Action Points
- Point out that this is a small, noncontrolled study and larger phase III studies will be required.
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
NATIONAL HARBOR, Md. -- Two-thirds of patients with triple-negative breast cancer achieved pathologic complete response (pCR) with neoadjuvant chemotherapy consisting of carboplatin and docetaxel (Taxotere), data from a small clinical study showed. Nine of 14 patients had confirmed pCR with the regimen, which was generally well tolerated. The findings are consistent with those of a larger patient series reported recently showing a high rate of pCR in patients with triple-negative locally advanced breast cancer treated with neoadjuvant platinum-docetaxel chemotherapy. The favorable prognostic outcomes associated with pCR, including survival, warrant larger, prospective investigations of the regimen in patients with triple-negative breast cancer, German investigators reported here at the American Society of Clinical Oncology's Breast Cancer Symposium. "As a surrogate marker for progression-free survival, pathologic complete response opens the opportunity for similar survival rates in patient groups with triple-negative, in addition to non-triple negative, breast cancer," Anne Kalisch, of University Hospital Essen, told MedPage Today. "To achieve higher pathologic complete response rates with neoadjuvant therapy and associated better long-term survival, a multimodal approach utilizing several new targeted agents should be investigated to improve the relatively poor prognosis of patients with triple-negative breast cancer." About 15% to 20% of breast cancer patients have the so-called triple-negative histology: negative for estrogen, progesterone, and HER2 receptors. Triple-negative histology is associated with more aggressive cancer and poor long-term survival. No clinical guidelines specific to management of triple-negative breast cancer have been developed to date, Kalisch and co-investigators noted in a poster presentation at the symposium. Molecularly targeted therapy, such as endocrine agents, has proven ineffective in triple-negative breast cancer, essentially leaving chemotherapy as the only therapeutic option for many of the patients. Use of a platinum-taxane combination in triple-negative disease has several lines of supporting evidence, Kalisch continued. Platinum agents have produced high response rates in ER-negative breast cancer and in patients with cancer associated with BRCA-1 mutations. The addition of platinum analogues to other chemotherapeutic agents appears to benefit patients with and without triple-negative breast cancer. Taxanes have demonstrated activity in metastatic breast cancer. The favorable clinical experience with platinum-taxane doublets led Kalisch and colleagues to evaluate docetaxel in combination with carboplatin, which has better tolerability compared with cisplatin. All 14 patients had clinical T2 disease, which was grade 3 in a majority of cases. They received six three-week cycles of carboplatin-docetaxel chemotherapy. The primary endpoint was pCR, and the principal secondary endpoint was toxicity. All 14 patients completed the planned therapy. Alopecia occurred in 11 patients and extremity pain, mucositis, and anemia in eight patients each, and nausea and leukopenia in seven patients each. No patient had dose-limiting toxicity. Severe (grade 3-4) toxicity consisted of extremity pain in one patient, neutropenia in six, edema in two, and allergic reaction, vomiting, and nervous-system disorders in one each. "Our preliminary results demonstrate a high antitumor activity, high rates of tumor regression and pathologic complete response, and acceptable toxicity," said Kalisch. "Our study is ongoing, but we believe the results warrant consideration of larger, phase III clinical trials." The investigators reported that they had no relevant disclosures. | 
