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CALGB 9741 A Randomized Trial of Dose-Dense vs Conventionally Scheduled and Sequential vs Concurrent Combination Chemotherapy as Postoperative Adjuvant.

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Presentation on theme: "CALGB 9741 A Randomized Trial of Dose-Dense vs Conventionally Scheduled and Sequential vs Concurrent Combination Chemotherapy as Postoperative Adjuvant."— Presentation transcript:

1 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 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.

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

3 C9741—Major Toxicities Seq q3Seq q2Con q3Con q2 No. treated484493501495 No. with detailed data103101104 Granulocytes < 0.5/µL24%3%43%9% Febrile neutropenia, hospitalized 3%2%6%2% Red cell transfusion0%3%4%13% Platelet transfusion0% Neurologic: severe sensory loss or motor weakness 5% 7%5% 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 Years from Study Entry Proportion Disease-Free 01234 0.0 0.2 0.4 0.6 0.8 1.0 Disease-Free Survival By Density q2wk q3wk N = 988 N = 985 Events = 136 Events = 179 q 2 q 3 With permission from Citron M, et al. J Clin Oncol. 2003;21:1431-1439. RR = 0.74; P =.010

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

6 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 01234567 Year C9741—DFS by Dose Density at Median 5-Year Follow-up q2wk q3wk Disease-Free Survival Q2 n = 988 Events = 230 Q3 n = 984 Events = 278 Hudis C, et al. 2005 San Antonio Breast Cancer Symposium. Abstract 41. With permission from C. Hudis, MD. P =.012

7 C9741—DFS by ER Status and Dose Density at 5-Year Median Disease-Free Survival 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 01234567 Year ER+ q3wk ER- q3wk ER- q2wk ER+ q2wk ER+ q2 n = 636 Events = 126 ER- q2 n = 336 Events = 99 ER+ q3 n = 639 Events = 133 ER- q3 n = 327 Events = 127 P =.014 P = NS ER = estrogen receptors With 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 FEC 14 = q2wk (w/G-CSF) for 10 wk FEC 21 = q3wk for 15 wk Accrued N = 1214 10.4 yr median follow-up 359 events F = fluorouracil 600 mg/m 2 E = epirubicin 60 mg/m 2 C = cyclophosphamide 600 mg/m 2 Accelerated vs Standard FEC Regimen GONO-MIG1 Protocol Venturini M, et al. J Natl Cancer Inst. 2005;97:1724-1733.

10 Accelerated vs Standard FEC Regimen GONO-MIG1 Results ToxicityFEC 14 FEC 21 Asthenia36%29% Anemia38%19% Bone pain33%4% Leukopenia12%45% No significant differences in: Event-free survival Event-free survival - HR for FEC 14 /FEC 21 = 0.88, 95% CI (0.71–1.08) P =.219 Risk of death Risk of death - HR for FEC 14 /FEC 21 = 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 HR = 0.79 (0.49–1.28) p =.34 Years 109876543210 % SURVIVAL 100 90 80 70 60 50 40 30 20 10 0 FEC21 FEC14 HER2 negative 31 92161244297308314318320FEC14 No. at risk 3792160233286296303307308FEC21 1 HR = 0.91 (0.65–1.27) P =.57 Years 109876543210 % Event Free 100 90 80 70 60 50 40 30 20 10 0 FEC21 FEC14 HER2 negative 116 52105179235266286309320FEC14 No. at risk 1652107178227247281297308FEC21 EFSOS 81% 82% 91% 92% 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. GONO-MIG1—Accelerated FEC Provides No Significant Benefit for HER2 Negative

12 HR = 0.54 (0.27–1.11) P =.092 Years 109876543210 Eent Free (%) 100 90 80 70 60 50 40 30 20 10 0 FEC21 FEC14 HER2 positive 510152733394450 FEC14 No. at risk FEC212 716233132414853 HR = 0.59 (0.25–1.37) P =.22 Years 109876543210 Survival (%) 100 90 80 70 60 50 40 30 20 10 0 FEC21 FEC14 HER2 positive 5142339464750 FEC14 FEC21492033424547475253 No. at risk EFSOS 63% 78% 75% 90% 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. GONO-MIG1—Accelerated FEC Showed Trend Toward Benefit for HER2 Positive


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