Outcomes research examining treatments, quality of life and costs in HER2-negative and triple-negative metastatic breast cancer: a systematic literature review
Abstract
Aim: With the aggregation of real-world data in healthcare, opportunities for outcomes research are growing. In this study, we summarize published literature examining comparative effectiveness research (CER), treatment patterns, quality of life (QoL) and costs in HER2-negative and triple-negative (TN) metastatic breast cancer (mBC). Methods: PubMed (2010–January 2016) and four conferences (2013–January 2016) were searched using MeSH/keywords, including mBC, QoL, morbidity and therapeutics. Studies relating to CER, treatment patterns, QoL, costs or treatment appropriateness in US patients with HER2-negative/TN mBC were included in the review. Results: Of 1782 identified records, 33 studies met full inclusion criteria: seven related to CER, 18 to treatment patterns, one to treatment appropriateness/navigation, two to QoL and five to costs. Studies varied in objectives, designs and outcomes. Study designs included retrospective chart reviews (52%), retrospective secondary database analyses (27%), economic models (12%), physician surveys (6%) and patient surveys (3%). 25 studies reported results on HER2-negative mBC, six on TN mBC and two on both subtypes. The most common end points examined were treatment patterns, overall survival and progression-free survival. Conclusion: Outcomes research in HER2-negative mBC in the USA was limited, specifically among TN patients, indicating an opportunity for further research in this high unmet need population. Endpoints and treatment options varied, thus, it is difficult to draw summary conclusions about these studies. Outcomes research examining real-world data in mBC has increased in recent years, and may continue to grow with the implementation of new policy programs.
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References
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1.
Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J. Clin. 66(1), 7–30 (2016).
2.
Clark O, Botrel TE, Paladini L, Ferreira MB. Targeted therapy in triple-negative metastatic breast cancer: a systematic review and meta-analysis. Core Evid. 9, 1–11 (2014).
3.
Lin NU, Vanderplas A, Hughes ME et al. Clinicopathologic features, patterns of recurrence, and survival among women with triple-negative breast cancer in the National Comprehensive Cancer Network. Cancer 118(22), 5463–5472 (2012).
4.
National Cancer Institute. SEER Cancer Statistics Review, 1975–2013 (2016). http://seer.cancer.gov/csr/1975_2013/.
5.
National Cancer Institute. Surveillance, Epidemiology, and End Results Program (SEER) cancer statistics factsheets: female breast cancer (2016). http://seer.cancer.gov/statfacts/html/breast.html.
6.
Redig AJ, McAllister SS. Breast cancer as a systemic disease: a view of metastasis. J. Intern. Med. 274(2), 113–126 (2013).
7.
O'Shaughnessy J. Extending survival with chemotherapy in metastatic breast cancer. Oncologist 10(Suppl. 3), 20–29 (2005).
8.
Bauer KR, Brown M, Cress RD, Parise CA, Caggiano V. Descriptive analysis of estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and HER2-negative invasive breast cancer, the so-called triple-negative phenotype: a population-based study from the California cancer Registry. Cancer 109(9), 1721–1728 (2007).
9.
Partridge AH, Rumble RB, Carey LA et al. Chemotherapy and targeted therapy for women with human epidermal growth factor receptor 2-negative (or unknown) advanced breast cancer: American Society of Clinical Oncology Clinical Practice Guideline. J. Clin. Oncol. 32(29), 3307–3329 (2014).
10.
Rakha EA, El-Sayed ME, Green AR, Lee AHS, Robertson JF, Ellis IO. Prognostic markers in triple-negative breast cancer. Cancer 109, 25–32 (2007).
11.
Yabroff KR, Lund J, Kepka D, Mariotto A. Economic burden of cancer in the United States: estimates, projections, and future research. Cancer Epidemiol. Biomarkers Prev. 20(10), 2006–2014 (2011).
12.
Mariotto AB, Yabroff KR, Shao Y, Feuer EJ, Brown ML. Projections of the cost of cancer care in the United States: 2010–2020. J. Natl Cancer Inst. 103(2), 117–128 (2011).
13.
Reed E, Simmonds P, Haviland J, Corner J. Quality of life and experience of care in women with metastatic breast cancer: a cross-sectional survey. J. Pain Symptom Manage. 43(4), 747–758 (2012).
14.
Smith AW, Reeve BB, Bellizzi KM et al. Cancer, comorbidities, and health-related quality of life of older adults. Health Care Financ. Rev. 29(4), 41–56 (2008).
15.
