Table 3. Patient demographics and baseline characteristics.
Age | Gender | ECOG PS | Histology | Criteria for study participation | Number of prior 131 therapies.* | Prior Cumulative I131 dose | Time since last I131 therapy (Months) | Times since diagnosis of metastatic disease (months) | Metastatic sites | PFS |
---|---|---|---|---|---|---|---|---|---|---|
72 | Male | 0 | Follicular | 3 | 3 | 930 | 23 | 78 | Lung, Bone | 107 |
37 | Female | 0 | Papillary arising in a Struma ovarii | 4 | 3 | 757 | 14 | 50 | Liver, retroperitoneal lymphadenopathy | 147 |
58 | Male | 0 | Papillary-follicular | 4 | 2 | 290 | 6 | 18 | Bone | 433 |
54 | Male | 0 | Papillary | 3 | 1 | 154 | 49 | 49 | Lung, bone | 202 |
65 | Female | 1 | Papillary | 1,2 | 1 | 158 | 5 | 5 | Lung | 548 |
59 | Male | 1 | Papillary | 1 | 2 | Unknown | 80 | 80 | Bone, Mediastinal mass | 253 |
*. Criteria to participate in the study 1) One or more measurable lesions with low or absent 131I uptake on the most recent pre-study radioiodine scans. 2) Disease progression according to RECIST criteria in imaging studies within 12 months of 131I therapy despite 131I uptake on RAI scan. 3) >50% increase in suppressed thyroglobulin levels during 12 months of I-131 therapy despite 131I uptake on RAI scan). 4) Evidence of at least one site of known disease with preserved 131I uptake above background levels on a diagnostic post-therapy 131I scan prior to study entry.