott D. , Moatamed Neda A. , Brackert Sandra , Kalbasi Anusha , Rao Jianyu , Singh Arun S.
Published: March 2020

11072

Background: Surgery is the standard of care for uterine leiomyosarcoma, but recurrence rates are high and outcomes are poor. Standard adjuvant treatment of localized uterine leiomyosarcoma(uLMS) has not yet been established as clinical trials to address this question have been small or hindered by slow accrual. Methods: We reviewed the medical records of patients with uLMS who underwent upfront surgery between 2000-2018. We evaluated the clinical characteristics and adjuvant therapy on outcomes. Patient characteristics and treatment outcomes were described using descriptive statistics. Kaplan-Meier survival analysis was used for DFS. Cox proportional hazard regression was used to compare difference between groups. Results: 59 patients with a median age of 52 years were analyzed and the median time from surgery to adjuvant treatment was 47 days. 48/59 (81.4%) underwent TAH-BSO. 64.4% were FIGO stage I, 16.9% were stage II and 6.7% were stage III. The median tumor size was 11 cm (range: 3-21cm) and the median mitotic rate was 13 mitoses/ 10 high-power fields (HPF), (range: 1-63). 34/59 (57.6%) of patients received adjuvant chemotherapy +/- radiation therapy and 25 patients (42.3%) did not receive adjuvant treatment. With a median follow-up time of 42.8 months, 42 patients (71.2%) had disease relapse and 15 (35.7%) had pulmonary metastases. The median disease-free survival (mDFS) for all patients was 23.1 months. Any adjuvant treatment (chemotherapy or radiation) had a trend toward longer mDFS than no adjuvant treatment (36.6 vs 13.6 months, p = 0.14). Patients who had adjuvant chemotherapy had a non-significant longer mDFS compared to who did not receive any adjuvant treatment (33.8 vs 13.6 months, p = 0.18). Patients with stage I disease had trend towards higher mDFS in the chemotherapy group, it was not statistically significant (29.7 vs 16.6 months, p = 0.59). Multivariate analysis found that the independent prognostic factors for worse DFS included tumor size larger than 10 cm, and mitotic rate over 10/ 10HPF. More morcellated specimens were found in non-adjuvant treatment arm (36%) compare to 8% in adjuvant arm. In the non-treatment arm, 14 patients had recurrences within 6 months. Conclusions: In a retrospective uLMS population, the mDFS was 23.1 months. Tumor size > 10cm and mitotic rate > 10/10 HPF were independent prognostic factors for lower DFS. The non-treatment group had a significantly higher number of patient with morcellization and relapsed within 6 months, confounding analyses of the impact of adjuvant chemotherapy.
Efficacy and dosimetry prognostic factors of image guided 125I seed implantation for locally recurrent soft tissue sarcoma.
Authors: Jiang Weijuan , Jiang Ping , Qu Ang , Wang Junjie , Sun Haitao
Published: March 2020

11073

Background: To observe the effect of ultrasound / CT guided radioactive 125I seed implantation in the treatment of recurrent soft tissue sarcoma and its relationship with physical dosimetry prognostic factors. Methods: The data of 37 patients with recurrent soft tissue sarcoma who received ultrasound/CT-guided 125I seed implantation from November 2005 to December 2015 were retrospectively analyzed. The local progression-free survival rate and overall survival rate were evaluated. The relationship of local progression-free survival rate and overall survival with physical dosimetric parameters was analyzed. Results: Thirty-seven patients, 20 males and 17 females, with a median age of 53 years (16-79 years), received a median radiation dose of 60 Gy (28 Gy-120 Gy). The median tumor volume was 46.8 cm3 (0.5-252.2 cm3), the median particle activity was 0.67 mCi (0.4-0.84 mCi), and the median implanted particle number was 60 (3-158). The median follow-up time was 20 months (range: 1~144 months). The median overall survival time was 20.0 months (95% CI 16.4-23.6 months). The overall survival rates of 1, 3 and 5 years were 62.2%, 34.3% and 27.7% respectively. The median local progression-free time was 63.0 months. The 1-year, 3-year and 5-year local progression-free survival rates were 68.9%, 55.0% and 47.1%, respectively. Correlation analysis showed that HI was positively correlated with total survival and local progression-free survival (P = 0.001). Multivariate analysis showed that HI ( > 0.25) was an independent prognostic factor for long overall survival (P = 0.048, HR 0.39), and D90 ( > 110 Gy) was an independent prognostic factor for long local progression-free survival (P = 0.024, HR 0.17). Conclusions: Ultrasound/CT guided 125I seed implantation is a safe and effective method for the treatment of recurrent soft tissue sarcoma with high local control rate. The HI and D90 of the postoperative plan maybe affect the therapeutic efficacy.
A randomized, double-blind, placebo-controlled phase III trial evaluating olanzapine 5 mg combined with standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based chemotherapy: J-FORCE Study.
Authors: Hashimoto Hironobu , Abe Masakazu , Nakao Masahiko , Mizutani Hideaki , Sakata Yasuhiko , Fujita Yukiyoshi , Nishimura Tomoyasu , Hirano Katsuya , Okada Hideaki , Inui Naoki , Sakata Yukio , Iihara Hirotoshi , Zenda Sadamoto , Uchitomi Yosuke , Yamaguchi Takuhiro , Hoshina Yukari , Yanai Takako , Iwasa Satoru , Yamamoto Noboru , Ohe Yuichiro
Published: March 2020

