E1308
E1308: Phase II Trial of Induction Chemotherapy Followed by Reduced-Dose Radiation and Weekly Cetuximab in Patients With HPV-Associated Resectable Squamous Cell Carcinoma of the Oropharynx
Phase 2N = 90NCT01084083
- Population
- HPV16-positive and/or p16-positive stage III-IV oropharyngeal squamous cell carcinoma; median age 57 years
- Design
- Single-arm phase II trial: 90 patients with HPV16 and/or p16-positive stage III-IV oropharyngeal squamous cell carcinoma were enrolled and 80 were evaluable. Three cycles of induction cisplatin, paclitaxel and cetuximab; patients with a primary-site complete clinical response received IMRT 54 Gy with weekly cetuximab, and those with less than a complete response at the primary site or nodes received 69.3 Gy with cetuximab to those regions. Primary end point: 2-year progression-free survival. Median follow-up 35.4 months.
- Primary endpoint
- PFS
- Arms
- Induction chemotherapy then response-adapted radiation (experimental): Induction cisplatin, paclitaxel and cetuximab for three cycles, then IMRT 54 Gy with weekly cetuximab for primary-site complete responders (69.3 Gy otherwise)
- People
- Marur S, ECOG-ACRIN Cancer Research Group
Show the numbers
| Endpoint | Analysis | Induction chemotherapy then response-adapted radiation | Control | Effect |
|---|---|---|---|---|
| PFSPatients with primary-site complete clinical response to induction chemotherapy treated with 54 Gy | primarymedian follow-up 35.4 monthsMarur 2017 | 80% at 2 y | — | 51 patients treated with 54 Gy after primary-site complete clinical response. |
| OSPatients with primary-site complete clinical response to induction chemotherapy treated with 54 Gy | primarymedian follow-up 35.4 monthsMarur 2017 | 94% at 2 y | — | 51 patients treated with 54 Gy after primary-site complete clinical response. |
| PFSSubgroup: less than T4, less than N2c, 10 pack-years or fewer, treated with 54 Gy or less | exploratorymedian follow-up 35.4 monthsMarur 2017 | 96% at 2 y | — | 27 patients in this subgroup. |
| OSSubgroup: less than T4, less than N2c, 10 pack-years or fewer, treated with 54 Gy or less | exploratorymedian follow-up 35.4 monthsMarur 2017 | 96% at 2 y | — | 27 patients in this subgroup. |
| Endpoint | Analysis | Induction chemotherapy then response-adapted radiation | Control | Effect |
|---|---|---|---|---|
| PFSPatients with primary-site complete clinical response to induction chemotherapy treated with 54 Gy | primarymedian follow-up 35.4 monthsMarur 2017 | 80% at 2 y | — | 51 patients treated with 54 Gy after primary-site complete clinical response. |
| OSPatients with primary-site complete clinical response to induction chemotherapy treated with 54 Gy | primarymedian follow-up 35.4 monthsMarur 2017 | 94% at 2 y | — | 51 patients treated with 54 Gy after primary-site complete clinical response. |
| PFSSubgroup: less than T4, less than N2c, 10 pack-years or fewer, treated with 54 Gy or less | exploratorymedian follow-up 35.4 monthsMarur 2017 | 96% at 2 y | — | 27 patients in this subgroup. |
| OSSubgroup: less than T4, less than N2c, 10 pack-years or fewer, treated with 54 Gy or less | exploratorymedian follow-up 35.4 monthsMarur 2017 | 96% at 2 y | — | 27 patients in this subgroup. |
Appears in
Sources
Marur S, Li S, Cmelak AJ, Gillison ML, Zhao WJ, Ferris RL, et al. E1308: Phase II Trial of Induction Chemotherapy Followed by Reduced-Dose Radiation and Weekly Cetuximab in Patients With HPV-Associated Resectable Squamous Cell Carcinoma of the Oropharynx- ECOG-ACRIN Cancer Research Group. J Clin Oncol. 2017;35(5):490-497.