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991224P - REFLECTIONS ON THE STATISTICAL DESIGN AND ANALYSIS OF ADJUVANT THERAPY CLINICAL TRIALS

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Abstract written for a symposium on the Role of Adjuvant Therapy organized by the Malaysian Oncological Society 23-24th October 1999 at Hyatt Regency Saujana, Subang, Selangor Darul Ehsan by Prof Omar Hasan Kasule, Sr., Faculty of Medicine, International Islamic University, Kuantan, Malaysia


ABSTRACT
Introduction: The paper defines adjuvant therapy and its role in cancer therapy

Objective: The paper proposes for purposes of discussion a new approach to the design and analysis of adjuvant clinical trials. It argues that since adjuvant therapy is complimentary to the primary therapy, the final result should be considered as an interaction between the primary and adjuvant therapy. Adjuvant therapy could also be considered as a form of effect modification for the primary therapy. Statistical techniques used for interaction and effect modification in epidemiological studies can be applied to clinical trials of adjuvant therapy.

Methodology: The design and analysis of recent adjuvant trials of breast cancer were analyzed

Results: Current design does not provide full information.

Conclusion: Interactions and effect modification should be modeled in trials of adjuvant therapy.

References:
Norton L. Adjuvant breast cancer therapy: current status and future strategies--growth kinetics and the improved drug therapy of breast cancer. Semin Oncol. 1999 Feb;26(1 Suppl 3):1-4. Review.

Hudis CA. The current state of adjuvant therapy for breast cancer: focus on paclitaxel. Semin Oncol. 1999 Feb;26(1 Suppl 2):1-5. Review.

Lindman H, et al. FEC mobilized stem cells for high-dose therapy in breast cancer patients. SB6 9401 Study Group. Acta Oncol. 1999;38(2):239-45.

Turpin F, et al. Treatment with a nonanthracycline regimen in advanced breast cancer: vinorelbine, cyclophosphamide, and 5-fluorouracil with folinic acid. Am J Clin Oncol. 1999 Apr;22(2):196-8.

Schwartzberg LS, et al. Adjuvant dose-intense chemotherapy with peripheral blood stem cell support in stage II-III breast cancer with five to nine involved axillary lymph nodes. Am J Clin Oncol. 1999 Apr;22(2):136-42.

Theriault RL, et al. Pamidronate reduces skeletal morbidity in women with advanced breast cancer and lytic bone lesions: a randomized, placebo-controlled  trial. Protocol 18 Aredia Breast Cancer Study Group. J Clin Oncol. 1999 Mar;17(3):846-54.

D'Andrea G, et al. Phase I study of escalating doses of edatrexate in combination with paclitaxel in patients with metastatic breast cancer. Clin Cancer Res. 1999 Feb;5(2):275-9.

van der Zee J, et al. Reirradiation combined with hyperthermia in recurrent breast cancer results in a worthwhile local palliation. Br J Cancer. 1999 Feb;79(3-4):483-90

Dowsett M, et al. The effect of anastrozole on the pharmacokinetics of tamoxifen in post-menopausal women with early breast cancer. Br J Cancer. 1999 Jan;79(2):311-5.