Faculty Collaboration Database

Phase II evaluation of gemcitabine monotherapy for cutaneous T-cell lymphoma. Clin Lymphoma Myeloma 2006 Jul;7(1):51-8

Date

08/02/2006

Pubmed ID

16879770

DOI

10.3816/CLM.2006.n.039

Scopus ID

2-s2.0-33748320723 (requires institutional sign-in at Scopus site)   146 Citations

Abstract

PURPOSE: The purpose of this study was to investigate safety and efficacy of gemcitabine monotherapy for cutaneous T-cell lymphoma (CTCL).

PATIENTS AND METHODS: Twenty-five patients with CTCL on a phase II open-label trial and 8 patients off study received intravenous gemcitabine (1000 mg/m2) on day 1, 8, and 15 for > or = 6 cycles. Physicians' global assessment was based on body surface area involvement in skin, measurement of lymph nodes, and blood by flow cytometry.

RESULTS: Two patients with CD30+ anaplastic large T-cell lymphoma and 31 with mycosis fungoides (stage IB [T2, n = 2], stage IIA [T2, n = 1], stage IIB [T3, n = 13], stage IVA [T3 N3, n = 3; T4b2, n = 2; T4b2 N3, n = 2], and stage IVB [T4b2 N1, n = 6; T4 N3b2 M1, n = 1; T3 N3 M1, n = 1]) had received a median of 5 previous therapies (range, 1-13 therapies). Responses were seen in 17 of 25 (68%) study patients (2 complete responses [8%]) and 4 of 8 patients (1 complete response) off protocol. Seven of 13 patients with mycosis fungoides (T3) responded, 10 had tumor burden reductions, and 8 of 11 patients with Sezary syndrome responded. Gemcitabine was well tolerated. Myelosuppression (n = 14; grade 3, n = 8), hemolytic uremic syndrome (in 2 elderly patients with Sezary syndrome), pulmonary embolism (n = 2), and 1 episode each of congestive heart failure, acute myocardial infarction, and stable angina were observed. Increased hepatic transaminases (n = 4), mucositis (n = 3), lethargy (n = 7), fever (n = 8), cutaneous hyperpigmentation (n = 6), infusion-related maculopapular rash (n = 1), and radiation recall (n = 1) were also seen.

CONCLUSION: Gemcitabine is an effective monotherapy with a 68% overall response rate in patients with advanced, heavily pretreated CTCL.

Author List

Duvic M, Talpur R, Wen S, Kurzrock R, David CL, Apisarnthanarax N

Author

Razelle Kurzrock MD Center Associate Director, Professor in the Medicine department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adult
Aged
Aged, 80 and over
Antineoplastic Agents
Deoxycytidine
Female
Humans
Infusions, Intravenous
Lymphoma, T-Cell, Cutaneous
Male
Middle Aged
Mycosis Fungoides
Receptors, Interleukin-2
Sezary Syndrome
Skin Neoplasms
Treatment Outcome