Real-world dosing and drug costs with everolimus or axitinib as second targeted therapies for advanced renal cell carcinoma: a retrospective chart review in the US

Pal, Sumanta K.; Jonasch, Eric; Signorovitch, James; Reichmann, William M.; Li, Nanxin; Liu, Zhimei; Perez, Jose Ricardo; Vogelzang, Nicholas J.

doi:10.3111/13696998.2015.1131705

Cited by 7 publications

(6 citation statements)

References 24 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Higher ORR (20–30%) was reported with VEGF-TKI compared to mTORi (≤ 10%), which is supported by our analysis [38]. Dose titration to 7 or 10 mg bid was feasible in 24% (35/148) of our patients, lower than the axitinib Asian trial (61.5%) [39] or the AXIS trial (37%) [10], but higher than other real-world studies (16%) [21–23, 40, 41]. We reported no differences in both mOS (p = 0.115) and mPFS (p = 0.1), in accordance to the phase II study of first-line axitinib [17, 23] but in contrast to Matias et al results, in which dose escalation at 2-weeks was associated to better ORR, PFS and TTF, but not OS.…”

Section: Discussionsupporting

confidence: 81%

Second line therapy with axitinib after only prior sunitinib in metastatic renal cell cancer: Italian multicenter real world SAX study final results

et al. 2019

View full text Add to dashboard Cite

Background This multi-institutional retrospective real life study was conducted in 22 Italian Oncology Centers and evaluated the role of Axitinib in second line treatment in not selected mRCC patients. Methods 148 mRCC patients were evaluated. According to Heng score 15.5%, 60.1% and 24.4% of patients were at poor risk, intermediate and favorable risk, respectively. Results PFS, OS, DCR and ORR were 7.14 months, 15.5 months, 70.6% and 16.6%, respectively. The duration of prior sunitinib treatment correlated with a longer significant mPFS, 8.8 vs 6.3 months, respectively. Axitinib therapy was safe, without grade 4 adverse events. The most frequent toxicities of all grades were: fatigue (50%), hypertension (26%), and hypothyroidism (18%). G3 blood pressure elevation significantly correlated with longer mPFS and mOS compared to G1-G2 or no toxicity. Dose titration (DT) to 7 mg and 10 mg bid was feasible in 24% with no statistically significant differences in mPFS and mOS. The sunitinib-axitinib sequence was safe and effective, the mOS was 41.15 months. At multivariate analysis, gender, DCR to axitinib and to previous sunitinib correlated significantly with PFS; whereas DCR to axitinib, nephrectomy and Heng score independently affected overall survival. Conclusions Axitinib was effective and safe in a not selected real life mRCC population. Trial registration INT – Napoli – 11/16 oss. Registered 20 April 2016. http://www.istitutotumori.na.it

show abstract

Section: Discussionsupporting

confidence: 81%

Second line therapy with axitinib after only prior sunitinib in metastatic renal cell cancer: Italian multicenter real world SAX study final results

et al. 2019

View full text Add to dashboard Cite

show abstract

“…In our analysis, the mPFS was 5.83 months (95% CI 3.93–7.73 months) with mOS of 13.3 months (95% CI 8.6–17.9 months). These results are similar to the Axis trial and the other real-life experiences (Vogl et al, 2013 ; Basso et al, 2014 ; Maroto et al, 2014 ; Matias et al, 2014 ; Signorovitch et al, 2015 ; Vogelzang et al, 2015 , 2016 ; Guida et al, 2016 ; Hutson et al, 2016 ; Laskey et al, 2016 ; Pal et al, 2016 ; Wagstaff et al, 2016 ). The majority of the evaluated studies are retrospective analysis of indirect comparison between standard second-line treatments (Everolimus vs. Axitinib) and use Axitinib in second or third line with the median duration of therapy as surrogate of mPFS; others are available only in abstract form, therefore not comparable.…”

Section: Discussionsupporting

confidence: 81%

“…Evidences from randomized clinical trials, retrospective studies or single-institution experiences do not provide clear and conclusive information which might guide the clinician in choosing Axitinib rather than Everolimus than Sorafenib, or vice versa, in the second-line setting, hence the decision is made exclusively on the basis of the safety profile and patients medical history. Several “real world” studies have showed the efficacy and safety of Axitinb in unselected populations (Vogl et al, 2013 ; Basso et al, 2014 ; Maroto et al, 2014 ; Matias et al, 2014 ; Signorovitch et al, 2015 ; Vogelzang et al, 2015 , 2016 ; Guida et al, 2016 ; Hutson et al, 2016 ; Laskey et al, 2016 ; Pal et al, 2016 ; Wagstaff et al, 2016 ), we thought to further reinforce such evidences publishing our own experience with the drug.…”

Section: Introductionmentioning

confidence: 99%

Axitinib after Sunitinib in Metastatic Renal Cancer: Preliminary Results from Italian “Real-World” SAX Study

D’Aniello

Vitale²,

Farnesi

et al. 2016

Front. Pharmacol.

