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  • 1
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 6600-6600
    Abstract: 6600 Background: Chemotherapy has been a part of the evolving landscape of treatment for women with early-stage breast cancer (EBC). Over the last 20 years, standard treatment has included over 20 different drug combinations recommended by the National Comprehensive Cancer Network (NCCN), with nearly 45 variations on dosing and schedule across drug combinations. Little is known about the real-world landscape of chemotherapy used in EBC and how treatment patterns have changed with the advent of new standards of care. We evaluated chemotherapy patterns for women with EBC in the Optimal Breast Cancer Dosing (OBCD) Study, which uses electronic health record (EHR) data from KPNC (Kaiser Permanente Northern California) and Kaiser Permanente Washington (KPWA). Methods: In a cohort of 34,322 women diagnosed and treated for primary stage I-IIIA breast cancer aged 18+ at KPNC and KPWA, we explored patterns of chemotherapy use over time, from 2006 to 2019. We conducted stratified analyses based on receipt of pertuzumab and/or trastuzumab, due to their longer treatment duration. Results: Overall, 13,383 (39.0%) women received intravenous chemotherapy, with a decline observed in receipt of chemotherapy over time (40.5% in 2006 vs 35.9% in 2019) (p-trend 〈 0.001). Of the women who received chemotherapy, 8.5% received neoadjuvant treatment, increasing from 4.1% in 2006 to 14.5% in 2019 (p-trend 〈 0.0001). The average duration of chemotherapy was 5.4 months in 2006, increasing to 6.3 months in 2019 (p-trend 〈 0.0001), and the number of chemotherapy infusion visits increased from an average of 10.7 visits in 2006 to an average of 12.5 in 2019 (p-trend 〈 0.0001). Of those who received chemotherapy, 26.8% received trastuzumab or pertuzumab, with receipt of trastuzumab/pertuzumab increasing over time (p-trend 〈 0.0001). For those receiving trastuzumab/pertuzumab, there was a decrease in treatment duration and average number of chemotherapy administration visits (p-trend 〈 0.0001 for both). Conversely, for those not receiving trastuzumab/pertuzumab, there was an increase in the treatment duration and average number of visits (p-trend 〈 0.0001 for both). Conclusions: While the prevalence of women receiving chemotherapy in our cohort has decreased since 2006, there has been a marked increase in neoadjuvant chemotherapy among those women receiving chemotherapy, as well as an increase in both the duration of chemotherapy treatment and number of associated chemotherapy administration visits, a pattern specifically observed in non-trastuzumab/pertuzumab containing regimens.The change in average duration and number of visits represents a shift in treatment patterns for patients and providers. Understanding trends in breast cancer chemotherapy is useful to inform clinical care and administrative planning for sites delivering chemotherapy for early-stage breast cancer.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
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  • 2
    Online Resource
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    Springer Science and Business Media LLC ; 2017
    In:  Journal of Cancer Research and Clinical Oncology Vol. 143, No. 4 ( 2017-4), p. 735-743
    In: Journal of Cancer Research and Clinical Oncology, Springer Science and Business Media LLC, Vol. 143, No. 4 ( 2017-4), p. 735-743
    Type of Medium: Online Resource
    ISSN: 0171-5216 , 1432-1335
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    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2017
    detail.hit.zdb_id: 1459285-X
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  • 3
    In: Quality of Life Research, Springer Science and Business Media LLC, Vol. 31, No. 4 ( 2022-04), p. 1081-1081
    Type of Medium: Online Resource
    ISSN: 0962-9343 , 1573-2649
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2008960-0
    SSG: 5,1
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  • 4
    In: Journal of Pain and Symptom Management, Elsevier BV, Vol. 63, No. 2 ( 2022-02), p. 311-320
    Type of Medium: Online Resource
    ISSN: 0885-3924
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2022
    detail.hit.zdb_id: 1500639-6
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  • 5
    In: Cancer Research, American Association for Cancer Research (AACR), Vol. 83, No. 5_Supplement ( 2023-03-01), p. P3-03-16-P3-03-16
