- Email: [email protected]
Using the patient-reported outcomes measurement information system (PROMIS) to investigate symptom burden enrichment in stage IV patients at an academic center
abstracts 362P
Patterns and predictors of first-line (1L) taxane use in US patients with metastatic triple-negative breast cancer (mTNBC)
Background: TNBC accounts for approximately 15% to 20% of breast cancers. Patients with TNBC tend to have a worse prognosis and are typically diagnosed at a younger age compared with patients with other breast cancer subtypes. Chemotherapy has been the foundation of care for patients with mTNBC, but new targeted treatment (tx) options are now available (olaparib, veliparib, atezolizumab). The IMpassion130 study showed that the combination of atezolizumab þ nab-paclitaxel (pac) improved efficacy outcomes in 1L mTNBC. This analysis was conducted to assess the characteristics of patients receiving taxanes in current US clinical practice. Methods: A total of 2250 female patients newly diagnosed with mTNBC and who received 1L tx between 2005 and 2015 were identified in the Truven MarketScan database. Descriptive statistics were used to summarize baseline characteristics. Multivariate logistic regression models were used to identify independent predictors of treatment choice. Models included all prognostic variables. Results: The median age of patients at 1L tx for mTNBC was 58 years. Most patients lived in metropolitan areas (86%) and were covered by commercial health insurance (74%). Taxane-containing regimens accounted for 54% of all 1L tx, with 23% receiving monotherapy and 26% receiving combination. nab-Pac was most commonly given as a single agent (64%), whereas pac and docetaxel were more commonly given in combination with other agents (62% and 67%, respectively). Single-agent vs combination taxane use, as well as the use of nab-pac regimens (vs docetaxel or pac) increased after 2010 compared with prior to 2010. Patients enrolled in a health maintenance organization plan were less likely to receive nab-pac than pac (odds ratio [OR], 0.41 [0.210.79]) or docetaxel (OR, 0.25 [0.12-0.51]). Other factors, such as comorbidities and number of metastatic sites, were not clearly associated with any specific taxane monotherapy tx. Conclusions: Taxanes were the most common tx choice for 1L mTNBC. Patient characteristics were similar among patients who received pac and nab-pac monotherapy, suggesting that they are prescribed interchangeably when reimbursed by insurance. Editorial acknowledgement: Medical writing assistance for this abstract was provided by Chris Lum, PhD, of Health Interactions, and funded by F. Hoffmann-La Roche, Ltd. Legal entity responsible for the study: F. Hoffmann-La Roche, Ltd. Funding: F. Hoffmann-La Roche, Ltd. Disclosure: J. O’Shaughnessy: Honoraria (self): AbbVie Inc.; Honoraria (self): Agendia; Honoraria (self): Amgen Biotechnology; Honoraria (self): AstraZeneca; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Celgene; Honoraria (self): Eisai; Honoraria (self): Genentech; Honoraria (self): Genomic Health; Honoraria (self): GRAIL; Honoraria (self): Immunomedics; Honoraria (self): Heron Therapeautics; Honoraria (self): Ipsen Biopharmaceuticals; Honoraria (self): Jounce Therapeutics; Honoraria (self): Lilly; Honoraria (self): Merck; Honoraria (self): Myriad; Honoraria (self): Novartis; Honoraria (self): Ondonate Therapeutics; Honoraria (self): Pfizer; Honoraria (self): Puma Biotechnology; Honoraria (self): Seattle Genetics; Honoraria (self): Syndax Pharmaceuticals. L.A. Emens: Officer / Board of Directors: Society for Immunotherapy of Cancer (SITC); Honoraria (self): Abbvie; Honoraria (self): Amgen; Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Travel / Accommodation / Expenses: Bayer; Honoraria (self): Celgene; Research grant / Funding (institution), Travel / Accommodation / Expenses: Genentech/Roche; Honoraria (self): Gritstone; Honoraria (self): Medimmune; Honoraria (institution), Travel / Accommodation / Expenses: Macrogenics; Nonremunerated activity/ies, No Compensation: eTHeRNA; Travel / Accommodation / Expenses: Novartis; Honoraria (self): Peregrine; Honoraria (self), Travel / Accommodation / Expenses: Replimune; Honoraria (self): Syndax; Honoraria (self): Vaccinex; Research grant / Funding (institution): Aduro Biotech; Research grant / Funding (institution): Breast Cancer Research Foundation; Research grant / Funding (institution): Corvus; Research grant / Funding (institution): Department of Defense; Research grant / Funding (institution): EMD Serono; Research grant / Funding (institution): HeritX, Inc.; Research grant / Funding (institution): Maxcyte; Honoraria (self), Travel / Accommodation / Expenses: Bristol Meyers Squibb; Research grant / Funding (institution): Merck; Licensing / Royalties, IND Licensing/vaccine <25K: Aduro. S. Chui: Shareholder / Stockholder / Stock options, Full / Part-time employment: Roche/Genentech. K. Russell: Full / Part-time employment: F. Hoffmann-La Roche, Ltd. S. Lin: Shareholder / Stockholder / Stock options, Full / Part-time employment: Roche/Genentech. C. Flores Avile: Full / Part-time employment: Genesis Research. P. Luhn: Shareholder / Stockholder / Stock options, Full / Part-time employment: Roche/Genentech. A. Schneeweiss: Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Celgene; Honoraria (self), Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Research grant / Funding (institution): AbbVie; Research grant / Funding (institution): Molecular Partner; Honoraria (self), Speaker Bureau / Expert testimony: AstraZeneca; Honoraria (self), Travel / Accommodation / Expenses: Pfizer; Honoraria (self): Novartis; Honoraria (self): MSD; Honoraria (self): Tesaro; Honoraria (self): Lilly.
