Patricia A Ganz1,2, Hanna Bandos3,4, Charles E Geyer3,5, André Robidoux3,6, Alexander H G Paterson3,7, Jonathan Polikoff3,8, Luis Baez-Diaz3,9, Adam M Brufsky3,10, Louis Fehrenbacher3,11, Ann W Parsons3,12, Patrick J Ward3,13, Louise Provencher3,14, John T Hamm3,15, Philip J Stella3,16, Robert L Carolla3,17, Richard G Margolese3,18, Henry R Shibata3,19, Edith A Perez3,20,21, Norman Wolmark3,10. 1. NSABP/NRG Oncology, Pittsburgh, PA, USA. pganz@mednet.ucla.edu. 2. Department of Health Policy and Management, UCLA Fielding School of Public Health, Jonsson Comprehensive Cancer Center, University of California at Los Angeles, 650 Charles Young Drive South, Rm A2-125 CHS, Los Angeles, CA, 90095, USA. pganz@mednet.ucla.edu. 3. NSABP/NRG Oncology, Pittsburgh, PA, USA. 4. Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA. 5. Division of Hematology and Medical Oncology, Houston Methodist Cancer Center, Houston, TX, USA. 6. Department of Surgery, Breast Cancer Research Group (GRCS), Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, PQ, Canada. 7. Department of Oncology, Tom Baker Cancer Centre, University of Calgary, Calgary, AB, Canada. 8. Department of Research and Evaluation-Clinical Trials-Oncology, Kaiser Permanente-San Diego Mission, San Diego, CA, USA. 9. Department of Cancer Medicine, Puerto Rico NCORP/UPR Comprehensive Cancer Center, San Juan, Puerto Rico. 10. UPMC Hillman Cancer Center, Pittsburgh, PA, USA. 11. Department of Oncology, Kaiser Permanente, Northern CA Region, Vallejo, CA, USA. 12. Department of Presbyterian Oncology, MBCCOP, University of New Mexico, Albuquerque, NM, USA. 13. Department of Medical Oncology, Oncology/Hematology Care Clinical Trials, Cincinnati, OH, USA. 14. Centre des Maladies du Sein Deschenes-Fabia, CHU de Québec/Université Laval, Québec City, PQ, Canada. 15. Department of Medical Oncology, Norton Cancer Institute-a part of Norton Healthcare, Louisville, KY, USA. 16. Department of Medical Oncology, St Joseph Mercy Hospital, Ann Arbor, MI, USA. 17. CCOP, Ozark Health Ventures LLC-Cancer Research for the Ozarks, Springfield, MO, USA. 18. Department of Oncology, Jewish General Hospital, Montréal, PQ, Canada. 19. Department of Surgery, McGill University Health Centre, Montréal, PQ, Canada. 20. Department of Hematology/Oncology and Cancer Biology, Mayo Clinic Jacksonville, Jacksonville, FL, USA. 21. NCCTG/ALLIANCE, Rochester, MN, USA.
Abstract
BACKGROUND: The NSABP B-36 compared four cycles of doxorubicin and cyclophosphamide (AC) with six cycles of 5-fluorouracil, epirubicin, and cyclophosphamide (FEC-100) in node-negative early-stage breast cancer. A sub-study within B-36, focusing on symptoms, quality of life (QOL), menstrual history (MH), and cardiac function (CF) was conducted. PATIENTS AND METHODS: Patients completed the QOL questionnaire at baseline, during treatment, and every 6 months through 36 months. FACT-B Trial Outcome Index (TOI), symptom severity, and SF-36 Vitality and Physical Functioning (PF) scales scores were compared between the two groups using a mixed model for repeated measures analysis. MH was collected at baseline and subsequently assessed if menstrual bleeding occurred within 12 months prior to randomization. Post-chemotherapy amenorrhea outcome was examined at 18 months and was defined as lack of menses in the preceding year. Logistic regression was used to test for association of amenorrhea and treatment. CF assessment was done at baseline and 12 months. Correlation analysis was used to address associations between changes in baseline and 12-month PF and concurrent CF changes measured by LVEF. RESULTS: FEC-100 patients had statistically significantly lower TOI scores during chemotherapy (P = 0.02) and at 6 months (P < 0.001); lower Vitality score at 6 months (P < 0.01), and lower PF score during the first year than AC patients. There were no statistically significant QOL score differences between the two groups beyond 12 months. No significant differences in symptom severity between the two groups were observed. Rates of amenorrhea were significantly different between FEC-100 and AC (67.4% vs. 59.1%, P < 0.001). There was no association between changes in LVEF and PF (P = 0.38). CONCLUSIONS: Statistically significant QOL differences between the two groups favored AC; however, the magnitude was small and unlikely to be clinically meaningful. There was a clinical and statistically significant difference in risk for amenorrhea, favoring AC. TRIAL REGISTRY: NCT00087178; Date of registration: 07/08/2004.