    Abstract: Introduction Chemotherapy administration in real-world cancer care can differ extensively from clinical trials. It is important to understand real-world practice to identify dose reductions, delays, regimen changes and early discontinuations that impact cancer outcomes. Such variables require knowledge of intended regimens, which may not be well-documented in structured data in electronic health records (EHRs). We examined EHR data from the Kaiser Permanente Northern California (KPNC) site of the Optimal Breast Cancer Chemotherapy Dosing (OBCD) study to develop a process to identify each patient’s intended regimen. Methods In this study of women diagnosed and treated with primary stage I-IIIA breast cancer at KPNC from 2006-2019, and ages 18+y at diagnosis, we analyzed treatment patterns using structured EHR data on the drugs, dosages, and dates at which they were administered (from which intervals and total length can be derived). Chemotherapy agents were identified using the NCI’s CANMED database augmented with other sources. We used these data to categorize patients into the 22 drug combinations described in the National Cancer Care Network (NCCN) guidelines for breast cancer treatment. Within these 22 drug combinations, women were then subcategorized into 45 distinct chemotherapy administration schedules, defined as NCCN guideline regimens (NGRs). For this step, algorithms were developed that categorized patients into NGRs if they received the exact regimen described in the guidelines. For the second step, we conducted a manual review of the EHR data for patients who were unable to be categorized. This enabled us to gradually loosen the criteria (in terms of cycle intervals or number of cycles) so patients whose chemotherapy administration aligned closely with NGRs were categorized into each of the 45 NGRs. Clear patterns emerged of regimens that were administered to multiple patients, despite being outside of the NCCN guidelines, which we have defined as non-standard NGRs. For example, in the drug combination TC (cyclophosphamide and docetaxel) the NGR was TC every 21 days for 4 cycles. We found approximately 1 in 10 patients received 6 cycles, which we defined as a non-NGR. For the remaining uncategorized patients, medical chart abstraction was undertaken as a third step, at which point patients were categorized into either existing regimens or new non-NGRs if their intended regimen had not been previously described in the guidelines. Results Among 31,418 women with breast cancer, 12,427 (39.6%) received chemotherapy. We determined the intended chemotherapy regimens for 6,559 (52.8%) receiving the 45 NGRs using EHR data. We further expanded the algorithms through a manual review of the EHR data, which enabled us to categorize 2,977 (24.0%) additional women into their intended regimens. Abstracted medical notes were reviewed for the remaining patients for whom we had not been able to identify the intended regimen. Across both the manual review and abstraction processes, we were able to identify additional non-standard NGR regimens. In total, 9,536 (76.7%) of women were categorized into their intended regimen through the algorithm/manual review process, while 2891 (23.3%) of women underwent medical chart abstraction to identify the intended regimen. Conclusion Here, we describe the challenges and approaches to operationalize complex, real-world data to identify intended chemotherapy regimens at a granularity and scale not seen previously. We are adapting this method at a second OBCD study site, Kaiser Permanente Washington, where all women have undergone medical chart abstraction. We hope this methodology leads to increased feasibility and efficiency of use of large-scale clinical data, in turn improving cancer care delivery, patient outcome evaluation, and other real-world questions. Citation Format: Jenna Bhimani, Kelli O’Connell, Rachael P. Burganowski, Isaac J. Ergas, Marilyn J. Foley, Grace B. Gallagher, Jennifer J. Griggs, Narre Heon, Tatjana Kolevska, Yuriy Kotsurovskyy, Candyce H. Kroenke, Kanichi G. Nakata, Sonia Persaud, Donna R. Rivera, Janise M. Roh, Sara Tabatabai, Emily Valice, Erin J. Bowles, Elisa V. Bandera, Lawrence H. Kushi, Elizabeth D. Kantor. A methodology for using real-world data from electronic health records to assess chemotherapy administration in women with breast cancer [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P3-03-16.
