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Outcomes and Prognostic Factors of Extensive Stage
Small Cell Lung Cancer: A Retrospective Study
Veena PS1Sajeed A1Geethi MH1K. M. Jagathnath Krishna2Sivananadan CD1Arun Sankar S1
Roshni S1Lijeesh AL1
1Department of Radiation Oncology, Regional Cancer Centre,
Thiruvananthapuram, Kerala, India
2Department of Medical Biostatistics, Regional Cancer Centre.
Thiruvananathapuram, Kerala, India
South Asian J Cancer
Address for correspondence Veena PS, MD Radiotherapy, Regional
Cancer Centre, Thiruvananthapuram, Kerala 695011, India
(e-mail: drveenaps@gmail.com).
Keywords
►outcome
►PCI
►prognostic factors
►small cell lung cancer
Abstract Introduction Small cell lung cancer (SCLC) represents about 15% of all lung cancers.
Extensive stage (ES) SCLC represents around 60% of diagnosed SCLC cancers. The
median survival in untreated ES SCLC is 2 to 4 months and that of treated cases is 8 to
13 months.
Aim and Objectives This retrospective analysis aims to find out the clinical outcome
of patients with ES SCLC and the prognostic factors affecting their survival.
Methods Details of patients registered in the department of radiation oncology from
January 1, 2010 to September 30, 2019 were retrieved from the hospital records. This
includes the demographic characteristics, treatment received, toxicity, and follow-up
details.
Results Two-hundred eighty-three patients were included. Median age of presenta-
tion was 62 years. Around 97.5% of patients were men. Smokers constitute 94% of all
cases. About 86.9% (246 patients) of cases were not alive at the end of the study period.
The median estimated overall survival (OS) was 7 months 0.47 (95% confidence
interval [CI]: 6.026–7.974) and progression-free survival (PFS) was 5 months 0.535
(95% CI: 3.952–6.048). Multivariate analysis showed that Eastern Cooperative Oncolo-
gy Group performance status (ECOG PS), hyponatremia, number of chemotherapy
cycles, consolidative radiotherapy (RT) and prophylactic cranial irradiation (PCI) were
found to have prognostic effect on OS. Smoking, ECOG PS, number of chemotherapy
cycles, consolidative RT, and PCI were found to have prognostic effects on PFS.
Conclusion There is a difference in OS and PFS patterns of ES SCLC patients among
various Indian studies even though the available data is scarce. Our study shows that
the OS and PFS of our study population are comparable to other South Indian studies
available. PS, serum sodium level, number of chemotherapy cycles, consolidative RT,
and PCI were found to be independent prognostic factors for survival of ES SCLC. The
identification of these factors will help physicians to tailor treatment.
DOI https://doi.org/10.1055/s-0043-1768476 ISSN 2278-330X
How to cite this article: PS V, A S, MH G, et al. Outcomes and
Prognostic Factors of Extensive Stage Small Cell Lung Cancer: A
Retrospective Study. South Asian J Cancer 2023;00(00):00–00
© 2023. MedIntel Services Pvt Ltd. All rights reserved.
This is an open access article published by Thieme under the terms of the
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Sector 2, Noida-201301 UP, India
Veena PS
THIEME
Original Article: Lung Cancer
Article published online: 2023-06-09
Introduction
As per Globocan data 2020, lung cancer accounts for 11.4% of
all cancer incidence worldwide and 18% of all cancer-related
deaths.1Small cell lung cancer (SCLC) represents about 15%
of all lung cancers. As per the ICMR National Cancer Registry
report 2020, SCLC accounts for 10% of all the lung cancer
incidences in males and 6% among the female cases in India.2
SCLC is distinguished clinically from most types of non-
small cell lung cancer (NSCLC) by its rapid doubling time,
high growth fraction, and early development of metastases
and very good sensitivity to chemotherapy and radiotherapy
(RT). Patients with SCLC are typically divided into those with
limited-stage (LS SCLC) and extensive-stage (ES SCLC)
according to the Veterans Administration Lung Study Group
(VALG) in 1957.3ES disease is one that extends beyond
ipsilateral hemithorax, which includes distant metastases,
malignant pericardial or pleural effusions, and those cancers
that cannot be safely encompassed within a single radiation
field. It has been found that around 60% of diagnosed SCLC
cancers are of the ES.4
Combined modality treatment proved to be beneficial in
the treatment of LS SCLC. The primary therapeutic modality
is systemic chemotherapy in ES SCLC. The preferred combi-
nation of chemotherapy for is cisplatin-etoposide combina-
tion (EP).5Even though it responds well to chemothera py, the
majority of these patients progress and hence the survival is
limited. Hence, for patients who respond well to initial
systemic therapy, consolidative thoracic RT and prophylactic
cranial irradiation (PCI) were found to provide additional
benefits.6–8
The median survival in untreated ES SCLC is 2 to 4 months
and it is 8 to 13 months in treated cases.9Less than 5% of
those with ES-SCLC survive beyond 2 years.
