Initiation Of Chemotherapy In Patients Research Articles

Impact of cetuximab plus cisplatin alone and cetuximab plus cisplatin and paclitaxel regimen on humanistic outcome in head and neck cancer

BackgroundThe prevalence of head and neck cancer (HNC) is increasing rapidly, and the prognosis is poor in the advance stage. For the patient suffering from advance stage HNC, the improvement in quality of life and decrease mortality remain as the mainstay of treatment. The aim was to assess the change in quality-adjusted life-years (QALYs) in recurrent or metastatic HNC patients receiving cetuximab plus cisplatin and cetuximab plus cisplatin-paclitaxel.MethodsIt was a single-centric prospective-observational study. Patients were divided into two cohorts based on the chemotherapy regimens they were prescribed. Patients in cohort 1 were prescribed with cetuximab and cisplatin and in cohort 2 were prescribed with cetuximab, cisplatin, and paclitaxel. The QALYs were the primary outcome of the study, and it was calculated using EQ-5D-5L instrument. Patients were followed until the completion of the therapy, i.e., six chemotherapy cycles. The statistical analysis was carried out using SPSS for descriptive and inferential analysis.ResultsAmongst 175 patients screened, 100 patients were enrolled which further distributed in cohorts 1 and 2 equally. The mean QALYs were 0.016 and 0.017 at the time of diagnosis, i.e., before initiation of chemotherapy for patients in cohorts 1 and 2, respectively. At every chemotherapy cycle, the QALYs were calculated. After the completion of six chemotherapy cycles, the mean QALYs were 0.029 and 0.032 for patients in cohorts 1 and 2, respectively.ConclusionThe three-drug therapy consisting of cetuximab, cisplatin, and paclitaxel has shown significant improvement in patients’ QALYs compared to two-drug regimens of cetuximab and cisplatin. Thus, if the therapy consisted of three-drug regimen is used instead of two-drug regimen, it will have a positive impact on humanistic outcome in recurrent or metastatic HNC patients.

Characterization of Oral Microbiota Following Chemotherapy in Patients With Hematopoietic Malignancies.

Oral microbiota may be associated with serious local or systemic medical conditions resulting from chemotherapy. This study was conducted to evaluate the changes in the oral microbiota following the initiation of chemotherapy in patients with hematopoietic malignancies and to identify the characteristics of the oral microbiota associated with oral mucositis. Oral samples were collected from 57 patients with hematopoietic malignancies at 2 time points: before the start of chemotherapy and 8 to 20 days after the start of chemotherapy, when chemotherapy-induced oral mucositis often occurs, and 16S rRNA metagenomic analyses were performed. Comparative and linear discriminant analysis effect size (LEfSe) analyses were used to determine the characteristic bacterial groups before and after the initiation of chemotherapy and in those who developed oral mucositis. The alpha and beta diversities of oral microbiota before and after the initiation of chemotherapy differed significantly (operational taxonomic unit index, P < .001; Shannon's index, P < .001; unweighted UniFrac distances, P = .001; and weighted UniFrac distances, P = .001). The LEfSe analysis revealed a group of bacteria whose abundance differed significantly before and after the initiation of chemotherapy. In the group of patients who developed oral mucositis, a characteristic group of bacteria was identified before the start of chemotherapy. In conclusion, we characterized the oral microbiota associated with the initiation of chemotherapy in patients with hematopoietic malignancies. In addition, our findings suggest that oral microbiota composition before the start of chemotherapy may be associated with oral mucositis. The results of this study emphasize the importance of oral management focusing on the oral microbiota during chemotherapy in patients with hematologic malignancies.

Frailty as a predictor of delayed initiation of adjuvant chemotherapy in patients with ovarian cancer

ObjectiveThis study aimed to identify whether frailty is associated with the time between surgery and the initiation of chemotherapy for patients with ovarian cancer.MethodsThis retrospective cohort study included patients 18...

Abstract P4-11-33: Continuous glucose monitoring and hyperglycemia during chemotherapy for early-stage breast cancer

