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Articles by D Tu
Total Records ( 3 ) for D Tu
  N Mittmann , H. J Au , D Tu , C. J O'Callaghan , P. K Isogai , C. S Karapetis , J. R Zalcberg , W. K Evans , M. J Moore , J Siddiqui , B Findlay , B Colwell , J Simes , P Gibbs , M Links , N. C Tebbutt , D. J Jonker and Working Group on Economic Analysis of the National Cancer Institute of Canada Clinical Trials GroupA
  Background

The National Cancer Institute of Canada Clinical Trials Group CO.17 study showed that patients with advanced colorectal cancer had improved overall survival when cetuximab, an epidermal growth factor receptor–targeting antibody, was given in addition to best supportive care. We conducted a cost-effectiveness analysis using prospectively collected resource utilization and health utility data for patients in the CO.17 study who received cetuximab plus best supportive care (N = 283) or best supportive care alone (N = 274).

Methods

Direct medical resource utilization data were collected, including medications, physician visits, toxicity management, blood products, emergency department visits, and hospitalizations. Mean survival times for the study arms were calculated for the entire population and for the subset of patients with wild-type KRAS tumors over an 18- to 19-month period. All costs were presented in 2007 Canadian dollars. One-way and probabilistic sensitivity analysis was used to determine the robustness of the results. Cost-effectiveness acceptability curves were determined. The 95% confidence intervals (CIs) for the incremental cost-effectiveness ratios and the incremental cost–utility ratios were estimated by use of a nonparametric bootstrapping method (with 1000 iterations).

Results

For the entire study population, the mean improvement in overall and quality-adjusted survival with cetuximab was 0.12 years and 0.08 quality-adjusted life-years (QALYs), respectively. The incremental cost with cetuximab compared with best supportive care was $23 969. The incremental cost-effectiveness ratio was $199 742 per life-year gained (95% CI = $125 973 to $652 492 per life-year gained) and the incremental cost–utility ratio was $299 613 per QALY gained (95% CI = $187 440 to $898 201 per QALY gained). For patients with wild-type KRAS tumors, the incremental cost with cetuximab was $33 617 and mean gains in overall and quality-adjusted survival were 0.28 years and 0.18 QALYs, respectively. The incremental cost-effectiveness ratio was $120 061 per life-year gained (95% CI = $88 679 to $207 075 per life-year gained) and the incremental cost–utility ratio was $186 761 per QALY gained (95% CI = $130 326 to $334 940 per QALY gained). In a sensitivity analysis, cetuximab cost and patient survival were the only variables that influenced cost-effectiveness.

Conclusions

The incremental cost-effectiveness ratio of cetuximab over best supportive care alone in unselected advanced colorectal cancer patients is high and sensitive to drug cost. Incremental cost-effectiveness ratios were lower when the analysis was limited to patients with wild-type KRAS tumors.

  P. A Bradbury , D Tu , L Seymour , P. K Isogai , L Zhu , R Ng , N Mittmann , M. S Tsao , W. K Evans , F. A Shepherd , N. B Leighl and on behalf of the NCIC Clinical Trials Group Working Group on Economic Analysis
  Background

The NCIC Clinical Trials Group conducted the BR.21 trial, a randomized placebo-controlled trial of erlotinib (an epidermal growth factor receptor tyrosine kinase inhibitor) in patients with previously treated advanced non–small cell lung cancer. This trial accrued patients between August 14, 2001, and January 31, 2003, and found that overall survival and quality of life were improved in the erlotinib arm than in the placebo arm. However, funding restrictions limit access to erlotinib in many countries. We undertook an economic analysis of erlotinib treatment in this trial and explored different molecular and clinical predictors of outcome to determine the cost-effectiveness of treating various populations with erlotinib.

Methods

Resource utilization was determined from individual patient data in the BR.21 trial database. The trial recruited 731 patients (488 in the erlotinib arm and 243 in the placebo arm). Costs arising from erlotinib treatment, diagnostic tests, outpatient visits, acute hospitalization, adverse events, lung cancer–related concomitant medications, transfusions, and radiation therapy were captured. The incremental cost-effectiveness ratio was calculated as the ratio of incremental cost (in 2007 Canadian dollars) to incremental effectiveness (life-years gained). In exploratory analyses, we evaluated the benefits of treatment in selected subgroups to determine the impact on the incremental cost-effectiveness ratio.

Results

The incremental cost-effectiveness ratio for erlotinib treatment in the BR.21 trial population was $94 638 per life-year gained (95% confidence interval = $52 359 to $429 148). The major drivers of cost-effectiveness included the magnitude of survival benefit and erlotinib cost. Subgroup analyses revealed that erlotinib may be more cost-effective in never-smokers or patients with high EGFR gene copy number.

Conclusion

With an incremental cost-effectiveness ratio of $94 638 per life-year gained, erlotinib treatment for patients with previously treated advanced non–small cell lung cancer is marginally cost-effective. The use of molecular predictors of benefit for targeted agents may help identify more or less cost-effective subgroups for treatment.

  P Hoskins , I Vergote , A Cervantes , D Tu , G Stuart , P Zola , A Poveda , D Provencher , D Katsaros , B Ojeda , P Ghatage , R Grimshaw , A Casado , L Elit , C Mendiola , A Sugimoto , V D'Hondt , A Oza , J. R Germa , M Roy , L Brotto , D Chen and E. A. Eisenhauer
  Background

Topotecan has single-agent activity in recurrent ovarian cancer. It was evaluated in a novel combination compared with standard frontline therapy.

Methods

Women aged 75 years or younger with newly diagnosed stage IIB or greater ovarian cancer, Eastern Cooperative Oncology Group Performance Status of 1 or less, were stratified by type of primary surgery and residual disease, treatment center, and age; then randomly assigned to one of the two 21-day intravenous regimens. Patients in arm 1 (n = 409) were administered four cycles of cisplatin 50 mg/m2 on day 1 and topotecan 0.75 mg/m2 on days 1–5, then four cycles of paclitaxel 175 mg/m2 over 3 hours on day 1 followed by carboplatin (area under the curve = 5) on day 1. Patients in arm 2 (n = 410) were given paclitaxel plus carboplatin as in arm 1 for eight cycles. We compared progression-free survival (PFS), overall survival, and cancer antigen-125 normalization rates in the two treatment arms. A stratified log-rank test was used to assess the primary endpoint, PFS. All statistical tests were two-sided.

Results

A total of 819 patients were randomly assigned. At baseline, the median age of the patients was 57 years (range = 28–78); 81% had received debulking surgery, and of these, 55% had less than 1 cm residual disease; 66% of patients were stage III and 388 (47.4%) patients had measurable disease. After a median follow-up of 43 months, 650 patients had disease progression or died without documented progression and 406 had died. Patients in arm 1 had more hematological toxicity and hospitalizations than patients in arm 2; PFS was 14.6 months in arm 1 vs 16.2 months in arm 2 (hazard ratio = 1.10, 95% confidence interval = 0.94 to 1.28, P = .25). Among patients with elevated baseline cancer antigen-125, fewer in arm 1 than in arm 2 had levels return to normal by 3 months after random assignment (51.6% vs 63.3%, P = .007)

Conclusions

Topotecan and cisplatin, followed by carboplatin and paclitaxel, were more toxic than carboplatin and paclitaxel alone, but without improved efficacy. Carboplatin plus paclitaxel remains the standard of care for advanced epithelial ovarian cancer.

 
 
 
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