Only PD-1/PD-L1 immunotherapy to demonstrate a
significant survival benefit in combination with etoposide and a
choice of carboplatin or cisplatin chemotherapy
AstraZeneca today announced that IMFINZI® (durvalumab) has been
approved in the US as a 1st-line treatment for adult patients with
extensive-stage small cell lung cancer (ES-SCLC) in combination
with standard-of-care (SoC) chemotherapies, etoposide and either
carboplatin or cisplatin (platinum-etoposide).
The approval by the US Food and Drug Administration was based on
positive results from the Phase III CASPIAN trial showing IMFINZI
in combination with SoC platinum-etoposide demonstrated a
statistically significant and clinically meaningful improvement in
overall survival (OS) versus SoC alone.
SCLC is a highly aggressive, fast-growing form of lung cancer
that typically recurs and progresses rapidly despite initial
response to chemotherapy.1,2
Dave Fredrickson, Executive Vice President, Oncology Business
Unit, said: “The US approval of IMFINZI brings a new medicine to
extensive-stage small cell lung cancer patients in urgent need of
new options. IMFINZI is the only immunotherapy to show both a
significant survival benefit and improved response rate in
combination with chemotherapy for these patients, an important step
forward in treating this devastating disease.”
Jonathan Goldman, MD, Associate Professor of Hematology &
Oncology, UCLA Medical Center, Santa Monica, California and a lead
investigator in the Phase III CASPIAN trial, said: “Patients with
extensive-stage small cell lung cancer continue to face a poor
prognosis, and finding new medicines to improve outcomes in this
setting has been a formidable challenge. The CASPIAN trial enables
clinicians to choose durvalumab in combination with etoposide and
either carboplatin or cisplatin, making this an important new
1st-line treatment option for patients that is both effective and
well-tolerated.”
The Phase III CASPIAN trial had two primary endpoints comparing
experimental arms to SoC. In the IMFINZI plus SoC arm, the risk of
death was reduced by 27% (equal to a hazard ratio of 0.73; 95% CI
0.59-0.91; p=0.0047), with median OS of 13.0 months versus 10.3
months for SoC alone. Results also showed an increased confirmed
objective response rate in the IMFINZI plus SoC arm (68% versus 58%
for SoC alone). The safety and tolerability for IMFINZI plus SoC
was consistent with the known safety profiles of these medicines.
The IMFINZI plus SoC data from the CASPIAN trial were published in
The Lancet.3
The second experimental arm testing tremelimumab added to
IMFINZI and SoC recently read out but did not meet the primary
endpoint. Details will be presented at a forthcoming medical
meeting.
The most common adverse reactions (≥20% of patients with
extensive-stage SCLC) were nausea, fatigue/asthenia and
alopecia.
The CASPIAN trial used a fixed dose of IMFINZI (1500 mg)
administered every three weeks for four cycles while in combination
with chemotherapy and then every four weeks until disease
progression as a single medicine. As part of a broad development
program, IMFINZI is also being tested following concurrent
chemoradiation therapy in patients with limited-stage SCLC in the
Phase III ADRIATIC trial with data anticipated in 2021.
IMFINZI received its first approval based on the Phase III
CASPIAN trial in Singapore for patients with ES-SCLC in February
2020. IMFINZI in combination with etoposide and either carboplatin
or cisplatin is currently under regulatory review for the treatment
of ES-SCLC in the 1st-line setting based on the Phase III CASPIAN
trial in the EU and Japan.
Important Safety Information
There are no contraindications for IMFINZI® (durvalumab).
IMFINZI can cause serious, potentially fatal adverse reactions
including immune-mediated pneumonitis, hepatitis, colitis,
endocrinopathies, nephritis, dermatologic reactions, other
immune-mediated adverse reactions, infection, and infusion-related
reactions. Please refer to the full Prescribing Information for
important dosage modification and management information specific
to adverse reactions.