11503

Background: Olanzapine (OLZ) 10 mg added to standard antiemetic therapy including aprepitant (APR), palonosetron (PALO), and dexamethasone (DEX) has been recommended for the prevention of chemotherapy-induced nausea and vomiting (CINV) caused by highly emetogenic chemotherapy (HEC). Guidelines suggest that a dose of 5 mg should be taken into consideration in patients at risk of sedation. OLZ 5 mg showed an equivalent activity and favorable toxicity to somnolence in several phase II studies. We conducted a randomized, double-blind, placebo-controlled phase III trial to evaluate OLZ 5 mg in addition to standard antiemetic therapy for the prevention of CINV in patients receiving cisplatin-based chemotherapy. Methods: Patients receiving cisplatin (≥ 50 mg/m2) were randomly assigned to either OLZ 5 mg or placebo on days 1–4, combined with APR, PALO and DEX. The primary endpoint was complete response (CR), defined as no vomiting and no rescue medications in the delayed phase (24–120 h). A total of 690 patients were required to detect a 10% increase in CR from 65% in the placebo to 75% in the OLZ, with a one-sided alpha of 2.5% and a power of 80%. Results: A total of 710 patients were enrolled (OLZ 356 and placebo 354). CR in the delayed phase was 79.1% (95% CI: 74.9–83.3) in the OLZ 5 mg and 65.8% (95% CI: 60.9–70.8) in the placebo ( p < 0.001). Other efficacy results are summarized in Table. The most common treatment-related adverse events was somnolence (43.1% for OLZ vs. 33.0% for placebo). Conclusions: OLZ 5 mg combined with APR, PALO and DEX can be considered a new standard antiemetic therapy in patients receiving cisplatin-based chemotherapy. Clinical trial information: UMIN000024676. [Table: see text]
Randomized controlled trial (RCT) of a patient navigation (PN) intervention to increase early access to supportive care (SC) for patients with metastatic cancer in a resource-limited setting.
Authors: Soto Perez De Celis Enrique , Chavarri Guerra Yanin , Ramos-Lopez Wendy Alicia , Covarrubias-Gómez Alfredo , Navarro-Lara Africa , Quiroz Paulina , Sanchez Sofia , Alcocer Natasha , Alcalde Castro Mirza , Aguilar Velazco Jose Carlos , Bukowski Alexandra , Chavarri Maldonado Juan Alberto , Contreras-Garduño Sergio , Krush Lindsay , Inoyo Itoro E. , Medina-Campos Andrea , Moreno-García María Luisa , Pérez-Montessoro Viridiana , Goss Paul E.
Published: March 2020

11505

Background: Early integration of SC to the treatment of advanced cancer can improve outcomes, but this may be challenging in developing countries due to a lack of resources and knowledge. In this RCT, we examined whether PN could improve early access to SC among Mexican patients with metastatic solid tumors as recommended by ASCO guidelines. Methods: Adult patients with newly-diagnosed metastatic cancer were randomly assigned to PN or standard oncologic care. At baseline, a navigator assessed the patients’ SC needs (depression, anxiety, fatigue, pain, caregiver burden) using validated questionnaires administered with an electronic tablet. For those in the PN arm, a personalized SC plan was created and implemented by a multidisciplinary team (palliative care, physical therapy, geriatrics, psychology, psychiatry). The primary outcome was access to SC, defined as receipt of SC interventions in the first 3 months (mo) after diagnosis. Secondary outcomes included advanced directive (AD) completion (for patients with expected survival ≤6 mo in accordance to Mexican law), changes in SC needs, and changes in quality of life (assessed using FACT-G). Results: 133 patients (median age 60, range 23-93; 52% male) were randomized (66 PN, 67 control). 61% of patients had gastrointestinal tumors. 94% of patients in the PN arm completed baseline assessments and received recommendations from the navigator. At 3 mo, 37 patients died or were lost to follow-up (16 PN, 21 control; p = 0.45), and 96 completed assessments. SC interventions were provided to 73% of patients in the PN arm and 24% of controls (p < 0.01). In the PN arm, 48% of 29 eligible patients completed AD, compared to 0% of eligible controls (p < 0.01). At 3 mo, patients in the PN arm were significantly less likely to report moderate/severe pain than controls (10 vs 33%, p = 0.006). There were no significant differences in other symptoms or in FACT-G scores (76 vs 76.3, p = 0.46) between PN and control arms at 3 mo. Conclusions: PN can lead to significant improvements in early access to SC, AD completion, and pain control among patients with metastatic cancer treated in a resource-limited setting. Clinical trial information: NCT03293849.
Predictive factors of grade 3-5 toxicity in older patients with cancer treated with chemotherapy: A prospective multicenter study.
Authors: Feliu Batlle Jaime , Basterretxea Laura , Torregrosa Maria Dolores , Llabres Elisenda , Losada Vila Beatriz , Jimenez-Munarriz Beatriz , Rebollo Maite Antonio , Custodio Ana B. , Girones Regina , Cruz Patricia , Sanchez Mar Munoz , Pinto Alvaro , Soler Gemma , Soria Comes Teresa , Telleria Hellis , Molina-Garrido MJ
Published: March 2020

