2012 EDUCATIONAL BOOK - American Society of Clinical Oncology

Research and Standard of Care: Lung Cancer
in Romania
Overview: In Romania, lung cancer is the most frequent
cancer in men and fourth most frequent in women, and its
incidence and mortality continue to rise. Recently, firm antitobacco
policies were implemented, in agreement with the
MPOWER strategies recommended by the World Health Organization
(WHO). As of January 2012, the recognized “official”
standard of care in lung cancer is still represented by the 2009
edition of the European Society for Medical Oncology (ESMO)
guidelines. Cancer treatment is free, as the National Program
of Oncology covers the budget for all cytotoxic agents and
targeted therapy. However, reimbursement for several expen-
ROMANIA BECAME a member of the European Union
in 2007. With 21.3 million inhabitants and a size
roughly the same as Great Britain, the country inherited a
predominantly “state-owned” health system, with welltrained
health professionals but limited resources and a
centralized organization.
Cancer is the second cause of death in Romania, following
cardiovascular diseases, and the drugs used for its management
are funded by a dedicated National Program of
Oncology. 1
Patterns of Lung Cancer Epidemiology
According to Globocan 2008, 70,300 new patients with
cancer and 46,300 cancer deaths were encountered in Romania.
2 Lung cancer was the most frequently diagnosed cancer
in both genders. Incidence of lung cancer was 10,384 new
cases (14.8% of all cancers), with an age standardized rate
(ASR) of 30%. This compares favorably with nearby Hungary,
with the highest rate of lung cancer in the world and
an ASR of 52%. Mortality in Romania was 9,427 cases
(20.4%) with an ASR of 26.8%. The 5-year prevalence was
59.3%.
According to the Romanian National Center for Health
Statistics, the crude incidence of lung cancer rose continuously
in a 25-year period, rising from 32.14% in men in 1982
to 56.14% in 2007 and from 5.93% in women to 15.5%.
Within 50 years, (from 1959 to 2010), the ASR for lung
cancer mortality more than doubled both in men and women
(men, 17.65% to 48.04%; women, 4.43% to 8.94%). Not all of
the eight regional Cancer Registries are yet providing accurate
data because of a lack of trained personnel, insufficient
funds, or methodological gaps. According to the Cluj County
Registry, the cumulative lifetime risk of developing lung
cancer is 7.46% for men and 1.21% for women.
As compared with Western Europeans, more Romanian
patients have squamous cell carcinoma and less adenocarcinoma.
A study at the Pneumology Institute of Bucharest
found 48% squamous cell, 29% adenocarcinomas, 7% large
cell carcinomas, and 16% small cell lung cancers (SCLC)
among 7,792 patients with confirmed lung carcinomas.
Sixty-five percent of the patients were aged 55 to 74 years at
diagnosis. 3
Standards of Lung Cancer Care
Until recently, the management of lung cancer was rather
heterogenous among centers, although previous collabora-
By Tudor E. Ciuleanu, MD, PhD
sive drugs such as pemetrexed, erlotinib, and bevacizumab is
individually approved by a centralized commission. All new
drugs registered in Europe by the European Medicines Agency
are concomitantly registered in Romania. However, no new
drugs (such as gefitinib) or new indications (such as first-line
tyrosine-kinase inhibitors or maintenance treatment) have
been accepted for reimbursement since 2008. Clinical research
is rapidly growing, and Romanian centers demonstrate
a high recruitment rate in pivotal trials, despite initial delays
because of a slow approval of the studies by authorities.
tion efforts led to published Romanian therapeutic guidelines.
4 In 2009, the National Commission of Oncology
officially adopted the European Society for Medical Oncology
(ESMO) guidelines, but no update followed. 5 Recently, the
third Central European Cooperative Oncology Group
(CECOG) Consensus on the Treatment of non-small cell
lung cancer (NSCLC) was published and is expected to
influence the management of lung cancer in Romania. 6
Briefly, the consensus included the following recommendations:
(1) early (operable) NSCLC: surgery (followed by
adjuvant chemotherapy in stage II and III and in selected
patients with stage IB disease; (2) locoregionally advanced
NSCLC: combined chemoradiotherapy and; (3) advanced
NSCLC: four to six courses of cisplatin-based chemotherapy
with a third generation cytotoxic drug (pemetrexed in nonsquamous
NSCLC) for first-line treatment, with bevacizumab
providing modest benefit with added toxicity;
epidermal growth factor receptor (EGFR) TKIs depending
on EGFR-activating mutation status; pemetrexed as maintenance
of response immediately following cisplatin-based
chemotherapy resulting in significantly improved survival
(particularly in patients with nonsquamous NSCLC). Docetaxel,
pemetrexed (for nonsquamous NSCLC), or erlotinib
for second-line therapy.
First-line tryrosine kinase inhibitors (TKIs), as well as
maintenance treatment, are not reimbursed in Romania,
although the drugs are registered and available at the
patient’s expense.
The standard ESMO guidelines apply for SCLC, which
include: (1) limited disease: combined chemoradiotherapy;
(2) extended disease: chemotherapy alone (platinum and
etoposide); (3) prophylactic cranial radiotherapy: recommended
for responders, in both limited and extended disease
and; (4) second-line chemotherapy: recommended in patients
with good performance status, with drugs such as
topotecan (oral or IV), ifosfamide, taxanes, or the CAV
(cyclophosphamide, doxorubicin, vincristine) combination.
From the Medical Oncology Department, Institute of Oncology Ion Chiricuta, Cluj-
Napoca, Romania.
Author’s disclosures of potential conflicts of interest are found at the end of this article.
Address reprint requests Tudor Ciuleanu, MD, PhD, Institute of Oncology Ion Chiricuta,
St. Republicii 34-36, Cluj-Napoca, 400015, Romania; email: tudor@iocn.ro.
© 2012 by American Society of Clinical Oncology.
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