BOLERO-6: Phase II study of everolimus plus exemestane versus everolimus or capecitabine monotherapy in HR+, HER2- advanced breast cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. TPS660-TPS660 ◽  
Author(s):  
Bent Ejlertsen ◽  
Guy Heinrich Maria Jerusalem ◽  
Sara A. Hurvitz ◽  
Richard H. De Boer ◽  
Tanya Taran ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Combination Therapy ◽  
Advanced Breast Cancer ◽  
Clinical Benefit ◽  
Performance Status ◽  
Objective Response ◽  
Eastern Cooperative Oncology Group ◽  
Advanced Breast ◽  
Clinical Activity ◽  
Objective Evidence

TPS660 Background: Everolimus (EVE), an orally bioavailable inhibitor of the mammalian target of rapamycin (mTOR), has shown clinical activity as monotherapy and in combination with endocrine therapy (ET) in hormone-receptor–positive (HR+; estrogen and/or progesterone receptors) advanced breast cancer (ABC). In a pivotal phase 3 trial in patients with HR+ ABC progressing on ET, EVE + exemestane (EXE) significantly prolonged median progression-free survival (PFS) vs EXE alone per local (7.8 vs 3.2 months; log-rank P<.0001) or central (11.0 months for EVE+EXE vs 4.1 months for EXE alone; log-rank P<.0001) assessment. Capecitabine, an orally administered fluoropyrimidine carbamate indicated as monotherapy in paclitaxel and/or anthracycline-refractory ABC, has shown clinical benefit in patients with HR+, human epidermal growth factor receptor 2-negative (HER2-) ABC. The BOLERO-6 study in patients with HR+, HER2- ABC progressing on prior anastrozole or letrozole will compare PFS following EVE+EXE combination therapy vs EVE or capecitabine monotherapy. Methods: In this multicenter, open-label, randomized, 3-arm, phase 2 study, 300 patients will be randomized to receive either EVE (10 mg/d) + EXE (25 mg/d) combination therapy, or EVE (10 mg/d) alone, or capecitabine (1,250 mg/m2twice daily for 14 d/3-wk cycle) alone, until disease progression. Patients will be stratified based on the presence of visceral disease. Key eligibility criteria include age ≥18 years, postmenopausal status; histologic or cytologic confirmation of estrogen-receptor–positive, HER2- ABC; radiologic or objective evidence of recurrence or progression on prior aromatase inhibitors; Eastern Cooperative Oncology Group (ECOG) performance status ≤2. The primary endpoint is PFS with EVE+EXE vs EVE, based on local radiologic assessment (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1). The key secondary endpoint is PFS with EVE+EXE vs capecitabine. Other secondary endpoints include overall survival, objective response rate, clinical benefit rate, safety, quality of life, and patient satisfaction with treatment. Enrollment will start in Q1 2013. Estimated study completion in Q1 2015. Clinical trial information: NCT01783444.

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

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Stephen Johnston ◽  
Joyce O’Shaughnessy ◽  
Miguel Martin ◽  
Jens Huober ◽  
Masakazu Toi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Progesterone Receptor ◽  
Liver Metastases ◽  
Advanced Breast Cancer ◽  
Performance Status ◽  
Objective Response ◽  
Advanced Breast ◽  
Treatment Benefit ◽  
Significant Treatment

AbstractIn 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.

MONARCH 2: Abemaciclib in combination with fulvestrant in patients with HR+/HER2- advanced breast cancer who progressed on endocrine therapy

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 1000-1000 ◽  
Author(s):  
George W. Sledge ◽  
Masakazu Toi ◽  
Patrick Neven ◽  
Joohyuk Sohn ◽  
Kenichi Inoue ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Endocrine Therapy ◽  
Objective Response ◽  
Metastatic Breast ◽  
Advanced Breast ◽  
Rank Test ◽  
Clinical Activity ◽  
Phase 3 ◽  
Measurable Disease