Abstract Background: There are a growing number of breast cancer (BC) survivors who are at risk for short and long-term treatment-related toxicities. BC survivors may be at higher risk of developing diabetes mellitus (DM), and chemotherapy may potentiate this risk due to concurrent corticosteroid use. DM is associated with both short and long-term treatment toxicities and worse BC outcomes. The prevalence of hyperglycemia (HG) during chemotherapy for early-stage BC (ESBC), and the association between HG during chemotherapy and treatment-related toxicities is unknown. Methods: We are conducting a single-arm pilot study to evaluate the prevalence of hyperglycemia among patients with ESBC during chemotherapy (NCT04473378). Patients are eligible if ≥18 years old, initiating chemotherapy with corticosteroid use, not receiving systemic steroids except as supportive care for chemotherapy, and known DM is allowed if patients are not treated with insulin. Within 7 days of chemotherapy initiation, the Freestyle Libre Pro (Abbott Diabetes Care) continuous glucose monitoring system is applied to the posterior arm of each participant. Patches are reapplied every 2-3 weeks and worn continuously until chemotherapy completion (duration per regimen). The Freestyle Libre Pro monitors interstitial glucose every 15 minutes via subcutaneous sensor filaments adhered to the skin without a finger prick. Data is downloaded using a wireless scan of the sensor by a reader. The primary endpoints are: 1) the prevalence of HG, defined as the number of participants who have ≥1 glucose value (fasting or non-fasting) of ≥140 mg/dL at any point from chemotherapy initiation to completion; 2) Among participants who develop HG, the proportion of time in which they have HG, measured as the number of hyperglycemic values (glucose value of ≥140 mg/dL) divided by the total number of glucose values recorded in an individual for the duration of chemotherapy. Secondary endpoints include the prevalence of impaired glucose tolerance (hemoglobin A1c [HgbA1c] ≥5.7%) prior to chemotherapy initiation in patients without a history of DM, and changes in glucose biomarkers (HgbA1c, fructosamine, and serum creatinine) during treatment. Results: Between December 2020 and April 2021, 7 patients were enrolled, with evaluable data for 5 patients. At baseline median age was 60 (range, 37-74) and median BMI was 33.0 (range, 24.6-41.6). Chemotherapy regimens were: docetaxel/cyclophosphamide (40%); docetaxel/cyclophosphamide/trastuzumab/pertuzumab (20%); weekly paclitaxel (20%); and paclitaxel followed by doxorubicin/cyclophosphamide (20%). All patients (100%) developed hyperglycemia. Of 18,768 sensor readings (281,265 minutes) the proportion of time participants were hyperglycemic (≥140 mg/dL) during the period of adjuvant/neoadjuvant chemotherapy was 22.1%, and the mean time from first corticosteroid administration to first hyperglycemic episode was 7.6 hours. Of three patients with no history of DM (including one patient with glucose intolerance), the proportion of time spent hyperglycemic (≥140 mg/dL) was 9.9% (range, 1.7-13.8%), and the mean daily glucose was 106.7 mg/dL (SD 10.3). Of the two patients with DM, the proportion of time spent hyperglycemic was 70.2% (range, 67.2-79.5%) and the mean daily glucose was 171.7 mg/dL (SD 3.1). Changes in glucose biomarkers will be presented with the full cohort. Conclusion: Hperglycemia during chemotherapy occurred in 100% of the cohort, including those without a history of DM or glucose intolerance. It is currently unknown if HG during chemotherapy is a modifiable risk factor for short and long-term BC treatment toxicities including neuropathy. Understanding glucose trends in this setting will help determine a successful intervention for HG during chemotherapy which may reduce short and long-term treatment toxicities. Citation Format: Melissa K Accordino, John H Spivack, Sophie Ulene, Erin Honan, Meghna S Trivedi, Katherine D Crew, Erik Harden, Cynthia Law, Dawn L Hershman. Continuous glucose monitoring and hyperglycemia during chemotherapy for early-stage breast cancer [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P4-11-33.

Pathogenic variants of homologous recombination repair-related genes in advanced pancreatic cancer and oxaliplatin-based chemotherapy: Prospective multicenter observational study.

555 Background: The latest National Comprehensive Cancer Network Guidelines for pancreatic adenocarcinoma recommended platinum-based chemotherapy for the patients with germline BRCA1/2 or PALB2 variants based on retrospective studies. However, the association between the efficacy of oxaliplatin-based chemotherapy and homologous recombination repair (HRR)-related gene variants has not yet been evaluated in a prospective study. Methods: This was a multicenter, prospective, observational study. Key inclusion criteria were: histologically confirmed pancreatic adenocarcinoma or adenosquamous carcinoma; candidates for systemic chemotherapy or currently under systemic chemotherapy for unresectable disease; age ≥ 20 years; Eastern Cooperative Oncology Group Performance Status 0–2; formalin-fixed paraffin-embedded cancer tissue available for genomic sequencing; and adequate hematological, liver, and renal function. Patients were assessed with the next generation sequencing (NGS)-based ACT-repair panel (ACT genomics; Taipei, Taiwan). ACT-repair panel is accredited by College of American Pathologists and is designed to detect short variants (SVs) including substitutions, insertions, deletions, and copy number variants of 35 genes including 8 HRR-related genes ( ATM, ATR, BRCA1, BRCA2, PALB2, RAD51B, RAD51C, RAD51D). The primary endpoint was the one-year overall survival rate (1yr-OS%) after the initiation of oxaliplatin-based chemotherapy in patients who harbored pathogenic HRR gene variants. On the basis of published retrospective data, expected 1yr-OS% was set at ≥ 60% in this study. Results: Forty patients were enrolled from August 2018 to March 2020. Median age was 67 years (range, 49–81 years). Sequencing data were obtained from 39 patients (NGS success rate = 97.5%). Nine patients (22.5%) harboring HRR gene; ATM SVs (n = 4), BRCA2 loss of heterozygosity (LOH) (n = 3), BRCA2 SVs (n = 1), and PALB2 LOH (n = 1). Three patients received oxaliplatin-based chemotherapy as first-line chemotherapy, while the remaining six patients received it as second- or later-line oxaliplatin-based chemotherapy. The 1yr-OS% was 44.4%, and the median overall survival was 221 days (95% confidence interval, 79–NA days) after the initiation of oxaliplatin-based chemotherapy. In three patients who received oxaliplatin-based chemotherapy as first-line treatment, overall survivals were 703 (alive), 694 (alive), and 405 (dead) days, respectively. Conclusions: Efficacy of oxaliplatin-based chemotherapy on advanced pancreatic cancer harboring HRR-related gene variants did not meet the primary endpoint of 1yr-OS% (≥ 60%). Clinical trial information: UMIN000033655.

