RANDOMIZED COMPARISON BETWEEN CHEMOTHERAPY PLUS BEST SUPPORTIVE CARE WITH BEST SUPPORTIVE CARE IN ADVANCED GASTRIC-CANCER

Background: The extent to which chemotherapy may relieve tumour-relate d symptoms, improve quality of life and prolong survival in patients w ith gastric cancer is not known in spite of the extensive use of this treatment modality. The aim of this study was to estimate any gain in the quantity and quality of life produced by chemotherapy in these pat ients. Patients and methods: Between January 1991 and February 1995, 6 1 patients with gastric cancer were randomized to either chemotherapy in addition to best supportive care or to best supportive care. Chemot herapy was allowed in the latter group if the supportive measures did not lead to palliation. Chemotherapy was the ELF-regimen consisting of 5-fluorouracil, leucovorin and etoposide, or, in elderly patients wit h poor performance, a 5-fluorouracil/leucovorin regimen (FLv). Quality of life was evaluated with the EORTC-QLQ-C30 instrument. Results: Mor e patients in the chemotherapy group (45%, 14/31) had an improved or p rolonged high quality of life for a minimum period of 4 months compare d to those in the best supportive care group (20%, 6/30, P < 0.05). A similar difference was seen in the treating physician's evaluation of whether the patient was subjectively improved or continued to do well for at least 4 months (17/31, 55% versus 6/30, 20%, P < 0.01). Overall survival was longer in the chemotherapy group (median 8 vs. 5 months) although the difference was not statistically significant (P = 0.12). After corrections for imbalances in pre treatment characteristics, ch emotherapy treatment was, however, associated with a survival benefit (P = 0.003). Also, the quality-adjusted survival time and time to dise ase progression were longer for patients randomized to chemotherapy (m edian 5 vs. 2 months, P = 0.03). Conclusions: The results show that ch emotherapy can add to both quantity and quality of life in advanced ga stric cancer. The number of patients who benefit from treatment is, ho wever, still rather limited.