1000 Background: Abemaciclib, an oral, selective inhibitor of CDK4 & 6, dosed on a continuous schedule, demonstrated clinical activity as monotherapy in patients (pts) with treatment refractory hormone receptor positive (HR+) metastatic breast cancer (MBC). The tolerability and activity of abemaciclib + fulvestrant (F) supported Phase 3 evaluation. Methods: MONARCH 2 is a double-blind Phase 3 trial of abemaciclib + F vs placebo (P) + F in women with HR+/HER2- advanced breast cancer. Women who progressed on (neo)adjuvant endocrine therapy (ET), ≤12 months from end of adjuvant ET, or on first line ET for MBC and who had not received chemotherapy for metastatic disease were eligible. Pts were randomized 2:1 to receive abemaciclib at 150 mg Q12H (or 200 mg prior to amendment) or P plus F (500 mg, per label) and stratified by metastatic site (visceral, bone only, or other) and resistance to prior ET (primary vs secondary). Pre/perimenopausal pts received a gonadotropin-releasing hormone agonist. The primary objective was investigator-assessed progression-free survival (PFS). Secondary endpoints included objective response rate (ORR) and other efficacy and safety endpoints. Assuming a hazard ratio (HR) of 0.703 in favor of abemaciclib + F, 378 events were needed for 90% power at one sided α=.025. Results: 669 pts were randomized to abemaciclib + F (N=446) and to P + F (N=223). 56% of pts had visceral disease, 72% had measurable disease, 25% had primary ET resistance, and 82% were postmenopausal. In the ITT population 379 PFS events were observed with a median PFS of 16.4 m for abemaciclib + F and 9.3 m for P + F (HR: 0.553; 95% CI: 0.449, 0.681, P<.0000001 by log-rank test). In pts with measurable disease, the ORR was 48.1% (3.5% complete response [CR]) for abemaciclib + F and 21.3% (0% CR) for P + F. The most frequent treatment emergent adverse events for abemaciclib + F vs P + F were diarrhea (86.4% vs 24.7%), neutropenia (46.0% vs 4.0%), nausea (45.1% vs 22.9%), and fatigue (39.9% vs 26.9%). Conclusions: Abemaciclib + fulvestrant was an effective treatment in patients with HR+/HER2- advanced breast cancer who progressed on endocrine therapy with significantly improved PFS and ORR. Clinical trial information: NCT02107703.

scholarly journals Multicentre, phase II study of eribulin in combination with S-1 in patients with advanced breast cancer

BMC Cancer ◽  
2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Tsutomu Iwasa ◽  
Junji Tsurutani ◽  
Satomi Watanabe ◽  
Ryoji Kato ◽  
Yutaka Mizuno ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Combination Therapy ◽  
Advanced Breast Cancer ◽  
Phase Ii ◽  
Poor Prognosis ◽  
Phase Ii Study ◽  
Objective Response ◽  
Advanced Breast ◽  
Her2 Receptor ◽  
Multicentre Phase

Abstract Background We previously reported the synergistic effect of S-1 and eribulin in preclinical models. In addition, our phase I study revealed the recommended dose for the phase II study of the combination therapy in advanced breast cancer (ABC) patients pre-treated with anthracycline and taxane. Our current study reports on the efficacy and safety of the combined use of eribulin and S-1 in patients with ABC and poor prognosis. Methods Patients with breast cancer who received prior anthracycline- and/or taxane-based therapy were assigned to receive a combination therapy of eribulin (1.4 mg/m2 on days 1 and 8, every 21 days) and S-1 (65 mg/m2, on days 1 to 14, every 21 days) for advanced/metastatic disease. All patients had at least one clinicopathological factor such as being oestrogen receptor negative, Human Epidermal Growth Factor Receptor 2 (HER2) receptor negative, presence of visceral involvement, presence of three or more metastatic sites, or having a disease-free interval shorter than 2 years. The primary endpoint was the independent-reviewer assessed objective response rate (ORR). Secondary endpoints were clinical benefit rate, disease control rate, progression-free survival (PFS), and overall survival (OS). Results This study enrolled 33 patients. Confirmed ORR was 33.3% (95% CI: 17.3 to 52.8). Median PFS was 7.5 months (95% CI: 4.0 to 14.3). Median OS time was not reached during the current experimental periods. The most common grade 3/4 adverse event was neutropenia (68.8%). Conclusions The combination of eribulin and S-1 is safe and effective for treatment in patients with ABC and poor prognosis. Trial registration Current Controlled Trials UMIN000015049, date of registration: September 5th 2014.

Randomized Phase II Trial on Mitomycin-C/Cisplatin ± KLT in Heavily Pretreated Advanced Breast Cancer

2008 ◽  
Vol 36 (04) ◽  
pp. 665-674 ◽  
Author(s):  
H.Y. Guo ◽  
Y. Cai ◽  
X.M. Yang ◽  
Z.H. Wang ◽  
J.L. Wang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Phase Ii ◽  
Clinical Benefit ◽  
Progressive Disease ◽  
Objective Response ◽  
Advanced Breast ◽  
Randomized Phase Ii ◽  
Heavily Pretreated ◽  
And Control

