Use Of Chemotherapy In Patients Research Articles

Abstract PD4-04: Tailored axillary surgery to omit axillary lymph node dissection independently from the use of neoadjuvant chemotherapy in patients with clinically node-positive breast cancer: Pre-specified subproject within TAXIS (SAKK 23/16 / IBCSG 57-18 / ABCSG-53 / GBG 101)

Abstract Introduction: We developed tailored axillary surgery (TAS) to selectively remove positive nodes and omit axillary lymph node dissection (ALND) in patients with clinically node-positive breast cancer irrespective of the use of neoadjuvant chemotherapy. In this study, we evaluate the performance of this novel surgical concept that tailors the extent of axillary surgery to the extent of axillary disease. Methods: A prospective study was pre-specified to assess the performance of TAS in the international multicenter phase-III TAXIS trial randomizing patients with clinically node-positive breast cancer to undergo ALND or axillary radiation after TAS. TAS consists of selective removal of all palpably suspicious findings and the SLNs followed by specimen radiography to document removal of the clip placed in the sampled node. Imaging-guided localization is encouraged to increase the chances of clip removal. Only patients with confirmed nodal disease at the time of surgery can be randomized in TAXIS; the first 200 randomized patients were analyzed together with the ones achieving nodal pCR in this study. ClinicalTrials.gov Identifier: NCT03513614. Results: A total of 296 patients with a median age of 56.5 years (range: 25-88 years) were included at 28 breast centers from four European countries, 125 (42.3%) of whom underwent NACT and 75 (25.3%) of whom had nodal pCR. Subtype was hormone receptor (HR) positive (+) and human epidermal growth factor receptor 2 (HER2) negative (-) in 194 (65.5%), HR+/HER2+ in 40 (13.5%), HR-/HER2+ in 17 (5.7%) and HR-/HER2- in 39 (13.2%) patients. Breast-conserving surgery was performed in 178 patients (60%) and mastectomy in 117 (40%). Imaging-guided localization was attempted in 258 patients (87.2%) and was successful in 243 (82.1%). TAS removed a median of two (interquartile range [IQR] 0-3) palpably suspicious lesions and two (IQR 1-3) SLNs, thereby successfully removing the clip in 279 (94.3%) patients. There were no significant differences by use of imaging-guided localization (94.6% with vs 92.1% without, p=0.47) or type of clip (p=0.19), but a trend toward lower rate of clip removal after NACT (91.2% with vs 96.5% without NACT, p=0.075). Palpable disease was left behind after TAS in two (2.1%) patients and no SLN was detected in three (3.1%). In the 200 randomized patients with confirmed nodal disease at the time of surgery, lymph node metastases were palpable at the time of initial diagnosis in 102 (51%) patients and detectable only by imaging in 98 (49%). The median number of lymph nodes removed by TAS was four (IQR 2-8), two (IQR 1-4) of which were positive. Completion ALND following TAS removed additional positive nodes in 71 of 100 (71%) patients in the control group (20% with one additional node, 9% with 2, 8% with 3, 6% with 4, and 28% with >4). The median number of additional lymph nodes removed by ALND was 14 (IQR 10-18), two (IQR 0-6) of which were positive. Of the 200 randomized patients, one in the TAS group received a radiotherapy boost and one in the ALND group returned to the operating room for residual suspicious findings on imaging. Discussion: The present results suggest that TAS has the potential to become the new axillary surgery standard in patients with clinically node-positive breast cancer. TAS was successfully performed in the vast majority of patients, with no further improvement by imaging-guided localization, which makes the procedure feasible at most breast centers. TAS selectively removed positive lymph nodes and was much less radical than ALND, but ALND removed additional positive nodes in more than two thirds of patients. Disease-free survival and quality of life will be assessed in the randomized trial. Citation Format: Walter Paul Weber, Guido Henke, Stefanie Hayoz, Karin Ribi, Stefanie Seiler, Charlotte Maddox, Thomas Ruhstaller, Daniel Rudolf Zwahlen, Simone Muenst, Markus Ackerknecht, Florian Fitzal, Mihály Újhelyi, Christian Kurzeder, Loïc Lelièvre, Christoph Tausch, Daniel Egle, Jörg Heil, Zoltan Matrai, Michael Knauer. Tailored axillary surgery to omit axillary lymph node dissection independently from the use of neoadjuvant chemotherapy in patients with clinically node-positive breast cancer: Pre-specified subproject within TAXIS (SAKK 23/16 / IBCSG 57-18 / ABCSG-53 / GBG 101) [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PD4-04.

The association of comorbidities with administration of adjuvant chemotherapy in stage III colon cancer patients: a systematic review and meta-analysis.