Kent EE, Malinoff R, Rozjabek HM et al. Revisiting the Surveillance Epidemiology and End Results Cancer Registry and Medicare Health Outcomes Survey (SEER-MHOS) linked data resource for patient-reported outcomes research in older adults with cancer. J. Am. Geriatr. Soc. 64(1), 186–192 (2016).
16.
Foster TS, Miller JD, Boye ME, Blieden MB, Gidwani R, Russell MW. The economic burden of metastatic breast cancer: a systematic review of literature from developed countries. Cancer Treat. Rev. 37(6), 405–415 (2011).
17.
Skrepnek GH. Health economic and outcomes research in cancer. In: Supportive Cancer Care. Alberts D, Lluria-Prevatt M, Kha S et al. (Eds). Springer International Publishing, Cham, Switzerland, 291–316 (2016).
18.
Centers for Medicare & Medicaid Services (CMMS). Oncology care model (2017). https://innovation.cms.gov/initiatives/Oncology-Care/.
19.
U.S. National Library of Medicine at the National Institutes of Health. Health Services Research (HSR) PubMed queries (2016). www.nlm.nih.gov/nichsr/hedges/search.html.
20.
National Cancer Institute. FDA approval for everolimus (2013). www.cancer.gov/about-cancer/treatment/drugs/fda-everolimus.
21.
Evidence Partners Incorporated. DistillerSR (Version 2.0) (2015). http://systematic-review.ca.
22.
Dawood S, Broglio K, Buzdar AU, Hortobagyi GN, Giordano SH. Prognosis of women with metastatic breast cancer by HER2 status and trastuzumab treatment: an institutional-based review. J. Clin. Oncol. 28(1), 92–98 (2010).
23.
Dranitsaris G, Gluck S, Faria C, Cox D, Rugo H. Comparative effectiveness analysis of monotherapy with cytotoxic agents in triple-negative metastatic breast cancer in a community setting. Clin. Ther. 37, 134–144 (2015).
• Eribulin was used as a later line of therapy and was reported to have had comparable drug activity and tolerability versus other cytotoxic agents in patients with metastatic triple-negative breast cancer in a community oncology setting.
24.
Li N, Hao Y, Xie J et al. Everolimus-based therapy versus chemotherapy among patients with HR+/HER2- metastatic breast cancer: comparative effectiveness from a chart review study. Int. J. Breast Cancer 2015, 240750 (2015).
25.
Li N, Hao Y, Kageleiry A et al. Time on treatment of everolimus and chemotherapy among postmenopausal women with HR+/HER2- metastatic breast cancer: a retrospective claims study in the US. Curr. Med. Res. Opin. 32(2), 385–394 (2016).
• Analyses of large US insurance claim databases revealed that hormone receptor (HR)-positive/HER2-negative metastatic breast cancer (mBC) patients receiving everolimus had significantly longer time on treatment than those on chemotherapy.
26.
Lin PL, Hao Y, Xie J et al. Real-world effectiveness of everolimus-based therapy versus endocrine monotherapy and chemotherapy in patients of HR+/HER2- breast cancer with liver metastasis in the USA. Expert Opin. Pharmacother. 16, 2101–2111 (2015).
27.
Xie J, Hao Y, Li N et al. Comparative effectiveness of everolimus-based therapy versus endocrine monotherapy among postmenopausal women with HR+/HER2- metastatic breast cancer: a retrospective chart review in community oncology practices in the US. Curr. Med. Res. Opin. 31, 1095–1103 (2015).
28.
Dranitsaris G, Tripathy D, Beegle NL, Kalberer TL, Cox JD, Faria C. Real-world analysis of eribulin in metastatic breast cancer (MBC): an assessment of time to treatment failure (TTF) in a community oncology setting. Presented at: ASCO 2013 Breast Cancer Symposium. San Francisco, CA, USA, 7–9 September 2013.
29.
Koshy N, Quispe D, Shi R, Mansour R, Burton GV. Cisplatin–gemcitabine therapy in metastatic breast cancer: improved outcome in triple negative breast cancer patients compared with non-triple negative patients. Breast 19(3), 246–248 (2010).
30.
Li N, Hao Y, Xie J et al. Everolimus use and associated factors among post-menopausal women with hormonal receptor positive/human epidermal growth factor receptor 2 negative metastatic breast cancer. Curr. Med. Res. Opin. 31(8), 1573–1582 (2015).
• This retrospective chart review study of community-based oncology practices indicates that in HR-positive/HER2-negative mBC, everolimus is used in more severe patients than endocrine therapy but in less severe patients than chemotherapy.
