Andrew D. Seidman, MD

Andrew Seidman, MD, medical director of the Bobst International Center at Memorial Sloan Kettering Cancer Center, discusses the FeDeriCa trial (NCT03493854) of intravenous (IV) versus subcutaneous (SC) trastuzumab (Herceptin) and pertuzumab (Perjeta) for neoadjuvant treatment of HER2-positive breast cancer.

The phase 3 FeDeriCa trial randomized 500 patients 1:1 to receive either an IV regimen or the SC regimen, called Phesgo. Patients in the IV arm received 840 mg of pertuzumab plus 8 mg/kg of trastuzumab followed by a maintenance dose of 420 mg of pertuzumab and 6 mg/kg of trastuzumab, while those in the SC arm received a fixed-dose combination of 1200 mg of pertuzumab and 600 mg of trastuzumab in 15 mL, followed by 600 mg of pertuzumab plus 600 mg of trastuzumab maintenance doses in 10 mL. Each arm was administered every 3 weeks along with neoadjuvant chemotherapy.

The primary end point was based on the serum trough levels of pertuzumab at the end of theseventh cycle, according to Seidman. The investigators found the geometric mean ratio of pertuzumab in the SC arm versus the IV arm to be 1.22 (90% CI, 1.14–1.31), meaning Phesgo demonstrated non-inferior efficacy to an IV infusion. The secondary end point of pathological complete response (pCR) rate was 59.7% (95% CI, 53.3%-65.8%) for SC versus 59.5% (95% CI, 53.2%-65.6%) for IV.

 Cycle 7 trough levels of both trastuzumab and pertuzumab were measured and it was shown that there was noninferiority of the PK of both trastuzumab and pertuzumab. When administered subcutaneously, as compared [with] intravenously, a very important secondary end point was the pCR rate that patients experienced at the time of surgery. And here for Phesgo, it was 59.7%; for IV administration of antibodies, it was 59.5%. So basically, [they were] virtually identical, and certainly [Phesgo] was non-inferior. So that was very supportive of the ultimate approval of this agent as an option for patients with breast cancer.

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Andrew Seidman, MD, discusses the FeDeriCa trial of intravenous versus subcutaneous trastuzumab and pertuzumab for neoadjuvant treatment of HER2-positive breast cancer. 

Subcutaneous Regimen Shows Non-Inferiority for HER2+ Breast Cancer

Andrew D. Seidman, MD, attending physician, Breast Cancer Medicine Service, Memorial Sloan-Kettering Cancer Center, discusses the present lack of a biomarker for targeted therapies in patients with ER-positive, HER2-negative metastatic breast cancer. Seidman says currently there is not a HER2 histochemical test for gene amplification or signatures to best select patients for either CDK46 or MTOR inhibitor, as well for PI3 kinase inhibition.

Seidman says these biomarkers could help in selecting patients for the best targeted therapies available for their particular cancers.

Seidman says currently there is not a HER2 histochemical test for gene amplification or signatures to best select patients for either CDK46 or MTOR inhibitor, as well for PI3 kinase inhibition.

Dr. Andrew D. Seidman on the Lack of a Biomarker in Certain Breast Cancers

Andrew D. Seidman, MD, attending physician, Breast Cancer Medicine Service, Memorial Sloan-Kettering Cancer Center, discusses the shift paradigm of breast cancer treatment and the development of targeted agents that disrupt certain pathways. Seidman says historically treatment and management of breast cancer has been accomplished with chemotherapy, endocrine therapy and HER2-targeted therapy.

&#8203;Andrew D. Seidman, MD, attending physician, Breast Cancer Medicine Service, Memorial Sloan-Kettering Cancer Center, discusses the shift paradigm of breast cancer treatment and the development of targeted agents that disrupt certain pathways.

Dr. Andrew D. Seidman on Targeted Treatments in Breast Cancer

Andrew D. Seidman, MD, a professor of medicine at the Weill Cornell Cancer Center and an attending physician at the Memorial Sloan-Kettering Cancer Center, discusses breast cancer treatment with surgery and radiotherapy.

Seidman says that a study by Dr. Emiel J. Rutgers comes at a time when the oncology community has seen that it is possible to perform less surgery without putting patients at an increased risk of lymph node recurrence under the arm or in the axilla. In this study, patients with involvement of a sentinel lymph node were randomly assigned to undergo a complete axillary lymph node dissection or axillary radiotherapy.

The findings from this trial showed that the two approaches were equally effective in controlling breast cancer recurrence, but the radiotherapy led to substantially less swelling of the arm and hand (lymphedema) 1 year and 5 years afterward. Seidman says this represents a new option for patients.

Less surgery does not equate to an increased risk of lymph node recurrence

In a trial, complete axillary lymph node dissection and axillary radiotherapy were equally effective in controlling breast cancer recurrence

Andrew D. Seidman, MD, from Memorial Sloan-Kettering Cancer Center, discusses breast cancer treatment with surgery and radiotherapy.

Surgery and Radiotherapy for Patients With Breast Cancer

Andrew D. Seidman, MD, attending physician, Breast Cancer Medicine Service, Memorial Sloan-Kettering Cancer Center, comments on the findings of the phase III S0221 trial, which compared two schedules of paclitaxel as adjuvant therapy for breast cancer.

Seidman says that he uses the dose-dense paclitaxel regimen given every two weeks in his practice. This regimen does lend itself to the injection of a growth factor to stimulate white blood cell recovery. This injection has a significant cost and toxicity profile, Seidman says.

The trial found that either the dose-dense paclitaxel administered every two weeks or weekly paclitaxel given over 12 weeks is acceptable.

Dose-dense paclitaxel (every two weeks) requires the injection of a growth factor to stimulate white blood cell recovery, which has a significant cost and toxicity profile

The phase III S0221 trial found that either dose-dense paclitaxel administered every two weeks or weekly paclitaxel given over 12 weeks is acceptable

View all coverage from the 2013 ASCO Meeting

Andrew D. Seidman, MD, comments on the findings of the phase III S0221 trial, which compared two schedules of paclitaxel as adjuvant therapy for breast cancer.

Andrew D. Seidman, MD | Authors

Articles

Subcutaneous Regimen Shows Non-Inferiority for HER2+ Breast Cancer

Dr. Andrew D. Seidman on the Lack of a Biomarker in Certain Breast Cancers

Dr. Andrew D. Seidman on Targeted Treatments in Breast Cancer

Surgery and Radiotherapy for Patients With Breast Cancer

Using Paclitaxel Schedules as Adjuvant Therapy for Breast Cancer