v132 | Breast Cancer, Metastatic
363P
Maintenance chemotherapy is effective in patients with metastatic triple negative breast cancer after first-line platinum-based chemotherapy
J. Zhang, Y. Chen, X. Hu Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China Background: Platinum-based chemotherapy (PBCT) has gained an important position as a first-line treatment for metastatic triple-negative breast cancer (mTNBC). We assessed whether maintenance chemotherapy is superior to observation after first-line PBCT in patients with mTNB. Methods: A total of 265 patients with mTNBC who exhibited disease control after 4-6 cycles of first-line PBCT at the Fudan University Shanghai Cancer Center from January 2008 to November 2016 were retrospectively analyzed. 107 patients who continued without additional treatment were defined as the control observation group, and the remaining 158 patients who continued to receive maintenance therapy were defined as the maintenance treatment group. Results: The median progression-free survival (PFS) time in the maintenance group was 9.63 months, which was significantly longer than the PFS time of 7.47 months in the observation group (HR 0.49, 95% CI 0.37-0.67, P < 0.0001). The median overall survival (OS) of the observation group and the maintenance group was 25.37 months and 31.27 months, respectively (HR 0.65, 95% CI 0.44-0.95, P ¼ 0.019). Multivariate analyses suggested that maintenance chemotherapy is an independent predictive factor for PFS and OS. Interaction and stratified analyses showed no difference in the PFS between the single-drug maintenance group and the two-drug maintenance group. The most common adverse event in this study was hematologic toxicity. Except for handfoot syndrome (0 vs. 7.6%, P ¼ 0.004), the incidence of other adverse events was not significantly different between the observation and maintenance groups. Conclusions: After achieving disease control with first-line PBCT in mTNBC patients, single-drug maintenance chemotherapy is recommended. Legal entity responsible for the study: Fudan University Shanghai Cancer Center. Funding: Shanghai Municipal Science and Technology Commission Guidance Project, China (contract no. 18411967800); Shanghai Municipal Commission of Health and Family Planning (grant no. 201640069); Shanghai Natural Science Foundation (grant no. 17ZR1405700); and research grant from Shanghai Hospital Development Center (grant no. SHDC12018X03). Disclosure: All authors have declared no conflicts of interest.