11509

Background: Older patients have increased risk of toxicity from chemotherapy. The purpose of this study was to analyse predictive factors for developing grade 3-5 toxicity in older patients treated with chemotherapy. Methods: This prospective multicenter study included 500 cancer patients ≥ 70 years between Feb 2014 and Jun 2018. A prechemotherapy assessment including sociodemographics, tumor/treatment variables, laboratory test results, and geriatric assessment variables (function, comorbidity, cognition, psychological state, social activity/support, and nutritional status) was performed. Logistic regression was used to examine the association between these factors and the development of grade 3-5 toxicity. Results: Mean age of the patients was 77 years (70-92), ECOG PS 0/1/2: 25%/63%/12%. 223 (45%) had a primary dose reduction.167 (33%) patients developed grade 3-5 toxicity (28% grade 3, 5% grade 4, 1% grade 5). Univariate analysis found a higher risk of grade 3-5 toxicity in patients with creatinine clearance ≤ 60 mL/min, IADL ≤7, VES13 ≥ 6, and the administration of standard chemotherapy doses. In multivariable analysis, only the chemotherapy dose (odds ratio [OR] 1.179; 95% confidence interval [CI] 1.215–2.655) and creatinine clearance (odds ratio [OR] 0.989; 95% confidence interval [CI] 0.981–0.997) were independently associated with toxicity. Conclusions: Renal function and chemotherapy dose were significant predictors of grade 3-5 toxicity among older patients treated with chemotherapy.
Outcomes that matter to patients: The Geriatric Oncology Surgical Assessment and Functional rEcovery after Surgery (GOSAFE) study—Analysis of 471 patients.
Authors: Montroni Isacco , Ugolini Giampaolo , Spinelli Antonino , Ercolani Giorgio , Jacklitsh Michael T. , Rostoft Siri , Somasundar Ponnandai Sadasivan , Van Leeuwen Barbara , de Liguori Carino Nicola , Saur Nicole M. , Ferrari Giovanni , Ghignone Federico , Sermonesi Giacomo , Di Candido Francesca Rita , Foca Flavia , Zingaretti Chiara , Vertogen Bernadette , Audisio Riccardo ,   SIOG Surgical Task Force/ESSO GOSAFE Study Group
Published: March 2020

11511

Background: Older cancer patients value functional outcomes as much as survival but surgical studies lack functional recovery (FR) data. The international, multicenter GOSAFE study (ClinicalTrials.gov NCT03299270) aims to evaluate patients’ quality of life (QoL)and FR after cancer surgery and to assess predictors of FR. Methods: GOSAFE prospectively collects functional and clinical data before and after major elective cancer surgery on senior adults (≥70 years). Surgical outcomes are recorded (30 days, 90 days, and 180 dayspost-operatively) with QoL(EQ-5D-3L) and FR (Activities of Daily Living (ADL) + Timed Up and Go (TUG) + MiniCog), 28centers are prospectively enrolling patients; accrual ends February 2019. Results: 643 patients underwent major cancer surgery with curative(94%) or palliative (6%) intent (February 2017-September 2018). Median age was 78(range 70-94); 51.6% males, ASA III-IV 52%. Patients dependent (ADL < 5) were 8%. Frailty was detected by G8 > 14 in 32% and fTRST≥2 in 36% of patients. 639 (99%) lived at home, 32% lived alone, and 88% were able to go out. Major comorbidities (CCI > 6) were detected in 36% and 22% had cognitive impairment according to MiniCog (5% self-reported). 26% had > 3 kg weight loss, 30% were hospitalized in the last 90 days, 45% had ≥3 medications (6% none). For 471 patients, a 90-day comprehensive evaluation was available. Postoperative morbidity was 42% (30 day) and 63.3% (90 day), but Clavien-Dindo III-IV complications were only 11.2% and 17.6%. 90-day mortality was 7.4% (5% 30-day). QoL improved 90 days after surgery (mean EQ-5D index from 0.76 to 0.80). Patients with EQ-5D VAS score > 60 raised from 73.9% at baseline to 82.8% at 90 days. 29% had complete FR (ADL score > 4, MiniCog > 2, TUG < 20). Decreased functional capacity was seen in 23.4% of patients alive at 90-days. Conclusions: GOSAFE is the largest prospective study on older cancer patients undergoing major surgery. Interim analysis reports decreased functional capacity in a quarter of patients. The study will allow clinicians to associate clinical outcomes with individual factors of the preoperative assessment and create a user-friendly tool to predict outcomes that matter to patients.
A randomized controlled trial of a novel artificial intelligence-based smartphone application to optimize the management of cancer-related pain.
Authors: Kamdar Mihir , Centi Amanda Jayne , Agboola Stephen , Fischer Nils , Rinaldi Simone , Strand Jacob J. , Traeger Lara , Temel Jennifer S. , Greer Joseph , El-Jawahri Areej , Jackson Vicki , Kvedar Joseph , Jethwani Kamal
Published: March 2020

11514

Background: Cancer pain is a significant problem that impairs patient quality of life and increases healthcare utilization. ePAL is a smartphone application that utilizes patient-reported outcomes (PROs) and artificial intelligence (AI) to optimize cancer pain management. This randomized controlled trial examined the impact of ePAL on cancer pain severity, attitudes toward cancer pain, and healthcare utilization. Methods: Patients with pain from metastatic solid tumors (n = 112) undergoing treatment in a palliative care clinic were randomized to either a control group (n = 56) that received usual care or an intervention group (n = 56) that received ePAL in addition to usual care for 8 weeks. Measures of pain severity (Brief Pain Inventory), attitudes towards cancer treatment (Barriers Questionnaire II) and anxiety (General Anxiety Disorder-7) were assessed. We used repeated measures mixed modeling to assess change in outcome measures over time. We also conducted a chart review to identify pain-related hospital admissions and emergency department (ED) visits and compared risk between study groups. Results: Pain severity (BPI) and negative attitudes toward cancer treatment (BQ-II) decreased significantly for those assigned to ePAL compared to controls (ß = -0.09, p = 0.034 and ß = -0.037, p = 0.042, respectively). Patients assigned to ePAL reported higher anxiety scores compared to controls (ß = 0.21, p = 0.015). Patients assigned to ePAL had significantly fewer pain-related hospital admissions (n = 4 vs. n = 20, per patient risk ratio 0.31, p = 0.018) and fewer pain-related admissions through the ED (n = 2 vs. n = 14, per patient risk ratio 0.18, p = 0.008) compared to control group. Conclusions: To our knowledge, this is the first mobile app to utilize patient reported outcomes and artificial intelligence to significantly decrease pain scores and pain-related hospitalizations in patients with cancer-related pain. Future directions include examining the efficacy of ePAL in settings with limited access to palliative care.
Improving person-centered communication of goals, proxy, and advance directives in older patients with advanced cancer: Secondary analysis from a University of Rochester NCI Community Oncology Research Program (NCORP) cluster randomized controlled trial (CRCT).
Authors: Flannery Marie Anne , Culakova Eva , Loh Kah Poh , Epstein Ronald M. , Kamen Charles Stewart , Obrecht Spencer , Melnyk Nataliya , Whitehead Mary I. , Geer Jodi , Giguere Jeffrey K. , Mustian Karen Michelle , Duberstein Paul , Dale William , Mohile Supriya Gupta
Published: March 2020