Decreasing inpatient chemotherapy initiation delays at Memorial Regional Hospital.

225 Background: Between June and December 2019, hematology-oncology patients admitted for elective chemotherapy at Memorial Regional Hospital had a median delay of 10 hours to initiate chemotherapy infusion from time of admission. This contributes to increased cost to the healthcare system and patient dissatisfaction. By September 2020, elective inpatient median time from admission to chemotherapy initiation at Memorial Regional Hospital will be reduced by 20%. Methods: Multidisciplinary team formed to evaluate the time from admission to initiation of chemotherapy for patients who are electively admitted for chemotherapy in 8 Central based on time stamps available in the electronic health records. Patients electively admitted by a non MCI oncologist were excluded. Data collections included time stamp between each process from admission to administration of 1st chemotherapy. Longest time lapse between each process was counted as an occurrence/contributor to delay. Top 80% contributors identified from Pareto chart allowed team to identify countermeasures. Priority Matrix of implementation in PDSA cycle based on highest impact and ease of implementation. Statistical process control chart was developed. Results: (see table). Conclusions: PDSA Cycle 1, obtaining labs 24-48 hours prior to admission, resulted in a 10% reduction in chemotherapy initiation time. PDSA Cycle 2, enhancing “ok to treat” communication, resulted in a further reduction of time to treatment. The combination of PDSA Cycle 1 &amp; 2 resulted in a 40% reduction in time to chemotherapy initiation, exceeding the planned aim of 20%. Balance measures reflected no reduction in the mean number of overnight stays between baseline and PDSA Cycle 2 (4 nights) that could contribute to a decreased cost. Results and recommendations to adopt at all inpatient oncology departments within the healthcare system will be presented to leadership for support. Data automation through collaborative efforts with information technology is in process to assist with continuous monitoring. Future state, the quality improvement tools gained from ASCO QTP will be utilized to evaluate and improve workflow issues in the outpatient oncology setting. Nationally recognized organizations are encouraged to propose a benchmark for admission time to first chemotherapy administration based on the evaluation of current available data. Additional studies are needed to evaluate chemotherapy treatment delays in other settings.[Table: see text]

P44.02 Mild Interstitial Pneumonia as a Risk Factor for Chemotherapy-Induced Acute Exacerbation of Interstitial Pneumonia in Patients with Lung Cancer

Co-existing of interstitial pneumonia is reported to be a risk factor for chemotherapy-induced acute exacerbation of interstitial pneumonia in patients with lung cancer (LC). Although it has been recently demonstrated that co-existing of interstitial lung abnormalities on chest CT is associated with poor prognosis in patients with advanced non-small cell lung cancer, it has not been clarified the association between mild interstitial pneumonia and chemotherapy-induced acute exacerbation of interstitial pneumonia in detail. The goal of this study was to determine the clinical significance of mild interstitial pneumonia shadows on chest CT prior to the initiation of chemotherapy in patients with advanced LC. We retrospectively analyzed the patients with advanced LC treated with chemotherapy in our department from 2014 to 2016. Chest CT findings at the diagnosis of LC (baseline CT) were reviewed, and the patients were divided into three groups; 1) patients without interstitial pneumonia shadows, 2) with interstitial pneumonia shadows which was recognized (RIPS), and 3) with mild interstitial pneumonia shadows which had not been recognized (UMIPS) by treating physicians on baseline CT. The frequency of chemotherapy-induced acute exacerbation of interstitial pneumonia in patients with RIPS and UMIPS was compared with that of chemotherapy-induced lung injury in patients without interstitial pneumonia shadows. We included 112 patients with treatment naïve IIIB/IV LC in this study. The median age was 69 years (37-87 years), and the frequency of non-small cell lung cancer was 79%. The number of advanced LC patients with RIPS and UMIPS were 26 (23%) and 13 (12%), respectively. Chemotherapy-induced acute exacerbation of interstitial pneumonia was found in 7 (27%) RIPS and 2 (13%) UMIPS patients. On the other hand, chemotherapy-induced lung injury was occurred in only 3 out of 73 (4%) patients without interstitial pneumonia shadows on baseline CT. In patients with advanced LC, interstitial pneumonia shadows on chest CT, even in instances of mild shadows, should be considered as a risk factor of chemotherapy-induced acute exacerbation of interstitial pneumonia.