View full text Add to dashboard Cite

Axitinib is an oral angiogenesis inhibitor, currently approved for treatment of metastatic renal cell carcinoma (mRCC) after failure of prior treatment with Sunitinib or cytokine. The present study is an Italian Multi-Institutional Retrospective Analysis that evaluated the outcomes of Axitinib, in second-line treatment of mRCC. The medical records of 62 patients treated with Axitinib, were retrospectively reviewed. The Progression Free Survival (PFS), the Overall Survival (OS), the Objective Response Rate (ORR), the Disease Control Rate (DCR), and the safety profile of axitinib and sunitinib–axitinib sequence, were the primary endpoint. The mPFS was 5.83 months (95% CI 3.93–7.73 months). When patients was stratified by Heng score, mPFS was 5.73, 5.83, 10.03 months according to poor, intermediate, and favorable risk group, respectively. The mOS from the start of axitinib was 13.3 months (95% CI 8.6–17.9 months); the observed ORR and DCR were 25 and 71%, respectively. When stratified patients by subgroups defined by duration of prior therapy with Sunitinib (≤ vs. >median duration), there was a statistically significant difference in mPFS with 8.9 (95% CI 4.39–13.40 months) vs. 5.46 months (95% CI 4.04–6.88 months) for patients with a median duration of Sunitinib >13.2 months. DCR and ORR to previous Sunitinib treatment was associated with longer statistically mPFS, 7.23 (95% CI 3.95–10.51 months, p = 0.01) and 8.67 (95% CI 4.0–13.33 months, p = 0.008) vs. 2.97 (95% CI 0.65–5.27 months, p = 0.01) and 2.97 months (95% CI 0.66–5.28 months, p = 0.01), respectively. Overall Axitinib at standard schedule of 5 mg bid, was well-tolerated. The most common adverse events of all grades were fatig (25.6%), hypertension (22.6%), gastro-intestinal disorders (25.9%), and hypothyroidism (16.1%). The sequence Sunitinib–Axitinib was well-tolerated without worsening in side effects, with a median OS of 34.7 months (95% CI 18.4–51.0 months). Our results are consistent with the available literature; this retrospective analysis confirms that Axitinib is effective and safe in routine clinical practice.

show abstract

“…16 Starting daily dose of each drug, dose escalation, highest daily dose, and treatment duration were reported. Pal et al (2016) also conducted a medical record review of patients with RCC using axitinib or everolimus after discontinuation of a tyrosine kinase inhibitor. 17 Their study mainly focused on costs but also reported whether patients' initiation dose was with the recommended dose and whether dose adjustments were made.…”

Section: Summary Of Literaturementioning

confidence: 99%

A Comprehensive Review of Methods to Measure Oral Oncolytic Dose Intensity Using Retrospective Data

Slejko

Rueda

Trovato

et al. 2019

JMCP

View full text Add to dashboard Cite

BACKGROUND: Understanding the real-world use of oral oncolytics is essential to assess drug effectiveness. Retrospective analyses using medical and pharmacy claims data allow observation of drug use patterns and health outcomes. However, studies of medication adherence to oral oncolytics may not be sufficient in characterizing exposure because they typically measure refill frequency, not the administered dose or dose changes. Patients who appear fully adherent by traditional measures may be receiving different doses and experiencing differing effectiveness. Relative dose intensity (RDI) is a measure that has been used for intravenous drugs to capture the amount of a particular chemotherapeutic agent administered per unit of time (dose intensity), expressed as the fraction of the amount recommended in evidence-based guidelines. Such a measure would be useful for real-world studies of comparative effectiveness to characterize patient exposure to oral oncolytics. OBJECTIVE: To identify studies that used administrative claims data to measure real-world oral oncolytic dose intensity, RDI, or similar constructs. METHODS: Two health sciences librarians conducted a literature search (PubMed, January 1, 1809-February 6, 2018) including terms in each of the following concept areas: oncology drugs, dosage, and retrospective data sources. At least 2 reviewers scanned each title and abstract of publications retrieved from PubMed. Abstracts that indicated the study reported dose or related concepts and oral oncolytics using retrospective data sources were marked for full-text review. During full-text review, papers were excluded if they did not study oral oncolytics (i.e., only described intravenous chemotherapy); if they did not report drug dosage; or if the study was not retrospective. Resulting studies were included for full-text data extraction. RESULTS: Of the 1,640 publications returned from the search, 41 were marked for full-text review. Full-text review established that 17 studies addressed a concept related to dose of oral oncolytics using retrospective data. Twenty-four studies were excluded: 11 did not measure dose; 9 did not study oral oncolytics; and 4 were not retrospective studies. Among the 17 articles marked for extraction, 5 articles reported dose intensity or RDI using medical records or electronic health record (EHR) data.CONCLUSIONS: This study reveals not only the need for a claims-based measure of dose intensity for oral oncolytics, but also provides a basis for the development of such a measure based on previous EHR-based studies. While several claims data studies have characterized oral oncolytic dosing and duration, we found that no studies combined these dimensions into a single measure such as dose intensity. Methods using EHR data may be translatable to a claims data study. Future research is needed to develop and validate such measures.

show abstract

Real-world dosing and drug costs with everolimus or axitinib as second targeted therapies for advanced renal cell carcinoma: a retrospective chart review in the US

Cited by 7 publications

References 24 publications

Second line therapy with axitinib after only prior sunitinib in metastatic renal cell cancer: Italian multicenter real world SAX study final results

Second line therapy with axitinib after only prior sunitinib in metastatic renal cell cancer: Italian multicenter real world SAX study final results

Axitinib after Sunitinib in Metastatic Renal Cancer: Preliminary Results from Italian “Real-World” SAX Study

A Comprehensive Review of Methods to Measure Oral Oncolytic Dose Intensity Using Retrospective Data

Contact Info

Product

Resources

About