Significantly Longer Progression-Free Survival Withnab-Paclitaxel Compared With Docetaxel As First-Line Therapy for Metastatic Breast Cancer

PurposeIn patients with metastatic breast cancer (MBC), nab-paclitaxel produced significantly higher antitumor activity compared with patients who received solvent-based paclitaxel. This phase II study examined the antitumor activity and safety of weekly and every 3 week (q3w) nab-paclitaxel compared with docetaxel as first-line treatment in patients with MBC.Patients and MethodsIn this randomized, multicenter study, patients (N = 302) with previously untreated MBC received nab-paclitaxel 300 mg/m2q3w, 100 mg/m2weekly, or 150 mg/m2weekly or docetaxel 100 mg/m2q3w.Resultsnab-Paclitaxel 150 mg/m2weekly demonstrated significantly longer progression-free survival (PFS) than docetaxel by both independent radiologist assessment (12.9 v 7.5 months, respectively; P = .0065) and investigator assessment (14.6 v 7.8 months, respectively; P = .012). On the basis of independent radiologist review, both 150 mg/m2(49%) and 100 mg/m2(45%) weekly of nab-paclitaxel demonstrated a higher overall response rate (ORR) than docetaxel (35%), but this did not reach statistical significance. This trend was supported by statistically significant investigator ORR for both weekly nab-paclitaxel doses versus docetaxel. nab-Paclitaxel q3w versus docetaxel was not different for PFS or ORR. On the basis of both the independent radiologist and investigator review, disease control rate was significantly higher for patients receiving either dose of weekly nab-paclitaxel compared with docetaxel. Grade 3 or 4 fatigue, neutropenia, and febrile neutropenia were less frequent in all nab-paclitaxel arms. The frequency and grade of peripheral neuropathy were similar in all arms.ConclusionThis randomized study in first-line MBC demonstrated superior efficacy and safety of weekly nab-paclitaxel compared with docetaxel, with a statistically and clinically significant prolongation of PFS (> 5 months) in patients receiving nab-paclitaxel 150 mg/m2weekly compared with docetaxel 100 mg/m2q3w.

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Conventional versus cytokinetic polychemotherapy with estrogenic recruitment in metastatic breast cancer: results of a randomized cooperative trial.

Journal of Clinical Oncology ◽

10.1200/jco.1987.5.3.339 ◽

1987 ◽

Vol 5 (3) ◽

pp. 339-347 ◽

Cited By ~ 42

Author(s):

P F Conte ◽

P Pronzato ◽

A Rubagotti ◽

A Alama ◽

D Amadori ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Statistical Significance ◽

Objective Response ◽

Metastatic Breast ◽

Dose Intensity ◽

Progression Free Survival ◽

Free Survival ◽

Significant Prolongation ◽

Significant Difference

Diethylstilbestrol (DES) can induce a recruitment into the proliferative pool of previously resting breast cancer cells in vivo. In order to verify if estrogenic recruitment could result in a larger tumor cell killing by chemotherapy, 117 patients with metastatic breast cancer were randomized to receive CEF (cyclophosphamide, 600 mg/m2; epidoxorubicin, 60 mg/m2; and 5-fluorouracil, 600 mg/m2 on day 1); DES-CEF (cyclophosphamide, 600 mg/m2 on day 1; DES, 1 mg orally on days 5, 6, and 7; and epidoxorubicin, 60 mg/m2, and 5-fluorouracil, 600 mg/m2, on day 8) every 21 days. No significant difference in objective response rates, survival, or progression-free survival was seen between the two regimens. Patients in the DES-CEF arm experienced a higher complete response (CR) rate (24.1% v 16.1%), which reached statistical significance in the case of soft-tissue metastasis (48% v 27.3%; P less than .05) and estrogen receptor-negative tumors (35.7% v 11.1%; P less than .025). Survival and progression-free survival of patients refractory to treatment were not worsened by estrogenic recruitment. In the subset of patients failing after adjuvant polychemotherapy, DES-CEF unexpectedly induced a significantly longer survival (greater than 802 days v 375 days; P = .029) and progression-free survival (239 days v 192 days; P = .041) than CEF. The DES-CEF regimen was more myelotoxic, and 43.3% of the DES-CEF cycles had to be delayed because of leukopenia in comparison with 11.8% of the CEF cycles (P less than .0001). In conclusion, chemotherapy with estrogenic recruitment was able to induce more CRs in certain subsets of patients and a significant prolongation in survival and progression-free survival of patients failing after adjuvant polychemotherapy. These results have been achieved despite a significantly lower dose intensity of chemotherapy.

