Palbociclib in hormone positive metastatic breast cancer: A real world multicenter Indian experience.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e13057-e13057
Author(s):  
Amit Rauthan ◽  
Poonam Patil ◽  
S.P. Somashekhar ◽  
Linu Abraham Jacob ◽  
Lokanatha D ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Hormonal Therapy ◽  
Metastatic Breast ◽  
Standard Of Care ◽  
Second Line ◽  
Efficacy And Safety ◽  
First Line ◽  
Indian Patients ◽  
Visceral Metastases

e13057 Background: Palbociclib, a selective CDK4/6 inhibitor, in combination with hormonal therapy has become the standard of care in the treatment of hormonal positive (HR+) metastatic breast cancer (MBC). There is limited efficacy and safety data in Indian patients. Methods: This is a multicenter retrospective study of real world experience of patients with HR+, Her 2 neu negative MBC who received Palbociclib in 5 centers of south India between Oct 2016 and Aug 2019. Endpoints were overall response rate (ORR), progression free survival (PFS) and toxicity. Results: 133 patients received Palbociclib; 83 (62.4%) in the first line setting (hormone naïve MBC) and 50 (37.6%) in the second line (MBC progressed on at least one line of hormonal therapy). Median age was 56 years (range 48-76). All patients started with 125mg/day. In the 83 first line patients, 46 (55.4%) had denovo MBC, 37 (44.6%) had post-adjuvant relapse. 38 (45.8%) had bone only and 45 (54.2%) had visceral metastases. Letrozole was the companion drug in 76%, Fulvestrant in 18%, Exemestane in 6%. 5 (6%) patients achieved complete response (CR), 54 (65%) partial response (PR), 12 (14.5%) stable disease (SD) and 12 (14.5%) had progressive disease (PD). ORR was 71%. At a median followup of 18 months, the median PFS was not reached (maximum ongoing followup 38 months). The median PFS in the denovo metastatic disease versus relapsed disease was not reached versus 18 months (p = 0.021). The median PFS was significantly better in bone only versus visceral metastases (not reached versus 28 months, p = 0.007). In the 50 second line patients, 15 (30%) had bone only and 35 (70%) had visceral metastases. Companion drug was Fulvestrant in 64%, Letrozole in 20%, Exemestane in 16%. 60% received prior chemotherapy. Best response was CR 3 (6%), PR 23 (46%), SD 4 (8%), PD 17 (34%), not assessed 3 (6%). ORR was 52%. The median PFS was 14 months. PFS in bone only versus visceral disease was 14 months versus 13 months (p = 0.382). Neutropenia was present in 75.2%, thrombocytopenia in 19.5%, anaemia in 18%. Neutropenia was grade 1 in 26%, grade 2 in 51%, grade 3 in 23%; with no febrile neutropenia. 30% had dose delays and 8.2% had dose reduction. Conclusions: Palbociclib has resulted in similar efficacy and safety in Indian patients as the PALOMA trials. Neutropenia was the commonest side effect, which was uncomplicated and easily managed with dose delays. Using CDK4/6 inhibitors with hormonal therapy has become the standard of care in HR+ MBC Indian patients.

scholarly journals Phase II trail of nab-paclitaxel in metastatic breast cancer patients with visceral metastases

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yizhao Xie ◽  
Chengcheng Gong ◽  
Jian Zhang ◽  
Leiping Wang ◽  
Jun Cao ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Treatment Outcome ◽  
Metastatic Breast Cancer ◽  
Brain Metastasis ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Metastatic Breast ◽  
Efficacy And Safety ◽  
First Line ◽  
Visceral Metastases

