Study Showed Lilly's GEMZAR(R) (gemcitabine HCl for injection) Improved Progression-Free Survival in Cervical Cancer Patients
31 May 2009 - 10:30PM
PR Newswire (US)
ORLANDO, Fla., May 31 /PRNewswire-FirstCall/ -- Eli Lilly and
Company announced today that Phase III trial data showed the
addition of Lilly's GEMZAR(R) (gemcitabine HCl for injection) to
the current standard of care provided a statistically significant
increase in progression-free survival at three years for women with
locally advanced cervical cancer. Cervical cancer is the world's
second most commonly diagnosed women's cancer, and the second most
common cause of cancer death in women.(1) The current standard of
care for women with locally advanced cervical cancer consists of
the chemotherapy cisplatin and radiation (chemoradiation). This has
been the recommended course of treatment since 1999. Results from
this global, multicenter, open-label, randomized Phase III trial
were presented at the 45th Annual Meeting of the American Society
of Clinical Oncology (ASCO) during an ASCO-sponsored press
conference on May 31 at 8:30 a.m. EDT, and as an oral presentation
at the meeting at 10:30 a.m. EDT (ASCO Abstract #CRA5507).(2) With
515 patients evaluated, the data showed a statistically significant
(p=0.029) increase in progression-free survival at three years for
patients treated with the gemcitabine chemoradiation combination
versus those treated only with chemoradiation (74% vs. 65%,
respectively). Patients on the gemcitabine arm experienced
significantly more grade 3/4 toxicities. Additionally, two patients
on the gemcitabine arm died due to causes possibly attributed to
treatment-related toxicities. Most side effects were hematologic,
including anemia (low red blood cell count), neutropenia (low white
blood cell count) and thrombocytopenia (low blood platelet count).
"While there have been tremendous advances in cervical cancer
prevention in the form of early screening and vaccination,
oncologists have essentially been using the same treatment standard
for the last decade," said study lead author Alfonso
Duenas-Gonzalez, M.D., Ph.D., Investigador de la Unidad de
Investigacion Biomedica en Cancer, Instituto Nacional de
Cancerologia e Instituto de Investigaciones Biomedicas in Mexico.
"Lilly continues to look for ways to improve the survival of people
living with cancer and fill unmet needs in difficult to treat
cancers," said Richard Gaynor, M.D., vice president, cancer
research and global oncology platform leader for Lilly. Researchers
also found that overall survival (p=.0224) and time-to-progressive
disease (p=.0008) improved significantly. However, results for
these two secondary endpoints are considered interim. The 515
patients had a median age of 46 years and had either stage IIB,
III, or IVA carcinoma of the cervix. Patients in the trial were
randomly assigned to two arms with well-balanced baseline
characteristics between both. Patients on arm A were treated with
cisplatin (40 mg/m(2)) and gemcitabine (125 mg/m(2)) weekly for six
doses along with concurrent external radiation (50.4 Gy: 1.8
Gy/day, 5 days per week), followed by brachytherapy (30-35 Gy) and
then two adjuvant 21-day cycles of gemcitabine (1000 mg/m(2)) on
days 1 and 8 plus cisplatin (50 mg/m(2)) on day 1. Patients on arm
B were treated with cisplatin (40 mg/m(2)) weekly for six doses
along with concurrent external radiation (50.4 Gy: 1.8 Gy/day, 5
days per week), followed by brachytherapy (30-35 Gy). Important
Safety Information for GEMZAR (gemcitabine HCl for injection)
GEMZAR is indicated in combination with cisplatin (another type of
chemotherapy) for the first-line treatment of patients with locally
advanced (Stage IIIA or Stage IIIB) or metastatic (Stage IV or
cancer that has spread) non-small cell lung cancer for whom surgery
is not possible. GEMZAR is indicated in combination with
carboplatin (another type of chemotherapy) for the patient with
ovarian cancer that has returned at least 6 months after the
patient had finished platinum-based therapy. GEMZAR is indicated as
a single agent (given alone) as the first-line treatment for
patients with locally advanced (Stage II or Stage III when surgery
is not an option) or metastatic (Stage IV) adenocarcinoma of the
pancreas. GEMZAR is also indicated for patients previously treated
with 5-FU (another type of chemotherapy). GEMZAR in combination
with paclitaxel is approved by the FDA for the first-line treatment
of patients with metastatic breast cancer after they have received
another type of chemotherapy called an anthracycline, unless their
medical condition did not allow them to receive an anthracycline.