A new childhood ALL case with an extremely complex karyotype and acute spontaneous tumor lysis syndrome

BackgroundB cell precursor acute lymphoblastic leukemia (B-ALL) is the most common malignancy of childhood, with, after corresponding treatment, an overall complete remission rate of 90%. Approximately 75% of B-ALL cases harbor recurrent abnormalities, including so-called complex karyotypes (CK). Tumor lysis syndrome (TLS) is a metabolic abnormality which may arise during cancer therapy and also, extremely rarely, as spontaneous TLS before initiation of chemotherapy in patients with ALL.Case presentationHere we report a 9-year-old male, diagnosed with a de novo pre-B-ALL according to the WHO classification. Cytogenetic, molecular cytogenetic approaches and array comparative genomic hybridization analyses revealed a unique CK involving five chromosomes. It included four yet unreported chromosomal aberrations: a der(11)t(7;11)(p22.1;q24.2), a der(18)t(7;18)(q21.3;p11.22), del(11)(q24.2q25) and dup(18)(q11.1q23). Unfortunately, the patient died 3 months after the initial diagnosis.ConclusionsTo the best of our knowledge, a comparable childhood ALL case was not previously reported. Thus, the combination of the here seen chromosomal aberrations in childhood primary ALL seems to indicate for an extremely adverse prognosis.

Factors associated with the initiation of chemotherapy within 90 days of death in metastatic colorectal cancer patients: a population-based study.

Initiation of chemotherapy in patients with cancer near end-of-life (EOL) has become more frequent due to an increasing number of treatment options. We aimed to analyze the proportion of metastatic colorectal cancer patients (mCRC) in Alberta, Canada, who were started on a new chemotherapy regimen within 90days of death. This was a retrospective, population-based study using data from the cancer measurement outcomes and evaluation (C-MORE) database. All patients who received chemotherapy for mCRC in a large Canadian province from January 1, 2011, to December 31, 2016, were included in the current analysis. We identified the proportion of patients who initiated chemotherapy near EOL. Further, we analyzed the associations of baseline factors with initiation of chemotherapy near EOL. We identified 511 patients with mCRC who received chemotherapy. Of these, 132 (25.8%) initiated chemotherapy near EOL. Charlson's comorbidity index (CCI) score (score 1: OR, 0.524; 95% CI, 0.279-0.985; P = 0.045; CCI score > 1: OR, 0.366; 95% CI, 0.180-0.746; P = 0.006) and Eastern cooperative oncology group performance status (ECOG PS) (ECOG PS 2: OR, 4.457; 95% CI 2.518-7.890; P < 0.0001; ECOG PS > 2: OR 7.725; 95% CI 3.465-17.222; P < 0.0001) were predictive of initiation of chemotherapy near EOL. The most frequent chemotherapy regimens initiated were FOLFIRI (17%), capecitabine (15%), and panitumumab (15%), respectively. Chemotherapy is frequently initiated near EOL in patients with mCRC. Routine clinical assessments including ECOG PS and comorbid medical conditions can help select patients with mCRC who are unlikely to benefit from palliative chemotherapy and prevent the adverse events and healthcare costs associated with such interventions near EOL.

Abstract P2-14-04: Delayed initiation of adjuvant chemotherapy in older women with breast cancer

