Fludarabine plus alemtuzumab versus fludarabine alone in patients with previously treated chronic lymphocytic leukemia: A randomised phase 3 trial
The Lancet Oncology,  Clinical Article

Elter T et al. – The combination of fludarabine and alemtuzumab is another treatment option for patients with previously treated CLL.

Methods

  • Patients (aged ≥18 years) with CLL Binet stage A, B, or C or Rai stages I—IV were randomly assigned in a 1:1 ratio according to a computer-generated allocation schedule to open-label combination treatment (fludarabine 30 mg/m2 per day and alemtuzumab 30 mg per day on days 1—3) or monotherapy (fludarabine 25 mg/m2 on days 1—5) by use of an interactive voice response system
  • Both regimens were given intravenously for a maximum of six 28-day cycles
  • Primary endpoint was PFS
  • Analysis was by intention to treat

Results

  • Fludarabine plus alemtuzumab (n=168) resulted in better PFS than did fludarabine monotherapy (n=167; median 23·7 months [95% CI 19·2—28·4] vs 16·5 months [12·5—21·2]; HR 0·61 [95% CI 0·47—0·80]; p=0·0003) and OS (median not reached vs 52·9 months [40·9—not reached]; 0·65 [0·45—0·94]; p=0·021) compared with fludarabine alone
  • All-cause AEs occurred in 161 (98%) of 164 patients in combination treatment group and 149 (90%) of 165 in the fludarabine alone group
  • Patients in fludarabine plus alemtuzumab group had more cytomegalovirus events (23 [14%] vs one [<1%]) and grade 1 or 2 potentially alemtuzumab infusion-related adverse reactions (102 [62%] vs 22 [13%])
  • Grade 3 or 4 toxicities in combination treatment and monotherapy groups were leucopenia (121 [74%] of 164 vs 55 [34%] of 164), lymphopenia (149 [94%] of 158 vs 53 [33%] of 161), neutropenia (93 [59%] of 157 vs 110 [68%] of 161), thrombocytopenia (18 [11%] of 164 vs 27 [17%] of 163), and anaemia (14 [9%] of 163 vs 28 [17%] of 164)
  • Incidence of serious AEs was higher in combination treatment group (54 [33%] of 164 vs 41 [25%] of 165); deaths due to AEs were similar between 2 groups (10 [6%] vs 12 [7%])

Please login or register to follow this author.
► Click here to access 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 Coffee intake and gastric cancer risk Cancer Epidemiology, Biomarkers & Prevention, March 20, 2014    Clinical Article

2 The dirty side of soap UC San Diego Health System, November 20, 2014

3 Optimal duration of low molecular weight heparin for the treatment of cancer-related deep vein thrombosis: The Cancer-DACUS Study Journal of Clinical Oncology, October 10, 2014    Clinical Article

4 Molecular breakthrough could halt the spread of prostate cancer University of Bristol Research News, November 14, 2014

5 Dacomitinib as first-line treatment in patients with clinically or molecularly selected advanced non-small-cell lung cancer: A multicentre, open-label, phase 2 trial The Lancet Oncology, November 10, 2014    Clinical Article

6 Long-term results of a randomised phase III trial of weekly versus three-weekly paclitaxel/platinum induction therapy followed by standard or extended three-weekly paclitaxel/platinum in European patients with advanced epithelial ovarian cancer European Journal of Cancer, August 6, 2014    Clinical Article

7 Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): A randomised, multicentre, open-label, phase 3 non-inferiority trial The Lancet Oncology, October 23, 2014    Clinical Article

8 Metformin in chemotherapy-naive castration-resistant prostate cancer: A multicenter phase 2 trial (SAKK 08/09) Full Text European Urology, August 15, 2014    Free full text    Clinical Article

9 New insight on oral cancer culprits Vanderbilt University Medical Center Research News, November 17, 2014

10 Coffee plus honey versus topical steroid in the treatment of chemotherapy-induced oral mucositis: A randomized controlled trial Full Text BMC Complementary and Alternative Medicine, August 28, 2014    Free full text    Clinical Article

11 Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): A randomised, multicentre, open-label, phase 3 non-inferiority trial The Lancet Oncology, October 30, 2014    Clinical Article

12 Serum copper is a simple but valuable prognostic marker in B-cell chronic lymphocytic leukemia International Journal of Hematology, October 24, 2014    Clinical Article

13 Randomized phase III trial of amrubicin versus topotecan as second-line treatment for patients with small-cell lung cancer Journal of Clinical Oncology, November 19, 2014    Clinical Article

14 Phase II trial of the anti-CD19 bispecific T cell–engager blinatumomab shows hematologic and molecular remissions in patients with relapsed or refractory B-precursor acute lymphoblastic leukemia Journal of Clinical Oncology, November 17, 2014    Clinical Article

15 Smoking associated with elevated risk of developing a second smoking-related cancer American Society of Clinical Oncology (ASCO) News, November 12, 2014

16 Oxaliplatin, fluorouracil, and leucovorin versus fluorouracil and leucovorin as adjuvant chemotherapy for locally advanced rectal cancer after preoperative chemoradiotherapy (ADORE): an open-label, multicentre, phase 2, randomised controlled trial The Lancet Oncology, October 6, 2014    Clinical Article

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

18 Zoledronic acid combined with adjuvant endocrine therapy of tamoxifen versus anastrozol plus ovarian function suppression in premenopausal early breast cancer: Final analysis of the Austrian Breast and Colorectal Cancer Study Group Trial 12 Annals of Oncology, November 21, 2014    Clinical Article

19 Phase II randomized study of whole-brain radiation therapy with or without concurrent temozolomide for brain metastases from breast cancer Annals of Oncology, November 4, 2014    Clinical Article

20 Effects of BRCA1- and BRCA2-related mutations on ovarian and breast cancer survival: A meta-analysis Clinical Cancer Research, November 17, 2014    Evidence Based Medicine

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