Combined results of two phase II studies of Taxol® (Paclitaxel) in patients with relapsed or refractory lymphomas

Paul E. Goss, A. Keith Stewart, Felix Couture, Richard Klasa, Stefan Glück, Leonard Kaizer, Ronald Burkes, Danielle Charpentier, Martin Palmer, Lesley Tye, Helene Dulude

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

This study was performed to determine the clinical activity and safety of paclitaxel in the treatment of patients with refractory or relapsing aggressive Non-Hodgkin's lymphoma (NHL). Between May 3, 1994 and February 16, 1996, 39 patients with refractory or relapsing NHL consented to be enrolled in two, multicenter, open-labelled studies to evaluate the efficacy safety, time to progression and overall survival of paclitaxel given at a dose of 175 mg/m2 by a 3 hour IV infusion every three weeks without G-CSF use. Data from the two studies is combined. One patient, although registered, did not receive treatment. Of the remaining 38 patients, 17 men and 21 women aged 26-82 years (median 60) were given 104 courses of paclitaxel [median 2 (range 1-6)]. Seventeen patients had stage IV, 7 stage III, 8 stage II, 5 stage 1 and 1 unknown stage of disease. Histologic grades included 1 low, 33 intermediate, and 4 high. Three patients had bone marrow involvement. Median time from diagnosis to study entry was 19 months (1-160). The median number of previous chemotherapy regimens was 2 (range 1-6). Three of the 35 (8.6%) patients evaluable for response had partial remission (PR) of their disease for 1-7 months (median 2) and 11/35 (31.4%) stable disease (SD) for 1 to 19 months (median 3). All three responders and 3 of the 11 SD patients had received paclitaxel after relapsing from a CR. At analysis, nine of the 38 patients were alive. Median duration of follow up at analysis was 6 months (3 days - 29 months). The estimated survival rates for all patients at 1 and 2 years are 34% and 27% respectively (Kaplan-Meier) from the start of paclitaxel treatment. The median survival time was 5.4 months (3 days to 28+ months). Febrile neutropenia occurred in two patients. Seven (18%) patients developed a neutrophil nadir of < 0.5 x 109/L and 2 (5%) patients developed a platelet nadir of < 50 x 109/L. Six patients received blood transfusions. Non-hematologic toxicity was generally mild to moderate with all patients experiencing some toxicity. Twenty-seven patients experienced grade III toxicity including: alopecia (n = 19), pain (n = 9), fatigue (n = 5), nausea/vomiting (n = 3), diarrhoea (n = 2), pulmonary/shortness of breath (n = 2), anorexia (n = 1) and fluctuating levels of consciousness and somnolence (n = 1). Two patients experienced grade IV toxicity (infection, peripheral neuropathy, pain). No patient discontinued paclitaxel for a severe hypersensitivity reaction. In summary, administered as a 3-hour infusion, paclitaxel 175 mg/m2 results in mild myelotoxicity but minimal antitumor activity in patients with refractory NHL.

Original languageEnglish
Pages (from-to)295-304
Number of pages10
JournalLeukemia and Lymphoma
Volume34
Issue number3-4
StatePublished - Aug 24 1999
Externally publishedYes

Fingerprint

Paclitaxel
Lymphoma
Non-Hodgkin's Lymphoma
Safety
Pain
Febrile Neutropenia
Survival
Alopecia
Anorexia
Peripheral Nervous System Diseases
Granulocyte Colony-Stimulating Factor
Consciousness

Keywords

  • Non-Hodgkin's lymphoma
  • Refractory
  • Taxol® (paclitaxel)

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

Cite this

Goss, P. E., Stewart, A. K., Couture, F., Klasa, R., Glück, S., Kaizer, L., ... Dulude, H. (1999). Combined results of two phase II studies of Taxol® (Paclitaxel) in patients with relapsed or refractory lymphomas. Leukemia and Lymphoma, 34(3-4), 295-304.

Combined results of two phase II studies of Taxol® (Paclitaxel) in patients with relapsed or refractory lymphomas. / Goss, Paul E.; Stewart, A. Keith; Couture, Felix; Klasa, Richard; Glück, Stefan; Kaizer, Leonard; Burkes, Ronald; Charpentier, Danielle; Palmer, Martin; Tye, Lesley; Dulude, Helene.

In: Leukemia and Lymphoma, Vol. 34, No. 3-4, 24.08.1999, p. 295-304.

Research output: Contribution to journalArticle

Goss, PE, Stewart, AK, Couture, F, Klasa, R, Glück, S, Kaizer, L, Burkes, R, Charpentier, D, Palmer, M, Tye, L & Dulude, H 1999, 'Combined results of two phase II studies of Taxol® (Paclitaxel) in patients with relapsed or refractory lymphomas', Leukemia and Lymphoma, vol. 34, no. 3-4, pp. 295-304.
Goss PE, Stewart AK, Couture F, Klasa R, Glück S, Kaizer L et al. Combined results of two phase II studies of Taxol® (Paclitaxel) in patients with relapsed or refractory lymphomas. Leukemia and Lymphoma. 1999 Aug 24;34(3-4):295-304.
Goss, Paul E. ; Stewart, A. Keith ; Couture, Felix ; Klasa, Richard ; Glück, Stefan ; Kaizer, Leonard ; Burkes, Ronald ; Charpentier, Danielle ; Palmer, Martin ; Tye, Lesley ; Dulude, Helene. / Combined results of two phase II studies of Taxol® (Paclitaxel) in patients with relapsed or refractory lymphomas. In: Leukemia and Lymphoma. 1999 ; Vol. 34, No. 3-4. pp. 295-304.
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