Survival and cost-effectiveness of docetaxel (D) and paclitaxel (P) in patients with metastatic breast cancer (MBC): A population-based evaluation

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6117-6117
Author(s):  
T. T. Vu ◽  
S. Ellard ◽  
I. Olivotto ◽  
S. C. Taylor ◽  
M. L. De Lemos ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Sensitivity Analysis ◽  
Metastatic Breast Cancer ◽  
Cost Effectiveness ◽  
Single Agent ◽  
Metastatic Breast ◽  
Population Based ◽  
List Price ◽  
Rank Test ◽  
Eligibility Criteria

6117 Background: A randomized comparison between P and D for MBC reported that overall survival (OS) was significantly superior for D (Ravdin, et al). We report a population-based comparison of P (3-hour infusion) to D (1-hour infusion) in MBC patients with prior exposure to anthracycline in terms of OS and cost-effectiveness (CE). Methods: Data on MBC patients treated with single-agent P or D (January 1999 - December 2002) were retrospectively reviewed. OS, defined as time from initiation of taxane to death from any cause, was compared using a 2-tailed log-rank test and expressed as Kaplan-Meier plots. A CE analysis, including cost of drug (list price $CDN), labour and supplies, was performed using median cost/patient and median OS (MOS). Incremental CE ratios (ICERs) were compared in a sensitivity analysis varying MOS to the extremes of the 95% confidence interval (95% CI). Results: 435 patients met eligibility criteria. MBC prognostic factors were balanced between D and P groups ( table ). MOS was significantly longer for D vs. P. (10.9 vs. 8.3 months; HR 0.76; 95% CI, 0.62 to 0.92; P = 0.006). The median number of cycles administered were 4 (D) and 3 (P). The respective cost/month of MOS is $805 (D) and $303 (P). The ICER of D vs. P was $2,434/month MOS gained. The range of ICERs in the sensitivity analysis was $1,121 to 7,361/month MOS gained. These results were robust except that P dominates when the low end of the 95%CI of MOS for D is compared to the high end for P. Conclusion: This population-based study corroborates the randomized trial’s conclusion that for patients with metastatic breast cancer, D provided superior survival compared to P. Each additional month of survival had an incremental cost of $2,434. [Table: see text] [Table: see text]

scholarly journals Real-world survival outcomes of heavily pretreated patients with refractory HR+, HER2−metastatic breast cancer receiving single-agent chemotherapy—a comparison with MONARCH 1

2020 ◽  
Vol 184 (1) ◽  
pp. 161-172
Author(s):  
Hope S. Rugo ◽  
Veronique Dieras ◽  
Javier Cortes ◽  
Debra Patt ◽  
Hans Wildiers ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Real World ◽  
Single Agent ◽  
Metastatic Breast ◽  
Clinical Context ◽  
Eligibility Criteria ◽  
The Real ◽  
Heavily Pretreated ◽  
Single Agent Chemotherapy

Abstract Purpose In MONARCH 1 (NCT02102490), single-agent abemaciclib demonstrated promising efficacy activity and tolerability in a population of heavily pretreated women with refractory HR+, HER2− metastatic breast cancer (MBC). To help interpret these results and put in clinical context, we compared overall survival (OS) and duration of therapy (DoT) between MONARCH 1 and a real-world single-agent chemotherapy cohort. Methods The real-world chemotherapy cohort was created from a Flatiron Health electronic health records-derived database based on key eligibility criteria from MONARCH 1. The chemotherapies included in the cohort were single-agent capecitabine, gemcitabine, eribulin, or vinorelbine. Results were adjusted for baseline demographics and clinical differences using Mahalanobis distance matching (primary analysis) and entropy balancing (sensitivity analysis). OS and DoT were analyzed using the Kaplan–Meier method and Cox proportional hazards regression. Results A real-world single-agent chemotherapy cohort (n = 281) with eligibility criteria similar to the MONARCH 1 population (n = 132) was identified. The MONARCH 1 (n = 108) cohort was matched to the real-world chemotherapy cohort (n = 108). Median OS was 22.3 months in the abemaciclib arm versus 13.6 months in the matched real-world chemotherapy cohort with an estimated hazard ratio (HR) of 0.54. The median DoT was 4.1 months in MONARCH 1 compared to 2.9 months in the real-world chemotherapy cohort with HR of 0.76. Conclusions This study demonstrates an approach to create a real-world chemotherapy cohort suitable to serve as a comparator for trial data. These exploratory results suggest a survival advantage and place the benefit of abemaciclib monotherapy in clinical context.

