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Docetaxel/Cisplatin Shows Promising Therapeutic Index in Patients With Advanced Gastroesophageal Cancer

Docetaxel combined with cisplatin with or without human granulocyte colony stimulating factor (G-CSF) and/or erythropoietin appears to show a promising therapeutic index in patients with advanced gastroesophageal cancer.

Cytotoxic chemotherapy has been demonstrated to be effective in the palliative management of gastroesophageal cancer. However, use of chemotherapy in patients with disseminated disease is aimed at producing palliative effects, and the anticancer activity and side effects must be weighted carefully.

Birgit Schüll, MD, with the Vienna University Medical School, Austria, and colleagues conducted a phase II trial to determine the antitumour efficacy and tolerance of combined docetaxel and cisplatin with or without haematopoietic growth factor support in 37 patients with advanced gastroesophageal cancer.

Treatment consisted of 4-weekly courses of docetaxel 50 mg/² and cisplatin 50 mg/m² both given on day 1 and 15. In addition, a 5-day course of G-CSF 5 µ/kg/day was given subcutaneously, depending on absolute neutrophil counts on the days of scheduled chemotherapy. If haemoglobin was less than 12.0 mg/dL, erythropoietin was also administered subcutaneously 3 times per week.

Overall response rate of the intent-to-treat population was 46%. This included 4 complete responses (11%) and 13 partial responses (35%). Of the patients, 11 (30%) had stable disease, and 9 (24%) had progressive disease.

The median time to response was 3 months, median time to progression was 7 months, and the median overall survival time was 11.5 months. A total of 43% of the patients remained alive at the end of the study period.

Haematologic toxicity was common, although grade 4 neutropenia occurred in only 3 patients. Nonhaematologic toxicity was generally mild; grade 3 toxicities included alopecia in 14% of patients, infection in 3%, neutrotoxicity in 5%, and anaphylaxis in 1 patient.

"The results of this trial indicate that the described bimonthly combination regimen of docetaxel plus cisplatin with or without G-CSF and/or erythropoietin is an effective and tolerable regimen for patients with disseminated gastroesophageal cancer," Dr. Schull and colleagues conclude.

The researchers note that the promising therapeutic index of the described regimen warrants its further evaluation in patients with advanced gastroesophageal cancer, including those in the neoadjuvant setting.

"In these or other clinical trials, it might also be of particular interest to try to define precisely the impact of correcting anaemia with erythropoietin in terms of quality of life and therapeutic outcome," they suggest.


Oncology 2003;65:211-217. "Effective Combination Chemotherapy with Bimonthly Docetaxel and Cisplatin with or without Hematopoietic Growth Factor Support in Patients with Advanced Gastroesophageal Cancer"

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