Abstract Background: Early stage breast cancer patients benefit from adjuvant chemotherapy, but delays in initiation of treatment can negatively impact outcomes. Delays may be more common in older women. In this study we evaluate the survival impact of delays in adjuvant chemotherapy initiation in patients over 65 years of age and identify factors associated with delays. Methods: Patients age 66 years and older diagnosed between 2001 and 2013 with localized or regional breast cancer were identified in the SEER-Medicare and Texas Cancer Registry-Medicare databases. All patients received adjuvant chemotherapy within 9 months of surgery. Patients were required to have continuous Medicare Parts A and B coverage and no HMO enrollment 12 months before and 12 months after diagnosis. We grouped patients according to time from surgery to chemotherapy in 4 groups: 0-30, 31-60, 61-90, and &amp;gt; 90 days. Delayed chemotherapy initiation was defined as &amp;gt; 90 days. We used multivariable logistic regression to identify predictors of delayed chemotherapy. We estimated overall survival (OS) and breast cancer-specific survival (BCSS) using Kaplan-Meier method. Inverse probability treatment weights were applied to survival analyses. Cox proportional hazard models were used to determine the association between delays in chemotherapy and outcome after adjustment for other variables. Results: 25,902 women were included in the analysis, and the median age was 71 years. The median time from surgery to chemotherapy was 43 days. From 2001-2013 this interval increased from 38 days to 47 days (p &amp;lt; 0.001). Chemotherapy delays were observed in 10.6% of the patients. In multivariable analysis, factors associated with an increased risk in chemotherapy delays included: older age, black or Hispanic race/ethnicity, being single, more comorbidities, hormone receptor positivity, mastectomy, Oncotype DX testing, and having a full state buy-in Medicare plan. Chemotherapy delay was associated with worse OS. The 5 year OS estimates for patients receiving chemotherapy 0-30, 31-60, 61-90 and &amp;gt; 90 days after surgery were 0.82, 0.81, 0.80 and 0.73 respectively (p &amp;lt; 0.001). A similar trend was seen with BCSS (p &amp;lt; 0.001). After multivariable adjustment chemotherapy delay was associated with worse OS (HR=1.32, 95%CI 1.24-1.40) and BCSS (HR=1.38, 95%CI 1.24 - 1.52) compared with patients in the 0-30 day category. In a stratified analysis among patients with known breast cancer subtype, we observed that a delay in adjuvant chemotherapy initiation was associated with worse OS among patients with hormone receptor-positive (HR=1.45, 95%CI 1.05-2.01), HER2-positive (HR=1.52, 95%CI 1.03-2.23), and triple negative (HR=1.90, 95%CI 1.32-2.73) breast cancer. Discussion: Delays in initiating adjuvant chemotherapy in older women with breast cancer are associated with worse OS and BCSS. Our data demonstrates that delays should be avoided and should encourage providers to initiate chemotherapy ≤ 90 days after surgery. In addition, the multidisciplinary medical team should be aware of the socioeconomic factors that may impact patients’ ability to receive timely treatment. Further studies should seek to elucidate the causes of these inequities in care. Citation Format: Demetria Smith-Graziani, Xiudong Lei, Sharon Giordano, Hui Zhao, Meghan Karuturi, Mariana Chavez-MacGregor. Delayed initiation of adjuvant chemotherapy in older women with breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-14-04.

A survey of clinical practices among oncologists regarding hepatitis B screening in patients with cancer.

Background & objectives:Screening for hepatitis B prior to the initiation of chemotherapy in patients with cancer is recommended by all major hepatology and oncology societies. This study was aimed to determine the screening practices for hepatitis B among oncologists from India and their experience with hepatitis B reactivation.Methods:A questionnaire-based survey was conducted among oncologists attending the Evidence-Based Medicine Conference at Tata Memorial Centre, Mumbai, India. The questionnaire was developed in keeping with the recent guidelines for hepatitis B reactivation on chemotherapy, with questions regarding demographics, years in practice and hepatitis B screening practices and management. There was 78 per cent response rate to the questionnaire.Results:Most respondents were <35 yr of age (69%), with <five years of experience (39%), practicing in an academic institution (81%). Seventy four per cent respondents always screened their patients with cancer for hepatitis prior to chemotherapy, whereas 19 per cent in special settings and seven per cent never screened; 96 per cent respondents used hepatitis B surface antigen (HBsAg) as a screening test, while 17 per cent also used antibody to hepatitis B core antigen. Sixty one per cent respondents used entecavir or tenofovir for prophylaxis; 70 per cent continued prophylaxis till 6-12 months after completion of chemotherapy, while 21 per cent continued only till the end of chemotherapy.Interpretation & conclusions:More than 25 per cent of the oncologists were not screening their patients with cancer for viral hepatitis prior to cancer-directed therapy, and only 17 per cent of the oncologists used the recommended tests for screening. Better training of oncologists regarding viral hepatitis screening and management is needed.

Investigating Relationship between Pre- and Post- Chemotherapy Cognitive Performance with Levels of Depression and Anxiety in Breast Cancer Patients: A Cross-Sectional Study.

Introduction:Evidence suggests that cancer and chemotherapy-related cognitive impairments are an important clinical issue that can have a negative impact on the quality of life (QOL) of many cancer patients during and after treatment. The aim of the current study was to investigate the relationship between cognitive performance before and after chemotherapy with levels of depression and anxiety in patients with breast cancer.Materials and Methods:This cross-sectional descriptive-analytical study was performed on 100 women with breast cancer in south of Iran. Patients included in the study were evaluated for cognitive performance before chemotherapy and 1, 3, and 6 months after chemotherapy. Patients’ cognitive performance was assessed by Mini-Mental State Examination (MMSE). Patients were also assessed for their level of anxiety and depression using Beck Depression Inventory (BDI) and Beck Anxiety Inventory (BAI). Descriptive tests (percentage, frequency and mean) and ANOVA test used for statistical analysis. Results:Results of ANOVA test showed a significant difference between the cognitive performance of patients with breast cancer at 1, 3, and 6 months after chemotherapy compared to pre- chemotherapy phase. The above test also revealed a significant relationship between cognitive performance of patients and anxiety and depression. Conclusion:The results showed that, due to the decrease in cognitive performance and increased anxiety and depression after initiation of chemotherapy in patients with breast cancer, it is necessary to closely monitor the mental and psychological status of these patients by their family and the treatment staffs so that the patient be able to cope with the disease more optimally and to recover.

