ITALIAN BREAST ACNCER STATISTICS

October 22, 2010 (Milan, Italy) — Breast cancer patients in Italy tend to be older and to be diagnosed at an early stage of the disease. According to the results of a retrospective study presented here at the 35th European Society for Medical Oncology (ESMO) Congress, 73.6% of breast cancer patients are older than 50 years, and 22% are older than 70 years.

This was the first important observation of the study — the demographics of breast cancer, said study author Matteo Clavarezza, MD, medical oncologist at Ospedale Sacro Cuore Don Calabria, Negrar, Italy, in a press briefing. "The breast cancer population in Italy is today composed mostly of elderly patients."

The researchers found that 22.3% of breast cancers were identified before they were more than 1 cm in diameter, and 61% were node-negative. In fact, only 9.9% of tumors were classified as high risk; this fact highlights the very early diagnosis of breast cancer in Italy, Dr. Clavarezza noted.

"This study shows what is occurring in real-life settings. The findings are very interesting and, for me, some of them are unexpected," said Fortunato Ciardiello, MD, PhD, ESMO's press officer and moderator of the session. "For example, 83.5% of the study population was hormone-receptor-positive, and that is higher than what would be expected."

This was a surprising aspect of the data, Dr. Clavarezza agreed. "The probability of being hormone-receptor-positive is about 70% to 75%, and our data showed 83%. I think that this has to do with age, because with increasing age, the probability of being hormone-receptor-positive increases."

Patients were also less likely to express the HER2 gene. In general, HER2-positive breast cancer typically accounts for 20% to 25% of all breast cancers, but in this study, only 16.1% of tumors were HER2-positive.

Treatment Influenced by Tumor Stage

The study also looked at the use of adjuvant treatment for early breast cancer.

Dr. Clavarezza noted that they were surprised to learn that the treatment regimen was primarily influenced by disease stage, not biological parameters. Recurrence risk and predictive factors, such as estrogen-receptor or HER2 status, influence whether or not to prescribe adjuvant chemotherapy, he said.

The authors found that oncology centers in Italy frequently use adjuvant chemotherapy in early breast cancer, and that there is still widespread use of first-generation chemotherapeutic agents. More specifically, they observed that taxanes are underused for pN0–pN1 tumors; instead, they are primarily used for patients at high risk for recurrence (pN2 and pN3).

Overall, 38.4% of patients received a combination of anthracyclines and taxanes and 3.7% received taxanes alone; 9.1% of patients received combination cyclophosphamide-based regimens.

"The most effective regimens were used more often with increasing stage," he said, and biological parameters did not influence type of chemotherapy. However, patients with HER2-positive tumors were more likely to receive combination anthracycline and taxanes than those with HER2-negative tumors.

Chemotherapy Influenced by pN

Dr. Clavarezza and colleagues evaluated 1894 breast cancer patients who were treated at 63 oncology centers between January 1 and July 30, 2008. There was widespread geographic distribution among the oncology centers, and there were different types of institutions (university, public, private).

In the cohort, 67.0% of the tumors were pT1 (22.3% were pT1mic + pT1a + pT1b). For nodal stage, 61.0% of the tumors were pN0, 29.1% were pN1, 6.3% were pN2, and 3.6% were pN3. Estrogen-receptor status was positive in 81.2% of the tumors and negative in 18.6%. The median ki 67 index was 15%, and 16.1% of the tumors were HER2-positive.

Overall, 1095 patients (57.8%) received systemic chemotherapy; the remaining 799 patients (42.2%) received adjuvant therapy without chemotherapy.

The authors note that the decision to use chemotherapy was influenced by lymph node involvement; 94.2% of patients with pN3 tumors received systemic treatment, but only 43.5% of those with pN0 tumors did.

In the pN0 group, the use of chemotherapy was influenced by pathologic stage: 71.6% of tumors larger than 2.0 cm received chemotherapy, whereas only 30.6% of those 0.1 to 1.0 cm did.

In addition, the type of chemotherapeutic agents used was influenced by the risk for recurrence.

Types of Chemotherapy Used
Nodal Stage
Cyclophosphamide-Based (%)Anthracycline (%) Anthracycline + Taxane (%) Taxane (%)
pN0 13.4 63.7 19.9 3.0
pN1 5.5 44.8 45.0 4.7
pN2 6.6 12.2 78.3 2.8
pN3 4.6 18.5 72.3 4.6
All 9.1 48.8 38.4 3.7


Dr. Ciardiello pointed out that in Italy, as in many European Union nations, there is an aging population. "So the diagnosis is going to be at a later age, and a higher percentage of cases [will be] in older women," he said. "Many patients are being diagnosed at a very early state, and that means that the screening programs are being implemented and are successful."

Alessandra Gennari, MD, from Galliera Hospital in Genova, Italy, said that she was surprised that it was not tumor biology driving the treatment decision, but tumor stage. "This is not modern oncology," she said.

Dr. Gennari, who was not involved in the study, also expressed surprise that most Italian oncologists are still prescribing anthracyclines alone. "After 6 cycles of anthracyclines alone, you might get cardiovascular toxicity," she said.

Although "you may save their life" using anthracyclines, the patient is put at risk because of the safety issues, she added.

Another safety issue is the risk for bladder cancer in breast cancer patients treated with cyclophosphamide, Dr. Gennari pointed out.

The study was sponsored by Sanofi-Aventis. Dr. Clavarezza has disclosed no relevant financial relationships. Coauthor M. Venturini, from Sacro Cuore Don Calabria Hospital, in Negrar, reports being a member of the advisory board for this study; Coauthor S. Rossi is employed by Sanofi-Aventis.

35th European Society for Medical Oncology (ESMO) Congress: Abstract 239P. Presented October 10, 2010.