Clinical parameters like age, sex, performance status (PS),
smoking status; blood parameters like lactate dehydroge-
nase (LDH), sodium level; tumor related factors like initial
tumor size, number and site of metastases are important
prognostic factors in ES SCLC.10,11
This tertiary care center in South India registers around
1,000 lung cancers annually, of which around 10 to 15% is
SCLC.12 This retrospective analysis aims to find out the
clinical outcome of patients with ES small cell carcinoma
and the prognostic factors affecting their survival.
Materials and Methods
Study Population
Patients registered in a tertiary care center in South India
from January 1, 2010 to September 30, 2019 with ES small
cell carcinoma were identified from the hospital-based
cancer registry. A total of 283 patients were included.
Data Collection
The demographic characteristics like age, gender, smoking
status, Eastern Cooperative Oncology performance status
(ECOG PS), and comorbid conditions were collected from
the case files. Clinical parameters retrieved from the case
files included the presenting symptoms and signs of SCLC,
TNM stage at the time of diagnosis, site and size and the
number of metastases. Biochemical characteristics like he-
moglobin level, total count, baseline liver function test, renal
function test and LDH, protein, and electrolyte values were
retrieved from case files and in-hospital lab data. Treatment
received, including the type of chemotherapy, number of
cycles of chemotherapy, PCI and its dose, consolidative RT
and its dose were collected from the case files and radiation
treatment charts.
Follow-up details including the date of progression if
available and date of last follow-up were retrieved from
the hospital records. All the details were entered in a
structured proforma. Data retrieved till January 1, 2021.
Endpoints and Statistical Analysis
Primary Objective
Overall survival (OS)
Secondary Objective
1) Progression-free survival (PFS)
2) To assess the clinicodemographic and hematological
and biochemical factors affecting survival
OS was calculated from the date of histological diagnosis to
the date of death or last follow-up. PFS was calculated from
the date of histolo gical diagnosis to the date of p rogression or
death or last follow-up.
Continuous variables were expressed as mean and stan-
dard deviation and categorical variables as counts and per-
centage. OS and PFS were computed using the Kaplan–Meier
method. The significant difference of various prognostic
factors on OS and PFS was compared using a log-rank test.
The risk of biochemical and prognostic factors was estimated
using the Cox regression model. A p-value less than 0.05 was
considered significant.
Results
Patient Characteristics
Data of 283 patients were available for retrospective analysis .
Baseline characteristics are summarized in ►Table 1.
The majority of the cases were men (97.5%). The median
age is 62 years. Smokers constitute 94% of all cases. ECOG PS
was more than two in most cases (57.6%). About 50% of
patients did not have any comorbidities at presentation.
The most common presenting symptom was cough (67%)
and the most common presenting sign was pleural effusion
(28.2%). Neurologi cal impairment was present for 8% of cas es
and around 4.2% (12 patients) had paraneoplastic syndrome
at the presentation. The most common paraneoplastic syn-
drome at presentation was hyponatremia associated with
syndrome of inappropriate antidiuretic hormone (SIADH).
One patient presented with paraneoplastic dermatitis.
About 92% had distant metastasis at presentation, of
which 48.8% of cases had more than two sites of metastasis.
The most common site of metastasis is the liver. About 73%
South Asian Journal of Cancer © 2023. MedIntel Services Pvt Ltd. All rights reserved.
Outcomes and Prognostic Factors of ES SCLC Veena PS et al.
had a good baseline hemoglo bin level of more than 12 gm/dL.
LDH values were available only for 24% of patients. Among
that, 23% had elevated LDH values. Abnormal sodium levels
were seen in 42.4% of cases. For some patients, details of T
stage and N stage were not available. Regarding the stage at
presentation, about half of the cases are represented by
composite stage IV B.
Treatment Characteristics
Around 75% of the total study populati on received some form
of chemotherapy. Rest of the patients either received best
supportive care or palli ative RT due to poor general con dition
(GC) or defaulted treatment after workup. The majority of
the patients received EP chemotherapy followed by Carbo-
platin- Etoposide combination and single agent Carboplatin.
