Gemcitabine and paclitaxel associated pneumonitis in non-small cell lung cancer: report of a phase I/II dose-escalating study

Eur J Cancer. 2000 Dec;36(18):2329-34. doi: 10.1016/s0959-8049(00)00341-5.

Abstract

The aim of this phase I/II dose escalating study was to establish the maximum tolerated dose (MTD) of gemcitabine and paclitaxel given in combination in non-small cell lung cancer (NSCLC). 12 patients with stage IIIB and IV NSCLC received paclitaxel administered intravenously over 1 h followed by gemcitabine given over 30 min on days 1, 8 and 15 every 28 days. Pneumonitis was the principal side-effect observed with 4 patients affected. Of these, 1 experienced grade 3 toxicity after one cycle of treatment and the others had grade 2 toxicity. All 4 cases responded to prednisolone. No other significant toxicities were observed. Of the 8 evaluable patients, 3 had a partial response and 2 had minor responses. The study was discontinued due to this dose-limiting toxicity. The combination of paclitaxel and gemcitabine shows promising antitumour activity in NSCLC, however, this treatment schedule may predispose to pneumonitis.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects*
  • Carcinoma, Non-Small-Cell Lung / drug therapy*
  • Cohort Studies
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / adverse effects*
  • Deoxycytidine / analogs & derivatives
  • Dose-Response Relationship, Drug
  • Female
  • Gemcitabine
  • Humans
  • Lung Neoplasms / drug therapy*
  • Male
  • Maximum Allowable Concentration
  • Middle Aged
  • Paclitaxel / administration & dosage
  • Paclitaxel / adverse effects*
  • Pneumonia / chemically induced*

Substances

  • Deoxycytidine
  • Paclitaxel
  • Gemcitabine