An interim report of a prospective, randomized, controlled study of adjuvant chemotherapy in operable gastric cancer: British stomach cancer group

Abstract

A prospective, randomized, controlled study of adjuvant chemotherapy in operable gastric cancer was commenced in 1976. Four hundred and eleven patients have been randomized into 1 of 3 treatment groups. Group A received a placebo injection of intravenous normal saline (10 ml) at 3-week intervals. Group B received a 5-day induction course of 5-fluorouracil (5-FU), vincristine, cyclophosphamide, and methotrexate followed by 3-week intravenous injections of 5-FU and mitomycin C (MMC). Group C received 3-week intravenous injections of 5-FU and MMC. The treatment was to be given for 2 years. Patients were stratified for age, sex, preoperative duration of symptoms, and clinicopathologicai stage prior to randomization. At this interim analysis, preoperative duration of symptoms and clinicopathological stage were statistically significant prognostic factors (p = <0.05 and <0.001, respectively).At the time of this analysis, there has been no significant improvement in survival in either of the treatment groups compared to the control group. While treatment could begin at any time during the first 3 postoperative months, survival at 1 year was significantly improved (p = 0.013) by treatment C in those who started treatment within I month of surgery; however, this benefit of treatment was not maintained at 3 years. Of the 279 deaths, 16 (5.7%) have been drug-related, 11 resulting from renal toxicity associated with this therapeutic regimen.This study has confirmed the poor prognosis of gastric cancer, and the early results demonstrate that there is no m

The selection of cases for randomised trials: a registry survey of concurrent trial and non-trial patients

“…The trial protocol has been described (Fielding et al, 1983). Patients with histologically proven, resected primary carcinoma of the stomach aged between 15-74 were suitable for referral to the trial.…”

“…The Registry notes of each case were therefore reviewed by the BSCG data manager and clinical research fellow to complete the standard trial entry form. Attention was focused on determining the stage of disease following operation using the classification used by the BSCG (Fielding et al, 1983). Where the operation could not be categorised as palliative or curative it was not possible to stage the patient.…”

Somatostatin binding in normal and malignant human gastrointestinal mucosa

“…All assay points were performed in triplicate and the coefficient of variation of the triplicates was less than 10%. Fielding et al, 1983).…”

Gastric cancer – the recognition of a chemosensitive tumour

“…There have been several trials of adjuvant chemotherapy in gastric cancer (Longmire et al, 1968;Dixon et al, 1971;Serlin et al, 1969;Douglas & Stanlein, 1982;Engestrom et al, 1985;Higgins et al, 1983;Boice et al, 1983;Fielding et al, 1983) and all of these, apart from one (Douglas & Stanlein, 1982), have failed to show any benefit on survival. Indeed, two further randomised trials presented at this year's ASCO, one comparing the combination of doxorubicin and 5-fluorouracil with no treatment (Krook et al, 1988), and one comparing FAM with no treatment (Wils et al, 1988), showed no benefit from adjuvant chemotherapy.…”