11523

Background: Quality person-centered care relies on effective communication between the clinical team and the patient/caregiver eliciting goals and discussing wishes. In a PCORI- and NCI-funded CRCT, we found that providing community-based oncologists with geriatric assessment-guided recommendations led to more and higher quality discussions of age-related issues for older patients with advanced cancer. In this secondary analysis, we assessed whether specific recommendations to oncologists to discuss patient goals, proxy and advance directives resulted in increased communication about these topics. Methods: Patients aged 70+ with advanced solid tumors or lymphoma and at least one impaired geriatric domain (e.g., function, cognition) were enrolled (URCC 13070; PI: Mohile). Oncology practices were randomized to the intervention (oncologists received recommendations to elicit goals and discuss wishes) or usual care. The clinic visit after the oncologist received recommendations was recorded and transcribed; two blinded coders evaluated the transcripts for discussion of the specific topic areas recommended in the intervention. Between arm differences were compared using generalized linear models controlling for practice cluster. Results: From 2014-17, 528 patients (284 intervention) provided transcripts from 31 practices (mean age = 77, range 70-96 years; 49% female; mixed cancer diagnoses). Topics related to patient goals, proxy and advance directive wishes were more often discussed in the intervention arm (goals of care preferences: 9 vs 2%, p = .02, treatment goals: 35 vs 20%. p = .04, elicit caregiver input: 28 vs 3%. p < .01, assess values and goals: 25 vs 7%, p = .07, health care proxy: 40 vs 1%, p = .004, advance directive: 25 vs 1%, p = .002). Conclusions: In this community-based study of older adults providing recommendations to oncologists to discuss specific topics resulted in increased person-centered discussions with patients and caregivers about goals, proxy and advance directive wishes. However, the content areas were discussed in less than half of all visits. Clinical trial information: NCT02107443.
Accelerated sarcopenia and outcomes in older adults with cancer: The Health ABC Study.
Authors: Williams Grant Richard , Chen Yanjun , Kenzik Kelly , McDonald Andrew Michael , Shachar Shlomit S. , Klepin Heidi D. , Kritchevsky Stephen , Bhatia Smita
Published: March 2020

11526

Background: Progressive loss of muscle mass and strength (sarcopenia) is a well-known phenomenon of aging; however, little is known about the contribution of a cancer diagnosis to sarcopenia and its subsequent impact on disability. Using a prospective cohort of older adults from pre- to post-cancer diagnosis and a similarly-followed non-cancer cohort, we examined the trajectory of sarcopenia measures and their association with overall survival (OS) and major disability among those with cancer. Methods: The Health, Aging, and Body Composition (Health ABC) Study is a prospective longitudinal study where 3,075 community-dwelling older adults (70-79y) underwent 6 annual assessments of body composition and were followed for development of sentinel events (cancer, disability, death). Appendicular lean mass (ALM [kg]) was a sum of DXA-based lean tissue of all extremities. Hand grip strength (HGS [kg]) was averaged from 2 trials per hand. Gait speed (GS) was evaluated over a 20m course. We used linear mixed effect models to compare the change in ALM, HGS, and GS between individuals who subsequently developed cancer and those who did not, adjusting for age, race, gender, enrollment site. Among patients with cancer, we used multivariable cox regression for time from cancer diagnosis to mortality and major disability (cane/walker, inability to walk 0.25 mile/climb 10 steps, assistance with activities of daily living) treating sarcopenia measures as time-varying covariates. Results: Mean age at enrollment was 75y; 52% female; 42% black; 515 new cancers (prostate: 23%, colorectal: 15%, lung: 13%, breast: 11%). Compared with non-cancer controls, we found significantly steeper declines in HGS ( p= 0.03) and GS ( p< 0.001), and a trend in ALM ( p= 0.07) prior to cancer diagnosis; and a significantly steeper decline in ALM ( p< 0.001), but no difference in HGS ( p= 0.6) or GS ( p= 0.4) after cancer diagnosis. Slow GS was associated with a 44% increase in mortality ( p= 0.02) and a 70% increase in disability ( p= 0.02), but not ALM or HGS. Conclusions: Accelerated loss in sarcopenia measures both prior to and after a cancer diagnosis, and association with disability and mortality in older adults with cancer, present opportunities for targeted interventions.
Age disparities among cancer clinical trial participants: The role of industry sponsorship.
Authors: Ludmir Ethan B. , Mainwaring Walker , Miller Austin B. , Lin Timothy , Jethanandani Amit , Espinoza Andres F. , Fuller Clifton David
Published: March 2020