Background:Chemotherapy is an established treatment for stage III colon cancer cases. Older age is known to be associated with less chemotherapy use in these patients, but there might be other relevant factors besides age that influence treatment administration. We summarized evidence on associations between comorbidity and adjuvant chemotherapy administration in stage III colon cancer patients in a systematic review and meta-analysis.Methods:We searched the PubMed and Web of Science databases up to 2 June 2020 for studies on comorbidities and chemotherapy use in patients with stage III colon cancer. Summary odds ratios (OR) and 95% confidence intervals (95% CI) were estimated using random-effects models. Subgroup analyses according to year of colon cancer diagnosis, timing of comorbidity assessment, and geographical region were also conducted.Results:Thirty-three studies were included in this review, including 219,406 stage III colon cancer patients overall. Chemotherapy administration was 60.9% (95% CI: 56.9% to 64.9%), increasing from 57.1% before 2001 to 66.3% after 2010. There were inverse associations between comorbidities and chemotherapy administration. Compared with patients with Charlson comorbidity score 0, those with scores 1 (OR = 0.79, 95% CI = 0.72–0.87) and 2+ (OR = 0.49, 95% CI = 0.42–0.56) received chemotherapy less often. Among comorbidities, the strongest predictors of chemotherapy non-use were dementia (OR = 0.37, 95% CI = 0.33–0.54), followed by heart failure (OR = 0.44, 95% CI = 0.28–0.70) and stroke (OR = 0.56, 95% CI = 0.38–0.81).Conclusions:Merely 60% of stage III colon cancer patients receive chemotherapy. Comorbidities are strong predictors of chemotherapy non-use, but the association differs by comorbid condition and is strongest with dementia. Given the survival disadvantage of colon cancer patients with comorbidities, further evidence on the risk–benefit ratio of chemotherapy according to the type and severity of comorbidity and on the extent to which the survival disadvantage of comorbidity is explained by less use or lower tolerability of chemotherapy is needed to foster personalized medical care in these patients.

Management, outcomes, and prognostic factors of adult primary spinal cord gliomas

PurposePrimary spinal cord tumors are rare, particularly in the adult population, and national guidelines remain ambiguous with regard to management approaches. To address this knowledge gap, we evaluated management, outcomes, and prognostic factors of these neoplasms. MethodsThe National Cancer Database was queried (2004–2016) for newly-diagnosed, histologically-confirmed WHO grades I-III astrocytomas and glioblastoma. Statistics included Kaplan-Meier overall survival (OS) analysis, along with Cox proportional hazards modeling. ResultsOf 1,033 subjects, 196 (19%) were pilocytic astrocytomas (PAs), 539 (52%) were grade II/III astrocytomas, and 298 (29%) were glioblastomas (GBMs). Respectively, 11%, 30%, and 27% did not undergo resection (biopsy only). RT was delivered to 27%, 54%, and 73%; chemotherapy was given to 5%, 21%, and 37%, respectively. The median OS was not reached for PAs, but was 101.2 months for grade II/III astrocytomas, and 23.9 months for GBMs (p < 0.001). Neither chemotherapy nor RT (or dose thereof) was associated with increased OS for grade II/III astrocytomas (p > 0.05 for all), though there was a trend toward improved OS with the use of chemotherapy for patients with GBM. Surgical resection was associated with improved OS for grade II/III astrocytomas and GBM (p < 0.05). Independent prognostic factors for survival in this cohort included histologic classification and resection (compared to biopsy only) (p < 0.05 for both). ConclusionsThis study sheds light onto the management of these rare tumors; surgery was associated with OS benefit for patients with GBM and Grade II/III astrocytomas. Neither RT nor chemotherapy were associated with OS benefit. Although not implying causation, these data can be used to guide patient counseling and therapeutic approaches.

Adjuvant chemotherapy for intrahepatic cholangiocarcinoma: approaching clinical practice consensus?

Intrahepatic cholangiocarcinoma (ICC) is rare with limited evidence-based guidelines. This retrospective study evaluates the use of chemotherapy in patients with resected ICC. The Surveillance Epidemiology and End Results (SEER) program database was used to identify patients with resected ICC. Patients were stratified by date of diagnosis (2000-2004, 2005-2009, 2010-2014), T, and N stage. Multivariable logistic regression models identified predictors of chemotherapy use. Kaplan-Meier and Cox proportional hazard models were used to identify survival trends. One thousand and two hundred twenty-three patients met inclusion criteria. Chemotherapy utilization increased over time (33% to 41%, P≤0.05). Chemotherapy use increased in lymph node (LN) positive patients [32% to 60% in 2010-2014; (P≤0.05) and T3/T4 disease (40% to 60% in 2010-2014; P≤0.01], but not in patients with LN negative or T1/T2 disease. LN positivity was associated with utilization of chemotherapy in 2005-2009 and 2010-2014. Overall survival increased from 32 to 41 months (P≤0.05). In LN positive patients, chemotherapy was associated with a decreased hazard ratio of death (P≤0.05) and T3/T4 disease was associated with an increased hazard ratio of death (P≤0.05). Adjuvant chemotherapy use in ICC has increased. More LN positive or patients with T3/T4 tumors are receiving chemotherapy, which may explain the improvement in overall survival.

Oncoplastic Breast-Conserving Surgery: Can We Reduce Rates of Mastectomy and Chemotherapy Use in Patients with Traditional Indications for Mastectomy?