A randomized phase II study using mitomycin (MMC)/cisplatin (DDP) regimen with or without Kanglaite (KLT, a traditional Chinese medicine) as salvage treatment was conducted to exploit KLT's potential effects on patients with advanced breast cancer (ABC). Triweekly regimen consisted of mitomycin (8 mg/m2) administered intravenously on day 1, and cisplatin (25 mg/m2) intravenously on days 1 to 3. KLT (100 ml) was given intravenously per day on days 1 to 14 every 3 weeks. Between April 2006 and July 2007, 60 patients with a median age of 48 years were randomized into MMC/DDP with or without KLT treatment. In all, the objective response rate (ORR) was 17.5%. There were no significant differences between experimental and control treatments in terms of ORR (14.3% vs. 20.7%, p = 0.730), clinical benefit rates (24.1% vs. 28.6%, p = 0.468), median time to progression (TTP; 3.63 vs. 4.0, p = 0.872), and overall survival (OS; 7.17 vs. not reached, p = 0.120). The median TTP for patients with complete or partial responses was 6.0 months, but only 2.1 months for patients with stable or progressive disease (SD or PD; p = 0.028). While the median OS for patients who obtained clinical benefit from chemotherapy was not reached, that of patients with SD of no more than 6 months or PD was only 7.17 months (p = 0.004). There is no additional benefit when KLT is added to the MMC/DDP doublet in the management of ABC. Patients who obtained clinical benefit from chemotherapy had a longer TTP and OS.

First-Line Treatment of Advanced Breast Cancer With Sunitinib in Combination With Docetaxel Versus Docetaxel Alone: Results of a Prospective, Randomized Phase III Study

2012 ◽  
Vol 30 (9) ◽  
pp. 921-929 ◽  
Author(s):  
Jonas Bergh ◽  
Igor M. Bondarenko ◽  
Mikhail R. Lichinitser ◽  
Annelie Liljegren ◽  
Richard Greil ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Combination Therapy ◽  
Advanced Breast Cancer ◽  
Objective Response ◽  
Advanced Breast ◽  
Phase Iii ◽  
Line Treatment ◽  
First Line ◽  
Phase Iii Study ◽  
First Line Treatment

Purpose To investigate whether sunitinib plus docetaxel improves clinical outcomes for patients with human epidermal growth factor receptor 2 (HER2)/neu–negative advanced breast cancer (ABC) versus docetaxel alone. Patients and Methods In this phase III study, patients were randomly assigned to open-label combination therapy (sunitinib 37.5 mg/d, days 2 to 15 every 3 weeks; and docetaxel 75 mg/m2, day 1 every 3 weeks) or monotherapy (docetaxel 100 mg/m2 every 3 weeks). Progression-free survival (PFS) was the primary end point. Results Two hundred ninety-six patients were randomly assigned to combination therapy, and 297 patients were assigned to monotherapy. Median PFS times were 8.6 and 8.3 months with combination therapy and monotherapy, respectively (hazard ratio, 0.92; one-sided P = .265). The objective response rate (ORR) was significantly higher with the combination (55%) than with monotherapy (42%; one-sided P = .001). Duration of response was similar in both arms (7.5 months with the combination v 7.2 months with monotherapy). Median overall survival (OS) times were 24.8 and 25.5 months with combination therapy and monotherapy, respectively (one-sided P = .904). There were 107 deaths with the combination and 91 deaths with monotherapy. The frequency of common adverse events (AEs) was higher with the combination, as were treatment discontinuations caused by AEs. Conclusion The combination of sunitinib plus docetaxel improved ORR but did not prolong either PFS or OS compared with docetaxel alone when given to an unselected HER2/neu-negative cohort as first-line treatment for ABC. Sunitinib combination therapy may also have resulted in AEs that yield an unfavorable risk-benefit ratio. The sunitinib-docetaxel regimen evaluated in this study is not recommended for further use in ABC.

Phase III, randomized, double-blind, placebo-controlled multicenter trial of daily everolimus plus weekly trastuzumab and vinorelbine in trastuzumab-resistant, advanced breast cancer (BOLERO-3).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 505-505 ◽  
Author(s):  
Ruth O'Regan ◽  
Mustafa Ozguroglu ◽  
Fabrice Andre ◽  
Masakazu Toi ◽  
Guy Heinrich Maria Jerusalem ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Group Performance ◽  
Phase 1 ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Advanced Breast ◽  
Phase Iii ◽  
Adult Women ◽  
Metastatic Setting