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Phase III Trial of Epirubicin Plus Paclitaxel Compared With Epirubicin Plus Cyclophosphamide As First-Line Chemotherapy for Metastatic Breast Cancer: United Kingdom National Cancer Research Institute Trial AB01

Journal of Clinical Oncology ◽

10.1200/jco.2005.01.1817 ◽

2005 ◽

Vol 23 (33) ◽

pp. 8322-8330 ◽

Cited By ~ 44

Author(s):

Ruth E. Langley ◽

James Carmichael ◽

Alison L. Jones ◽

David A. Cameron ◽

Wendi Qian ◽

...

Keyword(s):

Breast Cancer ◽

Overall Survival ◽

Metastatic Breast Cancer ◽

Survival Time ◽

Metastatic Breast ◽

Progression Free Survival ◽

First Line ◽

Free Survival ◽

Grade 3 ◽

Line Chemotherapy

Purpose To compare the effectiveness and tolerability of epirubicin and paclitaxel (EP) with epirubicin and cyclophosphamide (EC) as first-line chemotherapy for metastatic breast cancer (MBC). Patients and Methods Patients previously untreated with chemotherapy (except for adjuvant therapy) were randomly assigned to receive either EP (epirubicin 75 mg/m2 and paclitaxel 200 mg/m2) or EC (epirubicin 75 mg/m2 and cyclophosphamide 600 mg/m2) administered intravenously every 3 weeks for a maximum of six cycles. The primary outcome was progression-free survival; secondary outcome measures were overall survival, response rates, and toxicity. Results Between 1996 and 1999, 705 patients (353 EP patients and 352 EC patients) underwent random assignment. Patient characteristics were well matched between the two groups, and 71% of patients received six cycles of treatment. Objective response rates were 65% for the EP group and 55% for the EC group (P = .015). At the time of analysis, 641 patients (91%) had died. Median progression-free survival time was 7.0 months for the EP group and 7.1 months for the EC group (hazard ratio = 1.07; 95% CI, 0.92 to 1.24; P = .41), and median overall survival time was 13 months for the EP group and 14 months for the EC group (hazard ratio = 1.02; 95% CI, 0.87 to 1.19; P = .8). EP patients, compared with EC patients, had more grade 3 and 4 mucositis (6% v 2%, respectively; P = .0006) and grade 3 and 4 neurotoxicity (5% v 1%, respectively; P < .0001). Conclusion In terms of progression-free survival and overall survival, there was no evidence of a difference between EP and EC. The data demonstrate no additional advantage to using EP instead of EC as first-line chemotherapy for MBC in taxane-naïve patients.

