Table 3.
Tumor Response According to RECIST
| Parameter | PTC Arm A and Chemotherapy- Naïve PTC Arm B Patients |
Arm B |
||||||
|---|---|---|---|---|---|---|---|---|
| PTC (patients with prior chemotherapy) |
HTC or FTC |
ATC |
||||||
| No. | % | No. | % | No. | % | No. | % | |
| Total patients | 33 | 8 | 11 | 4 | ||||
| Assessable patients | 28 | 85 | 8 | 100 | 10 | 91 | 4 | |
| Best response by RECIST | ||||||||
| Complete response | 0 | 0 | 0 | 0 | ||||
| PR* | 5 | 15 | 1 | 13 | 0 | 0 | ||
| SD | 19 | 57 | 6 | 75 | 9 | 82 | 1 | 25 |
| Progressive disease | 4 | 12 | 1 | 12 | 1 | 9 | 3 | 75 |
| Durable SD, ≥ 6 months | 19 | 57 | 4 | 50 | 6 | 54 | 1 | 25 |
| Objective response, % | 15 | 13 | — | — | — | — | ||
| 95% CI | 5 to 32 | 0.3 to 53 | ||||||
| Median time to PR, months | 12 | 20 | — | — | — | — | ||
| Range | 2 to 12 | |||||||
| Median duration of PR† | 9 | 6 | — | — | — | — | ||
| Range | 6 to 14 | |||||||
| PFS | ||||||||
| Kaplan-Meier estimate of median PFS, months | 16 | 10 | 4.5 | |||||
| 95% CI | 8 to 27.5 | 4 to 28 | 2 to 16 | |||||
| Kaplan-Meier estimate of 1-year PFS rate, % | 59 | 47 | 30 | |||||
| 95% CI | 40 to 78 | 10 to 83 | 5 to 55 | |||||
| OS | ||||||||
| Median Kaplan-Meier median estimate, months | 23 | 37.5 | 24. 2 | |||||
| 95% CI | 18 to 34 | 4 to 42.5 | 11 to 37.5 | |||||
| Kaplan-Meier 1-year estimate, % | 87 | 63 | 64 | |||||
| 95% CI | 75 to 99 | 29 to 96 | 38 to 90 | |||||
Abbreviations: RECIST, Response Evaluation Criteria in Solid Tumors; PTC, papillary thyroid cancer; HTC, Hürthle cell carcinoma; FTC, follicular thyroid cancer; ATC, anaplastic thyroid cancer; PR, partial response; SD, stable disease; PFS, progression-free survival; SD, stable disease.
*
Partial response was confirmed at 2 months in four patients and at 3 months in two patients.
†
One patient has partial response of at least 14 months duration as evaluated at the last response assessment and is still on therapy; 14 months duration of PR has been taken as duration of response in this case.