scholarly journals Abiraterone acetate and docetaxel with androgen deprivation therapy in high-volume metastatic hormone-sensitive prostate cancer in China: an indirect treatment comparison and cost analysis

2019 ◽  
Vol 17 (1) ◽  
Author(s):  
Xin Hu ◽  
Shuli Qu ◽  
Xingxing Yao ◽  
Chaoyun Li ◽  
Yanjun Liu ◽  
...  
Keyword(s):  
Cost Analysis ◽  
Patient Perspective ◽  
High Volume ◽  
Abiraterone Acetate ◽  
Indirect Treatment Comparison ◽  
Treatment Comparison ◽  
Significant Difference ◽  
Therapy Costs ◽  
Hormone Sensitive ◽  
Indirect Treatment

Abstract Background To conduct an indirect treatment comparison of patients with high-volume mHSPC and a cost analysis between Abi-ADT and Doc-ADT therapies in China. Methods The Bucher technique for indirect treatment comparison was used. A cost analysis was conducted from both healthcare and patient perspectives. Results The indirect treatment comparison demonstrated no significant difference in PFS for Abi-ADT versus Doc-ADT (HR: 0.84, 95% CI 0.66–1.07). Doc-ADT therapy costs less than Abi-ADT, with potential savings of up to RMB 887,057 per patient from the healthcare perspective and RMB 226,210 per patient from the patient perspective. Conclusions No significant differences in PFS between Doc-ADT and Abi-ADT therapy for patients with high-volume mHSPC. Doc-ADT therapy is a cost-saving alternative to Abi-ADT in China.

scholarly journals Comparative Efficacy and Safety of Dupilumab and Benralizumab in Patients with Inadequately Controlled Asthma: A Systematic Review

2020 ◽  
Vol 21 (3) ◽  
pp. 889 ◽  
Author(s):  
Koichi Ando ◽  
Akihiko Tanaka ◽  
Hironori Sagara
Keyword(s):  
Systematic Review ◽  
Eosinophil Count ◽  
Blood Eosinophil ◽  
Efficacy And Safety ◽  
Exacerbation Rate ◽  
Blood Eosinophil Count ◽  
Indirect Treatment Comparison ◽  
Treatment Comparison ◽  
Significant Difference ◽  
Indirect Treatment

No head-to-head trials have compared the efficacy and safety between the licensed dosage and administration dosage of dupilumab and benralizumab for inadequately controlled asthma. We conducted an indirect treatment comparison to estimate differences in the efficacy and safety between dupilumab and benralizumab for inadequately controlled asthma using the Bayesian approach. The primary efficacy endpoint was annual exacerbation rate (AER). A subgroup analysis by blood eosinophil count was also performed. The primary safety endpoint was the incidence of any adverse events (AAEs). The results demonstrate that there was no significant difference in the AER between dupilumab and benralizumab in overall patients and the subgroup with the blood eosinophil count of <150. However, the AER was significantly lower in the dupilumab group than in the benralizumab group in the subgroup with a blood eosinophil count of ≥150 but <300, and ≥300 with the rate ratio and 95% credible interval of 0.51 (0.29–0.92) and 0.58 (0.39–0.84), respectively. There was no significant difference in the AAEs between the dupilumab and benralizumab groups. This indirect treatment comparison indicates that dupilumab is superior to benralizumab in patients with inadequately controlled asthma having higher blood eosinophil counts. A direct comparison is required to provide definitive evidence. Systematic Review Registration: UMIN-CTR no. UMIN000036256.

Indirect treatment comparison of the efficacy and safety of olaparib 300 mg tablets BID and talazoparib 1 mg once daily in the treatment of patients with germline BRCA-mutated (gBRCA) HER2-negative metastatic breast cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12570-e12570 ◽  
Author(s):  
Charles McCrea ◽  
Robert Hettle
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Metastatic Breast ◽  
Nausea And Vomiting ◽  
Efficacy And Safety ◽  
Indirect Treatment Comparison ◽  
Treatment Comparison ◽  
Increased Risk ◽  
Significant Difference ◽  
Indirect Treatment

