The evidence supporting this protocol is provided by a phase III intergroup randomised trial (RTOG 85-01) involving 123 patients, comparing chemoradiotherapy versus radiotherapy alone in patients with localised oesophageal cancer.rr 62 patients were randomised to receive radiotherapy alone (64 Gy over 6.4 weeks) and 61 patients were randomised to receive 4 cycles of cisplatin and fluorouracil with radiotherapy (50 Gy) delivered during the first 5 weeks.rr Cisplatin 75 mg/m2 was administered on day 1 of weeks 1, 5, 8 and 11, and fluorouracil 1000 mg/m2 per day was administered on day 1 to 4 of weeks 1, 5, 8 and 11. The primary end point was overall survival and secondary endpoints were patterns of treatment failure and toxicities.
Although small numbers (62 patients), the dramatic survival differences at 5 years has led to the adoption of this study and continuing use of this regimen 25 years after study publication.
In the RTOG 85-01 trial, combined therapy (chemoradiotherapy) significantly increased overall survival compared to radiotherapy alone. At 5 years of follow-up the overall survival for chemoradiotherapy was 26% (95% CI, 15%-37%) compared with 0% for radiotherapy alone. Persistence of disease was less common in the chemoradiotherapy group (26%) than in the radiotherapy alone group (37%).r
There is some uncertainty over whether SCC has a higher response than adenocarcinoma.
In the RTOG 85-01 trial grade 4 toxicities were greater in the chemoradiotherapy group compared with the radiotherapy alone group. Grade 4 toxicities were reported in 8% of patients in the chemoradiotherapy group, compared with 2% in the radiation alone group.rr 1 patient in the chemoradiotherapy group died from renal and bone marrow failure. There were no significant differences in severe late toxicities between the two groups.rr
© NEJM 1992