GEMZAR may not be appropriate for some patients. If you are
allergic to GEMZAR, tell your doctor you should not receive it.
GEMZAR can suppress bone marrow function. There have been rare
reports of serious kidney or liver toxicity with GEMZAR treatment,
sometimes fatal. Serious lung toxicity has also been reported,
sometimes fatal. If you think you are pregnant, are planning to
become pregnant, or are nursing, please tell your healthcare team.
GEMZAR may harm your unborn or nursing baby. If you have had prior
kidney or liver problems or impairment, please tell your healthcare
professional. GEMZAR may not be right for you. GEMZAR has not been
shown to work in children. Tell your doctor if you are taking other
medicines, including prescription and non-prescription medicines,
vitamins, or herbal supplements. There is a risk of side effects
associated with GEMZAR therapy. The most common side effects are
low blood cell counts (red blood cells, white blood cells, and
platelets); fever; infection; hair loss; tiredness; nausea,
vomiting, constipation, and diarrhea; rash; shortness of breath;
muscle aches; and numbness or tingling in your toes or fingers.
These are not all of the side effects of GEMZAR. If you have any
side effect that bothers you or that does not go away, be sure to
talk with your healthcare professional. Call your healthcare
professional right away if you have fever or chills. These symptoms
could mean you have an infection. You will have regular blood tests
before and during your treatment with GEMZAR. Your doctor may
adjust your dose of GEMZAR or delay your treatment based on the
results of your blood test and on your general condition. For more
information about all of the side effects of GEMZAR, please talk
with your healthcare team or to see the full Prescribing
Information, visit http://www.gemzar.com/, or call 1-800-545-5979.
You are encouraged to report negative side effects of prescription
drugs to the FDA. Visit http://www.fda.gov/medwatch, or call
1-800-FDA-1088. Notes to Editor About Cervical Cancer With
approximately 470,000 cases diagnosed globally each year, cervical
cancer is the second most common cancer diagnosed among women
worldwide. Additionally, approximately 232,000 women will die from
the disease each year, giving it the second highest rate of cancer
mortality among women worldwide. Eighty percent of diagnoses and
nearly 83 percent of deaths from cervical cancer occur in
developing nations.(3) About Lilly Oncology, a Division of Eli
Lilly and Company For more than four decades, Lilly Oncology has
been dedicated to delivering innovative solutions that improve the
care of people living with cancer. Because no two cancer patients
are alike, Lilly Oncology is committed to developing novel
treatment approaches. Our quest is to develop a broad portfolio of
tailored therapies that accelerate the pace and progress of cancer
care. To learn more about Lilly's commitment to cancer, please
visit http://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. P-LLY GEMZAR(R)
(gemcitabine HCl for injection), Lilly This press release contains
forward-looking statements about the potential of GEMZAR for the
treatment of cervical 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 products will receive additional regulatory
approvals. There is also no guarantee that the products will
continue to be commercially successful. For further discussion of
these and other risks and uncertainties, see Lilly's filings with
the United States Securities and Exchange Commission. Lilly
undertakes no duty to update forward-looking statements. (1) World
Health Organization. Vaccine research and development - Vaccines
against Human Papillomavirus. Available at:
http://www.who.int/vaccines/en/hpvrd.shtml. Accessed May 1, 2009.
(2) Duenas A, Zarba JJ, Alcedo JC, et al: Phase III Randomized
Comparison Of Concurrent Gemcitabine, Cisplatin, And Radiation
Followed By Adjuvant Gemcitabine And Cisplatin Versus Concurrent
Cisplatin And Radiation In Cancer Of The Cervix Stages IIb To Iva.
Abstract #CRA5507, 45th American Society of Clinical Oncology
(ASCO) annual meeting 2009. (3) World Health Organization. Vaccine
research and development - Vaccines against Human Papillomavirus.
Available at: http://www.who.int/vaccines/en/hpvrd.shtml. Accessed
May 1, 2009. (Logo:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO DATASOURCE:
Eli Lilly and Company CONTACT: Amy Sousa, Lilly, +1-317-276-8478
(office), +1-317-997-1481 (mobile), ; or Neil Hochman, TogoRun,
+1-212-453-2067 (office), +1-516-784-9089 (mobile),
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