Traditional indications for mastectomy include multiple ipsilateral lesions and/or disease spanning ≥ 5cm. Neoadjuvant chemotherapy increases breast conservation but does not improve survival. We hypothesized that oncoplastic breast-conserving surgery (OPS) may allow for breast conservation while providing full staging and tumor profiling information to guide systemic therapy decisions, thereby permitting more judicious chemotherapy use. This was an observational cohort of patients with invasive breast cancer with multiple lesions and/or disease spanning ≥ 5cm who underwent OPS from 2012 to 2018. Clinicopathologic features, mastectomy rate, chemotherapy use, and recurrence were evaluated. Overall, 100 patients were identified. Average disease span was 62.8 ± 20.1mm, with an average of 2.9 lesions (range 1-13). 'No ink on tumor' was achieved at the index operation in 80 patients; 13 patients underwent completion mastectomy to achieve adequate margins. Eighty-one patients completed radiation therapy. Breast conservation was possible in 50/58 (86%) patients who did not receive chemotherapy. Forty-two patients received chemotherapy (8 neoadjuvant, 34 adjuvant), of whom 37 (88%) achieved breast conservation. Twenty-six patients with high-risk features received adjuvant chemotherapy. Oncotype DX testing demonstrated the need for chemotherapy in an additional eight patients. After a median follow-up of 40months, four patients had a local recurrence, including two who declined radiation therapy. OPS can facilitate breast conservation in most patients with traditional indications for mastectomy. Additionally, OPS may reduce unnecessary chemotherapy, especially in patients who qualify for Oncotype DX testing. Further study evaluating long-term oncologic and cosmetic outcomes is warranted.

Oncotype DX testing in node-positive breast cancer strongly impacts chemotherapy use at a comprehensive cancer center.

In 2016,weinitiated standardized "reflex"Oncotype DX Recurrence Score (RS) testingforpatients ≤ 65yearswith pT1-2N0-1HR+/HER2- breast cancer. Here, we examine RS testing patterns, RS distribution,andfactors associated with chemotherapy use in patients with pN1 breast cancer. Patientswith stage I-IIIHR+/HER2- pN1 breast cancer treated with upfront surgeryfrom February 2016 to March 2019 were identified. Clinical characteristics were compared between patients meeting reflex RS testing criteria, those with RS ordered outside of reflex criteria, and those without RS testing. RS was categorized as low (< 18), intermediate (18-30),and high (≥ 31). Multivariate logistic regressionwas performed toidentifyfactors associated with adjuvant chemotherapy receipt. We examined 3-year recurrence-free survival (RFS) and overall survival (OS) stratified by chemotherapy use. We identified 347HR+/HER2- pN1 patients; 272 (78.4%) received RS testing, and 194 (71.3%) metreflex criteria. RS was < 18 in 164 (61.4%) patients,18-30 in 89 (32.7%) patients, and ≥ 31 in 16 (5.9%) patients.On multivariate analysis, RS < 18 (OR 0.47, 95% CI 0.24-0.92) was associated with lower odds of chemotherapy use, whereas presence of lymphovascular invasion (OR 1.77, 95% CI 1.03-3.07) and lobular subtype (OR 2.40, 95% CI 1.21-4.78) were associated with higher odds. No differences in 3-year RFS (p = 0.97) or OS (p = 0.19) based on chemotherapy receipt were observed. Most RS-tested HR+/HER2- pN1 patients at our center had low genomic risk. A low RS independently influenced chemotherapy omission and in RS-tested patients, short-term outcomes were excellent. Our study demonstrates increased use of RS in guiding adjuvant treatment decisions in node-positive disease.

The association between functional impairment pre- and post-cystectomy with neoadjuvant chemotherapy use in patients with muscle-invasive bladder cancer.

e17008 Background: Standard of care treatment for muscle-invasive bladder cancer (MIBC) includes neoadjuvant chemotherapy (NAC) followed by radical cystectomy (RC), which can be associated with major toxicity. It is unknown whether patients who receive NAC have differences in functional impairment prior to RC, degree of functional decline post-RC, or time to return to baseline functional status post-RC compared to patients who do not receive NAC. Methods: A total of 80 patients were included in this study. Patients completed an initial geriatric assessment (GA) post-NAC but prior to RC, which was repeated at 30, 90 days, and 1 year post-cystectomy. Patients were classified as impaired or not impaired on each GA domain based on previously established cut points. Percentage impairment was calculated as the number of domains impaired out of the total number of domain assessments completed for each patient at each time point. Results: Median age was 68 for patients who received NAC (66% received gemcitabine/cisplatin) and 72 for patients who did not (p = 0.06), with elevated creatinine as the most common reason for not receiving NAC (57%). Overall, 74% of patients were impaired on at least 1 GA domain pre-surgery (NAC 75%; no NAC 71%) and 86% at 30 days post-RC (NAC 86%; no NAC 87%). Groups did not differ significantly in percentage of patients impaired on each GA domain or median percentage impairment at any time point. For both groups, median percentage impairment increased significantly at 30 days post-RC compared to pre-RC (NAC: 36% vs. 15%, p &lt; 0.001; No NAC: 32% vs. 15%, p = 0.002), followed by a decrease in percentage impairment at 90 days post-RC compared to 30 days post-RC (NAC: 14% vs. 36%, p &lt; 0.001; No NAC: 16% vs. 32%, p = 0.15). There was no difference in impairment at 90 days post-RC compared to pre-RC (NAC: 14% vs. 15%, p = 0.41; No NAC: 16% vs. 15%, p = 0.31). Conclusions: Patients with MIBC frequently have functional impairments at baseline, and their degree of impairment worsens in the short term post-RC. However, patients return to their baseline function by 3 months post-RC. Receipt of NAC was not associated with increased levels of functional impairment at any time point or a delayed return to baseline.