    Type of Medium: Online Resource
    ISSN: 1538-7445
    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2023
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    detail.hit.zdb_id: 1432-1
    detail.hit.zdb_id: 410466-3
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  • 6
    In: Cancer Research, American Association for Cancer Research (AACR), Vol. 83, No. 5_Supplement ( 2023-03-01), p. P3-03-09-P3-03-09
    Abstract: Background: Most cytotoxic drugs are dosed according to body surface area (BSA), yet not all patients receive the full BSA-determined dose. Prior work suggests that dose reduction may occur more frequently in obese patients, likely due to concern about inducing toxicity at high doses. Other factors, such as race/ethnicity, have been suggested to be associated with dosing, yet the factors associated with dose reduction remain poorly understood, with little known about dosing patterns in integrated healthcare delivery systems and how such patterns have changed over time. Methods: We examined chemotherapy dosing in 452 women diagnosed with stage I-IIIA primary breast cancer at Kaiser Permanente Northern California. All study participants were a part of the Pathways Study, diagnosed between 2006-2013, and treated with the common breast cancer regimen, ACT (cyclophosphamide and doxorubicin, followed by paclitaxel). We explored the association between obesity and dose reduction, and further explored other factors in relation to dose reduction, including various sociodemographic characteristics, tumor characteristics, and comorbidities. We assessed dosing using first cycle dose proportion ( & lt; 90% expected dose) and average relative dose intensity (ARDI, a metric of dose intensity over the entire course of chemotherapy). Results: Overall, 8% of women received a dose reduction & gt;10% in the first cycle of chemotherapy and 21.2% of patients had an ARDI & lt; 90%. Obesity was a strong predictor of dose reduction, both in the first cycle and across all cycles. In the first cycle, 21.9% of severely obese patients (body mass index, BMI: 35+ kg/m2) were dose reduced, whereas no normal weight patients (BMI: 18.5- & lt; 25 kg/m2) experienced a first cycle dose reduction. Across all cycles, 38.4% of severely obese women had an ARDI & lt; 90%, as compared 12.8% of normal weight women. In logistic regression models adjusted for age, race/ethnicity, and white blood cell count, obese women had 4.1-fold higher odds of receiving a dose reduction of 10% or more over the course of chemotherapy than their normal weight counterparts (95% CI: 1.9, 8.9; p-trend: 0.006). Increasing age was positively associated with dose reduction across the course of chemotherapy, as was the presence of comorbidity. Importantly, dose reduction was less common in later calendar years. Sensitivity analyses revealed that the positive association between obesity and dosing was robust to further adjustment for these other significantly associated factors. Impact: These results offer insight on factors associated with variation in chemotherapy dosing for a common breast cancer treatment regimen. Larger studies are required to evaluate relevance of these findings to other treatment regimens. Further work will be needed to determine whether dose reductions impact breast cancer outcomes. Citation Format: Elizabeth D. Kantor, Kelli O’Connell, Isaac J. Ergas, Emily Valice, Janise M. Roh, Jenna Bhimani, Narre Heon, Jennifer J. Griggs, Jean Lee, Erin J. Bowles, Donna R. Rivera, Tatjana Kolevska, Elisa Bandera, Lawrence H. Kushi. Assessment of Breast Cancer Chemotherapy Dose Reduction in an Integrated Healthcare Delivery System [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P3-03-09.
    Type of Medium: Online Resource
    ISSN: 1538-7445
    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2023
    detail.hit.zdb_id: 2036785-5
    detail.hit.zdb_id: 1432-1
    detail.hit.zdb_id: 410466-3
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  • 7
    In: Quality of Life Research, Springer Science and Business Media LLC, Vol. 31, No. 4 ( 2022-04), p. 1069-1080
    Abstract: Missing scores complicate analysis of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) because patients with and without missing scores may systematically differ. We focus on optimal analysis methods for incomplete PRO-CTCAE items, with application to two randomized, double-blind, placebo-controlled, phase III trials. Methods In Alliance A091105 and COMET-2, patients completed PRO-CTCAE items before randomization and several times post-randomization ( N  = 64 and 107, respectively). For each trial, we conducted between-arm comparisons on the PRO-CTCAE via complete-case two-sample t -tests, mixed modeling with contrast, and multiple imputation followed by two-sample t -tests. Because interest lies in whether CTCAE grades can inform missing PRO-CTCAE scores, we performed multiple imputation with and without CTCAE grades as auxiliary variables to assess the added benefit of including them in the imputation model relative to only including PRO-CTCAE scores across all cycles. Results PRO-CTCAE completion rates ranged from 100.0 to 71.4% and 100.0 to 77.1% across time in A091105 and COMET-2, respectively. In both trials, mixed modeling and multiple imputation provided the most similar estimates of the average treatment effects. Including CTCAE grades in the imputation model did not consistently narrow confidence intervals of the average treatment effects because correlations for the same PRO-CTCAE item between different cycles were generally stronger than correlations between each PRO-CTCAE item and its corresponding CTCAE grade at the same cycle. Conclusion For between-arm comparisons, mixed modeling and multiple imputation are informative techniques for handling missing PRO-CTCAE scores. CTCAE grades do not provide added benefit for informing missing PRO-CTCAE scores. ClinicalTrials.gov Identifiers: NCT02066181 (Alliance A091105); NCT01522443 (COMET-2).