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First-Line Treatment with Bevacizumab and Paclitaxel Prolongs Progression-Free Survival in Metastatic Breast Cancer

Clinical Breast Cancer ◽

10.1016/s1526-8209(11)70706-6 ◽

2005 ◽

Vol 6 (2) ◽

pp. 105-107 ◽

Cited By ~ 4

Author(s):

Preeta Tyagi ◽

Debu Tripathy

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Metastatic Breast ◽

Progression Free Survival ◽

Line Treatment ◽

First Line ◽

Free Survival ◽

First Line Treatment

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Abstract P6-11-01: Intermittent High Dose Proton Pump Inhibitor Improves Progression Free Survival as Compared to Standard Chemotherapy in the First Line Treatment of Patients with Metastatic Breast Cancer

10.1158/0008-5472.sabcs12-p6-11-01 ◽

2012 ◽

Author(s):

X Hu ◽

B Wang ◽

S Sun ◽

A Chiesi ◽

J Wang ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Metastatic Breast ◽

Progression Free Survival ◽

High Dose ◽

Line Treatment ◽

First Line ◽

Standard Chemotherapy ◽

Free Survival ◽

First Line Treatment

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Abstract P5-11-21: Retrospective analysis of first-line progression free survival compared endocrine therapy and chemotherapy inpatients with HR+/HER2-metastatic breast cancer

10.1158/1538-7445.sabcs19-p5-11-21 ◽

2020 ◽

Author(s):

Junnnan Xu ◽

Tao Sun

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Retrospective Analysis ◽

Endocrine Therapy ◽

Metastatic Breast ◽

Progression Free Survival ◽

First Line ◽

Free Survival

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Treatment of Metastatic Breast Cancer in a Real‐World Scenario: Is Progression‐Free Survival With First Line Predictive of Benefit From Second and Later Lines?

The Oncologist ◽

10.1634/theoncologist.2015-0002 ◽

2015 ◽

Vol 20 (7) ◽

pp. 719-724 ◽

Cited By ~ 30

Author(s):

Marta Bonotto ◽

Lorenzo Gerratana ◽

Donatella Iacono ◽

Alessandro Marco Minisini ◽

Karim Rihawi ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Real World ◽

Metastatic Breast ◽

Progression Free Survival ◽

First Line ◽

Free Survival

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Paclitaxel plus carboplatin versus paclitaxel plus epirubicin as first-line treatment for metastatic breast cancer: Efficacy and safety results of a randomized, phase III trial.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.1087 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. 1087-1087

Author(s):

Zhongsheng Tong ◽

Shufen Li ◽

Yehui Shi ◽

Xu Wang ◽

Chen Wang ◽

...

Keyword(s):

Breast Cancer ◽

Overall Survival ◽

Metastatic Breast Cancer ◽

Response Rate ◽

Metastatic Breast ◽

Progression Free Survival ◽

Phase Iii ◽

First Line ◽

Free Survival ◽

Significant Difference

1087 Background: Paclitaxel/carboplatin combinations are highly active in metastatic breast cancer (MBC). We conducted a randomized, phase III, non-inferiority trial comparing paclitaxel/carboplatin (TP) with paclitaxel/epirubicin (TE) as first-line therapy for MBC. Progression-free survival (PFS) was the primary efficacy endpoint. Secondary endpoints included response rate, overall survival, tolerability, and quality of life (QoL). Methods: From June 2009 to January 2015, 231 patients were randomly assigned, 115 of whom were randomized to TP and 116 to TE. Baseline characteristics were relatively well-balanced in the two treatments. Results: After a median follow-up of 29 months, no significant difference was observed between the two treatments in objective response rate (ORR) (38.3% vs. 39.7%, respectively). Both the progression-free survival (p=0.158) and overall survival (p=0.369) were very similar between the two treatments. Both regimens were well tolerated. The main toxicities were myelosuppression, gastrointestinal reactions, and alopecia. TP showed higher grades 3–4 alopecia and higher nausea (p<0.05). TE showed higher incidence of myelosuppression than TP (p<0.05) (Table). Those patients whose epirubicin cumulative dose was more than 1000 mg/m2 did not suffer worse cardiotoxicity. Conclusions: Our study suggests that TP arm is an effective therapeutic alternative for patients with MBC, especially in those previously exposed to epirubicin in the adjuvant setting. TP has some advantages, such as less cost and less side effects (myelosuppression and fatigue). Clinical trial information: NCT02207361. [Table: see text]

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