The evidence supporting this protocol is provided by a phase III intergroup randomised trial (RTOG 85-01) involving 123 patients, comparing chemoradiation therapy versus radiation therapy alone in patients with localised oesophageal cancer.rr 62 patients were randomised to receive radiation therapy alone (64 Gy over 6.4 weeks) and 61 patients were randomised to receive 4 cycles of cisplatin and fluorouracil with radiation therapy (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 (chemoradiation therapy) significantly increased overall survival compared to radiation therapy alone. At 5 years of follow-up the overall survival for chemoradiation therapy was 26% (95% CI, 15%-37%) compared with 0% for radiation therapy alone. Persistence of disease was less common in the chemoradiation therapy group (26%) than in the radiation therapy 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 chemoradiation therapy group compared with the radiation therapy alone group. Grade 4 toxicities were reported in 8% of patients in the chemoradiation therapy group, compared with 2% in the radiation alone group.rr 1 patient in the chemoradiation therapy group died from renal and bone marrow failure. There were no significant differences in severe late toxicities between the two groups.rr
© NEJM 1992