    Type of Medium: Online Resource
    ISSN: 0962-9343 , 1573-2649
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2008960-0
    SSG: 5,1
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  • 8
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 36, No. 31 ( 2018-11-01), p. 3120-3125
    Abstract: The US National Cancer Institute (NCI) Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) was developed to enable patient reporting of symptomatic adverse events in oncology clinical research. This study was designed to assess the feasibility and resource requirements associated with implementing PRO-CTCAE in a multicenter trial. Methods Patients with locally advanced rectal cancer enrolled in the National Cancer Institute–sponsored North Central Cancer Treatment Group (Alliance) Preoperative Radiation or Selective Preoperative Radiation and Evaluation before Chemotherapy and Total Mesorectal Excision trial were asked to self-report 30 PRO-CTCAE items weekly from home during preoperative therapy, and every 6 months after surgery, via either the Web or an automated telephone system. If participants did not self-report within 3 days, a central coordinator called them to complete the items. Compliance was defined as the proportion of participants who completed PRO-CTCAE assessments at expected time points. Results The prespecified PRO-CTCAE analysis was conducted after the 500th patient completed the 6-month follow-up (median age, 56 years; 33% female; 12% nonwhite; 43% high school education or less; 5% Spanish speaking), across 165 sites. PRO-CTCAE was reported by participants at 4,491 of 4,882 expected preoperative time points (92.0% compliance), of which 3,771 (77.2%) were self-reported by participants and 720 (14.7%) were collected via central coordinator backup. Compliance at 6-month post-treatment follow-up was 333 of 468 (71.2%), with 122 (26.1%) via backup. Site research associates spent a median of 15 minutes on PRO-CTCAE work for each patient visit. Work by a central coordinator required a 50% time commitment. Conclusion Home-based reporting of PRO-CTCAE in a multicenter trial is feasible, with high patient compliance and low site administrative requirements. PRO-CTCAE data capture is improved through centralized backup calls.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2018
    detail.hit.zdb_id: 2005181-5
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  • 9
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. e16018-e16018
    Abstract: e16018 Background: Pain is common in men with mCRPC and can substantially impair function and quality of life. For assessment of pain as a clinical trial endpoint, substantial validation work has been conducted on the BPI “pain at its worst in the last 24 hours” item, but additional qualitative study of patient understanding of this item is necessary to fully meet FDA labeling standards. Methods: Twenty-six patients with mCRPC in a non-randomized expansion cohort (N=144) of phase II study XL184-203 were interviewed to confirm their comprehension of the BPI “pain at its worst in the last 24 hours” item, and elicit their interpretation of points on the 0-10 response scale to establish levels of intra-patient pain rating consistency. Patient descriptions were evaluated and further compared with previously identified associations between pain severity and pain interference ratings. Results: Patients (median age = 68; range 44-81) had ECOG performance status of 0 (38%) and 1 (62%). Nearly all patients answered the question as intended – by considering the past 24 hours (72%; 18% did not specify); including non-cancer related pain (96%); and reporting pain experienced with analgesia (100%). Patients described pain of “2” as relatively mild, noticeable, and not limiting; pain of “5” as moderate and limiting activity; and pain of “8” as severe and more or less incapacitating. Interpretation of the response scale was highly consistent both among patients and in comparison to levels of pain severity and interference identified in previous large statistical analyses. Conclusions: This study provides important qualitative support for the use of the BPI “pain at its worst in the last 24 hours” item to assess pain per FDA labeling standards in men with mCRPC. Consistent with prior qualitative work, these results confirm this item is well understood by patients. The interpretation of the response scale is remarkably consistent among patients, as well as with results from large statistical analyses, demonstrating the reliability of this item to assess patient-reported pain in cancer trials.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
    detail.hit.zdb_id: 2005181-5
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  • 10
    In: BMJ Leader, BMJ, Vol. 7, No. Suppl 2 ( 2023-08), p. 1.11-5
    Type of Medium: Online Resource
    ISSN: 2398-631X
    Language: English
    Publisher: BMJ
    Publication Date: 2023
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