CHICAGO, June 2 /PRNewswire/ --
-- Five Phase III Early-Stage Breast Cancer Studies Underway With GEMZAR
GEMZAR(R) (gemcitabine HC1 for injection), approved in combination with paclitaxel (Taxol(R)) in the first-line, post-surgical treatment of metastatic breast cancer, was the subject of a study presented today with encouraging results in the pre-surgical treatment of breast cancer. The study was presented at the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO).
Results showed that adding GEMZAR to the current standard-of-care treatment was a promising regimen for patients with stage II-III breast cancer. Eli Lilly and Company, the manufacturer and marketer of GEMZAR, also cited five completed or ongoing Phase III trials which will further study GEMZAR as a chemotherapeutic foundation for the treatment of early-stage breast cancer.
Today's Phase II study (Abstract # 595(i)) evaluated the addition of GEMZAR to the current standard-of-care of epirubicin and cyclophosphamide followed by paclitaxel in patients with stage II-III breast cancer. The treatment schedule was a dose-dense sequential neoadjuvant (pre-surgical) chemotherapy combination, meaning that the combination was administered at shorter intervals between treatments. Results showed a promising regimen in terms of pathologic complete response (pCR-the absence of invasive tumor in the breast). In addition, patients who tested positive for the HER-2 gene also were given trastuzumab (Herceptin(R)) and demonstrated additional response.
"The data released today reflects our ongoing, aggressive research plan involving GEMZAR as a key therapeutic foundation for the treatment of breast cancer," said Allen Melemed, M.D., medical director, global oncology at Lilly. "We are encouraged with the activity GEMZAR has shown in this breast cancer study."
Enrollment has been completed in one trial, and is ongoing in an additional four, Phase III early-stage breast cancer studies evaluating the addition of GEMZAR to commonly-used treatment regimens. Two adjuvant (post-surgical) therapy trials, NSABP B-38 (4,400 patients) and TANGO (3,000 patients), will compare the addition of GEMZAR to the paclitaxel arm of each study. A third adjuvant trial, SUCCESS (3,600 patients), will compare the addition of GEMZAR to a docetaxel-based regimen. Two additional trials, which are neoadjuvant specific, NSABP B-40 (1,200 patients) and Neo-TANGO (800 patients), will evaluate the addition of GEMZAR to the paclitaxel or docetaxel arm of the treatment regimen. For more information on these studies, log on to www.lillytrials.com or www.clinicaltrials.gov.
More About ASCO Abstract # 595
The trial enrolled stage II-III breast cancer patients (with a median age of 45), including inflammatory tumors, a type of breast cancer that causes the breast to swell, redden and feel warm. Of the 73 patients enrolled in the study, 2 Jun. (57.5%) - were classified as T2; 12 (16.5%) as T3, and; 19 (26%) as T4, which included 13 patients with inflammatory tumors. A T-classification represents the stage of the tumor with T4 being the most advanced. A biopsy was performed before treatment for the biomarker component of the study.
Patients received a first sequence of epirubicin and cyclophosphamide (90/600 mg/m squared) for three cycles followed by a second sequence of paclitaxel and GEMZAR (150/2500 mg/m squared) for six cycles. Treatment was administered on day one, every two weeks, with growth factor support. HER-2 positive patients (20 patients, 27.3%), were given trastuzumab (2 mg/kg with a loading dose 4 mg/kg) concomitantly. Afterward, the patients underwent surgery, radiotherapy and adjuvant hormonal therapy according to institutional practice.
All patients from the study showed response to the regimen. Of the entire study group, 27 (36.9%) patients achieved a pCR (absence of invasive tumor in the breast), with 50% representation from the HER-2 positive patients who also were given trastuzumab. Forty-seven patients (64.4%) underwent conservative surgery.
The grade 3/4 hematological toxicities were: leukopenia in six patients (9%); neutropenia (a decrease in white blood cells) in eight patients (12%), and; anemia (a decrease in red blood cells) in one (2%). Nausea (13%) and vomiting (15%) were the most frequent grade 3/4 non-hematological toxicities. Asymptomatic decrease in cardiac ejection fraction was observed in one patient treated with trastuzumab with subsequent normalization.
About Breast Cancer
Breast cancer is the most common form of cancer among women, affecting nearly one out of every eight women.(ii) The disease is diagnosed in more than 1.1 million women worldwide each year.(iii) Breast cancer progresses in stages based on tumor size, how the cancer affects the lymph nodes and whether it has metastasized to other parts of the body.(iv) In general, individuals with earlier stages of disease have better chances for long-term survival and recovery.
GEMZAR
Indications
GEMZAR in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.
GEMZAR is indicated in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (stage IIIA or IIIB), or metastatic (stage IV) non-small cell lung cancer.
GEMZAR is indicated as first-line treatment for patients with locally advanced (nonresectable stage II or stage III) or metastatic (stage IV) adenocarcinoma of the pancreas. GEMZAR is indicated for patients previously treated with 5-FU.
GEMZAR in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.
Important Safety Information for GEMZAR
Myelosuppression is usually the dose-limiting toxicity with GEMZAR therapy.
Contraindication
Known hypersensitivity to GEMZAR. Anaphylactoid reaction has been reported rarely.
Warnings
Infusion times of GEMZAR longer than 60 minutes and more frequent than weekly dosing have been shown to increase toxicity.
Pulmonary toxicity has been reported with the use of GEMZAR. In cases of severe lung toxicity, GEMZAR therapy should be discontinued immediately and appropriate supportive care measures instituted.
Hemolytic Uremic Syndrome (HUS) and/or renal failure have been reported following one or more doses of GEMZAR. Renal failure leading to death or requiring dialysis, despite discontinuation of therapy, has been rarely reported. The majority of the cases of renal failure leading to death were due to HUS.
Serious hepatotoxicity, including liver failure and death, has been reported very rarely in patients receiving GEMZAR alone or in combination with other potentially hepatotoxic drugs.
GEMZAR is Pregnancy Category D. GEMZAR can cause fetal harm when administered to a pregnant woman.
Precautions
Use caution in patients with pre-existing renal impairment or hepatic insufficiency. Administration of GEMZAR may exacerbate underlying hepatic insufficiency.
The optimum regimen for safe administration of GEMZAR with therapeutic doses of radiation has not yet been determined in all tumor types. GEMZAR has radiosensitizing activity and radiation recall reactions have been reported.
It is not known whether GEMZAR or its metabolites are excreted in human milk.
The effectiveness of GEMZAR in pediatric patients has not been demonstrated.
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