Gemcitabine for relapsed or resistant lymphoma

Savage, David G.; Rule, Simon; Tighe, Mary; Garrett, T. J.; Oster, Martin W.; Lee, R. T.; Ruiz, J; Heitjan, Daniel F.; Keohan, Mary Louise; Flamm, Michael; Johnson, S. A. N.

doi:10.1023/a:1008307528519

Cited by 63 publications

(29 citation statements)

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“…Preliminary evidence of single-agent efficacy and satisfactory tolerability for gemcitabine against relapsed and refractory lymphoma has seen it incorporated into treatment combinations. 15,16 Combination therapy with vinorelbine and gemcitabine has been found to be effective in the management of advanced nonsmall cell lung cancer, 17 and we have previously shown that the combination of vinorelbine and gemcitabine is an effective and tolerable salvage approach for both NHL and HL with overall response rates of 70%, and 47%, for patients in first relapse or with more advanced disease, respectively. 18 Combinations of gemcitabine and vinorelbine with liposomal doxorubicin (GND) have been used successfully for the salvage of Hodgkin disease.…”

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confidence: 99%

A multicenter phase 2 study of risk‐adjusted salvage chemotherapy incorporating vinorelbine and gemcitabine for relapsed and refractory lymphoma

Pasricha¹,

Grigg²,

Catalano³

et al. 2008

Cancer

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BACKGROUND.Administration of salvage chemotherapy to patients with relapsed or refractory lymphoma is associated with significant toxicity. Vinorelbine and gemcitabine are novel chemotherapeutic agents with minimal overlapping toxicity. We present a phase 2 study of vinorelbine and gemcitabine with or without ifosfamide administered in an ambulatory care setting for relapsed or refractory lymphoma.METHODS.Ninety patients were enrolled. Group 1 comprised patients with “good” risk disease, Group 2 comprised patients with “high” risk disease, and Group 3 comprised patients relapsing after prior stem cell transplant. Patients in Group 1 and Group 3 received vinorelbine and gemcitabine with filgrastim support (VGF); those in Group 2 received the above regimen with ifosfamide (FGIV). We incorporated a standardized interim evaluation with dose escalation for patients with suboptimal response after 2 cycles.RESULTS.Toxicities were acceptable. Febrile neutropenia was uncommon: 7% after VGF (7 of 107 cycles) and 19% for FGIV (26 of 148 cycles). Unplanned admissions occurred in 23 of 107 cycles (21%) after VGF and 50 of 148 (34%) after FGIV. Overall response for Groups 1, 2 and 3, respectively was 76%, 39% and 50%, with median overall survival of 28, 9 and 30 months.CONCLUSIONS.Vinorelbine‐based and gemcitabine‐based chemotherapy is effective in the salvage setting against lymphoma and can be administered in an ambulatory setting. Cancer 2008. © 2008 American Cancer Society.

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confidence: 99%

A multicenter phase 2 study of risk‐adjusted salvage chemotherapy incorporating vinorelbine and gemcitabine for relapsed and refractory lymphoma

Pasricha¹,

Grigg²,

Catalano³

et al. 2008

Cancer

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“…Preclinical studies of gemcitabine and cisplatin have demonstrated synergy both in vitro and in vivo (Peters et al, 1995). Phase I studies evaluating this combination in relapsed and refractory HL and NHL have also reported higher RRs (Aviles et al, 2004;Emmanouilides et al, 2004) compared to either agent given as monotherapy (Fossa et al, 1999;Santoro et al, 2000;Savage et al, 2000;Zinzani et al, 2000). The mechanisms underlying this synergy may be due to increased incorporation of gemcitabine into DNA and RNA, and increased cisplatin -DNA adduct formation by inhibition of exonuclease and DNA repair (van Moorsel et al, 1999).…”

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Gemcitabine, cisplatin and methylprednisolone (GEM-P) is an effective salvage regimen in patients with relapsed and refractory lymphoma