Choosing Wisely: Optimizing Outpatient Cancer Care and Conserving Resources with a New Algorithm to Report Automated ANC Results in the Presence of Analyzer Flags

Background: The complete blood cell count (CBC) with white blood cell (WBC) differential is an essential laboratory test used to screen cancer patients prior to chemotherapy. WBC differential analysis is performed by automated hematology platforms in the clinical laboratory. However, automated results often require manual review if the analysis is associated with instrument flags that indicate the potential for inaccurate results. Review and confirmation of flagged results by laboratory technologists is time consuming and increases test result turnaround time (TAT), thereby prolonging patient appointments. Since chemotherapy administration requires an adequate absolute neutrophil count (ANC), we examined the reliability of the automated ANC in the presence of instrument flags, in outpatients with solid tumor malignancies, to determine if discrete ordering of a "CBC with ANC only" test could be used to replace the traditional CBC with full WBC differential and shorten patient wait times. Methods: We performed a retrospective analysis of ANC test results (N=1422) performed for patients with solid tumor malignancies across 5 outpatient sites, over the course of one month. The accuracy of automated ANC results (Sysmex XN) was assessed by comparison to the manual differential using Rumke statistics. Results: Of the 1422 CBC with WBC differential results evaluated, 74% (N= 1046) were flagged for manual review. Instrument flags included blasts/abnormal lymphocytes, nucleated red blood cells (NRBC), WBC abnormal scattergram, monocytosis, previous sample with blasts, lymphocytosis, atypical lymphoid cells, eosinophilia, basophilia, and new patients with leukocytosis. Peripheral blood smear review confirmed the automated ANC in 312/1046 (30%) cases. A full manual differential was performed in 734/1046 cases (70%) and confirmed the automated ANC in 604/1046 (58%) cases. Discordant automated and manual ANC results were identified in 130 cases. In the majority of these (N=113), the automated ANC was &gt; 2000/µL, well above chemotherapy administration thresholds, and generally lower than the manual ANC (Figure 1). The automated ANC was ≤ 2000/µL in only 30/1046 (2.9%) flagged WBC differential results. Conclusion: These findings support the concept of creating a distinct test order for "CBC with ANC only," when the ANC is required for the initiation of chemotherapy in patients with solid tumors. The data demonstrate that the automated ANC performed by the Sysmex XN can be safely resulted, even in the presence of analyzer flags, when the automated ANC is greater than 2000/µL. This would reduce patient wait times, increase patient satisfaction, as well as conserve laboratory and clinical resources. In our institution, the TAT for an automated and manual ANC is 10-15 minutes and 30-60 minutes, respectively. A reduction in manual differential analysis from 734 to 30 would represent a laboratory labor savings of approximately 2 full time equivalents (FTE). Additional savings are expected based on more efficient management of chemotherapy appointments. Further studies are ongoing to extend this testing algorithm to other outpatient groups such as patients with lymphoma. Disclosures No relevant conflicts of interest to declare.

Decreasing Time to Initiation of Chemotherapy for Patients Electively Admitted to a Hematologic Malignancy Service.

Delays in initiating elective inpatient chemotherapy can decrease patient satisfaction and increase length of stay. At our institution, we observed that 86% of patients who were admitted for elective chemotherapy experienced a delay-more than 6 hours-with a median time to chemotherapy of 18.9 hours. We developed a process improvement initiative to improve time to chemotherapy for elective chemotherapy admissions. Our outcome measure was the time from admission to chemotherapy administration in patients who were admitted for elective chemotherapy. Process measures were identified and monitored. We collected baseline data and used performance improvement tools to identify key drivers. We focused on these key drivers to develop multiple plan-do-study-act cycles to improve our outcome measure. Once we started an intervention, we collected data every 2 weeks to assess our intervention. At the time of interim analysis, we observed a median decrease in time to chemotherapy administration from 18.9 hours to 8.85 hours (P = .005). Median time to laboratory results resulted decreased from 3.17 hours to 0.00 hours. There was no change in time from signing chemotherapy to nurse releasing the chemotherapy. We noted that more providers were signing the chemotherapy before patient admission. By implementing new admission workflows, optimizing our use of the electronic medical record to communicate among providers, and improving preadmission planning we were able to reduce our median time to chemotherapy for elective admissions by 53.2%. Improvement is still needed to meet our goals and to ensure the sustainability of these ongoing efforts.