11527

Background: Randomized controlled trials (RCTs) in oncology, which often establish the standard of care for cancer patients, do not necessarily enroll trial participants representative of the broader patient population. We sought to characterize age disparities for cancer patients enrolled on RCTs, and asked whether certain trial-related factors (such as industry sponsorship) predispose trials to larger age disparities between trial enrollees and the general population. Methods: All phase 3 RCTs in clinical oncology with results available were identified through ClinicalTrials.gov. Only randomized multi-arm trials assessing a therapeutic intervention for cancer patients were included. The scope of trials was limited to breast, colorectal, lung, and prostate disease sites. Trial participant median ages were compared to national SEER data for population median ages by disease site. Results: Three-hundred and two trials met inclusion criteria. For all trials, the trial median age was an average 6.23 years younger than the population median age (95% CI: -5.55 to -6.91 years, p < 0.001). Trials with industry sponsorship had significantly younger trial patient populations compared with non-industry-sponsored trials (mean difference from population -6.57 vs -4.48 years, p = 0.02). Younger patients were enrolled on trials evaluating targeted agents (p = 0.04), superiority-design trials (p = 0.02), and trials utilizing a surrogate primary endpoint (p = 0.03). By disease site, lung cancer trials enrolled the youngest patients relative to the population median (-8.98 years), followed by breast (-7.76 years), colorectal (-6.96 years), and prostate (+2.66 years, p < 0.001). Conclusions: Industry-funded clinical trials are associated with larger age disparities among trial participants; we believe this represents a novel finding both in clinical oncology and academic medicine more broadly. Underrepresentation of older patients on RCTs has major ramifications for the generalizability of results as well as equity of access to care; future efforts to address trial participant age disparities may focus on those trials at greatest risk for disparities based on the identified risk factors, including industry sponsorship.
Cumulative burden of new-onset chronic health conditions (CHCs) among older cancer survivors.
Authors: Kenzik Kelly , Williams Grant R. , Bhakta Nickhill , Robison Leslie L. , Bhatia Smita
Published: March 2020

11528

Background: In the US there are an estimated 11 million survivors of cancer diagnosed at ≥65y of age. Description of the morbidity in these survivors has been limited to single complications or to prevalence of comorbidities. The cumulative burden of CHCs remains unstudied, and is critically needed to inform healthcare delivery in this burgeoning population. Methods: Using SEER-Medicare, we identified 300,082 patients with breast (34%), prostate (33%), colorectal (16%), non-small cell lung (NSCLC 10%) or non-Hodgkin lymphoma (NHL 7%) diagnosed between 2000 and 2011 at age > 65y (mean age at diagnosis: 75y; 47% males, 88% non-Hispanic whites). An age-, race-, and sex-similar non-cancer cohort (n = 97,842) was assembled. New-onset non-malignant health conditions (n = 109) were consolidated into 10 organ-specific CHCs. Inpatient CHC visits were used to describe severe CHCs. The cumulative incidence (CI) and cumulative burden (CB) of CHCs was described up to 10y from cancer diagnosis and by attained age – up to six months prior to death or until 12/31/2013. Subsequent malignant neoplasms (SMNs) were described 10y from primary cancer diagnosis. Results: The 10y CI of any CHC and severe CHC was 98% (95%CI 98-99%) and 73% (72-73%) in cancer patients and 92% (91-92%) and 55% (54-55%) in non-cancer controls (hazard ratio [HR10y]: 1.65, 95%CI 1.64-1.66). Cardiovascular conditions were the largest contributor to severe non-malignant CHCs (10y CI: 49%-69%). Prostate cancer survivors had the highest 10y CI for SMNs (19.4%). The CI for severe CHCs was 44% by age 80y and 85% by age 90y, compared to 34% and 54% in controls (p < 0.001). The 10y CB of CHCs was highest among NSCLC (42 CHCs/survivor) and NHL (41 CHCs/survivor) survivors; in comparison, the 10y CB was 31 CHCs/individual in controls. Colorectal cancer survivors had greatest overall burden at age 80y (27 CHCs/survivor) and 90y (36 CHCs/survivor), compared to 13 and 16 CHCs/individual in controls. Conclusions: The cumulative burden of new-onset multimorbidity among older cancer survivors is substantially greater than that of their non-cancer counterparts, providing quantifiable evidence that survivor-adapted healthcare management policies and risk-based interventions are needed.
Early mortality after resection of locally advanced rectal cancer in elderly United States patients.
Authors: Sineshaw Helmneh M. , Yabroff K Robin , Tsikitis Vassiliki Liana , Jemal Ahmedin , Mitin Timur
Published: March 2020

11529

Background: Early mortality after resection of locally advanced rectal cancer in patients age 75 and older has not been studied in the United States. This information could inform clinical decision-making for patients who achieve complete clinical response after neoadjuvant therapy and consider watchful waiting versus surgical resection. Methods: Using the National Cancer Data Base, we identified patients age 75 years and older who underwent surgery for clinical stage II or III rectal cancer between 2004-2015. We performed multivariable logistic regression analyses to assess associations between patient and facility characteristics and 30-day, 90-day, and 6-month mortality. Results: Among 11,326 patients, 94% underwent resection and the remaining 6% underwent local excision. Overall early mortality rates after surgery were 4%, 7.6% and 11% for 30-day, 90-day and six-month, respectably. Six-month mortality varied by age subgroup (8% in 75-79 years old to 17.7% in 85 years and older), and comorbidity score (9.5% for comorbidity score = 0 to 18.5% for comorbidity score ≥ 2). Between 2004 and 2015, six-month mortality declined significantly from 11.9% in 2004-2007 to 9.8% in 2012-2015 ( P trend = 0.0029), with the decline larger among patients age 85 years and older (from 19.4% in 2004-2007 to 15.3% in 2012-2015, P trend = 0.0377). In the multivariable analysis, older age, higher comorbidity score, and lower facility case volume were significantly associated with higher odds of six-month mortality. Patients treated at National Cancer Institute (NCI) designated centers had 32% lower odds of six-month mortality compared with those treated at non-NCI designated teaching/research centers. Conclusions: Post-operative six-month mortality among patients age 75 years and older with locally advanced rectal cancer in the US declined steadily over the past decade. Older age, high comorbidity score, and low facility case volume were associated with higher six-month mortality after surgery. Additional efforts are needed to guide elderly patients and their physicians in discussing treatment options for locally advanced rectal cancer.
Unraveling the high cost of end-of-life care: An oncology care model experience.
Authors: Hoverman J. Russell , Taniguchi Cynthia B. , Hayes Jad , Eagye Kathryn , Mann B. Brooke , Neubauer Marcus A.
Published: March 2020

