RTOG 91-11
Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer (Intergroup RTOG 91-11)
Phase 3N = 547NCT00002496
- Population
- Patients with locally advanced (stage III or IV) glottic or supraglottic squamous cell carcinoma of the larynx
- Design
- Intergroup randomised trial in locally advanced laryngeal cancer (stage III or IV glottic or supraglottic squamous cell cancer): 547 patients were randomised to induction cisplatin plus fluorouracil followed by radiotherapy, radiotherapy with concurrent cisplatin, or radiotherapy alone. The 2003 report names preservation of the larynx as the primary end point; the long-term report (520 patients analysed) names the composite end point of laryngectomy-free survival. The long-term paper calls induction chemotherapy followed by radiotherapy the control arm and describes laryngectomy-free survival as the primary end point.
- Primary endpoint
- Larynx preservation, Laryngectomy-free survival
- Arms
- Induction cisplatin-fluorouracil then radiotherapy (control): Induction cisplatin plus fluorouracil followed by radiotherapy
- Radiotherapy with concurrent cisplatin (experimental): Radiotherapy with concurrent administration of cisplatin
- Radiotherapy alone (control): Radiotherapy alone
- People
- Forastiere AA, Radiation Therapy Oncology Group (Intergroup)
Δ 24-month Larynx preservation+13 pointsΔ Locoregional control+17 pointsLaryngectomy-free survivalHR 0.75 (95% CI 0.59–0.95)Laryngectomy-free survivalHR 0.78 (95% CI 0.61–0.98)Larynx preservationHR 0.58 (95% CI 0.37–0.89)OSHR 1.25 (95% CI 0.98–1.61)
Show the numbers
| Endpoint | Analysis | Radiotherapy with concurrent cisplatin | Induction cisplatin-fluorouracil then radiotherapy / Radiotherapy alone | Effect |
|---|---|---|---|---|
| Larynx preservationRandomised patients (547); analysis population not stated in the abstractProportion of patients with an intact larynx at two years | primarymedian follow-up 3.8 yearsForastiere 2003 | 88% at 2 y | 75% at 2 y | P=0.005 versus induction; <0.001 versus radiotherapy alone |
| Locoregional controlRandomised patients (547); analysis population not stated in the abstract | primarymedian follow-up 3.8 yearsForastiere 2003 | 78% | 61% | The abstract does not restate the time point for these rates (the preceding sentence refers to two years); no p-value is given for this sentence. |
| Laryngectomy-free survivalPatients analysed in the long-term report (520) | long term-updatemedian follow-up 10.8 yearsForastiere 2013 | — | — | HR 0.75 (95% CI 0.59–0.95)P=0.02520 patients analysed. Hazard ratio for induction cisplatin-fluorouracil followed by radiotherapy versus radiotherapy alone. Median follow-up (10.8 years) is for surviving patients. |
| Laryngectomy-free survivalPatients analysed in the long-term report (520) | long term-updatemedian follow-up 10.8 yearsForastiere 2013 | — | — | HR 0.78 (95% CI 0.61–0.98)P=0.03Hazard ratio for concurrent cisplatin plus radiotherapy versus radiotherapy alone (Table 2 footnote: hazard of the first treatment listed over the second). The abstract misprints the lower confidence bound as 0.78; the full-text table gives 0.61. |
| Larynx preservationPatients analysed in the long-term report (520)Time to laryngectomy; the hazard ratio is the hazard of laryngectomy with concurrent cisplatin plus radiotherapy over the hazard with induction chemotherapy plus radiotherapy | long term-updatemedian follow-up 10.8 yearsForastiere 2013 | — | — | HR 0.58 (95% CI 0.37–0.89)P=0.0050A hazard ratio below 1 means fewer laryngectomies with concurrent cisplatin plus radiotherapy than with induction chemotherapy followed by radiotherapy. |
| OSPatients analysed in the long-term report (520) | long term-updatemedian follow-up 10.8 yearsForastiere 2013 | — | — | HR 1.25 (95% CI 0.98–1.61)P=0.08Hazard ratio for concurrent cisplatin plus radiotherapy versus induction chemotherapy followed by radiotherapy. |
| Endpoint | Analysis | Radiotherapy with concurrent cisplatin | Induction cisplatin-fluorouracil then radiotherapy / Radiotherapy alone | Effect |
|---|---|---|---|---|
| Larynx preservationRandomised patients (547); analysis population not stated in the abstractProportion of patients with an intact larynx at two years | primarymedian follow-up 3.8 yearsForastiere 2003 | 88% at 2 y | 75% at 2 y | P=0.005 versus induction; <0.001 versus radiotherapy alone |
| Locoregional controlRandomised patients (547); analysis population not stated in the abstract | primarymedian follow-up 3.8 yearsForastiere 2003 | 78% | 61% | The abstract does not restate the time point for these rates (the preceding sentence refers to two years); no p-value is given for this sentence. |
| Laryngectomy-free survivalPatients analysed in the long-term report (520) | long term-updatemedian follow-up 10.8 yearsForastiere 2013 | — | — | HR 0.75 (95% CI 0.59–0.95)P=0.02520 patients analysed. Hazard ratio for induction cisplatin-fluorouracil followed by radiotherapy versus radiotherapy alone. Median follow-up (10.8 years) is for surviving patients. |
| Laryngectomy-free survivalPatients analysed in the long-term report (520) | long term-updatemedian follow-up 10.8 yearsForastiere 2013 | — | — | HR 0.78 (95% CI 0.61–0.98)P=0.03Hazard ratio for concurrent cisplatin plus radiotherapy versus radiotherapy alone (Table 2 footnote: hazard of the first treatment listed over the second). The abstract misprints the lower confidence bound as 0.78; the full-text table gives 0.61. |
| Larynx preservationPatients analysed in the long-term report (520)Time to laryngectomy; the hazard ratio is the hazard of laryngectomy with concurrent cisplatin plus radiotherapy over the hazard with induction chemotherapy plus radiotherapy | long term-updatemedian follow-up 10.8 yearsForastiere 2013 | — | — | HR 0.58 (95% CI 0.37–0.89)P=0.0050A hazard ratio below 1 means fewer laryngectomies with concurrent cisplatin plus radiotherapy than with induction chemotherapy followed by radiotherapy. |
| OSPatients analysed in the long-term report (520) | long term-updatemedian follow-up 10.8 yearsForastiere 2013 | — | — | HR 1.25 (95% CI 0.98–1.61)P=0.08Hazard ratio for concurrent cisplatin plus radiotherapy versus induction chemotherapy followed by radiotherapy. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| Laryngectomy-free survival | 0.75 | 0.59–0.95 |
| Laryngectomy-free survival | 0.78 | 0.61–0.98 |
| Larynx preservation | 0.58 | 0.37–0.89 |
| OS | 1.25 | 0.98–1.61 |
Appears in
Sources
Forastiere AA, Goepfert H, Maor M, Pajak TF, Weber R, Morrison W, et al. Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer. N Engl J Med. 2003;349(22):2091-8.
Forastiere AA, Zhang Q, Weber RS, Maor MH, Goepfert H, Pajak TF, et al. Long-term results of RTOG 91-11: a comparison of three nonsurgical treatment strategies to preserve the larynx in patients with locally advanced larynx cancer. J Clin Oncol. 2013;31(7):845-52.