Immune-Mediated Pneumonitis
IMFINZI can cause immune-mediated pneumonitis, defined as
requiring use of corticosteroids. Fatal cases have been reported.
Monitor patients for signs and symptoms of pneumonitis and evaluate
with radiographic imaging when suspected. Administer
corticosteroids for Grade 2 or greater pneumonitis. Withhold
IMFINZI for Grade 2 pneumonitis; permanently discontinue for Grade
3 or 4 pneumonitis.
In clinical studies enrolling 1889 patients with various cancers
who received IMFINZI, pneumonitis occurred in 5% of patients,
including Grade 3 (0.8%), Grade 4 (<0.1%), and Grade 5 (0.3%)
pneumonitis. Pneumonitis led to discontinuation of IMFINZI in 1.5%
of the 1889 patients. The incidence of pneumonitis (including
radiation pneumonitis) was higher in patients in the PACIFIC study
who completed treatment with definitive chemoradiation within 42
days prior to initiation of IMFINZI (34%) compared to patients in
other clinical studies (2.3%) in which radiation therapy was
generally not administered immediately prior to initiation of
IMFINZI. In the PACIFIC study, the incidence of Grade 3 pneumonitis
was 3.4% and of Grade 5 pneumonitis was 1.1% in the IMFINZI arm. In
the PACIFIC study, pneumonitis led to discontinuation of IMFINZI in
6% of patients.
The frequency and severity of immune-mediated pneumonitis were
similar whether IMFINZI was given as a single agent in patients
with various cancers or in combination with chemotherapy in
patients with ES-SCLC.
Immune-Mediated Hepatitis
IMFINZI can cause immune-mediated hepatitis, defined as
requiring use of corticosteroids. Fatal cases have been reported.
Monitor patients for signs and symptoms of hepatitis during and
after discontinuation of IMFINZI, including clinical chemistry
monitoring. Administer corticosteroids for Grade 2 or higher
elevations of ALT, AST, and/or total bilirubin. Withhold IMFINZI
for ALT or AST greater than 3 but less than or equal to 8 times the
ULN or total bilirubin greater than 1.5 but less than or equal to 5
times the ULN; permanently discontinue IMFINZI for ALT or AST
greater than 8 times the ULN or total bilirubin greater than 5
times the ULN or concurrent ALT or AST greater than 3 times the ULN
and total bilirubin greater than 2 times the ULN with no other
cause.
In clinical studies enrolling 1889 patients with various cancers
who received IMFINZI, hepatitis occurred in 12% of patients,
including Grade 3 (4.4%), Grade 4 (0.4%), and Grade 5 (0.2%)
hepatitis. Hepatitis led to discontinuation of IMFINZI in 0.7% of
the 1889 patients.
Immune-Mediated Colitis
IMFINZI can cause immune-mediated colitis, defined as requiring
use of corticosteroids. Administer corticosteroids for Grade 2 or
greater colitis or diarrhea. Withhold IMFINZI for Grade 2 colitis
or diarrhea; permanently discontinue for Grade 3 or 4 colitis or
diarrhea.
In clinical studies enrolling 1889 patients with various cancers
who received IMFINZI, colitis or diarrhea occurred in 18% of
patients, including Grade 3 (1.0%) and Grade 4 (0.1%)
immune-mediated colitis. Diarrhea or colitis led to discontinuation
of IMFINZI in 0.4% of the 1889 patients.
Immune-Mediated Endocrinopathies
IMFINZI can cause immune-mediated endocrinopathies, including
thyroid disorders, adrenal insufficiency, type 1 diabetes mellitus,
and hypophysitis/hypopituitarism. Monitor patients for clinical
signs and symptoms of endocrinopathies.
- Thyroid disorders—Monitor thyroid function prior to and
periodically during treatment. Initiate hormone replacement therapy
or medical management of hyperthyroidism as clinically indicated.