31.
Lin PL, Hao Y, Xie J et al. Physician experiences and preferences in the treatment of HR+/HER2- metastatic breast cancer in the United States: a physician survey. Cancer Med. 5(2), 209–220 (2015).
• A survey of physicians suggested that after first-line endocrine therapy, mono- or combination-endocrine therapy was commonly used for second- and third-line treatments and chemotherapy monotherapy for third or later line treatments for HR-positive/HER2-negative metastatic breast cancer; efficacy was the most important factor for treatment choice.
32.
Macalalad AR, Hao Y, Lin PL et al. Treatment patterns and duration in post-menopausal women with HR+/HER2- metastatic breast cancer in the US: a retrospective chart review in community oncology practices (2004–2010). Curr. Med. Res. Opin. 31, 263–273 (2015).
33.
Morris PG, Murphy CG, Mallam D et al. Limited overall survival in patients with brain metastases from triple negative breast cancer. Breast J. 18, 345–350 (2012).
34.
Seah DS, Luis IV, Macrae E et al. Use and duration of chemotherapy in patients with metastatic breast cancer according to tumor subtype and line of therapy. J. Natl Compr. Canc. Netw. 12(1), 71–80 (2014).
35.
Swallow E, Zhang J, Thomason D, Tan RD, Kageleiry A, Signorovitch J. Real-world patterns of endocrine therapy for metastatic hormone-receptor-positive (HR+)/human epidermal growth factor receptor-2-negative (HER2-) breast cancer patients in the United States: 2002–2012. Curr. Med. Res. Opin. 30, 1537–1545 (2014).
36.
Vaz-Luis I, Lin NU, Keating NL et al. Racial differences in outcomes for patients with metastatic breast cancer by disease subtype. Breast Cancer Res. Treat. 151, 697–707 (2015).
• An analysis of Medicare data of ≥66-year-old women with de novo mBC indicated that patients with HER2-positive disease experienced longer median overall survival compared with HER2-negative disease; racial differences in overall survival were observed in patients with HER2-positive tumors.
37.
Xie J, Hao Y, Li N et al. Clinical outcomes among HR+/HER2- metastatic breast cancer patients with multiple metastatic sites: a chart review study in the US. Exp. Hematol. Oncol. 4, 31 (2015).
38.
Zeichner SB, Herna S, Mani A et al. Survival of patients with de-novo metastatic breast cancer: analysis of data from a large breast cancer-specific private practice, a university-based cancer center and review of the literature. Breast Cancer Res. Treat. 153, 617–624 (2015).
39.
Clarke CA, Chu L, Tao L et al. Characteristics of de novo metastatic breast cancer in California, 2005–2011. Presented at: Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium. San Antonio, TX, USA, 9–13 December 2014.
40.
Engel-Nitz NM, Hao Y, Gomez Rey G, Sullivan J, Willemann Rogerio J. Survival among patients with hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer: a real-world observational study. Presented at: Thirty-Sixth Annual CTRC-AACR San Antonio Breast Cancer Symposium. San Antonio, TX, USA, 10–14 December 2013.
41.
Faria C, Jackson J, Lunacsek O, Hennenfent KL. Time to progression and time to treatment failure in patients with triple-negative metastatic breast cancer receiving eribulin mesylate in a community oncology setting. Presented at: 2014 ASCO Annual Meeting. Chicago, IL, USA, 30 May–3 June 2014.
42.
Hao Y, Engel-Nitz NM, Sullivan J, Henk HJ, Willemann Rogerio J, Newcomer L. Chemotherapy and endocrine therapy treatment patterns among patients with hormone receptor positive (HR+)/HER2 negative advanced breast cancer. Presented at: Thirty-Sixth Annual CTRC-AACR San Antonio Breast Cancer Symposium. San Antonio, TX, USA, 10–14 December 2013.
43.
Karve S, Pawaskar M, Davis KL, Dalvi T, Deeter R. Treatment patterns and survival in elderly women with HER2-negative, hormone receptor positive metastatic breast cancer: analysis of the SEER-Medicare database. Presented at: 2013 ASCO Annual Meeting. Chicago, IL, USA, 31 May–4 June 2013.
44.
Krook JE, Kumar A, Fishman ML et al. Community use of anthracyclines in metastatic breast cancer (MBC). Presented at: 2013 ASCO Annual Meeting. Chicago, IL, USA, 31 May–4 June 2013.
45.
