Drug costs: acquisition costs are critical but not the entire story of financial toxicity

Kaye, Deborah R.

doi:10.1111/bju.16092

Cited by 1 publication

(1 citation statement)

References 7 publications

(8 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…A sequential design was chosen in preference to an upfront combination approach, for two reasons: (1) so that intensified treatment could be directed to those most likely to require it, sparing others from unnecessary potential treatment-related toxicity, and (2) to reduce cost associated with treatment and improve the likelihood of securing government reimbursement for ongoing supply of the drug(s), if the trial was successful. There are currently no subsidized anti-cancer therapies for this population in Australia and financial toxicity is a concern for patients and health systems [22].…”

Section: Introductionmentioning

confidence: 99%

A phase II trial of nivolumab followed by ipilimumab and nivolumab in advanced non‐clear‐cell renal cell carcinoma

Conduit,

Davis,

Goh

et al. 2023

BJU International

View full text Add to dashboard Cite

ObjectiveTo evaluate the efficacy of sequential treatment with ipilimumab and nivolumab following progression on nivolumab monotherapy in individuals with advanced, non‐clear‐cell renal cell carcinoma (nccRCC).Materials and MethodsUNISoN (ANZUP1602; NCT03177239) was an open‐label, single‐arm, phase 2 clinical trial that recruited adults with immunotherapy‐naïve, advanced nccRCC. Participants received nivolumab 240 mg i.v. two‐weekly for up to 12 months (Part 1), followed by sequential addition of ipilimumab 1 mg/kg three‐weekly for four doses to nivolumab if disease progression occurred during treatment (Part 2). The primary endpoint was objective tumour response rate (OTRR) and secondary endpoints included duration of response (DOR), progression‐free (PFS) and overall survival (OS), and toxicity (treatment‐related adverse events).ResultsA total of 83 participants were eligible for Part 1, including people with papillary (37/83, 45%), chromophobe (15/83, 18%) and other nccRCC subtypes (31/83, 37%); 41 participants enrolled in Part 2. The median (range) follow‐up was 22 (16–30) months. In Part 1, the OTRR was 16.9% (95% confidence interval [CI] 9.5–26.7), the median DOR was 20.7 months (95% CI 3.7‐not reached) and the median PFS was 4.0 months (95% CI 3.6–7.4). Treatment‐related adverse events were reported in 71% of participants; 19% were grade 3 or 4. For participants who enrolled in Part 2, the OTRR was 10%; the median DOR was 13.5 months (95% CI 4.8–19.7) and the median PFS 2.6 months (95% CI 2.2–3.8). Treatment‐related adverse events occurred in 80% of these participants; 49% had grade 3, 4 or 5. The median OS was 24 months (95% CI 16–28) from time of enrolment in Part 1.ConclusionsNivolumab monotherapy had a modest effect overall, with a few participants experiencing a long DOR. Sequential combination immunotherapy by addition of ipilimumab in the context of disease progression to nivolumab in nccRCC is not supported by this study, with only a minority of participants benefiting from this strategy.

show abstract

Section: Introductionmentioning

confidence: 99%