Gemcitabine plus docetaxel versus docetaxel in patients with predominantly human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer: A randomized, phase III study by the Danish breast cancer cooperative group Full Text
Journal of Clinical Oncology,  Clinical Article

Nielsen DL et al. – GD compared with docetaxel demonstrated increased TTP in metastatic breast cancer. RR and OS were similar. The addition of gemcitabine failed to demonstrate any clinically meaningful benefit when combined with docetaxel.

Methods

  • Predominantly human epidermal growth factor receptor 2 (HER2) –negative patients were randomly assigned to gemcitabine (1,000 mg/m2) on days 1 and 8 plus docetaxel (75 mg/m2) on day 8 or to docetaxel (100 mg/m2) on day 1, every 21 days
  • Patients were untreated or had prior (neo)adjuvant chemotherapy or a single anthracycline-based chemotherapy regimen for metastatic breast cancer
  • Primary end point was time to progression (TTP), and secondary end points were OS, response rate (RR), and toxicity

Results
  • 170 patients were allocated to GD, and 167 were allocated to docetaxel
  • Median TTP on GD was 10.3 months versus 8.3 months on docetaxel (HR, 0.77; 95% CI, 0.59 to 1.01; log-rank P = .06)
  • Adjusted Cox proportional model for TTP showed significant difference favoring combination (HR, 0.68; 95% CI, 0.51 to 0.90; P = .007)
  • RR was similar (GD, 36%; docetaxel, 34%), and OS was not different (P = .57)
  • Grades 3 to 4 neutropenia was common (GD, 75%; docetaxel, 69%); infection was reported in 26% and 21% of patients in the GD and docetaxel groups, respectively
  • Grades 3 to 4 thrombocytopenia was more frequent with GD (GD, 16%; docetaxel, 0.6%), and peripheral neuropathy was higher with docetaxel (GD, 5%; docetaxel, 16%)

Please login or register to follow this author.
Are you sure you want to Unfollow this Author?
► Click here to access Full Text, PubMed, Publisher and related articles...
<< Previous Article | Next Article >>

Your Unread Messages in Oncology

See All >> Messages include industry-sponsored communications and special communications from MDLinx

Most Popular Oncology Articles

1 Randomized phase III trial of erlotinib versus docetaxel as second- or third-line therapy in patients with advanced non-small-cell lung cancer: Docetaxel and Erlotinib Lung Cancer Trial (DELTA) Journal of Clinical Oncology, May 29, 2014    Clinical Article

2 Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia New England Journal of Medicine, June 4, 2014    Evidence Based Medicine    Clinical Article

3 Effect of radiotherapy after mastectomy and axillary surgery on 10-year recurrence and 20-year breast cancer mortality: meta-analysis of individual patient data for 8135 women in 22 randomised trials The Lancet, March 25, 2014    Evidence Based Medicine    Clinical Article

4 A randomised phase II study of pemetrexed versus pemetrexed+erlotinib as second-line treatment for locally advanced or metastatic non-squamous non-small cell lung cancer European Journal of Cancer, May 23, 2014    Clinical Article

5 Rituximab versus a watch-and-wait approach in patients with advanced-stage, asymptomatic, non-bulky follicular lymphoma: an open-label randomised phase 3 trial The Lancet Oncology, March 7, 2014    Clinical Article

6 Survival of women with inflammatory breast cancer: A large population based study Annals of Oncology, April 16, 2014    Clinical Article

7 Coffee intake and gastric cancer risk Cancer Epidemiology, Biomarkers & Prevention, March 20, 2014    Clinical Article

8 Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers: American Society of Clinical Oncology Clinical Practice Guideline Journal of Clinical Oncology, May 5, 2014    Clinical Guideline

9 Panitumumab versus cetuximab in patients with chemotherapy-refractory wild-type KRAS exon 2 metastatic colorectal cancer (ASPECCT): a randomised, multicentre, open-label, non-inferiority phase 3 study The Lancet Oncology, May 27, 2014    Clinical Article

10 Radiotherapy of follicular lymphoma: updated role and new rules Current Treatment Options in Oncology, May 16, 2014    Clinical Guideline    Clinical Article

11 Adjuvant exemestane with ovarian suppression in premenopausal breast cancer New England Journal of Medicine, June 9, 2014    Evidence Based Medicine    Clinical Article

12 Everolimus for women with trastuzumab-resistant, HER2-positive, advanced breast cancer (BOLERO-3): a randomised, double-blind, placebo-controlled phase 3 trial The Lancet Oncology, May 27, 2014    Clinical Article

13 Open versus laparoscopic surgery for mid-rectal or low-rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): survival outcomes of an open-label, non-inferiority, randomised controlled trial The Lancet Oncology, June 11, 2014    Clinical Article

14 Oral contraceptives, hormone replacement therapy and breast cancer risk: A cohort study of 16 928 women 48 years and older Acta Oncologica, May 22, 2014    Clinical Article

15 Resistance mechanisms for the Bruton's tyrosine kinase inhibitor ibrutinib New England Journal of Medicine, June 3, 2014    Evidence Based Medicine    Clinical Article

16 PEAK: A randomized, multicenter phase II study of panitumumab plus modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) or bevacizumab plus mFOLFOX6 in patients with previously untreated, unresectable, wild-type KRAS exon 2 metastatic colorectal cancer Journal of Clinical Oncology, May 9, 2014    Clinical Article

17 Exposure to infections and risk of leukemia in young children Cancer Epidemiology, Biomarkers & Prevention, May 6, 2014    Clinical Article

18 Underuse of trimodality treatment affects survival for patients with inflammatory breast cancer: an analysis of treatment and survival trends from the National Cancer Database Journal of Clinical Oncology, June 13, 2014    Clinical Article

19 Risk of late effects of treatment in children newly diagnosed with standard-risk acute lymphoblastic leukaemia: a report from the Childhood Cancer Survivor Study cohort The Lancet Oncology, June 20, 2014    Clinical Article

20 Coffee intake and gastric cancer risk Cancer Epidemiology, Biomarkers & Prevention, March 11, 2014    Clinical Article

Indexed Journals in Oncology: Journal of Clinical Oncology, Cancer Research, Annals Oncologymore

Register now to view all the MDLinx contents (FREE)!

  • Stay current on the latest literature, research and clinical news
  • Get special communications and offers from MDLinx and our sponsors
  • Receive invitations to paid market research
View Samples and Register

Connect with us, stay current.

Receive the latest mecial news
updates for free via email

Sign up!

Subscribe to our free RSS feeds:

Get the latest news in your specialty automatically added to your newsreader or your personal My Yahoo!, Google, My MSN or My AOL page. Learn More

Close