11534

Background: Simply put, cancer care in the last 30 days of life (30DAY) is often aggressive and expensive without best meeting the wishes and needs of patients and caregivers. In this study, we evaluated total and 30DAY cost data for patients who died while enrolled from July 1, 2016 to June 30, 2017 in the Oncology Care Model (OCM), a Medicare (CMS) program initiated by the Center for Medicare and Medicaid Innovation. Methods: CMS provided claims data on 16 OCM-participating US Oncology Network practices. We measured 30DAY OCM episode expenditures (“EXP30”) for n = 5017 deceased patients, as well as patient demographics, clinical outcomes (hospital, ICU, and ER visits) and 30DAY treatments . The population was divided into two cohorts: those with ≥ 3 days of hospice care (“HC”) and those without (“NOHC”). EXP30 was compared between HC and NOHC at the univariate level using Wilcoxon Rank-sums; categorical variables were compared using Chi-squared tests. Multivariate regression was used to determine the effect of HC on EXP30 adjusted for demographic and disease factors. Results: HC had mean EXP30 reduction of $7,192 vs. NOHC [95%CI -$7,628, -$6,730] adjusted for demographics and disease. HC had lower rates of death in hospital (0.03% vs. 43.3%, p < .0001). Mean expense by days before death: NOHC values 0-30 days = $20,701; 31-60 days = $12,962; 61-90 days = $9,952 and HC values 0-30 days = $10,877; 31-60 days = $10,376; 61-90 days = $9,064. Conclusions: All categories of care except HC are associated with significantly higher cost in the last 30 days of life. The dramatic and steep trajectory in the last 30 days suggests high expense but also loss of choices as to how best to live the end of one’s life. The results will be updated as new data become available. [Table: see text]
Palliative Prognostic Index application at an inpatient palliative care service from a Brazilian tertiary Hospital: A prospective observational study.
Authors: Branco Tiago Pugliese , dos Santos Tavares Alze Pereira , Braz Mariana Sarkis , Monteiro Mariana Ribeiro , Kinupe Abrahao Ana Beatriz , A. F. de Menezes Thiago , Paparelli Carolina , Kishimoto Carolina Sassaki , M. F. Medeiros Helena , Ebina Karen , R. B. Cabral Luciana , Fernandes Maria Clara , Cortizo Silvia , Borges Fabiola , Nagashima Simone , Aguiar Pedro Nazareth
Published: March 2020

11537

Background: Palliative Care Index (PPI) has been proposed to improve the accuracy of survival prediction for advanced cancer patients. The aim of this study is to investigate the feasibility and real-world prognosis survival of oncology inpatients from a Brazilian tertiary hospital using PPI. Methods: Hospitalized advanced cancer patients who have been referred to the Palliative Care Team were enrolled from May 2011 to December 2018. The PPI was collected within 24 hours of the referral by the palliative care physician. Primary endpoint was median overall survival (OS), estimated with the use of the Kaplan–Meier method, in three groups: PPI < 4.0; 4.0 ≤ PPI > 6.0 and PPI ≥ 6.0. Secondary endpoints were OS rate at 3-week for patients with PPI ≥ 6.0, and the most accurate PPI value to predict 6 and 3-week survival, calculated by ROC curve. Results: Total of 1.381 patients were included in this cohort with a median age of 68-year-old, and 51.3% of females. The most frequent primary cancer sites were lung/chest (17,2%), colorectal (14,3%), breast (11,2%), and biliopancreatic (10,9%). Among 454 patients with PPI < 4.0, median OS was 44 days (95% CI: 35,5-52,4); 20 days (95% CI: 15,4-24,5) for 260 patients with 4.0≤ PPI < 6.0 and 8 days (95% CI: 7-8,9) between 655 patients with PPI ≥ 6. Differences in OS among the groups adjusted for primary site, age and gender were significant (p < 0,001). OS rate at 3 weeks for PPI≥ 6.0 was 28.1% (OR 5,39 p < 0.001). PPI value of < 5,5 best predicted 6-week OS (79% sensibility, 55% specificity, AUC 0,714) and the PPI value of ≥ 5,5 predicted 3-week OS (67% sensibility, 73% specificity, AUC 0,753). Conclusions: PPI is feasible and suitable for routine clinical practice to predict survival among Brazilian patients with advanced cancer. In our study, PPI 5.5 seems to be the most accurate value to predict survival within 3 weeks.
Predictive value of an electronic frailty index (FI) in U.S. Veterans with newly diagnosed non-small cell lung cancer (NSCLC).
Authors: Sheikh Ayesha Rizwan , Cheng David , Fillmore Nathanael , Do Nhan , Brophy Mary T. , Tuck David P.
Published: March 2020

