Turkish study(small, not optimallyrandomized)=no statistical improvemnt w 1yr vs 9wks

[Lani]

herceptin

pub ahead of print]
Nine weeks versus 1 year adjuvant trastuzumab in patients with early breast cancer: an observational study by the Turkish Oncology Group (TOG).
Içli F, Altundağ K, Akbulut H, Paydaş S, Başaran G, Saip P, Doğu GG, Eralp Y, Uslu R, Sevinç A, Onur H, Mandel NM, Sezgin C, Altınbaş M, Güler N, Işıkdoğan A, Gökmen E, Uygun K, Ustüner Z, Yaren A, Demirkan B, Coşkun U, Ata A, Ozkan M, Arican A.
Author information

Abstract
BACKGROUND:
Optimal duration of adjuvant trastuzumab in early breast cancer is an unresolved issue. In this observational study, we compared the outcome of 9 weeks and 1 year adjuvant trastuzumab in early breast cancer patients in Turkey.
METHODS:
Records of 680 patients with HER2-positive early breast cancer who received adjuvant trastuzumab plus chemotherapy were obtained and patients were followed up to compare the disease-free survival (DFS) outcome of 9 weeks versus 1 year trastuzumab.
RESULTS:
Nine weeks and 1 year trastuzumab was given to 202 (29.7 %) and 478 (70.3 %) patients, respectively. There was a significantly lower rate of patients with negative lymph nodes in the 9-week trastuzumab group. At median 3 years of follow-up from the date of starting trastuzumab, the DFS rates were 88.6 and 85.6 %, respectively (p = 0.670). When adjusted for all the prognostic factors that were significant on univariate analysis, again there was no significant difference in DFS between the groups (HR 0.675; 95 % CI 0.370-1.231; p = 0.200). Cardiac toxicity defined as a ≥15 % decrease in LVEF was significantly higher in the 1-year trastuzumab group (1.88 % versus none for 1-year and 9-week trastuzumab groups, respectively; p = 0.050).
CONCLUSION:
The results of this observational study suggest that DFS outcome of 9 weeks of adjuvant trastuzumab may be comparable to 1 year adjuvant trastuzumab: this needs confirmation by randomized trials.
PMID: 24338610 [PubMed - as supplied by publisher]

['lizbeth]

The follow up was only 3 years - so far. It might identify a group (node negative) that does not benefit from an entire year.

They might be node negative because they lack another characteristic of aggressive cancer. Interesting information.