Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) as second-line chemotherapy in HER2-negative, taxane-pretreated metastatic breast cancer patients: prospective evaluation of activity, safety, and quality of life.
BACKGROUND
A prospective, multicenter trial was undertaken to assess the activity, safety, and quality of life of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) as second-line chemotherapy in HER2-negative, taxane-pretreated metastatic breast cancer (MBC).


METHODS
Fifty-two women with HER2-negative MBC who were candidates for second-line chemotherapy for the metastatic disease were enrolled and treated at three centers in Northern Italy. All patients had previously received taxane-based chemotherapy in the adjuvant or first-line metastatic setting. Single-agent nab-paclitaxel was given at the dose of 260 mg/m(2) as a 30-minute intravenous infusion on day 1 each treatment cycle, which lasted 3 weeks, in the outpatient setting. No steroid or antihistamine premedication was provided. Treatment was stopped for documented disease progression, unacceptable toxicity, or patient refusal.


RESULTS
All of the enrolled patients were evaluable for the study endpoints. The objective response rate was 48% (95% CI, 31.5%-61.3%) and included complete responses from 13.5%. Disease stabilization was obtained in 19 patients and lasted >6 months in 15 of them; the overall clinical benefit rate was 77%. The median time to response was 70 days (range 52-86 days). The median progression-free survival time was 8.9 months (95% CI, 8.0-11.6 months, range 5-21+ months). The median overall survival point has not yet been reached. Toxicities were expected and manageable with good patient compliance and preserved quality of life in patients given long-term treatment.


CONCLUSIONS
Our results showed that single-agent nab-paclitaxel 260 mg/m(2) every 3 weeks is an effective and well tolerated regimen as second-line chemotherapy in HER2-negative, taxane-pretreated MBC patients, and that it produced interesting values of objective response rate and progression-free survival without the concern of significant toxicity. Specifically, the present study shows that such a regimen is a valid therapeutic option for that 'difficult to treat' patient population represented by women who at the time of disease relapse have already received the most active agents in the adjuvant and/or metastatic setting (ie, conventional taxanes).
Departmental Unit of Oncology, IRCCS Fondazione Salvatore Maugeri, Pavia, Italy.
Raffaella
R
Palumbo
Departmental Unit of Oncology, IRCCS Fondazione Salvatore Maugeri, Pavia, Italy.
Federico
F
Sottotetti
Unit of Nuclear Medicine, IRCCS Fondazione Salvatore Maugeri, Pavia, Italy.
Giuseppe
G
Trifirò
Medical Oncology Luigi Sacco Hospital, Milano, Italy.
Elena
E
Piazza
Medical Oncology, Legnano Hospital, Legnano, Italy.
Antonella
A
Ferzi
Medical Oncology Luigi Sacco Hospital, Milano, Italy.
Anna
A
Gambaro
Unit of Nuclear Medicine, IRCCS Fondazione Salvatore Maugeri, Pavia, Italy.
Elena Giulia
EG
Spinapolice
Departmental Unit of Oncology, IRCCS Fondazione Salvatore Maugeri, Pavia, Italy.
Emma
E
Pozzi
Departmental Unit of Oncology, IRCCS Fondazione Salvatore Maugeri, Pavia, Italy.
Barbara
B
Tagliaferri
Departmental Unit of Oncology, IRCCS Fondazione Salvatore Maugeri, Pavia, Italy.
Cristina
C
Teragni
Departmental Unit of Oncology, IRCCS Fondazione Salvatore Maugeri, Pavia, Italy.
Antonio
A
Bernardo
D000328:Adult; D000368:Aged; D000418:Albumins / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects* / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000523:psychology; D018450:Disease Progression; D018572:Disease-Free Survival; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D008875:Middle Aged; D053758:Nanoparticles; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D010349:Patient Compliance; D011446:Prospective Studies; D011788:Quality of Life; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000235:genetics*; D043823:Taxoids / Q000627:therapeutic use*
D000418:Albumins; D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel; D018719:Erb-b2 Receptor Tyrosine Kinases; D043823:Taxoids; C520255:130-nm albumin-bound paclitaxel; C508053:ERBB2 protein, human
metastatic breast cancer; nab-paclitaxel; quality of life; taxanes