Chemotherapy use near the end-of-life in patients with metastatic breast cancer

IntroductionVery few data are available regarding the use of chemotherapy in patients with metastatic breast cancer (MBC) near the end-of-life, i.e., the final month. The aim of this study was to provide a descriptive analysis of its use in two different European geographic areas (Sweden and Greece).Materials and methodsWe retrospectively collected data regarding clinicopathologic characteristics, survival, and use of chemotherapy during the final 30 days of life using two sources: for the Swedish cohort, patients who were diagnosed with MBC in 2010–2015 were identified from the Stockholm-Gotland population-based Breast Cancer Registry and treatment data were collected using hospital charts. For the Greek cohort, patients with MBC were identified from hospital charts at two hospitals in Athens and Crete.ResultsIn the Swedish cohort, 1571 patients were identified; median overall survival was 16.96 months (95% CI 15.4–18.4). 23.2% of patients were treated with chemotherapy during the final month of life, with higher rates among patients ≤ 60 years (p < 0.001). Per OS monotherapy such as capecitabine or vinorelbine was most commonly used. In contrast, median OS in the Greek cohort (n = 966) was 49.8 months (95% CI 45.6–54.1) and 46.5% of patients received chemotherapy at the end-of-life, most commonly intravenous drug combinations. In multivariable analysis, age and albumin levels were statistically significantly associated with chemotherapy use in the Swedish cohort.ConclusionChemotherapy use near the end-of-life was common, which might negatively impact patient quality of life.

Adjuvant Chemotherapy Use in Patients With Locally Advanced Rectal Cancer: A Single-Institution Experience

BackgroundNational Comprehensive Cancer Network guidelines for the treatment of locally advanced rectal cancer advocate neoadjuvant chemoradiotherapy followed by total mesorectal excision and adjuvant chemotherapy (AC). The aim of this retrospective study was to determine our local patterns of AC use and to examine factors that influenced initiation and completion of AC among patients with stage II/III rectal cancer. Patients and MethodsThe study population consisted of stage II/III rectal cancer patients who were treated at the University of Rochester from 2011 to 2014. Chart reviews were conducted to determine rates of AC initiation and completion. The documented reasons for failure to initiate or complete AC were examined. A multivariate analysis was also completed to evaluate factors that may have influenced the initiation and use of AC. ResultsEighty-one patients were included in the analysis. Median age was 62 years, and 53 (65.4%) were male. Median time from surgery to initiation of AC in those who received AC was 8.0 weeks. Forty-seven patients (58.0%) completed their prescribed AC course. Twenty-four patients (29.6%) did not start AC and 9 patients (11.1%) were unable to complete their course of AC. Primary reasons for not undergoing AC were patient preference (37.5%) and prolonged surgical recovery (33.3%). Primary reasons for not completing AC were treatment toxicities (55.5%) and patient preference (22.2%). Multivariate analysis identified a positive association between clinical stage III disease at diagnosis and initiation of AC. There was no independent association between pathologic response to neoadjuvant therapy at time of surgery and receipt of AC. ConclusionA large proportion of patients at a single academic center did not start or complete their prescribed postoperative AC for locally advanced rectal cancer. Ongoing studies are investigating a total neoadjuvant approach, which may result in better chemotherapy adherence and further improve the pathologic downstaging rate.

Abstract ML: What would Bill think?

Abstract Since the untimely passing of Bill McGuire in 1992, breast cancer mortality rates have declined by approximately 40% despite stable incidence rates, largely due to mammographic screening and broader application of systemic adjuvant therapy in early stage disease. Continued progress is likely given recently reported clinical trials demonstrating improved survival in metastatic disease, including immune checkpoint blockade in triple negative disease, CDK4/6 inhibitors in ER-positive disease, and second-generation immunconjugates in HER2-positive disease. This remarkable progress in reducing breast cancer mortality has come with a price - broader use of adjuvant chemotherapy in patients with early stage disease who might have been adequately treated and perhaps cured without chemotherapy, and the short and long term side effects that may accompany it - which raises the question - what would Bill think of our progress? How would he challenge us to do better?This lecture will focus on three distinct topics that address some potential challenges: (1) How can gene expression profiles and other diagnostic tests be used to guide the use of adjuvant systemic therapy? (2) is time for reappraisal of active surveillance to detect impending recurrence and prevent it? (3) Are there diagnostic and therapeutic strategies that can be used to identify tumors at highest risk of systemic dissemination, and novel therapeutic strategies that block dissemination? Citation Format: JA Sparano. What would Bill think? [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 ML.

Evaluation to the chemotherapy use in patients with diffuse large B-cell lymphoma.

