Table 2:
Activity outcomes (overall cohort and subgroups)
| Overall response |
Clinical benefit |
Median time to treatment failure |
12-month overall survival |
|||
|---|---|---|---|---|---|---|
| n/N | % (95% CI) | n/N | % (95% CI) | |||
| Overall cohort | 30/112 | 27% (19–36) | 83/112 | 74% (65–82) | 6·7 (5·5– 8·6) | 51% (39–62) |
| Histology | ||||||
| Papillary | 18/66 | 27% (17–40) | 48/66 | 73% (60–83) | 6·9 (4·6–10·1) | 46% (31–60) |
| Xp11.2 translocation | 5/17 | 29% (10–56) | 14/17 | 82% (57–96) | 8·3 (4·6–NR) | 69% (36–87) |
| Unclassified | 2/15 | 13% (2–40) | 10/15 | 67% (38–88) | 6·0 (1·4–9·9) | 36% (8–67) |
| Chromophobe | 3/10 | 30% (7–65) | 7/10 | 70% (35–93) | 5·7 (1·1–7·8) | 60% (16–87) |
| Collecting duct | 2/4 | 50% (7–93) | 4/4 | 100% (40–99) | NC | NC |
| Sarcomatoid features | ||||||
| Yes | 6/30 | 20% (8–39) | 23/30 | 77% (58–90) | 5·1 (2·8–6·2) | 25% (8–47) |
| No | 13/51 | 25% (14–40) | 34/51 | 67% (52–79) | 7·4 (4·6–11·0) | 48% (31–64) |
| Treatment | ||||||
| First line | 5/22 | 23% (8–45) | 18/22 | 82% (60–95) | 7·6 (5·5–17·2) | 60% (29–81) |
| Second line or more | 25/90 | 28% (19–38) | 65/90 | 72% (62–81) | 6·2 (4·6–8·6) | 49% (36–61) |
| Type of previous systemic therapies | ||||||
| Immunotherapy | 4/12 | 33% (10–65) | 10/12 | 83% (52–98) | 5·1 (1·8–7·8) | 27% (1–66) |
| Tyrosine kinase inhibitor | 11/39 | 28% (15–45) | 24/39 | 62% (45–77) | 6·2 (3·4–10·6) | 54% (36–70) |
| Tyrosine kinase inhibitor and immunotherapy | 10/36 | 28% (14–45) | 28/36 | 78% (61–90) | 6·9 (4·6–11·0) | 48% (28–66) |
| Other | 0/3 | 0 | 3/3 | 100% (29–99) | NC | NC |
| IMDC risk group | ||||||
| Favourable | 5/9 | 56% (21–86) | 8/9 | 89% (52–99) | 11·0 (6·2–NR) | 67% (19–90) |
| Intermediate | 15/71 | 21% (12–32) | 52/71 | 73% (61–83) | 6·0 (4·6–7·8) | 51% (36–64) |
| Poor | 9/29 | 31% (15–51) | 21/29 | 72% (53–87) | 8·0 (3·7–15·9) | 46% (23–66) |
| Presence of bone metastasis* | ||||||
| Yes | 10/49 | 20% (10–34) | 38/49 | 78% (63–88) | 6·9 (4·8–9·0) | 44% (27–60) |
| No | 20/63 | 32% (21–45) | 45/63 | 71% (59–82) | 6·4 (4·6–11·0) | 57% (41–71) |
Data are n/N, % (95% CI), or months (95% CI). NR=not reached. NC=not calculated (too few patients to calculate reliably). IMDC=International Metastatic Renal Cell Carcinoma Database Consortium.
*
All patients with bone metastasis also had either lymph node or visceral metastases.