One person each (CAV) received cyclophosphamide, doxoru-
bicin, and vincristine and single-agent etoposide. Around
half of the population received more than four cycles of
chemotherapy. Complete response after four cycles of che-
motherapy was seen in 2.5% of the total study population
(4.9% of those who completed more than 4 cycles of chemo-
therapy). Partial response was obtained for 33% of the study
population (43% of those who received more than 4 cycles of
chemotherapy). Data about the number of chemotherapy
cycles was not available for one patient. Consolidative tho-
racic RT was received by 20.8% of cases and PCI by 24% of the
total population. Among the patients who received more
than four cycles of chemotherapy, consolidative RT was
received by 39.4% and PCI by 49%. Most common dose
used for consolidative RT was 30 Gy in 10 fractions and for
PCI it was 25 Gy in 10 fr actions. Consolidative thoracic RT an d
PCI were given concurrently for 8.8% of cases and for the rest
of the patients, it was given sequentially.
Treatment-related complications were not available for
most patients of the available data, leukopenia was the most
common hematological toxicity found.
About 86.9% of cases were not alive at the end of the
study period. Last follow-up details were not available for
31 patients. The median estimated OS was 7 months 0.47
(95% confidence interval [CI]: 6.026–7.974) and PFS was 5
months 0.535 (95% CI: 3.952–6.048) in our study. The 1-
year su rvival pro bability i s 19.5 2.5% and 1 year PFS
probability is 13.4 2.1%. Two-year survival probability is
3.5 1.5%. Two-year PFS probability is 2 0.9% (►Figs. 1
and 2).
On univariate Cox regression analysis, we have found that
PS, total white blood cell (WBC) count more than or equal to
10,000 cells /cm
3
, serum glutamic oxaloacetic transaminase
(SGOT) more than 45 units/L, hyponatremia, presence of
paraneoplastic syndrome, chemotherapy received or not,
number of chemotherapy cycles, consolidative RT, and PCI
were the statistically significant prognostic factors for OS.
Similarly, PS, smoking status, total WBC count more than or
equal to 10,000 cells/cm
3
, SGOT more than 45 units/L,
hyponatremia, chemotherapy received or not and the num-
ber of chemotherapy cycles, and consolidative RT and PCI
were the statistically significant prognostic factors for PFS
Multivariate analysis showed that ECOG PS, hyponatre-
mia, number of chemotherapy cycles, and consolidative RT
and PCI were the statistically significant prognostic factors
for OS. Smoking, ECOG PS, number of chemotherapy cycles,
Table 1 Demographic features
Character Number Percentage
Mean age: 62 8 years
Range in years (40–84)
Age <65 years
65 years
170
113
60.1
39.9
Sex: Males
Females
276
7
97.5
2.5
Smokers
Nonsmokers
Not available
266
12
5
94
4.2
1.7
Performance status: 0-1
2
120
163
42.4
57.6
Comorbidity: Nil
Present
142
118
50.2
41.7
Fig. 1 Kaplan–Meier chart showing overall survival.
Fig. 2 Kaplan–Meier chart showing progression-free survival.
South Asian Journal of Cancer © 2023. MedIntel Services Pvt Ltd. All rights reserved.
Outcomes and Prognostic Factors of ES SCLC Veena PS et al.
and consolidative RT and PCI were the ones for PFS
(►Tables 2 and 3).
ECOG PS less than or equal to 2 was associated with a
median OS of 8 months 0.527 (95% CI: 7.006–8.994),
whereas the ECOG PS of more than or equal to 2 was
associated with a median OS of 5 months 0.811 (95% CI:
3.411–6.589). The median PFS in patients with ECOG PS less
than or equal to 2 was 7 months 0.408 (95% CI: 6.200–
7.800) and in those with more than or equal to 2 was
30.552 (95% CI: 1.918–4.082) months.
Total chemotherapy cycles more than or equal to 4 were
associated with a median OS of 10 months 0.531 (95% CI:
8.960–11.040) and if it was less than 4, the median OS was
only 2 months 0.338 (95% CI: 1.337–2.663). The median
PFS was 8 months 0.394(95% CI: 7.227–8.773) if the total
number of chemotherapy cycles was more than 4 and it was
only 1 month 0.378 (95% CI: 0.259–1.741) if it was on ly less
than four cycles.
The median OS was 13 months 1.214 (95% CI: 10.620–
15.380) if the patient received consolidative RT, whereas it
was only 5 months 0.551 (95% CI: 3.921–6.079) without it.
The median PFS was 11 months 1.225 (95% CI: 8.598–
13.402) with consolidative RT an d i t was 3 months 0.362
(95% CI: 2.290–3.710) without consolidative RT.
