Authors: | Bartlett, N. L.; Niedzwiecki, D.; Johnson, J. L.; Friedberg, J. W.; Johnson, K. B.; van Besien, K.; Zelenetz, A. D.; Cheson, B. D.; Canellos, G. P. |
Article Title: | Gemcitabine, vinorelbine, and pegylated liposomal doxorubicin (GVD), a salvage regimen in relapsed Hodgkin's lymphoma: CALGB 59804 |
Abstract: | 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. © 2007 European Society for Medical Oncology. |
Keywords: | adult; cancer survival; controlled study; treatment outcome; aged; aged, 80 and over; disease-free survival; middle aged; survival analysis; treatment failure; major clinical study; overall survival; clinical trial; drug tolerability; fatigue; neutropenia; salvage therapy; cisplatin; doxorubicin; diarrhea; drug dose reduction; drug efficacy; patient selection; side effect; gemcitabine; cancer radiotherapy; disease free survival; cytarabine; anorexia; dacarbazine; controlled clinical trial; infection; multiple cycle treatment; pain; phase 2 clinical trial; hemolysis; etoposide; esophagitis; leukopenia; mucosa inflammation; nausea; randomized controlled trial; stomatitis; thrombocytopenia; vomiting; antineoplastic combined chemotherapy protocols; myalgia; melphalan; autologous stem cell transplantation; hemoglobin blood level; dose-response relationship, drug; carmustine; vinblastine; hodgkin disease; alanine aminotransferase blood level; arthralgia; aspartate aminotransferase blood level; dizziness; drug dose escalation; drug hypersensitivity; dyspnea; febrile neutropenia; hyperglycemia; lymphocytopenia; pneumonia; pruritus; rash; syncope; dysphagia; hypokalemia; hyponatremia; malaise; depression; cancer regression; hodgkin's lymphoma; bleomycin; anxiety disorder; cancer relapse; headache; phase 1 clinical trial; navelbine; deoxycytidine; lethargy; pericardial effusion; neurologic disease; gastrointestinal disease; thrombotic thrombocytopenic purpura; liposomal doxorubicin; polyethylene glycols; larynx disorder; desquamation; adult respiratory distress syndrome; recurrent; pharyngitis; stridor; vinorelbine; methylprednisolone sodium succinate |
Journal Title: | Annals of Oncology |
Volume: | 18 |
Issue: | 6 |
ISSN: | 0923-7534 |
Publisher: | Oxford University Press |
Date Published: | 2007-06-01 |
Start Page: | 1071 |
End Page: | 1079 |
Language: | English |
DOI: | 10.1093/annonc/mdm090 |
PUBMED: | 17426059 |
PROVIDER: | scopus |
DOI/URL: | |
Notes: | --- - "Cited By (since 1996): 46" - "Export Date: 17 November 2011" - "CODEN: ANONE" - "Source: Scopus" |