scholarly journals Cost-Effectiveness of Pertuzumab in Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer

2016 ◽  
Vol 34 (9) ◽  
pp. 902-909 ◽  
Author(s):  
Ben Y. Durkee ◽  
Yushen Qian ◽  
Erqi L. Pollom ◽  
Martin T. King ◽  
Sara A. Dudley ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Sensitivity Analysis ◽  
Epidermal Growth Factor Receptor ◽  
Metastatic Breast Cancer ◽  
Cost Effectiveness ◽  
Growth Factor Receptor ◽  
Metastatic Breast ◽  
Cost Effective ◽  
Life Years ◽  
Epidermal Growth

Purpose The Clinical Evaluation of Pertuzumab and Trastuzumab (CLEOPATRA) study showed a 15.7-month survival benefit with the addition of pertuzumab to docetaxel and trastuzumab (THP) as first-line treatment for patients with human epidermal growth factor receptor 2 (HER2) –overexpressing metastatic breast cancer. We performed a cost-effectiveness analysis to assess the value of adding pertuzumab. Patient and Methods We developed a decision-analytic Markov model to evaluate the cost effectiveness of docetaxel plus trastuzumab (TH) with or without pertuzumab in US patients with metastatic breast cancer. The model followed patients weekly over their remaining lifetimes. Health states included stable disease, progressing disease, hospice, and death. Transition probabilities were based on the CLEOPATRA study. Costs reflected the 2014 Medicare rates. Health state utilities were the same as those used in other recent cost-effectiveness studies of trastuzumab and pertuzumab. Outcomes included health benefits expressed as discounted quality-adjusted life-years (QALYs), costs in US dollars, and cost effectiveness expressed as an incremental cost-effectiveness ratio. One- and multiway deterministic and probabilistic sensitivity analyses explored the effects of specific assumptions. Results Modeled median survival was 39.4 months for TH and 56.9 months for THP. The addition of pertuzumab resulted in an additional 1.81 life-years gained, or 0.62 QALYs, at a cost of $472,668 per QALY gained. Deterministic sensitivity analysis showed that THP is unlikely to be cost effective even under the most favorable assumptions, and probabilistic sensitivity analysis predicted 0% chance of cost effectiveness at a willingness to pay of $100,000 per QALY gained. Conclusion THP in patients with metastatic HER2-positive breast cancer is unlikely to be cost effective in the United States.

scholarly journals Cost-Effectiveness Analysis of Abemaciclib Plus Fulvestrant in the Second-Line Treatment of Women With HR+/HER2– Advanced or Metastatic Breast Cancer: A US Payer Perspective

2021 ◽  
Vol 8 ◽  
Author(s):  
Yingcheng Wang ◽  
Mingjun Rui ◽  
Xin Guan ◽  
Yingdan Cao ◽  
Pingyu Chen
Keyword(s):  
Breast Cancer ◽  
Sensitivity Analysis ◽  
Metastatic Breast Cancer ◽  
Cost Effectiveness ◽  
Metastatic Breast ◽  
Cost Effective ◽  
Additional Cost ◽  
Line Treatment ◽  
Second Line ◽  
The Us

