Phase III Trial of Doxorubicin /Cyclophosphamide (AC), Docetaxel (D), and Alternating AC and D (AC-D) as Front-Line Chemotherapy for Metastatic Breast Cancer: Japan Clinical Oncology Group Trial (JCOG9802)
20 Years
75 Years
Female
Breast Cancer, Neoplasm Metastasis
Trial Information
Phase III Trial of Doxorubicin /Cyclophosphamide (AC), Docetaxel (D), and Alternating AC and D (AC-D) as Front-Line Chemotherapy for Metastatic Breast Cancer: Japan Clinical Oncology Group Trial (JCOG9802)
power to detect a 50% increase in median TTF at 0.025 one-sided alpha in AC vs. D and AC vs.
AC-D.
Results: 441pts (146 in AC, 147 in D, 148 in AC-D) were randomized between 01/99 and 05/03.
Major grade 3-4 toxicities were neutropenia (26/45/46% for AC/D/AC-D), febrile neutropenia
(3/4/6%), nausea/vomiting (3/3/4%). There was no toxic death. One grade 4 diarrhea in AC-D
and 1 secondary leukemia (APL) in D were reported. Response (CR/PR) rates were 30, 41, and
35% for AC, D, and AC-D respectively. Median TTF (AC, D, and AC-D) are 6.4, 6.4, and 6.7
months (p =.255 for AC vs. D, p =.275 for AC vs. AC-D), and median overall survival are
22.4, 25.7, and 25.0 months (p=.092 for AC vs. D, p=.076 for AC vs. AC-D). The same
difference was shown by the adjusted Cox model.
Conclusions: No benefit was demonstrated in D and AC-D over AC in TTF, however, D and AC-D
tended to be superior to AC in response rate and overall survival. Survival benefit of
front-line docetaxel should be re-evaluated by further long follow-up.
Inclusion Criteria:
1. Hormonal therapy-resistant MBC
2. ER (-), failure of hormonal therapy for MBC, or relapse within 6 months after
adjuvant hormonal therapy
3. No anthracyclines for MBC and no prior taxanes
4. At least 6 months from the completion of adjuvant chemotherapy
5. Measurable or evaluable lesions
6. Age: 20 to 75 years
7. PS: 0-3
8. WBC >= 4,000 /mm3 or ANC >=1,000 /mm3, Platelet >= 100,000 /mm3, SGOT/SGPT <= 1.5 x
ULN, T-Bil <= 1.5 mg/dL, Cr <= 1.5 mg/dL
9. normal ECG
10. Written informed consent
Exclusion Criteria:
1. pregnant
2. malignant pleural effusion, ascites, or pericardial effusion that requires emergent
treatment
3. Active infection
4. other cancer present within the last 5 years
5. previous stem cell transplantation
6. brain metastasis that requires emergent treatment
7. relapse within 6 months after completion anthracycline or during anthracycline
8. more than 250mg/m2 of anthracyclines
9. hypersensitivity of drug
10. interstitial pneumonitis or pulmonary fibrosis
11. positive HBs
12. antipsychotic medication
13. doctor's judgement
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
time to treatment failure
Principal Investigator
Shigemitsu Takashima, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
National Shikoku Cancer Center
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
JCOG9802
NCT ID:
NCT00190489
Start Date:
January 1999
Completion Date:
May 2006
Related Keywords:
- Breast Cancer
- Neoplasm Metastasis
- metastatic breast cancer
- drug therapy
- doxorubicin
- docetaxel
- Breast Neoplasms
- Neoplasms
- Neoplasm Metastasis
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