Seminars in Oncology
Volume 35, Issue 5 , Pages 522-529 , October 2008

The Half Century of Clinical Trials of the National Surgical Adjuvant Breast and Bowel Project

  • D. Lawrence Wickerham

      Affiliations

    • National Surgical Adjuvant Breast and Bowel Project (NSABP) Operations Office, Pittsburgh, PA
    • Corresponding Author InformationAddress correspondence to D. Lawerence Wickerham, MD, NSABP, Four Allegheny Center, Pittsburgh, PA 15212
    • ,
  • Michael J. O'Connell

      Affiliations

    • National Surgical Adjuvant Breast and Bowel Project (NSABP) Operations Office, Pittsburgh, PA
    • ,
  • Joseph P. Costantino

      Affiliations

    • NSABP Biostatistical Center and Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA
    • ,
  • Walter M. Cronin

      Affiliations

    • NSABP Biostatistical Center and Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA
    • ,
  • Soonmyung Paik

      Affiliations

    • Division of Pathology, NSABP, Pittsburgh, PA
    • ,
  • Charles E. Geyer Jr

      Affiliations

    • National Surgical Adjuvant Breast and Bowel Project (NSABP) Operations Office, Pittsburgh, PA
    • ,
  • Patricia A. Ganz

      Affiliations

    • UCLA School of Medicine and Public Health, Jonsson Comprehensive Cancer Center, Los Angeles, CA
    • ,
  • Nicholas Petrelli

      Affiliations

    • Helen F. Graham Cancer Center, Newark, DE
    • ,
  • Eleftherios P. Mamounas

      Affiliations

    • Aultman Hospital Cancer Center, Canton, OH
    • ,
  • Thomas B. Julian

      Affiliations

    • National Surgical Adjuvant Breast and Bowel Project (NSABP) Operations Office, Pittsburgh, PA
    • Department of Human Oncology, Allegheny General Hospital, Pittsburgh, PA
    • ,
  • Norman Wolmark