Background Non-Hodgkin lymphoma (NHL) is a large group of primary malignancies of solid lymphoid tissue. Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of NHL. DLBCL has an aggressive natural history but responds well to chemotherapy. The objective of this study was to review the use of chemotherapy, identify its side effects, and examine the response to chemotherapy in patients with NHL at Dr. Soetomo General Hospital. Methods This study was a retrospective observational study using secondary data obtained from patients' medical records from 2016 to 2018. Demographic data (age, sex), clinical characteristics, chemotherapy regimens, side effects of chemotherapy, and response to chemotherapy were recorded. Results Results revealed that of the 43 patients (age ranged from 21 to 80 years) who were included in this study, the prevalence of DLBCL was higher in male patients (74%) and about 44% patients were at stage III. R-CHOP (rituximab-cyclophosphamide, doxorubicin, vincristine/oncovin, prednisone) (53%) was the most used chemotherapy regimen in this study. A total of 65% of patients showed good responses and 35% showed no response to the therapy. The most common side effect was myelosuppression, including 25% and 8% of the patients having anemia and leukopenia, respectively. Conclusions R-CHOP is the most used regimen. Most of patients with NHL have a complete response and the predominant side effect is anemia.

Data resource description: Systemic Anti-Cancer Therapy (SACT) Dataset

Background The Systemic Anti-Cancer Therapy (SACT) dataset is a unique source of national, real-world data reporting chemotherapy activity delivered by NHS treatment providers in England. SACT data are collected with the intent of improving disease-free or progression-free survival.&#x0D; Main Aim The SACT dataset aims to provide a detailed resource on systemic treatments delivered in secondary and tertiary settings in England for patients with cancer.&#x0D; Approach The SACT dataset is collected and curated by the National Cancer Registration and Analysis Service (NCRAS) at Public Health England. The dataset was launched in a phased implementation from April 2012. From April 2014 submission of SACT data became mandatory for all NHS treatment providers. Data are collected on the patient, tumour, regimen, treatment cycle, drug details, and treatment outcomes. The SACT dataset can be linked to other data held by NCRAS, for example the cancer registry1, Hospital Episodes Statistics2, and the national Radiotherapy Dataset to provide a complete picture of the cancer patient pathway.&#x0D; Results The SACT dataset is being used: for the appraisal of drugs funded through the Cancer Drugs Fund; to review the quality of cancer care as part of the National Cancer Audits; and for observational research purposes, including investigating 30-day mortality following chemotherapy3, and sociodemographic variation in the use of chemotherapy in patients with stage IV lung, oesophageal, stomach and pancreatic cancer4. The data are also released to external researchers via the Office for Data Release.&#x0D; Conclusion The SACT dataset is a unique resource in terms of the breadth and depth of information on chemotherapy prescribed to cancer patients. The key strengths are: the national coverage; real-world data; detailed clinical information beyond cancer registration data; and the ability to link to other cancer datasets.&#x0D; References&#x0D; &#x0D; Henson KE, Elliss-Brookes L, Coupland VH, Payne E, Vernon S, Rous B et al. Data Resource Profile: National Cancer Registration Dataset in England. Int J Epidemiol 2019; doi 10.1093/ije/dyz076.&#x0D; Herbert A, Wijlaars L, Zylbersztejn A, Cromwell D, Hardelid P. Data Resource Profile: Hospital Episode Statistics Admitted Patient Care (HES APC). Int J Epidemiol 2017; 46(4): 1093-1093i; e-pub ahead of print 2017/03/25; doi 10.1093/ije/dyx015.&#x0D; Wallington M, Saxon EB, Bomb M, Smittenaar R, Wickenden M, McPhail S et al. 30-day mortality after systemic anticancer treatment for breast and lung cancer in England: a population-based, observational study. The Lancet Oncology 2016; 17(9): 1203-1216; doi 10.1016/s1470-2045(16)30383-7.&#x0D; Henson KE, Fry A, Lyratzopoulos G, Peake M, Roberts KJ, McPhail S. Sociodemographic variation in the use of chemotherapy and radiotherapy in patients with stage IV lung, oesophageal, stomach and pancreatic cancer: evidence from population-based data in England during 2013-2014. Br J Cancer 2018; doi 10.1038/s41416-018-0028-7.&#x0D;

Increasing Rates of Perioperative Chemotherapy are Associated With Improved Survival in Men With Urothelial Bladder Cancer With Prostatic Stromal Invasion