364P
Using the patient-reported outcomes measurement information system (PROMIS) to investigate symptom burden enrichment in stage IV patients at an academic center
M. Matthys, A. Dempsey, A. Basu, N. Dreher, L. Esserman, L. van ’t Veer, M. Melisko Surgery, UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA Background: Symptom burden and reduced quality of life are considerable hurdles in cancer treatment. The Patient-Reported Outcomes Measurement Information System (PROMIS) assesses physical and psychosocial functional status in clinical and research settings. We use PROMIS scores to establish mean symptom burden within a breast cancer patient population, identifying how subgroups compare to one another, examining potential drivers, and characterizing severe symptom burden between subgroups. Methods: New cancer patients at the UCSF Breast Care Center (BCC) receive electronic intake questionnaires assessing demographics, health history, and 8 PROMIS domains: depression, anxiety, fatigue, sleep-related impairment and disturbance, cognitive function, applied cognition and physical function. Patients were separated by age and stage of cancer and mean PROMIS reference values for each group were calculated using the NCI’s Health Measures scoring system. We computed enrichment of higher levels of anxiety, sleep impairment, fatigue, physical function impairment, and cognitive decline in metastatic patients versus all other cases. Results: Compared to stage 0-III, BCC stage IV patients had lower mean values for all assessed domains (p < 0.05). Within the stage IV population, high levels of anxiety were uniquely predictive of low functional status in 6 out of the other 7 domains. The stage IV population was significantly enriched for severe symptomatology in all domains except sleep-related impairment and disturbance when compared to the stage 0-III population. Conclusions: PROMIS scores indicate that stage IV patients have impaired quality of life in multiple domains. Reference values for demographic groups provide improved guidance in tailoring supportive care referrals. Anxiety emerged as one of the biggest drivers of impairment of other physical, mental, and social functions and thus increased priority addressing anxiety early will likely correspond with improved symptom burden. Our analysis on quality of life will also help determine appropriate thresholds of intervention to trigger referrals and manage a patient’s quality-of-life trajectory more systematically. Legal entity responsible for the study: Athena Breast Health Network. Funding: Athena Breast Health Network, University of California, San Francisco. Disclosure: All authors have declared no conflicts of interest.
Volume 30 | Supplement 5 | October 2019
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz242.059/5577372 by guest on 24 October 2019
J. O’Shaughnessy1, L.A. Emens2, S. Chui3, K. Russell4, S.-W. Lin5, C. Flores Avile6, P. Luhn5, A. Schneeweiss7 1 Baylor Charles A. Sammons Cancer Center, Texas Oncology, Dallas, TX, USA, 2UPMC Hillman Cancer Center, Magee Womens’ Hospital, Pittsburgh, PA, USA, 3Product Development Oncology, Genentech, Inc, South San Francisco, CA, USA, 4Pharma Development Medical Affairs, Oncology, F. Hoffmann-La Roche, Ltd., Basel, Switzerland, 5 Real-World Data Oncology, Genentech, Inc, South San Francisco, CA, USA, 6RWD Oncology, Genesis Research, Hoboken, NJ, USA, 7National Center for Tumor Disease, Heidelberg University Hospital and German Cancer Research Center, Heidelberg, Germany
Annals of Oncology
Patterns and predictors of first-line (1L) taxane use in US patients with metastatic triple-negative breast cancer (mTNBC)
Background: TNBC accounts for approximately 15% to 20% of breast cancers. Patients with TNBC tend to have a worse prognosis and are typically diagnosed at a younger age compared with patients with other breast cancer subtypes. Chemotherapy has been the foundation of care for patients with mTNBC, but new targeted treatment (tx) options are now available (olaparib, veliparib, atezolizumab). The IMpassion130 study showed that the combination of atezolizumab þ nab-paclitaxel (pac) improved efficacy outcomes in 1L mTNBC. This analysis was conducted to assess the characteristics of patients receiving taxanes in current US clinical practice. Methods: A total of 2250 female patients newly diagnosed with mTNBC and who received 1L tx between 2005 and 2015 were identified in the Truven MarketScan database. Descriptive statistics were used to summarize baseline characteristics. Multivariate