Epitopes-HPV02
Docetaxel, cisplatin, and fluorouracil chemotherapy for metastatic or unresectable locally recurrent anal squamous cell carcinoma (Epitopes-HPV02): a multicentre, single-arm, phase 2 study
Phase 2N = 69NCT02402842
- Population
- Adults with histologically confirmed anal squamous cell carcinoma, metastatic or with unresectable local recurrence, ECOG performance status 0 or 1, at least one RECIST-evaluable lesion; 69 enrolled, 66 treated (36 standard DCF, 30 modified DCF).
- Design
- Multicentre single-arm phase 2 study at 25 French hospitals and centres. Chemotherapy-naive patients received six cycles of standard DCF (docetaxel 75 mg/m2 and cisplatin 75 mg/m2 on day 1, fluorouracil 750 mg/m2 per day for 5 days, every 3 weeks) or eight cycles of modified DCF (docetaxel 40 mg/m2 and cisplatin 40 mg/m2 on day 1, fluorouracil 1200 mg/m2 per day for 2 days, every 2 weeks); the choice was recommended by age (75 or younger vs older than 75) and ECOG performance status (0 vs 1), not randomised. Primary endpoint: investigator-assessed progression-free survival at 12 months, met if at least 11 of 66 patients (17%) were alive and progression-free. Analysis in a modified intention-to-treat population.
- Primary endpoint
- 12-month progression-free rate
- Arms
- Docetaxel, cisplatin and fluorouracil (experimental, n = 66): Standard DCF (six cycles every 3 weeks; 36 patients) or modified DCF (eight cycles every 2 weeks; 30 patients), as recommended by age and performance status
- People
- Kim S, senior author Borg C
Show the numbers
| Endpoint | Analysis | Docetaxel, cisplatin and fluorouracil | Control | Effect |
|---|---|---|---|---|
| 12-month progression-free rateModified intention-to-treat population: patients evaluable for progression at 12 months who received at least one DCF cycle (n = 66)Alive and progression-free 12 months from the first DCF cycle, by investigator assessment | finalKim 2018 | 47% | — | 31 of 66 patients were alive and progression-free at 12 months; the primary endpoint was prespecified as met if at least 11 of 66 (17%) were. |
| Grade 3 or 4 adverse eventsTreated patients (n = 66) | finalKim 2018 | 70% | — | 46 of 66 patients had at least one grade 3-4 adverse event: 30 of 36 (83%) with standard DCF and 16 of 30 (53%) with modified DCF. The regimens were not randomised. |
| Endpoint | Analysis | Docetaxel, cisplatin and fluorouracil | Control | Effect |
|---|---|---|---|---|
| 12-month progression-free rateModified intention-to-treat population: patients evaluable for progression at 12 months who received at least one DCF cycle (n = 66)Alive and progression-free 12 months from the first DCF cycle, by investigator assessment | finalKim 2018 | 47% | — | 31 of 66 patients were alive and progression-free at 12 months; the primary endpoint was prespecified as met if at least 11 of 66 (17%) were. |
| Grade 3 or 4 adverse eventsTreated patients (n = 66) | finalKim 2018 | 70% | — | 46 of 66 patients had at least one grade 3-4 adverse event: 30 of 36 (83%) with standard DCF and 16 of 30 (53%) with modified DCF. The regimens were not randomised. |
Appears in
Sources
Kim S, François E, André T, Samalin E, Jary M, El Hajbi F, et al. Docetaxel, cisplatin, and fluorouracil chemotherapy for metastatic or unresectable locally recurrent anal squamous cell carcinoma (Epitopes-HPV02): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2018;19(8):1094-1106.