Withhold IMFINZI for Grades 2–4 hyperthyroidism, until clinically
stable. Continue IMFINZI for hypothyroidism. In clinical studies
enrolling 1889 patients with various cancers who received IMFINZI,
hypothyroidism occurred in 11% of patients, while hyperthyroidism
occurred in 7% of patients. Thyroiditis occurred in 0.9% of
patients, including Grade 3 (<0.1%) thyroiditis. Hypothyroidism
was preceded by thyroiditis or hyperthyroidism in 25% of
patients.
- Adrenal insufficiency—Administer corticosteroids as
clinically indicated and withhold IMFINZI until clinically stable
for Grade 2 or higher adrenal insufficiency. In clinical studies
enrolling 1889 patients with various cancers who received IMFINZI,
adrenal insufficiency occurred in 0.7% of patients, including Grade
3 (<0.1%) adrenal insufficiency.
- Type 1 diabetes mellitus—Initiate treatment with insulin
as clinically indicated. Withhold IMFINZI for Grades 2–4 type 1
diabetes mellitus, until clinically stable. In clinical studies
enrolling 1889 patients with various cancers who received IMFINZI,
type 1 diabetes mellitus occurred in <0.1% of patients.
- Hypophysitis—Administer corticosteroids and hormone
replacement as clinically indicated and withhold IMFINZI until
clinically stable for Grade 2 or higher hypophysitis.
Hypopituitarism leading to adrenal insufficiency and diabetes
insipidus occurred in <0.1% of 1889 patients with various
cancers who received IMFINZI.
Immune-Mediated Nephritis
IMFINZI can cause immune-mediated nephritis, defined as evidence
of renal dysfunction requiring use of corticosteroids. Fatal cases
have occurred. Monitor patients for abnormal renal function tests
prior to and periodically during treatment with IMFINZI. Administer
corticosteroids as clinically indicated. Withhold IMFINZI for
creatinine greater than 1.5 to 3 times the ULN; permanently
discontinue IMFINZI and administer corticosteroids in patients with
creatinine greater than 3 times the ULN.
In clinical studies enrolling 1889 patients with various cancers
who received IMFINZI, nephritis (reported as any of the following:
increased creatinine or urea, acute kidney injury, renal failure,
decreased glomerular filtration rate, tubulointerstitial nephritis,
decreased creatinine clearance, glomerulonephritis, and nephritis)
occurred in 6.3% of the patients including Grade 3 (1.1%), Grade 4
(0.2%), and Grade 5 (0.1%) nephritis. IMFINZI was discontinued in
0.3% of the 1889 patients.
Immune-Mediated Dermatologic Reactions
IMFINZI can cause immune-mediated rash. Stevens Johnson Syndrome
(SJS)/toxic epidermal necrolysis (TEN) has occurred with other
products in this class. Administer corticosteroids for Grade 2 rash
or dermatitis lasting for more than 1 week or for Grade 3 or 4 rash
or dermatitis. Withhold IMFINZI for Grade 2 rash or dermatitis
lasting longer than 1 week or Grade 3 rash or dermatitis;
permanently discontinue IMFINZI in patients with Grade 4 rash or
dermatitis.
In clinical studies enrolling 1889 patients with various cancers
who received IMFINZI, 26% of patients developed rash or dermatitis
and 0.4% of the patients developed vitiligo. Rash or dermatitis led
to discontinuation of IMFINZI in 0.1% of the 1889 patients.
Other Immune-Mediated Adverse Reactions
IMFINZI can cause severe and fatal immune-mediated adverse
reactions. These immune-mediated reactions may involve any organ
system. While immune-mediated reactions usually manifest during
treatment with IMFINZI, immune-mediated adverse reactions can also
manifest after discontinuation of IMFINZI. For suspected
immune-mediated adverse reactions, exclude other causes and
initiate corticosteroids as clinically indicated. Withhold IMFINZI
for Grade 3 immune-mediated adverse reactions, unless clinical
judgment indicates discontinuation; permanently discontinue IMFINZI
for Grade 4 adverse reactions.
