title: Treatment of recurrent and platinum-refractory stage IV non-small cell lung cancer with nanoparticle albumin-bound paclitaxel (nab-paclitaxel) as a single agent.
abstract: The role of single-agent nab-paclitaxel in relapsed or platinum-refractory advanced non-small cell lung cancer (NSCLC) has not been well reported in Western populations. We reviewed our own institution's experience using nab-paclitaxel in these settings. We analyzed the records of stage IV NSCLC patients with relapsed or platinum-refractory disease treated with single-agent nab-paclitaxel at Weill Cornell Medical College between October 2008 and December 2013. The primary endpoint of the study was treatment failure-free survival (TFFS), defined as the time from the start of nab-paclitaxel therapy to discontinuation of the drug for any reason. The best overall response was recorded for each patient, and overall response and disease control rates were calculated. Thirty-one stage IV NSCLC patients received a median of 4 cycles (range 1-40) of nab-paclitaxel. Dose reduction or drug discontinuation due to toxicity occurred in 10 patients, mainly because of grade 2/3 fatigue or peripheral neuropathy. The overall response rate was 16.1 %, and the disease control rate was 64.5 %. Median TFFS was 3.5 months (95 % CI 1.3-5.3 months). No statistically significant difference in TFFS based on line of therapy or prior taxane exposure was identified. There was a statistically significant decrease in TFFS for patients with non-adenocarcinoma histology, although there were only five patients in this group. There was a trend toward reduction in the risk of treatment failure with increasing age. One patient remained on nab-paclitaxel therapy for over 3 years. Single-agent nab-paclitaxel was well tolerated and demonstrated efficacy in advanced NSCLC patients with relapsed or platinum-refractory disease. Further prospective clinical trials with nab-paclitaxel in these settings are warranted.
authors.affiliation: Division of Hematology and Medical Oncology, Department of Medicine, Weill Cornell Medicine, 1305 York Avenue, 7th Floor, New York, NY, 10021, USA. ahs9018@med.cornell.edu.
authors.forename: Ashish
authors.identifier: http://orcid.org/0000-0003-3353-129X
authors.initials: A
authors.lastname: Saxena
authors.affiliation: Division of Hematology and Medical Oncology, Department of Medicine, Weill Cornell Medicine, 1305 York Avenue, 7th Floor, New York, NY, 10021, USA.|Division of Hematology/Oncology, Department of Internal Medicine, University of Michigan Health System, Cancer Center Floor B1, Reception C, 1500 E Medical Center Dr, Ann Arbor, MI, 48109, USA.
authors.forename: Bryan J
authors.initials: BJ
authors.lastname: Schneider
authors.affiliation: Division of Biostatistics and Epidemiology, Department of Healthcare Policy and Research, Weill Cornell Medicine, 402 East 67th Street, New York, NY, 10065, USA.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Christos
authors.affiliation: Division of Hematology and Medical Oncology, Department of Medicine, Weill Cornell Medicine, 1305 York Avenue, 7th Floor, New York, NY, 10021, USA.|Pulmonary and Sleep Medicine, The Mount Sinai Hospital, 5 East 98th St, 8th Floor, New York, NY, 10029, USA.
authors.forename: Lauren F
authors.initials: LF
authors.lastname: Audibert
authors.affiliation: Division of Hematology and Medical Oncology, Department of Medicine, Weill Cornell Medicine, 1305 York Avenue, 7th Floor, New York, NY, 10021, USA.|Breast Cancer Medicine Service, Breast and Imaging Center, Memorial Sloan Kettering Cancer Center, 300 East 66th St, New York, NY, 10065, USA.
authors.forename: Jennifer M
authors.initials: JM
authors.lastname: Cagney
authors.affiliation: Division of Hematology and Medical Oncology, Department of Medicine, Weill Cornell Medicine, 1305 York Avenue, 7th Floor, New York, NY, 10021, USA.
authors.forename: Ronald J
authors.initials: RJ
authors.lastname: Scheff
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000418:Albumins / Q000009:adverse effects / Q000627:therapeutic use*; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D017239:Paclitaxel / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: C520255:130-nm albumin-bound paclitaxel; D000418:Albumins; D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel
keywords: Carcinoma; Neoplasm recurrence; Non-small cell lung; Taxane 130-nm albumin-bound paclitaxel; Treatment failure