DOXORUBICIN Clinical Studies

(doxorubicin hydrochloride)

14 CLINICAL STUDIES

14.1 Adjuvant Breast Cancer

The efficacy of doxorubicin hydrochloride-containing regimens for the post-operative, adjuvant treatment of surgically resected breast cancer was evaluated in a meta-analysis conducted by the Early Breast Cancer Trialists Collaborative Group (EBCTCG). The EBCTCG meta-analyses compared cyclophosphamide, methotrexate, and fluorouracil (CMF) to no chemotherapy (19 trials including 7523 patients) and doxorubicin hydrochloride-containing regimens with CMF as an active control (6 trials including 3510 patients). Data from the meta-analysis of trials comparing CMF to no therapy were used to establish the historical treatment effect size for CMF regimens. The major efficacy outcome measures were disease-free survival (DFS) and overall survival (OS).

Of the 3510 women (2157 received doxorubicin hydrochloride-containing regimens and 1353 received CMF treatment) with early breast cancer involving axillary lymph nodes included in the six trials from the meta-analyses, approximately 70% were premenopausal and 30% were postmenopausal.

At the time of the meta-analysis, 1745 first recurrences and 1348 deaths had occurred. The analyses demonstrated that doxorubicin hydrochloride-containing regimens retained at least 75% of the historical CMF adjuvant effect on DFS with a hazard ratio (HR) of 0.91 (95% CI: 0.82, 1.01) and on OS with a HR of 0.91 (95% CI: 0.81, 1.03). Efficacy results are provided in Table 3 and Figures 1 and 2.

Table 3. Summary of Randomized Trials Comparing Doxorubicin Hydrochloride-Containing Regimens Versus CMF in Meta-Analysis
Study
(starting year)		RegimensNo. of CyclesNo. of PatientsDoxorubicin Hydrochloride-Containing Regimens vs. CMF
HR* (95% CI)
DFSOS
Abbreviations: DFS = disease free survival; OS = overall survival; AC = doxorubicin hydrochloride, cyclophosphamide; AVbCMF = doxorubicin hydrochloride, vinblastine, cyclophosphamide, methotrexate, fluorouracil; CMF = cyclophosphamide, methotrexate, fluorouracil; CMFVA = cyclophosphamide, methotrexate, fluorouracil, vincristine, doxorubicin hydrochloride; FAC = fluorouracil, doxorubicin hydrochloride, cyclophosphamide; FACV = fluorouracil, doxorubicin hydrochloride, cyclophosphamide, vincristine; HR = hazard ratio; CI = confidence interval
*
Hazard ratio of less than 1 indicates that the treatment with doxorubicin hydrochloride-containing regimens is associated with lower risk of disease recurrences or death compared to the treatment with CMF.
†
Includes pooled data from patients who received either AC alone for 4 cycles, or who were treated with AC for 4 cycles followed by 3 cycles of CMF.
‡
Patients received alternating cycles of AVb and CMF.

NSABP B-15
(1984)

AC

4

1562†

0.93 (0.82, 1.06)

0.97 (0.83, 1.12)

CMF

6

776

SECSG 2
(1976)

FAC

6

260

0.86 (0.66, 1.13)

0.93 (0.69, 1.26)

CMF

6

268

ONCOFRANCE
(1978)

FACV

12

138

0.71 (0.49, 1.03)

0.65 (0.44, 0.96)

CMF

12

113

SE Sweden BCG A
(1980)

AC

6

21

0.59 (0.22, 1.61)

0.53 (0.21, 1.37)

CMF

6

22

NSABC Israel Br0283
(1983)

AVbCMF‡

4
6

55

0.91 (0.53, 1.57)

0.88 (0.47, 1.63)

CMF

6

50

Austrian BCSG 3
(1984)

CMFVA

6

121

1.07 (0.73, 1.55)

0.93 (0.64, 1.35)

CMF

8

124

Combined Studies

Doxorubicin Hydrochloride-Containing Regimen

      2157

0.91 (0.82, 1.01)

0.91 (0.81, 1.03)

CMF

      1353

Figure 1. Meta-analysis of Disease-Free Survival

Figure 1

Figure 2. Meta-analysis of Overall Survival

Figure 2

Find DOXORUBICIN medical information:

Find DOXORUBICIN medical information:

