Italian trials show success with PET adjuvant therapy

American and European chemotherapy treatments use different drugs. So when I read about research done in Italy that showed significant response to a battery of chemo drugs, I was curious. The more I read about the study, though, the more I wondered. Look at the drugs used below. That’s a lot. A whole lot. Still, the response is good. But the toxic reactions are also significant.

Here’s the scoop:

Eight weekly cycles of cisplatin, epirubicin, and paclitaxel (PET) before surgery showed improvement in disease-free survival for women with triple negative breast cancer, in a phase II trial of women studied from 1999 through 2008. All had large ER-, PR-, Her2- tumors.

Seventy-four women received cisplatin (30 mg/m²) , (epirubicin 50 mg/m²), paclitaxel (Taxol) (120 mg/m²), with granulocyte colony-stimulating factor support. Within three weeks of chemo, all had surgery, primarily breast-conserving surgery. Forty-six of the women were in complete remission after surgery.

After that, those with fewer than four affected lymph nodes had combination chemotherapy with cyclophosphamide, methotrexate, and fluorouracil. Those with more than four affected nodes had an additional four cycles of fluorouracil-epirubicin-cyclophosphamide (FEC) (epirubicin instead of methotrexate)

Forty-six of the women had pathologically complete response (pCR)—their cancer was effectively gone—after this regimen.

At 41 months, five-years projected disease-free survival (DFS) was 90 percent for the pCR women. For those without a pCR, the five-year DFS was 57 percent.

The 90 percent number, of course, is great. Still, that’s a lot of chemo. And 31 of the patients had severe neutropenia and anemia. Fewer than 20 percent had severe non-hematological toxicity.

The study was published in the July 2009 Annals of Oncology.

For comparison, in the United States, the current therapy consists of high-doses of cytoxan and adriamycin (AC) every two weeks; taxol is added (ACT) for those with affected lymph nodes. This offers a five-year overall survival rate of 83 percent for hormone-negative and a five-year disease-free survival rate of 73 percent. This research was published in the Journal of the American Mecial Association in 2006.

ACT was also found to improve disease-free survival for triple negative in a study published in the Journal of Oncology in 2009.