Second Opinion

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DR LOVE: Dan, in Dr Buzdar’s study and the NOAH trial, trastuzumab wasadministered concurrently with an anthracycline. Why didn’t they see increasedcardiac toxicity with the combination in either trial?DR HAYES: I spoke with Luca after his presentation and asked him thatquestion. His answer was twofold. First, in the metastatic setting, where we haveseen cardiac toxicity, the patients had already received a substantial amount ofadjuvant doxorubicin.<strong>Second</strong>, he felt that data from clinical trials in which heart failure was carefullymonitored prospectively, as opposed to retrospectively, were probably moreaccurate. Based on Buzdar’s and Gianni’s studies, it appears that administeringconcurrent anthracycline and trastuzumab may be safe, although I still swallowhard when I say that because I’ve been trained to believe otherwise.DR MAMOUNAS: The Buzdar neoadjuvant approach is not standard, but clinicianshave adopted it to some extent and we have used it a couple of times inour center with good results.With regard to the low rate of cardiac dysfunction seen in these trials, theBuzdar study used 75 mg/m 2 of epirubicin for four cycles, which is less than wetraditionally use. In Luca’s trial, patients received only three cycles of doxorubicin/paclitaxel,rather than the customary four cycles. It would appear that ifwe minimize exposure to the anthracycline, we might get away with concurrenttrastuzumab.4.1Neoadjuvant Chemotherapy with Trastuzumab in Patients with LocallyAdvanced, HER2-Positive Breast Cancer: Primary Efficacy DataPathologic complete response rate for primary tumors: Intent-to-treat populationChemotherapy +trastuzumab Chemotherapy p-valueHER2-positive tumors 43% 23% 0.002Chemotherapy + trastuzumab versus chemotherapyProbability HR 95% CI p-valueEvent-free survival 0.56 0.36-0.85 0.006*Overall survival 0.65 0.34-1.23 0.18* Unadjusted for stratification variables: Adjusted HR = 0.55, p = 0.0062SOURCE: Gianni L et al. Presentation. San Antonio Breast Cancer Symposium 2008;Abstract 31.SELECT PUBLICATIONSBuzdar AU et al. Significantly higher pathologic complete remission rate after neoadjuvanttherapy with trastuzumab, paclitaxel, and epirubicin chemotherapy: Resultsof a randomized trial in human epidermal growth factor receptor 2-positive operablebreast cancer. J Clin Oncol 2005;23(16):3676-85. AbstractGianni L et al. Neoadjuvant trastuzumab in patients with HER2-positive locallyadvanced breast cancer: Primary efficacy analysis of the NOAH trial. Presentation. SanAntonio Breast Cancer Symposium 2008;Abstract 31.14
From the practice of Samuel N Bobrow, MDA 37-year-old woman is diagnosed with a 0.4-cm, moderately differentiated IDC. Thetumor is ER/PR-negative and HER2-positive by FISH.Track 73DR LOVE: How do you think this patient should be treated?PROF CROWN: I would find it difficult to justify the use of adjuvant trastuzumabfor a patient with a tumor smaller than five millimeters. In fact, althoughI’m in the minority on this, I would not recommend any systemic therapy forthis patient outside of a clinical trial.I believe many people would recommend the TCH regimen for this patient. It hasa manageable side-effect profile. In our BCIRG 006 trial, we’ve seen a small riskof leukemia for the anthracycline-containing arms and none as yet with TCH.Also, the rate of cardiac failure is four out of 1,000 patients and the cardiactoxicity associated with trastuzumab appears to improve with time in most cases,which suggests that the qualitative nature of the trastuzumab cardiac lesion isdifferent from that seen with an anthracycline.DR LOVE: Would you consider using trastuzumab alone?PROF CROWN: We have no data in the adjuvant setting for trastuzumabmonotherapy. I believe a good rule is that if a patient satisfies a practitioner’scriteria for offering adjuvant chemotherapy and has HER2-positive disease,trastuzumab should be administered.Track 87DR LOVE: George, how would you approach treatment for this patient?DR SLEDGE: First, I would tell the patient that we have no data with tumorsthis small but that the data we do have across a variety of sizes and nodalstatuses show us that trastuzumab is beneficial. Her risk of recurrence may beless because the tumor is small, but when a patient tells you she wants no stoneunturned, then you have your answer.I probably would not recommend anthracycline-based chemotherapy because ofthe frightening possibility of turning this young woman into a cardiac cripple.Rather, I would use a regimen such as TCH. I’m also comfortable with thisregimen for patients with larger tumors and positive nodes, up to a point.DR LOVE: When was the last time you used an anthracycline as treatment for aHER2-positive tumor?DR SLEDGE: It’s probably been 18 months or so, but I must add that I alsohaven’t seen many patients with early breast cancer and 13 positive nodes.15
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Second Opinion

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