Number needed to treat and treatment cost per fracture avoided with denosumab compared with zoledronic acid in patients with breast cancer with bone metastases.

2011 ◽  
Vol 29 (27_suppl) ◽  
pp. 151-151 ◽  
Author(s):  
E. Q. Wu ◽  
J. Xie ◽  
J. Signorovitch ◽  
M. Diener ◽  
R. Sorg ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Treatment Outcome ◽  
Zoledronic Acid ◽  
Treatment Cost ◽  
Phase Iii ◽  
Inpatient Cost ◽  
Number Needed To Treat ◽  
Phase Iii Trial ◽  
Monitoring Costs ◽  
The Mean

151 Background: Pathologic fractures (PF) are a common and expensive-to-treat skeletal-related event (SRE), which affect over two-thirds of metastatic breast cancer (MBC) patients, and cost $26,936 (2009 US dollars) per event on average for inpatient treatment. In a phase III trial ( NCT20050136 ), MBC patients randomized to denosumab (Dmab; n=1,026) demonstrated longer time to SRE, but comparable rates of survival and disease progression relative to those randomized to zoledronic acid (ZOL; n=1,020). We calculated the number needed to treat (NNT) to avoid one PF and the treatment cost per PF avoided with Dmab vs. ZOL in MBC patients. Methods: Phase III trial results from the Dmab product label were used to determine the rate of PFs and SREs in MBC patients treated with Dmab vs. ZOL. Treatment cost included only the wholesale acquisition cost of Dmab and ZOL, and assumed 12 months of treatment. The NNT calculated the number of patients who would need to be treated with Dmab vs. ZOL to avoid one additional PF. Sensitivity analyses included expanding the treatment outcome from PFs to SREs and adding drug administration costs for Dmab and ZOL, and, renal monitoring costs only for ZOL. Results: Based on the estimated differences in PF risk of 2.7%, 37.4 patients would need to be treated with Dmab vs. ZOL to avoid one additional PF, resulting in a treatment cost per PF avoided of $346,911. The lower 95% confidence limit for the cost per PF avoided with Dmab vs. ZOL was $148,114, which is significantly greater than the mean inpatient cost of treating a PF event. Including drug administration and renal monitoring costs led to a cost per PF avoided of $323,069. Expanding the treatment outcome from PFs to SREs showed that 17.3 patients would need to be treated with Dmab vs. ZOL to avoid one additional SRE (95% CI: 10.2 to 59.7; absolute risk reduction 5.8%), resulting in a treatment cost of $160,595 per SRE avoided. Conclusions: PFs have a debilitating effect on patients, and treatment with Dmab compared to ZOL was associated with a treatment cost per PF avoided that exceeded 12 times the mean inpatient cost of a PF. Decision makers need to consider the high costs associated with Dmab prior to formulary inclusion.

Endocrine Effects of Adjuvant Letrozole Compared With Tamoxifen in Hormone-Responsive Postmenopausal Patients With Early Breast Cancer: The HOBOE Trial

2009 ◽  
Vol 27 (19) ◽  
pp. 3192-3197 ◽  
Author(s):  
Emanuela Rossi ◽  
Alessandro Morabito ◽  
Francesca Di Rella ◽  
Giuseppe Esposito ◽  
Adriano Gravina ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Zoledronic Acid ◽  
Early Breast Cancer ◽  
Phase Iii ◽  
Endocrine Effects ◽  
Phase Iii Trial ◽  
Treatment Groups ◽  
To Receive ◽  
Ongoing Phase ◽  
Over Time

Purpose We compared the endocrine effects of 6 and 12 months of adjuvant letrozole versus tamoxifen in postmenopausal patients with hormone-responsive early breast cancer within an ongoing phase III trial. Patients and Methods Patients were randomly assigned to receive tamoxifen, letrozole, or letrozole plus zoledronic acid. Serum values of estradiol, follicle-stimulating hormone (FSH), luteinizing hormone (LH), testosterone, dehydroepiandrosterone-sulphate (DHEA-S), progesterone, and cortisol were measured at baseline and after 6 and 12 months of treatment. For each hormone, changes from baseline at 6 and 12 months were compared between treatment groups, and differences over time for each group were analyzed. Results Hormonal data were available for 139 postmenopausal patients with a median age of 62 years, with 43 patients assigned to tamoxifen and 96 patients assigned to letrozole alone or combined with zoledronic acid. Baseline values were similar between the two groups for all hormones. Many significant changes were observed between drugs and for each drug over time. Namely, three hormones seemed significantly affected by one drug only: estradiol that decreased and progesterone that increased with letrozole and cortisol that increased with tamoxifen. Both drugs affected FSH (decreasing with tamoxifen and slightly increasing with letrozole), LH (decreasing more with tamoxifen than with letrozole), testosterone (slightly increasing with letrozole but not enough to differ from tamoxifen), and DHEA-S (increasing with both drugs but not differently between them). Zoledronic acid did not have significant impact on hormonal levels. Conclusion Adjuvant letrozole and tamoxifen result in significantly distinct endocrine effects. Such differences can explain the higher efficacy of letrozole as compared with tamoxifen.

Prospective, Multicenter, Randomized Phase III Trial Evaluating the Impact of Lymphoscintigraphy as Part of Sentinel Node Biopsy in Early Breast Cancer: SenSzi (GBG80) Trial

2019 ◽  
Vol 37 (17) ◽  
pp. 1490-1498 ◽  
Author(s):  
Sherko Kuemmel ◽  
Johannes Holtschmidt ◽  
Bernd Gerber ◽  
Albert Von der Assen ◽  
Joerg Heil ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Lymph Node ◽  
Early Breast Cancer ◽  
Phase Iii ◽  
Axillary Lymph ◽  
End Points ◽  
Phase Iii Trial ◽  
Node Biopsy ◽  
The Mean ◽  
The Impact

PURPOSE The aim of the current work was to clarify whether a preoperative lymphoscintigraphy (LSG) enhances staging accuracy of sentinel lymph node biopsy (SLNB). PATIENTS AND METHODS In a prospective, multicenter, randomized phase III trial, patients with cN0 early breast cancer or extensive/high-grade ductal carcinoma in situ planned for standard radioactive-labeled colloid LSG with subsequent SLNB were randomly assigned 1:1 to receive SLNB either with knowledge of the LSG findings or without. As the false-negative rate of SLNB correlates with the number of resected sentinel lymph nodes (SLNs), our primary end point was the mean number of histologically detected SLNs per patient. One thousand one hundred two evaluable patients were necessary to demonstrate noninferiority of SLNB without LSG. Stratified one-sided 95% CI for the difference (without LSG − with LSG) in the mean number of histologically detected SLNs had to be greater than −0.27 (10% noninferiority margin). Stratification was performed according to tumor focality and trial site. Additional predefined secondary end points (rates of node-positive patients and of completion axillary lymph node dissection) were analyzed to rule out differences in the reliable detection of nodal metastases. RESULTS Between May 2014 and October 2015, 1,198 patients were randomly assigned in 23 German and Swiss breast centers. Modified intention-to-treat analysis (n = 1,163) showed a mean number of histologically detected SLNs of 2.21 with LSG and 2.26 without LSG (difference 0.05; stratified 95% CI, −0.18 to infinity), thus establishing noninferiority of omitting preoperative LSG. Secondary end points displayed no statistically significant differences. CONCLUSION We show that SLNB is equally effective irrespective of the surgeon’s knowledge of preoperative LSG results. SLNB without LSG will speed up the preoperative workflow and reduce cost.

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