Originally published as JCO Early Release 10.1200/JCO.2009.23.3239 on September 8 2009

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Randomized Comparison of the Stanford V Regimen and ABVD in the Treatment of Advanced Hodgkin's Lymphoma: United Kingdom National Cancer Research Institute Lymphoma Group Study ISRCTN 64141244

From the Mount Vernon Cancer Centre, Department of Clinical Oncology; Lymphoma Trials Office, Cancer Research United Kingdom and University College London Cancer Trials Centre; Department of Radiotherapy, Institute of Cancer Research and Royal Marsden Hospital; Medical Research Council Cancer Trials Unit; St George's Hospital Medical School; Royal Marsden Hospital; and University College London Cancer Institute, London; St James' Institute of Oncology, Haematological Malignancy Diagnostic Service, Leeds; Cancer Research United Kingdom Clinical Centre, University of Southampton, Southampton; Academic Unit of Clinical Oncology, Weston Park Hospital, Sheffield; and University of Liverpool, Liverpool, United Kingdom; and Cleveland Clinic Taussig Cancer Institute, OH.

Corresponding author: Peter J. Hoskin, MD, Mount Vernon Cancer Centre, Mount Vernon Hospital, Rickmansworth Rd, Northwood, Middlesex, HA6 2RN, United Kingdom; e-mail: peterhoskin{at}nhs.net.

Purpose This multicenter, prospective, randomized controlled trial compared the efficacy and toxicity of two chemotherapy regimens in advanced Hodgkin's lymphoma (HL): the weekly alternating Stanford V and the standard, twice-weekly regimen of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD).

Patients and Methods Patients had stage IIB, III, or IV disease or had stages I to IIA disease with bulky disease or other adverse features. Radiotherapy was administered in both arms to sites of previous bulk (> 5 cm) and to splenic deposits, although this was omitted in the latter part of the trial for patients achieving complete remission (CR) in the ABVD arm. A total of 520 patients were randomly assigned and were assessed for the primary outcome measure of progression-free survival (PFS). Five hundred patients received protocol treatment, and radiotherapy was administered to 73% in the Stanford V arm and to 53% in the ABVD arm.

Results The overall response rates after completion of all treatment were 91% for Stanford V and 92% for ABVD. During a median follow-up of 4.3 years, there was no evidence of a difference in projected 5-year PFS and overall survival (OS) rates (76% and 90%, respectively, for ABVD; 74% and 92%, respectively, for Stanford V). More pulmonary toxicity was reported for ABVD, whereas other toxicities were more frequent with Stanford V.

Conclusion In a large, randomized trial, the efficacies of Stanford V and ABVD were comparable when given in combination with appropriate radiotherapy.

Supported by Cancer Research United Kingdom Grant No. C2422/A2858.

Presented at the Annual Meeting of the American Society of Hematology, San Francisco, CA, December, 6-9, 2008; and in part at the 9th International Conference on Malignant Lymphoma, Lugano, Switzerland, June, 7-11, 2005.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical trial information can be found for the following: ISRCTN64141244 [controlled-trials.com] .

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