Abstract Background Visceral metastases account for 48–67% of metastatic breast cancer (MBC) patients and presage a worse overall survival. Previous study suggested potential effect of nab-paclitaxel on patients with visceral metastases subgroups. This phase II trial was conducted to explore the efficacy and safety of nab-paclitaxel in such a high-risk group of patients. Methods In this prospective, single-center, open-label, phase II study, MBC patients with visceral metastases (N = 80) received nab-paclitaxel (Abraxane, 125 mg/m2, D1, D8, D15 every 28 days). Results The median PFS was 5.1 months (95% CI: 4.2–6.0 months), with an ORR of 33.8% (95% CI 21.3–43.8%) and CBR of 66.2% (95% CI 56.3–75.0%). In univariate analysis, patients with premenopausal status had a trend of better treatment outcome. Multivariate analysis demonstrated non brain metastasis (adjusted HR 0.31, 95% CI 0.12–0.83, P = 0.019) and first line treatment (adjusted HR 0.37, 95% CI 0.17–0.81, P = 0.013) as independent predictors of longer PFS. The overall safety was acceptable with most common treatment-related, grade ≥ 3 toxicities of neutropenia (16.3%) and sensory neuropathy (3.7%). Conclusions This phase II trial documented satisfactory efficacy and safety of nab-paclitaxel in MBC patients with visceral metastases, providing evidence for relative clinical practice. Patients in first line therapy had better treatment outcome. For patients with premenopausal status or brain metastasis, further alternatives (for example, combined chemotherapy or targeting therapy) might be required. This study also demonstrated the efficacy and safety of 125 mg/m2 nab-paclitaxel among Asian patients. Trial registration This research is registered under clinicaltrials.gov (NCT 02687490, February 22, 2016).

Efficacy and safety of combined trastuzumab and paclitaxel therapy as a second-line treatment in women with metastatic Breast Cancer: A single institutional experience

Breast Cancer ◽  
2006 ◽  
Vol 13 (4) ◽  
pp. 329-333 ◽  
Author(s):  
Keiko Furukawa ◽  
Yoshinori Ito ◽  
Shunji Takahashi ◽  
Masataka Sawaki ◽  
Nobuyuki Mizunuma ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Metastatic Breast ◽  
Line Treatment ◽  
Second Line ◽  
Efficacy And Safety ◽  
Institutional Experience

scholarly journals The role of capecitabine and eribulin in the treatment of metastatic HER2-negative metastatic breast cancer

2018 ◽  
Vol 20 (3) ◽  
pp. 26-29
Author(s):  
I V Kolyadina ◽  
I V Poddubnaya
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Comparative Analysis ◽  
Metastatic Breast ◽  
Antitumor Action ◽  
Line Treatment ◽  
Second Line ◽  
Efficacy And Safety

The review analyzed the role of capecitabine and eribulin in the treatment of HER2-negative metastatic breast cancer in patients pretreated with anthracyclines and taxanes. The mechanism of the antitumor action of capecitabine and eribulin, the efficacy in various biological subtypes of breast cancer and safety of treatment is described. The results of a comparative analysis of the efficacy and safety of eribulin monotherapy compared with capecitabine therapy as a second-line treatment for advanced HER2-negative breast cancer are presented.

scholarly journals Patterns of treatment with everolimus exemestane in hormone receptor-positive HER2-negative metastatic breast cancer in the era of targeted therapy

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Mariya Rozenblit ◽  
Sophia Mun ◽  
Pamela Soulos ◽  
Kerin Adelson ◽  
Lajos Pusztai ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Treatment Option ◽  
Metastatic Breast ◽  
Prior Treatment ◽  
Second Line ◽  
First Line ◽  
Effective Treatment Option ◽  
Third Line ◽  
Line Following

Abstract Background There is currently no clinical trial data regarding the efficacy of everolimus exemestane (EE) following prior treatment with CDK4/6 inhibitors (CDK4/6i). This study assesses the use and efficacy of everolimus exemestane in patients with metastatic HR+ HER2− breast cancer previously treated with endocrine therapy (ET) or endocrine therapy + CDK4/6i. Methods Retrospective analysis of electronic health record-derived data for HR+ HER2− metastatic breast cancer from 2012 to 2018. The proportion of patients receiving EE first-line, second-line, or third-line, and the median duration of EE prior to next line of treatment (TTNT) by line of therapy was calculated. OS for patients receiving EE first-line, second-line, or third-line, indexed to the date of first-line therapy initiation and stratified by prior treatment received, was calculated with Kaplan-Meier method with multivariable Cox proportional hazards regression analysis. Results Six hundred twenty-two patients received EE first-line (n = 104, 16.7%), second-line (n = 273, 43.9%) or third-line (n = 245, 39.4%). Median TTNT was 8.3 months, 5.5 months, and 4.8 months respectively. Median TTNT of EE second-line was longer following prior ET alone compared to prior ET + CDK4/6i (6.2 months (95% CI 5.2, 7.3) vs 4.3 months (95% CI 3.2, 5.7) respectively, p = 0.03). Similarly, EE third-line following ET alone vs ET + CDK4/6i in first- or second-line resulted in median TTNT 5.6 months (95% CI 4.4, 6.9) vs 4.1 months (95% CI 3.6, 6.1) respectively, although this was not statistically significant (p = 0.08). Median OS was longer for patients who received EE following prior ET + CDK4/6i. EE second-line following ET + CDK 4/6i vs ET alone resulted in median OS 37.7 months vs. 32.7 months (p = 0.449). EE third-line following ET + CDK4/6i vs prior ET alone resulted in median OS 59.2 months vs. 40.8 months (p < 0.010). This difference in OS was not statistically significant when indexed to the start of EE therapy. Conclusion This study suggests that EE remains an effective treatment option after prior ET or ET + CDK4/6i use. Median TTNT of EE was longer for patients who received prior ET, whereas median OS was longer for patients who received prior ET + CDK4/6i. However, this improvement in OS was not statistically significant when indexed to the start of EE therapy suggesting that OS benefit is primarily driven by prior CDK4/6i use. EE remains an effective treatment option regardless of prior treatment option.