e12570 Background: PARP inhibitor treatment with olaparib or talazoparib has been shown to improve progression-free survival (PFS) versus chemotherapy treatment of physician’s choice in patients with germline BRCA-mutated (gBRCA) HER2-negative metastatic breast cancer. In the absence of head-to-head evidence, an indirect treatment comparison (ITC) analysis was performed to simulate the comparative efficacy and safety of alternative PARP treatment in this setting. Methods: Bayesian fixed effects ITCs of data published for OlympiAD (NCT02000622) and EMBRACA (NCT01945775) was conducted using the gemtc package in R. Efficacy analyses were performed on the primary endpoint of PFS by blinded independent central review. Safety analyses included the odds ratio (OR) of adverse event (AE)-related discontinuations, and common AEs of any grade reported in each study. All analyses compared olaparib with talazoparib. Results: Efficacy analyses show no significant difference in PFS across treatments (PFS hazard ratio of 1.09, 95% credible interval [0.72; 1.65]). Safety analyses predict differences in AEs across PARP treatment, including hematological events, alopecia, nausea and vomiting (Table). No difference in AE-related discontinuations was observed (0.93 [0.25–3.42]). Conclusions: Results of the ITC suggest that olaparib and talazoparib are equally efficacious on PFS, and differ in AE risk profile, with olaparib predicted to have fewer common hematological and alopecia events, but an increased risk of nausea and vomiting versus talazoparib. Observed differences require confirmation in comparative studies. Limitations of the analysis include heterogeneity in study design, reporting of AEs, and mix of chemotherapies used in the control arm of the studies. [Table: see text]

Indirect treatment comparison of olaparib and talazoparib in germline BRCA-mutated HER2-negative metastatic breast cancer

2021 ◽  
Author(s):  
Charles McCrea ◽  
Robert Hettle ◽  
Poonam Gulati ◽  
Ankush Taneja ◽  
Preety Rajora
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Fixed Effects ◽  
Parp Inhibitor ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Indirect Treatment Comparison ◽  
Treatment Comparison ◽  
Significant Difference ◽  
Indirect Treatment

Aim: Two poly(ADP-ribose) polymerase (PARP) inhibitors olaparib and talazoparib are approved for patients with germline BRCA-mutated (gBRCAm) HER2-negative metastatic breast cancer. Methods: A Bayesian fixed-effects indirect treatment comparison (ITC) analysis was performed to simulate the comparative efficacy (primary outcome of progression-free survival [PFS]) and safety of PARP inhibitor monotherapy. Results: ITC of data from the OlympiAD (olaparib) and EMBRACA (talazoparib) studies suggested no significant difference in efficacy (PFS) between olaparib and talazoparib. However, there were differences in specific adverse events; patients receiving olaparib had a higher rate of nausea and vomiting, while those receiving talazoparib had a higher rate of alopecia and anemia. Discussion: These data support the benefit of the PARP inhibitor class in gBRCAm HER2-negative metastatic breast cancer.

Population-adjusted indirect treatment comparison (PAITC) of maintenance PARP inhibitor (PARPi) with or without bevacizumab versus bevacizumab in women with newly diagnosed ovarian cancer (OC).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 6052-6052
Author(s):  
Robert Hettle ◽  
Charles McCrea ◽  
Chee Khoon Lee ◽  
Richard Davidson
Keyword(s):  
Phase Iii ◽  
Stage Iii ◽  
Disease Stage ◽  
Effective Sample Size ◽  
Chemotherapy Response ◽  
Newly Diagnosed ◽  
Indirect Treatment Comparison ◽  
Treatment Comparison ◽  
Significant Difference ◽  
Indirect Treatment

