Chicago (ots/PRNewswire) -
- Five Phase III Early-Stage Breast Cancer Studies Underway With
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
"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
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, 42 (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
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
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
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
Known hypersensitivity to GEMZAR. Anaphylactoid reaction has been
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.
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
The effectiveness of GEMZAR in pediatric patients has not been
The toxicities of GEMZAR observed in pediatric patients were
similar to those reported in adults.
GEMZAR clearance is affected by age as well as gender.
Patients receiving therapy with GEMZAR should be monitored closely
by a physician experienced in the use of cancer chemotherapeutic
Monitoring and Dosage Modifications
Dosage adjustments for hematologic toxicity may be required.
Serum creatinine, potassium, calcium, and magnesium should be
monitored during combination therapy with cisplatin.
Patients should be assessed with a CBC, including differential and
platelet count, prior to each dose of GEMZAR. Modify or suspend
therapy according to the Dosage Reduction Guidelines in the full
Hepatic and renal function (including transaminases and serum
creatinine) should be evaluated prior to therapy with GEMZAR and
The most severe adverse events (grades 3/4) with GEMZAR plus
paclitaxel for the treatment of patients with MBC were neutropenia
(48%); alopecia (18%); leukopenia (11%); anemia (7%); fatigue (7%);
thrombocytopenia (6%); ALT elevation (6%); and neuropathy-sensory
(6%). The most common adverse events (all grades) were nausea (50%);
fatigue (40%); myalgia (33%); and vomiting (29%). The most severe
adverse events (grades 3/4) with GEMZAR for the first-line treatment
of patients with pancreatic cancer were neutropenia (24%-26%);
alkaline phosphatase elevation (16%-20%); AST elevation (12%-17%);
nausea/vomiting (12%-13%); ALT elevation (10%-11%); anemia (10%);
leukopenia (9%-10%); thrombocytopenia (8%-10%); bilirubin elevation
(4%-8%); and pain (2%-7%). The most common adverse events (all
grades) were AST (72%-78%); alkaline phosphatase (71%-77%); anemia
(65%-73%); ALT (72%); leukopenia (64%-71%); nausea and vomiting
(64%-71%); neutropenia (61%-62%); thrombocytopenia (36%-47%); pain
(10%-42%); fever (30%-38%); proteinuria (10%-32%); constipation
(10%-31%); diarrhea (24%-30%); rash (24%-28%); and bilirubin
The most severe adverse events (grades 3/4) with GEMZAR plus
cisplatin for the first-line treatment of patients with NSCLC were
neutropenia (57%-64%); thrombocytopenia (50%-55%); leukopenia
(29%-46%); anemia (22%-25%); nausea (27%); vomiting (23%);
nausea/vomiting (39%); neuromotor (12%); hypomagnesemia (7%);
neurohearing (6%); creatinine elevation (5%); alopecia (1%-13%); and
dyspnea (1%-7%). The most common adverse events (all grades) were
paresthesias (38%); hyperglycemia (30%); infection (18%-28%); and
The most severe adverse events (grades 3/4) with GEMZAR plus
carboplatin for the treatment of patients with advanced ovarian
cancer were neutropenia (71%), thrombocytopenia (35%), leukopenia
(53%), anemia (28%), nausea (6%), vomiting (6%), and constipation
(7%). The most common adverse events (all grades) were RBC
transfusion (38%), alopecia (49%), neuropathy/sensory (29%), nausea
(69%), fatigue (40%), vomiting (46%), diarrhea (25%), and
See complete Warnings, Precautions, Adverse Reactions, and Dosage
and Administration sections in the accompanying full Prescribing
Information for safety and dosing guidelines.
About Lilly Oncology, a Division of Eli Lilly and Company
For more than four decades, Lilly Oncology has been collaborating
with cancer researchers to deliver innovative treatment choices and
valuable programs to patients and their physicians. Inspired by
courageous patients living with cancer, Lilly Oncology is providing
treatments that are considered global standards of care and
developing a broad portfolio of novel targeted therapies to
accelerate the pace and progress of cancer care. To learn more about
Lilly's commitment to cancer, please visit www.LillyOncology.com.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a
growing portfolio of first-in-class and best-in-class pharmaceutical
products by applying the latest research from its own worldwide
laboratories and from collaborations with eminent scientific
organizations. Headquartered in Indianapolis, Ind., Lilly provides
answers - through medicines and information - for some of the world's
most urgent medical needs.
ALIMTA(R) (pemetrexed for injection), Lilly
GEMZAR(R) (gemcitabine HCl for injection), Lilly
Taxol(R) (paclitaxel), Bristol-Meyers Squibb
Herceptin(R) (trastuzumab), Genentech
This press release contains forward-looking statements about the
potential of GEMZAR for the treatment of breast cancer and reflects
Lilly's current beliefs. However, as with any pharmaceutical product
under development, there are substantial risks and uncertainties in
the process of development, commercialization, and regulatory review.
There is no guarantee that the product will receive additional
regulatory approvals. There is also no guarantee that the product
will continue to be commercially successful. For further discussion
of these and other risks and uncertainties, see Lilly's filing with
the United States Securities and Exchange Commission. Lilly
undertakes no duty to update forward-looking statements.
(i) Sanchez-Munoz A, Duenos-Garcia R, et al. Neoadjuvant
chemotherapy with a dose-dense sequential combination of epirubicin
and cyclophosphamide followed by paclitaxel and gemcitabine +/-
trastuzumab in stage II and III breast cancer. Correlation between
pathologic complete response and biologic markers. Abstract #595,
American Society of Clinical Oncology (ASCO) Annual Meeting 2007.
(ii) American Cancer Society, "What Are the Key Statistics for
Breast Cancer?," American Cancer Society, www.cancer.org, (May 2,
(iii) Pan American Health Organization, "Guidelines for
International Breast Health and Cancer Control," www.paho.org, (March
(iv) American Cancer Society, "How is Breast Cancer Staged?,"
American Cancer Society, www.cancer.org (February 28, 2007).
ots Originaltext: Eli Lilly and Company
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