Treatment of Primary Breast Cancer with Chemotherapy and Tamoxifen
List of authors.
Bernard Fisher, M.D.,
Carol Redmond, Sc.D.,
Ann Brown, Sc.D.,
Norman Wolmark, M.D.,
James Wittliff, Ph.D.,
Edwin R. Fisher, M.D.,
David Plotkin, M.D.,
David Bowman, M.D.,
Sidney Sachs, M.D.,
Janet Wolter, M.D.,
Robert Frelick, M.D.,
Richard Desser, M.D.,
Nicholas LiCalzi, M.D.,
Peter Geggie, M.D.,
Thomas Campbell, M.D.,
E. George Elias, M.D.,
David Prager, M.D.,
Paul Koontz, M.D.,
Herbert Volk, M.D.,
Nikolay Dimitrov, M.D.,
Bernard Gardner, M.D.,
Harvey Lerner, M.D.,
and Henry Shibata, M.D.
Abstract
We studied the possibility that the addition of tamoxifen to L-phenylalanine mustard combined with 5-fluorouracil enhances the benefit from the latter two drugs that has been observed in women with primary breast cancer and positive axillary nodes. Recurrence of disease was reduced at two years in patients given the three-drug regimen whose tumor estrogen-receptor levels were ≥10 fmol. Among patients ≥50 years old treatment failure was significantly reduced (P<0.001): by 51 per cent in those with one to three positive nodes and by 64 per cent in those with four or more. Higher receptor levels were associated with a greater probability of disease-free survival. Patients ≤49 years old were less responsive: those with one to three positive nodes received no benefit from tamoxifen at any receptor level, whereas those with four or more appeared to have reduced treatment failure associated with higher receptor levels.
This adjuvant chemotherapy is not indicated in patients ≤49 years old whose tumor receptor levels are below 10 fmol; there is a suggestion of benefit in patients ≥50 years old whose levels are low. (N Engl J Med. 1981; 305:1–6.)
Funding and Disclosures
Supported by a grant (R-01-CA-12027) from and a contract (N01-CB-23876) with the U.S. Public Health Service and by a grant (RC-13) from the American Cancer Society.
See Appendix 1 for a list of NSABP institutions and principal investigators.
We are indebted to the members of the NSABP Endocrine Monitoring Committee — George Escher, M.D., Marc Lippman, M.D., Edwin Savlov, M.D., and Albert Segaloff, M.D. — and to Ms. Elizabeth A. Saffer for her aid in the preparation of the manuscript.
Author Affiliations
Other NSABP Investigators
From the National Surgical Adjuvant Breast and Bowel Project (NSABP) Headquarters, Room 914, Scaife Hall, 3550 Terrace St., Pittsburgh, PA 15261, where reprint requests should be addressed.
Appendix 1
The following is a list of NSABP institutions and principal investigators: Albany Regional Cancer Center, Albany, N.Y., Thomas Cunningham; Albert Einstein College of Medicine, Bronx, N.Y., Herbert Volk; Albert Einstein Medical Center, Philadelphia, Pa., Stanley Levick; Allentown Hospital, Allentown, Pa., David Prager; Berkshire Medical Center, Pittsfield, Mass., Jesse Spector and Harvey Zimbler; Boston University, Boston, Mass., Peter J. Deckers and Merrill Feldman; Cross Cancer Institute, Edmonton, Alta., Canada, Sandy Paterson; Daniel Freeman Hospital, Inglewood, Calif., Elliott Hinkes; Dekalb General Hospital, Decatur, Ga., S. Angier Wills; Denver General Hospital, Denver, Colo., George Moore; Downstate Medical Center, Brooklyn, N.Y., Bernard Gardner; Ellis Fischel State Cancer Hospital, Columbia, Mo., William Kraybill; Geisinger Medical Center, Danville, Pa., Philip Breen; Group Health Medical