TABLE 3.
Arm A, n (%) | Arm B, n (%) | |
---|---|---|
Overall response rates (n = 76)b | ||
CR | 2/40 (5) | 1/33 (3) |
PR | 19/40 (47)c | 10/33 (30)c |
SD | 12/40 (30) | 9/33 (27) |
PD | 7/40 (18) | 13/33 (39) |
Not evaluable | 2 | 1 |
Antitumor activity assessed by PET EORTC criteria when available and by CT RECIST criteria 1.0 when no PET was available.
Six patients did not get repeat imaging: Three patients (one in Arm A and two in Arm B) died before repeat imaging and were assigned as PD. One patient in Arm A went to surgery during cycle 1, and one patient was taken off trial for toxicity without progression. In Arm B, one patient was removed for toxicity without progression.
95% confidence interval for overall response (CR + PR) 36–68% and 18–52% for Arm A and B, respectively.
CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; PET, positron emission tomography; EORTC, European Organization for Research and Treatment of Cancer.