6052 Background: In patients (pts) with newly diagnosed OC, bevacizumab (B), PARPi, and PARPi + B have shown benefit as maintenance treatment options after platinum chemotherapy response. Phase III trials have demonstrated longer median progression-free survival (PFS) with PARPi + B (PAOLA-1, olaparib [O]; NCT02477644) vs placebo (P) + B and with PARPi alone (PRIMA, niraparib [N]; NCT02655016) vs P. As there are no randomized head-to-head trials comparing PARPi + B vs PARPi, or PARPi vs B, we performed indirect treatment comparison across these regimens. Methods: Unanchored PAITC was performed with individual pt data (IPD) from a PAOLA-1 subset comprising pts with stage IV disease, stage III with residual disease after primary surgery, inoperable stage III disease, or any patient who received neoadjuvant chemotherapy. Propensity weights were used to match the baseline (BL) characteristics of the PRIMA population. PRIMA dataset was reconstructed using published PFS curves. Both datasets were pooled; treatment efficacy was assessed by weighted Cox regression and Kaplan–Meier methods. PAITC was performed in all pts (biomarker unselected) and the homologous recombination repair deficiency positive (HRD+; cut-off 42) subgroup. Results: 595/806 (266/387 HRD+) PAOLA-1 pts were included. After matching, the effective sample size (ESS) for PAOLA-1 was 532 (242 HRD+; weights 0.241–2.37). Weighted BL data were balanced across cohorts. Conclusions: In biomarker-unselected and HRD+ pts, PAITC suggests that adding O to B significantly improved PFS vs. N or B alone. In biomarker-unselected pts, PAITC results show no significant difference in PFS between N and B. In HRD+, improved efficacy with N appears to translate into improved PFS vs. B alone, although follow-up was <2 years (14 vs 22 months, respectively). Results are hypothesis generating and could guide randomized trial design. Clinical trial information: NCT02477644 and NCT02655016. [Table: see text]

scholarly journals Impact of pretreatment anemia on upfront abiraterone acetate therapy for metastatic hormone-sensitive prostate cancer: a multicenter retrospective study

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Teppei Okamoto ◽  
Daisuke Noro ◽  
Shingo Hatakeyama ◽  
Shintaro Narita ◽  
Koji Mitsuzuka ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Prognostic Factor ◽  
Abiraterone Acetate ◽  
Tumor Burden ◽  
Hazard Ratio ◽  
Historical Cohort ◽  
High Tumor Burden ◽  
Significant Difference ◽  
Hormone Sensitive ◽  
The Impact

Abstract Background Anemia has been a known prognostic factor in metastatic hormone-sensitive prostate cancer (mHSPC). We therefore examined the effect of anemia on the efficacy of upfront abiraterone acetate (ABI) in patients with mHSPC. Methods We retrospectively evaluated 66 mHSPC patients with high tumor burden who received upfront ABI between 2018 and 2020 (upfront ABI group). We divided these patients into two groups: the anemia-ABI group (hemoglobin < 13.0 g/dL, n = 20) and the non-anemia-ABI group (n = 46). The primary objective was to examine the impact of anemia on the progression-free survival (PFS; clinical progression or PC death before development of castration resistant PC) of patients in the upfront ABI group. Secondary objectives included an evaluation of the prognostic significance of upfront ABI and a comparison with a historical cohort (131 mHSPC patients with high tumor burden who received androgen deprivation therapy (ADT/complete androgen blockade [CAB] group) between 2014 and 2019). Results We found that the anemia-ABI group had a significantly shorter PFS than the non-anemia-ABI group. A multivariate Cox regression analysis showed that anemia was an independent prognostic factor of PFS in the upfront ABI group (hazard ratio, 4.66; P = 0.014). Patients in the non-anemia-ABI group were determined to have a significantly longer PFS than those in the non-anemia-ADT/CAB group (n = 68) (P < 0.001). However, no significant difference was observed in the PFS between patients in the anemia-ABI and the anemia-ADT/CAB groups (n = 63). Multivariate analyses showed that upfront ABI could significantly prolong the PFS of patients without anemia (hazard ratio, 0.17; P < 0.001), whereas ABI did not prolong the PFS of patients with anemia. Conclusion Pretreatment anemia was a prognostic factor among mHSPC patients who received upfront ABI. Although the upfront ABI significantly improved the PFS of mHSPC patients without anemia, its efficacy in patients with anemia might be limited.

scholarly journals An indirect treatment comparison of the efficacy of semaglutide 1.0 mg versus dulaglutide 3.0 mg and 4.5 mg

2021 ◽  
Author(s):  
Richard E. Pratley ◽  
Andrei‐Mircea Catarig ◽  
Ildiko Lingvay ◽  
Adie Viljoen ◽  
Abby Paine ◽  
...  
Keyword(s):  
Indirect Treatment Comparison ◽  
Treatment Comparison ◽  
Indirect Treatment
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