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Citron M, et al. J Clin Oncol. 2003;21:1431-1439.

CALGB 9741 A Randomized Trial of Dose-Dense vs Conventionally Scheduled and Sequential vs Concurrent Combination Chemotherapy as Postoperative Adjuvant Treatment of Node-Positive Primary Breast Cancer. Citron M, et al. J Clin Oncol. 2003;21:1431-1439. C9741—Protocol. 2X2 Factorial Design.

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Citron M, et al. J Clin Oncol. 2003;21:1431-1439.

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  1. CALGB 9741A Randomized Trialof Dose-Dense vsConventionally Scheduledand Sequential vs Concurrent Combination Chemotherapy as Postoperative Adjuvant Treatment of Node-Positive Primary Breast Cancer Citron M, et al. J Clin Oncol. 2003;21:1431-1439.

  2. C9741—Protocol 2X2 Factorial Design q3wk q2wk + Filgrastim SEQUENTIAL 36 wk“Seq Q3” 24 wk “Seq Q2” CONCURRENT 24 wk“Con Q3” 16 wk“Con Q2” Doxorubicin 60 mg/m2 Cyclophosphamide 600 mg/m2 Paclitaxel 175 mg/m2 over 3 h With Permission from Citron M, et al. J Clin Oncol. 2003;21:1431-1439.

  3. C9741—Major Toxicities Citron M, et al. J Clin Oncol. 2003;21:1431-1439 Erratum published in J Clin Oncol, 2003;21:2226.

  4. C9741—Disease-Free Survival by Dose Density Disease-Free Survival By Density 1.0 q 2 0.8 q 3 0.6 Proportion Disease-Free q2wk N = 988 Events = 136 q3wk N = 985 Events = 179 0.4 0.2 RR = 0.74; P = .010 0.0 0 1 2 3 4 Years from Study Entry With permission from Citron M, et al. J Clin Oncol. 2003;21:1431-1439.

  5. Cox Model—Retrospective Analysis of Dose Density (q2) Therapy by ER Status in C9741 ER = estrogen receptor; DFS = disease-free survival; OS = overall survivalCourtesy of Marc Citron, MD.With permission from C. Hudis, MD.

  6. C9741—DFS by Dose Density at Median 5-Year Follow-up 1.0 0.9 q2wk 0.8 0.7 q3wk 0.6 Disease-FreeSurvival 0.5 0.4 0.3 Q2 n = 988 Events = 230 Q3 n = 984 Events = 278 P = .012 0.2 0.1 0.0 0 1 2 3 4 5 6 7 Year Hudis C, et al. 2005 San Antonio Breast Cancer Symposium. Abstract 41.With permission from C. Hudis, MD.

  7. C9741—DFS by ER Status and Dose Density at 5-Year Median 1.0 0.9 ER+ q2wk 0.8 ER+ q3wk 0.7 0.6 ER- q2wk Disease-Free Survival 0.5 ER- q3wk 0.4 0.3 0.2 0.1 0.0 0 1 2 3 4 5 6 7 Year ER+ q2 n = 636 Events = 126 ER- q2 n = 336 Events = 99 ER+ q3 n = 639 Events = 133ER- q3 n = 327 Events = 127 P = .014 P = NS ER = estrogen receptorsWith permission from Hudis C, et al. 2005 San Antonio Breast Cancer Symposium. Abstract 41.

  8. Dose-Dense Chemotherapy-Induced Pulmonary Toxicity Courtesy of Marc Citron, MD.

  9. Accelerated vs Standard FEC RegimenGONO-MIG1 Protocol FEC14 = q2wk (w/G-CSF) for 10 wk FEC21 = q3wk for 15 wk F = fluorouracil 600 mg/m2 E = epirubicin 60 mg/m2 C = cyclophosphamide 600 mg/m2 Accrued N = 1214 10.4 yr median follow-up 359 events Venturini M, et al. J Natl Cancer Inst. 2005;97:1724-1733.

  10. Accelerated vs Standard FEC RegimenGONO-MIG1 Results No significant differences in: • Event-free survival - HR for FEC14/FEC21 = 0.88, 95% CI (0.71–1.08) P =.219 • Risk of death - HR for FEC14/FEC21 = 0.87, 95% CI (0.67–1.13) P = .293 FEC = fluorouracil, epirubicin, cyclophosphamide; HR = hazard ratio.Venturini M, et al. J Natl Cancer Inst. 2005;97:1724-1733.

  11. GONO-MIG1—Accelerated FEC Provides No Significant Benefit for HER2 Negative EFS OS HER2 negative HER2 negative 92% 100 100 90 90 82% 91% 80 80 81% 70 70 60 60 50 50 % Event Free % SURVIVAL 40 40 FEC21 FEC21 30 30 20 20 HR = 0.91 (0.65–1.27) P = .57 HR = 0.79 (0.49–1.28) p = .34 FEC14 10 FEC14 10 0 0 0 1 2 3 4 5 6 7 8 9 10 0 1 2 3 4 5 6 7 8 9 10 Years Years No. at risk No. at risk FEC14 320 309 286 266 235 179 105 52 16 1 FEC14 320 318 314 308 297 244 161 92 31 1 FEC21 308 297 281 247 227 178 107 52 16 FEC21 308 307 303 296 286 233 160 92 37 GONO-MIG1 = Gruppo Oncologico Nord-Ovest-Mammella Intergruppo; FEC = fluorouracil, epirubicin, cyclophosphamide; EFS = event-free survival; OS = overall survival. With permission from Del Mastro L, et al. Br J Cancer. 2005;93:7-14.

  12. GONO-MIG1—Accelerated FEC Showed TrendToward Benefit for HER2 Positive EFS OS HER2 positive HER2 positive 100 90% 100 FEC21 90 90 78% FEC21 80 80 75% 70 70 FEC14 FEC14 60 60 63% 50 50 Survival (%) Eent Free (%) 40 40 30 30 20 20 HR = 0.54 (0.27–1.11) P = .092 HR = 0.59 (0.25–1.37) P = .22 10 10 0 0 0 1 2 3 4 5 6 7 8 9 10 0 1 2 3 4 5 6 7 8 9 10 Years Years No. at risk No. at risk FEC14 50 50 50 47 46 39 23 14 5 FEC14 50 50 44 39 33 27 15 10 5 FEC21 53 52 47 45 42 33 20 9 4 FEC21 53 48 41 32 31 23 16 7 2 GONO-MIG1 = Gruppo Oncologico Nord-Ovest-Mammella Intergruppo; FEC = fluorouracil, epirubicin, cyclophosphamide; EFS = event-free survival; OS = overall survival. With permission from Del Mastro L, et al. Br J Cancer. 2005;93:7-14.

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