Abstract 141P
Background
This study describes the real-world prescribing patterns, effectiveness, and tolerability of cabozantinib in patients in Taiwan with advanced renal cell carcinoma (aRCC) that progressed despite prior antiangiogenic therapy.
Methods
This retrospective cohort study used clinical records from seven hospitals in Taiwan (October 2018–quarter 4 2020). Adults (aged ≥ 20 years, living or deceased) who had received at least one dose of cabozantinib for aRCC after at least one prior antiangiogenic therapy enrolled. Participants were characterized at baseline, and cabozantinib use (dose, treatment line, prior therapies), effectiveness (objective response rate [ORR], progression-free survival [PFS]) and tolerability (adverse events [AEs]) were described.
Results
In total, 51 patients enrolled (Table). Cabozantinib was 2L therapy for 20 patients (39%), 3L for 17 (33%) and 4+L for 14 (27%). The most common prior therapies were sunitinib and pazopanib. Seven patients (14%; 2L, 1; 3L, 3; 4+L, 3) received cabozantinib combined with another therapy. Initial cabozantinib dose was 60 mg/day for 57% of patients and 40 mg/day for 33%; of these, 72% and 12%, respectively, had a dose reduction. Treatment was interrupted for 26% of patients and discontinued for 49%. During a median treatment duration of 9.7 (range, 3–29) months, mean daily cabozantinib dose was 44.4 mg. ORR was 39%; 20 patients had a partial response and 0 a complete response. Duration of response and PFS (median [95% CI]) were 9.5 (9.1, NE) and 12.4 (8.2, 16.3) months, respectively. The most common AEs were diarrhea (39% of patients) and palmar–plantar erythrodysesthesia (37%). Eleven patients (22%) had AEs of grade 3 or higher; four patients (8%) had serious AEs related to cabozantinib. One patient died due to an AE (consciousness disturbance not related to cabozantinib).
Conclusions
In this real-world study in Taiwan, cabozantinib prescribing patterns broadly aligned with the label. Outcomes were generally consistent with the pivotal, phase 3 METEOR trial. No new safety signals were found Table: 141P
2L cabozantinibN = 20 | 3L cabozantinibN = 17 | 4+L cabozantinibN = 14 | TotalN = 51 | |
Male, n (%) | 17 (85.0) | 14 (82.4) | 10 (71.4) | 41 (80.4) |
Agea, yrs, mean (SD) | 61.8 (10.4) | 59.4 (9.3) | 62.5 (11.4) | 61.2 (10.2) |
Metastatic RCCa, n (%) | 18 (90.0) | 16 (94.1) | 13 (92.9) | 47 (92.2) |
Clear cell RCC, n (%) | 15 (75.0) | 13 (76.5) | 13 (92.9) | 41 (80.4) |
Prior sunitinib, n (%) | 8 (40.0) | 13 (76.5) | 11 (78.6) | 32 (62.7) |
Prior pazopanib, n (%) | 11 (55.0) | 8 (47.1) | 8 (57.1) | 27 (52.9) |
Cabozantinib dose, mg/day, mean (SD) | 47.3 (10.4) | 39.9 (9.5) | 45.7 (10.4) | 44.4 (10.4) |
Cabozantinib treatment duration, months, median (range) | 10.5 (3–29) | 9.5 (3–15) | 8.8 (3–29) | 9.7 (3–29) |
Objective response rate, % | 55.0 | 23.5 | 35.7 | 39.2 |
aAt cabozantinib initiation.
.Clinical trial identification
Editorial acknowledgement
Dr Ruth Gandolfo of Oxford PharmaGenesis, Oxford, UK, provided medical writing and editorial support, which was sponsored by Ipsen, in accordance with Good Publication Practice guidelines.
Legal entity responsible for the study
Ipsen.
Funding
Ipsen.
Disclosure
Y. Tsai: Financial Interests, Personal, Advisory Board: Ipsen; Financial Interests, Personal, Invited Speaker: Ipsen. J. Guo: Financial Interests, Personal, Speaker’s Bureau, Honoraria: Ipsen. E. Wang, V. Perrot: Financial Interests, Personal, Full or part-time Employment: Ipsen. All other authors have declared no conflicts of interest.
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