The median OS was 11 months 0.929 (95% CI: 9.179–
12.821) with PCI and 4 m onths 0.529 (95% CI: 2.963–5.037)
without PCI. The median PFS was 9 months 0.745 (95% CI:
7.539–10.461) with PCI and 3 months 0.357 (95% CI:
2.300–3.700) without it.
The medi an OS was found to be 1 2 months 3.2 (95% CI:
5.571–18.429) in nonsmokers compared with 7 months
0.52 (5.981-8.019) in smokers. The median PFS in the
case of normonatremia is 6 months 0.674 (95% CI:
4.680–7.320) and in the case of hyponatremia, it was 4
months 0.725 (95% CI: 2.579–5.421).
Discussion
SCLC is an aggressive neuroendocrine tumor. Even though it
is highly sensitive to chemotherapy, it progresses rapidly
after first-line chemotherapy and h as a very poor outcome. In
this retrospective study, we have analyzed the clinical out-
come and prognostic factors affecting ES SCLC.
The median age was 62 8 years in our st udy, which is like
other published series.13,14 Smoking is the most common
etiology of lung cancer and the prevalence of smokers was
94% in our study population that is similar to available
literature.13,15 In our study, 97.5% were male patients.
In the study by Osterlind and Andersen, demographic
factorslikeage,femalesex,andgoodPSwerefoundtobe
independent prognostic factors for survival.16 In another
study by De Almeida et al, PS and age less than 65 years
were found to have prognostic significanceinOSand
PFS.17–20 In our study, demographic features like PS and
smoking were found to have a statistically significant
relationship with PFS, whereas PS alone was a statisti-
cally significant prognostic factor for OS in both univari-
ate and multivariate analysis. No statistically significant
Table 2 Multivariate Cox regression for OS
Variables p-Value HR 95.0% CI for HR
Lower Upper
PS (>1 vs. 0 and1) 0.037 1.408 1.022 1.940
Na (<135 vs. 135–145) 0.012 1.544 1.102 2.164
Number of cycles (4vs.<4) 0.001 0.351 0.236 0.522
Consolidative RT (yes vs. no) 0.013 0.587 0.385 0.895
PCI (yes vs. no) 0.002 0.527 0.348 0.797
Abbreviations: CI, confidence interval; HR, hazard ratio; Na, serum sodium level; OS, overall survival; PCI, prophylactic cranial irradiation; PS,
performance status; RT, radiotherapy.
Table 3 Multivariate Cox regression for PFS
Variables p-Value HR 95.0% CI for HR
Lower Upper
Smoking (yes vs. no) 0.012 2.982 1.274 6.980
PS (>1 vs. 0 & 1) 0.012 1.494 1.094 2.040
Number of cycles (4vs.<4) 0.001 0.410 0.278 0.605
Consolidative RT (yes vs. no) 0.011 0.608 0.413 0.894
PCI (yes vs. no) 0.006 0.557 0.368 0.844
Abbreviations: CI, confidence interval; HR, hazard ratio; PFS, progression-free survival; PCI, prophylactic cranial irradiation; PS, performance status;
RT, radiotherapy.
South Asian Journal of Cancer © 2023. MedIntel Services Pvt Ltd. All rights reserved.
Outcomes and Prognostic Factors of ES SCLC Veena PS et al.
prognostic benefit was found with other demographic
features.
There is survival significance with the presenting symptom
and sign as observed by Athey et al.21 They have shown that
patients who are presented with breathlessness, weight loss,
chest pain, and systemic symptoms will be associatedwith less
survival. But we could not demonstrate such a statistically
significant benefit in our study. In the study by Shojaee et al,
malignant pleural effusion is found to be a negative prognostic
factor for survival.22 But in our study, malignant pleural
effusion was found to have a statistically significant negative
prognostic effect for PFS in univariate analysis only.
Paraneoplastic syndrome at presentation was found to be
associated with poor OS in univariate analysis in our study
but did not get a similar result in multivariate analysis. It has
got a borderline significance in PFS probability. This could be
due to the very limited number of available data about
paraneoplastic syndromes, for statistical analysis in our
study. The most common paraneoplastic syndrome at pre-
sentation in our study was SIADH. The median OS and PFS of
patients in the presence of paraneoplastic syndromes are
about 2 months in our study. The study by Wang et al, which
evaluated the role of SIADH and lung cancer, found that it is
associated with poor OS and PFS.23 The median PFS and OS in
patients with SIADH were 6.7 months and 11.6 months in
their study, which is much higher than our study group. This
could be due to the presence of comorbid conditions and
poor PS of our patient population.