11545

Background: Frailty is a well-established predictor of survival, but assessing it in a real-world healthcare setting is often time-consuming and impractical. We sought to determine if a quantitative measure of frailty, computed automatically from electronic health records using the cumulative deficit model, also predicts overall survival in patients with NSCLC. Methods: We conducted a retrospective cohort study of Veterans identified to have NSCLC in the VA Precision Oncology Data Repository. Frailty was assessed using a previously validated FI, the Frailty Index for Veterans Affairs (VA-FI), consisting of 31 deficits. We categorized non-frail patients into non-frail (0-0.1) and pre-frail (0.1-0.2) groups, and frail patients into mild (0.2-0.3), moderate (0.3-0.4) and severe ( > 0.4) groups. Associations of frailty and survival were assessed using Kaplan-Meier estimates and Cox models. The added value of frailty status for predictive performance was quantified using the continuous net-reclassification index (NRI). Results: The cohort included 359 patients with NSCLC. The mean age was 66 years, and 96.1% were male, including 76.3% Caucasian and 16.2% African-American. The majority had an advanced stage cancer (15.9% and 44.3% with stages III and IV respectively) with minority falling into the early stage category (15.3% and 6.1% with stages I and II respectively). A substantial proportion of patients were identified to be frail (30%). The frailty categories differentiated survival profiles of patients with 2-year survival ranging from 0.41 for non-frail patients to 0.08 for the severely frail patients (log-rank p < 0.001). Frail patients exhibited significantly shorter survival than non-frail group even after adjusting for age, gender, and stage in a multivariate Cox model (hazard ratio 1.7, p < 0.001). Inclusion of frailty status in the Cox model significantly improved 2-year risk estimates of survival (NRI 0.35; 95% CI 0.27–0.47). Conclusions: Frailty as determined by VA-FI is a significant predictor of survival independent of stage and demographic factors among NSCLC patients in this VA cohort. VA-FI is an automated and a practically feasible tool to better estimate life expectancy and help individualize patient care.
Pilot randomized trial of a transdisciplinary geriatric intervention for older adults with cancer.
Authors: Kay Paul , El-Jawahri Areej , Fuh Charn-Xin , Temel Brandon , Landay Sophia , Lage Daniel , Franco-Garcia Esteban , Scott Erin , Stevens Erin , O'Malley Terrence , Mohile Supriya Gupta , Dale William , Traeger Lara , Jackson Vicki , Greer Joseph , Temel Jennifer S. , Nipp Ryan David
Published: March 2020

11549

Background: Oncologists often struggle with managing the unique care needs of older adults with cancer. We sought to determine the feasibility of delivering a transdisciplinary geriatric intervention designed to address the geriatric (physical function & comorbidity) and palliative care (symptoms & prognostic understanding) needs of older adults with cancer. Methods: We randomly assigned patients age ≥65 with newly diagnosed incurable gastrointestinal (GI) or lung cancer to receive a transdisciplinary geriatric intervention or usual care. Intervention patients received two visits with a geriatrician who was trained to address patients’ palliative care needs in addition to conducting a geriatric assessment. We defined the intervention as feasible if > 70% of patients enrolled in the study and > 75% completed study visits and surveys. At baseline and week 12, we assessed patients’ quality of life (QOL, Functional Assessment of Cancer Therapy General), symptoms (Edmonton Symptom Assessment System), and communication confidence (Perceived Efficacy in Patient Physician Interactions). As this was a pilot study, we calculated mean change scores in outcomes and estimated intervention effect sizes (ES). Results: From 2/2017-6/2018, we randomized 62 patients (55.9% enrollment rate [most common reason for refusal was feeling too ill]; median age = 72.3 [range 65.2-91.8]; 45.2% female; cancer types: 56.5% GI, 43.5% lung). Among intervention patients, 82.1% attended the first visit and 76.2% attended both. Overall, 77.8% completed all study surveys. Compared to usual care, intervention patients had less decrement in QOL scores (-0.77 vs -3.84, ES = .21), greater reduction in the number of moderate/severe symptoms (-0.69 vs +1.04, ES = .58), and more improvement in communication confidence (+1.06 vs -0.80, ES = .38). Conclusions: In this trial of older adults with advanced cancer, more than half enrolled in the study and over 75% of those who enrolled completed all study visits and surveys. Our effect size estimates suggest that a transdisciplinary intervention targeting patients’ geriatric and palliative care needs may be a promising approach to improve patients’ QOL, symptom burden, and communication confidence. Clinical trial information: NCT02868112.
Treatment completion and toxicity of trastuzumab or trastuzumab + lapatinib in older patients (pts): BIG 2-06; NCCTG N063D (Alliance).
Authors: Ponde Noam Falbel , Agbor-Tarh Dominique , Dal Lago Lissandra , Korde Larissa A. , Hilbers Florentine , Jackisch Christian , Werner Olena , Gelber Richard D. , Jatoi Aminah , Dueck Amylou C. , Moreno-Aspitia Alvaro , Sotiriou Christos , de Azambuja Evandro , Piccart Martine
Published: March 2020

11553

Background: Little is known about the toxicity of trastuzumab (T) or of trastuzumab + lapatinib (T + L), approved in the advanced setting, in older pts. We have performed a sub-analysis of the Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation (ALTTO) trial focused on treatment completion and toxicity of T and T+L in older pts (aged ≥65 years (yr)). Methods: The ALTTO trial (NCT00490139, NCCTG N063D) randomised 8381 pts with early HER2+ BC into 4 arms and we included the T and T+L arms in our analysis. Eligible pts for our study were those having received at least one dose of assigned treatment. Treatment completion was evaluated through the rate of temporary treatment interruptions (TTI), permanent treatment discontinuations (PTD) and lapatinib dose reductions (LDR). Toxicity was evaluated via a selected set of adverse events of interest (AEIs). Risk factors for TTI, PTD, LDR and AEIs were assessed, including comorbidities and polypharmacy at baseline (defined as use 5 or more co-medications) and AEIs during treatment. Results: A total of 430 pts≥65-year-old were identified for this sub-analysis, out of a total of 4190 pts with a median age of 68 yrs (range 65-80). Older pts were more likely to have comorbidities (70% vs 38%). Treatment completion was worse among older pts in the T+L arm but not in the T arm (Table). AEIs were more common in the T+L arm in all patients, with older patients having higher AEI rates (78.04% in older vs 63.38% in younger), particularly diarrhea (60.75% vs 38.0%). Identified risk factors (multivariate) for worse treatment completion in the T and T+ L arms included concomitant use of chemotherapy and the occurrence of grade 3 adverse events, among others. Conclusions: T + L has worse treatment completion and is more toxic in older patients, while T was well tolerated. Identifiable risk factors at baseline and during the course of treatment could be used to aid in regimen selection and management for both T and T + L in their respective indications. Support: UG1CA189823, Novartis;https://acknowledgments.alliancefound.org. [Table: see text]
Obesity paradox in older cancer patients for middle and long-term mortality: A prospective multicenter cohort study of 2,071 patients.
Authors: Martinez-Tapia Claudia , Diot Thomas , Oubaya Nadia , Paillaud Elena , Poisson Johanne , Gisselbrecht Mathilde , Caillet Philippe , Baudin Aurélie , Pamoukdjian Frédéric , Bastuji-Garin Sylvie , Laurent Marie , Canoui-Poitrine Florence
Published: March 2020