The following clinically significant, immune-mediated adverse
reactions occurred at an incidence of less than 1% each in 1889
patients who received IMFINZI: aseptic meningitis, hemolytic
anemia, immune thrombocytopenic purpura, myocarditis, myositis, and
ocular inflammatory toxicity, including uveitis and keratitis.
Additional clinically significant immune-mediated adverse reactions
have been seen with other products in this class (see Warnings and
Precautions Section 5.7 of IMFINZI full Prescribing
Information).
Infection
IMFINZI can cause serious infections, including fatal cases.
Monitor patients for signs and symptoms of infection and treat as
clinically indicated. Withhold IMFINZI for Grade 3 or 4 infection,
until clinically stable.
In clinical studies enrolling 1889 patients with various cancers
who received IMFINZI, infections occurred in 43% of patients,
including Grade 3 (8%), Grade 4 (1.9%), and Grade 5 (1.0%). The
overall incidence of infections in IMFINZI-treated patients in the
PACIFIC study (56%) was higher compared to patients in other
clinical studies (38%) in which radiation therapy was generally not
administered immediately prior to initiation of IMFINZI. In
patients with UC in Study 1108 (n=182), the most common Grade 3 or
higher infection was urinary tract infections, which occurred in 4%
of patients. In patients with Stage III NSCLC in the PACIFIC study,
the most common Grade 3 or higher infection was pneumonia, which
occurred in 5% of patients.
Infusion-Related Reactions
IMFINZI can cause severe or life-threatening infusion-related
reactions. Monitor patients for signs and symptoms of an
infusion-related reaction. Interrupt or slow the rate of infusion
for Grades 1–2 infusion-related reactions; permanently discontinue
for Grades 3–4 infusion-related reactions.
In clinical studies enrolling 1889 patients with various cancers
who received IMFINZI, infusion-related reactions occurred in 2.2%
of patients, including Grade 3 (0.3%).
Embryo-Fetal Toxicity
Based on its mechanism of action and data from animal studies,
IMFINZI can cause fetal harm when administered to a pregnant woman.
There are no data on the use of IMFINZI in pregnant women. Advise
pregnant women of the potential risk to a fetus and advise women of
reproductive potential to use effective contraception during
treatment and for at least 3 months after the last dose of
IMFINZI.
Lactation
There is no information regarding the presence of IMFINZI in
human milk; however, because of the potential for adverse reactions
in breastfed infants from IMFINZI, advise women not to breastfeed
during treatment and for at least 3 months after the last dose.
Most Common Adverse Reactions
- In patients with UC in Study 1108 (n=182), the most common
adverse reactions (≥15%) were fatigue (39%), musculoskeletal pain
(24%), constipation (21%), decreased appetite (19%), nausea (16%),
peripheral edema (15%), and urinary tract infection (15%). The most
common Grade 3 or 4 adverse reactions (≥3%) were fatigue, urinary
tract infection, musculoskeletal pain, abdominal pain, dehydration,
and general physical health deterioration
- In patients with UC in Study 1108, discontinuation due to
adverse reactions occurred in 3.3% of patients. Serious adverse
reactions occurred in 46% of patients. The most frequent serious
adverse reactions (>2%) were acute kidney injury (4.9%), urinary
tract infection (4.4%), musculoskeletal pain (4.4%), liver injury
(3.3%), general physical health deterioration (3.3%), sepsis,
abdominal pain, and pyrexia/tumor associated fever (2.7% each)
- In patients with Stage III NSCLC in the PACIFIC study (IMFINZI
n=475), the most common adverse reactions (≥20% of patients) were
cough (40%), fatigue (34%), pneumonitis or radiation pneumonitis
(34%), upper respiratory tract infections (26%), dyspnea (25%), and
rash (23%). The most common Grade 3 or 4 adverse reactions (≥3%)
were pneumonitis/radiation pneumonitis (3.4%) and pneumonia
(7%)