Efficacy and safety of oral vinorelbine (NVBO) in first- or second-line metastatic breast cancer (MBC).

2010 ◽  
Vol 28 (15_suppl) ◽  
pp. 1090-1090 ◽  
Author(s):  
I. Blancas ◽  
S. Morales ◽  
N. Diaz ◽  
A. Barnadas ◽  
M. L. Gonzalvez ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Metastatic Breast ◽  
Second Line ◽  
Efficacy And Safety ◽  
Oral Vinorelbine

Efficacy and safety of first-line bevacizumab combined with paclitaxel in 220 patients with metastatic breast cancer: The Hungarian AVAREG observational study.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e12022-e12022
Author(s):  
Magdolna Dank ◽  
Laszlo Budi ◽  
Laszlo Landherr ◽  
Bela Piko ◽  
Laszlo Mangel ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Safety Data ◽  
Real Life ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Efficacy And Safety ◽  
First Line ◽  
Er Positive ◽  
Oncology Practice

e12022^ Background: First-line bevacizumab (Bev) combined with paclitaxel (Pac) significantly improves progression-free survival (PFS) and response rate vs. Pac alone in HER2-negative metastatic breast cancer (mBC), as shown in the E2100 study. The efficacy and safety of first-line Bev-Pac treatment was investigated in a non-interventional study in routine oncology practice in Hungary. Methods: Patients (pts) who had received no prior chemotherapy for mBC received Bev–Pac combination therapy according to the EU label. The primary endpoint was PFS. Efficacy and safety were documented until progression, death, or Bev discontinuation, whichever occurred first. Subgroup analyses of efficacy were conducted in pts with triple-negative mBC (TNBC). Results: Efficacy and safety data were available from 220 treated pts. Baseline characteristics were: median age 56 years (range 30–79; 13% ≥65 years; 4% ≥70 years); 18%/23% stage III/IV disease at first diagnosis; 36% disease-free interval ≤2 years; 46%/44%/30% bone/lung/liver metastases; 75%/21%/3% ECOG status 0/1/2; 45% ER positive; 48% TNBC. The Bev schedule was 10 mg/kg q2w (median 14 q2w Bev cycles) in 51% of pts and 15 mg/kg q3w (median 10 q3w Bev cycles) in 49%. The median duration of follow-up was 12.2 months (range: 0.9–36.5). Median PFS was 9.3 months (95% CI 7.8–10.8) in the total population (events in 63%), 8.3 months (95% CI 7.8–8.8) in the TNBC subgroup, and 13.3 months (95% CI 10.9–15.6) in the non-TNBC subgroup (log-rank p=0.001 between the TNBC and non-TNBC subgroups). Median time to treatment failure was 7.0 months (95% CI 6.1–8.0). The 1-year survival rate was 68%. Median OS was not reached. Adverse events (AEs) occurred in 36% of pts, and were classified as serious in 8% (20 events). The most common AEs (any grade) were hypertension, neuropathy, proteinuria, and anemia. There were three deaths, from pulmonary embolism, venous thromboembolism, and cardiomyopathy, on Bev therapy. No new safety signals were seen. Conclusions: These data in the real-life setting reconfirm that first-line Bev–Pac therapy is an effective and well-tolerated treatment option for mBC pts, with notable activity in pts with TNBC. Clinical trial information: NCT01777932.

Sign in / Sign up

Export Citation Format

Share Document