Clatterbridge Cancer Centre, Wirral, United Kingdom
Jonathan Heseltine , Jennifer Allison , Sam Wong , Kellati Prasad , Helen Wong , Zhu Oong , Natalie Charnley , Andrea Law , Omi Parikh , Manon Rhys Pillai , Tom Waddell , Richard Griffiths , Shien Chow
Background: The TIVO-1 study demonstrated improved PFS in mRCC patients (pts) undergoing 1L treatment with T compared with sorafenib. We previously presented outcomes of our experience of T in 4 cancer centres in NWE. Here we present updated outcomes with longer follow-up (FU). Methods: mRCC pts commencing 1L T March 2017- May 2019 were identified. Outcomes of interest included overall response rate (ORR), survival (OS, PFS) and toxicity. Data cut off for this update was 30/11/2020. Results: 113 pts were identified with characteristics as in the table. Median FU was 25.9 mo (18.3-44.7mo), 18% pts remain on treatment at data cut-off. 88.5% commenced T at full dose, of which 67% maintained dose intensity. 11.5% commenced T with dose reduction due to prior TKI toxicities or comorbidities. Median number of cycles was 7 (1-33). In terms of efficacy, ORR was 29% (CR 0%, PR29%, SD39%, PD26%, NE 6%) and median PFS was 9.0 months (95% C.I. 6.0-12.1mo). Median PFS by IMDC risk group was: F= 23.0 months (95% C.I. 7.6-38.4mo); I= 10.0 months (95% C.I. 6.3-13.7mo); P= 3.0 months (95% C.I. 1.5.- 4.5mo), p value<0.0001. Median OS was 25.0 months (95% C.I. 15.4-34.6mo). Median OS by IMDC risk group was: F= NR with 72% alive at data cut-off; I= 26.0 months (95% C.I. 17.9-34.1mo); P= 7.0 months (95% C.I. 4.4-9.6mo), p value<0.0001. Adverse events (AEs) of any grade occurred in 77% (≥G3 13%) including fatigue 42% (≥G3 0%), diarrhoea 19% (≥G3 < 1%), mucositis 24% ( ≥G3 2%), anorexia 12% (≥G3 < 1%); and hypertension 7% (≥G3 2%). Notable ≥G3 events included abnormal liver function 3%; vascular events 2% and seizure < 1%. 18% of patients discontinued treatment due to toxicity with no treatment-related deaths. Conclusions: Our real world experience of 1L T suggests comparable activity with randomized data and other TKIs, particularly in F and I IMDC risk groups. The low incidence of serious AEs makes it an attractive option if unsuitable for combination therapies.
Median Age | 69 (range 42-84) |
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Karnofsky performance status | 88 (78%) PS 0 or 1 |
Histology | 93 (82%) confirmed clear cell, 20 (18%) undefined |
IMDC risk | Favourable (F) – 25 (22%); Intermediate (I) - 59 (52%); Poor (P) – 29 (26%) |
Previous nephrectomy | 75 (66%) |
First-line drug or 2nd line & switched from prior TKI due to toxicity | 102 (90%) |
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