logistic regression models were used to identify independent predictors of treatment choice. Models included all prognostic variables. Results: The median age of patients at 1L tx for mTNBC was 58 years. Most patients lived in metropolitan areas (86%) and were covered by commercial health insurance (74%). Taxane-containing regimens accounted for 54% of all 1L tx, with 23% receiving monotherapy and 26% receiving combination. nab-Pac was most commonly given as a single agent (64%), whereas pac and docetaxel were more commonly given in combination with other agents (62% and 67%, respectively). Single-agent vs combination taxane use, as well as the use of nab-pac regimens (vs docetaxel or pac) increased after 2010 compared with prior to 2010. Patients enrolled in a health maintenance organization plan were less likely to receive nab-pac than pac (odds ratio [OR], 0.41 [0.210.79]) or docetaxel (OR, 0.25 [0.12-0.51]). Other factors, such as comorbidities and number of metastatic sites, were not clearly associated with any specific taxane monotherapy tx. Conclusions: Taxanes were the most common tx choice for 1L mTNBC. Patient characteristics were similar among patients who received pac and nab-pac monotherapy, suggesting that they are prescribed interchangeably when reimbursed by insurance. Editorial acknowledgement: Medical writing assistance for this abstract was provided by Chris Lum, PhD, of Health Interactions, and funded by F. Hoffmann-La Roche, Ltd. Legal entity responsible for the study: F. Hoffmann-La Roche, Ltd. Funding: F. Hoffmann-La Roche, Ltd. Disclosure: J. O’Shaughnessy: Honoraria (self): AbbVie Inc.; Honoraria (self): Agendia; Honoraria (self): Amgen Biotechnology; Honoraria (self): AstraZeneca; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Celgene; Honoraria (self): Eisai; Honoraria (self): Genentech; Honoraria (self): Genomic Health; Honoraria (self): GRAIL; Honoraria (self): Immunomedics; Honoraria (self): Heron Therapeautics; Honoraria (self): Ipsen Biopharmaceuticals; Honoraria (self): Jounce Therapeutics; Honoraria (self): Lilly; Honoraria (self): Merck; Honoraria (self): Myriad; Honoraria (self): Novartis; Honoraria (self): Ondonate Therapeutics; Honoraria (self): Pfizer; Honoraria (self): Puma Biotechnology; Honoraria (self): Seattle Genetics; Honoraria (self): Syndax Pharmaceuticals. L.A. Emens: Officer / Board of Directors: Society for Immunotherapy of Cancer (SITC); Honoraria (self): Abbvie; Honoraria (self): Amgen; Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Travel / Accommodation / Expenses: Bayer; Honoraria (self): Celgene; Research grant / Funding (institution), Travel / Accommodation / Expenses: Genentech/Roche; Honoraria (self): Gritstone; Honoraria (self): Medimmune; Honoraria (institution), Travel / Accommodation / Expenses: Macrogenics; Nonremunerated activity/ies, No Compensation: eTHeRNA; Travel / Accommodation / Expenses: Novartis; Honoraria (self): Peregrine; Honoraria (self), Travel / Accommodation / Expenses: Replimune; Honoraria (self): Syndax; Honoraria (self): Vaccinex; Research grant / Funding (institution): Aduro Biotech; Research grant / Funding (institution): Breast Cancer Research Foundation; Research grant / Funding (institution): Corvus; Research grant / Funding (institution): Department of Defense; Research grant / Funding (institution): EMD Serono; Research grant / Funding (institution): HeritX, Inc.; Research grant / Funding (institution): Maxcyte; Honoraria (self), Travel / Accommodation / Expenses: Bristol Meyers Squibb; Research grant / Funding (institution): Merck; Licensing / Royalties, IND Licensing/vaccine <25K: Aduro. S. Chui: Shareholder / Stockholder / Stock options, Full / Part-time employment: Roche/Genentech. K. Russell: Full / Part-time employment: F. Hoffmann-La Roche, Ltd. S. Lin: Shareholder / Stockholder / Stock options, Full / Part-time employment: Roche/Genentech. C. Flores Avile: Full / Part-time employment: Genesis Research. P. Luhn: Shareholder / Stockholder / Stock options, Full / Part-time employment: Roche/Genentech. A. Schneeweiss: Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Celgene; Honoraria (self), Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Research grant / Funding (institution): AbbVie; Research grant / Funding (institution): Molecular Partner; Honoraria (self), Speaker Bureau / Expert testimony: AstraZeneca; Honoraria (self), Travel / Accommodation / Expenses: Pfizer; Honoraria (self): Novartis; Honoraria (self): MSD; Honoraria (self): Tesaro; Honoraria (self): Lilly.