- In patients with Stage III NSCLC in the PACIFIC study (IMFINZI
n=475), discontinuation due to adverse reactions occurred in 15% of
patients in the IMFINZI arm. Serious adverse reactions occurred in
29% of patients receiving IMFINZI. The most frequent serious
adverse reactions (≥2% of patients) were pneumonitis or radiation
pneumonitis (7%) and pneumonia (6%). Fatal pneumonitis or radiation
pneumonitis and fatal pneumonia occurred in <2% of patients and
were similar across arms
- In patients with extensive-stage SCLC in the CASPIAN study
(n=265), the most common adverse reactions (≥20%) were nausea,
fatigue/asthenia, and alopecia. The most common Grade 3 or 4
adverse reaction (≥3%) was fatigue/asthenia (3.4%)
- In patients with extensive-stage SCLC in the CASPIAN study
(n=265), IMFINZI was discontinued due to adverse reactions in 7% of
the patients receiving IMFINZI plus chemotherapy. Serious adverse
reactions occurred in 31% of patients receiving IMFINZI plus
chemotherapy. The most frequent serious adverse reactions reported
in at least 1% of patients were febrile neutropenia (4.5%),
pneumonia (2.3%), anemia (1.9%), pancytopenia (1.5%), pneumonitis
(1.1%), and COPD (1.1%). Fatal adverse reactions occurred in 4.9%
of patients receiving IMFINZI plus chemotherapy
The safety and effectiveness of IMFINZI have not been
established in pediatric patients.
Indications
IMFINZI is indicated for the treatment of adult patients with
locally advanced or metastatic urothelial carcinoma who:
- Have disease progression during or following
platinum-containing chemotherapy.
- Have disease progression within 12 months of neoadjuvant or
adjuvant treatment with platinum-containing chemotherapy.
This indication is approved under accelerated approval based on
tumor response rate and duration of response. Continued approval
for this indication may be contingent upon verification and
description of clinical benefit in confirmatory trials.
IMFINZI is indicated for the treatment of adult patients with
unresectable Stage III non-small cell lung cancer (NSCLC) whose
disease has not progressed following concurrent platinum-based
chemotherapy and radiation therapy.
IMFINZI, in combination with etoposide and either carboplatin or
cisplatin, is indicated for the first-line treatment of adult
patients with extensive-stage small cell lung cancer (ES-SCLC).
Please see complete Prescribing Information, including
Medication Guide.
NOTES TO EDITORS
About CASPIAN
CASPIAN was a randomized, open-label, multi-center, global,
Phase III trial in the 1st-line treatment of 805 adult patients
with ES-SCLC. The trial compared IMFINZI in combination with
etoposide and either carboplatin or cisplatin chemotherapy, or
IMFINZI and chemotherapy with the addition of a second
immunotherapy, tremelimumab, versus chemotherapy alone. In the
experimental arms, patients were treated with four cycles of
chemotherapy. In comparison, the control arm allowed up to six
cycles of chemotherapy and optional prophylactic cranial
irradiation. The trial was conducted in more than 200 centers
across 23 countries, including the US, Europe, South America, Asia
and the Middle East. The primary endpoint was OS in each of the two
experimental arms.
About Small Cell Lung Cancer
Lung cancer is the leading cause of cancer death among both men
and women and accounts for about one-quarter of all cancer deaths
in the United States.4 Lung cancer is broadly split into non-small
cell lung cancer (NSCLC) and SCLC, with about 15% classified as
SCLC.5 About two thirds of SCLC patients are diagnosed with
ES-SCLC, in which the cancer has spread widely through the lung or
to other parts of the body.6 Prognosis is particularly poor, as
only 6% of all SCLC patients will be alive five years after
diagnosis.7
About IMFINZI® (durvalumab)
IMFINZI is a human monoclonal antibody that binds to PD-L1 and
blocks the interaction of PD-L1 with PD-1 and CD80, countering the
tumor’s immune-evading tactics and releasing the inhibition of
immune responses.
