Tivozanib (T) as first-line (1L) treatment of metastatic renal cell carcinoma (mRCC): A real-world outcome review in North-West of England (NWE), UK.

Authors

null

Jonathan Heseltine

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

Organizations

Clatterbridge Cancer Centre, Wirral, United Kingdom, Christie NHS Foundation Trust, Manchester, United Kingdom, The Clatterbridge Cancer Centre, Wirral, United Kingdom, Rosemere Centre, Royal Preston Hospital, Preston, United Kingdom, Royal Preston Hospital, Preston, United Kingdom, Clatterbridge Cancer Centre NHS Foundation Trust, Wirral, United Kingdom, The Christie NHS Foundation Trust, Manchester, United Kingdom, Bebington, Wirral, United Kingdom

Research Funding

No funding received

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.

Baseline demographics.

Median Age
69 (range 42-84)
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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Abstract Details

Meeting

2022 ASCO Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session C: Renal Cell Cancer; Adrenal, Penile, Urethral, and Testicular Cancers

Track

Renal Cell Cancer,Adrenal Cancer,Penile Cancer,Testicular Cancer,Urethral Cancer

Sub Track

Therapeutics

Citation

J Clin Oncol 40, 2022 (suppl 6; abstr 335)

DOI

10.1200/JCO.2022.40.6_suppl.335

Abstract #

335

Poster Bd #

Online Only

Abstract Disclosures