Gemcitabine as Single Agent in Pretreated T-cell Lymphoma Patients
Background: Peripheral T-cell lymphoma unspecified (PTCLU) and mycosis fungoides (MF) often show resistance to conventional chemotherapy. Gemcitabine should be considered a suitable option. We report the long-term update of 39 pretreated T-cell lymphoma patients treated with gemcitabine.
Patients and methods: From May 1997 to September 2007, 39 pretreated MF and PTCLU patients received gemcitabine. Inclusion criteria were as follows: histologic diagnosis of MF or PTCLU; relapsed/refractory disease; age ≥18 years; and World Health Organization performance status of two or less. Nineteen patients had MF and 20 PTCLU. All patients with MF had a T3–T4, N0, and M0 disease and patients with PTCLU had stage III–IV disease. Gemcitabine was given on days 1, 8, and 15 on a 28-day schedule (1200 mg/m/day) for a total of three to six cycles.
Results: Overall response rate was 51% (20 of 39 patients); complete response (CR) and partial response (PR) rates were 23% (9 of 39 patients) and 28% (11 of 39 patients), respectively. Patients with MF had a CR rate of 16% and a PR rate of 32% compared with a CR rate of 30% and a PR rate of 25% of PTCLU patients. Among the CR patients, 7 of 9 are in continuous complete response with a variable disease-free interval (15–120 months).
Conclusion: In our experience, gemcitabine proved to be effective in pretreated MF and PTCLU patients, even in the long term.
The results of treatment of patients with aggressive T-cell lymphomas are generally worse than those for patients with diffuse large B-cell lymphomas. In particular, most aggressive peripheral T-cell lymphoma unspecified (PTCLU) patients are traditionally treated with an anthracycline-containing regimen and complete response (CR; CR requires the complete disappearance of all detectable clinical and radiographic evidence of disease, the disappearance of all disease-related symptoms, and normalization of biochemical abnormalities) rates of 50%–70% have been reported. However, the 5-year overall survival for PTCLU patients was 20%–30%. This did not significantly differ by the type of chemotherapy administered. The effects of high-dose therapy and stem-cell transplantation at the time of first CR were not easily evaluated due to difficult comparisons; however, stem-cell transplant at the time of relapse did offer an advantage over salvage chemotherapy.
Regarding the cutaneous T-cell lymphoma and in particular mycosis fungoides (MF), the use of systemic chemotherapy as a first-line treatment should be restricted with few exceptions to advanced/aggressive MF patients. The choice of treatment is often determined by institutional experience, particularly as there is a paucity of data from phase III trials and a lack of consensus concerning treatment of the later stages of MF. A strict rule is definitely nonappropriate in this regards; a careful and balanced evaluation of specific diagnosis, tumor load, cutaneous lesions' features, age, general conditions, and immune status of the patients is obviously the standard to date.
Among the several second-line and experimental drugs, gemcitabine should be considered one of the most suitable options to date for pretreated PTCLU and MF patients. Gemcitabine has been demonstrated to be an effective monotherapy with a 60%–70% overall response rate (ORR) in patients with advanced disease and heavily pretreated. In addition, there are also interesting data in untreated patients and even some data describing the efficacy of gemcitabine combinations in patients with T-cell lymphoma.
As well known, it is difficult to find in literature the long-term outcome regarding the efficacy of a single-agent drug in pretreated patients and, in particular, in rare diseases such as T-cell lymphomas. In this study, we report the long-term update of the outcome of 39 heavily pretreated T-cell lymphoma patients after salvage treatment with gemcitabine.
Abstract and Introduction
Abstract
Background: Peripheral T-cell lymphoma unspecified (PTCLU) and mycosis fungoides (MF) often show resistance to conventional chemotherapy. Gemcitabine should be considered a suitable option. We report the long-term update of 39 pretreated T-cell lymphoma patients treated with gemcitabine.
Patients and methods: From May 1997 to September 2007, 39 pretreated MF and PTCLU patients received gemcitabine. Inclusion criteria were as follows: histologic diagnosis of MF or PTCLU; relapsed/refractory disease; age ≥18 years; and World Health Organization performance status of two or less. Nineteen patients had MF and 20 PTCLU. All patients with MF had a T3–T4, N0, and M0 disease and patients with PTCLU had stage III–IV disease. Gemcitabine was given on days 1, 8, and 15 on a 28-day schedule (1200 mg/m/day) for a total of three to six cycles.
Results: Overall response rate was 51% (20 of 39 patients); complete response (CR) and partial response (PR) rates were 23% (9 of 39 patients) and 28% (11 of 39 patients), respectively. Patients with MF had a CR rate of 16% and a PR rate of 32% compared with a CR rate of 30% and a PR rate of 25% of PTCLU patients. Among the CR patients, 7 of 9 are in continuous complete response with a variable disease-free interval (15–120 months).
Conclusion: In our experience, gemcitabine proved to be effective in pretreated MF and PTCLU patients, even in the long term.
Introduction
The results of treatment of patients with aggressive T-cell lymphomas are generally worse than those for patients with diffuse large B-cell lymphomas. In particular, most aggressive peripheral T-cell lymphoma unspecified (PTCLU) patients are traditionally treated with an anthracycline-containing regimen and complete response (CR; CR requires the complete disappearance of all detectable clinical and radiographic evidence of disease, the disappearance of all disease-related symptoms, and normalization of biochemical abnormalities) rates of 50%–70% have been reported. However, the 5-year overall survival for PTCLU patients was 20%–30%. This did not significantly differ by the type of chemotherapy administered. The effects of high-dose therapy and stem-cell transplantation at the time of first CR were not easily evaluated due to difficult comparisons; however, stem-cell transplant at the time of relapse did offer an advantage over salvage chemotherapy.
Regarding the cutaneous T-cell lymphoma and in particular mycosis fungoides (MF), the use of systemic chemotherapy as a first-line treatment should be restricted with few exceptions to advanced/aggressive MF patients. The choice of treatment is often determined by institutional experience, particularly as there is a paucity of data from phase III trials and a lack of consensus concerning treatment of the later stages of MF. A strict rule is definitely nonappropriate in this regards; a careful and balanced evaluation of specific diagnosis, tumor load, cutaneous lesions' features, age, general conditions, and immune status of the patients is obviously the standard to date.
Among the several second-line and experimental drugs, gemcitabine should be considered one of the most suitable options to date for pretreated PTCLU and MF patients. Gemcitabine has been demonstrated to be an effective monotherapy with a 60%–70% overall response rate (ORR) in patients with advanced disease and heavily pretreated. In addition, there are also interesting data in untreated patients and even some data describing the efficacy of gemcitabine combinations in patients with T-cell lymphoma.
As well known, it is difficult to find in literature the long-term outcome regarding the efficacy of a single-agent drug in pretreated patients and, in particular, in rare diseases such as T-cell lymphomas. In this study, we report the long-term update of the outcome of 39 heavily pretreated T-cell lymphoma patients after salvage treatment with gemcitabine.
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