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

DOXORUBICIN Quick Finder

Prescribing Information
Download Prescribing Information

Health Professional Information

Clinical Studies

14 CLINICAL STUDIES

14.1 Adjuvant Breast Cancer

The efficacy of doxorubicin hydrochloride-containing regimens for the post-operative, adjuvant treatment of surgically resected breast cancer was evaluated in a meta-analysis conducted by the Early Breast Cancer Trialists Collaborative Group (EBCTCG). The EBCTCG meta-analyses compared cyclophosphamide, methotrexate, and fluorouracil (CMF) to no chemotherapy (19 trials including 7523 patients) and doxorubicin hydrochloride-containing regimens with CMF as an active control (6 trials including 3510 patients). Data from the meta-analysis of trials comparing CMF to no therapy were used to establish the historical treatment effect size for CMF regimens. The major efficacy outcome measures were disease-free survival (DFS) and overall survival (OS).

Of the 3510 women (2157 received doxorubicin hydrochloride-containing regimens and 1353 received CMF treatment) with early breast cancer involving axillary lymph nodes included in the six trials from the meta-analyses, approximately 70% were premenopausal and 30% were postmenopausal.

At the time of the meta-analysis, 1745 first recurrences and 1348 deaths had occurred. The analyses demonstrated that doxorubicin hydrochloride-containing regimens retained at least 75% of the historical CMF adjuvant effect on DFS with a hazard ratio (HR) of 0.91 (95% CI: 0.82, 1.01) and on OS with a HR of 0.91 (95% CI: 0.81, 1.03). Efficacy results are provided in Table 3 and Figures 1 and 2.

Table 3. Summary of Randomized Trials Comparing Doxorubicin Hydrochloride-Containing Regimens Versus CMF in Meta-Analysis
Study
(starting year)		RegimensNo. of CyclesNo. of PatientsDoxorubicin Hydrochloride-Containing Regimens vs. CMF
HR* (95% CI)
DFSOS
Abbreviations: DFS = disease free survival; OS = overall survival; AC = doxorubicin hydrochloride, cyclophosphamide; AVbCMF = doxorubicin hydrochloride, vinblastine, cyclophosphamide, methotrexate, fluorouracil; CMF = cyclophosphamide, methotrexate, fluorouracil; CMFVA = cyclophosphamide, methotrexate, fluorouracil, vincristine, doxorubicin hydrochloride; FAC = fluorouracil, doxorubicin hydrochloride, cyclophosphamide; FACV = fluorouracil, doxorubicin hydrochloride, cyclophosphamide, vincristine; HR = hazard ratio; CI = confidence interval
*
Hazard ratio of less than 1 indicates that the treatment with doxorubicin hydrochloride-containing regimens is associated with lower risk of disease recurrences or death compared to the treatment with CMF.
†
Includes pooled data from patients who received either AC alone for 4 cycles, or who were treated with AC for 4 cycles followed by 3 cycles of CMF.
‡
Patients received alternating cycles of AVb and CMF.

NSABP B-15
(1984)

AC

4

1562†

0.93 (0.82, 1.06)

0.97 (0.83, 1.12)

CMF

6

776

SECSG 2
(1976)

FAC

6

260

0.86 (0.66, 1.13)

0.93 (0.69, 1.26)

CMF

6

268

ONCOFRANCE
(1978)

FACV

12

138

0.71 (0.49, 1.03)

0.65 (0.44, 0.96)

CMF

12

113

SE Sweden BCG A
(1980)

AC

6

21

0.59 (0.22, 1.61)

0.53 (0.21, 1.37)

CMF

6

22

NSABC Israel Br0283
(1983)

AVbCMF‡

4
6

55

0.91 (0.53, 1.57)

0.88 (0.47, 1.63)

CMF

6

50

Austrian BCSG 3
(1984)

CMFVA

6

121

1.07 (0.73, 1.55)

0.93 (0.64, 1.35)

CMF

8

124

Combined Studies

Doxorubicin Hydrochloride-Containing Regimen

      2157

0.91 (0.82, 1.01)

0.91 (0.81, 1.03)

CMF

      1353

Figure 1. Meta-analysis of Disease-Free Survival

Figure 1

Figure 2. Meta-analysis of Overall Survival

Figure 2
Medication Guide

Health Professional Information

{{section_name_patient}}

{{section_body_html_patient}}

Resources

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985*

*Speak with a Pfizer Medical Information Professional regarding your medical inquiry. Available 9AM-5PM ET Monday to Friday; excluding holidays.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.