11555

Background: Overweight and obesity are associated with numerous adverse health outcomes. However, among older adults, substantial literature suggests an improved survival among overweight and obese patients. This phenomenon, referred to as the “obesity paradox” remains controversial. In the context of cancer, the association between overweight/obesity and mortality is complex due to the concomitant weight loss and cachexia. We aim to assess the impact of high Body Mass Index (BMI) on mortality in a large population of older cancer patients. Methods: We studied patients aged ≥70 from the ELCAPA prospective open-cohort (2007-2016; 10 geriatric oncology clinics, Great Paris urban area). Endpoints were 12- and 48-months mortality. A variable combining BMI at cancer diagnosis and weight loss (in the 6 months preceding the diagnosis) was created. BMI categories considered: underweight, (BMI < 22.4kg/m²), normal weight (BMI 22.5-24.9), overweight (BMI 25-29.9), and obese (BMI ≥30); weight loss (WL) categories: < 5%, 5- < 10%, ≥10%. Univariate and multivariate Cox proportional-hazards analysis were conducted in males and females. Results: A total of 2071 patients were included (mean age, 81; female, 48%; metastases, 49%; main localizations: digestive (37%), urinary (26%), breast (16%); underweight (30%), normal weight (23%), overweight (33%), obese (14%)). After adjustment for age, smoking, inpatient status, cancer site, metastasis, performance status and comorbidities, overweight women with < 5% WL were at lower risk of 12- and 48-months mortality compared to normal weight women with < 5% WL (aHR = 0.56; p = 0.043 and 0.65; p = 0.031, respectively). Obese women with < 5% WL had a lower mortality risk only at 48-months (aHR = 0.63; p = 0.036). The obesity paradox was stronger in overweight metastatic women. Overweight or obese women with 5- < 10% or ≥10% WL had no reduced risk of mortality compared to normal weight women. Overweight and obese men had no reduced risk of mortality irrespective of weight loss. Conclusions: By taking into account initial weight loss, we did not found evidence for obesity paradox in older patients with cancer except in the subgroup of women with minimal weight loss. Clinical trial information: NCT02884375.
Association of obesity with breast cancer outcome in relation to cancer subtypes.
Authors: Lohmann Ana Elisa , Soldera Sara V. , Pimentel Isabel , Ribnikar Domen , Ennis Marguerite , Amir Eitan , Goodwin Pamela Jean
Published: March 2020

11557

Background: Obesity at breast cancer (BC) diagnosis is associated with poor outcome, although the magnitude of effect in different BC subtypes is uncertain. Here we report on the association of obesity at BC diagnosis with disease-free (DFS) and overall survival (OS) in the following subtypes: (i) hormone receptor (ER/PgR) +ve, HER2-ve, (ii) HER2+ve, any ER/PgR and (iii) triple negative (TN). Methods: We searched MEDLINE, EMBASE and COCHRANE databases to December 31, 2018 and meeting presentations (past 5 years) using predefined search terms. Study eligibility, data abstraction were performed independently by two authors; those reporting hazard ratios (HR) for obesity and DFS/OS in BC subtypes were included. Using Review Manager pooled HRs were computed and weighted using generic inverse variance in fixed and random effects models (results were similar, random effects are presented). Results: Of 10,702 titles, 26 studies (108,793 patients) were included. Pooled HR for DFS for obese vs non-obese were (i) ER/PgR+ve HER2-ve 1.21 (95% Confidence interval, CI; 1.12-1.31, p < 0.00001), (ii) HER2+ve, any ER/PgR 1.16 (95%CI, 1.06-1.26; p = 0.0006) and (iii) TN, 1.13 (95%CI; 1.05-1.22 p = 0.002). Pooled HRs for OS were (i) ER/PgR+ve, HER2-ve 1.45 (95%CI; 1.30-1.62 p < 0.00001), (ii) HER2+ve any ER/PgR 1.21 (95%CI; 1.10-1.34 p = 0.0001) and (iii) TN 1.13 (95%CI, 1.04-1.23, p = 0.003).PooledHR for OS (but not DFS) were somewhat higher in observational vs interventional studies in (i) ER/PgR+ve, HER2-ve 1.57 vs 1.36, HER2+ve any ER/PgR (ii) 1.37 vs 1.09 but not (iii) TN 1.12 vs 1.22 (p = 0.21, 0.03 and 0.48, respectively). Conclusions: Obesity was associated with a worse outcome in all BC subtypes. Higher HR for OS in observational studies in (i) ER/PgR+ve, HER2- and (ii) HER2+ve any ER/PgR BC may reflect selection of healthier patients for intervention trials.