Authors: | Levine, A. M.; Noy, A.; Lee, J. Y.; Tam, W.; Ramos, J. C.; Henry, D. H.; Parekh, S.; Reid, E. G.; Mitsuyasu, R.; Cooley, T.; Dezube, B. J.; Ratner, L.; Cesarman, E.; Tulpule, A. |
Article Title: | Pegylated liposomal doxorubicin, rituximab, cyclophosphamide, vincristine, and prednisone in AIDS-related lymphoma: AIDS malignancy consortium study 047 |
Abstract: | Purpose: Infusional chemotherapy is efficacious in patients with AIDS-related lymphoma, but it may be difficult to administer. We studied standard agents with rituximab plus pegylated liposomal doxorubicin (DR-COP) in an attempt to provide a more practical approach to therapy while ascertaining rates of response, potential infectious complications, and prognostic role of biologic markers. Patients and Methods: We conducted a prospective, multi-institutional phase II trial, employing (day 1) pegylated liposomal doxorubicin 40 mg/m2, rituximab 375 mg/m2, cyclophosphamide 750 mg/m2, vincristine 1.4 mg/m2 (not > 2 mg), and prednisone 100 mg orally on days 1 through 5, with concomitant antiretroviral therapy. Results: In 40 evaluable patients, median CD4 cells was 114/μL (range, 5 to 1,026/μL), and median HIV-1 viral load (VL) was 25,000 copies/mL. High or intermediate/high age-adjusted International Prognostic Index was present in 28%. Overall response was 67.5%, with complete remission in 47.5% (95% CI, 31.5 to 63.9). Of 19 complete responders, 84% had extranodal disease, 47% had CD4 < 100/μL, and 47% had VL > 50,000 copies/mL; one relapsed. With 25.5-month median follow-up, 62% (95% CI, 44 to 75) of patients remain alive. Sixteen patients (40%) experienced 22 infections, with grade 4 in only two (5%). No patient died as a result of infection during treatment; one had opportunistic infection. Conclusion: Profound immunodeficiency and high HIV-1 viral load do not preclude attainment of complete response after DR-COP with highly active antiretroviral therapy. The regimen is tolerable, and use of rituximab was not associated with death as a result of infection during treatment. This approach may be useful in patients in whom the more intensive infusional regimens are impractical. © 2012 by American Society of Clinical Oncology. |
Keywords: | immunohistochemistry; adult; cancer chemotherapy; cancer survival; clinical article; controlled study; treatment response; aged; prednisone; fatigue; neutropenia; cancer recurrence; doxorubicin; treatment duration; rituximab; nuclear magnetic resonance imaging; follow up; anorexia; cd8+ t lymphocyte; progression free survival; computer assisted tomography; phase 2 clinical trial; anemia; thrombocytopenia; granulocyte macrophage colony stimulating factor; cyclophosphamide; vincristine; pneumocystis pneumonia; dizziness; dyspnea; pneumonia; cause of death; confusion; cancer regression; lymphoma; urinary tract infection; granulocyte colony stimulating factor receptor; cognitive defect; progressive multifocal leukoencephalopathy; acquired immune deficiency syndrome; antiretrovirus agent; cd4 lymphocyte count; highly active antiretroviral therapy; physical examination; virus load; recombinant granulocyte colony stimulating factor; lung infection; hand foot syndrome; catheter infection; antibiotic prophylaxis; electrocardiogram; leukoencephalopathy; skin infection; human immunodeficiency virus 1; upper respiratory tract infection; opportunistic infection; rhinitis; gait disorder; nail infection; abdominal infection; aids related lymphoma; mucosal infection; mycobacterium avium intracellulare infection; optic nerve disorder; peripheral motor neuropathy; small intestine infection |
Journal Title: | Journal of Clinical Oncology |
Volume: | 31 |
Issue: | 1 |
ISSN: | 0732-183X |
Publisher: | American Society of Clinical Oncology |
Date Published: | 2013-01-01 |
Start Page: | 58 |
End Page: | 64 |
Language: | English |
DOI: | 10.1200/jco.2012.42.4648 |
PROVIDER: | scopus |
PMCID: | PMC3530691 |
PUBMED: | 23169503 |
DOI/URL: | |
Notes: | --- - "Export Date: 1 February 2013" - "CODEN: JCOND" - "Source: Scopus" |