A phase II trial of low-dose gemcitabine in a prolonged infusion and cisplatin for malignant pleural mesothelioma

Viljem Kovac*, Matjaz Zwitter, Mirjana Rajer, Aleksander Marin, Andrej Debeljak, Uros Smrdel, Martina Vrankar

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

After a favorable experience with gemcitabine at a low dose in a prolonged infusion in combination with cisplatin for advanced non-small-cell lung cancer, here, we present the results from a phase II trial for patients with malignant pleural mesothelioma. Eligible patients had biopsy-proven malignant pleural mesothelioma, were chemo-naive, Eastern Cooperative Oncology Group performance status 0-2, had normal hematopoietic liver and renal function, and gave informed consent. Treatment consisted of gemcitabine 250mg/m(2) in a 6-h infusion on days 1 and 8 and cisplatin at 75mg/m(2) on day 2 of a 3-week cycle for four cycles, followed by two additional cycles without cisplatin. Seventy-eight patients (58 men, 20 women; age 33-82 years, median 58) were recruited into the trial. The histologic types were as follows: epitheloid 56 (71.8%); four sarcomatoid (5.1%); mixed 15 (19.2%); and mesothelioma, three not otherwise specified (3.8%). Grades 3-4 toxicity included two (2.6%) patients with anemia, 18 (23.1%) with neutropenia, and one with nausea/vomiting. Reversible thrombocytosis with platelets over 1000-10(9)/l was recorded in 10 (12.8%) patients and grade 2 alopecia in 60 (76.9%). Four (5.1%) patients showed a complete response and 35 (44.9%) showed a partial response with a response rate of 39/78 (50%). Minimal response or stable disease was seen in 35 (44.9%), whereas only four (5.1%) patients progressed during treatment. Most patients reported symptomatic improvement with a higher or a stable quality of life score in 70 (89.7%) cases. The median progression-free survival was 8.0 months (confidence interval 6.9-9.0). The median overall survival was 17.0 months (confidence interval 14.7-19.2). One-year, two-year, and three-year survival rates were 67.3, 32.7, and 19.8%, respectively. Epitheloid histological type was the only statistically significant favorable prognostic factor for progression-free survival and overall survival. Because of the acceptable toxicity, remarkable activity, and reasonable cost, this treatment should be further explored. Anti-Cancer Drugs 23: 230-238 (C) 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins.

Original languageEnglish
Pages (from-to)230-238
Number of pages9
JournalAnti-Cancer drugs
Volume23
Issue number2
DOIs
Publication statusPublished - Feb 2012

Keywords

  • chemotherapy
  • cisplatin
  • gemcitabine
  • long infusion
  • malignant pleural mesothelioma
  • CELL LUNG-CANCER
  • PREVIOUSLY UNTREATED PATIENTS
  • PEMETREXED PLUS CARBOPLATIN
  • SOLID TUMORS
  • EUROPEAN-ORGANIZATION
  • 1ST-LINE TREATMENT
  • 24-HOUR INFUSION
  • RANDOMIZED-TRIAL
  • BREAST-CANCER
  • CHEMOTHERAPY

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