Pahuja S, McGuire K, Davidson N et al. [P3–11–10] Response to subsequent therapies after failure to achieve pathologic complete response (pCR) after neo-adjuvant chemotherapy (NAC) in patients (pts) with triple negative breast cancer (TNBC). Presented at: Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium. San Antonio, TX, USA, 9–13 December 2014.
46.
Patt DA, Richardson P, Rembert D, Corzo D, Chen C. Treatment of patients (pts) with HER2- metastatic breast cancer (MBC) with nab-paclitaxel (nab-P) in the clinical practice setting – results of a US oncology survey. Presented at: 2014 ASCO Annual Meeting. Chicago, IL, USA, 30 May–3 June 2014.
47.
Ko NY, Darnell JS, Calhoun E et al. Can patient navigation improve receipt of recommended breast cancer care? Evidence from the National Patient Navigation Research Program. J. Clin. Oncol. 32, 2758–2764 (2014).
• Due to small sample size and limited variation in the receipt of recommended chemotherapy treatment, the authors were unable to assess the relationship between patient navigation and chemotherapy, concluding that the value of the addition of a navigator is inconclusive from available data.
48.
Walker MS, Hasan M, Yim YM, Yu E, Stepanski EJ, Schwartzberg LS. Retrospective study of the effect of disease progression on patient reported outcomes in HER-2 negative metastatic breast cancer patients. Health Qual. Life Outcomes 9, 46 (2011).
49.
Gupta S, Zhang J, Jerusalem G. The association of chemotherapy versus hormonal therapy and health outcomes among patients with hormone receptor-positive, HER2-negative metastatic breast cancer: experience from the patient perspective. Expert Rev. Pharmacoecon. Outcomes Res. 14(6), 929–940 (2014).
• A cross-sectional survey of postmenopausal women with hormone receptor-positive, HER2-negative mBC revealed that hormonal therapy was associated with better patient-reported outcomes than chemotherapy.
50.
Diaby V, Adunlin G, Zeichner SB et al. Cost-effectiveness analysis of everolimus plus exemestane versus exemestane alone for treatment of hormone receptor positive metastatic breast cancer. Breast Cancer Res. Treat. 147(2), 433–441 (2014).
• Concluded that everolimus plus exemestane is not cost-effective compared with exemestane alone for treatment of HR-positive/HER2-negative mBC, with an estimated incremental cost–effectiveness ratio of US$265,498.5/quality-adjusted progression-free years.
51.
Refaat T, Choi M, Gaber G et al. Markov model and cost–effectiveness analysis of bevacizumab in HER2-negative metastatic breast cancer. Am. J. Clin. Oncol. 37(5), 480–485 (2014).
52.
Xie J, Diener M, De G, Yang H, Wu EQ, Namjoshi M. Budget impact analysis of everolimus for the treatment of hormone receptor positive, human epidermal growth factor receptor-2 negative (HER2-) advanced breast cancer in the United States. J. Med. Econ. 16(2), 278–288 (2013).
53.
Pawaskar M, Karve S, Dalvi T, Davis KL, Deeter R. Health care utilization and costs among HER2-negative, HR-positive, elderly women with metastatic breast cancer in the United States. Presented at: 2013 ASCO Annual Meeting. Chicago, IL, USA, 31 May–4 June 2013.
54.
Zeichner SB, Avancha KKVR, Lopes G, Gluck S, Montero AJ. Cost–effectiveness of everolimus plus exemestane in post-menopausal hormone receptor positive metastatic breast cancer. Presented at: 2013 ASCO Annual Meeting. Chicago, IL, USA, 31 May–4 June 2013.
55.
Rules Committee Print 114-67 Text of House Amendment to the Senate Amendment to H.R. 34, Tsunami Warning, Education, and Research Act of 2015. http://docs.house.gov/billsthisweek/20161128/CPRT-114-HPRT-RU00-SAHR34.pdf.
56.
Visvanathan K, Levit LA, Raghavan D et al. Untapped potential of observational research to inform clinical decision making: American Society of Clinical Oncology Research Statement. J. Clin. Oncol. 35(16), 1845–1854 (2017).
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© 2018 Dasha Cherepanov.
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Received: 12 April 2017
Accepted: 1 September 2017
Published online: 5 January 2018
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Outcomes research examining treatments, quality of life and costs in HER2-negative and triple-negative metastatic breast cancer: a systematic literature review. (2018) Journal of Comparative Effectiveness Research. DOI: 10.2217/cer-2017-0027
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