The most common site of distant metastasis was the liver
followed by bone and the brain in our patient population that
is similar to available literature.13,24 Patients with bone-only
metastasis were found to have improved prognosis com-
pared to liver and brain metastasis in some reports.24,25 But
no statistically significant prognostic benefit in survival or
PFS was observed with the site of distant metastases or the
number of metastases in our patient group similar to other
reports available.17,25
Baseline blood parameters like normal WBC count, SGOT
value, and normonatremia were found to have a statistically
significant OS and PFS benefit in univariate Cox regression
analysis in our study. The study by Mohan et al showed that
laboratory parameters like hemoglobin more than 12.8
gm/dL and serum sodium level more than 138 mEq/dL
were associated with a sur vival benefit.26
Hemoglobin level was not found to have any statistically
significant survival benefit in our study population. The
study by Kawahara et al showed that elevated LDH level is
associated with poor survival in ES SCLC, but we did not get
such a result in our study probably due to a very small
number of patients whose baseline LDH values were
available.27
No statistically significant association has been found
with the tumor size or nodal stage or M stage or composite
stage with the OS or PFS. Studies have shown that as the
tumor size decreases, the survival will be better.28
Chemotherapy with EP regimen was the most common
regimen used in our patient population. The number of
chemotherapy cycles more than 4 has a statistically signifi-
cant better OS and PFS benefit in multivariate Cox regression
analysis compared to less than 4 cycles. The study by Hong
et al suggested at least 6 cycles of initial chemotherapy is
beneficial, whereas the one by Sallam et al suggested that
there is no benefit of prolonging chemotherapy beyond 4
cycles.20,29 Randomized controlled trial by Veslemes et al
have shown that 6 cycles of chemotherapy have survival
benefit only if patients do not have any completed response
to 4 cycles.30
The addition of consolidative RT improved OS and PFS in
this present study, similar to previous studies, but the
magnitude of benefit is less, probably due to the poor PS of
our study population.31 Similarly, PCI also has shown surviv-
al and PFS benefit in multivariate Cox regression analysis as
has been found with available literature.7,32,33
The median OS and PFS obtained in our study were 7 and
5 months, respectively. The retrospective analysis by Unal-
mis et al and Albain et al have shown a simil ar OS of 7 months
in ES SCLC.13,34 Many other studies have reported a higher
median OS of more than or equal to 10 months, which we
could not achieve, probably due to our patient population
with poor PS and poor socioeconomic status, ignorance
of clinical symptoms, delay in seeking and receiving
treatment.7,26,35
CR in ES SCLC is around 15 to 20% in various studies.17,36 It
is less in our study population compared to other studies
probably because only 50% of the total study population
could complete more than 4 cycles of chemotherapy. There is
paucity of data about ES SCLC in India. Very limited number
of studies and data are available about ES SCLC. There is wide
Table 4 Survival of ES SCLC from various Indian retrospective studies
Study Number of ES SCLC patients Median OS in months Median PFS in months
Mohan et al26 55 9.8 –
Puligundla et al38 103 7.2 5.6
Julka et al39 51 –10.9
Murali et al37 36 5.3 4.9
Ganguly et al40 154 12.6 9.1
Our study 283 7 5
Abbreviations:ES,extensivestage;OS,overallsurvival;PFS,progressionfreesurvival;SCLC,smallcelllungcancer.
South Asian Journal of Cancer © 2023. MedIntel Services Pvt Ltd. All rights reserved.
Outcomes and Prognostic Factors of ES SCLC Veena PS et al.
difference between the OS and PFS among different Indian
studies. The survival and PFS patterns of our study are
comparable to similar South Indian study.37,38 This could
be due to the similar genetic profile, pattern of presentation,
social reason s, and lack of access to t reatment. The sur vival of
ES SCLC from various retrospective studies from India is
shown in ►Table 4.26,37–40
The limitation of this study is its retrospective nature, the
nonavailability of data regarding the treatment-related toxic-
ities,and follow-updetails were notavailableto 11% of patients.
Conclusion
There is a difference in OS and PFS patterns of ES SCLC
patients among various Indian studies, even though the
available data is scarce. Our study shows that the OS and
PFS of our study population are comparable to other South
Indian studies available. PS, serum sodium level, number of
chemotherapy cycles, and consolidative RT and PCI were
found to be independent prognostic factors for survival of ES
SCLC. The identification of these factors will help physicians
to tailor treatment in future.
Funding
None declared
Conflict of Interest
None declared.
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