505 Background: Everolimus (EVE) is an inhibitor of mammalian target of rapamycin (mTOR), a protein kinase central to a number of signaling pathways regulating cell growth and proliferation. Data from preclinical and phase 1/2 clinical studies indicated that adding EVE to trastuzumab (TRAS) plus chemotherapy may restore sensitivity to and enhance efficacy of human epidermal growth factor receptor 2 (HER2)-targeted therapy. The international BOLERO-3 phase 3 study is being conducted to evaluate the addition of EVE to TRAS plus vinorelbine. Methods: Adult women with HER2+ advanced breast cancer and who received prior taxane therapy and experienced recurrence or progression on TRAS were randomized 1:1 to receive either EVE or placebo (5 mg/day) in combination with weekly TRAS and vinorelbine (25 mg/m2). The primary endpoint is progression-free survival (PFS). Secondary endpoints included overall survival, response rate, clinical benefit rate, safety, quality of life, and pharmacokinetics. Final analysis will be conducted after approximately 417 PFS events. Results: The trial accrued 569 patients between October 2009 and May 2012. Previous therapy included TRAS (100%), a taxane (100%), and lapatinib (28%). The median age was 54 years, and 76% of patients had visceral metastases, 5% had stable brain metastases, 56% had hormone-receptor–positive disease, 33% had Eastern Cooperative Oncology Group performance status of 1 or 2, and 41% had 3 or more metastatic sites. The median number of prior chemotherapy lines in the metastatic setting was 1. As of February 4, 2013, a total of 396 PFS events were reported. Conclusions: Final PFS analysis will be performed in early May 2013; primary and secondary efficacy endpoints will be presented. Clinical trial information: NCT01007942.

Fulvestrant in hormone receptor-positive advanced breast cancer: A UK retrospective multicenter study.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12525-e12525
Author(s):  
Karim Keshwani ◽  
anna lerner ◽  
Benjamin Sanderson ◽  
Ruth E. Board ◽  
Michael Flynn ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Clinical Benefit ◽  
Hormone Receptor ◽  
Performance Status ◽  
Locally Advanced ◽  
Real Life ◽  
Advanced Breast ◽  
Ecog Performance Status ◽  
Hormone Receptor Positive

e12525 Background: Fulvestrant is a selective oestrogen receptor (ER) down regulator used to treat hormone receptor-positive advanced breast cancer in postmenopausal women. It is used at various time points in treatment. However, variations in funding across the UK limit universal patient access to fulvestrant. We sought to investigate its use and efficacy in UK clinical practice. Methods: Medical records of 458 patients with ER positive advanced breast cancer treated with fulvestrant between August 2011 and November 2018 at ten UK centres were reviewed. Demographics and treatment responses were recorded. Efficacy was analysed by progression free survival (PFS), clinical benefit rate (CBR) and overall survival (OS) with alive patients censored to December 2018. Results: Of the 445 patients with analysable data, median age was 70 (range 21-95). ECOG performance status was 0-1 in 70% (n = 285). Bone was most commonly involved (73%, n = 323), 307 (69%) had visceral involvement and 228 (51%) had nodal metastases. Both locally advanced and metastatic patients had received a median 2 (range 0 – 5 for all patients) prior endocrine therapy lines and 0 (range 0 – 6) prior chemotherapy lines. Fulvestrant was the first line treatment in 49 (11%). Median duration of fulvestrant use was 5 months (range 1-88). Overall, median PFS was 6 months. This increased to 7 months in absence of visceral disease, in whom 22% of patients achieved a prolonged PFS extending to 30 months. Fulvestrant produced a CBR of 41% in 355 patients assessed, of which 16% partially responded. First radiological assessment occurred at median 3 months (range 1-37). Progressive disease accounted for 82% of discontinuation compared to 4% owing solely to adverse events in 341 assessed patients. Median OS for the whole cohort was 23 months. Conclusions: This is one of the largest studied patient cohorts treated with fulvestrant. This heavily pre-treated population reflects real life fulvestrant use. Reassuringly the results confirm its clinical benefit in maintaining disease response. Given its potential synergistic action with other systemic agents, fair access to this highly active drug for all patients is as important now as ever before.

A phase I dose escalation and expansion study of the next generation oral SERD AZD9833 in women with ER-positive, HER2-negative advanced breast cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 1024-1024
Author(s):  
Erika Paige Hamilton ◽  
Mafalda Oliveira ◽  
Udai Banerji ◽  
Cristina Hernando ◽  
Javier Garcia-Corbacho ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Clinical Benefit ◽  
Sinus Bradycardia ◽  
Phase 1 ◽  
Objective Response ◽  
Maximum Tolerated Dose ◽  
Primary Objective ◽  
Advanced Breast ◽  
Open Label

