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Montefiore Studies Discover "Sandwich" Therapy Best Treatment for Aggressive Uterine Cancer

“Sandwiched” Sequencing of Chemotherapy and Radiation Resulted in

More Than 80% Survival Rates in Early Stage Patients

New York City, NY (June 20, 2012) – “Sandwich” therapy that uses chemotherapy and radiation treatment in sequence has been found to be extremely effective in treating aggressive forms of uterine cancer, according to two concurrent Montefiore Medical Center studies.  These studies support that the combination therapy delivered in a “sandwich” fashion is well tolerated and leads to better outcomes in the adjuvant treatment of both completely surgically resected uterine carcinosarcoma (CS) and uterine papillary serous carcinoma (UPSC).

Entitled “Phase II trial of adjuvant pelvic radiation ‘sandwiched’ in combination paclitaxel and carboplatin in women with uterine papillary serious carcinoma” and “Phase II trial of adjuvant pelvic radiation ‘sandwiched’ between ifosfamide or ifosfamide plus cisplatin in women with uterine carcinosarcoma”, the studies were recently published in the journal, Gynecologic Oncology. 

“This research has transformed the way we treat these aggressive forms of uterine cancer,” said Mark H. Einstein, MD, MS, Director of Clinical Research, Division of Gynecologic Oncology, Department of Obstetrics & Gynecology and Women’s Health at Montefiore Medical Center and Associate Professor of Obstetrics & Gynecology and Women’s Health and of Epidemiology & Population Health, Albert Einstein College of Medicine of Yeshiva University. “We are optimistic that this breakthrough treatment has the potential to save thousands of lives.

“To our knowledge, these are the largest prospective trials for this rare tumor, and our survival rates exceed most prior reports and obviates the added toxicity of this combination regimen,” he added.

“Sandwich” sequencing allows for treatment of systemic disease with chemotherapy while controlling micrometastatic disease in the pelvis with radiation therapy (RT). In addition, it allows for the maximum therapeutic dosing for chemotherapy and radiation therapy while limiting the overall toxicity.

Eligible patients with surgically staged I-IV uterine cancers without evidence of gross residual disease after primary surgery were recruited from 1999 to 2009 to these concurrent registered phase II trials. They underwent surgical staging comprised of total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal cytology, lymph node sampling and omental biopsy. In UPSC patients, Taxol and Carboplatin was administered every three weeks for three cycles, followed by pelvic radiation therapy for the same amount of time and cycles, then followed by three more cycles of Taxol and Carboplatin.  In CS patients, Ifosfamide was administered for five days every 21 days for three cycles followed by pelvic radiation therapy for the same amount of time and cycles, then followed by three more cycles of Ifosfamide.

In the UPSC study, out of 81 patients, with an average age of 67, three-year survival probability was 84% in stage I/II patients and 50% in stage III/IV patients. In the CS study, out of 27 patients, with an average age of 65, the survival rate was 80.8% in stage I/II and 30.3% in stage II/IV patients. In contrast, survival rates with traditional treatment protocols are at least 25% lower, stage for stage.

Uterine papillary serious sarcoma (UPSC) is the most common form of the non-endometrioid subtypes of endometrial cancer. Although it only constitutes approximately 10% of endometrial cancers, it accounts for a disproportionate amount of all endometrial cancer deaths. It is an aggressive epithelial cancer subtype and is often diagnosed at an advanced stage. Recurrence of UPSC is common and difficult to control. Uterine carcinosarcoma (CS) is an aggressive uterine tumor with a poor prognosis and a high recurrence rate, resulting in 26% of uterine cancer deaths. The majority of CS patients have historically died of metastatic disease within two years of their diagnosis.

Additional clinical trials for patients with other types of cancers are being conducted on an ongoing basis through the Montefiore Einstein Center for Cancer Care.

Dr. Einstein, who is a member of the Gynecologic Oncology Program at the Montefiore Einstein Center for Cancer Care, focuses his primary research interests on the pathogenesis and therapy for gynecologic cancers.  He has developed and has been leading numerous multi-institutional clinical trials in in many gynecologic tumors.  He is active in clinical trial cooperative groups as Co-Chair of the Gynecologic Oncology Group Vaccine Committee and sits on the GOG Cervix Committee.  He is on the HPV working group of the NCI Aids Malignancy Consortium.  Dr. Einstein is also a program leader of the Gynecology Division of the New York Cancer Consortium and is the primary investigator of many of its gynecologic cancer therapeutics trials accruing patients throughout New York hospitals.  

In addition to Dr. Einstein, the research team included: Merieme Klobocista, June Hou, Stephen Lee, Subhakar Mutyala, Keyur Mehta, Laura Reimers, Dennis Y.-S. Kuo, Gloria Huang, Gary Goldberg and Marina Frimer.