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ABRAXANE® is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
ABRAXANE® is indicated for the first-line treatment of locally advanced or metastatic non–small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.
ABRAXANE® is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.
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THIS SITE IS INTENDED FOR U.S HEALTHCARE PROFESSIONALS ONLY.
Univariate survival analysis from a retrospective database of 346 patients diagnosed with MBC after first recurrence between 1970 and 1991.
All patients had undergone surgery for primary breast cancer and may have received radiation, hormonal therapy, and/or chemotherapy for metastatic disease.5
Univariate survival analysis of 1430 patients from 8 consecutive prospective trials conducted between 1977 and 1992 of anthracycline-based first-line chemotherapy in MBC.
CLOSE THE TABLearn More: Majority of Patients From ABRAXANE MBC Phase III Trial
Had Multiple and Visceral Metastases
Study design
Multicenter, 1:1 randomized, Phase III study comparing ABRAXANE 260 mg/m2 IV Q3W with paclitaxel injection 175 mg/m2 IV Q3W in 460 patients with MBC. The primary efficacy endpoint was recTLRR. recTLRR was based on independent radiologic assessment of target lesions reconciled with investigator-reported responses for the first 6 cycles of therapy. The recTLRR was lower than the investigator-reported response rates, which are based on all cycles of therapy. The secondary endpoints were time to disease progression and overall survival.
IV=intravenously; PS=performance status; Q3W=every 3 weeks; recTLRR=reconciled target lesion response rate.
Patients who completed 6 cycles of ABRAXANE therapy and did not progress were able to continue treatment at the investigator's discretion.24
CLOSE THE TABThe predominance of visceral metastases in the Phase III study is consistent with the National Comprehensive Cancer Network® (NCCN®) recommended* patient population for albumin-bound paclitaxel (ABRAXANE).3
NCCN Guidelines® (V.6.2020) recommend albumin-bound paclitaxel as Category 2A.
CLOSE THE TABLearn More: ABRAXANE Delivered Almost Double the Response Rates vs
Paclitaxel Injection in MBC
Primary endpoint was response rate in ITT population based on reconciled investigator and independent radiologic assessments of target lesions through cycle 6 (recTLRR)a ABRAXANE 260 mg/m2 IV Q3W vs paclitaxel injection 175 mg/m2 IV Q3W
ITT=intent-to-treat.
recTLRR was the prospectively defined, protocol-specific endpoint, based on independent radiologic assessment of tumor responses reconciled with investigator responses (which also included clinical information) for the first 6 cycles of therapy. The recTLRR was lower than the investigator-reported response rates, which are based on all cycles of therapy.
From Cochran-Mantel-Haenszel test stratified by first-line vs > first-line therapy.
recTLRR: ABRAXANE vs paclitaxel injection for patients who failed combination chemotherapy or relapsed within 6 months of adjuvant chemotherapy (indicated population)
Prior therapy included an anthracycline unless clinically contraindicated.
Analysis Limitations: Time to first reconciled response was an exploratory endpoint that was not powered to determine a treatment difference.
Compare Median Overall Survival (OS) Data: ABRAXANE vs Paclitaxel Injection
AST=aspartate aminotransferase; ECG=electrocardiogram;
SGOT=serum glutamic-oxaloacetic transaminase.
Paclitaxel injection patients received premedication.
Severe events are defined as at least Grade 3 toxicity.
