Adjuvant cyclophosphamide, methotrexate and fluorouracil after radical mastectomy in node-positive breast cancer (Istituto Nazionale Tumori, Milan)
N = 386
- Population
- Women with histologically positive axillary lymph nodes after radical mastectomy for primary breast cancer.
- Design
- Randomised trial begun in 1973 at the Istituto Nazionale Tumori, Milan: no further treatment after radical mastectomy versus 12 monthly cycles of adjuvant combination chemotherapy (CMF); 20-year follow-up reported in 1995.
- Arms
- Radical mastectomy alone (control, n = 179): No further treatment after radical mastectomy
- CMF (experimental, n = 207): 12 monthly cycles of adjuvant combination chemotherapy with cyclophosphamide, methotrexate and fluorouracil
- People
- Bonadonna G, Istituto Nazionale Tumori, Milan
Δ 27-month Treatment failure−18.7 pointsRFSHR 0.71 (95% CI 0.56–0.90)OSHR 0.78 (95% CI 0.62–0.99)
Show the numbers
| Endpoint | Analysis | CMF | Radical mastectomy alone | Effect |
|---|---|---|---|---|
| Treatment failureRandomised women (386)Proportion with treatment failure after 27 months of study, as worded in the NEJM abstract; the abstract does not define the term (full text not read) | interimBonadonna 1976 | 5.3% at 27 mo | 24% at 27 mo | P<10^-6Interim report. The endpoint is 'treatment failure' as worded in the journal's own abstract, not 'relapse'; its definition is in the full text, which was not read. PubMed's text omits the word 'failure'. |
| RFSRandomised women (386) | long term-updatemedian follow-up 19.4 yearsBonadonna 1995 | — | — | HR 0.71 (95% CI 0.56–0.90)P=0.004Published as 'unadjusted relative risk of relapse' (CMF vs no further treatment); entered in the hazard-ratio field. Adjusted relative risk 0.65 also reported. |
| OSRandomised women (386) | long term-updatemedian follow-up 19.4 yearsBonadonna 1995 | — | — | HR 0.78 (95% CI 0.62–0.99)P=0.04Published as 'unadjusted relative risk of death' (total survival); entered in the hazard-ratio field. Adjusted relative risk 0.76 also reported. |
| Endpoint | Analysis | CMF | Radical mastectomy alone | Effect |
|---|---|---|---|---|
| Treatment failureRandomised women (386)Proportion with treatment failure after 27 months of study, as worded in the NEJM abstract; the abstract does not define the term (full text not read) | interimBonadonna 1976 | 5.3% at 27 mo | 24% at 27 mo | P<10^-6Interim report. The endpoint is 'treatment failure' as worded in the journal's own abstract, not 'relapse'; its definition is in the full text, which was not read. PubMed's text omits the word 'failure'. |
| RFSRandomised women (386) | long term-updatemedian follow-up 19.4 yearsBonadonna 1995 | — | — | HR 0.71 (95% CI 0.56–0.90)P=0.004Published as 'unadjusted relative risk of relapse' (CMF vs no further treatment); entered in the hazard-ratio field. Adjusted relative risk 0.65 also reported. |
| OSRandomised women (386) | long term-updatemedian follow-up 19.4 yearsBonadonna 1995 | — | — | HR 0.78 (95% CI 0.62–0.99)P=0.04Published as 'unadjusted relative risk of death' (total survival); entered in the hazard-ratio field. Adjusted relative risk 0.76 also reported. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| RFS | 0.71 | 0.56–0.9 |
| OS | 0.78 | 0.62–0.99 |
Appears in
Sources
Bonadonna G, Brusamolino E, Valagussa P, Rossi A, Brugnatelli L, Brambilla C, et al. Combination chemotherapy as an adjuvant treatment in operable breast cancer. N Engl J Med. 1976;294(8):405-10.
Bonadonna G, Valagussa P, Moliterni A, Zambetti M, Brambilla C. Adjuvant cyclophosphamide, methotrexate, and fluorouracil in node-positive breast cancer: the results of 20 years of follow-up. N Engl J Med. 1995;332(14):901-6.