Introduction: This study evaluated the cost-effectiveness of abemaciclib plus fulvestrant (ABE + FUL) vs. palbociclib plus fulvestrant (PAL + FUL), ribociclib plus fulvestrant (RIB + FUL) and fulvestrant monotherapy (FUL) as second-line treatment for hormone receptor-positive and human epidermal growth factor receptor 2- negative advanced or metastatic breast cancer in the US.Methods: The 3 health states partitioned survival (PS) model was used over the lifetime. Effectiveness and safety data were derived from the MONARCH 2 trial, MONALEESA-3 trial, and PALOMA-3 trial. Parametric survival models were used for four treatments to explore the long-term effect. Costs were derived from the pricing files of Medicare and Medicaid Services, and utility values were derived from published studies. Sensitivity analyses including one-way sensitivity analysis, probabilistic sensitivity analysis and scenario analysis were performed to observe model stability.Results: In the PS model, compared with PAL + FUL, ABE + FUL yielded 0.44 additional QALYs at an additional cost of $100,696 for an incremental cost-utility ratio (ICUR) of $229,039/QALY. Compared with RIB + FUL, ABE + FUL yielded 0.03 additional QALYs at an additional cost of $518 for an ICUR of $19,314/QALY. Compared with FUL, ABE + FUL yielded 0.68 additional QALYs at an additional cost of $260,584 for ICUR of $381,450/QALY. From the PS model, the ICUR was $270,576 /QALY (ABE + FUL vs. PAL + FUL), dominated (ABE + FUL vs. RIB + FUL) and $404,493/QALY (ABE + FUL vs. FUL) in scenario analysis. In the probabilistic sensitivity analysis, the probabilities that ABE + FUL was cost-effective vs. PAL + FUL, RIB + FUL and FUL at thresholds of $50,000, $100,000, and $200,000 per QALY gained were 0% and the probabilities that ABE + FUL was cost-effective vs. PAL + FUL and RIB + FUL at thresholds of $50,000, $100,000, and $200,000 per QALY gained were 0.2, 0.6, and 7.3%.Conclusions: The findings from the present analysis suggest that ABE + FUL might be cost-effective compared with RIB + FUL and not cost-effective compared with PAL + FUL and FUL for second-line treatment of patients with HR+/HER2– advanced or metastatic breast cancer in the US.

Phase III Trial of Sunitinib in Combination With Capecitabine Versus Capecitabine Monotherapy for the Treatment of Patients With Pretreated Metastatic Breast Cancer

2013 ◽  
Vol 31 (23) ◽  
pp. 2870-2878 ◽  
Author(s):  
John P. Crown ◽  
Véronique Diéras ◽  
Elzbieta Staroslawska ◽  
Denise A. Yardley ◽  
Thomas Bachelot ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Performance Status ◽  
Single Agent ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Eligibility Criteria ◽  
Phase Iii Trial ◽  
Free Survival

Purpose Metastatic breast cancer (MBC) remains an incurable illness in the majority of cases, despite major therapeutic advances. This may be related to the ability of breast tumors to induce neoangiogenesis, even in the face of cytotoxic chemotherapy. Sunitinib, an inhibitor of key molecules involved in neoangiogenesis, has an established role in the treatment of metastatic renal cell and other cancers and demonstrated activity in a phase II trial in MBC. We performed a randomized phase III trial comparing sunitinib plus capecitabine (2,000 mg/m2) with single-agent capecitabine (2,500 mg/m2) in patients with heavily pretreated MBC. Patients and Methods Eligibility criteria included MBC, prior therapy with anthracyclines and taxanes, one or two prior chemotherapy regimens for metastatic disease or early relapse after a taxane plus anthracycline adjuvant regimen, and adequate organ function and performance status. The primary end point was progression-free survival, for which the study had 90% power to detect a 50% improvement (from 4 to 6 months). Results A total of 442 patients were randomly assigned. Progression-free survival was not significantly different between the treatment arms, with medians of 5.5 months (95% CI, 4.5 to 6.0) for the sunitinib plus capecitabine arm and 5.9 months (95% CI, 5.4 to 7.6) for the capecitabine monotherapy arm (hazard ratio, 1.22; 95% CI, 0.95 to 1.58; one-sided P = .941). There were no significant differences in response rate or overall survival. Toxicity, except for hand-foot syndrome, was more severe in the combination arm. Conclusion The addition of sunitinib to capecitabine does not improve the clinical outcome of patients with MBC pretreated with anthracyclines and taxanes.