Waters

Cunningham

et al. 2005

Br J Cancer

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There is currently no standard salvage chemotherapy regimen in relapsed and refractory lymphoma. Gemcitabine is a novel nucleoside analogue, which acts synergistically with cisplatin both in vitro and in clinical studies. We evaluated the combination of gemcitabine, cisplatin and methylprednisolone (GEM-P) in 41 heavily pretreated patients with relapsed and refractory Hodgkin's and non-Hodgkin's lymphoma. The best-achieved response rate (RR) was 79% (95% CI 64 -91), with a complete RR of 21%. In patients with chemo-resistant disease, the RR was 63%. Myelosuppression was the main toxicity, the incidence of Grade 3 or 4 anaemia, neutropenia and thrombocytopenia was 17.1, 61.0 and 53.7% respectively. Only one patient had neutropenic sepsis and none of the patients suffered from haemorrhage. Grade 3 or 4 nonhaematological toxicity was minimal and stem cell mobilisation was not inhibited. GEM-P is an effective salvage regimen and its use prior to autologous stem cell transplant warrants further investigation.

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“…9). Gemcitabine is another new agent that has been studied in patients with indolent (25) and aggressive (26,27) relapsed or refractory NHL. Although the overall response rate was slightly higher than with SAM486A, gemcitabine was associated with a higher level of toxicity, especially hematological toxicity.…”

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confidence: 99%

Clinical Efficacy, Tolerability, and Safety of SAM486A, a Novel Polyamine Biosynthesis Inhibitor, in Patients with Relapsed or Refractory Non-Hodgkin’s Lymphoma

Pless

Belhadj²,

Menssen

et al. 2004

Clinical Cancer Research

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Purpose: SAM486A is a new inhibitor of S-adenosylmethionine-decarboxylase, a key enzyme for polyamine biosynthesis. It is more potent than the first generation Sadenosyl-methionine-decarboxylase inhibitor methylglyoxal bis-guanylhydrazone. This Phase IIa study reports the findings of SAM486A monotherapy in patients with refractory or relapsed non-Hodgkin's lymphoma (NHL).Patients and Methods: Forty-one previously treated patients with either diffuse large cell, follicular, or peripheral T-cell NHL were treated i.v. with 100 mg/m 2 SAM486A as a daily 1-h infusion for 5 days repeated every 3 weeks. Treatment was continued for a total of eight cycles or until disease progression.Results: Two patients, both with large B-cell lymphoma, showed a complete response at cycle 3 that was maintained for >13 and >28 months. Five patients had a partial response, and 3 had stable disease at last follow-up. The overall response rate (complete response plus partial response) was 18.9% for evaluable patients (7 patients). Anemia was the primary hematological toxicity and observed in 7 (17.1%) patients. Five patients experienced grade 3/4 anemia. Four patients (9.8%) experienced grade 3/4 febrile neutropenia and grade 3/4 thrombocytopenia, respectively. Nonhematological toxicities were mild to moderate in intensity. The most frequent side effects were nausea (39%), vomiting (22%), diarrhea (19.5%), asthenia (17.1%), abdominal pain (14.6%), and flushing (9.8%).Conclusion: SAM486A has a promising clinical activity in patients with poor prognosis NHL and manageable safety profile. To further define the role of SAM486A, in the treatment of NHL, additional studies are warranted.

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Gemcitabine for relapsed or resistant lymphoma

Abstract: Gemcitabine has substantial activity and acceptable toxicity in heavily pre-treated patients with advanced lymphoma. Further study is warranted.

Cited by 63 publications

References 10 publications

A multicenter phase 2 study of risk‐adjusted salvage chemotherapy incorporating vinorelbine and gemcitabine for relapsed and refractory lymphoma

A multicenter phase 2 study of risk‐adjusted salvage chemotherapy incorporating vinorelbine and gemcitabine for relapsed and refractory lymphoma

Gemcitabine, cisplatin and methylprednisolone (GEM-P) is an effective salvage regimen in patients with relapsed and refractory lymphoma

Clinical Efficacy, Tolerability, and Safety of SAM486A, a Novel Polyamine Biosynthesis Inhibitor, in Patients with Relapsed or Refractory Non-Hodgkin’s Lymphoma

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