Abstract P3-08-40: Prognostic factors associated with clinical outcomes in HR+, HER2- advanced breast cancer: Systematic literature review

Carter, Gebra C; Stenger, Keri; Mohanty, Maitreyee; Chong, Amy Lee; Basa, Pradeep; Singuru, S; Singh, Surjit; Tongbram, Vanita; Kümmel, Sherko; Guarneri, Valentina; Tolaney, Sara M.

doi:10.1158/1538-7445.sabcs19-p3-08-40

Cited by 4 publications

(8 citation statements)

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“…In this SLR in Japan, all of the collected studies were observational studies. This was consistent with the preceding global SLR, in which 90% of the collected studies were observational ( 29 ). This may mean that most of the studies on the prognostic factors in this field are of observational nature.…”

Section: Discussionsupporting

confidence: 90%

“…DFI, liver metastases and the number of MORG were consistently associated with survival in both UV and MV analyses and so identified as independent prognostic factors. A preceding systematic review for global population based on English literature also identified these three factors as poor prognostic factors ( 29 ). In this SLR in Japan, all of the collected studies were observational studies.…”

Section: Discussionmentioning

confidence: 99%

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A systematic literature review of prognostic factors in patients with HR+/HER2− advanced breast cancer in Japan

Hattori

Novick

Takaura

et al. 2021

Japanese Journal of Clinical Oncology

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Background Breast cancer is the most prevalent cancer in women in Japan and the fifth in mortality. This systematic review summarized the evidence for prognostic factors for patients with HR+/HER2− advanced and metastatic breast cancer in Japan. Methods MEDLINE and EMBASE were searched with keywords ‘breast neoplasms’ AND ‘Japan’ AND ‘advanced’ or equivalent, and Japan Medical Abstract Society database with ‘breast cancer’ AND ‘advanced/metastatic’ for publications from January 2010 to October 2019. ASCO, ESMO, ABC4 abstracts and WHO website were hand searched. The endpoints of interest were overall survival, progression-free survival, tumour response and post-progression survival. Factors were evaluated based on the consistency in direction and the strength (hazard ratios) of association. Results Searches identified 4530 publications, of which 27 were eligible. All were observational studies. Among the endpoints, overall survival was the most commonly assessed (n = 22) and evaluated further. Ki-67 expression, progesterone receptor expression status, tumour grade and lymph node metastases were consistently associated with poor overall survival in univariate analysis but not in multivariate analysis. Short disease-free interval, the number of metastatic organs and liver metastasis were consistently associated with poor overall survival in both of univariate and multivariate analysis. The association was strong for liver metastasis (hazard ratio ≥2.8 in the majority of studies) and moderate for disease-free interval and the number of metastatic organs (hazard ratio 1.3–2.8 in the majority of studies). Conclusions Disease-free interval, the number of metastatic organs and liver metastasis were identified as independent prognostic factors for overall survival. These findings may help clinical decision-making to improve outcomes in patients with HR+/HER2− advanced and metastatic breast cancer.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 99%

A systematic literature review of prognostic factors in patients with HR+/HER2− advanced breast cancer in Japan

Hattori

Novick

Takaura

et al. 2021

Japanese Journal of Clinical Oncology

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“…Previous studies support these findings that all 4 individual factors are associated with poorer prognosis. 15,25,[35][36][37][38][39] Currently, there is no consensus on what factors are most impactful when multiple factors are present. In addition, studies vary considerably on methodology, eligibility criteria, availability of biological and clinical parameters, and patient follow-up.…”

Section: Discussionmentioning

confidence: 99%

“…In addition, studies vary considerably on methodology, eligibility criteria, availability of biological and clinical parameters, and patient follow-up. 15,25,[35][36][37][38][39] Findings from a recent systematic literature review showed that the following prognostic factors were associated with clinical outcomes in HR þ /HER2 À MBC: PR status, TG, circulating tumor cell count, Ki67 level, number and sites of metastases, time to recurrence or progression of MBC, performance status, prior therapy attributes in the early or metastatic setting, race, and absence of prior therapy or higher lines of therapy in the early or metastatic setting. 35 Further research should explore the collective importance of these prognostic factors in treatment decisions.…”

Section: Discussionmentioning

confidence: 99%

Development of a Prognostic Factor Index Among Women With HR+/HER2− Metastatic Breast Cancer in a Community Oncology Setting

