Results from the initial analysis of event-free and overall survival for patients enrolled in the randomized, phase III Neoadjuvant Lapatinib (Tykerb?; GSK) and/or Trastuzumab (Herceptin?; Genentech) Treatment Optimization (NeoALTTO) trial, managed under the Breast International Group umbrella with two of its member groups, the BrEAST Data Centre and the SOLTI academic research group, were presented at at the annual San Antonio Breast Cancer Symposium(SABCS), held December. 10?14, 2013, in San Antonio, Texas.[1][2] The trial enrolled patients who have HER2 (ErbB2)-positive breast cancer, which is characterised by too much HER2 (ErbB2) protein in the tumor and a greater risk of the tumor coming back, was supported by GlaxoSmithKline.

The NeoALTTOstudy demonstrated a significantly higher breast pathological complete response (pCR) rate with dual HER2 blockade using lapatinib and trastuzumab compared with single HER2 blockade using either lapatinib or trastuzumab.

?NeoALTTO is a randomized, phase III clinical trial evaluating whether a combination of two HER2-targeted therapies, trastuzumab and lapatinib, given with standard paclitaxel neoadjuvant therapy, chemotherapy before surgery, is better than just one of the HER2-targeted therapies given with the same chemotherapy,? said Martine Piccart-Gebhart, M.D., Ph.D., chair of the Breast International Group (BIG) in Brussels, Belgium. ?We previously reported that the combination therapy resulted in more patients having a pathologic complete response.

…our results will be vital for the process of drug development in the field of early HER2-positive breast cancer

?In San Antonio, we’ve presented our analysis of whether improved pathologic complete response rates translate into better long-term outcomes for patients,? Piccart-Gebhart, continued. ?I believe that our results will be vital for the process of drug development in the field of early HER2-positive breast cancer.?

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Neo-adjuvant therapy
Neo-adjuvant therapy is treatment given to shrink or eliminate a tumor before surgery. In some patients with breast cancer, neoadjuvant therapy effectively eliminates the tumor, and no invasive cancer is detectable in breast tissue and lymph nodes removed during surgery. These patients are said to have had a pathologic complete response.

A new standard of care
In 2014, the results of NeoALTTO?s ?companion? trial, Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization (ALTTO), which is testing the effectiveness of dual treatment with trastuzumab and lapatinib after breast cancer surgery, will also become available, according to Piccart-Gebhart. ?If the results of both studies are in line with each other, and depending on the strength of the results, we could witness a new standard of care for managing primary HER2-positive breast cancer,? she said.

From January 2008 to May 2010, Piccart-Gebhart and colleagues enrolled in the NeoALTTO study 455 patients with HER2-positive primary breast cancer with tumors greater than 2 cm in diameter. Of those patients, 154 were randomly assigned to lapatinib, 149 to trastuzumab, and 152 to the combination. These HER2-targeted therapies were given alone for six weeks and then the chemotherapy paclitaxel was also administered for a further 12 weeks, at which point surgery was conducted. After surgery, patients received adjuvant chemotherapy followed by the same HER2-targeted therapy as in the neoadjuvant phase to complete 52 weeks. Follow-up is planned for 10 years after the last patient was randomized.

The researchers have previously reported that 51.3% of patients randomly assigned to neoadjuvant trastuzumab plus lapatinib had a pathologic complete response compared with 29.5% and 24.7% of patients randomly assigned to neoadjuvant trastuzumab and neoadjuvant lapatinib, respectively.

For more information
[1] Piccart-Gebhart M, Holmes AP, De Azambuja E, Di Cosimo S, Swaby R, Untch M, Jackisch C, Lang I, Smith I, et al. The association between event-free survival and pathological complete response to neoadjuvant lapatinib, trastuzumab or their combination in HER2-positive breast cancer. Survival follow-up analysis of the NeoALTTO study (BIG 1-06)Publication Number: S1-01.Presented by: Martine Piccart-Gebhart, M.D., Ph.D.
[2] Highlights from the 36th SABCS, San Antonio, Texas, USA – December 10 – 14, 2013 [Conference Overview]

Photo:Martine Piccart-Gebhart, M.D., Ph.D. Photo courtesy:The Cancer Therapy & Research Center (CTRC) at The University of Texas Health Science Center at San Antonio, the American Association for Cancer Research (AACR), and Baylor College of Medicine.

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