Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2015 Nov;26(11):2267-74.
doi: 10.1093/annonc/mdv324. Epub 2015 Sep 26.

A randomized, controlled phase III trial of nab-Paclitaxel versus dacarbazine in chemotherapy-naïve patients with metastatic melanoma

E M Hersh  1 , M Del Vecchio  2 , M P Brown  3 , R Kefford  4 , C Loquai  5 , A Testori  6 , S Bhatia  7 , R Gutzmer  8 , R Conry  9 , A Haydon  10 , C Robert  11 , S Ernst  12 , J Homsi  13 , J J Grob  14 , K Kendra  15 , S S Agarwala  16 , M Li  17 , A Clawson  17 , C Brachmann  17 , M Karnoub  17 , I Elias  17 , M F Renschler  17 , A Hauschild  18
Affiliations
Clinical Trial

A randomized, controlled phase III trial of nab-Paclitaxel versus dacarbazine in chemotherapy-naïve patients with metastatic melanoma

E M Hersh et al. Ann Oncol. 2015 Nov.

Abstract

Background: The efficacy and safety of nab-paclitaxel versus dacarbazine in patients with metastatic melanoma was evaluated in a phase III randomized, controlled trial.

Patients and methods: Chemotherapy-naïve patients with stage IV melanoma received nab-paclitaxel 150 mg/m(2) on days 1, 8, and 15 every 4 weeks or dacarbazine 1000 mg/m(2) every 3 weeks. The primary end point was progression-free survival (PFS) by independent radiologic review; the secondary end point was overall survival (OS).

Results: A total of 529 patients were randomized to nab-paclitaxel (n = 264) or dacarbazine (n = 265). Baseline characteristics were well balanced. The majority of patients were men (66%), had an Eastern Cooperative Oncology Group status of 0 (71%), and had M1c stage disease (65%). The median PFS (primary end point) was 4.8 months with nab-paclitaxel and 2.5 months with dacarbazine [hazard ratio (HR), 0.792; 95.1% confidence interval (CI) 0.631-0.992; P = 0.044]. The median OS was 12.6 months with nab-paclitaxel and 10.5 months with dacarbazine (HR, 0.897; 95.1% CI 0.738-1.089; P = 0.271). Independently assessed overall response rate was 15% versus 11% (P = 0.239), and disease control rate (DCR) was 39% versus 27% (P = 0.004) for nab-paclitaxel versus dacarbazine, respectively. The most common grade ≥3 treatment-related adverse events were neuropathy (nab-paclitaxel, 25% versus dacarbazine, 0%; P < 0.001), and neutropenia (nab-paclitaxel, 20% versus dacarbazine, 10%; P = 0.004). There was no correlation between secreted protein acidic and rich in cysteine (SPARC) status and PFS in either treatment arm.

Conclusions: nab-Paclitaxel significantly improved PFS and DCR compared with dacarbazine, with a manageable safety profile.

Keywords: BRAF; chemotherapy-naïve; dacarbazine; metastatic melanoma; nab-Paclitaxel.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
Independent radiologist-assessed progression-free survival (A) and final overall survival (B) Kaplan–Meier curves for the intent-to-treat population.
Figure 2.
Figure 2.
Subgroup analyses of progression-free survival by independent review.
See this image and copyright information in PMC

Comment in

References

    1. Boyle GM. Therapy for metastatic melanoma: an overview and update. Expert Rev Anticancer Ther 2011; 11: 725–737. - PubMed
    1. Hodi FS, O'Day SJ, McDermott DF et al. . Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med 2010; 363: 711–723. - PMC - PubMed
    1. Robert C, Thomas L, Bondarenko I et al. . Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med 2011; 364: 2517–2526. - PubMed
    1. Chapman PB, Hauschild A, Robert C et al. . Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med 2011; 364: 2507–2516. - PMC - PubMed
    1. Hauschild A, Grob JJ, Demidov LV et al. . Dabrafenib in BRAF-mutated metastatic melanoma: a multicentre, open-label, phase 3 randomised controlled trial. Lancet 2012; 380: 358–365. - PubMed

Publication types