HER2 Support Group Forums - Six Cycles of Doxorubicin and Cyclophosphamide or Paclitaxel Are Not Superior to Four

http://jco.ascopubs.org/content/earl....6405.full.pdf

For those who are sticking it out for 6 AC or Paclitaxel adjuvant chemo treatments - you likely are not receiving any additional benefits and just suffering needlessly . . .

Quote:

Purpose
The ideal duration of adjuvant chemotherapy for patients with lower risk primary breast cancer isnot known. Cancer and Leukemia Group B trial 40101 was conducted using a phase III factorial design to define whether six cycles of a chemotherapy regimen are superior to four cycles.

We also sought to determine whether paclitaxel (T) is as efficacious as doxorubicin/cyclophosphamide(AC), but with reduced toxicity.

Patients and Methods

Between 2002 and 2008, the study enrolled women with operable breast cancer and zero to three positive nodes. Patients were randomly assigned to either four or six cycles of either AC or T. Study stratifiers were estrogen receptor/progesterone receptor (ER/PgR), human epidermal growth factor receptor 2 (HER2), and menopausal status. After 2003, all treatment was administered in dose-dense fashion. The primary efficacy end point was relapse-free
survival (RFS).

Results
A total of 3,171 patients were enrolled; 94% were node-negative and 6% had one to three positive nodes. At a median follow-up of 5.3 years, the 4-year RFS was 90.9% and 91.8% for six and four cycles, respectively. The adjusted hazard ratio (HR) of six to four cycles regarding RFS was 1.03 (95% CI, 0.84 to 1.28; P.77).

The 4-year OS was 95.3% and 96.3% for six and four cycles,
respectively, with an HR of six to four cycles of 1.12 (95% CI, 0.84 to 1.49;P.44).

There was no interaction between treatment duration and chemotherapy regimen, ER/PgR, or HER2 status on RFS or OS.

Conclusion
For women with resected primary breast cancer and zero to three positive nodes, we found no evidence that extending chemotherapy regimens of AC or single-agent T from four to six cycles improves clinical outcome.

This study showed that the 2 additional treatments dropped overall survival by 1%.

Typically oncologists will treat patients with docetaxel instead, avoiding the 4 vs 6 treatment issue by saying comparing docetaxel with paclitaxel is like comparing apples and oranges.

If anyone decides to opt out of treatments 5 & 6 with Docetaxel you will be likely be asked to sign a waiver.