Our objective was to test whether the rates of perioperative chemotherapy (CHT) administration in patients with urothelial bladder cancer (UCUB) with prostatic stromal invasion (pT4a) changed over time. Moreover, we tested the effect of CHT on overall mortality (OM), as well as on cancer-specific mortality (CSM) in this patient population. Within the Surveillance, Epidemiology, and End Results database (2004-2016), we identified 1513 men with non-metastatic UCUB with prostatic stromal invasion who underwent radical cystectomy with lymph node dissection, with or without CHT administration. Estimated annual percentage change analyses, inverse probability of treatment-weighting (IPTW), Kaplan-Meier plots, Cox regression models, and landmark analyses were performed. Overall, 732 (48.4%) patients with pT4a UCUB disease underwent radical cystectomy with perioperative CHT administration between 2004 and 2016. The CHT administration rate increased from 29.0% in 2004 to 64.8% in 2016 (P< .001). In IPTW-adjusted analyses, the 5-year overall survival was 47.7% versus 39.8%, and cancer-specific survival was 53.6 versus 50.1%, for with versus without CHT administration, respectively. After multivariable and IPTW-adjusted Cox regression models, administration of CHT independently predicted lower OM (hazard ratio [HR], 0.62; 95% confidence interval [CI], 0.52-0.73), as well as lower CSM (HR, 0.66; 95% CI, 0.55-0.80). even after 3-month landmark analyses (OM HR, 0.64; 95% CI 0.54-0.76; CSM HR, 0.70; 95% CI, 0.58-0.85). The use of CHT in patients with pT4a UCUB increased from low to moderate in the most contemporary era. However, based on its impressive reduction in OM, as well as in CSM, further increases in CHT administration rates should be highly encouraged in this patient population.

Use of Chemotherapy in Patients Receiving Hypofractionated Whole-Breast Irradiation: An Analysis within a State-Wide Quality Consortium

Use of Chemotherapy in Patients Receiving Hypofractionated Whole-Breast Irradiation: An Analysis within a State-Wide Quality Consortium

Analysis of Real World Data To Evaluate Survival Benefit of Radiation Therapy in Stage III / N2 Non-Small Cell Lung Cancer

The clinical benefit of radiation therapy for patients with locally advanced stage III (N2) Non-Small Cell Lung Cancer (NSCLC) treated with surgery remains unclear due to a paucity of level 1 evidence. This study examined real-world evidence using a cohort of NSCLC patients from a multi-institution dataset to evaluate outcomes in patient treated with surgery alone, neoadjuvant or adjuvant radiation therapy. We extracted a sample of 415 fully-abstracted patients with pathologic stage III (N2) NSCLC defined at the initial surgical intervention performed within 6 months of initial diagnosis. Two- and five-year survival outcomes were evaluated for patients who received radiation neoadjuvant, adjuvant (PORT), or no radiation therapy. Sub-analyses and normalization of treatment groups were performed including use of chemotherapy, targeted therapy and IO therapy as well as age and gender using Cox proportionate hazards. Of the 415 patients evaluated, 54% (n=206) were treated with surgery alone, 16% (n=66) neoadjuvant radiation therapy and 34% (n=143) adjuvant radiation therapy. Chemotherapy use for patients across groups was balanced, 68% (n=140), 83% (n=56), 72% (n=103) for patient treated with surgery, neoadjuvant or adjuvant radiation therapy, respectively. Patients who received neoadjuvant radiation therapy had a 45% reduction in 2-year mortality risk (HR = .55, 95% CI 0.35 - 0.89), compared to patients treated with surgery alone (HR = 0.59, 95% CI .37 - 0.93). Radiation therapy did not improve 5-year mortality risk except in female patients, who show a 48% reduction in mortality risk at 5-years from radiation therapy pre- or post-operatively (HR = .52, 95% CI .29 - .94). There was no statistically significant difference in survival outcomes for patients treated with adjuvant radiation therapy, compared to surgery alone. Analysis of 415 abstracted patients this dataset suggests that the addition of preoperative radiation therapy improves 2 and 5-year survival for patients with pathologic stage III (N2) NSCLC, compared to patients treated with surgery alone. A significant survival benefit was not observed for adjuvant radiation therapy, however surgical margin status, performance status, and incidence of comorbidities was not included in the analysis due to the lack of granularity of the retrospective data.Abstract 3222; Table 1Surgery Only / No Radiation TherapyNeoadjuvant Radiation TherapyAdjuvant Radiation TherapyAll PatientsTotal (n)2-Year OS5-year OSTotal (n)2-Year OS5-Year OSTotal(n)2-Year OS5-Year OSTotal (n)2-Year OS5-Year OSAll patients20677%67%6692%86%14384%76%41582%71%Age >= 6015177%66%4994%78%10083%75%30082%71%Age < 605578%67%1712%71%4386%77%11583%71%Male10977%64%3090%70%7077%66%20979%66%Female9777%69%3694%81%7390%85%20685%77%Chemotherapy14076%74%5591%73%10380%70%29880%68%Neoadjuvant chemotherapy3093%87%4489%76%1090%80%8590%81%No chemotherapy6680%71%11100%91%4095%90%11787%79% Open table in a new tab

Practice Changing Potential of TAILORx: A Retrospective Review of the National Cancer Data Base from 2010 to 2015.