v132 | Breast Cancer, Metastatic
363P
Maintenance chemotherapy is effective in patients with metastatic triple negative breast cancer after first-line platinum-based chemotherapy
J. Zhang, Y. Chen, X. Hu Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China Background: Platinum-based chemotherapy (PBCT) has gained an important position as a first-line treatment for metastatic triple-negative breast cancer (mTNBC). We assessed whether maintenance chemotherapy is superior to observation after first-line PBCT in patients with mTNB. Methods: A total of 265 patients with mTNBC who exhibited disease control after 4-6 cycles of first-line PBCT at the Fudan University Shanghai Cancer Center from January 2008 to November 2016 were retrospectively analyzed. 107 patients who continued without additional treatment were defined as the control observation group, and the remaining 158 patients who continued to receive maintenance therapy were defined as the maintenance treatment group. Results: The median progression-free survival (PFS) time in the maintenance group was 9.63 months, which was significantly longer than the PFS time of 7.47 months in the observation group (HR 0.49, 95% CI 0.37-0.67, P < 0.0001). The median overall survival (OS) of the observation group and the maintenance group was 25.37 months and 31.27 months, respectively (HR 0.65, 95% CI 0.44-0.95, P ¼ 0.019). Multivariate analyses suggested that maintenance chemotherapy is an independent predictive factor for PFS and OS. Interaction and stratified analyses showed no difference in the PFS between the single-drug maintenance group and the two-drug maintenance group. The most common adverse event in this study was hematologic toxicity. Except for handfoot syndrome (0 vs. 7.6%, P ¼ 0.004), the incidence of other adverse events was not significantly different between the observation and maintenance groups. Conclusions: After achieving disease control with first-line PBCT in mTNBC patients, single-drug maintenance chemotherapy is recommended. Legal entity responsible for the study: Fudan University Shanghai Cancer Center. Funding: Shanghai Municipal Science and Technology Commission Guidance Project, China (contract no. 18411967800); Shanghai Municipal Commission of Health and Family Planning (grant no. 201640069); Shanghai Natural Science Foundation (grant no. 17ZR1405700); and research grant from Shanghai Hospital Development Center (grant no. SHDC12018X03). Disclosure: All authors have declared no conflicts of interest.
364P
Using the patient-reported outcomes measurement information system (PROMIS) to investigate symptom burden enrichment in stage IV patients at an academic center
M. Matthys, A. Dempsey, A. Basu, N. Dreher, L. Esserman, L. van ’t Veer, M. Melisko Surgery, UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA Background: Symptom burden and reduced quality of life are considerable hurdles in cancer treatment. The Patient-Reported Outcomes Measurement Information System (PROMIS) assesses physical and psychosocial functional status in clinical and research settings. We use PROMIS scores to establish mean symptom burden within a breast cancer patient population, identifying how subgroups compare to one another, examining potential drivers, and characterizing severe symptom burden between subgroups. Methods: New cancer patients at the UCSF Breast Care Center (BCC) receive electronic intake questionnaires assessing demographics, health history, and 8 PROMIS domains: depression, anxiety, fatigue, sleep-related impairment and disturbance, cognitive function, applied cognition and physical function. Patients were separated by age and stage of cancer and mean PROMIS reference values for each group were calculated using the NCI’s Health Measures scoring system. We computed enrichment of higher levels of anxiety, sleep impairment, fatigue, physical function impairment, and cognitive decline in metastatic patients versus all other cases. Results: Compared to stage 0-III, BCC stage IV patients had lower mean values for all assessed domains (p < 0.05). Within the stage IV population, high levels of anxiety were uniquely predictive of low functional status in 6 out of the other 7 domains. The stage IV population was significantly enriched for severe symptomatology in all domains except sleep-related impairment and disturbance when compared to the stage 0-III population. Conclusions: PROMIS scores indicate that stage IV patients have impaired quality of life in multiple domains. Reference values for demographic groups provide improved guidance in tailoring supportive care referrals. Anxiety emerged as one of the biggest drivers of impairment of other physical, mental, and social functions and thus increased priority addressing anxiety early will likely correspond with improved symptom burden. Our analysis on quality of life will also help determine appropriate thresholds of intervention to trigger referrals and manage a patient’s quality-of-life trajectory more systematically. Legal entity responsible for the study: Athena Breast Health Network. Funding: Athena Breast Health Network, University of California, San Francisco. Disclosure: All authors have declared no conflicts of interest.
Volume 30 | Supplement 5 | October 2019
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz242.059/5577372 by guest on 24 October 2019
J. O’Shaughnessy1, L.A. Emens2, S. Chui3, K. Russell4, S.-W. Lin5, C. Flores Avile6, P. Luhn5, A. Schneeweiss7 1 Baylor Charles A. Sammons Cancer Center, Texas Oncology, Dallas, TX, USA, 2UPMC Hillman Cancer Center, Magee Womens’ Hospital, Pittsburgh, PA, USA, 3Product Development Oncology, Genentech, Inc, South San Francisco, CA, USA, 4Pharma Development Medical Affairs, Oncology, F. Hoffmann-La Roche, Ltd., Basel, Switzerland, 5 Real-World Data Oncology, Genentech, Inc, South San Francisco, CA, USA, 6RWD Oncology, Genesis Research, Hoboken, NJ, USA, 7National Center for Tumor Disease, Heidelberg University Hospital and German Cancer Research Center, Heidelberg, Germany
Annals of Oncology