IMFINZI is approved in the curative-intent setting of
unresectable, Stage III NSCLC after chemoradiation therapy in the
US, Japan, China, across the EU and in many other countries, based
on the Phase III PACIFIC trial. IMFINZI is approved for the
1st-line treatment of ES-SCLC in combination with SoC chemotherapy
in the US and Singapore. IMFINZI is also approved for previously
treated patients with advanced bladder cancer in the US and a small
number of other countries.
As part of a broad development program, IMFINZI is also being
tested as a monotherapy and in combination with tremelimumab, an
anti-CTLA4 monoclonal antibody and potential new medicine, as a
treatment for patients with NSCLC, SCLC, bladder cancer, head and
neck cancer, liver cancer, biliary tract cancer, cervical cancer
and other solid tumors.
About tremelimumab
Tremelimumab is a human monoclonal antibody and potential new
medicine that targets the activity of cytotoxic
T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the
activity of CTLA-4, contributing to T cell activation and boosting
the immune response to cancer. Tremelimumab is being tested in a
clinical trial program in combination with IMFINZI in NSCLC,
bladder cancer, head and neck cancer, liver cancer and blood
cancers.
About AstraZeneca Support Programs
AstraZeneca strives to ensure that appropriate patients and
their oncologists have access to IMFINZI and relevant support
resources. These include educational resources, an Oncology Nurse
Educator program and affordability and reimbursement programs, such
as Access 360™.
Additionally, AstraZeneca has launched Lighthouse, a program
that provides support to patients during any immune-mediated
adverse events they may encounter during treatment, through
medically trained Lighthouse Advocates. The program aims to make
patients’ treatment experience as comfortable as possible. Find out
more about Lighthouse at LighthouseProgram.com or call
1-855-LHOUSE1(1-855-546-8731).
About AstraZeneca in lung cancer
AstraZeneca has a comprehensive portfolio of approved and
potential new medicines in late-stage development for the treatment
of different forms of lung cancer spanning different histologies,
several stages of disease, lines of therapy and modes of action. We
aim to address the unmet needs of patients with EGFR-mutated tumors
as a genetic driver of disease, which occur in 10-15% of NSCLC
patients in the US and EU and 30-40% of NSCLC patients in Asia,
with the approved medicine osimertinib, and ongoing Phase III
trials ADAURA, LAURA, and FLAURA2.8-10 We are also committed to
addressing tumor mechanisms of resistance through the ongoing Phase
II trials SAVANNAH and ORCHARD which test osimertinib in
combination with savolitinib, a selective inhibitor of c-MET
receptor tyrosine kinase, along with other potential new medicines.
Trastuzumab deruxtecan, a HER2-directed antibody drug conjugate is
in development for metastatic non-squamous HER2-overexpressing or
HER2-mutated NSCLC including trials in combination with other
anticancer treatments.
Our extensive late-stage Immuno-Oncology program focuses on lung
cancer patients without a targetable genetic mutation which
represents up to three-quarters of all patients with lung cancer.11
IMFINZI, an anti-PDL1 antibody, is in development for patients with
advanced disease (Phase III trials POSEIDON and PEARL) and for
patients in earlier stages of disease including
potentially-curative settings (Phase III trials AEGEAN, ADJUVANT
BR.31, PACIFIC-2, PACIFIC-4, PACIFIC-5, and ADRIATIC) both as
monotherapy and in combination with tremelimumab and/or
chemotherapy. IMFINZI is also in development in the Phase II
combination trials NeoCOAST, COAST and HUDSON in combination with
potential new medicines from the early-stage pipeline.