Uncertainty regarding chemotherapy benefit among breast cancer patients with intermediate Oncotype Dx® recurrence scores (RS; 11-25) led to the TAILORx study. We evaluated chemotherapy use in patients with intermediate RS to determine practice change potential based on the TAILORx results. National Cancer Data Base patients with hormone receptor-positive/human epidermal growth factor receptor 2 (HER2)-negative, N0 breast cancer were identified and were divided into three groups: Group A, ≤ 50years of age (RS 11-15); Group B, ≤ 50years of age (RS 16-25); and Group C, > 50years of age (RS 11-25). Demographic and clinical factors were compared using Chi square tests and Poisson regression models to determine predictors of chemotherapy receipt. Overall, 37,087 patients met the inclusion criteria, with 6.3% in Group A and 11.7% in Group C having received chemotherapy that may have been avoided based on TAILORx. The majority of Group B (64.7%) did not receive chemotherapy, whereas TAILORx showed potential benefit from treatment. Chemotherapy use decreased over time for all intermediate RS patients. T2 tumors, high grade, and treatment before 2012 increased the likelihood of chemotherapy receipt among both groups. Younger patients with the lower intermediate RS (Group A) were more likely to receive chemotherapy if they had treatment at community or comprehensive centers, whereas moderate grade was also a significant factor to receive chemotherapy in Group B. Significant factors in older patients (Group C) were Black race, estrogen receptor-positive/progesterone receptor-negative, and moderate/high grade. The most potential impact of TAILORx findings on practice change is for patients ≤ 50years of age with RS of 16-25 who did not receive chemotherapy but may benefit. These findings may serve as a baseline for future analysis of practice patterns related to TAILORx.

Disparities in the Use of Chemotherapy in Patients with Resected Pancreatic Ductal Adenocarcinoma

BackgroundIntroduction of effective systemic therapies for pancreatic ductal adenocarcinoma (PDAC) has demonstrated survival benefit. However, chemotherapy remains underutilized in these patients. We sought to investigate the implications of disparities on the trends in utilization of chemotherapy. MethodsA retrospective study using the Surveillance, Epidemiology, and End Results (SEER) database identified patients who underwent surgical resection for PDAC from 1998 to 2014. Clinicopathologic, demographic, racial, and geographical factors were analyzed to assess associations with receipt of chemotherapy and disease-specific survival. ResultsA total of 15,585 patients were included in the study. A majority (N = 9953, 63.9%) received chemotherapy. Factors associated with poorer odds of receiving chemotherapy included older age (p < 0.001), African-American race (p = 0.003), and living in the Southwest region of the USA (p < 0.001). Married patients were at higher odds of receiving chemotherapy (all p < 0.001). Receipt of chemotherapy was independently associated with improved disease-specific survival (p < 0.001). ConclusionsReceipt of chemotherapy results in an improved survival in patients with resected PDAC. Demographic, racial, and geographic factors influence the rate of receipt of chemotherapy. Despite prior reports, these trends have not changed over the recent decades.

Effects of Social and Contextual Factors Including Marital Status and Children on the Use of Palliative Chemotherapy in Metastatic Colorectal Cancer.

There is evidence that social and contextual factors such as living alone are associated with outcomes in cancer patients. However, little is known about their influence on the use of palliative chemotherapy in metastatic colorectal cancer (mCRC). In this study, we examined social and contextual factors, including marital status, having children, and distance to a cancer center, for their association with the use of chemotherapy in patients with mCRC. A cohort of patients with mCRC diagnosed from 2006 to 2010 in Saskatchewan was evaluated. Logistic regression analyses were performed to assess the relationship between the variables and use of chemotherapy. Of 569 patients, 326 (57%) received chemotherapy significant differences were noted between the chemotherapy versus no chemotherapy groups with respect to age (62 vs. 76 y), poor performance status (18% vs. 58%), comorbid illness (24% vs. 63%), low albumin (61% vs. 89%), anemia (61% vs. 87%), elevated alkaline phosphatase (53% vs. 84%), elevated creatinine (6% vs. 11%), hyponatremia (20% vs. 14%), primary tumor resection (61% vs. 47%), metastasectomy (21% vs. 9%), mean distance to cancer center (98.7±113.6 vs. 127.8±124.6 km), married/partnered (67% vs. 33%), and having children (64% vs. 36%). On multivariate logistic regression analysis, low performance status (odds ratio [OR], 5.1; 95% confidence interval [CI]: 3.1-8.1), not having children (OR, 3.3; 95% CI: 1.78-6.2), hyponatremia (OR, 2.9; 95% CI: 1.6-5.1), elevated alkaline phosphatase (OR, 2.9; 95% CI: 1.8-4.8), and low albumin (OR, 2.2; 95% CI: 1.2-3.8) were correlated with low rates of chemotherapy use. Our results showed that the use of chemotherapy in patients with mCRC significantly varies between those with and without children.