Combination chemotherapy with gencitabine and cisplatin in anthracycline and taxane pretreated metastatic breast cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 1108-1108 ◽  
Author(s):  
F. M. Peria ◽  
F. E. Zola ◽  
D. G. Tiezzi ◽  
H. H. Carrara ◽  
P. M. Philbert ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Combination Chemotherapy ◽  
Performance Status ◽  
Single Agent ◽  
Metastatic Breast ◽  
Hematological Toxicity ◽  
Eligibility Criteria ◽  
Metastatic Sites ◽  
The Right

1108 Background: Metastatic breast cancer (MBC) anthracycline (A) and taxane (T) resistant has a complicated management.Combination chemotherapy, even in 2nd line, may have advantages over single agent therapy. Gencitabine (G) - cisplatin (C) combinations have been used as synergistic salvage therapy in MBC and it’s another option for patients with important symptoms and aggressive visceral disseminated disease. Methods: This trial analyses the safety and efficacy of G-C in A-T pretreated MBC. Eligibility criteria include: confirmatory pathological analyses; measurable disease; adequate performance status, organ and hematological functions. It was not allowed patients with exclusive bone metastasis. They received IV G 750mg/m2 and C 30mg/m2, both d1 and d8 every three weeks for 6 cycles up to a maximum of 9 cycles. Response evaluation was performed every third cycle and in the end of treatment. Results: From February 2005 through December 2006, 31 patients have been evaluated for response and toxicity from G-C combination. For 20/31 patients this treatment was 2nd line palliative chemotherapy. 26/31 received at least 3 or more cycles (medium 4 cycles) and no one treatment was discontinued due to toxicity. The most frequent site of metastasis was lung (20/31), followed by hepatic in 13 patients, bone in 11, skin in 10, lymph nodes in 7, brain metastasis in 3 and pericardium in only one. Each patient had at least lung or hepatic metastasis and medium of 2 different metastatic sites. According to RECIST criteria, partial response were observed in 8/31, stable disease in 17/31 (55%) and progressive disease in 6 patients. 90% of cycles were given at full dose and at the right time. Hematological toxicity was modest with grade 2–3 (NCI-CTC) leucopenia in 58/140 cycles, grade 1–2 anemia in 40/140, grade 1–2 thrombocytopenia in 27/140 and was none febrile neutropenia. Non hematological toxicity: grade 2 fatigue in 4 patients and grade 2 nausea in 6/31. Following 22 months, global survival was at mean 4.8 months. Conclusions: Combination chemotherapy with gencitabine 750mg/m2 and cisplatin 30mg/m2 both d1 and d8 is feasible and effective in A-T pretreated MBC and demonstrated good tolerance with low intensity of collateral effects. No significant financial relationships to disclose.

Efficacy of low-dose capecitabine in metastatic breast cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 1065-1065
Author(s):  
Caitlin Bertelsen ◽  
Lingyun Ji ◽  
Christy Ann Russell ◽  
Darcy V. Spicer ◽  
Agustin Garcia ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Single Agent ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Eligibility Criteria ◽  
Flat Dose ◽  
Measurable Disease ◽  
Phase Iii Trials

