Title: High Rate of Pathological Complete Response Observed

Information about conventional breast cancer treatments - inc surgery, chemo, rads, hormonal, reconstruction, lymphedema, side effects
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Janette
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Title: High Rate of Pathological Complete Response Observed

Postby Janette » Sat Dec 18, 2010 5:06 pm

"High Rate of Pathological Complete Response Observed With 4-Drug Neoadjuvant Breast Cancer Therapy: Presented at SABCS"


By Ed Susman SAN ANTONIO, Tex -- December 12, 2010 -- A neoadjuvant regimen that includes carboplatin, docetaxel, lapatinib, and trastuzumab produced a high pathological complete response rate, according to a study presented here at the 33rd annual San Antonio Breast Cancer Symposium (SABCS). "We also found that the combination of carboplatin, docetaxel, lapatinib, and trastuzumab had manageable toxicity," said Rena Callahan, MD, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California, on December 9. "This is the first report of this 4-drug combination in early breast cancer among women with HER2-positive status," said Dr. Callahan. Twenty patients (mean age 50 years) have been recruited for the proposed 140-patient, 3-arm trial. Nineteen of the women had invasive ductal cancer, and 1 had invasive lobular cancer. Nine of the women were oestrogen receptor- and progesterone receptor-positive, 3 were oestrogen receptor-positive and progesterone receptor-negative, and the remaining 8 were oestrogen and progesterone receptor-negative. Patients in this run-in phase of the study were administered lapatinib 1,000 mg on days 1 through 21 plus trastuzumab 8 mg/kg intravenously. They were then given docetaxel 75 mg/m[2, carboplatin to an area under the curve of 5 or 6, and trastuzumab 6 mg/kg plus daily lapatinib 1,000 mg (on days 1-21) for six 21-day cycles.

Of those recruited, 9 of 18 evaluable patients achieved a pathological complete response, ie, no evidence of tumour cells after surgery. Of the 12 oestrogen receptor-positive women, 4 achieved a pathological complete response, whereas 5 of the women with oestrogen receptor-negative tumours achieved a pathological complete response.

Dr. Callahan said that the most common serious adverse event was grade 3 diarrhoea, which was experienced by 6 patients. All the patients in the study complained of some diarrhoea, but only 1 person discontinued treatment because of it. Two other patients discontinued treatment -- 1 because of Clostridium difficile infection and the other because of anaemia. The patient with C difficile underwent the run-in phase of the trial and 3 cycles of the 4-drug treatment before stopping therapy; however, she had achieved a pathological complete response.

Other grade 3 or 4 adverse events included neutropenia in 4 patients, infections in 4, and hypokalaemia in 3. No patients died in the treatment program, which extended about 5 months.

Patients are still being recruited for the study arm consisting of trastuzumab and lapatinib followed by docetaxel and carboplatin with just trastuzumab and the arm with trastuzumab and lapatinib followed by docetaxel and carboplatin with just lapatinib.

[Presentation title: Phase II Trial of Presurgical Treatment With Trastuzumab (H) or Lapatinib (Ty) or the Combination of Trastuzumab and Lapatinib (H + Ty), Followed by Six Cycles of Docetaxel (T) and Carboplatin (C) With Trastuzumab (TCH) or Lapatinib (TCTy) or the Combination of Trastuzumab and Lapatinib(TCHTy) in Patients With HER2+ Breast Cancer. Abstract P1-11-12]
Janette


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