Abstract P4-08-27: The 21-gene Recurrence® (RS) Score assay in estrogen receptor positive node negative breast cancer: Real-world chemotherapy usage and patient characteristics within the intermediate and high-risk RS category

Abstract Background: The Oncotype Dx, a 21-gene recurrence score (RS) assay, has been validated as a prognostic tool in early-stage, hormone receptor-positive, HER2-negative breast cancer. A RS of ≥ 31 is predictive for chemotherapy benefit. However, it has not been clearly established whether more intensive chemotherapy regimens for these patients provide further benefit and whether higher RS stratifications (≥41) influence treatment decisions. Methods: From the prospective British Columbia (BC) Breast Cancer Outcomes Unit database, we identified patients with N0 disease who received Oncotype Dx testing from May 2010 to December 2016. Patients with previous or synchronous breast cancer, and patients treated with neoadjuvant chemotherapy were excluded. Groups were defined that had an Oncotype Dx RS of 31-40 and ≥ 41. Demographic characteristics and type of chemotherapy received were collected. Additional subgroups were defined for patients who had a RS of 21-25 and who were ≤ 50 years old and &amp;gt; 50 years old. Results: We identified 1,202 patients who received Oncotype Dx testing over the time period studied, with 14.8% (n=178) having a RS of ≥ 31. Among these high-risk patients, the median age was 58 (range 34-79), 90% received hormonal therapy and 85% received chemotherapy. In this cohort, 46% received docetaxel and cyclophosphamide for 4 cycles and 28% received 3rd generation chemotherapy. The use of 3rd generation chemotherapy in patients with a RS of ≥ 41 was significantly higher than in patients with RS between 31-40 (39% vs 22%, p = 0.006). Among patients who had a RS of 21-25 and who were ≤ 50 years old (n = 49), 53% received chemotherapy. Of patients who had a RS of 21-25 and who were &amp;gt; 50 years old (n = 127), 16% received chemotherapy. Conclusions: Among patients with a RS ≥ 31, decisions regarding chemotherapy usage were heterogeneous with docetaxel and cyclophosphamide for 4 cycles being the most commonly used regimen. However, in those with a RS ≥ 41, 3rd generation chemotherapy was preferred. Patients with a RS between 21-25 and who were ≤ 50 years old received more chemotherapy than patients who were &amp;gt; 50 years old. RS 31-40 (n=116)RS ≥ 41 (n=62)RS ≥ 31 (n=178)Median age58.0 (range, 36-79)57.5 (range 34-78)58.0 (range 34-79)Pre-menopausal28.4%29.0%28.7%Hormonal therapy93.1%83.9%89.9%Chemotherapy86.2%82.3%84.8%DCx4 (1)54.3% (n=63/116) Median age 59.0 (range, 36 – 78)30.6% (n=19/62) Median age 64.0 (range, 42 – 78)46.1% (n=82/178) Median age 59.5 (range, 36 – 78)3rd generation chemo (2)21.6% (n=25/116) Median age 56.0 (range, 39 – 79)38.7% (n=24/62) Median age 52.0 (range, 34 – 76)27.5% (n=49/178) Median age 54.0 (range, 34 – 79)Other chemo10.3% (n=12/116) Median age 57.5 (range, 52 – 78)12.9% (n=8/62) Median age 64.0 (range, 42 – 72)11.2% (n=20/178) Median age 58.5 (range, 42 – 78)(1) Docetaxel and cyclophosphamide, 4 cycles (2) Anthracycline and Taxane containing regimens, 6 cycles or 8 cycles Citation Format: Le D, Chia S, Simmons C, Speers C, Gondara L, Nichol A, Lohrisch C, Gelmon KA. The 21-gene Recurrence® (RS) Score assay in estrogen receptor positive node negative breast cancer: Real-world chemotherapy usage and patient characteristics within the intermediate and high-risk RS category [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P4-08-27.

Simple interventions to decrease use of chemotherapy in patients at the end of life.

181 Background: Early palliative care referral has proven useful in reducing chemotherapy given to cancer patients in the last 30 days of life. We designed a program to help train primary oncologists in having goals of care (GOC) conversations with patients. We conducted this initiative across the Yale Cancer Center/Smilow Cancer Hospital Care Centers (SCHCCs). The aim was to determine whether simple tools could be used by general oncologists to improve patient care, as measured by chemotherapy utilization at the end of life. Methods: A multidisciplinary team completed process mapping and cause-and-effect barrier analysis regarding GOC discussion with patients. Five interventions (PDSA cycles) were chosen to improve physician skills with GOC conversations. SCHCC physicians (n = 21) utilized each tool on 5 patients per month from July to December 2017. Interventions included asking patients simple questions regarding GOC, using the phrase “allow natural death”, giving patients a “serious conversation starter kit”, and identifying patients with poor prognosis. A GOC survey was administered to physicians at baseline and after completion of the initiative. Data on chemotherapy and immunotherapy given during the last 30 days of life for SCHCC patients were measured. Results: SCHCC physicians who completed the baseline survey (n = 17) were 27% likely to discuss GOC repeatedly during the course of illness, compared to 70% post intervention (n = 10), while 88% felt comfortable discussing GOC at baseline compared to 100% after intervention. Chemotherapy within 30 days of death was administered to 30.3% patients (n = 109) in Q1 2017 and 23.3% in Q3 (n = 103) in the Care Centers. Of note, immunotherapy administered within 30 days of death was 6.4% in Q1 and 6.7% in Q3. Conclusions: A quality initiative focused on providing oncologists with simple tools to improve GOC conversations led to decrease from 30.3% to 23.3% of patients receiving chemotherapy within the last 30 days of life. Survey respondents felt more comfortable in discussing GOC and were more likely to do this throughout the course of illness. This pilot suggests that palliative care training of primary oncologists is feasible and may help to decrease unnecessary treatment at the end of life.