BACKGROUND: The NSABP B-36 compared four cycles of doxorubicin and cyclophosphamide (AC) with six cycles of 5-fluorouracil, epirubicin, and cyclophosphamide (FEC-100) in node-negative early-stage breast cancer. A sub-study within B-36, focusing on symptoms, quality of life (QOL), menstrual history (MH), and cardiac function (CF) was conducted. PATIENTS AND METHODS: Patients completed the QOL questionnaire at baseline, during treatment, and every 6 months through 36 months. FACT-B Trial Outcome Index (TOI), symptom severity, and SF-36 Vitality and Physical Functioning (PF) scales scores were compared between the two groups using a mixed model for repeated measures analysis. MH was collected at baseline and subsequently assessed if menstrual bleeding occurred within 12 months prior to randomization. Post-chemotherapy amenorrhea outcome was examined at 18 months and was defined as lack of menses in the preceding year. Logistic regression was used to test for association of amenorrhea and treatment. CF assessment was done at baseline and 12 months. Correlation analysis was used to address associations between changes in baseline and 12-month PF and concurrent CF changes measured by LVEF. RESULTS: FEC-100 patients had statistically significantly lower TOI scores during chemotherapy (P = 0.02) and at 6 months (P < 0.001); lower Vitality score at 6 months (P < 0.01), and lower PF score during the first year than AC patients. There were no statistically significant QOL score differences between the two groups beyond 12 months. No significant differences in symptom severity between the two groups were observed. Rates of amenorrhea were significantly different between FEC-100 and AC (67.4% vs. 59.1%, P < 0.001). There was no association between changes in LVEF and PF (P = 0.38). CONCLUSIONS: Statistically significant QOL differences between the two groups favored AC; however, the magnitude was small and unlikely to be clinically meaningful. There was a clinical and statistically significant difference in risk for amenorrhea, favoring AC. TRIAL REGISTRY: NCT00087178; Date of registration: 07/08/2004.
Authors: Patricia A Ganz; Reena S Cecchini; Thomas B Julian; Richard G Margolese; Joseph P Costantino; Laura A Vallow; Kathy S Albain; Patrick W Whitworth; Mary E Cianfrocca; Adam M Brufsky; Howard M Gross; Gamini S Soori; Judith O Hopkins; Louis Fehrenbacher; Keren Sturtz; Timothy F Wozniak; Thomas E Seay; Eleftherios P Mamounas; Norman Wolmark Journal: Lancet Date: 2015-12-11 Impact factor: 79.321
Authors: Soonmyung Paik; Gong Tang; Steven Shak; Chungyeul Kim; Joffre Baker; Wanseop Kim; Maureen Cronin; Frederick L Baehner; Drew Watson; John Bryant; Joseph P Costantino; Charles E Geyer; D Lawrence Wickerham; Norman Wolmark Journal: J Clin Oncol Date: 2006-05-23 Impact factor: 44.544
Authors: Soonmyung Paik; Steven Shak; Gong Tang; Chungyeul Kim; Joffre Baker; Maureen Cronin; Frederick L Baehner; Michael G Walker; Drew Watson; Taesung Park; William Hiller; Edwin R Fisher; D Lawrence Wickerham; John Bryant; Norman Wolmark Journal: N Engl J Med Date: 2004-12-10 Impact factor: 91.245
Authors: M J Brady; D F Cella; F Mo; A E Bonomi; D S Tulsky; S R Lloyd; S Deasy; M Cobleigh; G Shiomoto Journal: J Clin Oncol Date: 1997-03 Impact factor: 44.544
Authors: David T Eton; David Cella; Kathleen J Yost; Susan E Yount; Amy H Peterman; Donna S Neuberg; George W Sledge; William C Wood Journal: J Clin Epidemiol Date: 2004-09 Impact factor: 6.437
Authors: Stephanie R Land; Marcie W Ritter; Joseph P Costantino; Thomas B Julian; Walter M Cronin; Sarah R Haile; Norman Wolmark; Patricia A Ganz Journal: J Clin Oncol Date: 2007-11-10 Impact factor: 44.544
Authors: David Cella; Stephanie R Land; Chih-Hung Chang; Richard Day; Joseph P Costantino; Norman Wolmark; Patricia A Ganz Journal: Breast Cancer Res Treat Date: 2007-09-13 Impact factor: 4.872
Authors: Charles E Geyer; Hanna Bandos; Priya Rastogi; Samuel A Jacobs; André Robidoux; Louis Fehrenbacher; Patrick J Ward; Jonathan Polikoff; Adam M Brufsky; Louise Provencher; Alexander H G Paterson; John T Hamm; Robert L Carolla; Luis Baez-Diaz; Thomas B Julian; Sandra M Swain; Eleftherios P Mamounas; Norman Wolmark Journal: Breast Cancer Res Treat Date: 2022-03-01 Impact factor: 4.624