Frequencya of important treatment-emergent adverse events in the randomized study of an every-3-week schedule
Frequencya of important treatment-emergent adverse events in the randomized study of an every-3-week schedule
HEMATOLOGIC | ||
BONE MARROW | ||
Neutropenia | ||
<2.0 x 109/L | 80 | 82 |
<0.5 x 109/L (Grade 4) | 9 | 22 |
Thrombocytopenia | ||
<100 x 109/L | 2 | 3 |
<50 x 109/L (Grade ≥3) | <1 | <1 |
Anemia | ||
<11 g/dL | 33 | 25 |
<8 g/dL (Grade ≥3) | 1 | <1 |
Infections | 24 | 20 |
Febrile Neutropenia | 2 | 1 |
Neutropenic Sepsis | <1 | <1 |
Bleeding | 2 | 2 |
NONHEMATOLOGIC | ||
HYPERSENSITIVITY REACTIONc | ||
All | 4 | 12 |
Severed | 0 | 2 |
CARDIOVASCULAR | ||
Vital Sign Changes During Administration | ||
Bradycardia | <1 | <1 |
Hypotension | 5 | 5 |
Severe Cardiovascular Eventsd | 3 | 4 |
ABNORMAL ECG | ||
All Patients | 60 | 52 |
Patients With Normal Baseline | 35 | 30 |
RESPIRATORY | ||
Cough | 7 | 6 |
Dyspnea | 12 | 9 |
SENSORY NEUROPATHY | ||
Any Symptoms | 71 | 56 |
Severe Symptomsd | 10 | 2 |
MYALGIA/ARTHRALGIA | ||
Any Symptoms | 44 | 49 |
Severe Symptomsd | 8 | 4 |
ASTHENIA | ||
Any Symptoms | 47 | 39 |
Severe Symptomsd | 8 | 3 |
FLUID RETENTION/EDEMA | ||
Any Symptoms | 10 | 8 |
Severe Symptomsd | 0 | <1 |
GASTROINTESTINAL | ||
Nausea | ||
Any Symptoms | 30 | 22 |
Severe Symptomsd | 3 | <1 |
Vomiting | ||
Any Symptoms | 18 | 10 |
Severe Symptomsd | 4 | 1 |
Diarrhea | ||
Any Symptoms | 27 | 15 |
Severe Symptomsd | <1 | 1 |
Mucositis | ||
Any Symptoms | 7 | 6 |
Severe Symptomsd | <1 | 0 |
ALOPECIA | 90 | 94 |
HEPATIC (PATIENTS WITH NORMAL BASELINE) | ||
Bilirubin Elevations | 7 | 7 |
Alkaline Phosphatase Elevations | 36 | 31 |
AST (SGOT) Elevations | 39 | 32 |
INJECTION-SITE REACTION | <1 | 1 |
NCI=National Cancer Institute.
Based on worst grade by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.
Paclitaxel injection patients received premedication.
Includes treatment-related events related to hypersensitivity (eg, flushing, dyspnea, chest pain, hypotension) that began on a day of dosing.
Severe events are defined as at least Grade 3 toxicity.
CLOSE THE TABDownload the “Preparing for My Treatment” Brochure: Help Your
Patients With MBC Get Ready for Their Medical Appointments
Patients treated with ABRAXANE received a median of 6 cycles of therapy
FDA-approved dose and schedule for ABRAXANE in metastatic breast cancer:
Recommendations for starting dose in patients with hepatic impairment
SGOT (AST) LEVELS
<10 x ULN
AND
BILIRUBIN LEVELS
> ULN TO ≤1.5 x ULN
SGOT (AST) LEVELS
<10 x ULN
AND
BILIRUBIN LEVELS
> 1.5 TO ≤3 x ULN
SGOT (AST) LEVELS
<10 x ULN
AND
BILIRUBIN LEVELS
> 3 TO ≤5 x ULN
SGOT (AST) LEVELS
>10 x ULN
AND
BILIRUBIN LEVELS
>5 x ULN
Mild
Moderate
Severe
ABRAXANE dose
ILLUSTRATIVE PURPOSES ONLY
A dose increase to 260 mg/m2 in subsequent courses should be considered if the patient tolerates the reduced dose for 2 cycles.