The Impact of Early Corticosteroid Pretreatment Before Initiation of Chemotherapy in Patients With Primary Central Nervous System Lymphoma.

The optimal timing of corticosteroid (CS) treatment in patients with primary central nervous system (CNS) lymphoma (PCNSL) remains controversial. While poor clinical presentation may justify early treatment with CS, this may ultimately result in reduced concentrations of chemotherapeutic agents via perturbations in the permeability of the blood-brain barrier. To investigate whether early CS exposure is associated with beneficial outcomes and/or reduced occurrence of adverse events as opposed to delayed/concomitant administration. Herein we performed a retrospective observational analysis using patients that were prospectively entered into a database. All patients whom were admitted to the University Hospital between 2009 and 2015 with newly diagnosed PCNSL were included within our study. Our cohort included 50 consecutive patients diagnosed with PCNSL; of these, in 30 patients CS administration was initiated prior to chemotherapy (early), whilst in the remaining 20 patients CS administration was initiated concomitantly with their chemotherapeutic regimen (concomitant). Within the early vs concomitant CS administration groups, no significant differences were observed with regard to progression-free survival (PFS) (P=.81), overall survival (OS) (P=.75), or remission (P=.68; odds ratio 0.76 and confidence interval [95%] 0.22-2.71). Critically, the timing of CS initiation was not associated with either PFS (P=.81) or PFS (P=.75). Early CS administration was not associated with a deterioration in response to chemotherapy, PFS, or OS. As such, administration of CS prior to initiation of chemotherapy is both reasonable and safe for patients with newly diagnosed PCNSL.

Safety and feasibility of in-hospital early chemotherapy initiation after surgery in patients with stage II-IV colon cancer.

Although it is recommended to initiate postoperative chemotherapy for colon cancer within 8 weeks after surgery, the feasibility and impact of initiating chemotherapy before discharge after surgical resection has not been investigated.Patients with stage II–IV colon cancer who received postoperative chemotherapy were dichotomized into early (chemotherapy initiation before discharge) and control (chemotherapy initiation after discharge) groups. A multivariable logistic regression model was used to determine factors associated with delayed chemotherapy, defined as more than 6 or 8 weeks after surgery.From January 2004 to December 2012, of 729 patients with stage II–IV colon adenocarcinoma, 555 patients (76.1%) underwent postoperative chemotherapy. Of them, 181 (32.6%) patients were included in the early group. Time to initiation of chemotherapy was significantly shorter in the early group than in the control group (14.9 days vs 31.5 days, P < . 001). Multivariate analysis revealed that tumor stage and chemotherapy initiation strategy (odds ratio 8.4; 95% confidence interval, 1–66, P = .041) were independent predictors of delayed initiation of chemotherapy at more than 8 weeks. There was no difference in the completion rate of planned chemotherapy cycles between the 2 groups (P > .05).The strategy of initiating chemotherapy before discharge after surgery is safe and feasible and might reduce the potential delay in chemotherapy initiation in patients with colon cancer.

Investigating the time intervals between primary cytoreductive surgery and initiation of adjuvant chemotherapy in patients with advanced epithelial ovarian cancer who had optimal cytoreduction surgery with bowel resection

Investigating the time intervals between primary cytoreductive surgery and initiation of adjuvant chemotherapy in patients with advanced epithelial ovarian cancer who had optimal cytoreduction surgery with bowel resection

An easy-to-use nomogram to predict overall survival (OS) at 6 months after initiation of FOLFIRINOX first-line chemotherapy in patients (pts) with metastatic pancreatic cancer (mPC).

394 Background: FOLFIRINOX achieved a significant step forward in the treatment of mPC. However, patient prognosis remains dismal, and better discrimination of outcomes could be useful to guide clinical decision-making and patient stratification. We aimed at developing and validating a prognostic model and nomogram able to predict the risk of early death (within 6 months post-treatment initiation) in mPC pts treated with first-line FOLFIRINOX. Methods: Data from 137 mPC treated with the GONO FOLFOXIRI schedule at a single institution were used as developing set. Univariate associations with death in the first 6 months after treatment initiation were investigated. Based on the multivariate model, a nomogram was developed assigning points equal to its weighted relevance to each significant variable. The nomogram was externally validated on an independent, parallel cohort of 206 mPC pts treated with FOLFIRINOX at different Italian and French centers. Predictive ability was assessed with the concordance index (C-index) and visual inspection of the calibration plot. Results: 4 out of the 27 considered variables were retained in the multivariable model: ECOG performance status (PS), neutrophils-to-lymphocytes ratio (NLR), liver metastases, and basal serum CA19.9. The nomogram demonstrated adequate discriminative ability in the validation set with a C-index of 0.754. When grouped in different prognostic categories (according to none, 1, 2, or &gt; 2 risk factors), pts included in our study showed significantly different outcomes with median OS ranging from 6.2 ( &gt; 2 risk factors) to 19.5 months (no risk factors, P &lt; 0.05). Conclusions: PS, NLR, liver metastasis, and CA19.9 were the major determinants of 6-month OS. Our nomogram may help clinicians in discussing with pts the benefits and risks of therapy, and in designing future clinical trials. A visual format of the nomogram will be presented. [Table: see text]

