RTOG 0129
Human papillomavirus and survival of patients with oropharyngeal cancer: retrospective analysis of patients in a randomized trial of accelerated- versus standard-fractionation radiotherapy with cisplatin
Phase observationalN = 323NCT00047008
- Population
- Patients with stage III or IV oropharyngeal squamous-cell carcinoma and known tumour HPV status (206 HPV-positive, 117 HPV-negative)
- Design
- Retrospective, post hoc analysis by tumour HPV status of patients with stage III or IV oropharyngeal squamous-cell carcinoma enrolled in a randomised trial comparing accelerated-fractionation (concomitant boost) with standard-fractionation radiotherapy, each with cisplatin; the analysis was not part of the study protocol. The HPV comparison is not randomised. The parent trial is registered as phase III (ClinicalTrials.gov, RTOG 0129): 743 enrolled, 721 analysed, 433 with oropharyngeal cancer, of whom 323 had HPV status.
- Primary endpoint
- OS
- Arms
- HPV-negative tumours (exposure group, not a randomised arm) (control, n = 117): Cisplatin-based radiotherapy as assigned in the parent trial (59 standard fractionation, 58 accelerated); reference group for the HPV comparison
- HPV-positive tumours (exposure group, not a randomised arm) (experimental, n = 206): Cisplatin-based radiotherapy as assigned in the parent trial (106 standard fractionation, 100 accelerated)
- People
- Ang KK, senior author Gillison ML
OSHR 0.42 (95% CI 0.27–0.66)Δ 36-month OS+25.3 points
Show the numbers
| Endpoint | Analysis | HPV-positive tumours (exposure group, not a randomised arm) | HPV-negative tumours (exposure group, not a randomised arm) | Effect |
|---|---|---|---|---|
| OSPatients with oropharyngeal cancer in the analysis; HPV-positive vs HPV-negative tumours | exploratorymedian follow-up 4.8 yearsAng 2010 | 82.4% at 3 y (77.2–87.6%) | 57.1% at 3 y (48.1–66.1%) | HR 0.42 (95% CI 0.27–0.66)P<0.001Landmark OS compared by the log-rank test (P<0.001). The hazard ratio for death (HPV-positive vs HPV-negative) is adjusted for age, race, tumour and nodal stage, tobacco exposure and treatment assignment; the authors describe it as a 58% reduction in the risk of death. Not a randomised comparison. |
| Endpoint | Analysis | HPV-positive tumours (exposure group, not a randomised arm) | HPV-negative tumours (exposure group, not a randomised arm) | Effect |
|---|---|---|---|---|
| OSPatients with oropharyngeal cancer in the analysis; HPV-positive vs HPV-negative tumours | exploratorymedian follow-up 4.8 yearsAng 2010 | 82.4% at 3 y (77.2–87.6%) | 57.1% at 3 y (48.1–66.1%) | HR 0.42 (95% CI 0.27–0.66)P<0.001Landmark OS compared by the log-rank test (P<0.001). The hazard ratio for death (HPV-positive vs HPV-negative) is adjusted for age, race, tumour and nodal stage, tobacco exposure and treatment assignment; the authors describe it as a 58% reduction in the risk of death. Not a randomised comparison. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| OS | 0.42 | 0.27–0.66 |