Quality of life among patients with Stage II and III breast carcinoma randomized to receive high-dose chemotherapy with autologous bone marrow support or intermediate-dose chemotherapy

Results from Cancer and Leukemia Group B 9066

Authors

  • Jeffrey Peppercorn M.D., M.P.H.,

    1. Department of Medical Oncology, Dana Farber Cancer Institute, Boston, Massachusetts
    Search for more papers by this author
  • James Herndon II Ph.D.,

    1. Cancer and Leukemia Group B Statistical Center, Durham, North Carolina
    Search for more papers by this author
  • Alice B. Kornblith Ph.D.,

    1. Department of Medical Oncology, Dana Farber Cancer Institute, Boston, Massachusetts
    Search for more papers by this author
  • William Peters M.D., Ph.D., M.B.A.,

    1. Adherex Technologies Inc., Durham, North Carolina
    Search for more papers by this author
  • Tim Ahles Ph.D.,

    1. Department of Psychiatry, Dartmouth Medical School-Norris Cotton Cancer Center, Lebanon New Hampshire
    Search for more papers by this author
  • James Vredenburgh M.D.,

    1. Department of Medicine, Duke Comprehensive Cancer Center, Durham, North Carolina
    Search for more papers by this author
  • Gary Schwartz M.D.,

    1. Department of Medicine, Dartmouth Medical School-Norris Cotton Cancer Center, Lebanon New Hamphshire
    Search for more papers by this author
  • Elizabeth Shpall M.D.,

    1. Department of Blood and Marrow Transplantation, University of Texas M.D. Anderson Cancer Center, Houston, Texas
    Search for more papers by this author
  • David D. Hurd M.D.,

    1. Department of Hematology Oncology, Wake Foreset University School of Medicine, Winston-Salem, North Carolina
    Search for more papers by this author
  • Jimmie Holland M.D.,

    1. Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Ketterling Cancer Center, New York, New York
    Search for more papers by this author
  • Eric Winer M.D.,

    Corresponding author
    1. Department of Medical Oncology, Dana Farber Cancer Institute, Boston, Massachusetts
    • Dana Farber Cancer Institute, 44 Binney Street, Boston, MA 02115
    Search for more papers by this author
    • Fax: (617) 632-2616

  • The Cancer and Leukemia Group B (CALGB) and The Southwestern Oncology Group (SWOG)Group

    Search for more papers by this author
    • The following institutions participated in this study: CALGB Statistical Center, Durham, NC (Stephen George, Ph.D. [supported by CA33601]); Dana Farber Cancer Institute, Boston, MA (George P. Canellos, M.D. [supported by CA32291]); Dartmouth Medical School-Norris Cotton Cancer Center, Lebanon, NH (Marc Ernstoff, M.D.; [supported by CA04326]); Duke University Medical Center, Durham, NC (Jeffrey Crawford, M.D. [supported by CA47577]); McGill Cancer Center, Montreal, Quebec, Canada (Brian Leyland-Jones, M.D. [supported by CA31809]); Mount Sinai School of Medicine, New York, NY (Lewis Silverman, M.D. [supported by CA04457]); North Shore-Long Island Jewish Medical Center, Manhasset, NY (Daniel R. Budman, M.D. [supported by CA35279]); Rhode Island Hospital, Providence, RI (William Sikov, M.D. [supported by CA08025]); Roswell Park Cancer Institute, Buffalo, NY (Ellis Levine, M.D. [supported by CA02599]); State University of New York-Upstate Medical University, Syracuse, NY (Stephen L. Graziano, M.D. [supported by CA21060]); University of Alabama Birmingham, Birmingham, AL (Robert Diasio, M.D. [supported by CA47545]); University of California at San Diego, San Diego, CA (Stephen Seagren, M.D. [supported by CA11789]); University of California at San Francisco, San Francisco, CA (Alan Venook, M.D. [supported by CA60138]); University of Chicago Medical Center, Chicago, IL (Gini Fleming, M.D. [supported by CA41287]); University of Iowa, Iowa City, IA (Gerald Clamon, M.D. [supported by CA47642]); University of Maryland Cancer Center, Baltimore, MD (David Van Echo, M.D. [supported by CA31983]); University of Massachusetts Medical Center, Worcester, MA (Pankaj Bhargava, M.D. [supported by CA37135]); University of Minnesota, Minneapolis, MN (Bruce A Peterson, M.D. [supported by CA16450]); University of North Carolina at Chapel Hill, Chapel Hill, NC (Thomas C. Shea, M.D. [supported by CA47559]); Wake Forest University School of Medicine, Winston-Salem, NC (David D. Hurd, M.D. [supported by CA03927]); Washington University School of Medicine, St. Louis, MO (Nancy Bartlett, M.D. [supported by CA77440]); and Weill Medical College of Cornell University, New York, NY (Scott Wadler, M.D. [supported by CA07968]).


  • Presented as Abstract 1593 at the annual meeting of the American Society of Clinical Oncology, Atlanta, Georgia, May 15–19, 1999.

  • The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute.

Abstract

BACKGROUND

The objective of this study was to compare the quality of life (QOL) after treatment among patients who had breast carcinoma with multiple positive lymph nodes. The patients were randomized to receive either high-dose chemotherapy with autologous stem cell support (HDC) or intermediate-dose chemotherapy (IDC) in the adjuvant setting.

METHODS

Two hundred forty-six patients with AJCC Stage IIA, IIB, or IIIA breast carcinoma who had ≥ 10 positive lymph nodes and who were participants in Cancer and Leukemia Group B (CALGB) 9082 were enrolled in this companion study, CALGB 9066. Patients were randomized to receive either high-dose cyclophosphamide, carmustine, and cisplatin (CPA/cDDP/BCNU) and autologous bone marrow transplantation (the HDC arm) or intermediate-dose CPA/cDDP/BCNU as consolidation to adjuvant chemotherapy (the IDC arm). QOL was assessed at baseline and at 3 months, 12 months, 24 months, and 36 months using the Functional Living Index-Cancer (FLIC), the Psychosocial Adjustment to Illness Scale (PAIS)-Self Report, and the McCorkle Symptom Distress Scale (SDS).

RESULTS

At the 3-month assessment, patients in the HDC arm demonstrated significant worsening of QOL compared with the IDC arm in terms of their physical well being (FLIC, P = 0.023), social functioning (FLIC, P = 0.026; PAIS, P < 0.0001), symptom distress (SDS, P = 0.0002), and total QOL scores (FLIC, P = 0.042). At 12 months, the differences in QOL scores between the HDC arm and the IDC arm had resolved.

CONCLUSIONS

Patients who received more intensive adjuvant therapy experienced transient declines in QOL. By 12 months after therapy, QOL was comparable between the 2 arms, regardless of therapy intensity, and many QOL areas were improved from baseline. Cancer 2005. © 2005 American Cancer Society.

Ancillary