ABRAXANE dose-modification schedule for neuropathy
Mild to Moderate
The occurrence of Grade 1 or 2 sensory neuropathy does not generally require dose modification
Severe
If ≥ Grade 3 sensory neuropathy develops, hold until resolution to Grade 1 or 2 followed by a dose reduction for all subsequent courses of ABRAXANE
Recurrent
If severe (≥ Grade 3) neuropathy is recurrent, hold treatment until resolution to Grade 1 or 2, then reduce dose from 220 mg/m2 to 180 mg/m2 for all subsequent courses
ABRAXANE dose
ILLUSTRATIVE PURPOSES ONLY
ABRAXANE dose-modification schedule for neutropenia
Mild to Moderate
Severe
Recurrent
ABRAXANE dose
ILLUSTRATIVE PURPOSES ONLY
References: 1. Paclitaxel. Package insert. Hospira, Inc; 2018. 2. Taxotere. Package insert. Sanofi-Aventis U.S. LLC; 2020. 3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.6.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed September 15, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 4. Cardoso F, Costa A, Norton L, et al. ESO-ESMO 2nd international consensus guidelines for advanced breast cancer (ABC2). Ann Oncol. 2014;25(10):1871-1888. 5. Chang J, Clark GM, Allred DC, Mohsin S, Chamness G, Elledge RM. Survival of patients with metastatic breast carcinoma: importance of prognostic markers of the primary tumor. Cancer. 2003;97(3):545-553. 6. Pierga JY, Robain M, Jouve M, et al. Response to chemotherapy is a major parameter-influencing long-term survival of metastatic breast cancer patients. Ann Oncol. 2001;12(2):231-237. 7. Sledge GW, Neuberg D, Bernardo P, et al. Phase Ill trial of doxorubicin, paclitaxel, and the combination of doxorubicin and paclitaxel as front-line chemotherapy for metastatic breast cancer: an intergroup trial (E1193). J Clin Oncol. 2003;21(14):588-592. 8. Jung SY, Rosenzweig M, Sereika SM, Linkov F, Brufsky A, Weissfeld JL. Factors associated with mortality after breast cancer metastasis. Cancer Causes Control. 2012;23(1):103-112. 9. Gennari A, Conte P, Rosso R, Orlandini C, Bruzzi P. Survival of metastatic breast carcinoma patients over a 20-year period: a retrospective analysis based on individual patient data from six consecutive studies. Cancer. 2005;104(8):1742-1750. 10. Lobbezoo DJA, van Kampen RJW, Voogd AC, et al. Prognosis of metastatic breast cancer subtypes: the hormone receptor/HER2-positive subtype is associated with the most favorable outcome. Breast Cancer Res Treat. 2013;141(3):507-514. 11. Yamamoto N, Watanabe T, Katsumata N, et al. Construction and validation of a practical prognostic index for patients with metastatic breast cancer. J Clin Oncol. 1998;16(7):2401-2408. 12. Thientosapol ES, Tran TT, Della-Fiorentina SA, et al. Survival times of women with metastatic breast cancer starting first-line chemotherapy in routine clinical practice versus contemporary randomised trials. Intern Med J. 2013;43(8):883-888. 13. Harris LN, Broadwater G, Lin NU, et al. Molecular subtypes of breast cancer in relation to paclitaxel response and outcomes in women with metastatic disease: results from CALGB 9342. Breast Cancer Res. 2006;8(6):R66. 14. Chung M, Chang HR, Bland KI, Wanebo HJ. Younger women with breast carcinoma have a poorer prognosis than older women. Cancer. 1996;77(1):97-103. 15. Clark GM, Sledge GW Jr, Osborne CK, McGuire WL. Survival from first recurrence: relative importance of prognostic factors in 1,015 breast cancer patients. J Clin Oncol. 1987;5(1):55-61. 16. Azim HA Jr, Michiels S, Bedard PL, et al. Elucidating prognosis and biology of breast cancer arising in young women using gene expression profiling. Clin Cancer Res. 2012;18(5):1341-1351. 17. DeSantis CE, Fedewa SA, Sauer A, Kramer JL, Jemal A. Breast cancer statistics, 2015: convergence of incidence rates between black and white women. CA Cancer J Clin. 2016;66(1):31-42. 18. American Cancer Society. Cancer Facts & Figures for African Americans 2018. Atlanta, GA: American Cancer Society, 2018. 19. Samiee S, Berardi P, Bouganim N, et al. Excision of the primary tumour in patients with metastatic breast cancer: a clinical dilemma. Curr Oncol. 2012;19(4):e270-e279. 20. Wallwiener M, Hartkopf AD, Baccelli I, et al. The prognostic impact of circulating tumor cells in subtypes of metastatic breast cancer. Breast Cancer Res Treat. 2013;137(2):503-510. 21. Loibl S, Doering G, Müller L, et al. Multicenter phase II study with weekly bendamustine and paclitaxel as first- or later-line therapy in patients with metastatic breast cancer: RiTa II trial. Breast Care (Basel). 2011;6(6):457-461. 22. Villanueva C, Chaigneau L, Dufresne A, et al. Phase II trial of paclitaxel and uracil-tegafur in metastatic breast cancer. TEGATAX trial. Breast. 2011;20(4):329-333. 23. Gradishar WJ, Tjulandin S, Davidson N, et al. Phase Ill trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil–based paclitaxel in women with breast cancer. J Clin Oncol. 2005;23(31):7794-7803. 24. Data on file. Bristol-Myers Squibb Company.