Vidal

Carter

Gilligan

et al. 2021

Clinical Breast Cancer

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This analysis explored the impact of prognostic factors on clinical outcomes for patients with hormone receptor-positive/human epidermal growth factor 2-negative metastatic breast cancer. An index factor was created and included liver metastases, primary endocrine resistance, negative progesterone receptor status, and high tumor grade. The prognostic factor index may enable early identification of patients with a less favorable prognosis. Background: This study explored the impact of multiple prognostic factors on patient overall survival (OS) and realworld progression-free survival (rwPFS) for patients with hormone receptor-positive (HR þ )/human epidermal growth factor 2 negative (HER2 À ) metastatic breast cancer (MBC). Materials and Methods: This retrospective study used electronic health record data of patients in the United States from community oncology practices from January 1, 2008 to April 30, 2017. Eligibility included HR þ /HER2 À MBC diagnosis in 2008 or later and prior systemic therapy for MBC. An index variable was created to assess the effect of multiple clinical prognostic factors collectively, including liver metastases (LM), primary endocrine resistance (PER), negative progesterone receptor (PR À ) status, and high tumor grade (TG). Patients were grouped based on the number of prognostic factors present at MBC diagnosis: 0, 1, and 2þ. Differences in rwPFS and OS from start of first-line therapy were evaluated by the Kaplan-Meier method and multivariable Cox proportional hazards regression. Results: Approximately 29.1% of the 378 eligible patient sample had 0, 36.0% had 1, and 34.9% had 2þ prognostic factors. For the patients with 1 of the prognostic factors, 24.3% had high TG, 14.7% were LMþ, 39.7% had PER, and 21.3% were PR À . Univariate and multivariate results showed that rwPFS and OS were significantly (P < .05) shorter in patients with 1 and 2þ prognostic factors compared with patients with 0. Conclusions: The individual prognostic factors and the prognostic factor index may enable early identification of patients with a less favorable prognosis across the HR þ /HER2 À MBC population and help inform treatment decisions in difficult-to-treat populations.

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“…Finding effective treatments for patients with poor prognostic factors constitutes a major challenge in clinical practice, as some of these prognostic factors, such as PgR-negative and high-grade tumors 12,13 , have been implicated in ET resistance. Patients with poor prognostic factors have historically experienced low survival rates, thus validating the critical need to find effective therapies for these patients [14][15][16][17][18] . Consistent with previously disclosed exploratory analyses, these updated subgroup analyses continue to suggest that the numerically largest benefit was observed in patients with adverse prognostic factors, such as liver metastases, PgR-negative tumors, high-grade tumors, or short TFI.…”

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confidence: 99%

Abemaciclib as initial therapy for advanced breast cancer: MONARCH 3 updated results in prognostic subgroups

et al. 2021

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In MONARCH 3, continuous dosing of abemaciclib with an aromatase inhibitor (AI) conferred significant clinical benefit to postmenopausal women with HR+, HER2− advanced breast cancer. We report data for clinically prognostic subgroups: liver metastases, progesterone receptor status, tumor grade, bone-only disease, ECOG performance status, and treatment-free interval (TFI) from an additional 12-month follow-up (after final progression-free survival [PFS] readout). In the intent-to-treat population, after median follow-up of approximately 39 months, the updated PFS was 28.2 versus 14.8 months (hazard ratio [HR], 0.525; 95% confidence interval, 0.415–0.665) in abemaciclib versus placebo arms, respectively. Time to chemotherapy (HR, 0.513), time to second disease progression (HR, 0.637), and duration of response (HR, 0.466) were also statistically significantly prolonged with the addition of abemaciclib to AI. Treatment benefit was observed across all subgroups, as evidenced by objective response rate change from the addition of abemaciclib to AI, with the largest effects observed in patients with liver metastases, progesterone receptor-negative tumors, high-grade tumors, or TFI < 36 months. Extended follow-up in the MONARCH 3 trial further confirmed that the addition of abemaciclib to AI conferred significant treatment benefit to all subgroups, including those with poorer prognosis.

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Abstract P3-08-40: Prognostic factors associated with clinical outcomes in HR+, HER2- advanced breast cancer: Systematic literature review

Cited by 4 publications

References 0 publications

A systematic literature review of prognostic factors in patients with HR+/HER2− advanced breast cancer in Japan

A systematic literature review of prognostic factors in patients with HR+/HER2− advanced breast cancer in Japan

Development of a Prognostic Factor Index Among Women With HR+/HER2− Metastatic Breast Cancer in a Community Oncology Setting

Abemaciclib as initial therapy for advanced breast cancer: MONARCH 3 updated results in prognostic subgroups

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