1024 Background: AZD9833 is an oral selective estrogen receptor (ER) antagonist and degrader (SERD) that has shown antitumor efficacy in a range of preclinical models of breast cancer. Methods: SERENA-1 (NCT03616587) is an ongoing Phase 1, open-label study in pre- and post-menopausal women, after ≥1 endocrine therapy and ≤2 prior chemotherapies for ER+ HER2- advanced breast cancer (ABC). The primary objective is to determine the safety and tolerability of AZD9833 once daily (QD), with dose-limiting toxicities (DLTs) in 28d defining the maximum tolerated dose. Secondary objectives include pharmacokinetics and anti-tumor response. Pharmacodynamic (PD) analysis includes ER modulation in paired tumor biopsies and ctDNA dynamic changes. Results: At 20 January 2020: 60 patients were treated (median prior therapies 5 (1–9); prior fulvestrant (Fv) 82%; prior CDK4/6i 68%) across five doses; 25 mg QD n=12, 75 mg QD n=12, 150 mg QD n=13, 300 mg QD n=13, 450 mg QD n=10. AZD9833 exposure was dose proportional after multiple doses, with a median terminal t1/2 of 12h. Treatment-related AEs experienced by ≥10% of patients were visual disturbances (53%; 91% G1, 6% G2, 3% G3), bradycardia/sinus bradycardia (45%; 93% G1, 7% G2), nausea (18%; 46% G1, 55% G2), fatigue (13%; 38% G1, 63% G2), dizziness (10%; 83% G1, 17% G3) vomiting (10%; 50% G1, 33% G2, 17% G3), and asthenia (10%; 67% G1, 33% G2). Three patients experienced DLTs: G3 QTcF prolongation (300 mg); G3 vomiting (450 mg); and a combination of G2 visual disturbance, G2 headache and G2 gait disturbance (450 mg). DLTs resolved with dose reduction. No G4 or 5 AEs were reported. Efficacy data are presented in the table below; objective response rate (ORR) and clinical benefit rate (CBR) at 24 weeks. Clinical trial information: NCT03616587 . ER signalling pathway modulation was observed in all dose cohorts. In patients where clinical responses occurred and paired biopsies obtained, 98% reduction in Ki67 was measured. Updated data will be presented. Conclusions: AZD9833 has an encouraging efficacy and dose-dependent safety profile. Evidence of clinical benefit and target engagement was observed at all dose levels in women with ER+ ABC, including patients pre-treated with CDK4/6i and Fv, and those with ESR1 mutations. A Phase 2 study comparing efficacy and safety of three doses AZD9833 vs Fv is planned (NCT04214288). [Table: see text]

Development and validation of a nomogram for predicting survival of advanced breast cancer patients in China.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e13064-e13064
Author(s):  
Shaoyan Lin ◽  
Hongnan Mo ◽  
Yiqun Li ◽  
Xiuwen Guan ◽  
Yimeng Chen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Multivariate Analyses ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Local Therapy ◽  
Advanced Breast ◽  
Cancer Center ◽  
Breast Cancer Patients ◽  
Ecog Performance Status

e13064 Background: The prognosis of patients with advanced breast cancer (ABC) varied according to different prognostic factors. This study aimed to establish a nomogram to predict the overall survival (OS) of ABC patients in China. Methods: Data from the China National Cancer Center database that recorded 4039 patients diagnosed with breast cancer between 1987 and 2019 were extracted and a total of 2263 ABC patients with complete relevant information were included in this study, which were further randomized 3:1 and divided into training ( n = 1706) and validation ( n = 557) cohorts. The nomogram was built based on independent predictors identified by univariate and multivariate analyses. Harrell′s concordance index (C-index) and calibration plots were used to assessed the discriminatory and predictive capacities of the nomogram. Results: With a median OS of 45.4 months, the 2-year and 3-year OS rates of ABC patients were 75.2% and 60.2%, respectively. Univariate and multivariate analyses found that age, Eastern Cooperative Oncology Group (ECOG) performance status, T-stage, N-stage, tumor subtype, the presence of distant lymph node (DLN)/liver/brain metastasis, local therapy, efficacy of first-line therapy and metastatic-free interval (MFI) were significantly associated with OS (all P < 0.05). These variables were incorporated into a nomogram to predict the 2-year and 3-year OS of ABC patients. The C-indexes of the nomogram were 0.700 (95% confidence interval [CI]: 0.683-0.717) and 0.686 (95% CI: 0.652-0.719) for the training and the validation sets, respectively. The calibration curves revealed satisfactory agreement between actual survival and nomogram prediction in both the internal and external validations. The nomogram was able to stratify patients into different risk groups. Conclusions: We developed and validated a nomogram that might serve as an efficient tool to provide individual prediction for ABC patients and guide the physicians to make personalized treatment decisions for individual ABC patients.

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