1. ¹Department of Internal Medicine I, University Vienna, Waehringer Guertel 18-20, A-1090 Vienna, Austria
2. ²Department of Surgery, General Hospital of Wiener Neustadt, A-2700 Wiener Neustadt, Corvinusring 3-5, Austria
3. ³Department of Internal Medicine, General Hospital of Kirchdorf/Krems, A-4560 Kirchdof/Krems, Austria
4. ⁴Department of Surgery, General Hospital of Neunkirchen, A-2620 Neunkirchen, Peischinger Str 19, Austria

Correspondence: W Scheithauer, E-mail: werner.scheithauer@akh-wien.ac.at

Received 5 November 2001; Revised 5 March 2002; Accepted 9 April 2002.

Abstract

A phase II trial was performed to determine the antitumour efficacy and tolerance of combined paclitaxel and cisplatin with or without hematopoetic growth factor support in patients with advanced gastric cancer. Forty-five patients with histologically confirmed metastatic gastric cancer were entered in this trial. Treatment consisted of 2-weekly courses of paclitaxel 160 mg per m² and cisplatin 60 mg per m² both given on day 1. Depending on absolute neutrophil counts on the days of scheduled chemotherapeutic drug administration (1000–2000 per l), a 5-day course of human granulocyte colony-stimulating factor 5 g kg^-1 per day was given subcutaneously; in addition, if haemoglobin was <12.0 mg dl^-1, erythropoietin 10 000 IU was administered subcutaneously three times per week. The confirmed overall response rate (intent-to-treat) was 44%, including five complete (11%) and 15 partial remissions (33%). Twelve patients had stable disease (27%), 11 (24%) progressed while on chemotherapy, and two patients were not evaluable. The median time to response was 3 months, the median time to progression 7.0 months, and the median survival time was 11.2 months with 12 patients currently alive. Haematologic toxicity was common, though WHO grade 4 neutropenia occurred in only five patients (11%). Apart from total alopecia in 16 patients (36%), severe non-haematologic adverse reactions included grade 3 peripheral neuropathy in six (13%) and anaphylaxis in two patients. In addition, there was one patient each who experienced grade 3 emesis, diarrhea, and infection, respectively. Our data suggest that the combination of paclitaxel and cisplatin with or without G-CSF and/or erythropoietin has promising therapeutic activity in patients with advanced gastric cancer.