Center, Seattle, Wash., Robert Bourdeau; Harbor General Hospital, Torrance, Calif., David State and M. Michael Shabot; Hennepin County Medical Center, Minneapolis, Minn., Claude Hitchcock; Highland Hospital/University of Rochester, Rochester, N.Y., Sidney Sobel; Hôpital Avicenne, Paris, France, Lucien Israel; Hotel-Dieu, Quebec City, Que., Canada, Louis Dionne; Jewish General Hospital, Montreal, Que., Canada, Richard Margolese; Kaiser Permanente, Harbor City, Calif., Eugene Pollack; Kaiser Permanente, Portland, Oreg., Andrew Glass; Kaiser Permanente, San Diego, Calif., Thomas Campbell; Letterman Army Medical Center, San Francisco, Calif., David Gandara; Louisiana State University, New Orleans, La., Isidore Cohn; Louisiana State University, Shreveport, La., Leonard Goldman; Manitoba Cancer Foundation, Winnipeg, Man., Canada, David Bowman; Marin General Hospital, San Rafael, Calif., Peter Eisenberg; McMaster University, Hamilton, Ont., Canada, S. E. O'Brien; Medical College of Virginia, Richmond, Va., Walter Lawrence; Medical College of Wisconsin, Milwaukee, Wis., William Donegan; Memorial Cancer Research Foundation, Culver City, Calif., David Plotkin; Michael Reese Hospital, Chicago, III., Richard Desser; Michigan State University, East Lansing, Mich., Nikolay Dimitrov and Leif Suhrland; Montefiore Hospital and Medical Center, Bronx, N.Y., Richard G. Rosen; Montreal General Hospital, Montreal, Que., Canada, John MacFarlane; Mount Sinai Hospital, Cleveland, Ohio, Sidney Sachs; Newark Beth Israel Hospital, Newark, N.J., Frederick Cohen; Ottawa Civic Hospital/Ontario Cancer Foundation, Ottawa, Ont., Canada, James Devitt and Rebecca McDermot; Pennsylvania Hospital, Philadelphia, Pa., Harvey Lerner; Pondville Hospital, Walpole, Mass., Leo Stolbach; Royal Victoria Hospital, Montreal, Que., Canada, Henry Shibata; Rush–Presbyterian–St. Luke's Medical Center, Chicago, III., Steven Economou and Janet Wolter; St. Luc Hospital, Montreal, Que., Canada, Roger Poisson and S. Legault-Poisson; St. Luke's Hospital, Kansas City, Mo., Paul Koontz; St. Michael's Hospital, Toronto, Ont., Canada, Leo Mahoney; St. Vincent's Hospital, New York, N.Y., Thomas Nealon; South Nassau Communities Hospital, Ocean-side, N.Y., Nicholas LiCalzi; Southern Alberta Cancer Centre, Calgary, Alta., Canada, L. Martin Jerry; Tulane University, New Orleans, La., Carl Sutherland; U.S. Naval Hospital, Oakland, Calif., James Congdon; U.S. Naval Hospital, San Diego, Calif., Jim Guzik; University of California, San Diego, Calif., Yosef Pilch; University of Florida (JHEP), Jacksonville, Fla., Neil Abramson; University of Hawaii, Manoa, Hawaii, Noboru Oishi; University of Iowa, Iowa City, Iowa, Peter Jochimsen; University of Louisville, Louisville, Ky., Joseph C. Allegra; University of Maryland, Baltimore, Md., E. George Elias; University of North Carolina, Chapel Hill, N.C., Robert Capizzi; University of Pittsburgh, Pittsburgh, Pa., Bernard Fisher; University of Texas, San Antonio, Tex., A. B. Cruz and J. Bradley Aust; University of Vermont, Burlington, Vt., Roger Foster; Valley Hospital, Ridgewood, N.J., Hugh Auchincloss; Washington Regional Medical Center, Fayetteville, Ariz., Arthur Hoge; Washington University, St. Louis, Mo., Marc Wallack; West Suburban Hospital, Oak Park, III., Everett Nicholas; White Memorial Medical Center, Los Angeles, Calif., Matthew Tan; and Wilmington Medical Center, Wilmington, Del., Robert Frelick.