RTOG 85-01
Combined chemotherapy and radiotherapy compared with radiotherapy alone in patients with cancer of the esophagus (Radiation Therapy Oncology Group 85-01)
Phase 3N = 121
- Population
- Squamous-cell carcinoma or adenocarcinoma of the thoracic oesophagus; T1-3 N0-1 M0 per the 1999 report
- Design
- Phase III prospective, randomised, stratified trial (1985 to 1990) comparing four courses of fluorouracil (1000 mg/m2 daily for four days) and cisplatin (75 mg/m2 on day 1) with 5000 cGy of radiotherapy against 6400 cGy of radiotherapy alone. Stopped after accumulated results in 121 patients showed a survival advantage with chemotherapy plus radiotherapy. A non-randomised cohort followed the randomised study. No trial register number is recorded in PubMed. The 1999 JAMA abstract gives the randomised study as 1985 to 1990 in its design line and January 1986 to April 1990 in its context line.
- Primary endpoint
- OS
- Arms
- Chemotherapy plus radiotherapy (experimental): Fluorouracil and cisplatin, four courses, with 50 Gy radiotherapy (5000 cGy)
- Radiotherapy alone (control, n = 62): 64 Gy radiotherapy (6400 cGy) without chemotherapy
- People
- Herskovic A
Δ median OS+3.6 monthsΔ 12-month OS+17 pointsΔ 60-month OS+26 points
Show the numbers
| Endpoint | Analysis | Chemotherapy plus radiotherapy | Radiotherapy alone | Effect |
|---|---|---|---|---|
| OSRandomised patients at the trial's stopping point (121) | primaryHerskovic 1992 | median 12.5 months; 50% at 12 mo; 38% at 2 y | median 8.9 months; 33% at 12 mo; 10% at 2 y | P<0.001The P value is printed after the survival rates. Severe side effects occurred in 44% and life-threatening side effects in 20% of the combined-therapy group, vs 25% and 3% with radiotherapy alone. Combined therapy had fewer local (P<0.02) and distant (P<0.01) recurrences. |
| OSRandomised part of the trial, at least 5 years of follow-up | long term-updateCooper 1999 | 26% at 5 y (15–37%) | 0% at 5 y | In the succeeding non-randomised part, combined therapy gave a 5-year overall survival of 14% (95% CI 6% to 23%). The abstract gives 62 patients in the radiotherapy-only arm and 134 on combined therapy overall (randomised plus non-randomised); the randomised combined-therapy arm size is not stated. Chemotherapy could be given as planned in 89 (68%) of 130 patients. |
| Endpoint | Analysis | Chemotherapy plus radiotherapy | Radiotherapy alone | Effect |
|---|---|---|---|---|
| OSRandomised patients at the trial's stopping point (121) | primaryHerskovic 1992 | median 12.5 months; 50% at 12 mo; 38% at 2 y | median 8.9 months; 33% at 12 mo; 10% at 2 y | P<0.001The P value is printed after the survival rates. Severe side effects occurred in 44% and life-threatening side effects in 20% of the combined-therapy group, vs 25% and 3% with radiotherapy alone. Combined therapy had fewer local (P<0.02) and distant (P<0.01) recurrences. |
| OSRandomised part of the trial, at least 5 years of follow-up | long term-updateCooper 1999 | 26% at 5 y (15–37%) | 0% at 5 y | In the succeeding non-randomised part, combined therapy gave a 5-year overall survival of 14% (95% CI 6% to 23%). The abstract gives 62 patients in the radiotherapy-only arm and 134 on combined therapy overall (randomised plus non-randomised); the randomised combined-therapy arm size is not stated. Chemotherapy could be given as planned in 89 (68%) of 130 patients. |
- Chemotherapy plus radiotherapy (experimental)
- Radiotherapy alone (control)
Data table (modelled values)
| Months | Chemotherapy plus radiotherapy | Radiotherapy alone |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 6 | 72.6% | 63.8% |
| 13 | 47.7% | 29.5% |
| 19 | 41.1% | 17.4% |
| 26 | 38.0% | 10.0% |
Appears in
Sources
Herskovic A, Martz K, al-Sarraf M, Leichman L, Brindle J, Vaitkevicius V, et al. Combined chemotherapy and radiotherapy compared with radiotherapy alone in patients with cancer of the esophagus. N Engl J Med. 1992;326(24):1593-8.
Cooper JS, Guo MD, Herskovic A, Macdonald JS, Martenson JA Jr, Al-Sarraf M, et al. Chemoradiotherapy of locally advanced esophageal cancer: long-term follow-up of a prospective randomized trial (RTOG 85-01). Radiation Therapy Oncology Group. JAMA. 1999;281(17):1623-7.