1065 Background: The FDA-approved dose of capecitabine (cape) of 1250mg/m2 twice daily (BID) is associated with treatment-limiting toxicities. Published reports suggest that lower starting doses of cape can be as effective as the approved dose in treating metastatic breast cancer (MBC). We compared the efficacy of lower than previously published doses of cape with results of registrational Phase III trials using the approved dose. Methods: We performed a retrospective analysis of patients treated at the University of Southern California hospitals who received cape as the first, second, or third line of chemotherapy for MBC to determine the progression-free survival (PFS) associated with low starting doses. The primary endpoint was PFS among patients with measurable disease, and secondary aims were to analyze the relationships between PFS and various clinical characteristics for all patients. Results: Patients (n=84) received a median cape dose of 565 mg/m2 BID, often administered as a flat dose (not adjusted for body surface area) of 1000 mg BID. Median PFS among patients with measurable disease (n=62) was 4.1 months (95% confidence interval or CI = 2.9-5.7), which was similar to the median PFS values of 4.4 months (95% CI = 4.14-5.42, n=480) (Sparano et al. JCO 2010;28:3256) and 4.2 months (95% CI = 3.81-4.50, n=377) (Thomas et al. JCO 2008;25:5210) for single-agent cape reported in the major trials with similar eligibility criteria. Among all patients, PFS was shorter in measurable disease, triple negative and HER2+ subtypes, and was similar in all lines of therapy. Only two patients (2.4%) discontinued cape due to toxicity. Conclusions: These data support the efficacy of very low doses of cape for MBC. Prospective randomized controlled trials testing lower starting doses of cape are needed to optimize the benefit/risk ratio. [Table: see text]

scholarly journals Gemcitabine for the treatment of metastatic breast cancer

2009 ◽  
Vol 13 (Suppl 2) ◽  
pp. 1-7
Author(s):  
J Jones ◽  
A Takeda ◽  
SC Tan ◽  
K Cooper ◽  
E Loveman ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Sensitivity Analysis ◽  
Metastatic Breast Cancer ◽  
Cost Effectiveness ◽  
Indirect Comparison ◽  
Metastatic Breast ◽  
Base Case ◽  
Health State ◽  
Single Technology Appraisal ◽  
Quality Adjusted Life

This paper presents a summary of the evidence review group (ERG) report into the evidence for the clinical effectiveness and cost-effectiveness of gemcitabine with paclitaxel for the first-line treatment of metastatic breast cancer (MBC) in patients who have already received chemotherapy treatment with an anthracycline, compared with current standard of care, based upon the manufacturer’s submission to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The clinical evidence for gemcitabine as a treatment for MBC comes from the unpublished JHQG trial (some data commercial-in-confidence): overall survival was 3 months longer for the gemcitabine/paclitaxel arm (18.5 months) than for the paclitaxel arm (15.8 months) (p = 0.0489); gemcitabine/paclitaxel also improved tumour response and time to documented progression of disease compared with paclitaxel monotherapy, but haematological serious adverse events were more common. In the absence of any formal methods of indirect comparison there is insufficient robust evidence to compare the relative effectiveness of gemcitabine/paclitaxel with docetaxel monotherapy or docetaxel/capecitabine combination therapy. The manufacturers used a Markov state transition model to estimate the effect of treatment with five different chemotherapy regimes, adopting a 3-year time horizon with docetaxel monotherapy as the comparator. Health state utilities for different stages of disease progression and for patients experiencing treatment-related toxicity are used to derive quality-adjusted life expectancy with each treatment. The base-case cost-effectiveness estimate for gemcitabine/paclitaxel versus docetaxel is £17,168 per quality-adjusted life-year (QALY). When longer survival with docetaxel is assumed in a sensitivity analysis, the incremental cost-effectiveness ratio (ICER) is £30,000 per QALY. Probabilistic sensitivity analysis estimates a 70% probability of gemcitabine/paclitaxel being cost-effective relative to docetaxel at a willingness-to-pay threshold of £35,000. There is considerable uncertainty over the results because of the lack of formal quality assessment or assessment of the comparability of the 15 trials included in the input data, and the questionable validity of the indirect comparison method adopted. An illustrative analysis using a different method for indirect comparison carried out by the ERG produces an ICER of £45,811 per QALY for gemcitabine/paclitaxel versus docetaxel. The guidance issued by NICE in November 2006 as a result of the STA states that gemcitabine in combination with paclitaxel, within its licensed indication, is recommended as an option for the treatment of MBC only when docetaxel monotherapy or docetaxel plus capecitabine is also considered appropriate.

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