Association of Pre-Chemotherapy Peripheral Blood Pro-Inflammatory and Coagulation Factors with Physical Function in Women with Breast Cancer.

Pro-inflammatory and coagulation factors serve as biomarkers of aging and functional reserve. The purpose of this study was to determine if pro-inflammatory (interleukin-6 [IL-6], C-reactive protein [CRP]), and coagulation (D-dimer) factors were associated with pre-chemotherapy functional status in women with stage I-III breast cancer. Prior to chemotherapy initiation in patients with stage I-III breast cancer, the following was captured: IL-6, CRP, D-dimer blood levels, and physical function measures including activities of daily living (ADL, subscale of Medical Outcomes Study Physical Health); instrumental activities of daily living (IADL, subscale of the Older Americans Resources and Services Program); Timed Up and Go (TUG); physician-rated Karnofsky Performance Status (KPS); and self-rated KPS. The association of these biomarkers with physical function measures was evaluated. One hundred sixty patients (mean age 58.3 years, range 30-81 years) with stage I-III breast cancer (stages I [n = 34; 21.5%], II [n = 88; 55.7%], III [n = 36; 22.8%]) were enrolled. The group with poorest physical function (defined by ADL <70, IADL <14, and TUG ≥10 seconds) had higher levels of IL-6 (p = .05), D-dimer (p = .0004), and CRP (p = .05). There was no significant association between these biomarkers and KPS. Patients with at least two biomarkers in the highest quartile were more likely to have poorer physical function (odds ration [OR] 18.75, p < .001). In multivariate analysis adjusting for age, stage, number of comorbidities, and body mass index, the association remained (OR 14.6, p = .002). Pre-chemotherapy biomarkers of aging are associated with poorer physical function among patients with breast cancer across the aging spectrum. The Oncologist 2017;22:1189-1196 IMPLICATIONS FOR PRACTICE: Commonly used physical function assessment tools may not reflect the diverse nature of physical function and risk for chemotherapy toxicity, particularly in older adults. No laboratory test reflects functional reserve. Pro-inflammatory and coagulation factors, such as IL-6, CRP, and D-dimer, can serve as biomarkers of aging and physical function; however, few studies have evaluated their utility in patients with cancer. This study was designed to understand the association between pre-chemotherapy biomarkers and physical function in women with early stage breast cancer undergoing adjuvant chemotherapy. Results indicate that elevated pre-chemotherapy levels in two of the three peripheral biomarkers are associated with the poorest physical function among patients with breast cancer across the aging spectrum.

Abstract ES4-1: Longitudinal strategies in ER+ disease

Abstract Endocrine therapy is a relatively well-tolerated treatment for hormone receptor-positive (HR+) breast cancer. This therapy can be offered as first-line treatment before initiation of chemotherapy in patients with manageable symptoms from their disease and no evidence of clinically significant compromise of visceral organ function. Targeting the estrogen receptor pathway with agents such as the aromatase inhibitors, tamoxifen and fulvestrant can provide effective therapy with a durable response to treatment for some patients. This presentation will review clinical trial data to guide choice of endocrine therapy and the sequential use of these agents in patients with endocrine-responsive disease. Within HR+ breast cancer, there is molecular diversity that can influence responsiveness to endocrine therapy. In addition, recent insight into the complex interactions between the estrogen receptor and cell cycle survival and/or growth factor signalling pathways have uncovered potential mechanisms of endocrine therapy resistance in HR+ breast cancer. This improved understanding has led to new options for treatment. We will review the clinical trial evidence that supports the addition of a cell cycle inhibitor, palbociclib, to first-line letrozole and second-line fulvestrant. We will also review evidence supporting the combination of an mTOR inhibitor, everolimus, to second- or third-line exemestane. These targeted agents increase progression-free survival when added to endocrine therapy, however at the present time, there is no benefit in overall survival. With this limitation in mind, we will review the side effects of these agents, weigh the toxicity and potential benefits, and examine if patient and/or tumor-based factors may help to determine which patients are best suited for these agents. Lastly, we will discuss the subset of patients with bone-only HR+ disease, and the complexities of assessing imaging and their response to therapy. Citation Format: Dickler M. Longitudinal strategies in ER+ disease. [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 ES4-1.