Annals of Oncology Advance Access originally published online on April 10, 2007
Annals of Oncology 2007 18(6):1071-1079; doi:10.1093/annonc/mdm090
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© 2007 European Society for Medical Oncology
hematologic malignancies |
Gemcitabine, vinorelbine, and pegylated liposomal doxorubicin (GVD), a salvage regimen in relapsed Hodgkin's lymphoma: CALGB 59804
1 Siteman Cancer Center, Washington University School of Medicine, St Louis, MO
2 CALGB Statistical Center, Duke University Medical Center, Durham, NC
3 Dana Farber-Partners, Boston, MA
4 University of California at San Diego, San Diego, CA
5 University of Chicago, Chicago, IL
6 Memorial Sloan-Kettering Cancer Center, New York, NY
7 Georgetown University Medical Center, Washington, DC, USA
* Correspondence to: Dr Nancy L. Bartlett, Siteman Cancer Center, Washington University School of Medicine, 660 S Euclid, Box 8056, St Louis, MO 63110, USA. Tel: +314-362-5654; Fax: +314-747-5123; E-mail: nbartlet{at}im.wustl.edu
Background: Because of high single-agent activity and modest toxicity, we hypothesized the combination of gemcitabine (G), vinorelbine (V), and pegylated liposomal doxorubicin (D) would be an effective salvage therapy for Hodgkin's lymphoma (HL).
Patients and methods: A total of 91 patients participated. GVD was administered on days 1 and 8 every 21 days at doses of G 1000 mg/m2, V 20 mg/m2, and D 15 mg/m2 for transplant-naive patients, and G 800 mg/m2, V 15 mg/m2, and D 10 mg/m2 for post-transplant patients.
Results: The dose-limiting toxicity was mucositis for the transplant-naive patients and febrile neutropenia for post-transplant patients. The overall response rate (RR) for all patients was 70% [95% confidence interval (CI) 59.8, 79.7], with 19% complete remissions. The 4-year event-free and overall survival rates in transplant-naive patients treated with GVD followed by autologous transplant were 52% (95% CI 0.34, 0.68) and 70% (95% CI 0.49, 0.84), and in the patients in whom prior transplant failed, these were 10% (95% CI 0.03, 0.22) and 34% (95% CI 0.17, 0.52), respectively.
Conclusions: GVD is a well-tolerated, active regimen for relapsed HL with results similar to those reported for more toxic regimens. High RRs in patients in whom prior transplant failed confirms this regimen's activity even in heavily pretreated patients.
Key words: gemcitabine, Hodgkin's lymphoma, liposomal doxorubicin, recurrent, salvage therapy, vinorelbine
N. L. Bartlett designed research, performed research, analyzed data, and wrote the paper; D. Niedzwiecki designed research and analyzed data; J. L. Johnson designed research, collected data, and analyzed data; J. W. Friedberg treated significant proportion of patients on trial and edited the paper; K. B. Johnson treated significant proportion of patients on trial and edited the paper; K. van Besien treated significant proportion of patients on trial and edited the paper; A. D. Zelenetz designed research; B. D. Cheson edited the paper; and G. P. Canellos designed research and edited the paper.
Received for publication September 11, 2006. Revision received February 12, 2007. Accepted for publication February 13, 2007.
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