      Affiliations

    • Department of Human Oncology, Allegheny General Hospital, Pittsburgh, PA

References 

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  3. Fisher B, Jeong J, Anderson S, Bryant J, Fisher ER, Wolmark N. Twenty-five year follow-up of a randomized trial comparing radical mastectomy, total mastectomy, and total mastectomy followed by irradiation. N Engl J Med. 2002;347:567–575
  4. Moxley J, Allegra JC, Durant JR, Fisher B, Hellman S, Henney J, et al. The treatment of primary breast cancer: Management of local disease. National Institutes of Health Consensus Development Conference Statement Online June 5; 29-30, 1979 http://consensus.nih.gov/1979/1979PrimaryBreastCancer015html.htmAccessed July 26, 2007
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  6. Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, et al. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002;347:1233–1241
  7. Fisher B, Land S, Mamounas E, Dignam J, Fisher ER, Wolmark N. Prevention of invasive breast cancer in women with ductal carcinoma in situ: an update of the National Surgical Adjuvant Breast and Bowel Project experience. Semin Oncol. 2001;28:400–418
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  12. Fisher B, Redmond C, Wickerham DL, Wolkmark N, Bowman D, Couture J, et al. Systemic therapy in patients with node-negative breast cancer: a commentary based on two National Surgical Adjuvant Breast and Bowel Project (NSABP) clinical trials. Ann Intern Med. 1989;111:703–712
  13. Fisher B, Dignam J, Bryant J, Decillis A, Wickerham DL, Wolmark N, et al. Five versus more than five years of tamoxifen therapy for breast cancer patients with negative lymph nodes and estrogen receptor-positive tumors. J Natl Cancer Inst. 1996;88:1529–1542
  14. Mamounas EP. Overview of National Surgical Adjuvant Breast Project neoadjuvant chemotherapy studies. Semin Oncol. 1998;25(Suppl 3):31–35
  15. Fisher B, Dignam J, Wolmark N, Wickerham DL, Fisher ER, Mamounas E, et al. Tamoxifen in treatment of intraductal breast cancer: National Surgical Adjuvant Breast and Bowel Project B-24 randomized controlled trial. Lancet. 1999;353:1993–2000
  16. Fisher B, Costantino JP, Wickerham DL, et al. Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst. 1998;90:1371–1388
  17. Vogel VG, Costantino JP, Wickerham DL, Cronin WM, Cecchini RS, Atkins JN, et al. Effects of tamoxifen vs raloxifene on the risk of developing invasive breast cancer and other disease outcomes: the NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 trial. JAMA. 2006;295:2727–2741
  18. Wolmark N, Rockette H, Fisher B, Wickerham DL, Redmond C, Fisher ER, et al. The benefit of leucovorin-modulated fluorouracil as postoperative adjuvant therapy for primary colon cancer: results from National Surgical Adjuvant Breast and Bowel Project protocol C-03. J Clin Oncol. 1993;11:1879–1887
  19. O'Connell MJ, Wolmark N, Yothers G, Haile S, Colangelo L, Petrelli N. Durable improvement in disease-free survival (DFS) and overall survival (OS) for stage II or III colon cancer treated with leucovorin-modulated fluorouracil (FL): 10-year follow-up of National Surgical Adjuvant Breast and Bowel Project (NSABP) protocol C-03. Proc Am Soc Clin Oncol. 2005;23:3511;(abstr)
  20. Wolmark N, Rockette H, Mamounas E, Jones J, Wieand S, Wickerham DL, et al. Clinical trial to assess the relative efficacy of fluorouracil and leucovorin, fluorouracil and levamisole, and fluorouracil, leucovorin, and levamisole in patients with Dukes' B and C carcinoma of the colon: results from National Surgical Adjuvant Breast and Bowel Project C-04. J Clin Oncol. 1999;17:3353–3359
  21. Keubler JP, Wieand HS, O'Connell MJ, Smith RE, Colangelo LH, Youthers G, et al. Oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: results from NSABP C-07. J Clin Oncol. 2007;25:2198–2204
  22. Land SR, Kopec JA, Cecchini RS, Ganz PA, Wieand HS, Colangelo LH, et al. Neurotoxicity from oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: NSABP C-07. J Clin Oncol. 2007;25:2205–2211
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  24. Wolmark N, Wieand HS, Hyams DM, Colangelo L, Dimitrov NV, Romond EH, et al. Randomized trial of postoperative adjuvant chemotherapy with or without radiotherapy for carcinoma of the rectum: National Surgical Adjuvant Breast and Bowel Project Protocol R-02. J Natl Cancer Inst. 2000;92:388–396
  25. Roh MS, Colangelo L, Wieand S, O'Connell MJ, Petrelli N, Smith R, et al. Response to preoperative multimodality therapy predicts survival in patients with carcinoma of the rectum. Proc Am Soc Clin Oncol. 2004;22:3505;(abstr)
  26. Ganz PA, Day R, Ware JE, Redmond C, Fisher B, et al. Base-line quality-of-life assessment in the National Surgical Adjuvant Breast and Bowel Project Breast Cancer Prevention Trial. J Natl Cancer Inst. 1995;87:1372–1382
  27. Day R, Ganz PA, Costantino JP, Cronin WM, Wickerham DL, Fisher B, et al. Health-related quality of life and tamoxifen in breast cancer prevention: a report from the National Surgical Adjuvant Breast and Bowel Project P-1 study. J Clin Oncol. 1999;17:2659–2669
  28. Ganz PA, Day R, Costantino J. Compliance with quality of life data collection in the National Surgical Adjuvant Breast and Bowel Project (NSABP) Breast Cancer Prevention Trial. Stat Med. 1998;17:613–622
  29. Day R, Ganz PA, Costantino JP. Tamoxifen and depression: more evidence from the National Surgical Adjuvant Breast and Bowel Project's Breast Cancer Prevention (P-1) Randomized study. J Natl Cancer Inst. 2001;93:1615–1623
  30. Land SR, Wickerham DL, Costantino JP, Ritter MW, Vogel VG, Lee M, et al. Patient-reported symptoms and quality of life during treatment with tamoxifen or raloxifene for breast cancer prevention: the NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 trial. JAMA. 2006;295:2742–2751
  31. Land SR, Kopec JA, Yothers G, Anderson S, Day R, Tang G, et al. Health related quality of life in axillary node-negative, estrogen receptor-negative breast cancer patients undergoing AC versus CMF chemotherapy: findings from the National Surgical Adjuvant Breast and Bowel Project B-23. Breast Cancer Res Treat. 2004;86:153–164
  32. Kopec JA, Yothers G, Ganz PA, Land SR, Cecchini RS, Wieand HS, et al. Quality of life in operable colon cancer patients receiving oral compared with intravenous chemotherapy: results from National Surgical Adjuvant Breast and Bowel trial C-06. J Clin Oncol. 2007;25:424–430
  33. Kopec JA, Land SR, Cecchini RS, Ganz PA, Cella D, Costantino JP, et al. Validation of a self-reported neurotoxicity in patients with operable colon cancer receiving oxaliplatin. J Support Oncol. 2006;4:W1–W8
  34. Paik S, Shak S, Tang G, Kim C, Baker J, Cronin M, et al. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med. 2004;30:2817–2826

 Supported in part by National Cancer Institute Grants No. U10-CA37377, U10-CA69974, U10-CA69651, U10-CA12027, and U24-CA114732.

 Financial disclosure: D. Lawrence Wickerham, MD, Eli Lilly and Company (consulting) and AstraZeneca Pharmaceuticals (honorarium); Walter M. Cronin, MPH, AstraZeneca Pharmaceuticals (compliance advisory board); Soonmyung Paik, MD, Glaxo Smith Kline and Genentech (honorarium); Eleftherios P. Mamounas, MD, MPH, Aventis (consulting, honorarium), Genentech (consulting, honorarium), Genomic Health (honorarium), Roche (consulting), Glaxo Smith Kline (consulting), Eli Lilly (consulting).

PII: S0093-7754(08)00168-1

doi: 10.1053/j.seminoncol.2008.07.005

Seminars in Oncology
Volume 35, Issue 5 , Pages 522-529 , October 2008

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