About AstraZeneca’s approach to Immuno-Oncology (IO)
Immuno-oncology (IO) is a therapeutic approach designed to
stimulate the body’s immune system to attack tumors. Our IO
portfolio is anchored by immunotherapies that have been designed to
overcome anti-tumor immune suppression. AstraZeneca believes that
IO-based therapies offer the potential for life-changing cancer
treatments for the clear majority of patients.
We are pursuing a comprehensive clinical-trial program that
includes IMFINZI as a monotherapy and in combination with
tremelimumab in multiple tumor types, stages of disease, and lines
of therapy, using the PD-L1 biomarker as a decision-making tool to
define the best potential treatment path for a patient. In
addition, the ability to combine the IO portfolio with radiation,
chemotherapy, small targeted molecules from across AstraZeneca’s
Oncology pipeline, and from research partners, may provide new
treatment options across a broad range of tumors.
About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in oncology and offers a
quickly growing portfolio of new medicines that has the potential
to transform patients' lives and the Company's future. With at
least six new medicines to be launched between 2014 and 2020, and a
broad pipeline of small molecules and biologics in development, we
are committed to advancing oncology as a key growth driver for
AstraZeneca focused on lung, ovarian, breast and blood cancers. In
addition to AstraZeneca's main capabilities, the Company is
actively pursuing innovative partnerships and investments that
accelerate the delivery of our strategy, as illustrated by the
investment in Acerta Pharma in hematology.
By harnessing the power of four scientific platforms –
Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response
and Antibody Drug Conjugates – and by championing the development
of personalized combinations, AstraZeneca has the vision to
redefine cancer treatment and one day eliminate cancer as a cause
of death.
About AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development and commercialization of prescription medicines,
primarily for the treatment of diseases in three therapy areas -
Oncology, Cardiovascular, Renal and Metabolism, and Respiratory.
AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. For more
information, please visit www.astrazeneca-us.com and follow us on
Twitter @AstraZenecaUS.
References
- Oronsky B, et al. What's New in SCLC? A Review. Neoplasia.
2017;19(10):842–847.
- NIH Medline Plus. Lung Cancer-Small Cell. Available at
https://medlineplus.gov/ency/article/000122.htm. Accessed March
2020.
- Paz-Ares, L. et al. Durvalumab plus platinum–etoposide versus
platinum–etoposide in first-line treatment of extensive-stage
small-cell lung cancer (CASPIAN): a randomised, controlled,
open-label, phase 3 trial. Lancet. 2019;394(10212):1929-1939.
- American Cancer Society. Key Statistics for Lung Cancer.
Available at
https://www.cancer.org/cancer/lung-cancer/about/key-statistics.html.
Accessed March 2020.
- American Cancer Society. What is Lung Cancer?. Available at
https://www.cancer.org/cancer/lung-cancer/about/what-is.html.
Accessed March 2020.
- ASCO Cancer.net. Lung Cancer – Stages. Available at
https://www.cancer.net/cancer-types/lung-cancer-small-cell/stages.
Accessed March 2020.
- ASCO Cancer.net. Lung Cancer – Small Cell: Statistics.
Available at
https://www.cancer.net/cancer-types/lung-cancer-small-cell/statistics.
Accessed March 2020.
- Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on
Cytological and Histological Samples in Non-Small Cell Lung Cancer:
a Polish, Single Institution Study and Systematic Review of
European Incidence. Int J Clin Exp Pathol. 2013:6;2800-12.
- Keedy VL, et al. American Society of Clinical Oncology
Provisional Clinical Opinion: Epidermal Growth Factor Receptor
(EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell
Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor
Therapy. J Clin Oncol. 2011:29;2121-27.
- Ellison G, et al. EGFR Mutation Testing in Lung Cancer: A
Review of Available Methods and Their Use for Analysis of Tumour
Tissue and Cytology Samples. J Clin Pathol. 2013:66;79-89.
- Pakkala, S, et al. Personalized Therapy for Lung Cancer:
Striking a Moving Target. JCI Insight. 2018;3(15):e120858.
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